Screening for Hepatitis C Virus (HCV) in Adults

On behalf of The Wright Centers for Community Health (TWCCH) and Graduate Medical Education (TWCGME), collectively referred to as “The Wright Center,” we appreciate this opportunity to provide comments to the Centers for Medicare & Medicaid Services (CMS) regarding the national coverage analysis for “Screening for Hepatitis C Virus (HCV) in Adults” (CAG-00436R).

Introduction & Context
TWCCH is a Federally Qualified Health Center (FQHC), an Essential Community Provider delivering comprehensive whole-person safety-net primary health services with integrated primary care physician and interprofessional workforce development. TWCCH serves approximately 40,000 patients, operating eighteen, and soon to be twenty, primary care community health centers (CHCs), inclusive of a public district school-based health center and a mobile medical and dental unit (“Driving Better Health”) in Northeastern Pennsylvania. TWCCH serves as the cornerstone ambulatory whole-person primary care delivery organization and founding member of our Teaching Health Center (THC) Graduate Medical Education Safety-Net Consortium (GME-SNC) in partnership with our affiliated entity, TWCGME, our GME Sponsoring Institution accredited by the Accreditation Council on Graduate Medical Education.

Every year, The Wright Center’s GME-SNC and its academic and clinical partners train nearly 200 primary care residents and fellows, including three Advanced Education General Dentistry residents. We also train nearly 250 medical and interprofessional healthcare students from over a dozen partnering academic institutions. Utilizing our community-based needs-responsive interprofessional learning model, we are empowered to advance our shared mission to improve the health and welfare of our communities through responsive, whole-person health services for all and the sustainable renewal of an inspired, competent workforce that is privileged to serve. Our GME-SNC enterprise is community owned and governed, with a fiduciary responsibility for high-integrity stewardship of common pool public federal resources, including those from the Centers for Medicare and Medicaid (CMS) Inpatient Prospective Payment Systems (IPPS) and Inpatient Rehabilitation Facility (IRF) Graduate Medical Education (GME) programs through Affiliation Agreements, the HRSA THC GME Program, and the Department of Veterans Affairs GME programs, as well as TWCCH’s FQHC CMS Medicare, Medicaid, and multi-payer clinical revenues. As a HRSA Ryan White HIV/AIDS Program and FQHC grantee, Pennsylvania Opiate Use Disorder Center of Excellence (COE), and 340B-covered entity delivering integrated infectious disease, addiction and recovery services, and whole person primary care, The Wright Center is uniquely positioned to observe and experience how national screening policies for infectious diseases and other public health challenges directly intersect with and impact safety-net prevention and treatment services access and outcomes for patients and families especially those with complex trauma exposure and challenging health related social needs from vulnerable populations.

As the Centers for Medicare & Medicaid Services (CMS) considers updates to national screening determinations for Hepatitis C Virus (HCV), the beneficial public health impact of expanded screening depends heavily on the immediate availability, accessibility, and affordability of screening tests and direct-acting antiviral (DAA) therapy. For adults living with HIV - among whom HCV co-infection occurs at rates between 15% and 20% - Hepatitis C is an aggressive, accelerated hepatic disease and a major cause of preventable morbidity and mortality.

Hepatitis C behaves far more aggressively in the presence of HIV co-infection. Immune dysregulation accelerates the inflammatory and fibrotic pathways in liver tissue, notably leading to distinct clinical risks:

Accelerated Fibrosis & Cirrhosis: Co-infected individuals progress to end-stage liver disease and cirrhosis up to three times faster than those with HCV monoinfection.
Elevated Liver Cancer Risk: Rates of hepatocellular carcinoma (HCC) are significantly higher and occur at younger ages in HCV/HIV co-infected adults.
Complex Regimen Management: Treating Hep-C in co-infected patients requires specialized clinical monitoring to manage drug-drug interactions between DAAs and antiretroviral regimens for HCV and HIV, as well as baseline and follow-up liver function assessments (e.g., transient elastography / FibroScan).

Given this rapid disease trajectory, an HCV-positive screening result in a co-infected patient with HCV and HIV represents a narrow window for clinical intervention before irreversible liver damage occurs. However, even with successful screening and detection, high wholesale drug costs and complex administrative hurdles often stand between a screening diagnosis and actual drug dispensation to cure HCV.

The 340B Drug Pricing Program and Hepatitis C Treatment Access and Ryan White Care

The 340B Drug Pricing Program integrated with The Wright Center’s Patient Centered Medical Home FQHC delivery model infrastructure that integrates Opiate Use Disorder COE and Ryan White HIV/AIDS Program (RWHAP) services is the operational backbone that turns positive HCV screening results into accessible high-quality treatment and sustained engagement in care necessary for cure. When CMS expands or refines HCV screening coverage, RWHAP clinics, FQHCs, and Opiate Use Disorder COEs serve as a primary point of detection for high-risk and historically underserved populations. However, ensuring coverage for testing and identifying a positive antibody or RNA test are only step one. To achieve the goals of CAG-00436R, universal HCV screening must be tightly linked to stable, low-barrier treatment for cure access through 340B safety-net providers. Without stable 340B pricing and revenue:

Prohibitive Acquisition Costs: Safety-net clinics cannot maintain direct inventory or bridge supply for uninsured, underinsured, or dual-eligible patients awaiting complex prior authorization approvals.

Treatment Delays: Administrative barriers and retail/specialty pharmacy restrictions delay DAA initiation, allowing liver fibrosis to advance and secondary spread of HCV during crucial time to intervention windows. Complex conflicts of interest by larger integrated delivery systems competing for 340B resources often impose nonsensical barriers such as mandatory specialty referrals that paralyze safety net providers to meet patients where they are in the community and in their lives to provide affordable algorithmic treatment protocols. These complex financial coverage dynamics impair delivering Hepatitis C treatment for example to patients while imprisoned or actively struggling with addiction.

For The Wright Center, 340B savings help sustain the comprehensive clinical, pharmacy, case management, and supportive services that reduce barriers to engagement in care for people living with HIV and HCV, support medication adherence, and prevent HIV and/or HCV related comorbidities and secondary transmission. Our infrastructure also helps patients overcome the financial, transportation, and logistical barriers that can prevent individuals diagnosed with HCV from completing the evaluation and treatment necessary to achieve a cure.

Emerging manufacturer restrictions and external administrative hurdles - such as proposed 340B rebate models - directly threaten these interconnected screening-to-cure services by requiring substantially higher upfront drug expenditures, delaying access to funds while manufacturers process rebates, and diverting limited staff capacity toward complex reporting and compliance requirements. The Wright Center estimates that purchasing the 10 selected drugs at wholesale acquisition cost rather than 340B ceiling prices would increase upfront monthly drug spending by $281,710, while compliance with such rebate model administrative demands would require approximately 1,404 staff hours annually.

These financial and administrative pressures threaten our ability to preserve affordable medication access and the coordinated, whole-person health services that help vulnerable patients successfully navigate and engage in treatment after diagnosis. For Ryan White patients, whose care depends on more than the medication itself, reductions in 340B-supported resources could weaken the very infrastructure needed to maintain continuity of care, achieve positive health outcomes, and prevent avoidable disease progression and secondary transmission. A policy intended to advance screening and early intervention should not simultaneously destabilize the safety-net systems that make treatment interventions effective.

Restricting 340B access for Hep-C therapies breaks the clinical continuum between HCV detection and SVR (Sustained Virologic Response), leading to rapid liver decompensation and increased, preventable healthcare expenditures. Screening expanded under CAG-00436R will yield higher detection rates; however, if 340B restrictions prevent immediate connection to curative therapy, the clinical benefit of early detection is effectively lost.

Modernizing Medicare Coverage for HCV

To ensure that screening leads directly to cure, coverage policies must reflect contemporary evidence-based treatment practices and remove artificial barriers to care. Drawing upon the clinical expertise of our primary care, infectious disease, HIV, and SUD treatment providers, we strongly support modernizing Medicare coverage for HCV screening to reflect contemporary evidence-based recommendations and the realities of caring for patients with ongoing or changing exposure risks. In particular, we encourage CMS to expand universal screening eligibility, establish appropriate coverage for repeat risk-based screening, recognize the distinct testing needs of individuals with prior HCV infection, and remove unnecessary restrictions on the clinical settings in which screening may occur.

Costs for point of care HIV and HCV screening tests should be reimbursed to safety net providers, especially for high risk populations. We recommend that these costs should not be bundled into the existing Medicare or Medicaid Prospective Payment System (PPS) rates for FQHCs, as this paralyzes engagement in on site screening for the highest risk populations.

Under Section 10501 of the Affordable Care Act, Congress established the Medicare PPS rate for community health centers (CHCs), which uses a bundled payment methodology to account for services and supplies furnished during a qualifying visit. While the PPS provides CHCs with a predictable Medicare reimbursement structure, its effectiveness depends on whether the underlying payment accurately reflects the costs of furnishing care. Today, CHCs face limitations on qualifying visits, underpayment for certain services, and regulatory barriers that can prevent appropriate reimbursement for Medicare-covered care. In 2024, CHCs lost an average of $103 per Medicare visit, and the gap between the cost of care and average Medicare reimbursement was approximately 18 percent greater in rural areas than in urban areas, according to CMS cost report data. The Wright Center has experienced this under-resourcing first hand. With our successful designation as a health center in 2019, our per-visit reimbursement decreased by approximately $45 on average. At the same time, CHCs like The Wright Center face growing pressures from uncompensated care associated with anticipated Medicaid coverage losses and instability affecting other critical sources of support, including the 340B Drug Pricing Program.

Medicare has historically bundled payments for innovative new services directly into FQHC Medicare PPS payments, which often go unadjusted for the additional costs and expenses assumed. Examples include the bundling of depression, mental health, and substance use screening and brief interventions for positive tests; cardiovascular risk reduction and obesity counseling; and Home Health Certifications and Care Plan Oversight. These practices contribute to the persistent under-resourcing of comprehensive primary care in FQHCs.

These practices contribute to the persistent under-resourcing of comprehensive primary care in FQHCs and further demonstrate the need to ensure that new screening services, including point-of-care HIV and HCV testing, receive appropriate reimbursement without being absorbed into existing PPS rates. Additionally, as a THC GME-SNC, modernizing Medicare coverage rules also ensures that our resident and fellow physicians are equipped to deliver and model contemporary, guideline-concordant care without unproductive and costly administrative barriers.

Expanding Universal Screening and Screening During Pregnancy

From both a population health and fiscal stewardship perspective, investing in prevention and early detection is essential to reducing avoidable downstream healthcare costs and supporting the long-term solvency of Medicare. With federal healthcare expenditures placing an increasingly significant burden on our nation's fiscal sustainability, coverage policies should prioritize evidence-based interventions that improve health outcomes while reducing preventable costs and improving the health and welfare of the American public. This is particularly important for HCV, as infection frequently remains asymptomatic, and patients may not recognize, recall, or feel comfortable disclosing historical risk factors.

Restricting screening based on documented risk behaviors can therefore result in missed diagnoses, introduce unnecessary stigma, and delay opportunities for early intervention. HCV screening provides an opportunity to identify infection before patients develop advanced liver disease, cirrhosis, liver cancer, and other costly complications requiring extensive medical intervention and before secondary transmission to spread the virus. It is counterintuitive for Medicare to restrict access to relatively low-cost preventive screening while bearing the substantially greater financial burden associated with treating advanced, potentially preventable disease. Expanding access to universal HCV screening, coupled with timely linkage to curative treatment, represents an important opportunity to improve population health outcomes, strengthen the stewardship of finite federal healthcare resources, and contribute to the long-term financial sustainability of Medicare and our nation's healthcare system and the health and welfare of the American public. With these considerations in mind, The Wright Center supports aligning Medicare coverage with recommendations from the U.S. Preventive Services Task Force (USPSTF), Centers for Disease Control and Prevention (CDC), and American Association for the Study of Liver Diseases/Infectious Diseases Society of America (AASLD/IDSA).

We recommend that CMS modernize its national coverage determination to ensure coverage of at least one lifetime HCV screening for all adults ages 18 and older, consistent with CDC recommendations and the USPSTF's recommendation for adults ages 18 through 79. Current Medicare coverage remains unnecessarily limited by historical birth-cohort and risk-based eligibility criteria, despite the evolution of national clinical screening recommendations. We further encourage CMS to ensure that clinically indicated screening is covered beyond age 79, or at any other age when recommended by a qualified clinician, without arbitrary age-based restrictions or unnecessary administrative barriers.

We further support HCV screening during every pregnancy, regardless of previous screening history, in alignment with CDC recommendations. For pregnant patients with ongoing exposure risks, coverage should permit additional testing later in pregnancy when clinically indicated. More broadly, we encourage all public and private payers to align their coverage policies with contemporary evidence-based screening recommendations and ensure that clinically indicated HCV screening is accessible and reimbursable across the lifespan.We also encourage CMS to ensure all HIV and HCV test results are available to all essential community provider/safety net provider systems in a semantically aligned, universally accessible, interoperable data platform empowering all stakeholders to generate mutually reinforcing action strategies that support Healthy People Goals and Shared Metrics of Success emphasizing an achievable timeline for national elimination of these viruses .

Supporting Risk-Based Repeat Screening for Individuals with Ongoing Exposure
While universal screening provides an essential foundation, a single lifetime test is insufficient for individuals whose exposure risks persist or change over time. We therefore encourage CMS to establish clear coverage for repeat screening based on ongoing risk, rather than limiting annual screening primarily to individuals with continued injection drug use following a previous negative test.

Based on the clinical experience of our infectious disease, HIV, and Opiate Use Disorder COE treatment providers, we recommend the following:
Individuals with ongoing substance use-related exposure risks: Cover HCV testing, including point of care testing, at least annually for individuals with ongoing injection drug use, with flexibility for more frequent testing, including every six months, when supported by continued exposure, shared equipment, or other individual circumstances. Patients receiving SUD treatment should be offered HCV screening at their initial clinical evaluation when their screening status is unknown or testing is otherwise indicated. Coverage should also recognize the need for individualized testing among patients using non-injection drugs when associated behaviors or equipment-sharing practices create potential bloodborne exposure.
Individuals experiencing a return to substance use: Permit prompt HCV, inclusive of point of care, testing following a return to substance use when a potential HCV exposure has occurred. For suspected recent infection, HCV RNA testing may be necessary before antibodies become detectable. Testing and subsequent follow-up should be determined by the timing and nature of exposure rather than a rigid interval that may not be appropriate for every patient.
Men who have sex with men (MSM) and individuals receiving HIV pre-exposure prophylaxis (PrEP): Support HCV testing at least annually for MSM with ongoing exposure risks, including MSM receiving PrEP, consistent with AASLD/IDSA recommendations. Coverage should permit more frequent testing when clinically warranted by sexual practices, substance use, prior infection, or other recognized risk factors.
Individuals living with HIV: Support HCV testing, including point of care testing, upon entry into HIV care and at least annually thereafter for patients with ongoing exposure risks, with more frequent testing when clinically indicated. The presence of HIV, particularly when accompanied by relevant sexual or substance use-related exposure, underscores the importance of coordinated screening and ongoing clinical assessment.
Individuals experiencing homelessness or incarceration: Recognize the importance of HCV screening for individuals whose housing instability, incarceration history, or associated exposure circumstances may increase vulnerability to infection or interrupt access to preventive care. We encourage CMS to permit HIV and HCV screening upon entry into relevant care settings and repeat testing based on ongoing risk, including annual or more frequent testing when clinically justified.

Importantly, we recommend that CMS establish annual testing as a covered baseline for clearly defined populations with ongoing exposure risks, while permitting additional testing based on clinical judgment. A uniform annual limitation should not prevent medically appropriate testing following a new exposure or significant change in risk. We strongly encourage CMS to consider carved out, at least cost based reimbursement for point of care HIV and HCV testing in safety net provider systems and, as noted above, avoidance of bundling such testing expenses into the current suboptimal Medicare PPS or established Medicaid PPS payment rates to FQHCs.

Distinguishing Initial Screening from Testing for Reinfection
An important consideration in modernizing HCV coverage is recognizing that the appropriate testing method differs based on an individual's prior infection and treatment history. For individuals without a previously documented HCV infection, initial testing generally should include an HCV antibody test with reflex HCV RNA testing when the antibody result is positive. This approach facilitates timely confirmation of active infection and reduces the likelihood that patients with positive screening results will be lost to follow-up before receiving confirmatory testing.

For individuals with a history of HCV infection that has spontaneously cleared or been successfully treated, repeat antibody testing is generally not clinically useful because antibodies often remain positive indefinitely. These patients remain susceptible to reinfection, and HCV RNA testing is necessary to identify new active infection.

Consistent with CDC recommendations and the USPSTF's guidance on HCV screening, as well as the more detailed AASLD/IDSA recommendations regarding initial testing, ongoing exposure, and reinfection, we encourage CMS to distinguish between the following clinical circumstances when establishing coverage policy:,,,
Initial HCV screening: HCV antibody testing with reflex RNA confirmation for individuals without previously documented infection, including screening upon entry into SUD treatment or HIV care;
Repeat screening following a negative HCV antibody test: HCV antibody testing with reflex RNA confirmation at least annually for individuals with ongoing exposure risks, with flexibility for more frequent testing, including every six months, when clinically indicated;
Testing for reinfection following prior HCV clearance or successful treatment: HCV RNA testing at least annually for individuals with ongoing exposure risks, with flexibility for more frequent testing, including every six months, when clinically indicated; and
Testing following suspected recent exposure: Prompt HCV RNA testing when recent infection is suspected and may not yet be detectable through antibody testing, with appropriate follow-up based on the timing and nature of exposure.

We recognize that some HCV RNA testing, particularly testing prompted by a suspected exposure or symptoms, may be classified as diagnostic rather than preventive screening. Nevertheless, CMS should ensure that the revised coverage framework, together with applicable diagnostic testing policies, does not create gaps in access to clinically indicated RNA testing. This distinction is particularly relevant for patients receiving integrated HIV and SUD treatment, where prior infection, successful treatment, ongoing exposure, and potential reinfection may all be encountered during longitudinal care.

Expanding Screening Beyond Traditional Primary Care Settings
The Wright Center also strongly supports reconsidering the current NCD's restrictions requiring screening to be ordered solely within a primary care setting. As strong proponents of primary care as the foundation of comprehensive, coordinated, and longitudinal healthcare, we appreciate the intent behind the existing requirement and the importance of ensuring that primary care remains closely involved in preventive screening, early detection, and ongoing management of HCV.

However, we also recognize the realities of how patients access care, particularly individuals at increased risk for HCV who may receive services through infectious disease clinics, formal Ryan White Services Programs and other HIV treatment programs, SUD treatment facilities, correctional healthcare, emergency departments, community based mental health services agencies, and other community-based settings. These encounters represent important opportunities to identify previously undiagnosed infections and engage patients who may not otherwise be consistently connected to primary care. Requiring patients to obtain a separate primary care encounter solely to qualify for covered screening can be counterintuitive to the goal of improving access to preventive services, particularly for populations already facing significant barriers to healthcare. Such screening may provide priceless opportunities to encourage and establish primary care referrals and connections. CMS should avoid requirements that may inadvertently delay diagnosis, fragment care, and create additional obstacles to timely screening and treatment for all who need it.

Our recommendation is not to replace or diminish screening within primary care, but rather to generate collective ownership and stewardship of resources to engage all healthcare stakeholders in addressing our national public health problems related to HCV. With this spirit of all hands on deck for a national public health priority, we encourage CMS to expand coverage to additional clinically appropriate settings that complement primary care and support continuity of care. Drawing upon our experience delivering integrated whole person primary care, Ryan White HIV services, and Opiate COE SUD services, we encourage CMS to permit covered HCV screening when ordered by any appropriately qualified healthcare practitioner, regardless of clinical specialty or care setting. This approach would preserve the central role of primary care while expanding opportunities for early detection, confirmatory testing, timely treatment, and ongoing coordination of treatment for cure.

Conclusion
The Wright Center appreciates CMS's reconsideration of NCD 210.13 and the opportunity to advance a more comprehensive, evidence-based approach to HCV screening. More broadly, we encourage CMS to ensure that the revised NCD aligns with evolving CDC, USPSTF, and AASLD/IDSA recommendations while preserving appropriate clinical discretion to determine when and which repeat screening is warranted based on individual patient circumstances. Coverage policies should support collective action and evidence-based clinical decision-making rather than impose overly restrictive testing venues and intervals, narrowly defined risk categories, or unnecessary administrative or coverage barriers that may delay diagnosis or treatment or interrupt continuity of care.

Modernizing Medicare coverage to support universal HCV screening, individualized repeat testing, appropriate testing for reinfection, and access across clinically appropriate healthcare settings will help align federal coverage policy with contemporary clinical practice. These changes can support broader public understanding and engagement, earlier HCV diagnosis, timely linkage to and engagement in curative treatment, improved continuity of care, and reduced transmission and avoidable complications of HCV infection. We are excited and have great faith that HHS and CMS can and will lead the shared success and long-awaited national victory of eliminating Hep C and HIV in America. We hope federal leadership recognizes that our HRSA FQHC, FQHC Look Alike, and Ryan White Essential Community Provider networks are a ready major public health engine to deliver that achievement.

Thank you for your consideration of our recommendations and for your continued commitment to improving access to evidence-based preventive services for Medicare beneficiaries. If you have any questions about these comments, please contact Laura Spadaro at spadarol@thewrightcenter.org.

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Dear Dr. Oz,

The American College of Rheumatology (ACR), representing over 10,400 rheumatologists and rheumatology interprofessional team members, appreciates CMS opening a national coverage analysis (NCA) for Hepatitis C Virus (HCV) screening for adults. The ACR strongly supports expanding Medicare coverage for screening to align with current U.S. Preventive Services Task Force (USPSTF) and Centers for Disease Control and Prevention (CDC) recommendations, which advise that all adults should be screening for HCV once and those at increased risk should be screened more regularly.

The present National Coverage Determination (NCD) for HCV was issued in 2014 and does not reflect the latest clinical evidence and public health guidance. The NCD recommends HCV screening only for those at high risk of infection (injection drug users) or in a narrow age cohort (born between 1945 and 1965). Screening can only be covered if ordered by a primary care physician within a primary care setting.

The ACR urges CMS to revise the NCD to:

1) Allow one-time screening for all adults
2) Allow regular screening for individuals who belong to groups at higher risk of infection (to be decided at the discretion of the Medicare provider)
3) Remove the language in the NCD requiring that screening be performed in a primary care setting
4) Reimburse HCV screenings ordered by any Medicare provider
HCV is a major public health threat in the U.S., with approximately 2.4 to 4 million Americans impacted by the virus. The incidence of the infection also continues to rise annually. One study estimates that roughly 14 percent of all people with HCV in the United States are Medicare beneficiaries.

Although HCV is primarily a liver disease, the virus can have devastating impacts on multiple bodily systems. HCV can induce several autoimmune rheumatic conditions, including arthritis and fibromyalgia. HCV infection can also mimic rheumatic disease, as joint inflammation and muscle pain and weakness are common symptoms. People with rheumatic diseases potentially caused by HCV infection may consult a rheumatologist, making it important to test for HCV as part of the workup of many rheumatologic syndrome. HCV-related joint problems may be treated with medications that could be toxic for the liver, so it is critically important for rheumatology health care providers to be able to perform HCV screenings.

Since HCV infection is often asymptomatic in its earliest stages, screening is a critical component of preventive care. Earlier diagnosis can help patients avoid life-threatening complications, such as liver failure and supports improved long-term clinical outcomes.

An updated Medicare coverage determination would allow rheumatologists to integrate evidence-based screening into routine clinical practice, reducing the overall incidence of HCV and related conditions. Increased screening would also provide more data that could be used to improve quality across the HCV care spectrum, from screening to diagnosis to linkage to care to treatment to follow-up. Higher-quality screening data would help providers and health systems to evaluate quality improvement initiatives and monitor progress towards improving HCV-related outcomes on the population level.

ACR appreciates CMS’ reconsideration of the current national coverage determination around HCV screening and strongly recommends that CMS update the NCD to be consistent with the latest evidence and recommendations from public health authorities. Increasing screening across a variety of health care settings will result in a decrease in the many serious complications that can result from untreated HCV, which include cirrhosis and liver cancer. Reimbursing all physicians, regardless of specialty or treatment setting, for HCV tests, will broaden patient access to a crucial form of preventative care.

Please contact Sweta Haldar, MSPH, ACR Manager of Regulatory Affairs, at shaldar@rheumatology.org or (202) 807-5262 should you have any questions or if we can provide additional assistance.

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NASTAD, the leading non-partisan non-profit association representing public health officials who administer HIV and hepatitis programs in the U.S., is submitting the following comments in response to the Centers for Medicare & Medicaid Services (CMS) National Coverage Analysis (NCA), Screening for Hepatitis C Virus (HCV) in Adults (CAG-00436R). NASTAD commends CMS for initiating the NCA to update the National Coverage Determination (NCD) for Screening for Hepatitis C Virus (HCV) in Adults (NCD 210.13) in response to stakeholder requests, including a 2021 request co-signed by NASTAD. We urge CMS to prioritize completion of the NCA and promptly issue an updated NCD that aligns the agency’s HCV screening coverage guidelines with the 2020 United States Preventive Services Task Force (USPSTF) recommendation and the 2020 Centers for Disease Control and Prevention (CDC) screening recommendations. CMS should expand coverage for universal HCV screening and allow repeat screening for individuals with ongoing risk of exposure. An updated NCD must ensure that the setting in which Medicare beneficiaries receive care does not determine their access to HCV screening, timely diagnosis, and curative treatment.

When CMS established the current NCD in 2014, Medicare coverage reflected the 2013 USPSTF recommendation, which supported screening for individuals with certain risk factors and one-time screening for adults born between 1945 and 1965. Since 2014, evidence of HCV transmission among adults outside this birth cohort and advances in curative treatment have strengthened the case for universal screening. Adults ages 30-49 account for 48% of newly reported chronic HCV cases in 2023, and current oral direct-acting antiviral therapies cure more than 95% of cases in 8-12 weeks. In 2020, USPSTF updated its recommendation to support one-time screening for all adults ages 18 to 79, regardless of risk factors, and periodic screening for individuals with ongoing risk of HCV exposure. USPSTF assigned this a grade B recommendation, concluding that screening has substantial net benefit. CDC similarly updated its recommendations to support universal screening for adults ages 18 and older, and screening during each pregnancy, except in settings where the prevalence of current HCV infection, measured by HCV RNA positivity, is documented to be less than 0.1%. Despite these updates, Medicare’s existing NCD continues to reflect the narrower 2013 screening recommendations, creating unnecessary barriers for beneficiaries who fall outside the original birth cohort and do not meet the NCD’s definition of increased risk.

NASTAD strongly urges CMS to update the NCD to cover one-time HCV screening for all Medicare beneficiaries ages 18–79, regardless of identified risk factors, consistent with the 2020 USPSTF recommendation. We also encourage CMS to align coverage with CDC’s broader recommendation supporting universal screening for adults ages 18 and older, without an upper age limit. Given Medicare’s role in providing coverage for older adults, this broader approach would help ensure that beneficiaries can access clinically appropriate screening throughout their lives, including those who have never been screened.

One-time screening alone is insufficient for individuals who continue to experience increased risk of HCV exposure. Both USPSTF and CDC recognize the importance of periodic testing for individuals with ongoing risk factors, particularly people at risk of overdose and substance use disorder. However, Medicare’s current NCD limits annual repeat screening to individuals who have continued injection drug use since their previous negative screening test. This restriction does not fully account for circumstances in which repeat screening may be clinically appropriate, including changes in exposure or other factors that may warrant additional testing. NASTAD recommends that CMS allow providers to determine appropriate screening intervals based on clinical judgment and current screening recommendations, including more frequent screening when medically appropriate, rather than imposing a fixed annual limit. CMS should ensure that beneficiaries can access appropriate HCV screening without being required to disclose potentially stigmatizing risk factors as a condition of coverage. The updated NCD should also reflect CDC’s current definitions of increased risk, replace references to “illicit injection drug use” with “injection drug use,” and use people-first language such as “people with increased risk of HCV exposure” in place of “high-risk persons.”

NASTAD strongly encourages CMS to remove the current requirement that HCV screening be ordered by a beneficiary’s primary care physician or practitioner within the context of a primary care setting. This restriction limits Medicare coverage for screening in settings such as emergency departments, specialty care settings, substance use treatment programs, and other community-based health care settings. These locations play an important role in identifying people with undiagnosed HCV, particularly individuals who may not routinely access traditional primary care (1). Requiring screening to occur through a primary care setting delays diagnosis, creates additional barriers to care, and contributes to missed opportunities for treatment. NASTAD recommends that CMS allow reimbursement for HCV screening performed in other appropriate clinical and community-based settings by eligible Medicare providers. Removing this restriction will give providers greater flexibility to offer screening in settings where beneficiaries already receive care.

Advances in HCV testing technologies further support expanding access to screening beyond traditional primary care settings. Rapid point-of-care testing technologies have created new opportunities to identify HCV infection and connect individuals to care during a single encounter. Recent studies have demonstrated the feasibility and clinical utility of point-of-care HCV RNA testing in community-based programs, Tribal health care settings, emergency departments, and other settings where traditional laboratory testing and follow-up may be difficult (2). For example, a 2026 study of point-of-care HCV RNA testing in a Tribal health care setting found high acceptance of testing and opportunities for same-day treatment initiation (3). Another 2026 study examining point-of-care testing in a community-based program found that 97% of participants received their test results (4). These findings demonstrate how newer testing technologies can help address barriers to diagnosis and treatment. NASTAD encourages CMS to ensure that the updated NCD accommodates appropriate Food and Drug Administration (FDA)-approved or cleared HCV screening technologies, including rapid point-of-care tests. CMS also needs to consider how Medicare coverage policies can support timely diagnostic testing to confirm current HCV infection following an initial positive screening result.

Expanding Medicare coverage for HCV screening would help identify infections earlier, allowing more beneficiaries to receive treatment before serious complications develop. Untreated chronic HCV can cause progressive liver damage, cirrhosis, and hepatocellular carcinoma, with particularly serious consequences for older adults and individuals living with disabilities or serious or complex medical conditions. Direct-acting antiviral (DAA) therapies can cure more than 95% of people with HCV, making timely diagnosis and linkage to treatment especially valuable. Earlier diagnosis and treatment can also reduce the need for costly medical interventions associated with advanced liver disease, including hospitalizations and liver transplantation. A 2026 CDC-authored modeling study estimated that DAA treatment could reduce lifetime direct medical costs by an average of $65,841 per person in 2022 dollars, compared with no treatment. NASTAD encourages CMS to consider these clinical and economic benefits as it evaluates updates to the NCD.

NASTAD appreciates CMS’s decision to reconsider NCD 210.13 and urges the agency to promptly update Medicare’s HCV screening coverage requirements to reflect current USPSTF and CDC recommendations. Expanding screening coverage would help more beneficiaries receive timely diagnoses and curative treatment, advancing national efforts to eliminate hepatitis C as a public health threat. We welcome the opportunity to provide additional information as CMS completes its review. Please contact me (bntiri-reid@NASTAD.org) if you have questions related to these comments.

Sincerely,
Boatemaa Ntiri-Reid, JD, MPH
Executive Director
NASTAD

1. Haukoos J, Rothman RE, Galbraith JW, et al. Hepatitis C screening in emergency departments: the DETECT Hep C randomized clinical trial. JAMA. 2025. doi:10.1001/jama.2025.10563
2. Al Rawashdh N, Ferrufino CP, Cheng MM, et al. Cost-effectiveness of point-of-care hepatitis C virus RNA testing in the US. JAMA Netw Open. 2026;9(3):e262658. doi:10.1001/jamanetworkopen.2026.2658
3. Mera J, Blair A, Lewis K, et al. Point-of-care hepatitis C testing in a tribal setting. JAMA Netw Open. 2026;9(4):e267242. doi:10.1001/jamanetworkopen.2026.7242
4. Glick SN, Kingston S, Wilson-Weiberg K, et al. Successful implementation of hepatitis C virus point-of-care testing in a syringe services program. Subst Use Addctn J. 2026. doi:10.1177/29767342261462112

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NCD 210.13 should be revised to make evidence-based HCV screening and definitive diagnosis accessible to eligible Medicare beneficiaries.

I writing in support of coverage for one-time HCV screening for Medicare beneficiaries aged 18–79 without risk disclosure; HCV screening during every pregnancy; periodic testing with ongoing exposure, including patient-requested testing without mandated risk disclosure; coverage in clinically appropriate settings beyond primary care, including emergency departments and specialty services; automatic reflex HCV RNA testing after a reactive antibody result, plus RNA testing when reinfection is suspected.

Medicare’s 2014 birth-cohort screening rule no longer aligns with the USPSTF Grade B recommendation for ages 18–79. (CMS NCD 210.13 (2014); USPSTF (2020)) Approximately 75%–85% of people with hepatitis C lack symptoms, making symptom-triggered screening inadequate. (CDC (2025))

I ask that CMS adopt coverage language that supports appropriate screening frequency, decentralized delivery, diagnostic completion, and linkage to curative treatment.

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Dear Centers for Medicare & Medicaid Services:

OraSure Technologies appreciates the opportunity to comment on CMS’s reconsideration of National Coverage Determination 210.13, Screening for Hepatitis C Virus in Adults. OraSure has longstanding experience developing point-of-care infectious disease diagnostics, including an FDA-approved point-of-care rapid HCV antibody test.

We support CMS’s effort to reconsider Medicare HCV screening coverage considering changes in clinical guidance, HCV epidemiology, diagnostic technology, and treatment since NCD 210.13 was established. We broadly agree with the organizations that requested reconsideration and recommend that CMS modernize NCD 210.13 to cover universal one-time screening for adults aged 18–79, explicitly recognize FDA-approved or cleared point-of-care tests, remove primary-care-only restrictions, and permit periodic repeat screening based on ongoing or newly identified risk and clinical judgment.

1. Medicare coverage should align with current universal HCV screening recommendations

The current NCD provides one-time screening for adults born from 1945 through 1965 who do not otherwise meet its high-risk definition. This reflects outdated clinical guidance. In 2020, the U.S. Preventive Services Task Force issued a Grade B recommendation that all adults aged 18 through 79 years be screened for HCV, concluding with moderate certainty that screening in this population has substantial net benefit [3]. AASLD-IDSA further notes that people with previously unidentified HCV infection were born after 1965 and/or reported no history of injection drug use, populations that could be missed under traditional risk-based screening [4].

Economic evidence also supports universal screening. Barocas et al. estimated that screening all adults aged 18 years and older would identify approximately 256,000 additional HCV infections and result in approximately 280,000 additional cures compared with the then-standard birth-cohort strategy, with an incremental cost-effectiveness ratio of approximately $28,000 per quality-adjusted life-year [6]. Eckman et al. similarly found universal one-time screening cost-effective compared with birth-cohort screening, at approximately $11,378 per quality-adjusted life-year gained, and found universal screening remained cost-effective where HCV antibody prevalence outside the 1945–1965 birth cohort exceeded 0.07% [5]. Hall et al. estimated HCV antibody prevalence at 2.9% among U.S. adults aged 18–75, underscoring that prior HCV infection remains prevalent across the broader adult population [7].

OraSure therefore recommends that CMS replace the birth-cohort limitation with coverage of one-time screening for all Medicare beneficiaries aged 18 through 79 years, consistent with USPSTF guidance.

2. CMS should explicitly recognize point-of-care HCV screening

Advances in diagnostic technology have changed how HCV screening can be delivered. AASLD-IDSA HCV Guidance recommends initial testing with HCV antibody testing and recognizes FDA-approved point-of-care HCV tests. The guidance states that point-of-care assays are valuable in community settings and can use fingerstick collection rather than venipuncture [4].

Point-of-care testing can be particularly important where requiring a separate laboratory encounter creates another step between screening and diagnosis. Cunningham et al. identified multi-visit diagnostic pathways as a contributor to loss to follow-up and point-of-care testing as a means of simplifying HCV diagnosis [8].

In a systematic review and meta-analysis of 148 studies, Cunningham et al. found that point-of-care HCV antibody testing significantly improved multiple outcomes across the testing cascade compared with control approaches. The review also found that simplified testing strategies improved testing outcomes, while integrated care and patient navigation significantly improved linkage to care and initiation of direct-acting antiviral treatment [8].

CMS should clarify that covered HCV screening modalities include FDA-approved or cleared point-of-care tests performed in accordance with FDA labeling and applicable CLIA requirements, including settings operating under a CLIA Certificate of Waiver where appropriate.

3. Coverage should not be limited to primary care settings or primary care practitioners

The existing NCD requires screening to be ordered within a primary care setting and expressly excludes emergency departments, inpatient hospital settings, limited-focus clinics, and several other settings. That restriction is increasingly inconsistent with contemporary HCV screening practice and with the locations where many people with undiagnosed HCV encounter the health system. Ford et al. found 9% HCV antibody prevalence among 14,981 patients screened at the UC Davis emergency department and identified 563 patients with detectable HCV RNA [9]. Park et al. reported 2.9% antibody prevalence, 0.95% active infection, and linkage to care for 60.5% of patients diagnosed with chronic HCV in a community-hospital emergency department [10].

Other non-primary-care settings reach populations with still higher prevalence. Perry et al. found HCV antibody positivity in 24.9% of 389 people receiving point-of-care testing through a rural U.S. syringe-service program [11]. Spaulding et al. estimated that 15.2% of people in U.S. state prisons were HCV seropositive and 8.7% were viremic—nearly nine times the prevalence in the general population [12].

OraSure’s public and internal case studies further demonstrate the feasibility of decentralized testing. OraSure’s Health Betterment Initiative case study describes OraQuick HCV testing in churches, homeless shelters, harm-reduction organizations, substance-use rehabilitation clinics, health fairs, senior centers, and immigrant business centers [13]. This program has screened over 26,000 people for HCV outside of primary care settings. Ramsey County Public Health’s CareVan brings rapid HCV, HIV, and syphilis testing directly to underserved communities and connects participants to an in-house clinic for same-day treatment [14].

OraSure recommends that coverage follow the beneficiary rather than the site of care, provided that screening is ordered and performed by an eligible Medicare practitioner or provider consistent with applicable requirements. Coverage should extend to emergency departments, substance-use treatment programs, community health settings, harm-reduction programs, correctional health settings, and other sites where beneficiaries at increased risk may receive care.

4. CMS should modernize repeat-screening coverage

The current NCD limits annual repeat screening to beneficiaries who have continued illicit injection drug use since their prior negative screening test. Current clinical guidance supports a broader approach.

USPSTF recommends periodic screening for persons with continued HCV risk while acknowledging that evidence is insufficient to establish one optimal interval for all at-risk populations [3]. AASLD-IDSA recommends periodic testing for individuals with activities, exposures, conditions, or circumstances associated with increased HCV exposure and recommends annual testing for people who inject drugs and certain other populations. The guidance identifies risk factors beyond injection drug use, including certain non-injection drug use, incarceration, HIV or HBV infection, hemodialysis, and relevant blood exposures [4].

Emerging modeling evidence also suggests benefit from more frequent screening in particularly high-incidence populations. Zhu et al. reported that testing people who inject drugs approximately every six months reduced modeled HCV prevalence by up to 45%, incidence by up to 37%, and HCV-related mortality by up to 42% over the modeled period. The study also emphasized that testing must be paired with access to treatment and harm-reduction services [15].

Because the optimal frequency varies by clinical circumstance, OraSure recommends that CMS allow screening intervals to be determined by clinical judgement, rather than applying a single interval to all patients. CMS should cover at least annual screening where authoritative guidelines recommend it and additional periodic screening where clinically warranted based on ongoing or newly identified risk, with frequency determined by the treating practitioner consistent with evidence-based guidance.

Conclusion

OraSure supports CMS’s reconsideration of NCD 210.13 and urges CMS to modernize coverage to reflect contemporary HCV epidemiology, clinical guidance, and diagnostic practice. Specifically, CMS should:

Cover one-time screening for all adults aged 18 through 79 years;

Explicitly recognize FDA-approved or cleared point-of-care HCV screening tests;

Extend coverage to all sites where beneficiaries with increased risk receive health care;

Broaden coverage for repeat screening based on ongoing or newly identified HCV risk; and preserve practitioner discretion regarding repeat-testing frequency where the evidence does not establish a universal interval.

These changes would better align Medicare coverage with current evidence and clinical guidance and improve opportunities to identify HCV infection and link Medicare beneficiaries to curative treatment.

Sincerely,

Shane Hebel
Senior Director, External Relations and HIV
OraSure Technologies, Inc.

Appendix A. Recommended Changes to NCD 210.13

The language below is intended to give CMS a concise, operational summary of the requested coverage changes. Final wording should be conformed to CMS drafting conventions.

Covered testing modalities

Current language

CMS will cover screening for HCV with the appropriate U.S. Food and Drug Administration (FDA)-approved/cleared laboratory tests...

Proposed language

CMS will cover screening for HCV with appropriate FDA-approved or cleared HCV screening tests, including point-of-care tests, used consistent with FDA-approved labeling and applicable Clinical Laboratory Improvement Amendments requirements.

Site of care and ordering practitioner

Current language

...when ordered by the beneficiary’s primary care physician or practitioner within the context of a primary care setting...

Proposed language

...when ordered by an eligible Medicare physician or practitioner and performed by an eligible Medicare provider, without restriction to a primary care setting, consistent with applicable Medicare, FDA, and CLIA requirements.

Repeat screening

Current language

Repeat screening for high risk persons is covered annually only for persons who have had continued illicit injection drug use since the prior negative screening test.

Proposed language

Periodic repeat screening is covered for beneficiaries with ongoing or newly identified risk for HCV infection. Screening frequency should be based on individual risk, clinical circumstances, and applicable evidence-based clinical guidance as determined by the treating practitioner.

One-time screening

Current language

A single screening test is covered for adults who do not meet the high risk definition above, but who were born from 1945 through 1965.

Proposed language

A single screening test is covered for asymptomatic adults aged 18 through 79 years who have not previously been screened, consistent with the USPSTF Grade B recommendation.

References

[1] CMS. National Coverage Analysis Tracking Sheet: Screening for Hepatitis C Virus in Adults, CAG-00436R. https://www.cms.gov/medicare-coverage-database/view/ncacal-tracking-sheet.aspx?ncaid=325

[2] CMS. National Coverage Determination 210.13: Screening for Hepatitis C Virus in Adults. https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?ncdid=361&ncdver=1

[3] U.S. Preventive Services Task Force. Hepatitis C Virus Infection in Adolescents and Adults: Screening. 2020. https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/hepatitis-c-screening

[4] AASLD-IDSA. HCV Guidance: Recommendations for Testing, Managing, and Treating Hepatitis C. https://www.hcvguidelines.org/

[5] Eckman MH, Ward JW, Sherman KE. Cost Effectiveness of Universal Screening for Hepatitis C Virus Infection in the Era of Direct-Acting, Pangenotypic Treatment Regimens. Clinical Gastroenterology and Hepatology. 2019;17(5):930-939.e9. https://www.cghjournal.org/article/S1542-3565%2818%2930961-3/fulltext

[6] Barocas JA, Tasillo A, Eftekhari Yazdi G, et al. Population-level Outcomes and Cost-Effectiveness of Expanding the Recommendation for Age-based Hepatitis C Testing in the United States. Clinical Infectious Diseases. 2018;67(4):549-556. https://pubmed.ncbi.nlm.nih.gov/29420742/

[7] Hall EW, Bradley H, Barker LK, et al. Estimating hepatitis C prevalence in the United States, 2017–2020. Hepatology. 2025;81(2):625–636. https://stacks.cdc.gov/view/cdc/169976

[8] Cunningham EB, Wheeler A, Hajarizadeh B, et al. Interventions to enhance testing, linkage to care, and treatment initiation for hepatitis C virus infection: a systematic review and meta-analysis. The Lancet Gastroenterology & Hepatology. 2022;7(5):426–445. https://pubmed.ncbi.nlm.nih.gov/35303490/

[9] Ford JS, Chechi T, Toosi K, et al. Universal Screening for Hepatitis C Virus in the Emergency Department Using a Best Practice Advisory. Western Journal of Emergency Medicine. 2021;22(3):719–725. https://pmc.ncbi.nlm.nih.gov/articles/PMC8203013/

[10] Park JS, Wong J, Cohen H. Hepatitis C virus screening of high-risk patients in a community hospital emergency department: retrospective review of patient characteristics and future implications. PLOS ONE. 2021;16(6):e0252976. https://pmc.ncbi.nlm.nih.gov/articles/PMC8191914/

[11] Perry AN, Eccles E, Bardach SH, et al. Getting to the Point: A Community-Designed, Low-Barrier Hepatitis C Testing and Treatment Program for People Who Inject Drugs in Rural America. Viruses. 2025;17(12):1589. https://pmc.ncbi.nlm.nih.gov/articles/PMC12737676/

[12] Spaulding AC, Kennedy SS, Osei J, et al. Estimates of Hepatitis C Seroprevalence and Viremia in State Prison Populations in the United States. Journal of Infectious Diseases. 2023;228(Suppl 3):S160–S167. https://pubmed.ncbi.nlm.nih.gov/37703336/

[13] OraSure Technologies. Rapid Testing for Underserved Communities: Part 1. 2024. https://orasure.com/articles/rapid-testing-for-underserved-communities.html

[14] OraSure Technologies. A Mobile Approach to Rapid Syndemic Testing at the Point of Need: Ramsey County Public Health CareVan case study. https://orasure.com/case-study/mobile-syndemic-testing-case-study.html

[15] Zhu L, Furukawa NW, Thompson WW, et al. Potential Impact of Frequent Testing for Hepatitis C Virus Among People Who Inject Drugs Toward Hepatitis C Elimination in the United States. Clinical Infectious Diseases. 2026;83(1):e38–e46. https://academic.oup.com/cid/article/83/1/e38/8202696

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The National Viral Hepatitis Roundtable (NVHR) — a network of patients, providers, public health leaders, community-based organizations, and advocates working to eliminate viral hepatitis as a public health threat in the United States — welcomes the national coverage analysis for NCD 210.13 and submits the following comments.

NVHR encourages removal of the limitation of screening coverage "when ordered by the beneficiary’s primary care physician or practitioner within the context of a primary care setting." Both epidemiological research and implementation studies underscore the value of HCV screening across a broader range of clinical encounters, particularly for providers and settings serving significant numbers of patients from populations with elevated HCV risk and/or prevalence. For example, a significant body of evidence supports HCV screening in emergency department settings (Haukoos 2025, Czoty 2026, Manteuffel 2026). Similar analyses support the rationale for extending screening coverage to hospital inpatient settings (Scott 2026) and inpatient substance use disorder clinics (Riazi 2026, Dyer 2026). Other relevant clinical contexts include, but are not limited to, opioid treatment programs (Talal 2025, DeCamillis 2024, Pro 2021), mobile health clinics (Rennert 2023, Friedmann 2026), and street medicine (Medellin 2024, Mann 2025, Crooker 2026).

NVHR further encourages that any revisions to the NCD developed under the analysis allow for both recent and future innovations in diagnostic technology, as demonstrated by the introduction of point-of-care HCV RNA testing (Miller 2025, Havens 2026) and the interest in viral-first testing strategies (Feld 2018) as a component of test-and-treat models.

Lastly, while limited data is available to guide testing intervals for at-risk patients such as persons who inject drugs (Zhu 2025), NVHR believes that coverage for screening at least twice per year may be appropriate to address the emergence of clusters of transmission (Conners 2023).

We appreciate the opportunity to comment; please don't hesitate to reach out if we can provide further information for the national coverage analysis.

Daniel Raymond
Director of Policy
National Viral Hepatitis Roundtable (NVHR)

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October 23, 2026

JoAnna Baldwin
Acting Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services 7500 Security Boulevard Baltimore, MD 21244Dr.
7500 Security Boulevard
Baltimore, MD 21244

Re: National Coverage Analysis for Screening for Hepatitis C Virus (HCV) in Adults (CAG-00436R)

Dear Ms Baldwin,

The American Clinical Laboratory Association (ACLA) appreciates the opportunity to comment on the national coverage analysis (NCA) reconsidering National Coverage Determination (NCD) 210.13, Screening for Hepatitis C Virus (HCV) in Adults. We commend CMS for opening this reconsideration to align Medicare coverage with current clinical evidence and national screening recommendations.

ACLA is the national trade association representing leading laboratories that deliver essential diagnostic health information to patients and providers by advocating for policies that expand access to the highest quality clinical laboratory services, improve patient outcomes, and advance the next generation of personalized care.

ACLA urges CMS to (1) extend coverage to all adults aged 18 to 79 consistent with the U.S. Preventive Services Task Force (USPSTF) recommendation; (2) permit any authorized practitioner to order screening in any appropriate site of care; (3) cover periodic repeat screening for persons with continued risk; and (4) recognize the distinct needs of patients receiving maintenance hemodialysis, including routine surveillance ordered by nephrologists and dialysis facilities.

I. Align Coverage with the USPSTF Recommendation for Adults Aged 18 to 79

ACLA supports extending Medicare coverage to all adult beneficiaries aged 18 to 79, consistent with the USPSTF's 2020 Grade B recommendation. NCD 210.13 still reflects the 2013 framework of a one-time birth-cohort (1945–1965) screen plus narrowly defined high-risk groups. The USPSTF replaced that framework after concluding, with moderate certainty, that screening adults aged 18 to 79 has substantial net benefit.

The evidence underlying the recommendation is strong. The USPSTF's systematic review (Chou et al., JAMA 2020) found that current direct-acting antiviral (DAA) regimens achieve sustained virologic response (SVR) rates above 95% with few serious harms. Achieving SVR was consistently associated with substantially lower all-cause mortality, liver-related mortality, cirrhosis, and hepatocellular carcinoma. Screening with an anti-HCV antibody test followed by HCV RNA confirmation is highly accurate, and modeling found expanded age-based screening would identify hundreds of thousands of additional cases of HCV-related morbidity and mortality.

Subsequent evidence reinforces the need for broader screening. The CDC's 2020 recommendations call for screening all adults at least once and testing persons with risk factors periodically while risk persists. And a 2023 CDC analysis found that about one-third of people with diagnosed HCV infection had evidence of cure or clearance a decade after DAAs became available. Medicare beneficiaries include many individuals who were never screened under the birth-cohort approach, including younger beneficiaries eligible through disability or end-stage renal disease (ESRD). Aligning the NCD with the USPSTF recommendation is the first step toward closing these gaps.

II. Permit Any Authorized Practitioner to Order Screening in Any Appropriate Setting

ACLA recommends that CMS remove the requirement that screening be ordered by the beneficiary's primary care physician or practitioner within a primary care setting. Beneficiaries frequently receive ongoing care from specialists, including nephrologists, obstetrician-gynecologists, infectious disease physicians, hepatologists, and addiction medicine clinicians, who are well positioned to order screening and act on results. The USPSTF itself identifies low screening rates in many settings as a barrier, and limiting the benefit to primary care encounters compounds that barrier.

Consistent with the approach CMS proposed in its recent colorectal cancer screening reconsideration, ACLA recommends that the NCD allow screening when ordered by a physician or a non-physician practitioner, as defined in federal regulations, who is treating the beneficiary, in any appropriate site of care. Referencing the regulatory definition would keep the NCD current as care delivery and scope-of-practice standards evolve, without the need for future reconsiderations.

III. Cover Periodic Repeat Screening for Persons with Continued Risk

ACLA supports coverage of periodic repeat screening for beneficiaries with continued risk of HCV infection. The USPSTF recommends one-time screening for most adults but periodic screening for persons with continued risk, such as people who inject drugs. The current NCD limits repeat screening to annual testing for continued illicit injection drug use, which is narrower than national guidance.

CDC and the American Association for the Study of Liver Diseases–Infectious Diseases Society of America (AASLD-IDSA) recommend periodic testing while risk factors persist, including for persons receiving maintenance hemodialysis, with AASLD-IDSA specifying at least annual testing for people who inject drugs and certain other high-risk groups. Because the USPSTF noted limited evidence on optimal intervals, ACLA recommends that CMS cover repeat screening at intervals consistent with nationally recognized clinical guidelines, rather than fixing a single interval in the NCD. Where guidelines specify an interval for a defined population, as they do for hemodialysis, CMS should adopt it.

IV. Patients Receiving Maintenance Hemodialysis Require Repeat Screening Ordered by Their Nephrologists

CMS specifically requested evidence on screening intervals for persons at continued risk and on screening in non-primary care settings. Patients receiving maintenance hemodialysis illustrate both issues, and ACLA urges CMS to address them expressly in the final NCD.

HCV surveillance in dialysis is an infection-prevention function. HCV prevalence among hemodialysis patients is several times higher than in the general population, and CDC has documented repeated outbreaks in U.S. dialysis facilities linked to infection-control lapses. Because HCV is often asymptomatic, CDC recommends testing hemodialysis patients on admission, monthly alanine aminotransferase (ALT) monitoring and anti-HCV testing every six months for susceptible patients, and HCV nucleic acid testing to confirm a reactive antibody result. NCD 210.13 does not recognize dialysis as a risk category, even though repeated vascular access and a shared treatment environment create ongoing exposure risk.

Nephrology standards support continued surveillance. The 2018 Kidney Disease: Improving Global Outcomes (KDIGO) HCV guideline recommends screening at initial chronic kidney disease evaluation, upon initiation of in-center hemodialysis or transfer from another facility or modality, and every six months for in-center hemodialysis patients, with nucleic acid testing for any newly identified infection. The National Kidney Foundation's KDOQI U.S. Commentary, published in the American Journal of Kidney Diseases, reviews these recommendations for U.S. practice.

The primary care requirement does not fit dialysis care. Dialysis patients receive highly coordinated, recurring care in which the nephrologist and dialysis team have direct access to the patient, routinely draw laboratory specimens, and can act on results. Requiring a separate primary care encounter delays testing and fragments responsibility. Timely identification allows linkage to curative DAA therapy and informs transplant evaluation, medication planning, and infection-control response.

ACLA therefore recommends that CMS cover, for patients receiving maintenance hemodialysis:

1. HCV screening upon initiation of in-center hemodialysis or transfer from another dialysis facility or modality;
   
2. Repeat anti-HCV screening every six months for susceptible patients;
   
3. Additional HCV testing when indicated by unexplained ALT elevation or possible exposure; and
   
4. HCV nucleic acid testing following a reactive antibody result or a newly identified infection.
   

Thank you for your consideration of ACLA’s response to the national coverage analysis for Screening for Hepatitis C. Please feel free to reach out to me directly for additional information.

Sincerely,

Don May
Senior Vice President, Reimbursement & Strategy
American Clinical Laboratory Association

Key References

In 2023, the United States reported 4,966 new cases of acute hepatitis C and 101,525 new cases of chronic hepatitis C [1]. CDC data show that the reported rate of acute hepatitis C in 2023 was 1.7 times the 2016 rate, underscoring the need for California to expand screening to additional populations. The following are recommendations from AIDS Healthcare Foundation (AHF) to expand Hepatitis C screening.

California currently covers screening only for people who inject drugs and those born between 1945 and 1965, now approximately ages 61 to 81. Yet CDC data indicate that adults ages 30 to 39 had the highest rates of acute hepatitis C. Screening eligibility should therefore expand to ages 18 to 81, with particular attention to the heavily affected 30 to 39 age group.

Screening should also extend beyond primary care settings. Emergency departments can reach people without primary care providers and those who may not disclose risk factors during routine visits, helping identify infections earlier.

Finally, screening should prioritize vulnerable populations. People who are pregnant or may become pregnant should receive routine screening, and anyone with ongoing HCV risk factors should be screened periodically.

AHF is founded in Los Angeles, California in 1987 and now is the largest provider of HIV care globally. AHF is committed to staying at the cutting-edge of testing and prevention methods around the world.

1. CDC. Hepatitis C Surveillance. April 2025. https://www.cdc.gov/hepatitis-surveillance-2023/hepatitis-c/index.html

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DaVita welcomes the opportunity to submit comments to inform the Coverage and Analysis Group’s review of NCD 210.13, Screening for Hepatitis C (HCV) in Adults. We strongly urge the Centers for Medicare & Medicaid Services (CMS) to update and expand the NCD to ensure that Medicare coverage supports clinically appropriate HCV screening in the setting where dialysis patients routinely receive longitudinal care—the dialysis facility—under the direction of the treating nephrologist or other authorized clinician.

Medicare rules rightly hold dialysis providers to stringent infection control standards. Yet, the current policy, which has not substantively changed since 2014, creates a gap between Medicare coverage and dialysis providers’ infection-prevention responsibilities through its narrow risk definition and care setting constraints. The current restrictions do not reflect the clinical reality of dialysis care, where patients have clinical interactions each week in the dialysis facility; laboratory monitoring is integral to treatment; and the nephrologist-led dialysis team is often best positioned to identify potential infection, counsel the patient, arrange confirmatory testing, coordinate treatment, and protect other medically vulnerable patients. We elaborate on these points below, followed by our detailed recommendations.

I. Rationale for Updating and Expanding NCD 210.13
Dialysis Patients Need a Coverage Policy Designed for Their Care Setting
Dialysis patients receive highly coordinated, recurring care in dialysis facilities. The treating nephrologist and interdisciplinary care team have direct access to the patient, the ability to incorporate screening into routine laboratory workflows, and the infrastructure to act on results. Requiring a separate primary care encounter does not improve clinical decision-making. Instead, it can delay testing, fragment responsibility, and reduce the likelihood that screening is completed. CMS has an opportunity to make the benefit workable by recognizing qualified practitioners and dialysis facilities as appropriate points of access.

HCV Screening Is an Infection-Prevention and Patient-Safety Function
HCV may be asymptomatic; identifying infection cannot depend solely on symptoms. Centers for Disease Control and Prevention (CDC) guidance for chronic hemodialysis settings recommends testing patients for HCV infection upon admission to the facility and continued surveillance of patients who are not infected. The CDC dialysis guidance includes monthly alanine aminotransferase (ALT) monitoring and anti-HCV testing every six months for susceptible patients, with additional evaluation when ALT elevations are unexplained. CDC laboratory guidance also supports confirming a reactive HCV-antibody result with HCV nucleic acid testing to determine current infection. These recommendations recognize that repeated blood access and care in a shared treatment environment require a surveillance approach that goes beyond a one-time, primary-care-based screen. [3-5]

Nephrology Standards Support Continued HCV Screening and Surveillance
The 2018 Kidney Disease: Improving Global Outcomes (KDIGO) guideline recommends screening all patients for HCV infection at the time of initial CKD evaluation (Recommendation 1.1.1), screening all patients upon initiation of in-center hemodialysis or upon transfer from another dialysis facility or modality (Recommendation 1.1.2), and screening in-center hemodialysis patients for HCV infection every six months (Recommendation 1.2.1). KDIGO also recommends HCV nucleic acid testing for all patients with a new HCV infection identified in a hemodialysis unit (Recommendation 1.2.2). [1] The National Kidney Foundation (NKF) KDOQI U.S. Commentary evaluates the 2018 KDIGO HCV guideline for its application in U.S. kidney care. The commentary’s publication in the American Journal of Kidney Diseases provides a U.S.-focused nephrology reference that CMS can consider alongside the underlying KDIGO recommendations. Accordingly, the requested coverage changes would permit U.S. nephrologists and dialysis facilities to implement the dialysis-specific screening framework addressed by KDIGO and reviewed in the KDOQI commentary. [2]

Expanded HCV Screening Coverage Advances Early Diagnosis and Treatment
Routine screening enables earlier diagnosis, confirmatory testing, clinical evaluation, and linkage to curative direct-acting antiviral therapy when appropriate. For dialysis patients, timely identification can inform care coordination, transplantation evaluation, medication planning, and infection-prevention response. Updating the NCD would facilitate that pathway by eliminating an administrative barrier at its first step.

The Current NCD Does Not Adequately Address Dialysis Patients
NCD 210.13 currently defines high risk principally through injection drug use and transfusion history and separately covers a one-time birth-cohort screen. Dialysis treatment, including maintenance hemodialysis, is not expressly included, even though dialysis-specific public health and clinical guidance support surveillance. The primary care setting requirement compounds this omission by excluding the setting where the patient’s kidney care is delivered and reliable screening can occur. [8]

II. A Practical Coverage Framework for CMS
We recommend that CMS cover: (1) one-time screening consistent with the applicable USPSTF recommendation; (2) HCV screening when a patient initiates in-center hemodialysis or transfers from another dialysis facility or modality, consistent with KDIGO Recommendation 1.1.2; (3) repeat screening of susceptible in-center hemodialysis patients every six months, consistent with KDIGO Recommendation 1.2.1 and CDC dialysis surveillance guidance; (4) monthly ALT surveillance and additional HCV evaluation when clinically indicated by unexplained ALT elevation or possible exposure, consistent with CDC dialysis guidance; and (5) HCV nucleic acid testing following a reactive antibody result or a newly identified infection, consistent with CDC testing guidance and KDIGO Recommendation 1.2.2. CMS should permit these services when ordered by an authorized practitioner in any appropriate site of care, including a dialysis facility. [1,3-5,7]

DaVita strongly believes that Medicare’s HCV screening coverage policy should meet dialysis patients where they receive care and should empower their clinicians to apply evidence-based screening intervals based on patient and facility risk. This approach would make the preventive benefit accessible, reduce fragmented referrals, support earlier identification and treatment, and align payment policy with the infection-control duties already carried by dialysis providers. It would also provide clear national rules for providers, laboratories, Medicare Administrative Contractors, and Medicare Advantage organizations.

Conclusion

To summarize, we respectfully request that CMS revise NCD 210.13 to expressly include appropriate periodic HCV screening for the dialysis patient population, remove the primary care setting restriction, recognize nephrologists and other authorized dialysis practitioners as appropriate ordering providers, and cover the full screening-to-confirmation pathway. These changes would align Medicare coverage with the realities of kidney care and give clinicians the tools to protect a Medicare patient population that deserves consistent access to preventive laboratory testing.

We appreciate CMS’s consideration and would welcome the opportunity to provide dialysis-specific clinical and operational experience to support the national coverage analysis. Should you have any questions or need additional information, please contact Kayla Amodeo, PhD, Director, Federal Government Affairs, at (202) 210-1797 or kayla.amodeo@davita.com.

Policy and Clinical Sources Referenced

1. Kidney Disease: Improving Global Outcomes (KDIGO) Hepatitis C Work Group. KDIGO 2018 Clinical Practice Guideline for the Prevention, Diagnosis, Evaluation, and Treatment of Hepatitis C in Chronic Kidney Disease. Kidney International Supplements. 2018;8(3):91-165. See Recommendations 1.1.1, 1.1.2, 1.2.1, and 1.2.2.
2. Roth D, Bloom RD, Molnar MZ, et al. KDOQI US Commentary on the 2018 KDIGO Clinical Practice Guideline for the Prevention, Diagnosis, Evaluation, and Treatment of Hepatitis C. American Journal of Kidney Diseases. 2020;75(5):665-683.
3. Centers for Disease Control and Prevention. Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients. MMWR Recommendations and Reports. 2001;50(RR-5):1-43. See HCV testing and surveillance recommendations for chronic hemodialysis patients.
4. Centers for Disease Control and Prevention. Testing for HCV Infection: An Update of Guidance for Clinicians and Laboratorians. MMWR. 2013;62(18):362-365. Recommends HCV-antibody testing followed by HCV RNA testing when the antibody result is reactive.
5. Alter MJ, Kuhnert WL, Finelli L. Guidelines for Laboratory Testing and Result Reporting of Antibody to Hepatitis C Virus. MMWR Recommendations and Reports. 2003;52(RR-3):1-13, 15.
6. Centers for Disease Control and Prevention. CDC Recommendations for Hepatitis C Screening Among Adults, United States, 2020. MMWR Recommendations and Reports. 2020;69(2):1-17.
7. U.S. Preventive Services Task Force. Hepatitis C Virus Infection in Adolescents and Adults: Screening. JAMA. 2020;323(10):970-975.
8. Centers for Medicare & Medicaid Services. National Coverage Determination 210.13, Screening for Hepatitis C Virus in Adults.

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October 23, 2026

Submitted electronically via the CMS Medicare Coverage Database

JoAnna Baldwin
Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: National Coverage Analysis CAG-00436R – Reconsideration of NCD 210.13, Screening for Hepatitis C Virus (HCV) in Adults

Dear Ms. Baldwin:

Cepheid appreciates the opportunity to comment on CMS’s reconsideration of National Coverage Determination (NCD) 210.13. We strongly support aligning the NCD with the 2020 U.S. Preventive Services Task Force (USPSTF) recommendation for HCV screening in adults aged 18 to 79 years, and we welcome CMS’s specific interest in evidence on screening in non-primary care settings and on screening intervals for persons with ongoing risk.

Cepheid manufactures the Xpert® HCV test, the first FDA-authorized, CLIA-waived point-of-care (POC) HCV RNA test. Xpert HCV detects HCV RNA from a fingerstick capillary blood sample in about one hour, is authorized for testing adults at risk for HCV with or without HCV antibodies and does not require a confirmatory test. Because a single POC RNA result establishes current infection, clinicians can diagnose and begin treatment in the same encounter, consistent with the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) Hepatitis C POC Test and Treat Algorithm.

Medicare already recognizes HCV RNA screening under the current NCD, with coverage implemented through HCPCS code G0567 and related CMS transmittals. However, the NCD’s requirement that screening be ordered by a primary care practitioner within a primary care setting, together with claims processing instructions that limit G0567 to Place of Service (POS) codes 11, 19, 22, 49, 71, and 81, excludes many of the settings where people at highest risk for HCV receive care. Our comments focus on closing that place of service gap by ensuring that all patients eligible for HCV screening can receive it in the settings where they seek care, that is meeting patients where they are rather than requiring them to navigate additional barriers to screening.

Cepheid respectfully requests that the revised NCD:

1. Align with the 2020 USPSTF recommendation: cover one-time screening for all adults aged 18 to 79 years, and periodic screening for persons with ongoing risk at the discretion of the treating clinician.
   
2. Remove the primary care ordering and setting restriction: cover screening ordered by any eligible Medicare practitioner, in any setting where at-risk beneficiaries present, including hospital emergency departments, street medicine and outreach programs, syringe services programs, FQHCs, and community health centers.
   
3. Explicitly recognize HCV RNA testing as a covered screening modality: state that FDA-authorized HCV RNA tests, including CLIA-waived POC RNA tests, are covered as first-line screening, consistent with the AASLD/IDSA Point-of-Care Test and Treat Algorithm.
   
4. Extend G0567 coverage to all CLIA-waived settings serving at-risk beneficiaries: direct contractors to pay for G0567 in all POS where a provider holds a valid CLIA Certificate of Waiver and at-risk individuals present (POS 04, 05, 06, 07, 08, 09, 15, 20, 23, 27, 50, 55, 57, 58, and 72), in addition to the POS currently covered.

1. The Primary Care Restriction Excludes the Beneficiaries Most Likely to Be Infected

The current NCD defines a primary care setting by a sustained, accountable relationship between a patient and clinician, and expressly names emergency departments and clinics with a limited focus of services as settings that do not qualify. Many people at highest risk for HCV, including people who inject drugs, people experiencing homelessness, people involved with the justice system, and people without stable insurance, do not have that relationship. They are far more likely to encounter the health system in an emergency department, a syringe services program, a street medicine visit, a substance use treatment program, or a safety-net clinic.

These settings are also where the conventional laboratory-based, multi-visit testing pathway breaks down. A reactive antibody test followed by a separate blood draw for RNA confirmation, a return visit for results, and a later treatment visit creates multiple opportunities for loss to follow-up among highly mobile and underserved populations. A primary care restriction therefore keeps screening out of the settings where it would identify the most undiagnosed infections. Removing that restriction, consistent with the HIV screening NCD (210.7), would allow Medicare to reach these beneficiaries.

2. Peer-Reviewed Evidence Supports POC HCV RNA Screening in Non-Primary Care Settings

In response to CMS’s request for literature on screening in non-primary care settings, a growing body of peer-reviewed evidence shows that POC HCV RNA testing is feasible, accurate, and effective at improving linkage to care in the settings where at-risk individuals present:

- According to Manteuffel J et al., in an urban hospital ED screening program in Detroit, MI, 25.6% (12/47) of patients with HCV RNA detected by POC testing were linked to care at 6 months vs. 12.8% (6/47) of historical controls (RR 2.00).
- In a syringe services program in Seattle, WA, Glick SN et al. screened 200 SSP clients (74.5% with history of injection drug use); 15.5% had HCV RNA detected and 97% received their results.
- In a street medicine / outreach in Detroit, MI, Crooker KG, et al. tested people experiencing homelessness during weekly street medicine runs in Detroit; 65% (13/20) RNA-positive, all eligible for simplified treatment; 69% of RNA-positive patients initiated treatment through the street medicine program.
- In a tribal clinic and harm reduction site in Cherokee Nation, OK, Mera J, et al. demonstrated POC HCV screening implementation and 86% of participants offered POC RNA testing accepted; 10% had HCV RNA detected; 67% of those who initiated treatment did so on the same day.
- Harvey L, et al. demonstrated feasibility in a non-clinical setting (community supervision in Providence, RI) in which Xpert HCV showed sensitivity 96.8% and specificity 99.4% vs. laboratory HCV RNA testing.

Clinical performance of Xpert HCV in real-world CLIA-waived settings.
In a prospective study at 15 U.S. CLIA-waived sites enrolling 1,279 participants at risk for or with signs of HCV infection, Xpert HCV showed a positive percent agreement of 93.4% and a negative percent agreement of 99.8% relative to patient infected status (Havens JR, et al. Clin Infect Dis 2026). Independent laboratory evaluation showed detection of most HCV genotypes below 100 IU/mL in capillary whole blood (Miller LS, et al. PLoS One 2025).

Economic value of POC RNA testing.
A U.S. cost-effectiveness analysis across care settings serving people at high risk for HCV projected that a POC HCV RNA-first strategy would increase diagnosis, linkage to care, treatment initiation, and cure, and would reduce onward transmission over one year. Over a lifetime horizon, the model showed that the POC HCV RNA-first strategy reduced incidence of chronic HCV, complications, and deaths, and was the dominant strategy (more effective and less costly than traditional laboratory-based multi-step testing) in every care setting modeled. Higher short-term treatment costs were offset by long-term savings to U.S. payers (Al Rawashdh N, et al. JAMA Netw Open 2026).

Together, this evidence shows that the value of POC RNA testing lies in reaching populations for whom conventional, centralized laboratory pathways have not reliably diagnosed and treated. Coverage policy should allow that value to be realized in the settings where those populations seek care.

3. Priority Settings Outside Primary Care

Hospital emergency departments: EDs are a main point of contact for many at-risk adults who lack a usual source of care. The current NCD explicitly excludes EDs. POC RNA testing enables ED teams to diagnose active infection during the visit and start linkage before discharge, which doubled 6-month linkage to care in the study by Manteuffel J, et al.

Street medicine and outreach programs: Street medicine teams provide care for populations experiencing homelessness or unstable housing. Fingerstick RNA testing with results in about one hour allows diagnosis and treatment planning without referral to a fixed-site laboratory, as shown in the Detroit street medicine program.

Syringe services programs: SSPs serve people who inject drugs, a population at highest risk for new HCV infection. In the SSP implementation study (Seattle, WA), nearly all clients received results at the point of care, removing a key barrier to linkage and treatment.

FQHCs and community health centers: CMS should expressly cover HCV screening for eligible Medicare beneficiaries in safety-net clinics, including FQHCs and RHCs. Coverage should include on-site HCV RNA screening using FDA-authorized, CLIA-waived tests. This would allow eligible beneficiaries to receive screening and results during the same visit rather than being referred elsewhere solely for screening. CMS should also clarify how FQHCs and RHCs may bill for screening under HCPCS code G0567 and ensure that its claims-processing instructions support the revised coverage. This includes addressing any payment edits involving place-of-service codes 50 for FQHCs and 72 for RHCs that would prevent payment for otherwise covered screening.

4. Operationalizing Coverage: Extend G0567 to All CLIA-Waived Settings Serving At-Risk Beneficiaries

G0567 was created to report HCV RNA screening with CLIA-waived POC tests. Yet the POS codes currently payable for G0567 leave out many settings that hold CLIA Certificates of Waiver and serve at-risk beneficiaries. We request that CMS, when implementing the revised NCD, instruct contractors to pay for G0567 in POS 23, 50, 72, 27, 15, 4, 55, 57, 58, 5, 6, 7, 8, 9 and 20, in addition to POS 11, 19, 22, 49, 71, and 81

5. Screening Interval for Persons with Ongoing Risk

Consistent with USPSTF and CDC guidance, persons with ongoing risk, such as people who inject drugs, should be screened periodically while that risk continues. Because individual risk varies widely, we recommend that the NCD cover repeat screening at the discretion of the treating clinician rather than limiting it to a fixed annual interval tied only to continued illicit injection drug use. Covering RNA screening is especially important for this group: HCV antibodies usually persist after cure or spontaneous clearance, so antibody testing cannot detect reinfection. RNA testing is required to identify current or new infection in previously exposed individuals.

6. Suggested NCD Language

For CMS’s consideration, we suggest the following revisions to the Indications and Limitations of Coverage:

This approach mirrors the structure of other Medicare preventive screening NCDs, such as HIV screening (NCD 210.7), which do not restrict coverage to primary care settings.

Conclusion:
Effective, curative direct-acting antiviral therapy is widely available, yet many Medicare beneficiaries with HCV remain undiagnosed or untreated because testing does not reach them where they receive care. Aligning NCD 210.13 with the USPSTF recommendation, removing the primary care restriction, explicitly covering HCV RNA screening, and extending G0567 to all CLIA-waived settings that serve at-risk beneficiaries would allow Medicare to support guideline-recommended, same-visit test-and-treat care. These changes would advance national HCV elimination goals and, as the economic evidence shows, reduce long-term costs to the Medicare program.

Thank you for considering these comments. We would welcome the opportunity to provide the referenced publications or to meet with CMS staff. Please contact Anne Beaubrun, VP Value & Access, Anne.Beaubrun@cephied.com, 832.370.2353, or Angela Stewart, VP Government Affairs, AStewart02@dhdiagnostics.com, 408.507.3956 with any questions.

Respectfully submitted,

Anne Beaubrun
Vice President, Value & Access
Cepheid

Angela Stewart
Vice President, Government Affairs
Danaher Diagnostics

References
1. U.S. Preventive Services Task Force. Screening for Hepatitis C Virus Infection in Adolescents and Adults: Recommendation Statement. JAMA. 2020.
2. AASLD/IDSA. Hepatitis C Point-of-Care Test and Treat Algorithm. HCV Guidance (hcvguidelines.org).
3. Miller LS, et al. Independent Assessment of a Point of Care HCV RNA Test by Laboratory Analytical Testing and a Prospective Field Study in the U.S. PLoS One. 2025;20(7):e0324088.
4. Havens JR, et al. Performance Validation of the Xpert® HCV Test on Fingerstick Blood in a Prospective Observational Clinical Study at CLIA-waived Sites in the United States. Clin Infect Dis. 2026;ciag173.
5. Harvey L, et al. Feasibility and Performance of a Point-of-Care Hepatitis C RNA Assay in a Community Supervision Cohort. JAMA Netw Open. 2024;7(10):e2438222.
6. Mera J, et al. Point-of-care Hepatitis C Testing in a Tribal Setting. JAMA Netw Open. 2026;9(4):e267242.
7. Glick SN, et al. Successful Implementation of Hepatitis C Virus Point-of-Care Testing in a Syringe Services Program. Subst Use Addctn J. 2026. DOI: 10.1177/29767342261462112.
8. Crooker KG, et al. Implementation of Novel Point-of-Care Hepatitis C RNA Platform and Clinical Characteristics of Treatment in Persons Experiencing Homelessness in Detroit, Michigan. Open Forum Infect Dis. 2026;13(Suppl 1):ofaf695.071.
9. Manteuffel J, et al. Impact of Point-of-Care Hepatitis C Virus RNA Testing on an Emergency Department Screening Program. Acad Emerg Med. 2026. SAEM Abstract 821. doi:10.1111/acem.70305.
10. Al Rawashdh N, et al. The Cost-effectiveness of One-step Point-of-Care Hepatitis C Virus RNA Testing in the United States. JAMA Netw Open. 2026;9(3):e262658.
11. van Dijk M, Drenth JP, et al. Loss to follow-up in the hepatitis C care cascade: a substantial problem but opportunity for micro-elimination. J Viral Hepat. 2020;27(12):1270-1283.

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October 23, 2026

SUBMITTED ONLINE: https://www.cms.gov/medicare-coverage-database/view/ncacal-public-comments.aspx?ncaId=325

JoAnna Baldwin
Acting Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare and Medicaid Services
Mailstop S3-02-01
7500 Security Boulevard
Baltimore MD 21244

Subject: Medicare National Coverage Determination for Screening for Hepatitis C Virus (HCV) in Adults, NCD 210.13 (CAG-00436R)

Dear Ms. Baldwin:

On behalf of the HIV+Hepatitis Policy Institute, an organization advocating for quality and affordable healthcare for people and communities affected by HIV, viral hepatitis, and other serious and chronic health conditions, we thank you for the opportunity to comment on CMS’s update of the National Coverage Determination (NCD) for hepatitis C screening. In June 2021, HIV+Hep, along with the National Viral Hepatitis Roundtable, Caring Ambassadors Program, NASTAD, and The AIDS Institute, formally requested this reconsideration [1], and we are grateful that CMS has initiated the process.

The current NCD was finalized in 2014 and reflects the treatment landscape, testing technology, and evidence of more than a decade ago. Since that time, curative direct-acting antivirals (DAAs) have become the standard of care, CDC and USPSTF have recommended universal adult screening, and new rapid, point-of-care and self-testing technologies have emerged. Telehealth, now used far more widely than in 2014, allows people screened in community and correctional settings to access treatment without a traditional in-person office visit. Together, these changes have transformed the potential for broad access by Medicare beneficiaries to screening and curative treatments.

The March 2020 USPSTF recommendation for universal screening of adults 18-79 is the foundation of the National Coverage Analysis. The current NCD, issued in 2014, only addresses “high-risk” adults and those who were born between 1945 and 1965. Many years have passed since the USPSTF recommendation was updated, and CMS’s NCD must now follow. As you do this, we urge CMS to ensure expanded coverage is implemented in ways that benefit the greatest number of Medicare beneficiaries. Therefore, we urge CMS to (1) not limit screening to primary care settings; (2) allow for self- and home-based testing as they become available; and (3) not require documentation of risk to access repeat testing.

Hepatitis C and the Medicare population

Hepatitis C in Medicare is not primarily a disease of people aged over 65. An analysis of Medicare claims found that only 28 percent of beneficiaries with chronic hepatitis C qualified on the basis of age alone, while 63 percent qualified due to disability. They averaged 57 years of age, 14 years younger than other beneficiaries, and carried a much heavier burden of comorbidities [2].

Failure to screen and delayed screening fall hardest on Medicare and other public programs. Untreated infection progresses silently towards cirrhosis, liver cancer, and transplantation, and when it is found, people are more likely to have aged into Medicare or qualified through disability, with the costs of advanced liver disease falling heavily on Medicare, Medicaid, and correctional health systems. Yet Medicare is well positioned to turn a diagnosis into a cure, with the highest rate of viral clearance of any payer in CDC’s clearance cascade [3].

The evidence shows that broader screening is cost-effective. In the DETECT Hep C randomized trial in three hospital emergency departments, offering testing to every patient identified more infections than testing only those reporting risk factors [4]. Modeling based on the trial found that universal ED screening diagnosed and cured more infections and prevented more deaths than risk-based or no screening, and that no screening was more costly than universal screening [5].

Do not limit screening to primary care settings

The current NCD covers screening only when it is ordered by the beneficiary’s primary care provider in a primary care setting. We urge CMS to cover screenings ordered or furnished by any Medicare-enrolled provider in any clinically appropriate setting. This should include, at a minimum, safety-net settings such as federally qualified health centers and Ryan White, rural, and homeless health clinics; mobile vans and other street outreach settings; hospital inpatient, outpatient, and emergency departments; health department and sexual health clinics; syringe services and other harm reduction programs; pharmacies; correctional facilities and reentry programs; and community-based organizations. Retaining a setting restriction imposes an insurance barrier on beneficiaries who may face out-of-pocket costs as well as providers who cannot count on payment, and prevents Medicare from screening the beneficiaries who are hardest to reach.

Non-traditional settings are key to reaching people most likely to have undiagnosed hepatitis C, including people who use drugs, people who are unhoused, and people who have been released from incarceration. Many are poorly connected or not at all connected to primary care or traditional health care, but are reached very effectively through emergency departments and trusted community-based organizations. This population is large and growing, with an estimated 3.7 million people who inject drugs in the United States in 2018, more than five times a previous estimate for 2011 [6]. Because hepatitis C is part of a syndemic with HIV and substance use, settings that address these conditions together are particularly efficient screening sites. One model estimated that from 2015 to 2019, injection drug use was associated with 120,000 overdose deaths, 17,000 new HIV infections, and 144,000 new hepatitis C infections [7]. Researchers have noted that U.S. payers generally do not cover HCV screening outside primary care, even though non-traditional settings successfully identify infections in high-prevalence vulnerable populations [8].

Hospital emergency departments are an important example of a non-traditional setting. Many people with undiagnosed HCV use emergency departments as their only regular point of contact with the health system. In the DETECT trial, offering testing to all emergency department patients found more infections than risk-based testing [4], and modeling based on the trial found universal screening cost-effective [5]. Emergency departments are also a clear example of a setting where providers may not have an ongoing relationship with a patient, yet which is a critical, cost-effective setting for diagnosis of HCV.

The evidence from community settings is equally strong. A systematic review and meta-analysis found that approaches that simplify testing, including opt-out screening, point-of-care antibody testing, and reflex RNA testing, significantly improved testing, and that integrated care and patient navigation improved treatment uptake [9]. In rural New Hampshire and Vermont, a community-designed testing program engaged people who inject drugs who had been poorly served by more traditional health care [10].

A setting-neutral NCD is also consistent with the CDC recommendation that anyone who requests hepatitis C testing should receive it, even if no risk is disclosed [11].

Telehealth is extending what screening can achieve outside the primary care setting

The wider availability of telehealth has changed hepatitis C care models in ways that make the NCD’s setting restriction even harder to justify. Until recently, a positive result in a community setting usually meant a referral to a specialist, and many patients were lost to follow-up at this stage. Innovative programs now can combine screening in community and street settings with treatment delivered remotely, so that a person can be tested, diagnosed, and started on curative treatment without ever stepping into a specialist’s office.

Berkshire Harm Reduction in Massachusetts has fully integrated HCV testing and treatment into its harm reduction services using telehealth, a model the state’s Department of Public Health highlights in its hepatitis C best practices toolkit [12]. Clients are screened at the syringe services program, positive antibody tests lead to RNA confirmatory testing, pre-treatment labs are drawn onsite, the prescriber sees the client by a telehealth visit including an assessment for PrEP, and a specialty pharmacy delivers the medication to the program, with a navigator supporting adherence and follow-up.

In a randomized trial in rural northern New England, Baystate Health and Tufts University found that mobile telemedicine at syringe service sites was associated with higher rates of treatment initiation and viral clearance among rural people who inject drugs than traditional care [13].

Correctional systems have used the same approach in a setting where the unmet need is substantial, and where screening and linkage before release can mean that Medicare beneficiaries, who lose their coverage while incarcerated, are already diagnosed and on a path to curative treatment after release. Roughly 1.4 million people were held in federal and state prisons in 2019 [14], with 15.2 percent of people in state prisons estimated to be HCV seropositive and 8.7 percent of people in state prisons living with viremic hepatitis C, nearly nine times the prevalence in the general population [15]. Since 2010, the University of Illinois at Chicago has partnered with the Illinois Department of Corrections to provide HIV and hepatitis C specialty care by telehealth in state prisons [16], and a telehealth treatment protocol in the Virginia Department of Corrections reported a 97 percent cure rate among over 600 people completing treatment [17]. California’s provision of opt-out testing to everyone entering state correctional facilities without regard to known risk factors has improved equitable access to treatment, particularly for people who use drugs [18].

Each of these models begins with screening outside the primary care setting. We urge CMS to clarify that screening is covered when ordered by a clinician seeing the patient remotely by telehealth.

Repeat screening, risk, and stigma

Many people are reluctant to disclose substance use or other stigmatized practices to their providers. We urge CMS not to reinforce stigma by requiring beneficiaries to attest to, or clinicians to document, these risk factors as a condition of repeat screening.

USPSTF recommends periodic screening of people with continuing risk for HCV [19], and, as discussed below, clinical guidelines now recommend at least annual screening for several groups, and every six months for dialysis patients [20, 21]. We urge CMS to cover repeat screening at the frequencies recommended in current guidelines, rather than relying on a frequency restriction such as a once-a-year cap. Requirements to elicit risk factors may deter exactly those people most in need of screening, and questions about substance use at triage often do not receive meaningful answers, as noted in commentary on the DETECT study [22]. AASLD/IDSA recommendations note that many people at greatest risk “do not readily report their highly stigmatized risk activities,” and that 15-25 percent of people with previously undiagnosed HCV would be “missed by even perfect implementation of risk-based testing” [20]. There is substantial benefit to frequent testing. CDC researchers found that testing people who inject drugs every six months, combined with treatment, could reduce hepatitis C prevalence by up to 45 percent and related deaths by 42 percent over ten years, with a modest increase in total costs [23].

CMS should also replace references to persons at “high risk” with “increased risk” and align the definition of risk with CDC’s current recommendations, which call for testing all persons with risk factors regardless of age or setting [11], rather than limiting “high risk” to injection drug use and transfusion before 1992. As we noted in our comments on the PrEP NCD, many people who would benefit from a preventive service do not see themselves as being at high risk, and some providers stigmatize those seen as high risk.

CMS also asked specifically for evidence related to screening intervals for those at increased risk. The evidence supports the frequencies set in current clinical guidelines rather than a fixed cap. AASLD/IDSA guidance recommends at least annual testing for people who inject drugs, men living with HIV who have condomless sex with men, and men on PrEP, with more frequent testing when risk warrants it. Given high reinfection rates of about 6 per 100 person-years, annual RNA testing is also recommended for people who continue to inject drugs after the completion of curative treatment [20, 24]. CDC already recommends testing every six months for hemodialysis patients [21], showing that a once-a-year limit is too low for some groups with ongoing exposure. The NCD should cover repeat screening, including RNA testing after curative treatment, at the frequencies recommended in current clinical guidelines.

Finally, the NCD should cover screenings during each pregnancy, as recommended by CDC, and, because CDC sets no upper age limit, the NCD should at a minimum cover screening of beneficiaries 80 and older at the beneficiary’s request [11].

Allow for new testing modalities

Our 2021 request asked CMS to account for new testing modalities, including rapid point-of-care and self-tests. Conventional testing often requires multiple visits, as a reactive antibody test requires confirmatory RNA testing whose results often arrive after the patient is no longer on-site. Data show very substantial loss to follow-up, with only 62-68 percent of patients completing the full testing process when a second visit was required [25]. Point-of-care testing can make diagnosis and linkage to care possible in a single visit.

Self-testing and home collection offer similar advantages to beneficiaries with disabilities, those in rural areas or with limited access to transportation, and people who are discouraged by stigma. WHO recommended HCV self-testing in 2021 and prequalified the first HCV self-test in 2024 [26], and dried blood spot samples self-collected at home have been shown to detect HCV RNA [27]. The current NCD, however, limits screening coverage to FDA-approved or cleared laboratory tests and ties screening to a primary care visit. We encourage CMS to allow the NCD to encompass FDA-authorized point-of-care, self-testing, and home testing as they become available, as well as to cover confirmatory RNA testing following any reactive screening result, including self-tests or rapid tests.

Coverage must keep pace with scientific innovation and evidence-based guidelines

USPSTF and CDC both updated HCV screening recommendations in 2020, yet Medicare coverage still reflects the 2014 NCD. Our request for reconsideration was filed in June 2021, but this analysis will only be completed in June 2027. When USPSTF or CDC updates HCV screening recommendations, or FDA authorizes new tests, those changes should be incorporated into Medicare coverage without delay, just as the HIV pre-exposure prophylaxis NCD extends to any future FDA-approved PrEP drugs without requiring a separate NCD [28]. Medicare beneficiaries should not have to wait years for access to scientific innovation, especially for a curable disease that remains one of the deadliest infectious diseases in the United States [29].

Conclusion

CDC has reported that hepatitis C kills more Americans than sixty other notifiable infectious diseases combined [29], and it still contributes to over 11,000 deaths a year [30], even though it can be cured. Even now, over a decade after curative treatments have been available, CDC found that only one in three people with evidence of infection had been cured [3], and the number of US adults estimated to be living with HCV was 2.5 to 4 million in 2017-2020, a prevalence unchanged from 2013-2016 [31]. Many of the easiest people to reach, those in primary care and traditional health care settings, have already accessed curative treatment. We urge CMS to issue this NCD without setting restrictions so that as many Medicare beneficiaries as possible can access these curative treatments.

If you have any questions or comments, please contact Carl Schmid, HIV+Hepatitis Policy Institute at cschmid@hivhep.org or (202) 462-3042, or Kevin Herwig, HIV+Hepatitis Policy Institute at kherwig@hivhep.org or (617) 666-6634.

Sincerely,

Carl E. Schmid II

References

[1] HIV+Hepatitis Policy Institute, National Viral Hepatitis Roundtable, Caring Ambassadors Program, NASTAD, and The AIDS Institute. Request for reconsideration of NCD 210.13, Screening for Hepatitis C Virus in Adults. June 2021. https://www.cms.gov/files/document/id325c.pdf

[2] Characteristics of Medicare beneficiaries with chronic hepatitis C virus. ISPOR 18th Annual International Meeting, 2013. https://www.ispor.org/heor-resources/presentations-database/presentation/ispor-18th-annual-international-meeting/characteristics-of-medicare-beneficiaries-with-chronic-hepatitis-c-virus

[3] Wester C, et al. Hepatitis C Virus Clearance Cascade — United States, 2013–2022. MMWR 2023;72(26):716–720. https://www.cdc.gov/mmwr/volumes/72/wr/mm7226a3.htm

[4] Haukoos J, Rothman RE, Galbraith JW, et al. Hepatitis C Screening in Emergency Departments: The DETECT Hep C Randomized Clinical Trial. JAMA 2025;334(6):497–507. https://doi.org/10.1001/jama.2025.10563

[5] Czoty LMW, Munroe S, Stewart E, et al. Cost-Effectiveness of HCV Screening in Emergency Departments Using DETECT Hep C Trial Results. JAMA Internal Medicine, published online October 19, 2026. https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2855588

[6] Bradley H, Hall EW, Asher A, et al. Estimated Number of People Who Inject Drugs in the United States. Clinical Infectious Diseases 2023;76(1):96–102. https://doi.org/10.1093/cid/ciac543

[7] Chiosi JJ, Mueller PP, Chhatwal J, Ciaranello AL. A multimorbidity model for estimating health outcomes from the syndemic of injection drug use and associated infections in the United States. BMC Health Services Research 2023;23(1):760. https://doi.org/10.1186/s12913-023-09773-1

[8] Choi et al. Cost-effectiveness analysis of emergency department-based hepatitis C screening and linkage-to-care program. BMC Health Services Research, 2024. https://pmc.ncbi.nlm.nih.gov/articles/PMC11523774

[9] Cunningham EB, Wheeler A, Hajarizadeh B, et al. Interventions to enhance testing, linkage to care, and treatment initiation for hepatitis C virus infection: a systematic review and meta-analysis. The Lancet Gastroenterology & Hepatology 2022;7(5):426–445. https://pubmed.ncbi.nlm.nih.gov/35303490/

[10] Perry AN, Eccles E, Bardach SH, et al. Getting to the Point: A Community-Designed, Low-Barrier Hepatitis C Testing and Treatment Program for People Who Inject Drugs in Rural America. Viruses 2025;17(12):1589. https://pmc.ncbi.nlm.nih.gov/articles/PMC12737676/

[11] Centers for Disease Control and Prevention. CDC Recommendations for Hepatitis C Screening Among Adults — United States, 2020. MMWR Recommendations and Reports 2020;69(No. RR-2):1–17. https://www.cdc.gov/mmwr/volumes/69/rr/rr6902a1.htm

[12] Massachusetts Department of Public Health. Hepatitis C Treatment Best Practices. https://www.mass.gov/info-details/hepatitis-c-treatment-best-practices

[13] Friedmann PD, et al. Mobile Telemedicine for Treating Chronic Hepatitis C Among Rural People Who Inject Drugs: A Randomized Clinical Trial. JAMA Network Open 2026;9(1):e2555125. https://doi.org/10.1001/jamanetworkopen.2025.55125

[14] Carson EA. Prisoners in 2019. Bureau of Justice Statistics, U.S. Department of Justice, 2020. https://bjs.ojp.gov/library/publications/prisoners-2019

[15] Spaulding AC, Kennedy SS, Osei J, et al. Estimates of Hepatitis C Seroprevalence and Viremia in State Prison Populations in the United States. Journal of Infectious Diseases 2023;228(Suppl 3):S160–S167. https://pubmed.ncbi.nlm.nih.gov/37703336/

[16] Illinois Department of Corrections. Press release on the IDOC–University of Illinois at Chicago Telemedicine Pilot Program for HIV and Hepatitis C. July 27, 2010. https://www.illinois.gov/news/press-release.8689.html

[17] HCV treatment through telehealth highly effective regardless of DAA regimen (Virginia Department of Corrections; Digestive Disease Week 2020). Healio. https://www.healio.com/hepatology/hepatitis-c/news/online/%7B59d07ad0-f03d-4756-926e-477865d451bf%7D/hcv-treatment-through-telehealth-highly-effective-regardless-of-daa-regimen

[18] Ye Z, Lucas K, Furukawa NW, et al. Universal Opt-Out Hepatitis C Virus Testing and Treatment on Entry in California State Prisons. JAMA Internal Medicine, published online 2026. https://doi.org/10.1001/jamainternmed.2026.4041

[19] U.S. Preventive Services Task Force. Screening for Hepatitis C Virus Infection in Adolescents and Adults: Final Recommendation Statement. March 2, 2020. https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/hepatitis-c-screening

[20] American Association for the Study of Liver Diseases and Infectious Diseases Society of America. HCV Guidance: HCV Testing and Linkage to Care. Last updated July 12, 2024. https://www.hcvguidelines.org/guidance/hcv-testing-and-linkage-to-care/

[21] Centers for Disease Control and Prevention. Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients. MMWR Recommendations and Reports 2001;50(RR-5):1–43. https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5005a1.htm

[22] Coupet E, Hawk KF, D’Onofrio G. Emergency Department Hepatitis C Virus Testing—To Do or Not to Do? JAMA Internal Medicine, published online October 19, 2026. https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2855593

[23] Zhu L, Furukawa NW, Thompson WW, et al. Potential Impact of Frequent Testing for Hepatitis C Virus Among People Who Inject Drugs Toward Hepatitis C Elimination in the United States. Clinical Infectious Diseases 2026;83(1):e38–e46. https://academic.oup.com/cid/article/83/1/e38/8202696. See also Zhu L, et al. Health and Economic Impact of Periodic Hepatitis C Virus Testing Among People Who Inject Drugs. JAMA Network Open, 2025. https://pmc.ncbi.nlm.nih.gov/articles/PMC12232219/

[24] Hajarizadeh B, Cunningham EB, Valerio H, et al. Hepatitis C reinfection after successful antiviral treatment among people who inject drugs: A meta-analysis. Journal of Hepatology 2020;72(4):643–657. https://pubmed.ncbi.nlm.nih.gov/31785345/

[25] Cartwright EJ, Patel P, Kamili S, Wester C. Updated Operational Guidance for Implementing CDC’s Recommendations on Testing for Hepatitis C Virus Infection. MMWR 2023;72(28):766–768. https://www.cdc.gov/mmwr/volumes/72/wr/mm7228a2.htm

[26] World Health Organization. WHO prequalifies the first self-test for hepatitis C virus. News release, July 10, 2024. https://www.who.int/news/item/10-07-2024-who-prequalifies-the-first-self-test-for-hepatitis-c-virus

[27] Prinsenberg T, et al. Dried blood spot self-sampling at home is a feasible technique for hepatitis C RNA detection. PLoS ONE 2020;15(4):e0231385. https://pmc.ncbi.nlm.nih.gov/articles/PMC7156069

[28] Centers for Medicare and Medicaid Services. Decision Memo: Preexposure Prophylaxis (PrEP) Using Antiretroviral Therapy to Prevent Human Immunodeficiency Virus (HIV) Infection (CAG-00464N). https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&ncaid=310

[29] Ly KN, et al. Rising Mortality Associated With Hepatitis C Virus in the United States, 2003–2013. Clinical Infectious Diseases 2016;62(10):1287–1288. https://pmc.ncbi.nlm.nih.gov/articles/PMC11089523/

[30] Centers for Disease Control and Prevention. 2023 Hepatitis C Surveillance Report. https://www.cdc.gov/hepatitis-surveillance-2023/hepatitis-c/index.html

[31] Hall EW, Bradley H, Barker LK, et al. Estimating hepatitis C prevalence in the United States, 2017–2020. Hepatology 2025;81(2):625–636. https://stacks.cdc.gov/view/cdc/169976

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RE: CMS Request for Comments on Screening for Hepatitis C Virus (HCV) in Adults

The Association of State and Territorial Health Officials (ASTHO) appreciates the opportunity to comment on CMS’s reconsideration of the National Coverage Determination (NCD) for hepatitis C virus (HCV) screening. ASTHO's membership is comprised of chief health officials from states, Washington, D.C., five U.S. territories, and three Freely Associated States. ASTHO is committed to supporting the work of state and territorial public health officials and furthering the development and excellence of public health policy nationwide.

ASTHO supports expanding CMS coverage of one-time HCV screening to eligible beneficiaries aged 18-79 years, consistent with the U.S. Preventive Services Task Force’s (USPSTF) Grade B recommendation. This change would align coverage with evidence-based preventive care and help identify and resolve infections early. The USPSTF’s 2020 evidence assessment establishes the clinical rationale for that approach; partner experiences and literature details how expanding screening eligibility can translate into additional diagnoses, better outcomes, and economic value.

As reflected in the current NCD, 42 CFR §410.64(b) permits consideration of the relationship between predicted outcomes and expenditures when evaluating additional preventive services.
The June 2021 joint letter from the HIV+Hepatitis Policy Institute, National Viral Hepatitis Roundtable, Caring Ambassadors, NASTAD, and The AIDS Institute connects expanded screening to national viral hepatitis elimination goals, emphasizing that awareness of infection is essential to accessing treatment. For state and territorial health departments, coverage aligned with these recommendations would support national efforts to expand diagnosis and linkage to care through their clinical and community partnerships.

Partner experiences also demonstrate how inconsistent coverage can impede implementation of evidence-based public health recommendations. Cleveland Clinic’s July 2021 submission reports Medicare claim denials for HCV screening performed in accordance with updated USPSTF recommendations. Similarly, the University of Vermont Medical Center’s August 2022 request describes a mismatch between providers’ screening practices and Medicare’s birth-cohort eligibility criterion.

Updating coverage would support health departments in streamlining provider education and technical assistance efforts, and would make the recommended screening more feasible.
In updating its recommendation, USPSTF cited rising HCV infection in younger adults and improvements in treatment that increased benefits and reduced harms. Its review described a 3.8-fold increase in acute HCV cases from 2010 to 2017, with the fastest increases among adults aged 20-39 who inject drugs.

Broader screening adds value even when risk-based testing is available. Barocas and colleagues compared the 1945-1965 birth-cohort approach with one-time screening beginning at ages 40, 30, or 18. Every strategy retained targeted testing for people who inject drugs. The study examined whether broader routine screening provides benefits beyond birth-cohort screening supplemented by risk-based testing. Among people with HCV born outside the birth cohort, the modeled proportion identified over a lifetime increased from 74% under the existing approach to 85% with screening beginning at age 18, demonstrating that broader screening can reach more people.

Screening creates an opportunity to intervene while infection is still asymptomatic, and delayed diagnosis exposes patients and payers to the costs of advanced disease. In a matched claims study, McAdam-Marx and colleagues found annual incremental costs (per patient, per year) of $5,870 for HCV without liver disease, compared with $27,845 for decompensated cirrhosis, $43,671 for hepatocellular carcinoma, and $93,609 for liver transplant. These historical estimates reflect commercially insured patients and 2009 dollars, rather than current Medicare payment amounts. They nevertheless illustrate the substantial escalation in costs associated with advanced complications and the economic importance of preventing progression.
ASTHO recommends that CMS replace the fixed 1945-1965 birth-cohort criterion with one-time screening coverage for eligible beneficiaries aged 18-79, while preserving appropriate screening for people at increased risk. Clear claims-processing instructions should accompany the change, so clinicians can offer recommended screening with confidence that coverage criteria are aligned. Expanding the NCD would allow CMS to act on the value demonstrated by the available evidence, through finding infections that the existing approach misses, identifying them before advanced disease, and creating opportunities to prevent avoidable illness and its associated costs.

Respectfully,
Joseph M. Kanter, MD, MPH
Chief Executive Officer, Association of State and Territorial Health Officials

References
Barocas JA, Tasillo A, Eftekhari Yazdi G, et al. Population-level outcomes and cost-effectiveness of expanding the recommendation for age-based hepatitis C testing in the United States. Clin Infect Dis. 2018;67(4):549–556. https://doi.org/10.1093/cid/ciy098 McAdam-Marx C, McGarry LJ, Hane CA, Biskupiak J, Deniz B, Brixner DI. All-cause and incremental per patient per year cost associated with chronic hepatitis C virus and associated liver complications in the United States: a managed care perspective. J Manag Care Pharm. 2011 Sep;17(7):531-46. doi: 10.18553/jmcp.2011.17.7.531. PMID: 21870894; PMCID: PMC10438304.
U.S. Preventive Services Task Force. Screening for hepatitis C virus infection in adolescents and adults: US Preventive Services Task Force recommendation statement. JAMA. 2020;323(10):970–975. https://doi.org/10.1001/jama.2020.1123

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October 23, 2026

SUBMITTED ELECTRONICALLY

JoAnna Baldwin
Coverage and Analysis Group, Center for Clinical Standards and Quality, Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: National Coverage Analysis for Screening for Hepatitis C Virus (HCV) in Adults (CAG-00436R)

Dear Ms. Baldwin:

Gilead Sciences, Inc. (“Gilead”) appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (“CMS”) reconsideration of National Coverage Determination 210.13, Screening for Hepatitis C Virus (HCV) in Adults. Gilead strongly supports updating this NCD and urges CMS to align Medicare coverage with current clinical recommendations and current understandings of how beneficiaries at risk for HCV access health care, as reflected in the current recommendation of the U.S. Preventive Services Task Force (“USPSTF”).

Gilead is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need, including viral hepatitis. For more than two decades, Gilead has played an important role in the nation’s response to viral hepatitis, including the development of the first all-oral direct-acting antiviral (“DAA”) cure for HCV. Through our FOCUS Program, we leverage implementation science to support health care organizations to implement and scale routine HIV, HCV and HBV screening and linkage to prevention and care services. We are particularly proud of the FOCUS program’s ongoing collaboration with CDC to evaluate and advance these science-based models of care in communities across the country.

NCD 210.13 was issued in 2014, when curative oral therapy had just entered the market and USPSTF’s recommendation was limited to high-risk individuals and adults born from 1945 through 1965. Scientific evidence and clinical guidance have since evolved. Gilead recommends that CMS:

1. Cover one-time screening for all adults aged 18 to 79, consistent with the current USPSTF Grade B recommendation.
2. Cover periodic repeat screening for beneficiaries with ongoing risk at least annually, or more often when clinically appropriate, using an updated, person-first definition of risk and HCV RNA testing for beneficiaries with a prior infection.
3. Remove the primary care practitioner and setting requirement so screening is covered wherever an eligible Medicare provider furnishes it.
4. Cover the full diagnostic sequence, including reflex HCV RNA testing and FDA-authorized point-of-care tests, described by FDA status rather than by technology, so a reactive screen leads to diagnosis and cure.

1. Cover one-time screening for all adults aged 18 to 79

CMS should adopt the 2020 USPSTF recommendation in full. The USPSTF recommends screening for HCV infection in all adults aged 18 to 79 years (Grade B), replacing the 2013 risk-based and generational recommendations on which NCD 210.13 rests.[1] The Centers for Disease Control and Prevention (“CDC”) recommends screening at least once in a lifetime for all adults aged 18 and older, and the AASLD-IDSA guidance recommends one-time, routine, opt-out testing for the same population.[2][3] Medicare coverage is now narrower than all three.

The gap is growing for Medicare in particular. Beneficiaries born from 1945 through 1965 are 61 to 81 years old this year. The first people born after 1965 reach age 65 in 2031, and from that point every person aging into Medicare will fall outside the birth cohort of the existing NCD. Beneficiaries under 65 who qualify through disability and were born after 1965 are already outside it, and today can be screened only if they disclose injection drug use or a transfusion before 1992. CDC has cautioned that many people are reluctant to disclose stigmatizing risks, which is one reason it moved to universal screening.[2] These younger adults are also the group least likely to have been cured: in CDC’s national clearance cascade, about one-third of people with evidence of HCV infection had been cured or had cleared the virus, falling to 24% among adults aged 20 to 39.[4]

2. Cover periodic repeat screening for beneficiaries with ongoing risk

CMS sought comments on peer-reviewed literature on the screening interval for people who remain at risk. The evidence supports annual screening as a minimum, with more frequent testing at the clinician’s discretion.

- Guidelines: The USPSTF states that most adults need to be screened only once and that people with continued risk should be screened periodically; it identifies the optimal repeat interval as a research need.[1] CDC recommends routine periodic testing for as long as risk persists, without naming an interval.[2] The AASLD-IDSA guidance is specific: annual testing for all people who inject drugs, for men with HIV who have unprotected sex with men, and for men who have sex with men taking pre-exposure prophylaxis, with periodic testing for others at increased risk.[3]

- Modeling of testing frequency: A 2025 network modeling study led by CDC investigators compared testing people who inject drugs every two years, annually, every six months, every three months, and monthly. The authors concluded that testing every 6 to 12 months, or even more often, could be a reasonable and cost-effective strategy.[5]

- Reinfection after cure: A meta-analysis of 36 studies found reinfection rates of 5.9 per 100 person-years among people with recent drug use and 6.2 per 100 person-years among people recently injecting drugs.[6] A beneficiary who has been cured can therefore need screening again.

Gilead recommends that the revised NCD:

- Cover repeat screening at least annually for beneficiaries with ongoing risk, and allow shorter intervals, such as every six months, when the ordering clinician judges it appropriate.

- Define ongoing risk consistently with CDC and AASLD-IDSA rather than limiting it to continued injection drug use, and leave room for clinical judgment as the evidence develops.

- Replace the term “high risk persons” with person-first language, such as “people who are at higher risk for becoming infected by HCV including people who inject drugs.”

- Cover HCV RNA testing as the screening test for beneficiaries with a prior infection, because HCV antibody generally remains detectable after cure and cannot identify reinfection.

Medicare already covers annual screening for beneficiaries at increased risk of HIV under NCD 210.7.[7] The same interval is a reasonable floor for HCV, which shares routes of transmission and affected populations.

3. Cover screening beyond primary care

CMS should remove the requirement that screening be ordered by a primary care practitioner in a primary care setting. NCD 210.13 expressly excludes emergency departments, inpatient hospital settings, ambulatory surgical centers, independent diagnostic testing facilities, skilled nursing facilities, inpatient rehabilitation facilities, clinics with a limited focus, and hospice. Those exclusions cover many of the places where people with undiagnosed HCV actually receive care; the AASLD-IDSA guidance notes that point-of-care HCV RNA testing can be performed in substance use disorder treatment facilities, syringe services programs, physician offices, and emergency departments.[3].

Primary care remains an important entry point, but it is not where many affected beneficiaries are found:

- People with HCV are heavy users of emergency and inpatient services. Five percent of patients—known as super-utilizers—are responsible for?50 percent of the nation’s healthcare costs. [8]

- In one health system, 8% of emergency department patients screened antibody-positive, compared with 1% in the system’s clinics.[9]

- Emergency department screening with linkage to care has been found cost-effective.[10]

Gilead’s experience supports the same conclusion. Since 2010, the FOCUS Program has worked with hospitals, emergency departments, community health centers, and other partners to develop and share best practices in routine HIV, HBV, and HCV screening and linkage to a first medical appointment, in accordance with CDC, USPSTF, and state and local health department guidelines. FOCUS partners have conducted more than 25 million HIV, HBV and HCV tests.[11] In 2025, FOCUS partners conducted over 1 million HCV Ab tests with 52% linkage to care rate among persons who tested positive for HCV RNA. Sixty-one (61%) of HCV Ab tests occurred in Emergency Departments. Almost 55% of persons who tested positive for HCV RNA came from the Emergency Department, making up the largest proportion of chronic infection among all setting types. FOCUS partners are also screening for and diagnosing chronic HCV in other setting types outside of primary care, reaching people where they are accessing health services.

Further, FOCUS partners are leveraging new testing technology to improve HCV RNA turnaround times through point of care implementation across setting types. In collaboration with clinical laboratory teams, FOCUS partners developed a venous specimen protocol lab-based test for use on a point of care platform in the hospital setting. Transitioning Emergency Department-based point-of-care HCV RNA confirmatory testing from Standard Lab to venous specimens reduced turnaround time from 2,354 to 179 minutes and increased same-visit linkage opportunities from 0% to 71% [12].

Three lessons from FOCUS partners bear directly on this NCD:

- Screening works when it is routine: Programs that test every eligible adult, using electronic health record prompts and opt-out consent, find infections that risk-based screening misses and reduce variation between clinicians.

- Much of the yield is outside primary care: At a FOCUS-supported safety-net system in Chicago, routine screening across emergency, inpatient, and outpatient entry points tested 21,018 adults; 6% were antibody-positive, and 68% of reflexed samples were HCV RNA-positive.[13] Under existing NCD 210.13, screening ordered for a Medicare beneficiary in that system’s emergency department or inpatient units would not be covered.

- Coverage determines sustainability: Health systems can build a screening and linkage to care workflow with grant support, but they implement it only if the test is reimbursed in the setting where it is ordered. A coverage rule limited to primary care leaves the most productive screening sites dependent on temporary funding.

CMS has a ready model. NCD 210.7 covers HIV screening when ordered by “the beneficiary’s physician or practitioner within the context of a healthcare setting,” with no primary care limitation.[7] Gilead recommends that CMS adopt the same language for HCV, so that screening is covered when ordered by any physician or qualified practitioner and furnished by an eligible Medicare provider. Coverage should plainly reach emergency departments, urgent care, hospital inpatient and outpatient departments, federally qualified health centers and rural health clinics, opioid treatment programs and other substance use disorder and behavioral health settings, infectious disease and obstetrics and gynecology practices, and skilled nursing facilities. Coverage should not be limited to a traditional primary care setting.

4. Direct-acting antivirals make screening actionable

The strongest reason to expand screening is that a diagnosis now leads to a cure. When NCD 210.13 was written, DAAs had been on the market for only a short time and the NCD referred to them sparingly. Today, all-oral DAA regimens cure more than 95% of patients with 8 to 12 weeks of therapy, across genotypes, and can be prescribed in primary care and other non-specialist settings. The USPSTF found that DAA regimens are associated with fewer harms and a shorter treatment course than the interferon-based therapies they replaced.[1]

Cure changes long-term outcomes. In a prospective cohort of nearly 10,000 patients, DAA treatment was associated with roughly half the risk of death from any cause and about one-third lower risk of hepatocellular carcinoma, compared with no treatment.[14] These benefits of early diagnosis significantly favor the conclusion that expanded screening is reasonable and necessary for Medicare beneficiaries.

A screening benefit delivers that value only if a reactive result becomes a confirmed diagnosis. Roughly one in eight people with a positive HCV test in CDC’s national cascade never received RNA testing,[4] and fewer than one in three insured people diagnosed with HCV began treatment within a year.[15] In the DETECT trial, fewer than one in ten newly diagnosed patients had a documented cure.[16] Gilead therefore recommends that the revised NCD:

- Cover reflex HCV RNA testing on the same specimen following a reactive antibody test, as CDC and AASLD-IDSA recommend,[2][3] so that no second visit is needed.

- Cover FDA-authorized point-of-care tests, including the CLIA-waived fingerstick HCV RNA test authorized in June 2024, which returns a result in about an hour.[17]

- Describe covered tests by FDA status rather than by technology, so that new modalities, including self-collected tests if authorized, are covered without another reconsideration.

Conclusion

HCV is a curable infection, and Medicare’s screening benefit should reflect that. Aligning NCD 210.13 with the USPSTF recommendation by covering one-time screening for all adults aged 18 to 79, covering periodic screening for beneficiaries with ongoing risk (using person-first language and HCV RNA testing for those previously infected), covering the full diagnostic sequence, including reflex HCV RNA testing and FDA-authorized point-of-care tests described by FDA status rather than by technology, and covering screening wherever beneficiaries receive care would bring Medicare into line with current evidence and with the national goal of eliminating viral hepatitis.

Gilead appreciates the opportunity to provide comment as it develops the proposed decision memorandum. If you have any questions, please contact Laura Okpala at laura.okpala@gilead.com.

Sincerely,

Rekha Ramesh Vice President, U.S. Policy Government Affairs Gilead Sciences, Inc.

References

[1] US Preventive Services Task Force. Screening for Hepatitis C Virus Infection in Adolescents and Adults: US Preventive Services Task Force Recommendation Statement. JAMA. 2020;323(10):970–975. doi:10.1001/jama.2020.1123

[2] Schillie S, Wester C, Osborne M, Wesolowski L, Ryerson AB. CDC Recommendations for Hepatitis C Screening Among Adults — United States, 2020. MMWR Recomm Rep. 2020;69(2):1–17. doi:10.15585/mmwr.rr6902a1

[3] AASLD-IDSA. HCV Guidance: Recommendations for Testing, Managing, and Treating Hepatitis C. HCV Testing and Linkage to Care. hcvguidelines.org. Accessed October 6, 2026.

[4] Wester C, Osinubi A, Kaufman HW, et al. Hepatitis C Virus Clearance Cascade — United States, 2013–2022. MMWR Morb Mortal Wkly Rep. 2023;72(26):716–720. doi:10.15585/mmwr.mm7226a3

[5] Zhu L, Furukawa NW, Thompson WW, et al. Health and Economic Impact of Periodic Hepatitis C Virus Testing Among People Who Inject Drugs. JAMA Health Forum. 2025;6(7):e251870. Full text

[6] Hajarizadeh B, Cunningham EB, Valerio H, et al. Hepatitis C reinfection after successful antiviral treatment among people who inject drugs: A meta-analysis. J Hepatol. 2020;72(4):643–657. doi:10.1016/j.jhep.2019.11.012

[7] Centers for Medicare & Medicaid Services. National Coverage Determination 210.7, Screening for the Human Immunodeficiency Virus (HIV) Infection. Effective April 13, 2015. Medicare Coverage Database

[8] Galbraith JW, Donnelly JP, Franco RA, Overton ET, Rodgers JB, Wang HE. National Estimates of Healthcare Utilization by Individuals With Hepatitis C Virus Infection in the United States. Clin Infect Dis. 2014;59(6):755–764. doi:10.1093/cid/ciu427

[9] Hluhanich R, Ford JS, Bruce D, et al. Comparing Hepatitis C Virus Screening in Clinics Versus the Emergency Department. West J Emerg Med. 2022;23(3):312–317. doi:10.5811/westjem.2021.11.53870

[10] Choi SA, Umashankar K, Maheswaran A, et al. Cost-effectiveness analysis of emergency department-based hepatitis C screening and linkage-to-care program. BMC Health Serv Res. 2024;24:1308. doi:10.1186/s12913-024-11793-4

[11] Gilead Sciences, Inc. ESG Performance. gilead.com. Accessed October 6, 2026.

[12] Gallo G, Lee L, Dinh, H, Wright, S, Parra K, Martinez D, Andrews D, Estay K, Montes De Oca V, (February 22-25, 2026). Reducing ED HCV Confirmatory Test Turnaround Time Through Point-of-Care Implementation, Conference on Retroviruses and Opportunistic Infections, Denver, CO. https://www.croiconference.org/abstract/412-2026/

[13] Hunt BR, Ahmed C, Ramirez-Mercado K, Patron C, Glick NR. Routine Screening and Linkage to Care for Hepatitis C Virus in an Urban Safety-Net Health System, 2017-2019. Public Health Rep. 2021;136(2):219–227. doi:10.1177/0033354920969179

[14] Carrat F, Fontaine H, Dorival C, et al. Clinical outcomes in patients with chronic hepatitis C after direct-acting antiviral treatment: a prospective cohort study. Lancet. 2019;393(10179):1453–1464. doi:10.1016/S0140-6736(18)32111-1

[15] Thompson WW, Symum H, Sandul A, et al. Vital Signs: Hepatitis C Treatment Among Insured Adults — United States, 2019–2020. MMWR Morb Mortal Wkly Rep. 2022;71(32):1011–1017. doi:10.15585/mmwr.mm7132e1

[16] Haukoos J, Rothman RE, Galbraith JW, et al. Hepatitis C Screening in Emergency Departments: The DETECT Hep C Randomized Clinical Trial. JAMA. Published online July 9, 2025. doi:10.1001/jama.2025.10563

[17] Cepheid. Cepheid Receives FDA Authorization with CLIA Waiver for Xpert HCV [press release]. June 27, 2024. cepheid.mediaroom.com

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To Whom It May Concern:

I am a physician with 36 years of practice in internal medicine including emergency medicine and infectious diseases. In the past few years, my practice has focused on patients at elevated risk of HIV, STIs, and viral hepatitis. Both as a clinician and as a researcher, I support CMS's decision to reconsider NCD 210.13 and to align coverage with the 2020 USPSTF Grade B recommendation for one-time HCV screening of all adults aged 18 to 79.

A. Alignment of age-based screening coverage with USPSTF

Most Medicare beneficiaries with HCV are under 65 and entitled through disability rather than age: in fee-for-service claims from 2014 to 2019, about 61% of newly diagnosed HCV patients were aged 18 to 64 [1]. Two thirds of beneficiaries who started direct-acting antivirals in 2014 to 2017 were dually eligible for Medicaid [2]. Any beneficiary in this group born after 1965 has no age-based screening coverage under the current NCD. Adopting the USPSTF 18 to 79 standard closes that gap.

B. Screening interval for people with ongoing risk

While no trial has compared testing intervals, three lines of evidence support covering screening at least once a year for any beneficiary with ongoing risk as defined by CDC and AASLD-IDSA, not only continued injection drug use. CMS should cover up to twice a year when the ordering clinician determines that risk is ongoing. Coverage should not depend on the beneficiary disclosing a specific risk behavior or on the clinician recording one, since many people will not disclose stigmatized behavior and the clinician's judgment is the appropriate basis for the order. This matches the cost-effectiveness frontier and does not endorse quarterly or monthly testing, which the CDC model cited below shows to be far less cost-effective.

On a related point, people who have cleared HCV or been cured stay antibody-positive for life. Repeat antibody testing cannot detect reinfection. The NCD should state clearly that HCV RNA testing, laboratory or point-of-care, is a covered screening test for anyone with prior infection, and as reflex testing after a reactive antibody, consistent with CDC's 2023 guidance on single-visit testing [10].

1) Measured incidence: In a meta-analysis of 36 studies, HCV reinfection after cure was 6.2 per 100 person-years among people with recent injecting, and 1.4 per 100 person-years among people on opioid agonist therapy without recent drug use [3]. In the US HERO trial, reinfection among people who inject drugs was 11.4 per 100 person-years overall and 15.5 per 100 person-years in the first six months after cure [4]. Among men who have sex with men on PrEP, pooled incidence was 0.83 per 100 person-years [5]. At these rates, annual testing leaves a new infection undiagnosed, and transmissible, for about six months on average.

2) Cost-effectiveness: A CDC-coauthored model of testing frequency among people who inject drugs found that annual and six-monthly testing cost $6,000 to $14,000 per QALY, every three months cost $24,000 to $30,000 per QALY, and monthly testing cost over $90,000 per QALY. In high-transmission networks, annual testing was dominated and six-monthly testing was on the efficiency frontier [6].

3) Guidelines: AASLD-IDSA recommends at least annual testing for people who inject drugs and for men who have sex with men who have HIV or take PrEP, with more frequent testing when risk is higher [7]. CDC recommends periodic testing while risk persists [8]. KDIGO recommends testing in-center hemodialysis patients every six months [9].

C. Screening in non-primary-care settings

The current NCD excludes emergency departments, inpatient settings, skilled nursing facilities, limited-focus clinics, and other non-traditional healthcare settings. These are the settings where undiagnosed HCV is concentrated and can be directly addressed.

Opt-out screening at four urban EDs tested 14,252 patients. 9.2% were antibody-positive and about 4.9% had active infection, roughly 50 times the 0.1% prevalence threshold CDC uses for universal screening. Nearly half of the antibody-positive patients were born after 1965 [11]. In a Baltimore ED, birth-cohort plus risk-based testing would have missed about one quarter of undiagnosed infections [12]. Universal opt-out screening in prisons costs $19,600 to $29,200 per QALY and prevents most new infections in the community after release [13]. The HERO randomized trial cured people actively injecting drugs at opioid treatment programs and community health centers in eight US cities [14].

CMS's 2014 rationale was that USPSTF evaluates services in primary care and that primary care coordinates follow-up [15]. USPSTF's scope describes who performs a service, not where it is reimbursable. CDC's 2020 recommendation is framed by setting prevalence, and EDs and addiction programs exceed the threshold many times over [8]. Reflex RNA testing, FDA-authorized point-of-care RNA testing [16], and patient navigation now handle coordination within the testing encounter. CMS already recognized this for HIV. NCD 210.7 covers screening ordered "within the context of a healthcare setting" [17].

Infectious disease, addiction medicine, emergency, hospital, nephrology, family practice, community doctors and other clinicians should be able to order a covered test. Medicine today is about meeting patients where they are. Whether a clinician decides the right place for a test is a traditional setting or a non-traditional one, such as a home, a school, a shelter, or a syringe services site, the NCD should cover it.

CMS should replace "primary care physician or practitioner within the context of a primary care setting" with "physician or practitioner within any setting deemed appropriate by that practitioner," consistent with the healthcare-setting approach CMS took in NCD 210.7. As compared to the current implementing transmittal (CR 8871, Transmittal R3215CP) [18], the new transmittal should delete the specialty list restriction and the place-of-service and bill-type restrictions. It should also strike the sentence in section 210.1 requiring that outpatient hospital screening be ordered "within the context of a primary care setting."

For the universal one-time screen, the new transmittal should accept Z11.59 with no risk code. For repeat screening, it should accept a screening or exposure code chosen by the clinician and should not require a substance use diagnosis as a condition of payment. To allow twice-yearly screening when the clinician determines risk is ongoing, the 11-month rule should become a 5-month rule. CMS should also ensure the NCD covers screening during pregnancy, as CDC recommends [8] and as NCD 210.7 does for HIV [17]. And before finalizing, CMS should analyze Part B claims for G0472 and G0567 by place of service and ordering specialty to identify which of these edits produce denials today.

D. Point-of-care RNA testing, self-collected specimens, and payment

Two testing methods now make single-visit diagnosis possible outside the clinic. Both are covered in principle by the existing NCD's test language, but neither is paid at a level that supports implementation.

Point-of-care RNA: The FDA authorized a CLIA-waived fingerstick HCV RNA test in June 2024 [16]. In the US registrational study at 15 CLIA-waived sites, positive agreement with laboratory RNA was 93.4% and negative agreement 99.8% [19]. A WHO-commissioned meta-analysis of 45 studies found that point-of-care RNA testing cut the median time from antibody test to treatment from 67 days to 19 days, and raised treatment uptake from 53% with laboratory testing to 77% with onsite point-of-care testing [20]. In a controlled study in an Australian reception prison, treatment within 12 weeks rose from 22% under standard care to 93% with point-of-care RNA testing on entry [21]. Independent cost-effectiveness analyses support point-of-care RNA in high-prevalence settings where people often do not return: prisons and jails, syringe services programs, opioid treatment programs, and safety-net emergency departments [22]. They do not support it as a replacement for all antibody testing. CMS should cover point-of-care RNA as a screening modality in any setting and leave the choice of method to the clinician.

Payment: On the 2026 Clinical Laboratory Fee Schedule, G0567 (RNA screening) pays $35.09, the same as 87521, the laboratory platform code it was crosswalked to [27]. The QW modifier allows a CLIA-waived site to bill but does not change the amount. A single-use point-of-care RNA cartridge costs about $30 in a bulk purchasing program, and the instrument costs $21,000 to $39,000. A laboratory analysis of more than 325,000 HCV results in one US health system concluded that point-of-care RNA testing in the safety-net emergency department was the efficient use of the technology and that it requires "specific reimbursement and funding mechanisms" [23]. The $35.09 rate leaves no room for the instrument, controls, or staff time. Because no existing modifier can carry a different absolute rate, CMS should establish a distinct code for point-of-care HCV RNA screening and price it by gapfill, or request reconsideration of the G0567 crosswalk at the next CLFS annual meeting.

Self-collected specimens: Dried blood spot and capillary specimens tested in a clinical laboratory detect HCV antibody with about 96% sensitivity and 99% specificity, and HCV RNA with about 98% sensitivity and 99% specificity, compared with venous samples [24]. Mailed collection programs reach people who do not come to clinics; in one mail-in program, about one quarter of users had never tested before [25]. The current transmittal does not restrict specimen source, and a laboratory can bill G0472 or G0567 at POS 81 for a specimen collected at home. The new transmittal should keep it that way and should state that a practitioner-ordered screening test on a specimen the beneficiary collected, using a lawfully marketed collection device, is covered on the same terms as a clinic draw. The gap is a lack of coverage for the collection kit and return transport. In a similar example, Medicare pays for mailed colorectal screening kits with the kit included in the laboratory rate (e.g. 81528 at $508.87) [27]. CMS should establish a code for HCV screening on a self-collected specimen that includes the kit, return transport, and laboratory analysis, priced by gapfill.

Reflex testing: Whatever the method, a reactive antibody should lead to an RNA result without a second visit. When Quest Diagnostics stopped offering stand-alone antibody orders in 2015, RNA follow-up of antibody-positive patients rose from 53% to 97% [26]. A meta-analysis found laboratory reflex testing raised RNA completion to 95% [28]. The transmittal should state that G0567 is payable as a reflex on a reactive G0472 without a separate order.

Thank you for your attention.

Aruna Mittapalli, MD
Medical Director
Neelyx Labs

[1] Zhang H, Bao Y, Hutchings K, et al. Association between claims-based setting of diagnosis and treatment initiation among Medicare patients with hepatitis C. Health Serv Res. 2024. doi:10.1111/1475-6773.14330. PMID 38773839

[2] Tran L, Jung J, Feldman R, Riley T. Disparities in the quality of care for chronic hepatitis C among Medicare beneficiaries. PLoS One. 2022;17(3):e0263913. doi:10.1371/journal.pone.0263913

[3] Hajarizadeh B, Cunningham EB, Valerio H, et al. Hepatitis C reinfection after successful antiviral treatment among people who inject drugs: a meta-analysis. J Hepatol. 2020;72(4):643-657. doi:10.1016/j.jhep.2019.11.012

[4] Litwin AH, Tsui JI, Heo M, et al. Hepatitis C virus reinfection among people who inject drugs: long-term follow-up of the HERO study. JAMA Netw Open. 2024;7(8):e2430024. doi:10.1001/jamanetworkopen.2024.30024

[5] Traeger MW, Harney BL, Sacks-Davis R, et al. Incidence and prevalence of hepatitis C virus among HIV-negative gay and bisexual men using HIV pre-exposure prophylaxis: a systematic review and meta-analysis. Open Forum Infect Dis. 2023;10(8):ofad401.

[6] Zhu L, Furukawa NW, Thompson WW, et al. Health and economic impact of periodic hepatitis C virus testing among people who inject drugs. JAMA Health Forum. 2025;6(7):e251870. doi:10.1001/jamahealthforum.2025.1870

[7] Ghany MG, Morgan TR; AASLD-IDSA Hepatitis C Guidance Panel. Hepatitis C guidance 2019 update: AASLD-IDSA recommendations for testing, managing, and treating hepatitis C virus infection. Hepatology. 2020;71(2):686-721. doi:10.1002/hep.31060. Current guidance at hcvguidelines.org.

[8] Schillie S, Wester C, Osborne M, Wesolowski L, Ryerson AB. CDC recommendations for hepatitis C screening among adults, United States, 2020. MMWR Recomm Rep. 2020;69(RR-2):1-17. doi:10.15585/mmwr.rr6902a1

[9] Kidney Disease: Improving Global Outcomes (KDIGO) Hepatitis C Work Group. KDIGO 2022 clinical practice guideline for the prevention, diagnosis, evaluation, and treatment of hepatitis C in chronic kidney disease. Kidney Int. 2022;102(6S):S129-S205.

[10] Cartwright EJ, Patel P, Kamili S, Wester C. Updated operational guidance for implementing CDC's recommendations on testing for hepatitis C virus infection. MMWR Morb Mortal Wkly Rep. 2023;72(28):766-768. doi:10.15585/mmwr.mm7228a2

[11] Galbraith JW, Anderson ES, Hsieh YH, et al. High prevalence of hepatitis C infection among adult patients at four urban emergency departments, Birmingham, Oakland, Baltimore, and Boston, 2015-2017. MMWR Morb Mortal Wkly Rep. 2020;69(19):569-574. doi:10.15585/mmwr.mm6919a1

[12] Hsieh YH, Rothman RE, Laeyendecker OB, et al. Evaluation of the Centers for Disease Control and Prevention recommendations for hepatitis C virus testing in an urban emergency department. Clin Infect Dis. 2016;62(9):1059-1065.

[13] He T, Li K, Roberts MS, et al. Prevention of hepatitis C by screening and treatment in U.S. prisons. Ann Intern Med. 2016;164(2):84-92. doi:10.7326/M15-0617

[14] Litwin AH, Lum PJ, Taylor LE, et al. Patient-centred models of hepatitis C treatment for people who inject drugs: a multicentre, pragmatic randomised trial. Lancet Gastroenterol Hepatol. 2022;7(12):1112-1127. doi:10.1016/S2468-1253(22)00275-8

[15] Centers for Medicare & Medicaid Services. Decision memo for screening for hepatitis C virus (HCV) in adults (CAG-00436N). June 2, 2014.

[16] U.S. Food and Drug Administration. FDA permits marketing of first point-of-care hepatitis C RNA test (Cepheid Xpert HCV). June 27, 2024.

[17] Centers for Medicare & Medicaid Services. Decision memo for screening for the human immunodeficiency virus (HIV) infection (CAG-00409R). April 13, 2015. NCD 210.7.

[18] Centers for Medicare & Medicaid Services. Transmittal R3215CP, Change Request 8871, Screening for Hepatitis C Virus (HCV) in Adults. March 11, 2015. Updated by Change Request 14119 (G0567), 2024. Medicare Claims Processing Manual, Chapter 18, Section 210.

[19] Havens JR, Fluker SA, Schimmel J, et al. Performance evaluation of the Xpert HCV test on fingerstick blood in a prospective observational clinical study at CLIA-waived sites in the United States. Clin Infect Dis. 2026;83(1):e71-e78. doi:10.1093/cid/ciag173. PMID 41823658

[20] Trickey A, Fajardo E, Alemu D, Artenie AA, Easterbrook P. Impact of hepatitis C virus point-of-care RNA viral load testing compared with laboratory-based testing on uptake of RNA testing and treatment, and turnaround times: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol. 2023;8(3):253-270. doi:10.1016/S2468-1253(22)00346-6

[21] Sheehan Y, Cunningham EB, Cochrane A, et al. A "one-stop-shop" point-of-care hepatitis C RNA testing intervention to enhance treatment uptake in a reception prison: the PIVOT study. J Hepatol. 2023;79(3):635-644. doi:10.1016/j.jhep.2023.04.019

[22] Shih STF, Cheng Q, Carson J, et al. Optimizing point-of-care testing strategies for diagnosis and treatment of hepatitis C virus infection in Australia: a model-based cost-effectiveness analysis. Lancet Reg Health West Pac. 2023;36:100750.

[23] Helm EW, Kim HN, Greninger AL. Optimizing hepatitis C virus testing in the era of point-of-care RNA diagnostics. J Clin Microbiol. 2026;64(1):e01259-25. doi:10.1128/jcm.01259-25

[24] Vázquez-Morón S, Ardizone Jiménez B, Jiménez-Sousa MA, et al. Evaluation of the diagnostic accuracy of laboratory-based screening for hepatitis C in dried blood spot samples: a systematic review and meta-analysis. Sci Rep. 2019;9:7316. PMCID PMC6514168

[25] Hecht J, Facente SN, Cohen S, et al. TakeMeHome: a novel method for reaching previously untested people through online ordering and self-collect HIV and STI testing. Sex Transm Dis. 2024;51(12):803-809. doi:10.1097/OLQ.0000000000002058

[26] Ly KN, Niles JK, Jiles RB, et al. Hepatitis C virus antibody and RNA testing, Quest Diagnostics, 2013-2021. Public Health Rep. 2024. doi:10.1177/00333549231224199

[27] Centers for Medicare & Medicaid Services. Clinical Laboratory Fee Schedule, CY2026 Q4 public use file.

[28] Tao Y, Tang W, Fajardo E, et al. Reflex hepatitis C virus viral load testing following an initial positive hepatitis C virus antibody test: a global systematic review and meta-analysis. Clin Infect Dis. 2023;77(8):1137-1156. PMID 37648655

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Blue Cross Blue Shield of Michigan appreciates the opportunity to submit a comment regarding the proposed alignment of the National Coverage Determination (CND) for Hepatitis C Virus (HCV) Screening in Adults with the US Preventative Services Task Force (USPSTF) guidelines.

We are in support of CMS updating NCD 210.13 to align with the current USPSTF recommendation. Medicare coverage should be revised to provide a one-time HCV screening for all eligible Medicare beneficiaries regardless of birth cohort with periodic rescreening for individuals who remain at risk for acquiring an HCV infection. We recommend that CMS cover annual HCV screening for beneficiaries with ongoing risk factors, particularly those with continued injection drug use, consistent with current evidence and national clinical guidelines. We also recommend allowing clinician discretion for more frequent testing when medically appropriate based on the individual’s risk profile and potential exposure. Additionally, we recommend CMS consider removing the current restriction requiring screening to be ordered and performed within a primary care setting.

Contemporary evidence demonstrates that emergency departments and other non-primary care settings are effective venues for identifying previously undiagnosed HCV infection, reaching populations that may not routinely access primary care and facilitating linkage to curative treatment. Expanding coverage to these settings would improve access to screening and support earlier diagnosis and treatment. Updating Medicare coverage in this manner would increase identification of undiagnosed HCV infection, reduce barriers to screening, support national HCV elimination efforts and better align with Medicare policy with current evidence-based clinical practice and national screening recommendations.

Key peer-reviewed references supporting this recommendation are as follows:

1. US Preventive Services Task Force. Screening for Hepatitis C Virus Infection in Adolescents and Adults. JAMA. 2020;323(10):970-975.
o Supports one-time universal screening for adults aged 18-79 years and periodic rescreening for individuals with ongoing risk factors.

2. Bhattacharya D, Aronsohn A, Price J, Lo Re V, et al. Hepatitis C Guidance 2023 Update: AASLD-IDSA Recommendations for Testing, Managing, and Treating HCV Infection. Clinical Infectious Diseases. 2023.
o Supports universal screening and periodic testing among populations with ongoing risk for HCV acquisition.

3. Hluhanich R, et al. Comparing Hepatitis C Virus Screening in Clinics Versus the Emergency Department. Western Journal of Emergency Medicine. 2022.
o Demonstrated a significantly higher yield of newly identified HCV infections through emergency department screening programs.

4. Jones AT, et al. Emergency Department versus Community Screening on Hepatitis C Follow-Up Care. American Journal of Emergency Medicine. 2022.
o Demonstrated successful linkage to care and treatment following emergency department-based HCV screening.

5. Haukoos JS, et al. DETECT Hep C Screening Trial. Trials. 2022.
o Supports emergency departments as important screening settings for identifying at-risk individuals who may not otherwise engage in primary care.

Thank you for the opportunity to comment on this NCA. Should you wish to discuss further please reach out to Laurrie Knight at LKnight@bcbsm.com.

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Dear CMS,

Thank you for the opportunity to comment on the National Coverage Analysis (CAG-00436R) to solicit input on updating the Medicare National Coverage Determination (NCD 210.13) for hepatitis C virus (HCV) screening in adults. I am writing as an individual (not on behalf of any government organization) with more than 18 years of experience leading a state health department hepatitis C program to make the following recommendations:

1) At minimum, cover one-time screening for all adults ages 18-79

a. Covering one-time hepatitis C screening for all adults ages 18-79 would align with recommendations of the U.S. Preventive Services Task Force (USPSTF) and U.S. Centers for Disease Control and Prevention (CDC).
b. Association for the Advanced Study of Liver Diseases (AASLD)/Infectious Diseases Society of America (IDSA) HCV guidelines recommend “One-time, routine, opt-out HCV testing for all individuals aged 18 years or older.”
c. Patterns of drug use, incarceration, and other HCV risk factors change over time. Rates of hepatitis C rose among young adults during the opioid epidemic-related shift from oral pill use to injection drug use—then fell as people switched from injecting heroin to smoking fentanyl, though this trend could change again at any time. The illicit drug supply is inherently unpredictable, which makes patterns of drug-related viral hepatitis infections unpredictable as well. Given how much the epidemiology of hepatitis C has changed since CMS last updated its policy, and how infrequently CMS updates its policies, encompassing all adults will enable Medicare providers to identify hepatitis C infections in all adult across age cohorts as drug use patterns and epidemiologic trends in HCV infections continue to co-evolve.

2) Cover hepatitis C screening during each pregnancy (regardless of underlying epidemiology)

a. Covering hepatitis C screening during each pregnancy would align with American College of Obstetrics and Gynecology (ACOG) recommendations.
b. Pregnancy screening coverage would also enable diagnosing clinicians to screen the pregnant patient’s other children and ensure the pregnant patient gets access to curative hepatitis C treatment after delivery, which would prevent potential vertical hepatitis C transmission in future pregnancies.
c. While CDC only recommends HCV screening in pregnancy in settings with at least 0.5% prevalence, Medicare should not impose this restriction because it may be too difficult for health systems to apply across a range of facilities where the prevalence of hepatitis C may vary. Covering hepatitis C screening in pregnancy regardless of underlying epidemiology would not *require* such screening. Thus, providers who truly find that less than 1 in a 1,000 pregnant patients test HCV antibody or RNA positive can curtail screening in their facility if they find it is not cost-effective.

3) Cover periodic hepatitis C screening in settings that are more likely to serve people at ongoing risk for hepatitis C

a. Currently, Medicare hepatitis C screening coverage is limited to primary care settings. However, research has consistently shown that people who inject drugs—and who are the highest risk for hepatitis C—often do not access primary care due to fear of stigma and other barriers to health care, such as transportation, competing survival priorities, and housing instability. Instead, people who inject drugs are often better reached in non-traditional settings, such as drug treatment programs, emergency departments, street medicine settings, and via telehealth.
b. In my experience managing a project that distributed thousands of in-kind hepatitis C rapid test kits to local health departments and community-based organizations in California, we consistently found the highest hepatitis C antibody positivity (>10%) in settings such as drug treatment programs, jails, outreach/mobile health/street medicine programs, and syringe services programs. A separate project supporting routine opt-out testing for HCV in emergency departments across California recently found 6% HCV antibody positivity, which is at least quadruple that of the general population.

Based on these and similar findings in other states, CMS should cover periodic screening based on settings, rather than individual level risk factors, which providers may be unwilling to solicit and patients may be unwilling to disclose. Priority Place of Service codes could include, but not be limited to:

i. 04 – homeless shelter
ii. 05 – 08 – tribal and Indian health facilities
iii. 09 – correctional facility
iv. 15 – mobile unit
v. 16 – temporary lodging
vi. 23 – emergency room/hospital
vii. 25 – birthing center
viii. 27 – outreach/street site
ix. 55-58 – mental health and substance use facilities
x. 71/72 – public health/rural health clinic

4) Cover reflex hepatitis C antibody to RNA testing to ensure complete diagnosis

a. CDC, AASLD/IDSA, and the Association of Public Health Laboratories all recommend that hepatitis C screening be immediately followed by a test for hepatitis C ribonucleic acid (RNA), which is needed to diagnose current infection. Such testing should ideally be performed on the same day at the same visit (using blood collected at the same time). Yet some healthcare providers still order antibody only testing, leaving patients confused about whether they are truly infected, either because they are concerned about RNA testing reimbursement or do not know about the current guidelines. In my experience evaluating HCV testing and linkage to care demonstration projects in California, when patients with a reactive HCV antibody result are asked to return to a laboratory or providers office for a second blood draw for HCV RNA testing, they often do not return and get lost to follow up.
b. CMS should make clear in its policy that HCV screening entails screening for HCV antibody with an automatic reflex to HCV RNA. Major commercial laboratories offer reflex testing, but some hospitals and primary care clinics may still be following old protocols that do not reflect national guidelines.
c. Including HCV antibody to RNA reflex testing in its recommendations will enable CMS to make clear to providers that such testing will be covered.

5) Cover periodic (e.g., annual) screening for people at ongoing risk, including people who ask for an HCV test

a. CMS asks for an ideal interval for screening. While recommendations vary, annual screening seems reasonable but this should be flexible.
b. In addition to the settings-based coverage recommended above, CMS should also cover periodic screening for people at ongoing risk, including people who inject drugs, people on hemodialysis, people with HIV, and people on HIV pre-exposure prophylaxis (PrEP).
c. CMS should cover HCV screening for people who request a test to cover testing among people who may not want to disclose stigmatized behaviors.

Expanding the CMS screening policy has the potential to greatly increase the number of people with hepatitis C who are aware of their infection and get treated and cured. This will in turn associated costs to Medicare for preventable liver transplantations and other liver-related hospitalization costs as well as prevent forward hepatitis C transmission. Thank you for your consideration.

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JoAnna Baldwin
Director
Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: National Coverage Analysis for Screening for Hepatitis C Virus (HCV) in Adults

Dear Ms. Baldwin:

The American Association for the Study of Liver Diseases (AASLD) appreciates the opportunity to comment on this reconsideration of National Coverage Determination 210.13 (Screening for Hepatitis C Virus (HCV) in Adults). We urge the Centers for Medicare & Medicaid Services (CMS) to modernize coverage of hepatitis C screening based on the joint AASLD and Infectious Diseases Society of America (IDSA) guidance (“the Guidance”) and the U.S. Preventive Services Task Force Grade B recommendation to screen all adults aged 18 to 79.

The AASLD is the leading member organization of scientists, researchers, and allied health care professionals committed to the prevention and cure of liver disease. The AASLD actively promotes liver health and quality patient care. Our members foster research, advance science, and provide practice guidance for hepatology through educational conferences, training programs, professional publications, and health policy advocacy. To achieve these goals, we have formed partnerships with patient organizations, government agencies, sister societies, and pharmaceutical companies. As such, we are committed to advancing policies that support the health of American patients who are living with the full spectrum of liver diseases.

Expand Routine Screening Eligibility

The AASLD supports covering one-time screening for all adults aged 18-79 consistent with the scope of this reconsideration, rather than limiting routine eligibility to the 1945-1965 birth cohort. The Guidance recommends routine opt-out testing for all adults aged 18 and older and screening during each pregnancy. CMS should expand coverage for adults and preserve existing risk-based eligibility for older Medicare beneficiaries clarifying applicable coverage pathways for clinically indicated testing outside the routine age range.

Earlier identification creates an opportunity to offer treatment before complications develop. The Guidance recommends treatment for nearly all people with acute or chronic HCV infection, except those with a short life expectancy that cannot be improved through therapy, liver transplantation, or another directed therapy. Screening policy should support this connection between diagnosis and effective care.

One-time universal adult HCV screening is justified because chronic HCV infection is common, asymptomatic, curable, and associated with substantial downstream morbidity and mortality. Universal screening outperforms risk-based approaches, facilitates implementation, reduces transmission, and is an essential component of national hepatitis C elimination efforts. With new point of care diagnostics, the new standard of care will be test and treat models to achieve elimination.

Cover Repeat Testing According to Ongoing Risk

The AASLD recommends that CMS revise NCD 210.13 to provide coverage for repeat HCV screening at least annually for those with ongoing risk of HCV infection, with more frequent testing permitted when clinically indicated. The current coverage policy, which limits annual repeat screening to individuals with continued injection drug use following a negative screening test, is unnecessarily restrictive and fails to account for other populations at increased risk of acquiring HCV.

Repeat testing should encompass other populations addressed by the Guidance, which recommends at least annual testing for individuals who inject drugs and men with HIV who have unprotected sex with men, including those with prior HCV exposure. For these populations, annual testing is recommended. Therefore, the AASLD urges CMS to adopt a coverage policy that provides for this regular testing. This recommendation is supported by epidemiological studies documenting elevated rates of HCV acquisition among these populations. For example, men with HIV who have sex with men experienced approximately six times the incidence of HCV infection compared with men without HIV. The Swiss HIV Cohort Study documented increasing HCV incidence among men with HIV who have sex with men. Similarly, the initiation of injection drug use was found to be associated with a substantially increased risk of HCV seroconversion, underscoring the importance of reassessing testing needs as exposure risks change.

Evidence also supports the clinical and economic value of periodic screening. Linas et al. evaluated the cost-effectiveness of different HCV screening strategies among men with HIV who have sex with men and found that routine screening improved life expectancy and was cost effective compared with symptom-based testing alone. The analysis supported periodic screening strategies, including annual HCV antibody testing combined with liver function testing every six months, while finding that more frequent monitoring could be appropriate in populations with higher HCV incidence. While the analysis predates the availability of direct-acting antiviral therapies, it provides evidence that repeat screening offers benefits beyond one-time testing.

The Guidance acknowledges that evidence establishing the optimal frequency of repeat testing remains limited and recommends that clinicians determine testing intervals based on individual risk of infection or reinfection. Accordingly, CMS should not establish a rigid annual testing limit that could prevent individuals with ongoing or increased exposure risk from receiving more frequent testing when medically appropriate. Instead, CMS should establish coverage for at least annual screening among individuals with ongoing risk and permit additional testing based on clinical judgement and patient circumstances.

Remove the Primary Care Ordering Restrictions

CMS should cover screening ordered by eligible treating clinicians in appropriate settings beyond primary care. Requiring a separate primary care encounter creates an avoidable barrier when a beneficiary is already receiving care elsewhere. The Guidance recommends integrating testing in substance use disorder treatment and syringe service programs with confirmatory testing and linkage to care. We urge CMS to accommodate these services through eligible Medicare providers, as well as screening in emergency departments and specialty practices.

Peer-reviewed evidence supports emergency department screening. The multicenter DETECT Hep C randomized trial found that nontargeted screening identified more new infections than targeted screening across three urban emergency departments. However, relatively few newly diagnosed patients reached treatment and sustained virologic response. These findings support broader screening and stronger linkage-to-care arrangements; they do not establish that screening alone ensures cure.

Additionally, the AASLD recommends that this coverage policy cover Food and Drug Administration (FDA)-approved point-of-care testing for hepatitis C, consistent with labeling and applicable laboratory requirements. Point-of-care HCV RNA testing offers an important opportunity to improve screening and linkage to care by providing results during the same patient encounter, reducing the need for multiple visits and minimizing loss to follow-up. It is particularly important to increase access in settings where those at risk of infection typically receive care, including in syringe services programs, emergency departments, and tribal health settings. The Guidance’s point-of-care test-and-treat algorithm supports reducing delays between diagnosis and treatment. These approaches should complement laboratory-based testing and referral arrangements.

CMS has already established coverage for HCV PCR screening under NCD 210.13 through the creation of HCPCS code G0567 and subsequent implementation instructions, but coverage is currently limited to certain places of service (POS 11, 19, 22, 49, 71, and 81). The AASLD recommends that CMS build upon this existing coverage policy by explicitly recognizing HCV PCR screening as a covered screening modality in the revised NCD, consistent with the Guidance’s point-of-care test-and-treat recommendations. CMS should also expand coverage of HCPCS code G0567 to all appropriate point-of-care settings operating under a valid Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver, including POS codes 04, 05, 06, 07, 08, 09, 15, 20, 23, 27, 50, 55, 57, 58, and 72. Expanding coverage to these settings would better align Medicare policy with evidence-based screening practices, support innovative approaches to reaching underserved and high-risk populations, and reduce missed opportunities to identify and treat HCV infection.

With an FDA-approved point-of-care diagnostic, the test-to-treat model of diagnosis and care can be adopted at these various sites of service. In addition, we respectfully request that CMS direct that this model be covered and reimbursement by Medicare Advantage plans, in addition to traditional Medicare, regardless of empanelment. With more than half of Medicare beneficiaries enrolled in Medicare Advantage plans, the AASLD believes this is critical to realize the promise of the test-to-treat model.

In summary, we urge CMS to adopt a policy that expands routine screening, covers risk-based repeat testing, removes unnecessary setting restrictions, and facilitates diagnosis and treatment. These changes would strengthen Medicare beneficiaries’ access to hepatitis C care. Should you have any questions or require further information, please contact Matthew D’Uva, the AASLD’s CEO, at mduva@aasld.org.

Sincerely,
Saul J. Karpen, MD, PhD, FAASLD
AASLD President

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I recommend expanding Medicare's Hepatitis C screening policy to include,

- all adults 18-79, to be consistent with CDC and US Preventive Services Task Force guidelines
- people in other settings than primary care, such as emergency departments or inpatient facilities
- reflex testing from positive HCV antibody to an RNA test (and all labs should do this automatically!)
- ongoing periodic screening for people with ongoing risk, especially in settings with high positivity like EDs and drug treatment programs
- testing during pregnancy

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October 22, 2026

VIA Electronic Submission to cms.gov

JoAnna Baldwin
Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Dear Ms. Baldwin:

On behalf of the Point of Care Testing Association (POCTA), we are pleased to provide comments in response to the opening of the above-captioned tracking sheet.

POCTA is a collaborative effort among manufacturers of point of care (POC) diagnostic technologies that enable clinicians to monitor chronic conditions, diagnose illnesses, and provide timely information for patients in a variety of care settings, from physician offices to pharmacies to urgent care centers to non-hospital facilities. POCTA seeks to facilitate access to safe, effective, and cost-effective patient testing at the time of treatment. POCTA works to develop reimbursement and regulatory policies that can improve health outcomes by supporting access to POC testing.

POCTA strongly supports stakeholder requests to revise NCD 210.13 “Screening for Hepatitis C Virus (HCV) in Adults” to align with United States Preventive Services Task Force (USPSTF) guidelines, which recommend HCV screening for all adults aged 18 to 79 years, including those who would not be considered “high risk” for HCV, or were born before 1945 or after 1965. Insofar as CMS is also considering other elements of the NCD – e.g., how often patients should receive screening, and whether screening should be made available in non-primary care settings – POCTA urges CMS to consider the following:

NCD 210.13 currently covers HCV screening tests only “when ordered by the beneficiary’s primary care physician or practitioner within the context of a primary care setting,” and excludes coverage in settings such as “[e]mergency departments, inpatient hospital settings, ambulatory surgical centers, independent diagnostic testing facilities, skilled nursing facilities, inpatient rehabilitation facilities, [and] clinics providing a limited focus of health care services.”¹ As such, CMS only pays for HCV screening when furnished in place of service (POS) 11 (office), 19 (off-campus outpatient hospital), 22 (on-campus outpatient hospital), 49 (independent clinic), 71 (public health clinic), and 81 (independent laboratory).²

POCTA understands and agrees that HCV screening tests should be made available in settings where patients will benefit from follow-up care (e.g., receive and fill prescriptions for anti-viral medication, where indicated). However, patients with HCV routinely present in non-primary care settings – such as emergency departments³ – as their primary or sole entry point into the healthcare system. As such, restricting coverage to primary care sites creates a significant gap in access, particularly for patients without regular access to primary care providers.

Published clinical evidence supports the availability of HCV screening tests and subsequent follow-up in several settings not currently covered by Medicare. For example:

• Individuals experiencing homelessness. In a non-randomized controlled trial of HCV treatment at the point of diagnosis where patients received HCV testing, disclosure, and treatment at a nonmedical community site, Morris et al. report that among 492 individuals experiencing homelessness, 246 (50%) tested positive for HCV antibodies, and 111 (23%) tested positive for HCV RNA. 98% (87/89) of eligible participants accepted and initiated HCV treatment; 78% (69/89) completed 12 weeks of antiviral treatment. Of the 66 participants who completed treatment and had a successful blood draw, 61 (92%) had undetectable HCV RNA at treatment completion. Of the 87 treated patients, 58 achieved sustained virologic response (SVR) at week 12, leading to a treatment response of 67% (95% CI, 56%-76%) among the intent-to-treat group and 84% (95% CI, 73%-92%) among the per-protocol group.⁴ Similarly, among 20 patients experiencing homelessness who received care during weekly street medicine runs and tested positive for HCV antibodies, 13/20 (65%) had positive POC HCV RNA. 9/13 (69%) with detected HCV RNA were initiated on treatment; 4/13 (31%) completed treatment and 3/13 (23%) achieved undetectable HCV RNA via street medicine program. Average time from test to treatment was 20 days.⁵
• Public health programs. Glick et al. found that 15.5% (31/200) individuals participating in a syringe services program tested positive (via POC RNA test) for HCV. Nearly all participants (97%) received their test result, and more than 25% (8/31) of positive patients had initiated treatment by scheduling at least 1 appointment, with 9.7% (3/31) starting HCV medications through the program.⁶
• Tribal settings. Mera et al. found that 86% (348/405) participants accepted POC HCV RNA testing when offered; 10% (26/274 valid tests) detected HCV RNA. 35% (9/26) of patients with detectable HCV started treatment; 67% (6/9) started treatment on the same day.⁷
• Emergency departments. Manteuffel et al. compared 47 patients with positive POC HCV RNA test results with 47 historical controls. 12/47 (25.6%) were linked to care in the POC HCV RNA cohort versus 6/47 (12.8%) in controls (RR 2.00, 95% CI 0.82–4.88, p = 0.19).⁸
• Correctional facilities. Using a POC HCV RNA test, Harvey et al. demonstrated feasibility of implementing HCV RNA screening and reported 96.8% (95% CI, 83.3%-99.9%) sensitivity and 99.4% (95% CI, 96.6%-100%) specificity.⁹

Given the benefits of HCV screening in non-primary settings, POCTA respectfully requests that CMS revise the NCD to:

• Remove the requirement for HCV screening to be “ordered by the beneficiary’s primary care physician or practitioner within the context of a primary care setting”; and
• Provide coverage for HCV screening in all settings where the test may be furnished to at-risk individuals (e.g., POS 4 (homeless shelter), 5 (Indian Health Service Freestanding Facility), 6 (Indian Health Service Provider-based Facility), 7 (Tribal 638 Free-standing Facility), 8 (Tribal 638 Provider-based Facility), 9 (Prison/ Correctional Facility), 15 (Mobile Unit), 20 (Urgent Care Facility), 23 (Emergency Room – Hospital), 27 (Outreach Site/Street), 50 (FQHC), 55 (Residential Substance Abuse Treatment Facility), 57 (Non-residential Substance Abuse Treatment Facility), 58 (Non-residential Opioid Treatment Facility) and 72 (Rural Health Clinic))

NCD 210.13 currently covers “U.S. Food and Drug Administration (FDA)-approved/cleared laboratory tests, used consistent with FDA-approved labeling and in compliance with the Clinical Laboratory Improvement Act regulations.”

Historically, HCV screening started with HCV antibody testing, followed by reflex HCV RNA testing to establish the presence of active infection. Indeed, the 2023 AASLD/IDSA Clinical Practice Guidance continues to support the use of “HCV antibody screening with reflex HCV RNA testing to establish the presence of active infection.”¹⁰

In 2024, FDA authorized its first single-step molecular test for HCV screening, noting this class of tests “enables a test-and-treat approach where a person can be tested for HCV, and if positive for HCV RNA, be linked to care and potentially receive treatment during the same health care visit.”¹¹

In a published analysis modeling the cost-effectiveness of POC HCV RNA-first testing vs. laboratory-based HCV antibody testing with reflex confirmatory RNA testing, POC HCV RNA-first testing projected to increase linkage to care (by 37.6%-73.4%), treatment initiation (by 12.1%-48.9%), and SVR at week 12 after treatment (by 3.6%-26.4%) across care settings. Forward transmission was projected to reduce by 16.3% to 53.3%. The model showed that while the initial costs would be higher in some settings, lifetime costs would be lower, with projected savings of $3,387 per person tested.¹²

The AASLD updated its “Hepatitis C Test and Treat Initial Visit” guidance in 2025 to support single-step POC HCV RNA testing for HCV.¹³

For these reasons, POCTA requests that CMS update the NCD to explicitly confirm that Medicare covers all FDA-approved and FDA-cleared HCV screening tests, including HCV antibody tests followed by RNA testing, as well as single-step HCV RNA testing.

NCD 210.13 currently limits coverage for annual repeat screening to “high risk persons… who have continued illicit drug use since the prior negative screening result.”

However, the nature, frequency, and extent of an individual’s (potential) exposure to HCV depends substantially on that person’s individual circumstances, which suggests a more flexible approach to HCV screening access may be appropriate. Indeed, both USPSTF and CDC recommend “periodic” HCV screening for individuals with ongoing risk factors, without identifying a specific interval.¹⁴ Furthermore, published studies suggest that more frequent testing – particularly in patients at higher risk for HCV – may be cost-effective as compared to commonly-used benchmarks.¹⁵

In light of these considerations, POCTA encourages CMS to revise the NCD to give treating providers the option to order HCV testing more frequently than once per year where medically necessary in the provider’s judgment.

We thank you in advance for your consideration of these comments. If you have any questions about these recommendations, we would be pleased to meet to discuss them at your convenience. Please contact Mike Ryan at 202.756.8088, or via e-mail to mryan@mcdermottlaw.com, if we can be helpful to CMS in any way.

Sincerely,

Mike Ryan
On behalf of the Point of Care Testing Association

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Abbott welcomes the opportunity to comment on the National Coverage Analysis (NCA) for Screening for Hepatitis C Virus (HCV) in Adults (CAG-00436R).

Abbott is a global leader in cardiovascular care, diabetes management, diagnostic testing, nutrition, pain and movement disorders, and more. For more than 135 years, we’ve never wavered in our purpose to help people live fuller lives through better health. Today, 122,000 Abbott employees are working to make a lasting impact on health in the more than 160 countries we serve.

Abbott’s laboratory diagnostics portfolio combines advanced instrumentation, robust assay menus, and advanced automation to help laboratories deliver fast, accurate diagnoses and drive operational efficiencies — ultimately improving patient care and supporting health systems around the world. Abbott Toxicology is a leading provider of drug and alcohol testing solutions, offering laboratory, rapid screening, and toxicology testing technologies that support public health, workplace safety, and informed clinical decision-making. Abbott Cancer Diagnostics develops and provides cancer screening, molecular diagnostic, and oncology testing solutions that support early detection, treatment selection, and disease monitoring.

Reconsideration of NCD 210.13

CMS is conducting an NCA to consider revisions to the National Coverage Determination (NCD) for Screening for Hepatitis C Virus (HCV) in Adults (NCD 210.13). The current NCD covers HCV screening when ordered by the beneficiary’s primary care physician or practitioner within the context of a primary care setting and performed by an eligible Medicare provider. Coverage is limited to adults with specified risk factors and adults born from 1945 through 1965. Annual repeat screening is covered only for individuals who have continued injection drug use since their prior negative screening test.¹

CMS has identified adults aged 18 to 79 years as the focus of this reconsideration and specifically requests evidence concerning repeat screening intervals for individuals with ongoing risk and screening in non-primary care settings.²

Abbott strongly supports updating NCD 210.13 to reflect current clinical evidence and national screening recommendations. Specifically, we urge CMS to cover one-time screening for all adult Medicare beneficiaries regardless of birth cohort or identified risk factors; provide repeat testing for beneficiaries with ongoing risk at clinically appropriate intervals; and remove both the primary care setting restriction and the restriction on ordering practitioners. We also encourage CMS to support automatic HCV RNA testing following a reactive antibody result and timely linkage to treatment.

Expanded Screening Would Address the Public Health Burden of HCV and Facilitate Curative Treatment

Chronic HCV infection remains a significant public health concern. In its 2020 recommendation statement, the U.S. Preventive Services Task Force (USPSTF) described HCV as the most common chronic blood-borne pathogen in the United States, citing an estimated 4.1 million people with past or current infection and more associated deaths than the other 60 reportable infectious diseases combined.³ Because infection can remain asymptomatic for years or decades, individuals may not seek testing until substantial liver damage has occurred. The Centers for Disease Control and Prevention (CDC) reports that approximately 75%–85% of people with hepatitis C have no symptoms and nearly one-third are unaware of their infection.⁴ Thus, screening based solely on recognized risk factors can leave infections undiagnosed. Universal screening offers an opportunity to identify these individuals before complications develop and connect them to appropriate care.

The availability of highly effective treatment strengthens the case for expanded screening. Oral direct-acting antiviral (DAA) therapies cure more than 95% of HCV infections in appropriately treated patients.⁵ Successful treatment is associated with reduced risks of cirrhosis, hepatocellular carcinoma, liver-related mortality, and all-cause mortality.⁶ Expanded screening, coupled with confirmatory testing and linkage to care, can help Medicare beneficiaries obtain treatment earlier in the course of disease.

National Recommendations Support Broader Medicare Screening Coverage

In a 2020 update to its HCV screening recommendations, the USPSTF recommends one-time screening for all adults aged 18 to 79 years, with repeat testing for populations with ongoing HCV exposure risk. This Grade B recommendation replaces its earlier approach based on risk factors and the 1945–1965 birth cohort. The benefits of screening extend to older adults, including Medicare beneficiaries within the recommended age range. The USPSTF concluded that broadening the age for HCV screening “will identify infected patients at earlier stages of disease who could greatly benefit from effective treatment before developing complications.”²

The Grade B recommendation provides an important foundation for Medicare coverage. Under 42 C.F.R. § 410.64, CMS may cover additional preventive services through the NCD process when it determines that they are reasonable and necessary for prevention or early detection, recommended with a Grade A or B by the USPSTF, and appropriate for Medicare beneficiaries.⁷ Updating NCD 210.13 would bring Medicare’s screening eligibility criteria into closer alignment with this recommendation.

CDC recommends at least one screening for all adults aged 18 years or older and screening during each pregnancy, except in settings where HCV RNA positivity is below 0.1%. CDC also recommends periodic testing for individuals with ongoing risk.⁴ Its recommendations thus extend beyond the USPSTF’s specified age range. The American Association for the Study of Liver Diseases and the Infectious Diseases Society of America (AASLD-IDSA) likewise endorse universal adult screening as “a crucial and necessary component of any HCV elimination strategy because it is the entry point into the HCV continuum of care.”⁶ Together, these recommendations support replacing Medicare’s birth-cohort restriction with broader screening eligibility.

Randomized Evidence Supports Screening Without Risk-Based Selection

The DETECT Hep C randomized clinical trial provides direct evidence that nontargeted screening can identify more HCV infections than risk-based screening in emergency departments. The study randomized 147,498 patient visits at three urban emergency departments to nontargeted screening, in which testing was offered regardless of risk, or targeted screening based on risk assessment. Nontargeted screening identified 154 new RNA-confirmed infections, compared with 115 under targeted screening, a statistically significant difference.⁸ These findings support offering screening without requiring identification or disclosure of specific risk factors and provide relevant evidence for screening outside primary care.

Repeat Screening Should Reflect Patient Risk and Clinical Judgment

Abbott supports Medicare coverage of periodic testing for beneficiaries who remain at risk for HCV infection. The USPSTF recommends periodic screening for individuals with continued risk but acknowledges limited evidence on the optimal interval.³

CMS should therefore provide coverage for annual testing in populations for whom guidelines recommend it, while allowing more frequent testing when warranted by individual exposure risk and clinical judgment.

Medicare Should Cover Screening Across Clinically Appropriate Health Care Settings

NCD 210.13 restricts both the setting in which screening occurs and the practitioners who may order it.¹ These limitations can prevent beneficiaries from receiving screening during encounters that offer an opportunity to identify undiagnosed infection.

We recommend that CMS remove the primary care setting restriction and permit HCV screening ordered by any physician or other qualified practitioner authorized to order the service under applicable Medicare requirements. Clinically appropriate settings include emergency departments, urgent care centers, behavioral health settings, dialysis facilities, and substance use treatment programs, as well as primary care practices and community health centers. Expanding HCV screening coverage across such clinically appropriate care settings could improve identification of undiagnosed infections and facilitate referrals to treatment.

Reflex RNA Testing and Streamlined Care Pathways Are Essential

A reactive HCV antibody result does not, by itself, establish current infection. Completing the testing sequence with HCV RNA testing is essential to distinguish current infection from resolved infection or a falsely reactive antibody result.⁴

CDC recommends the use of reflex HCV RNA testing, in which specimens testing anti-HCV positive undergo HCV RNA testing immediately and automatically in the laboratory on the same sample.? CDC’s 2023 operational guidance advises discontinuing approaches that require multiple patient visits to collect samples. Furthermore, published evidence supports interventions that simplify HCV testing, including reflex RNA testing and point-of-care testing, to improve testing outcomes.

Consequently, Abbott encourages CMS to promote automatic, single-encounter HCV RNA testing following a positive antibody result to streamline the care pathway and promote more timely treatment initiation.

Conclusion

Updating NCD 210.13 would allow Medicare coverage to better reflect current evidence, national screening recommendations, and the availability of curative therapy. Broader screening eligibility can improve identification of undiagnosed HCV infection, while appropriate repeat testing, access across health care settings, and streamlined diagnostic pathways can help beneficiaries obtain timely care — reducing the long-term clinical and economic burden of advanced liver disease.

Abbott therefore urges CMS to:

1. Cover one-time HCV screening for adult Medicare beneficiaries regardless of birth cohort or identified risk factors.
2. Cover repeat testing for beneficiaries with ongoing risk at intervals consistent with evidence-based recommendations and individual clinical circumstances.
3. Remove the primary care setting restriction and permit ordering by any physician or other qualified practitioner authorized under applicable Medicare requirements.
4. Support automatic HCV RNA testing following a reactive antibody result, with single-visit specimen collection.
5. Continue to identify and implement administrative policies that promote timely HCV diagnosis, confirmatory testing, and treatment.

Thank you for your consideration of our comments. Please contact me if you have any questions or need additional information.

Endnotes

1. Centers for Medicare & Medicaid Services. National Coverage Determination: Screening for Hepatitis C Virus (HCV) in Adults (210.13). Effective June 2, 2014. https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?ncdid=361&ncdver=1
2. Centers for Medicare & Medicaid Services. National Coverage Analysis: Screening for Hepatitis C Virus (HCV) in Adults (CAG-00436R)—Tracking Sheet. https://www.cms.gov/medicare-coverage-database/view/ncacal-tracking-sheet.aspx?ncaid=325
3. U.S. Preventive Services Task Force. Screening for hepatitis C virus infection in adolescents and adults: U.S. Preventive Services Task Force recommendation statement. JAMA. 2020;323(10):970–975. doi:10.1001/jama.2020.1123
4. Centers for Disease Control and Prevention. Clinical Screening and Diagnosis for Hepatitis C. https://www.cdc.gov/hepatitis-c/hcp/diagnosis-testing/index.html
5. Lo Re V III, Bhattacharya D, Price JC, et al. State-of-the-art review: hepatitis C. Clin Infect Dis. 2025;81(2)–e26. doi:10.1093/cid/ciaf334
6. Bhattacharya D, Aronsohn A, Price J, Lo Re V; AASLD-IDSA HCV Guidance Panel. Hepatitis C guidance 2023 update: AASLD-IDSA recommendations for testing, managing, and treating hepatitis C virus infection. Clin Infect Dis. Published online May 25, 2023. doi:10.1093/cid/ciad319
7. 42 C.F.R. § 410.64. Additional preventive services. https://www.ecfr.gov/current/title-42/section-410.64
8. Haukoos JS, Rothman RE, Galbraith JW, et al. Hepatitis C screening in emergency departments: the DETECT Hep C randomized clinical trial. JAMA. 2025;334(6):497-507. doi:10.1001/jama.2025.10563
9. Schillie S, Wester C, Osborne M, Wesolowski L, Ryerson AB. CDC recommendations for hepatitis C screening among adults — United States, 2020. MMWR Recomm Rep. 2020;69(2):1–17. doi:10.15585/mmwr.rr6902a1
10. Cartwright EJ, Patel P, Kamili S, Wester C. Updated operational guidance for implementing CDC’s recommendations on testing for hepatitis C virus infection. MMWR Morb Mortal Wkly Rep. 2023;72:766–768. doi:10.15585/mmwr.mm7228a2
11. Cunningham EB, Wheeler A, Hajarizadeh B, et al. Interventions to enhance testing, linkage to care, and treatment initiation for hepatitis C virus infection: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol. 2022;7(5):426–445. doi:10.1016/S2468-1253(21)00471-4

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October 22, 2026

JoAnna Baldwin
Acting Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: National Coverage Analysis (NCA) for Screening for Hepatitis C Virus (HCV) in Adults (CAG-00436R)

Dear Ms. Baldwin,

On behalf of the MedTech Association (AdvaMed), we appreciate the opportunity to submit comments on the National Coverage Analysis (NCA) for Screening for Hepatitis C Virus (HCV) in Adults (CAG-00436R). AdvaMed and the Centers for Medicare & Medicaid Services (CMS) share a common goal – ensuring timely access for Medicare beneficiaries to clinically appropriate, innovative technologies based on scientifically sound clinical evidence.

AdvaMed member companies develop and produce a wide range of medical devices, diagnostic tests, and digital health solutions that transform care through earlier detection, less invasive approaches, and more effective disease management. Our members, large and small, are united in their commitment to improving patient outcomes and ensuring Medicare beneficiaries have access to lifesaving and life-enhancing technologies.

Importance of National Coverage for Screening Tests

We applaud CMS for reconsidering NCD 210.13, which was most recently revised in 2014. The current NCD does not reflect Centers for Disease Control and Prevention (CDC) recommendations, and AdvaMed supports revisions to the coverage determination that incorporate CDC’s evidence-based recommendation that all adults over the age of 18 receive HCV screening at least once in their lifetime. Screening tests are critical for the timely detection and treatment of many conditions, and especially for infections like HCV where more than 75% of individuals do not show symptoms. National coverage for all adults over the age of 18 supports early detection and intervention for HCV infection, which can cause substantial and serious complications, and reduces the likelihood that the absence of the disclosure or identification of individual risk factors would limit access to clinically appropriate screening. We are especially supportive of CMS’s national coverage work for screening diagnostics, which are an essential foundation of care delivery and the basis of approximately 70% of healthcare decisions according to the CDC. Diagnostics are critical for many serious conditions that disproportionately affect Medicare beneficiaries, and we appreciate the agency’s prioritization of this screening reconsideration request.

Evidentiary Support for Universal HCV Screening

The CDC, United States Preventive Services Task Force (USPSTF), and American Association for the Study of Liver Diseases (AASLD)-Infectious Disease Society of America (IDSA) guidelines recommend routine adult screening and repeat testing for populations with ongoing HCV exposure risk.(1,2,3) Risk-based screening and birth-cohort screening have often failed to identify many infected individuals because risk factors remain unrecognized, undisclosed, or inconsistently assessed by healthcare providers. Universal screening removes barriers associated with risk-factor ascertainment and more accurately reflects the current epidemiology of HCV infection in the United States.(4)

Strong direct evidence supporting universal screening comes from the DETECT Hep C randomized clinical trial.(5) In this multicenter study involving 147,498 emergency department visits, nontargeted screening identified significantly more new HCV infections than targeted risk-based screening. Nontargeted screening resulted in 154 newly diagnosed infections compared with 115 diagnoses using targeted screening despite reliance on the same healthcare encounters. These findings demonstrate that screening strategies dependent upon documented risk factors miss substantial numbers of infections. Importantly, DETECT Hep C included Medicare beneficiaries and reflects real-world clinical practice across diverse U.S. health systems.

Universal screening is also supported by the availability of highly effective antiviral therapy. Modern HCV treatment is curative in more than 95% of appropriately treated patients and reduces the risk of cirrhosis, liver failure, hepatocellular carcinoma, transplantation, and liver-related mortality.6 Successful treatment reduces onward transmission and supports broader HCV elimination efforts.(3,6) We encourage CMS to view screening and treatment as complementary components of a robust, unified public health strategy.

Screening Intervals

Current AASLD-IDSA clinical recommendations support repeat screening for individuals with ongoing risk factors. However, available evidence does not establish a single optimal screening interval for all populations. Accordingly, we encourage CMS to allow testing frequency that is guided by clinical judgment, patient risk profiles, and evidence.(1,2)

Relatedly, we recommend that CMS establish a coverage policy that supports “virus-first” single-encounter direct RNA testing, which enables health systems to execute single-visit “test-and-treat” protocols that link patients to cure.(3,7,8) Standard multi-visit models, which require patients to return for a second visit to confirm RNA testing, suffer from high loss-to-follow-up rates in acute care settings. We encourage CMS to adopt HCV RNA testing following a positive antibody result to reduce this loss-to-follow-up, in alignment with supporting evidence.(7,8)

Screening Settings

AdvaMed appreciates CMS’s recognition that opportunities to identify undiagnosed HCV infection exist throughout the healthcare system. Emergency departments, urgent care centers, community health centers, behavioral health settings, correctional facilities, dialysis facilities, and substance-use treatment programs may all serve as important access points for HCV screening, particularly for populations at high risk.(4,6) Expanding coverage across appropriate care settings could improve identification of undiagnosed infections and facilitate linkage to treatment.(5) We encourage CMS to explicitly clarify that HCV screening coverage applies across all care settings in alignment with current evidence-based screening recommendations and in support of national Hepatitis C elimination efforts.

We look forward to continuing to work with CMS throughout this process. If you have any questions regarding these comments or require additional information, please contact me at astock@advamed.org.

Sincerely,

Amber Stock
Vice President, Payment & Healthcare Delivery Policy
AdvaMed

CITATIONS

1. Schillie S, Wester C, Osborne M, Wesolowski L, Ryerson AB. CDC recommendations for hepatitis C screening among adults—United States, 2020. MMWR Recomm Rep. 2020;69(2):1-17.
2. Owens DK, Davidson KW, Krist AH, et al; US Preventive Services Task Force. Screening for hepatitis C virus infection in adolescents and adults: US Preventive Services Task Force recommendation statement. JAMA. 2020;323(10):970-975.
3. AASLD-IDSA HCV Guidance Panel. Hepatitis C guidance 2019 update: AASLD-IDSA recommendations for testing, managing, and treating hepatitis C virus infection. Hepatology. 2020;71(2):686-721.
4. Barker LK, Doshani M, Jiles RB, Teshale E. Hepatitis C surveillance in the United States: past, present, and future. Public Health Rep. Published online August 28, 2025. doi:10.1177/00333549251351880
5. Haukoos JS, Rothman RE, Galbraith JW, et al. Universal vs risk-based screening for hepatitis C virus infection in emergency departments: a randomized clinical trial. JAMA. 2025;334(6):497-507.
6. Lo Re V III, Bhattacharya D, Price JC, et al. AASLD-IDSA hepatitis C guidance: recommendations for testing, managing, and treating hepatitis C. Clin Infect Dis. 2025;81(2):e15-e26.
7. Morris MD, McDonell C, Luetkemeyer AF, Thawley R, McKinney J, Price JC. Community-Based Point-of-Diagnosis Hepatitis C Treatment for Marginalized Populations: A Nonrandomized Controlled Trial. JAMA Netw Open. 2023 Oct 2;6(10):e2338792. doi: 10.1001/jamanetworkopen.2023.38792. PMID: 37862013; PMCID: PMC10589813.
8. Crooker KG, Mann Y, Garcia M, Numi M, Ho B, Bryce R, Zervos M, Shetty S, Joshi S. Implementation of Novel Point-of-Care Hepatitis C RNA Platform and Clinical Characteristics of Treatment in Persons Experiencing Homelessness in Detroit, Michigan, Open Forum Infectious Diseases, Volume 13, Issue Supplement_1, January 2026, ofaf695.071.

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On behalf of Quest Diagnostics, I appreciate the opportunity to provide comments regarding CMS’ reconsideration of National Coverage Determination (NCD) 210.13, Screening for Hepatitis C Virus (HCV) in Adults. We recommend updating Medicare coverage to include:

• Expanding one-time HCV screening for all Medicare beneficiaries ages 18-79, regardless of identified risk factors, consistent with the U.S. Preventative Services Task Force (USPSTF) Grade B recommendation;
• Allowing for periodic HCV screening for beneficiaries with ongoing risk, at intervals informed by clinical guidance; and
• Removing the primary care ordering and setting restrictions so that eligible treating physicians and practitioners may order HCV screening across clinically appropriate settings.

CMS’ initiation of this reconsideration provides an opportunity to update Medicare coverage of HCV screening consistent with current screening recommendations. HCV screening serves two complementary purposes: enabling timely diagnosis and treatment to improve individual health outcomes and supporting public health efforts to prevent further transmission of this communicable disease. These personal and public health benefits support expanding one-time screening eligibility, allowing periodic screening for beneficiaries with ongoing risk, and removing primary care ordering and setting restrictions.

In February 2021, I requested reconsideration of NCD 210.13 on behalf of Quest Diagnostics to align the one-time screening benefit with the USPSTF’s expanded age recommendation. I reaffirm this request and also offer the following recommendations in response to CMS’ specific interest in HCV repeat-screening intervals and HCV screening in non-primary care settings.

Align Screening Eligibility with Current Recommendations

The current NCD limits routine one-time HCV screening to adults born between 1945 and 1965, with separate coverage for narrowly defined high-risk populations. This birth-cohort restriction reflects the 2013 USPSTF recommendation and excludes beneficiaries outside the cohort who qualify for screening under the updated guidance. Expanding the age range would extend recommended screening to additional older beneficiaries and to those younger than 65 who are eligible for Medicare.

Since 2020, USPSTF has recommended one-time HCV screening for all adults ages 18-79, regardless of identified risk factors (Grade B recommendation). This screening expansion reflected advances in direct-acting antiviral therapies – which offer higher cure rates, shorter treatment courses, and fewer harms – along with concerns regarding increasing HCV infection among younger adults. Broader screening enables earlier detection and effective treatment, which is associated with substantially reduced risks of cirrhosis, hepatocellular carcinoma, liver-related mortality, and all-cause mortality. i The Centers for Disease Control and Prevention (CDC) likewise recommends screening adults at least once, and periodic testing while ongoing risk persists.

Based on these recommendations, we urge CMS to expand one-time HCV screening to all Medicare beneficiaries ages 18-79, regardless of identified risk factors.

Broaden Coverage for Repeat HCV Screening Based on Risk and Clinical Guidance

CMS should broaden repeat HCV screening coverage beyond the current restriction of annual testing for beneficiaries with continued injection drug use following a negative screen. Coverage criteria should encompass additional risk factors identified in national screening recommendations and relevant specialty guidance, with repeat screening based on ongoing exposure rather than remote risk alone. We support annual screening for beneficiaries with documented ongoing risk, with flexibility for more frequent testing when clinically warranted.

USPSTF recommends periodic HCV screening with continued risk but acknowledges limited evidence on the optimal interval.i Joint guidance from the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) recommends at least annual screening for specific high-risk groups including for those who inject drugs, and periodic testing while risk factors persist, such as for persons receiving maintenance hemodialysis. Coverage should also accommodate population-specific HCV screening intervals. For example, the relevant 2022 Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline recommends HCV screening every six months for in-center hemodialysis patients without current infection and increased testing when a unit identifies a new infection.

We recommend that CMS broaden coverage for repeat HCV screening at intervals consistent with nationally recognized clinical guidelines – such as those for patients receiving in-center hemodialysis – with flexibility for more frequent testing when supported by clinical guidance and documented exposure risk. Absent clear guidelines for HCV testing, recommendations should mirror recommendations that exist for other blood and body fluid transmitted communicable diseases.

Remove Primary Care Ordering and Setting Restrictions

Eligible treating physicians and other practitioners should be able to assess risk and order screening during appropriate clinical encounters, including those that occur within specialty practices, emergency and hospital outpatient departments, substance use treatment programs, and dialysis facilities. HCV screening in these settings provides opportunities to identify infections, connect beneficiaries with treatment, and provide education to prevent further transmission. Requiring an additional primary care encounter may create an avoidable barrier to care when a treating clinician can assess screening eligibility, communicate test results, and arrange follow-up care. The availability of highly effective direct acting antiviral therapy shifts the clinical utility curve further toward supporting broad testing of eligible beneficiaries.

Nephrology and dialysis care illustrate both the clinical and public health value of broader access to testing. KDIGO recommends HCV screening upon initiation of in-center hemodialysis and every six months thereafter for patients without current infection.vii Early detection allows beneficiaries to receive timely evaluation and antiviral treatment – reducing the risk of disease progression and HCV-associated morbidity – while enabling dialysis facilities to investigate potential transmission and strengthen infection control measures when dialysis-related HCV transmission is suspected.

We encourage CMS to remove the requirements that HCV screening be ordered by a primary care physician or practitioner within a primary care setting, so that eligible treating physicians and practitioners may order HCV screening across clinically appropriate settings.

Thank you for the opportunity to provide comments regarding the reconsideration of NCD 210.13. Expanding screening coverage would support earlier diagnosis and treatment for Medicare beneficiaries while advancing public health efforts to prevent further transmission of HCV. Please feel free to reach out to me directly should you require additional information.

Sincerely,

Lee H. Hilborne, MD, MPH, DLM(ASCP)CM
Senior Medical Director, Medical Affairs
lee.h.hilborne@questdiagnostics.com

References

U.S. Preventive Services Task Force. Screening for hepatitis C virus infection in adolescents and adults. JAMA. 2020;323(10):970–975. doi:10.1001/jama.2020.1123.
https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/hepatitis-c-screening

Hilborne LH. Quest Diagnostics formal request for reconsideration of NCD 210.13. February 23, 2021.
https://www.cms.gov/files/document/id325d.pdf

Centers for Medicare & Medicaid Services. NCA tracking sheet: Screening for Hepatitis C Virus in Adults. CAG-00436R. Review initiated September 23, 2026.
https://www.cms.gov/medicare-coverage-database/view/ncacal-tracking-sheet.aspx?ncaid=325

Centers for Medicare & Medicaid Services. National Coverage Determination (NCD) for Screening for Hepatitis C Virus (HCV) in Adults (210.13). Medicare Coverage Database. NCD - Screening for Hepatitis C Virus (HCV) in Adults (210.13)

Schillie S, Wester C, Osborne M, Wesolowski L, Ryerson AB. CDC recommendations for hepatitis C screening among adults—United States, 2020. MMWR Recomm Rep. 2020;69(2):1–17.
doi:10.15585/mmwr.rr6902a1.

https://www.cdc.gov/mmwr/volumes/69/rr/rr6902a1.htm

AASLD–IDSA. HCV Guidance: HCV Testing and Linkage to Care.
https://www.hcvguidelines.org/guidance/hcv-testing-and-linkage-to-care/

KDIGO. 2022 Clinical Practice Guideline for the Prevention, Diagnosis, Evaluation, and Treatment of Hepatitis C in Chronic Kidney Disease. Kidney Int. 2022;102(Suppl 6S):S129–S205.
https://kdigo.org/wp-content/uploads/2022/11/KDIGO-2022-Hepatitis-C-in-CKD-Guideline.pdf

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The American Gastroenterological Association (AGA) appreciates the opportunity to comment on National Coverage Decision (NCD) 210.13, “Screening for Hepatitis C Virus (HCV) in Adults,” (CAG-00436R). AGA is the trusted voice of the GI community, advancing the science and practice of gastroenterology. Our organization includes nearly 14,000 members from around the globe, including over 11,000 U.S. members, engaged in all aspects of the science, clinical practice, and advancement of gastroenterology.

AGA supports the formal requests to reconsider the NCD and align it with the scope of the requests and focus on screening for HCV infection in adults aged 18 to 79 years, as recommended by the US Preventive Services Task Force (USPSTF). To improve alignment with contemporary clinical guidelines and reduce barriers to HCV diagnosis and treatment, AGA recommends that CMS update NCD 210.13 in the following ways:

1) Align the NCD with 2020 USPSTF Grade B recommendation for HCV screening, including one-time screening for all adults ages 18-79.

AGA strongly recommends aligning the NCD with USPSTF recommendation statement, Hepatitis C Virus (HCV) Infection in Adolescents and Adults, Grade B recommendation of screening for HCV infection in all adults aged 18 to 79 years (1).

In addition to Baby Boomers born between 1945 and 1965, there is a second wave of HCV infection in the US among younger individuals who use illicit drugs (2) and the prevalence of infection in that group can be up to 19% (3). Therefore, we urge CMS to broaden coverage to include HCV screening for all adults aged 18 to 79 years. Many patients come to GI practices for evaluation of abnormal liver biochemistries or abnormal liver imaging. AGA (4), ACG (5) and AASLD (6) guidelines all recommend looking for both HCV and HBV in anyone with abnormal LFT’s or evidence of liver disease independent of age. UpToDate provides additional support for aligning the NCD with 2020 USPSTF recommendations (7).

The CDC 2020 recommendation for HCV screening (8) and systematic literature review (9) recommends screening for pregnant women with each pregnancy. The current language of the HCV NCD states: "Aligning the NCD with 2020 USPSTF Grade B recommendation for HCV screening, including one-time screening for all adults ages 18-79." AGA recommends modifying the language as follows: "Aligning the NCD with 2020 USPSTF Grade B recommendation for HCV screening, including one-time screening for all adults age 18-79, and with 2020 CDC recommendation for HCV screening in pregnant women with each pregnancy."

References:

1) USPSTF Final Recommendation Statement, Hepatitis C Virus Infection in Adolescents and Adults: Screening. March 02, 2020. https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/hepatitis-c-screening [Accessed 10/12/2026]
2) CDC 2024 Viral Hepatitis National Progress Report. Hepatitis C Virus – Reduce Rate Among PWID. https://www.cdc.gov/hepatitis/php/npr-2024/hep-c-reduce-infections-pwid.html [Accessed 10/12/2026]
3) Mazumder H, Hossain MF, Shrestha P, Mahmud S, Husain M, Ahmed R. Prevalence and associated risk factors of current hepatitis C infection among U.S. general population and injection drug users aged 20-59 years: NHANES 2009-2018. PLoS One. 2024 Aug 26;19(8):e0309345. doi: 10.1371/journal.pone.0309345. PMID: 39186570; PMCID: PMC11346729.
4) Kanwal F, Bacon B, Beste L, et al., Hepatitis C Virus Infection Care Pathway—A Report From the American Gastroenterological Association Institute HCV Care Pathway Work Group Gastroenterology, 152, 1588-1598
5) Kwo PY, Cohen SM, Lim JK. ACG Clinical Guideline: Evaluation of Abnormal Liver Chemistries. Am J Gastroenterol. 2017;112(1):18–35. doi:10.1038/ajg.2016.517
6) Debika Bhattacharya, Andrew Aronsohn, Jennifer Price, Vincent Lo Re, the American Association for the Study of Liver Diseases–Infectious Diseases Society of America HCV Guidance Panel , Hepatitis C Guidance 2023 Update: American Association for the Study of Liver Diseases – Infectious Diseases Society of America Recommendations for Testing, Managing, and Treating Hepatitis C Virus Infection, Clinical Infectious Diseases, 2023;, ciad319, https://doi.org/10.1093/cid/ciad319
7) Sanjiv Chopra, Sanjeev Arora. UpToDate, Screening and diagnosis of chronic hepatitis C virus infection. https://www.uptodate.com/contents/screening-and-diagnosis-of-chronic-hepatitis-c-virus-infection/print [Accessed 10/12/2026]
8) Schillie S, Wester C, Osborne M, Wesolowski L, Ryerson AB. CDC Recommendations for Hepatitis C Screening Among Adults - United States, 2020. MMWR Recomm Rep. 2020 Apr 10;69(2):1-17. doi: 10.15585/mmwr.rr6902a1. PMID: 32271723; PMCID: PMC7147910.
9) Andes A, Ellenberg K, Vakos A, Collins J, Fryer K. Hepatitis C Virus in Pregnancy: A Systematic Review of the Literature. Am J Perinatol. 2021 Aug;38(S 01):e1-e13. doi: 10.1055/s-0040-1709672. Epub 2020 Apr 22. PMID: 32323289.

2) Allow repeat screening at the discretion of the provider for individuals at high risk for HCV according to ongoing risk.

Restricting repeat HCV screening coverage to once annually for beneficiaries with ongoing risk factors may create unnecessary barriers to timely diagnosis. Because HCV exposure can occur at any point and risk profiles may change between annual visits, clinicians should have the flexibility to order repeat screening when medically appropriate based on an individual's circumstances. Allowing provider discretion would better align Medicare coverage with current clinical practice guidelines and support earlier identification of infection, facilitating prompt linkage to curative treatment and reducing the likelihood of preventable liver-related complications.

Repeat-testing coverage should extend to other populations identified in the Guidance, which recommends testing at least annually for individuals who inject drugs and men with HIV who have unprotected sex with men, including those with prior HCV exposure. Annual testing among these populations should be added to the NCD. One prospective cohort analysis found that HCV incidence among men with HIV who have sex with men was approximately six times that observed among men without HIV (10), while the Swiss HIV Cohort Study documented rising HCV incidence within this population (11). Research has also linked the initiation of injection drug use to a substantially increased risk of HCV seroconversion, highlighting the need to reassess testing frequency as an individual’s exposure risks change (12).

Periodic HCV screening offers clinical and economic benefits beyond one-time testing. In an analysis of screening strategies for men with HIV who have sex with men, Linas et al. found that routine testing improved life expectancy and was cost effective when compared with symptom-based testing. The study supported annual antibody screening with liver function testing every six months and suggested that more frequent monitoring may be appropriate where HCV incidence is higher (13). Although this research preceded the introduction of direct-acting antiviral therapies, it provides additional support for repeat screening.

Because the evidence does not identify an optimal repeat-testing frequency for every population, AASLD-IDSA guidance (6) recommends that clinicians tailor testing intervals to an individual’s risk of infection or reinfection. CMS should not treat annual screening as a maximum or deny more frequent testing when changing or continued exposure makes it clinically appropriate. AGA urges CMS to treat annual screening as a minimum coverage standard, rather than a maximum frequency, for individuals with ongoing risk and to cover more frequent testing when clinically appropriate based on the treating clinician’s judgment and the patient’s circumstances.

References:

10) Witt MD, Seaberg EC, Darilay A, et al. Incident hepatitis C virus infection in men who have sex with men: a prospective cohort analysis, 1984-2011. Clin Infect Dis. 2013 Jul;57(1):77-84. doi: 10.1093/cid/cit197.
11) Wandeler G, Gsponer T, Bregenzer A, et al. Swiss HIV Cohort Study. Hepatitis C virus infections in the Swiss HIV Cohort Study: a rapidly evolving epidemic. Clin Infect Dis. 2012 Nov 15;55(10):1408-16. doi: 10.1093/cid/cis694.
12) Bravo MJ, Vallejo F, Barrio G, et al. HCV seroconversion among never-injecting heroin users at baseline: no predictors identified other than starting injection. International Journal of Drug Policy. 2012;23(5):415–419.
13) Linas BP, Wong AY, Schackman BR, et al. Cost-effective screening for acute hepatitis C virus infection in HIV-infected men who have sex with men. Clin Infect Dis. 2012 Jul;55(2):279-90. doi: 10.1093/cid/cis382.

3) Update the definition of “high risk” consistent with the 2020 USPSTF recommendation and replace stigmatizing language references to “high risk persons” with person-first language.

AGA recommends CMS update the definition of high risk to “those with past or current injection drug use” consistent with the 2020 USPSTF recommendation and remove stigmatizing language referring to “high risk persons.”

Current NCD 210.13 language: “A screening test is covered for adults at high risk for HCV infection. “High risk” is defined as persons with a current or past history of illicit injection drug use; and persons who have a history of receiving a blood transfusion prior to 1992. Repeat screening for high risk persons is covered annually only for persons who have had continued illicit injection drug use since the prior negative screening test.” AGA recommends modifying the language as follows: “High risk” is defined as persons with past or current injection drug use; and persons who have a history of receiving a blood transfusion prior to 1992. Periodic screening of persons with continued risk for HCV infection (eg, persons with past or current injection drug use) is covered at the discretion of the treating clinician.”

4) Remove the requirement that the screening take place in a “primary care setting.”

AGA agrees with the American College of Obstetricians and Gynecologists that obstetric providers should be included among the clinicians who may order HCV screening. In addition to pregnant women, individuals with laboratory or radiological evidence of liver disease, and in other clinical scenarios (e.g., rare renal and skin conditions, all organ donors and recipients) should be screened for HCV infection.

CMS should not restrict the specialty of the prescribing provider. For example, having unprotected sex, which is a modality of HCV spread, should prompt testing for HBV, HCV, and HIV, which may be best ordered by emergency room providers, obstetricians and gynecologists, and other providers. Furthermore, obstetricians now routinely screen for HCV in pregnant women due to the recent surge of new HCV infections in the 15- to 40-year-old demographic in the US (14). This is a point of entry into the health system that can catch HCV early and lead to treatment and linkage to care post-delivery to reduce further transmission of HCV.

AGA recommends removing the requirement that screening must take place in a “primary care setting.”

References:

14) CDC 2023 Viral Hepatitis Surveillance Report. Figure 3.4 – Acute Hepatitis C: Case Rates by Age Group: https://www.cdc.gov/hepatitis-surveillance-2023/hepatitis-c/figure-3-4.html [Accessed 10/12/2026]

5) Allow reimbursement for any FDA-approved HCV test ordered by a Medicare provider.

Currently, there are FDA-approved point-of-care screening tests for HCV (e.g., Cepheid Xpert HCV test and GeneXpert Xpress System and the OraQuick HCV Rapid Antibody Test). AGA recommends that CMS update the HCV NCD to include coverage and reimbursement of any FDA-approved test.

6) Provide coverage of reflexive HCV RNA testing after a reactive antibody result, including testing performed from the original specimen without an additional office visit or separate patient encounter.

A reactive HCV antibody result indicates prior exposure to HCV but does not establish current infection. HCV RNA testing is necessary to determine whether the beneficiary has active HCV infection and should be evaluated for treatment. AGA therefore recommends that CMS explicitly provide coverage for reflex HCV RNA testing following a reactive HCV antibody result.

Whenever clinically and technically feasible, the laboratory should perform the HCV RNA test reflexively using the specimen collected for the initial antibody test, without requiring the beneficiary to return for a separate visit, undergo an additional blood draw, or obtain a separate order. Completing antibody and confirmatory RNA testing through a single testing sequence would reduce loss to follow-up, avoid unnecessary delays in diagnosis, and facilitate timely linkage to curative treatment. Accordingly, CMS coverage policy should support completion of the HCV diagnostic pathway rather than limiting coverage to the initial antibody screening test.

7) Add coverage of new and emerging testing modalities, including rapid point of care tests and self-tests, and explicitly require coverage of these modalities when FDA approved.

Because early detection of HCV can allow for early treatment and prevention of long-term morbidity and mortality, AGA recommends that CMS consider explicitly requiring coverage of new and emerging HCV testing modalities, including FDA-approved rapid point of care tests and self-tests. HCV tests are effective and generally low cost (< $100).

8) Consider the benefits of early diagnosis with access to direct-acting antivirals when evaluating whether expanded HCV screening is reasonable and necessary for Medicare beneficiaries.

Given the availability of highly effective curative therapy, screening and treatment should be viewed as an integrated continuum of care. The clinical value of expanded HCV screening cannot be fully assessed without considering the significant reductions in morbidity, mortality, and downstream healthcare utilization that result from successful treatment following diagnosis.

In addition to improving clinical outcomes, successful treatment of HCV has been associated with lower downstream healthcare expenditures among Medicare beneficiaries, underscoring the value of identifying infected individuals before they develop advanced liver disease (15, 16, 17, 18, 19).

References:

15) Jung J, Feldman R, Kalidindi Y, Riley T. Association of Direct-Acting Antiviral Therapy for Hepatitis C With After-Treatment Costs Among Medicare Beneficiaries. JAMA Netw Open. 2020;3(6):e208081. doi:10.1001/jamanetworkopen.2020.8081
16) Kaplan DE, Serper M, Kaushik A, Durkin C, Raad A, El-Moustaid F, Smith N, Yehoshua A. Cost-effectiveness of direct-acting antivirals for chronic hepatitis C virus in the United States from a payer perspective. J Manag Care Spec Pharm. 2022 Oct;28(10):1138-1148. doi: 10.18553/jmcp.2022.28.10.1138. PMID: 36125059; PMCID: PMC10373042.
17) Abimbola, T.O., Symum, H., Van Handel, M. et al. Lifetime medical costs of chronic hepatitis C in the United States. BMC Health Serv Res 26, 609 (2026). https://doi.org/10.1186/s12913-026-14360-1
18) Flemming JA, Kim WR, Brosgart CL, Terrault NA. Reduction in liver transplant wait-listing in the era of direct-acting antiviral therapy. Hepatology. 2017 Mar;65(3):804-812. doi: 10.1002/hep.28923. Epub 2016 Dec 24. PMID: 28012259; PMCID: PMC5333888.
19) Younossi ZM, Stepanova M, Al Shabeeb R, Eberly KE, Shah D, et al. The changing epidemiology of adult liver Transplantation in the United States in 2013-2022: The dominance of MASLD and alcohol associated liver disease. Hepatol Commun 2023: 8 (1): e0352

Thank you for this opportunity to comment on NCD 210.13.
If you have any questions about our request or if we may provide any additional information, please contact Leslie Narramore, Director of Regulatory Affairs, at 301-654-2055.

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Dear Centers for Medicare & Medicaid Services:

We appreciate the opportunity to comment on Medicare coverage for hepatitis C virus (HCV) screening. At Siemens Healthineers, our purpose is to enable healthcare providers to deliver greater value in medical delivery towards expanding precision medicine, transforming care delivery, and improving patient experience, all enabled by digitalizing healthcare. An estimated five million patients globally everyday benefit from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, radiation oncology, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services. We are a leading medical technology company with over 120 years of experience and 18,500 patents globally. With over 73,000 dedicated colleagues in over 70 countries, we continue to innovate and shape the future of healthcare.

Current clinical guidelines, epidemiologic evidence, implementation studies, randomized clinical data, and health-economic analyses collectively support expansion of Medicare coverage to include routine universal screening for HCV, regardless of birth cohort or documented risk factors.^1-6

Specifically, we support:

1. One-time universal HCV screening for all eligible adults.
2. Repeat testing for individuals with ongoing risk.
3. Screening in healthcare settings beyond traditional primary care.
4. Reflex HCV RNA testing following reactive antibody testing.
5. Timely linkage to curative therapy after diagnosis.

Universal screening is supported by current clinical guidelines

Risk-based screening and birth-cohort screening have historically failed to identify many infected individuals because risk factors are often unrecognized, undisclosed, or inconsistently assessed by healthcare providers. ^1,2

Recognizing these limitations, the CDC, USPSTF, and AASLD-IDSA guidance now recommend routine adult screening and repeat testing for populations with ongoing exposure risk.^1-3 Universal screening removes barriers associated with risk-factor ascertainment and better reflects the current epidemiology of HCV infection in the United States. ³

HCV remains a major public health burden

HCV continues to cause significant morbidity and mortality despite the availability of highly effective curative therapy. CDC surveillance data indicate that an estimated 67,400 new HCV infections occurred in 2022, approximately 2.2 million U.S. adults were living with hepatitis C during 2017-2020, and 12,717 HCV-related deaths occurred in 2022.⁴ Importantly, these figures likely underestimate actual disease burden because populations disproportionately affected by HCV, including people experiencing homelessness, incarceration, and injection drug use, are frequently underrepresented in national surveys.⁴

Universal screening outperforms targeted screening

The strongest direct evidence supporting universal screening comes from the DETECT Hep C randomized clinical trial. In this multicenter study involving 147,498 emergency department visits, nontargeted screening identified significantly more new HCV infections than targeted risk-based screening (relative risk, 1.34; 95% CI, 1.05-1.70). ⁵ Nontargeted screening resulted in 154 newly diagnosed infections compared with 115 diagnoses using targeted screening despite reliance on the same healthcare encounters. ⁵ These findings demonstrate that screening strategies dependent upon documented risk factors miss substantial numbers of infections. Importantly, this trial included Medicare beneficiaries and reflects real-world clinical practice across diverse U.S. healthcare systems. ⁵

Screening should not be limited to primary care settings

Many individuals with undiagnosed HCV do not routinely access preventive primary care services. Emergency departments, correctional facilities, substance use treatment programs, addiction medicine clinics, and public health settings frequently represent the principal point of healthcare contact for populations at greatest risk. ^4-6 The DETECT Hep C trial demonstrated that emergency departments can successfully identify previously undiagnosed infections through universal screening approaches.⁵ Similarly, contemporary HCV care guidance highlights the importance of expanding testing beyond traditional physician office settings to achieve national elimination goals.⁶ Restricting Medicare coverage to selected clinical environments risks missing patients who would otherwise not be tested.

Universal screening can be successfully implemented

Implementation studies demonstrate that universal screening can be operationalized effectively in routine clinical practice. Following deployment of an electronic health record prompt supporting universal HCV screening, one large U.S. healthcare system observed a 103% increase in monthly screening volume and a 62% increase in adjusted screening rates.⁸ These results demonstrate that healthcare systems can rapidly increase case finding when universal screening recommendations are paired with supportive workflows and reimbursement structures.⁸

Universal screening is cost-effective

Multiple economic analyses have shown that expanded HCV screening followed by treatment with direct-acting antivirals is a cost-effective healthcare intervention.^3,9-12 A contemporary U.S. economic analysis found that universal one-time screening coupled with pangenotypic direct-acting antiviral therapy remained highly cost-effective compared with historical screening approaches.⁹ A recent U.S. cost-effectiveness model evaluating newer diagnostic approaches similarly concluded that expanded HCV testing strategies improve diagnosis rates, increase treatment uptake, reduce HCV-related mortality, and provide favorable economic value.¹⁰ International analyses conducted across multiple healthcare systems have consistently demonstrated similar findings.^11,12 The economic rationale is straightforward: identifying HCV infection earlier permits treatment before progression to cirrhosis, hepatic decompensation, hepatocellular carcinoma, liver transplantation, and premature death.^6,9,11

Curative therapy strengthens the value of screening

A key reason universal screening is now strongly justified is the availability of highly effective antiviral therapy. Modern HCV treatment achieves cure in more than 95% of appropriately treated patients and substantially reduces the risk of cirrhosis, liver failure, hepatocellular carcinoma, transplantation, and liver-related mortality.^4,6 Successful treatment also reduces onward transmission, helping support broader HCV elimination efforts.^3,6 As a result, screening and treatment should be viewed as complementary components of a unified public health strategy.

Repeat screening remains important for ongoing risk

Universal screening should not replace repeat testing for individuals with continued exposure risk.

Current recommendations support periodic testing for ongoing risk populations and annual testing for certain groups at highest risk, including people who inject drugs.^1,3,6

Medicare coverage should therefore support both:

• One time universal screening.
• Repeat testing when ongoing exposure or reinfection risk is documented.

In addition, HCV RNA testing should be available when assessing reinfection after prior spontaneous clearance or successful treatment because HCV antibody positivity frequently persists after cure.^1,6

Recommendations

Based on the available evidence, we respectfully recommend that CMS:

1. Cover one-time universal HCV screening for all Medicare beneficiaries who have not previously undergone appropriate screening.^1-3
2. Remove birth-cohort restrictions and eliminate the requirement for documented risk factors before screening coverage.^1-3
3. Cover screening in emergency departments, correctional healthcare settings, substance-use treatment programs, hospital-based settings, and community-based programs in addition to primary care.^4-6
4. Support reflex HCV RNA testing after reactive antibody screening to ensure completion of the diagnostic pathway.^1,3,10
5. Cover repeat screening for individuals with ongoing HCV exposure risk.^1,3,6
6. Encourage linkage-to-care strategies that facilitate prompt initiation of curative direct-acting antiviral therapy.^5,6

Conclusion

Current evidence supports expansion of Medicare coverage for universal HCV screening. Contemporary CDC, USPSTF, and AASLD-IDSA recommendations endorse broader screening approaches; national surveillance demonstrates persistent disease burden; randomized clinical evidence shows that universal screening identifies more infections than risk-based screening; implementation studies demonstrate feasibility in real-world practice; and economic models consistently support screening as a cost-effective intervention.^1-12

Expanding Medicare coverage for universal HCV screening would align reimbursement policy with current clinical evidence, improve equitable access to diagnosis and treatment, reduce future liver-related morbidity and mortality, and support national goals for hepatitis C elimination.

Thank you for considering this request and thank you again for your diligent work on this important topic.

Sincerely,
Hilary Imai
Vice President, Reimbursement and Market Access

References

1. Schillie S, Wester C, Osborne M, Wesolowski L, Ryerson AB. CDC recommendations for hepatitis C screening among adults—United States, 2020. MMWR Recomm Rep. 2020;69(2):1-17
2. Owens DK, Davidson KW, Krist AH, et al; US Preventive Services Task Force. Screening for hepatitis C virus infection in adolescents and adults: US Preventive Services Task Force recommendation statement. JAMA. 2020;323(10):970-975.
3. AASLD-IDSA HCV Guidance Panel. Hepatitis C guidance 2019 update: AASLD-IDSA recommendations for testing, managing, and treating hepatitis C virus infection. Hepatology. 2020;71(2):686-721.
4. Barker LK, Doshani M, Jiles RB, Teshale E. Hepatitis C surveillance in the United States: past, present, and future. Public Health Rep. Published online August 28, 2025. doi:10.1177/00333549251351880
5. Haukoos JS, Rothman RE, Galbraith JW, et al. Universal vs risk-based screening for hepatitis C virus infection in emergency departments: a randomized clinical trial. JAMA. 2025;334(6):497-507.
6. Lo Re V III, Bhattacharya D, Price JC, et al. AASLD-IDSA hepatitis C guidance: recommendations for testing, managing, and treating hepatitis C. Clin Infect Dis. 2025;81(2):e15-e26.
7. Jhaveri R. Direct-acting antivirals for hepatitis C virus: historical perspective and future directions. Clin Ther. 2020;42(8):1434-1441.
8. Hack B, Sanghavi K, Gundapaneni S, et al. Real-world effectiveness and safety of direct-acting antivirals for chronic hepatitis C virus infection. PLoS One. 2023;18(3):e0279972.
9. Eckman MH, Ward JW, Sherman KE. Cost-effectiveness of universal screening for hepatitis C virus infection in the United States. Clin Gastroenterol Hepatol. 2019;17(5):930-939.e9.
10. Hall EW, Sandul AL, Kamili S, et al. Hepatitis C virus elimination in the United States: progress and challenges. Clin Infect Dis. 2025;81(5):934-942.
11. Lee HW, Lee H, Kim BK, et al. Evolution of hepatitis C virus treatment: from interferon to direct-acting antivirals. Clin Mol Hepatol. 2022;28(2):164-173.
12. Girardin F, Hearmon N, Castro E, et al. Cost-effectiveness of hepatitis C virus screening and treatment programs. Clin Infect Dis. 2019;69(11):1980-1986.

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I am an emergency physician treating patients in a safety net hospital in a community with poor access to health resources, and an infectious disease epidemiologist dedicated to preventing, identifying, and treating infections that present a public health threat. In that capacity, I am writing to suggest that CMS expand coverage for HCV screening to the emrgency department setting in addition to primary care settings. As demosntrated in the case of HIV, screening in the emergency department is cost-effective (PMID 38661620) and able to achieve prompt linkage to care, including during acute infection (PMID 27084781, PMID 26862233). Moreover, such screening programs can identify infections in populations that otherwise have limited access to screening in primary care settings (PMID 36818204). Screening for HCV in the emergency department has been demonstrated to measurably decrease the prevalence of infection (PMID 42797761) and is expected to be cost-effective (PMID 42895735). This evidence supports initiatives to expand screening in the emergency department, which I hope will be supported by CMS.

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San Francisco AIDS Foundation (SFAF) encourages CMS to improve its National Coverage Determination (NCD) on Screening for Hepatitis C Virus (HCV) in Adults by expanding the NCD to cover additional HCV-impacted populations and settings. SFAF is a community-based provider of HCV screening, as well as HCV treatment and a wide variety of other health and social services. Based on our experience, to more effectively respond to the HCV epidemic, we recommend that CMS strategically add to the NCD coverage of HCV screening:

- one time for everyone ages 18-79
- one time per pregnancy
- periodically for people at risk, including those who request an HCV test
- outside of primary care, as people at risk for HCV commonly access care in other settings, such as emergency departments
- with a reflex to the HCV RNA testing required for diagnosis

Thank you for your consideration.

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With respect to current data on the utility and necessity of supporting HCV screening in Emergency Departments (EDs), I would like to highlight the most recent data from Spain. As part of a nation-wide HCV elimination effort, the country of Spain integrated USPSTF recommended universal screening for HCV, and the incorporation of EDs to provide comprehensive access to all patients. Thus, even in Spain, a country with universal healthcare, the incorporation and support of EDs was recognized as necessary to provide screenings to under-served patients. Their most recent data has now demonstrated a drop in overall HCV prevalence after only five (5) years of integrated and financially supported screening across multiple healthcare venues including EDs. This paper shows what can be possible when there is a full understanding of the scope of the problem and a true appraisal and support of the ED as a necessary partner within overall healthcare systems to provide equitable access to recommended screening for diseases like HCV. Changing the coding to allow for funding to support HCV screening in EDs will provide more support for the spread of ongoing efforts to replicate the success in Spain using EDs in the US. EDs will now be able to recoup some funding to provide this recommended screening to underserved populations across the US. Please see the reference below for aforementioned data.

Ruiz-Cobo JC, Llaneras J, Rando-Segura A, Barreira-Díaz A, Rodríguez-Frías F, Romero-Vico J, Blanco-Grau A, Palom A, Vargas-Accarino E, Ferrer R, Esteban R, Riveiro-Barciela M, Buti M. Emergency Department-Based Screening and Linkage-to-Care for Hepatitis B, C, and D in a Referral Hospital in Barcelona, Spain: Reduction in Hepatitis C Prevalence After Five Years. Viruses. 2026 Aug 24;18(9):928. doi: 10.3390/v18090928. PMID: 42797761; PMCID: PMC13611998.

Abstract
Background: Emergency Department (ED) viral hepatitis screening programs typically report short-term outcomes. We evaluated the medium-term impact of an ED-based screening for Hepatitis C (HCV), Hepatitis B (HBV), and Hepatitis D (HDV) viruses. Methods: Prospective opportunistic screening conducted between January 2020 and December 2024 at a referral hospital in Barcelona. Adults attending the ED were screened for HBV, HCV, and HDV. Positive cases were evaluated and linked to care when appropriate. To assess screening impact, HCV RNA and HBsAg prevalences were compared between 2020–2021 and 2023–2024 among participants aged =80 years. Results: Over five years, 39,532 individuals were screened: 220 (0.56%) had detectable HCV RNA, 234 (0.59%) HBsAg, and 4 HDV RNA. Of 110 patients with detectable HCV RNA eligible for linkage, 84 (76%) were treated and cured. Among 135 HBV-positive individuals eligible for linkage, 116 (86%) attended outpatient follow-up. HCV RNA prevalence significantly decreased (0.58% vs. 0.35%, p = 0.005), whereas HBsAg prevalence did not vary (0.7% vs. 0.58%, p = 0.224). Conclusions: Sustained ED-based screening enabled the identification and linkage to care of several individuals with HBV and HCV. This strategy contributed to a reduction in HCV prevalence among ED attendees and supports opportunistic ED screening in viral hepatitis elimination goals.

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You should cover Hepatitis C screening in the following instances:

* One time for all adults ages 18-79
* During each pregnancy
* Periodically for people at ongoing risk, including those who request a hepatitis C test (anyone who asks. An individual might not wanna have to go into why they're at risk and they shouldn't have to)
* Outside of primary care because people at high risk for hepatitis C often access care in primarily other settings (e.g., emergency departments)

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Hepatitis C affects people across generations. Medicare rules should help people discover infection before preventable harm occurs.

I request coverage for one-time HCV screening for Medicare beneficiaries aged 18–79 without risk disclosure; HCV screening during every pregnancy; periodic testing with ongoing exposure, including patient-requested testing without mandated risk disclosure; coverage in clinically appropriate settings beyond primary care, including emergency departments and specialty services; automatic reflex HCV RNA testing after a reactive antibody result, plus RNA testing when reinfection is suspected.

Supporting evidence: In 2023, Americans aged 30–39 experienced the highest reported acute hepatitis C rates. (CDC surveillance (2023)) Adults aged 30–49 accounted for 48% of newly reported chronic hepatitis C cases in 2023. (CDC surveillance (2023)) CDC recommends periodic HCV testing for people with continued exposure risks, regardless of initial results. (CDC (2025)) DETECT randomized trial found 154 new HCV diagnoses with nontargeted emergency screening versus 115 targeted. (DETECT / JAMA (2025)) CDC-reported modeling projected 280,000 additional cures and 4,400 fewer liver cancers through broader adult screening. (CDC modeling summary)

Please update Medicare coverage so more people can get tested, learn whether they have hepatitis C, and obtain care.

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I urge CMS to update NCD 210.13 from a patient advocacy perspective. Patients should not face unnecessary barriers to HCV diagnosis.

I request coverage for one-time HCV screening for Medicare beneficiaries aged 18–79 without risk disclosure; HCV screening during every pregnancy; periodic testing with ongoing exposure, including patient-requested testing without mandated risk disclosure; coverage in clinically appropriate settings beyond primary care, including emergency departments and specialty services.

Supporting evidence: CDC recommends at least one HCV screening for nearly all adults aged 18 and older. (CDC (2025)) AASLD/IDSA notes prior risk-based strategies missed more than half of infections through underreporting and incomplete assessment. (AASLD/IDSA (2024/25)) CDC advises testing any person requesting HCV testing without requiring disclosure of stigmatized exposure histories. (CDC (2025)) Medicare’s 2014 screening NCD excludes emergency departments, despite their role reaching people outside routine primary care. (CMS NCD 210.13 (2014); DETECT / JAMA (2025)) Current oral direct-acting antiviral regimens cure more than 95% of hepatitis C cases in 8–12 weeks. (CDC clinical care (2025))

Please remove outdated restrictions and support screening, confirmatory diagnosis, and access to curative care.

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The American College of Obstetricians and Gynecologists (ACOG), representing more than 60,000 obstetrician-gynecologists (ob-gyns) and partners in women's health, provides indispensable decision support guidance and resources for the clinical delivery of women's health care that are grounded in scientific evidence and developed through a rigorous and inclusive process. ACOG has been collaborating with the Centers for Disease Control and Prevention (CDC) to ensure that stakeholders are aware of updated guidance that recommends screening for Hepatitis C (HCV) for all pregnant people. Further, we previously submitted a formal request to the Centers for Medicare and Medicaid Services (CMS) to reconsider and update the National Coverage Determination (NCD) 210:13: Screening for Hepatitis C Virus (HCV) in Adults, which has not been updated – outside of coding updates – since 2014. Consistent with these efforts, we appreciate CMS opening a national coverage analysis (NCA) and are submitting a new formal request for reconsideration of the NCD 210:13.

ACOG believes that aligning Medicare coverage policy with current evidence-based screening recommendations improves the quality of care delivered to beneficiaries. CDC data indicate that over two million adults in the United States are infected with HCV infection and the incidence continues to rise annually.ⁱ One study estimates that roughly 14 percent of all people with HCV in the United States are Medicare beneficiaries, with another study finding that 0.38 percent of live births were delivered by women with HCV.^ii,iii Given that Medicare sets the foundation for coverage policies across all other payers, this is particularly relevant to CMS and their quality improvement goals, as 42 percent of all births are financed by Medicaid, and approximately 22,000 pregnancies are covered by Medicare (including dual-eligible).^iv,v Additionally, there are significant health disparities in HCV outcomes. In 2019, HCV contributed to more than 14,200 deaths with death rates occurring at significantly higher rates among Black individuals (five per 100,000) and Hispanic individuals (four per 100,000) as compared to White individuals (three per 100,000).^vi The USPSTF updated their recommendations for HCV screening in 2020, indicating that adults ages 18 through 79 should be screened.^vii They also recommend that pregnant persons should be screened and further report that HCV prevalence has doubled in women aged 15 to 44 years from 2006 to 2014.^viii These recommendations, along with the recommendations from the CDC and ACOG, are not reflected in the current version of NCD 210.13.

Expanded access to HCV screening has the potential to improve patient outcomes through earlier identification of infection and timely linkage to treatment. Since HCV infection is frequently asymptomatic until advanced disease develops, screening remains a critical component of high-quality preventive care. Earlier diagnosis can help patients access appropriate clinical management before the onset of serious complications, such as liver failure, reducing missed opportunities for intervention, and supporting improved long-term health outcomes.^ix ACOG recommends aligning Medicare coverage with current evidence-based recommendations to promote more consistent delivery of preventive care services across care settings and patient populations.

This reconsideration presents an important opportunity to advance health equity and reduce disparities in HCV-related outcomes. Evidence suggests that disparities in access to screening and care persist among rural populations, racial and ethnic minority populations, Medicaid beneficiaries, and individuals with substance use disorder (SUD). A recent study found that lower screening rates among these communities were associated with disproportionate utilization of emergency departments for HCV-related complications.^x This same study found that while screening rates were lowered, there were increasing rates of office-based HCV care were observed among White, privately insured patients.^xi These findings highlight how gaps in access to preventive screening can contribute to inequitable care patterns and broader consequences to the health care continuum. Broader access to evidence-based HCV screening may help identify infections earlier, connect patients to appropriate treatment before complications arise, and reduce avoidable acute care utilization. In doing so, CMS can support both improved health outcomes and more efficient use of health care resources.

For ob-gyns and other health care professionals providing preventive services, updated Medicare coverage policy would further support the integration of evidence-based HCV screening into routine clinical practice. Increasing screening and identification of HCV infection could also support future quality improvement efforts by strengthening available data to monitor performance across the HCV care cascade, including screening, diagnosis, linkage to care, treatment initiation, and follow-up.^xii More comprehensive screening and diagnosis data enable providers, health systems, and policymakers to better identify gaps in care, evaluate quality improvement initiatives, and monitor progress toward improving HCV-related outcomes and reducing disparities. While ACOG is not recommending the creation of any specific quality measure as part of this reconsideration, improving access to appropriate screening is an important step toward supporting future quality measurement efforts and continued improvement in patient outcomes.

With this in mind, ACOG appreciates CMS' reconsideration of NCD 210.13 and recommends CMS update the NCD as requested, to be consistent with current guidelines. In our initial formal request in 2023, we recommended the following edits to the text of NCD 210.13:

Therefore, CMS will cover screening for HCV with the appropriate U.S. Food and Drug Administration (FDA)-approved/cleared laboratory tests, used consistent with FDA-approved labeling and in compliance with the Clinical Laboratory Improvement Act regulations, when ordered by the beneficiary’s primary care physician or practitioner, or obstetric provider within the context of a primary care setting, and performed by an eligible Medicare provider for these services, for beneficiaries who meet either of the following conditions:

A screening test is covered for adults at high risk for HCV infection. “High risk” is defined as persons with a current or past history of illicit injection drug use; and persons who have a history of receiving a blood transfusion prior to 1992. Repeat screening for high risk persons is covered annually only for persons who have had continued illicit injection drug use since the prior negative screening test.

A single screening test is covered for all asymptomatic adults aged 18 years through 79 years who do not meet the high risk definition above, but who were born from 1945 through 1965.

The determination of “high risk for HCV” is identified by the primary care physician or practitioner who assesses the patient’s history, which is part of any complete medical history, typically part of an annual wellness visit and considered in the development of a comprehensive prevention plan. The medical record should be a reflection of the service provided.

A screening test is covered for of all pregnant women, regardless of age, during each pregnancy, regardless of risk for HCV.

We continue to recommend these changes in this second formal request. Not only have HCV rates in women aged 15 to 44 doubled between 2006 and 2014, HCV rates in general have nearly quadrupled between 2010 and 2017.^xiii Accordingly, ACOG believes that undergoing HCV screenings during each pregnancy is crucial to prevent HCV prevalence from increasing further. In order to ensure this, obstetric providers must be able to order these screenings. Disregarding age and risk for pregnant women during these screenings allows for HCV to be caught and treated in adult pregnancies of all ages, not just within the 15 to 44 age range, and aligns with CMS’ broader focus on HCV screening in adults, ages 18 to 79.

CMS' inclusion of adult HCV screenings in Medicare coverage determinations is crucial and thus appreciated. Because screening a patient for HCV is the only way to know if they are infected, and because the screening is so accurate, a provider will know to start treatment more quickly if they catch it in an early enough screening.^xiv,xv Patients will experience decreased risk for liver diseases including cirrhosis and liver cancer as a result.^xvi Despite these benefits, many patients would miss out on them if CMS did not provide HCV screenings for free to anyone whose provider accepts assignment.^xvii Thirty percent of adults aged 18 to 64 with health insurance and 31 percent of women have postponed healthcare or skipped it entirely because they could not afford it, and 24 percent of insured adults aged 18 to 64 had problems paying or could not afford to pay their medical bills.^xviii Providing these screenings for free significantly decreases financial barriers for patients and thus increases their ease of access to quality health care. ACOG wholeheartedly supports CMS in this endeavor and recommends that in their changes to NCD 210.13, CMS continue to provide HCV screening coverage as comprehensively as possible.

***

Thank you for the opportunity to comment on this NCA. Should you wish to discuss these recommendations further, please contact Erin Alston, Director, Payment and Data Strategy, at ealston@acog.org.

Sincerely,
Lisa Satterfield, MS, MPH
Vice President, Practice Sustainability and Workforce Initiatives

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• Unexpected patient expenses: Clinicians appropriately order screening according to USPSTF guidelines, only for patients to subsequently discover that Medicare does not cover the test.
• Erosion of patient trust: Patients understandably question why their clinician recommended a preventive service that resulted in an unexpected bill.
• Increased administrative burden: Already overburdened primary care teams must manage billing questions, investigate denials, clarify coverage, and address patient dissatisfaction.
• Conflicting electronic health record guidance: EHR preventive-care reminders appropriately follow USPSTF recommendations but may prompt screening that Medicare does not cover.
• Potentially delayed diagnosis: Financial barriers and uncertainty about coverage may discourage patients and clinicians from pursuing indicated screening.

________________________________________

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October 6, 2026
To Whom It May Concern:

Lexington Health appreciates the opportunity to a submit comment in response to the proposal to align National Coverage Determination for the Hepatitis C Virus (HCV) Screening in Adults test with United States Preventive Services Task Force (USPSTF) guidelines. Lexington Health is a comprehensive network of care that includes six community medical and urgent care centers, nearly 80 physician practices, more than 9,000 health care professionals and Lexington Medical Center, a 607-bed teaching hospital in West Columbia, South Carolina. Our mission is to provide quality health services that meet the needs of our communities.

Lexington Health Inc. supports CMS’s reconsideration of National Coverage Determination (NCD) 210.13 and expansion of Medicare coverage for Hepatitis C virus (HCV) screening to align with current U.S. Preventive Services Task Force recommendations and contemporary clinical guidance.

The current Medicare coverage criteria reflects an earlier approach to HCV screening that focused primarily on individuals born between 1945 and 1965 and individuals with specifically identified risk factors. Since establishment of the current NCD, clinical recommendations have evolved in response to changes in the epidemiology of HCV infection and advances in the diagnosis and treatment of HCV.

The USPSTF recommends screening all adults aged 18 through 79 years for HCV infection and assigns this recommendation to a Grade B. The recommendation applies to asymptomatic adults, including pregnant women, without known liver disease. The USPSTF concluded with moderate certainty that screening adults within this age range provides a substantial net benefit. [1] This recommendation represents a significant expansion from the previous birth-cohort-based screening strategy and reflects evidence that HCV infection is no longer concentrated within the population born between 1945 and 1965. [1]

Lexington Health Inc. supports aligning Medicare coverage with this evidence-based clinical standard. Restricting routine screening to the 1945-1965 birth cohort no longer reflects the population for whom screening is recommended. CDC similarly recommends that all adults aged 18 years and older receive HCV screening at least once in their lifetime, with limited exceptions based on documented very low HCV prevalence. [2,3]

A universal age-based approach also reduces reliance on identification and disclosure of individual risk factors. HCV infection is frequently asymptomatic, and individuals may remain unaware of their infection. CDC reports that approximately 75%-85% of individuals with HCV do not have symptoms and nearly one in three individuals with HCV are unaware of their infection status. [3] Additionally, CDC recommends testing individuals who request HCV testing regardless of disclosed risk because patients may be reluctant to disclose stigmatizing risk factors.[2] Expanding coverage based on age rather than requiring identification of a qualifying risk factor therefore supports earlier identification of infection in individuals who might otherwise remain undiagnosed.

Lexington Health Inc. also supports coverage for periodic screening of beneficiaries who remain at increased risk for new HCV infection. This approach is consistent with both USPSTF and CDC recommendations. The USPSTF indicates that most adults generally require one-time screening, while individuals with continued risk for HCV infection should be screened periodically. [1] CDC likewise recommends routine periodic testing for individuals with ongoing risk factors, including persons who currently inject drugs and share injection equipment, and persons receiving maintenance hemodialysis. [3]

Importantly, the available evidence does not establish a single optimal repeat-screening interval applicable to all individuals with ongoing risk. The USPSTF notes that evidence regarding the optimal screening interval is limited and recommends periodic screening for persons with continued risk. [1] Because the nature, frequency, and persistence of HCV exposure may differ substantially among individuals, a uniform screening interval may not appropriately reflect individual clinical circumstances.

Accordingly, we recommend that CMS permit repeat screening based on documented ongoing risk and clinical judgment rather than establishing a single fixed interval for all beneficiaries. Such an approach would remain consistent with current USPSTF and CDC recommendations while allowing screening frequency to reflect the beneficiary’s clinical circumstances and evolving evidence. [1-3]

We further support removing the current limitation that HVC screening must be ordered by a primary care physician or practitioner within the context of a primary care setting. The USPSTF recommendation is defined by the population for whom screening is clinically indicated and does not limit the recommendation to screening performed within a primary care setting.[1] Similarly, CDC screening recommendations identify populations for whom testing is recommended without limiting testing to primary care environments. [2,3]

From a clinical perspective, opportunities to identify individuals who have never been screened or who have ongoing risk for HCV infection may occur throughout the continuum of care. Beneficiaries may receive services in specialty practices, hospital-based settings, emergency departments, dialysis facilities, substance use treatment settings, and other clinical environments where HCV screening may be appropriate. In particular, several populations for whom CDC recommends HVC testing because of ongoing or recognized risk may routinely interact with the health care system outside of traditional primary care. [2,3]

Restricting Medicare coverage based on the setting in which the need for screening is identified may therefore create missed opportunities for diagnosis and does not reflect the broader clinical approach established by current national screening recommendations. When an appropriately qualified practitioner determines that HCV screening is indicated and testing is performed using appropriate laboratory methods, Medicare coverage should not depend solely upon whether the clinical encounter occurred within a designated primary care setting.

Expanding screening also supports earlier linkage to confirmatory testing, evaluation, and treatment. Chronic HCV infection may remain clinically silent while progressive liver disease develops. Untreated chronic infection can result in serious complications, including cirrhosis and hepatocellular carcinoma. [3,4] Advances in direct-acting antiviral therapy have substantially changed the clinical implications of identifying HCV infection, with highly effective treatment now available for most individuals with HCV. [2,4] Screening, therefore, represents an important entry point into a clinical pathway that can identify active infection and facilitate timely treatment.

Accordingly, we support revision of NCD 210.13 to align Medicare HCV screening coverage with current evidence-based clinical recommendations by:

1. Providing one-time HCV screening for Medicare beneficiaries aged 18 through 79 years of age, consistent with the USPSTF Grade B recommendations;
2. Providing periodic screening for beneficiaries with ongoing risk for HCV infection;
3. Allowing the frequency of repeat screening to be informed by ongoing risk, clinical judgement, and evolving evidence rather than establishing a single uniform
4. Removing the current primary care setting limitation so that clinically appropriate HCV screening may occur across settings in which Medicare beneficiaries receive care.

Aligning NCD 210.13 with current USPSTF recommendations would establish a more clinically consistent Medicare coverage policy, support earlier identification of HCV infection, reduce reliance on recognition or disclosure of individual risk factors, and provide clinicians with appropriate flexibility to apply evidence-based screening recommendations across the continuum of care.

Thank you for your time and consideration.

Lexington Health Inc.
Quality Management Ambulatory
West Columbia, SC

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Re: NCD for Screening for Hepatitis C Virus (HCV) in Adults (210.13), CAG-00436R, https://www.cms.gov/medicare-coverage-database/view/nca.aspx?ncaid=325&ncacaldoctype=NCA&status=Open%20for%20Public%20Comment&sortBy=status&bc=17

To: Tamara Syrek Jensen, JD, Director, Coverage and Analysis Group, CMS

From: Mitchell Berger, (comments made in personal capacity), mazruia@hotmail.com. 10.3.26

Dear Ms. Jensen: I write to urge CMS to revise National Coverage Determination (NCD) 210.13 to reflect the latest (2020) U.S. Preventive Services Task Force (USPSTF or Task Force) recommendation (1). The current NCD was last revised in 2014 (2). I agree with the health providers who submitted the formal requests for reconsideration that this review is warranted. CMS seeks comments and “peer-reviewed literature that describes the specific screening interval that should occur in persons who continue to be at risk for new HCV infection and screening in non-primary care settings.” Below I address these issues. Please note that I am submitting these suggestions in my personal/private capacity. The views expressed are mine only and should not be imputed to other individuals nor to any public or private entity.

What screening interval is supported for beneficiaries who remain at risk for new HCV infection?

Based on the USPSTF recommendation and other guidelines, CMS should consider:

• One-time, voluntary screening for adults ages 18–79, consistent with the USPSTF recommendation (1).
• Screening during each pregnancy, consistent with Centers for Disease Control and Prevention (CDC) recommendations (3). Several major medical organizations recommend screening at the initial prenatal visit (4). However, I would not make Medicare coverage dependent on the CDC caveat concerning settings with HCV RNA prevalence below 0.1%, because local prevalence may be difficult to determine and can change over time.
• CDC recommends one-time risk testing “regardless of age or setting prevalence among persons with recognized risk factors or exposures,” including persons with HIV or those who “ever injected drugs and shared needles, syringes, or other drug preparation equipment, including those who injected once or a few times many years ago.”
• CDC recommends “routine periodic testing” for persons with ongoing risk factors while those risk factors persist, including persons who currently inject drugs and share needles, syringes, or other drug preparation equipment (3). CDC does not specify the interval. Based on guidelines from Australia (5), New Zealand (6), AASLD/IDSA (7), and the European Centre for Disease Prevention and Control (ECDC) (8), annual testing in this population is a reasonable Medicare coverage standard while ongoing risk persists. Some guidelines recommend testing every 6–12 months depending on risk (5), while AASLD/IDSA and ECDC support at least annual testing in relevant populations (7,8).
• CDC recommends that any person who requests HCV testing should receive it regardless of disclosure of risk because some persons may be reluctant to disclose stigmatizing risks (3). I recommend that CMS permit testing on an as-needed basis, with the patient and health care provider determining whether repeat testing is appropriate based on clinical circumstances rather than imposing an arbitrary frequency cap.

What evidence supports HCV screening in non-primary-care settings?

CMS should consider the following evidence supporting HCV screening and testing in non-primary-care settings:

• Community pharmacies in New Zealand and the United States (9).
• Opioid treatment programs (10).
• Homeless shelters (11).
• Certified community behavioral health clinics (12).
• Mental health, prison, and drug and alcohol treatment facilities (13).
• Federally qualified health centers (14).
• HIV and sexually transmitted infection programs (15).
• Emergency departments (16)
• Urgent Care settings (17)
• Public health departments and clinics (18)
• Other community-based organizations/outreach programs serving high-risk populations

CMS should consider these and other appropriate non-primary-care settings in its revised NCD and permit HCV testing to be covered and reimbursed when conducted by eligible Medicare providers using FDA-approved or FDA-cleared tests consistent with applicable requirements.

Sources cited: 1. https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/hepatitis-c-screening
2. https://www.cms.gov/medicare-coverage-database/view/ncacal-tracking-sheet.aspx?ncaid=325&ncacaldoctype=NCA&status=Open+for+Public+Comment&sortBy=status&bc=17
3. Schillie S, Wester C, Osborne M, Wesolowski L, Ryerson AB. CDC Recommendations for hepatitis C screening among adults—United States, 2020. MMWR Recomm Rep 2020;69(No. RR-2):1–17. https://doi.org/10.15585/mmwr.rr6902a1
4. Call to Action: Routine Hepatitis C Screening in Pregnancy: From the American Academy of Family Physicians; American College of Nurse-Midwives; American College of Obstetricians and Gynecologists; Association of Women's Health, Obstetric and Neonatal Nurses; National Association of Nurse Practitioners in Women’s Health; and Society for Maternal-Fetal Medicine. Aug. 2023, https://www.acog.org/news/news-articles/2023/08/call-to-action-routine-hepatitis-c-screening-in-pregnancy#
5. People who use drugs. Australian STI Management Guidelines. https://sti.guidelines.org.au/populations-and-situations/people-who-use-drugs/; Cordaro F, Qian S, Sinclair B. Investigating hepatitis C screening among people receiving opioid agonist treatment: A retrospective audit study. J Infect Prev. 2024 Mar;25(1-2):11-16. doi: 10.1177/17571774231208317
6. New Zealand STI Management Guidelines. https://sti.guidelines.org.nz/infections/hepatitis-a-b-and-c/
7. HCV in Key Populations: Identification and Management of HCV Infection in People Who Inject Drugs, AASLD/IDSA, 2018,https://www.hcvguidelines.org/guidance/key-populations-identification-and-management-of-hcv-in-people-who-inject-drugs/
8. Guidance in brief: Prevention and control of infectious diseases among people who inject drugs - 2023 update (2024), European Centre for Disease Prevention and Control, https://www.ecdc.europa.eu/en/publications-data/guidance-brief-prevention-and-control-infectious-diseases-among-people-who-inject; Prevention and control of infectious diseases among people who inject drugs - 2023 update, Nov. 2023, https://www.ecdc.europa.eu/en/publications-data/guidance-brief-prevention-and-control-infectious-diseases-among-people-who-inject
9. Gauld N, Perry J, Jackson C, Gane E. Feasibility and outcomes of a hepatitis C screening programme in community pharmacies. N Z Med J. 2020 Nov 20;133(1525):74-83. PMID: 33223550; Klepser DG, Klepser ME, Peters PJ, Hoover KW, Weidle PJ. Implementation and Evaluation of a Collaborative, Pharmacy-Based Hepatitis C and HIV Screening Program. Prev Chronic Dis 2022;19:220129. DOI: http://dx.doi.org/10.5888/pcd19.220129.
10. Substance Abuse and Mental Health Services Administration. Federal Guidelines for Opioid Treatment Programs. HHS Publication No. PEP24-02-011. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2024; Falade-Nwulia O, Price JC, Feld JJ, Eaton E, Franco RA, Barnaba B, Brown D, Hussain S, Verinumbe T, Wren C, Karimi-Sari H, Hirose K, Cavacuiti C, O'rear ST, Capraru C, Tobin K, Vaidya D, Schwartz S, Sulkowski M. Rapid hepatitis C test and treat with peer support at opioid treatment programs (RAPID HCV): a hybrid effectiveness-implementation type 1 randomized control trial. Lancet Reg Health Am. 2026 Mar 24;57:101439. doi: 10.1016/j.lana.2026.101439.
11. Hepatitis C Testing & Treatment in the Homeless Shelters in San Francisco, CA and Minneapolis, MN, https://www.globalhep.org/about/partner-programs/hepatitis-c-testing-treatment-homeless-shelters-san-francisco-ca-and
12. Certified Community Behavioral Health Clinics, Certification Criteria, https://www.samhsa.gov/communities/certified-community-behavioral-health-clinics/ccbhc-certification-criteria
13. McCartney EM, Ralton L, Dawe J, Richmond J, Zobel J, Wigg A, Cock V, Tse EY, Rees T, Shaw D, Ferguson C. Point-of-Care Testing for Hepatitis C in the Priority Settings of Mental Health, Prisons, and Drug and Alcohol Facilities-the PROMPt Study. Clin Infect Dis. 2024 Oct 15;79(4):965-973. doi: 10.1093/cid/ciae155; Mahoney BJ, Morford KL, Biegacki ET, Tetrault JM. Hepatitis C virus and integrated care for substance use disorders. Clin Liver Dis (Hoboken). 2024 Jun 28;23(1):e0241. doi: 10.1097/CLD.0000000000000241; Recommended Citation: Substance Abuse and Mental Health Services Administration. (2021). Screening and Treatment of Viral Hepatitis in People with Substance Use Disorders. Advisory.
14. Sabrina A. Assoumou et al, Hepatitis C Management at Federally Qualified Health Centers during the Opioid Epidemic: A Cost-Effectiveness Study, The American Journal of Medicine (2020). DOI: 10.1016/j.amjmed.2020.05.029
15. Solomon SS, Quinn TC, Solomon S, McFall AM, Srikrishnan AK, Verma V, Kumar MS, Laeyendecker O, Celentano DD, Iqbal SH, Anand S, Vasudevan CK, Saravanan S, Thomas DL, Sachdeva KS, Lucas GM, Mehta SH. Integrating HCV testing with HIV programs improves hepatitis C outcomes in people who inject drugs: A cluster-randomized trial. J Hepatol. 2020 Jan;72(1):67-74. doi: 10.1016/j.jhep.2019.09.022; Jangipour Afshar P, Yazdi-Feyzabadi V, Abdolahinia Z, Haghdoost A, Geerts JM, Goudarzi R, Tayeri K, Eshrati B, Sharifi H. Integration of HIV, Hepatitis B, and C, and sexually transmitted infections services: A scoping review of the benefits and challenges. PLoS One. 2026 May 7;21(5):e0348073
16. Haukoos J, Rothman RE, Galbraith JW, et al. Hepatitis C Screening in Emergency Departments: The DETECT Hep C Randomized Clinical Trial. JAMA. 2025;334(6):497-507. doi:10.1001/jama.2025.1056
17. Burrell CN, Sharon MJ, Davis SM, Wojcik EM, Martin IBK. Implementation of a Collaborative HIV and Hepatitis C Screening Program in Appalachian Urgent Care Settings. West J Emerg Med. 2018 Nov;19(6):1057-1064. doi: 10.5811/westjem.2018.9.39512
18. Seña AC, Willis SJ, Hilton A, et al. Efforts at the Frontlines: Implementing a Hepatitis C Testing and Linkage-to-Care Program at the Local Public Health Level. Public Health Rep. 2016;131(Suppl 2):57-64. doi:10.1177/00333549161310S210

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