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Back to Screening for the Human Immunodeficiency Virus (HIV) Infection

National Coverage Analysis (NCA) View Public Comments

Screening for the Human Immunodeficiency Virus (HIV) Infection

CAG-00409R

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Total Comments: 16

Commenter	Comment Information
Rayburn, Jack	Title: Senior Government Relations Manger Organization: Trust for America's Health Date: 02/28/2015 Comment: Please find below our comments on this NCA. A PDF copy of a formatted version of these comments is available. Please email me at jrayburn@tfah.org or contact me at (202) 223-9870 x 28 for a full copy. February 27, 2015 Stuart Caplan RN, MAS Lead Analyst Centers for Medicare and Medicaid Services Mail Stop C1-09-06 7500 Security Boulevard Baltimore, Maryland 21244-1850 Re: Centers for Medicare and Medicaid Services (CMS) National Coverage Analysis (NCA) for Screening for the Human Immunodeficiency Virus (HIV) Infection (CAG-00409R) Dear Mr. Caplan: On behalf of Trust for America’s Health (TFAH), thank you for the opportunity to comment on the proposed expansion of Medicare’s National Coverage Determination’s (NCD) Manual to include coverage of screenings for HIV infection for all beneficiaries between the ages of 15 to 65. TFAH is a nonprofit and nonpartisan public health advocacy organization dedicated to saving lives by making disease prevention a national priority. We strongly support Medicare’s proposed coverage of HIV screening as recommended by the U.S. Preventive Services Task Force (USPSTF) and the Centers for Disease Control and Prevention (CDC) for all beneficiaries between the ages of 15 and 65 regardless of risk, for adolescents younger than 15 and adults older than 65 who are at increased risk for HIV infection, and for all pregnant beneficiaries—including those who present in labor who are untested and whose HIV status is unknown. As you know, currently Medicare covers HIV screening for all beneficiaries with an increased risk for HIV infection as well as for pregnant Medicare beneficiaries. The expansion of screening for adolescents and adult beneficiaries between the ages of 15 to 65 years, without regards to perceived or actual risk, is a necessary and important step for the diagnosis and treatment of HIV/AIDS. Improved detection and surveillance of this epidemic will also help to better combat further spread of the HIV virus. We strongly urge you to reconsider whether reimbursement for HIV/AIDS screening need be necessarily limited to those “ordered by a beneficiary’s physician…within the context of a healthcare setting.” We respectfully refer you to both the U.S. Preventive Services Task Force and corresponding CDC screening guidelines, neither of which limit screenings to the primary care setting and/or primary care providers. The Proposed Decision Memo notes that in the U.S., nearly “1.2 million people are living with HIV infection, and approximately one in seven of those individuals are unaware of their infection.” The Proposed Decision Memo also notes the rapid and recent increase in the percentage of those infected with HIV aged 50 or older. By expanding routine testing to adults and adolescents between the age of 15 and 65, Medicare can play a decisive role in fighting the spread of HIV by helping identify the 16 percent of HIV-positive individuals in the U.S. who are unaware that they have HIV. Early testing is the first step in connecting HIV positive individuals with necessary care and treatment, and we believe that this will be an important step towards battling the HIV epidemic in the U.S. Despite our overall support for the Proposed Decision Memorandum, we are concerned that the frequency of testing may be too limited for those with a high risk of infection. The CDC has recommended that individuals at a high risk for HIV infection be screened at least annually —the Proposed Decision Memorandum, however, limits voluntary screening to a maximum of one annual screening for all non-pregnant beneficiaries. Indeed, as the CDC recommends: Anyone who has unsafe sex or shares injection drug equipment should get tested for HIV at least once a year. Sexually active gay and bisexual men may benefit from more frequent testing (e.g., every 3 to 6 months). We believe that Medicare should not limit reimbursement for HIV screening to a maximum of one screening, at least for beneficiaries who are at a high risk of infection, regardless of age, consistent with this CDC guidance. Still, the Proposed Decision Recommendation is an important and commendable step towards addressing the spread of HIV in the U.S., and we commend CMS for expanding screening through Medicare. We hope that these comments will assist CMS as you work collectively to finalize this coverage determination. If you have any questions, please do not hesitate to contact our Senior Government Relations Manager, Jack Rayburn, at (202) 223-9870 ext. 28, or via email at jrayburn@tfah.org. Sincerely, Jeffrey Levi, PhD Executive Director Trust for America’s Health Less Please find below our comments on this NCA. A PDF copy of a formatted version of these comments is available. Please email me at jrayburn@tfah.org or contact me at (202) 223-9870 x 28 for a full copy. February 27, 2015 Stuart Caplan RN, MAS Lead Analyst Centers for Medicare and Medicaid Services Mail Stop C1-09-06 7500 Security Boulevard Baltimore, Maryland 21244-1850 Re: Centers for Medicare and Medicaid Services (CMS) National More
McLaughlin, John	Title: Director, Policy & Alliance Development Organization: Quest Diagnostics Date: 02/27/2015 Comment: Quest Diagnostics is a national supplier to Medicare of high quality clinical laboratory tests. As such, we are impacted by CMS’ proposal to expand coverage of the existing HIV Infection screening Medicare benefit. We are pleased to submit comments to CMS' Proposed Decision Memo for Screening for the Human Immunodeficiency Virus (HIV) Infection (CAG-00409R) for CMS consideration. Quest Diagnostics applauds CMS for increasing the reach of its current HIV screening program by adding coverage of one annual voluntary screening for all adolescents and adults between the age of 15 and 65 without regard to perceived risk. Both the U.S. Preventive Services Task for and the Centers for Disease Control and Prevention (CDC) now strongly endorse routine HIV screening for all adolescents and adults aged 15-65 years in addition to those at increased risk of HIV infection. These recommendations underscore the importance of knowing one’s HIV status, knowledge which can lead to entry into care, prevention of significant morbidity and mortality, and decreased likelihood of HIV transmission. We also earnestly support CMS’ inclusion of 4th Generation HIV testing within the scope of the benefit. 4th Generation HIV testing offers improved sensitivity for detection of HIV infection via use of both HIV p24 antigen and antibody to HIV 1 and 2. This allows earlier diagnosis at a time when an infected individual’s viral load is usually very high, and the risk of transmitting infection is heightened. In addition, 4th Generation testing decreases the number of false positive or indeterminate results with Western blot confirmation assays. These advantages led CDC to update their recommended testing guidelines as standard of care in June 2014. Because 4th Generation HIV testing has become an established higher standard of diagnostic care, Quest Diagnostics further encourages CMS to ultimately remove 3rd Generation HIV testing from Medicare coverage. With regard to administration and claims processing of this expansion in HIV screening coverage, Quest Diagnostics sees a great opportunity for CMS to ensure every Medicare beneficiary in the targeted population whose physician has ordered HIV screening testing for him or her receives coverage under this benefit as intended. We recognize that there are several coding approaches CMS uses to administer screening benefits. CMS has in the past instructed laboratories to bill using AMA CPT codes for certain newly added screening benefits, as seen with Cardiovascular Disease screening. CMS has also instructed laboratories to bill for testing covered under other screening benefits using HCPCS codes, such as in the original HIV screening NCD and in the Prostate Cancer Screening NCD, for example. With regard to this proposed HIV screening expansion, Quest Diagnostics proposes a combined procedure coding coverage approach to ensure the intent of the proposed policy is carried out in practice - to allow coverage of one annual HIV screen to all qualified Medicare beneficiaries in the targeted age group without regard to perceived risk. Specifically, we urge CMS to recognize both the CMS HCPCS codes already in the HIV screening NCD, as well as the respective AMA CPT codes traditionally used for this HIV testing, to allow coverage and payment under the expanded screening benefit in either case. The proposed policy sets out to cover HIV screening for the targeted population without regard to perceived risk. However, the existing NCD specifies use of HCPCS codes to indicate screening, and to couple them with particular ICD-9 codes to indicate specific risk factors, pregnancy, or to indicate only V73.89 for beneficiaries not reporting increased risk factors. We believe that if CMS were to take a similar coding requirement approach with the newly proposed HIV screening coverage, this will heighten the probability of beneficiaries who qualify for the new screening criteria to be improperly denied coverage. Accordingly, in addition to allowing either the CMS HCPCS codes or AMA CPT codes to be used, we also urge CMS to avoid specifying any particular ICD-9 code(s) as criteria for allowing claims to pay under this new HIV screening coverage criteria. In this case, because the intent is to afford coverage without regard to perceived risk, Medicare claims should be paid for eligible beneficiaries in the targeted age range once per year whether the laboratory bills with a CPT or HCPCS code, and without regard to specific ICD-9 coding. This coding approach in the policy will place CMS in the best position to ensure the actual beneficiary HIV screening coverage experience is consistent with the intent of the proposed policy language, “without regard to perceived risk”, and will help prevent beneficiaries from getting caught in the middle of claim denials caused by well-intending physicians and office staff who may use a valid ICD-9 code that is not specified in the policy language. Thank you for the opportunity to provide our views regarding this important policy change to Medicare coverage of HIV screening. We hope you find these comments helpful. Of course, if you would like to discuss any of the comments herein, please do not hesitate to contact me. Sincerely, /s/ John McLaughlin Director, Policy & Alliance Development Quest Diagnostics Less Quest Diagnostics is a national supplier to Medicare of high quality clinical laboratory tests. As such, we are impacted by CMS’ proposal to expand coverage of the existing HIV Infection screening Medicare benefit. We are pleased to submit comments to CMS' Proposed Decision Memo for Screening for the Human Immunodeficiency Virus (HIV) Infection (CAG-00409R) for CMS consideration. Quest Diagnostics applauds CMS for increasing the reach of its current HIV screening program by More
Schmid, Carl	Title: Deputy Executive Director Organization: The AIDS Institute-on behalf of HIV Testing Reimbursement Group Date: 02/26/2015 Comment: HIV Testing Reimbursement Workgroup A subcommittee of the HIV Health Care Access Working Group (Affiliated with the Federal AIDS Policy Partnership) February 26, 2015 Stuart Caplan Office of Clinical Standards and Quality Centers for Medicare & Medicaid Services 7500 Security Blvd. Baltimore, MD 21244 Re: National Coverage Determination – Proposed Decision Memorandum for Screening for HIV Infection Dear Mr. Caplan: The undersigned parties are pleased to provide comments on the proposed expansion of Medicare coverage for HIV screening. We strongly support the proposal to update the National Coverage Determination (NCD) to allow for reimbursement of routine screening in healthcare settings for all beneficiaries age 15 to 65. Since 2009, Medicare national coverage for HIV screening has been limited to at-risk individuals and pregnant women. The proposed change would align Medicare coverage with current guidelines of the Center for Disease Control and Prevention (CDC) and recommendations of the U.S. Preventive Services Task Force (USPSTF), which in 2013 gave an “A” grade for routine HIV screening, finding a high certainty of substantial benefit in this practice. As recognized in your January 30, 2015, Proposed Decision Memorandum, screening for HIV in adults without regard to perceived risk is recommended for early diagnosis and reduced risk for progression to AIDS, AIDS-related events, and death. The Proposed Decision Memorandum notes that “late diagnosis of HIV is common in this country.” In fact, 14 percent of people living with HIV in the United States are unaware of their status. Each year another 50,000 are newly infected with HIV. As the Memorandum also notes, “essential to earlier treatment is the assumption that patients with HIV infection can be identified earlier in the course of their disease.” Early diagnosis also allows those who are living with HIV to take steps to avoid transmission to others, and to access treatment, which reduces viral load and therefore reduces likelihood of transmission. Reimbursement for annual testing without regard to risk, as proposed, will promote early diagnosis and linkage to HIV care in the Medicare population. Expanding access in this way is consistent with the intent of recent federal policy reforms that authorize Medicare to cover, on a national basis, preventive services that have been graded “A” or “B” by the USPSTF. The law further provides that beneficiaries should have access to these services without cost-sharing. We are especially pleased that the proposed NCD extends coverage to testing in “healthcare settings,” which we interpret as including emergency rooms as well as traditional primary care settings. We believe these additional access improvements are necessary for more patients and providers to engage in effective HIV prevention and care, which is the goal of routine testing practice. The CDC recommends testing those identified as high risk at least annually, and suggests three- and six-month intervals for certain groups at high risk for sexually transmitted diseases. Therefore, we would prefer to see reimbursement not limited to just one test per year for high risk individuals. However, aligning Medicare’s national policy with USPSTF recommendations is a necessary coverage improvement. We thank you and your office for undertaking this NCD and look forward to a final decision very soon. Thank you for your consideration. Sincerely, Acacia Network AIDS Action Baltimore AIDS Alabama AIDS Alliance for Women, Infants, Children, Youth & Families AIDS Foundation of Chicago AIDS Healthcare Foundation The AIDS Institute AIDS Legal Referral Panel AIDS Project Los Angeles AIDS United APLA Health & Wellness American Academy of HIV Medicine American Sexual Health Association Association of Asian Pacific Community Health Organizations Association of Nurses in AIDS Care Brooklyn Hospital Center Brothers Health Collective Central Care Community Health Center Chicago Center for HIV Elimination Cincinnati Exchange Project City of Baton Rouge Coalition of HIV/AIDS Nonprofits and Governmental Entities Community Access National Network Dab the AIDS Bear Project Department of Emergency Medicine of the Keck School of Medicine of USC Dignity Health St Mary Medical Center EXCELth Family and Medical Counseling Service Gay Men’s Health Crisis Georgia AIDS Coalition Global Network of People Living with HIV, North America Harris Health System HealthHIV Healthy BR Hepatitis Education Project HIV Access HIV Dental Alliance HIV Medicine Association HIV/AIDS Services for African Americans in Alaska Hope & Help Center Horizon Health Center Human Rights Campaign Institute for Population Health Interfaith Medical Center International AIDS Empowerment The JACQUES Initiative Johns Hopkins University AIDS Education and Training Center John Snow Inc. Latino Commission on AIDS Lifelong Louisiana AIDS Advocacy Network Mendocino County AIDS/Viral Hepatitis Network Mercy Atlanta Minnesota AIDS Project Morehouse School of Medicine Multicultural AIDS Coalition National Alliance of State and Territorial AIDS Directors National Association of County and City Health Officials National Viral Hepatitis Roundtable North Jersey Community Research Initiative Older Women Embracing Life The Philadelphia Center (Shreveport) Project HEAL, University of Illinois Hospital & Health Sciences System Providence Hospital (DC) Rhode Island Public Health Institute Rutgers, New Jersey Medical School Ruth M. Rothstein CORE Center Saban Community Clinic Sinai Health System - Chicago Southside Medical Center START at Westminster St. John’s Well Child and Family Center United Medical Center University of Chicago University of Illinois College of Medicine Urban Coalition for HIV Prevention Services Valley Community Healthcare Whitman-Walker Health Women Together for Change Woodhull Sexual Freedom Alliance Wyckoff Heights Medical Center Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings, 2006. Accessed at http://www.cdc.gov/mmwr/pdf/rr/rr5514.pdf. Sexually Transmitted Diseases Treatment Guidelines, Centers for Disease Control and Prevention, 2010. Accessed at http://www.cdc.gov/std/treatment/2010/std-treatment-2010-rr5912.pdf. Less HIV Testing Reimbursement Workgroup A subcommittee of the HIV Health Care Access Working Group (Affiliated with the Federal AIDS Policy Partnership) February 26, 2015 Stuart Caplan Office of Clinical Standards and Quality Centers for Medicare & Medicaid Services 7500 Security Blvd. Baltimore, MD 21244 Re: National Coverage Determination – Proposed Decision Memorandum for Screening for HIV Infection Dear Mr. More
Bocchino, Carmella	Title: Executive Vice President Organization: America's Health Insurance Plans (AHIP) Date: 02/26/2015 Comment: RE: Centers for Medicare and Medicaid Services (CMS) Proposed Decision Memo for Screening for the Human Immunodeficiency Virus (HIV) Infection (CAG-00409R) Dear Mr. Caplan: Thank you for the opportunity to comment on the Centers for Medicare and Medicaid Services (CMS) Proposed Decision Memo for Screening for the Human Immunodeficiency Virus (HIV) Infection (CAG-00409R). America’s Health Insurance Plans (AHIP) is the national association for the health insurance industry. Our members provide coverage to more than 200 million Americans, offering a broad range of health insurance products in the commercial market and demonstrating a strong commitment to participation in public programs. General Comments AHIP and our member plans continue to support CMS’s efforts to ensure that Medicare beneficiaries receive access to safe and effective preventive health services, as determined by current and robust clinical evidence, that can improve health outcomes. As previously noted in our comments submitted in response to the National Coverage Analysis (NCA) Tracking Sheet on the screening for HIV infection, health plans are currently implementing the US Preventive Services Task Force (USPSTF) recommendations related to HIV which call for screening adolescents and adults ages 15 to 65, all pregnant women (including those who present in labor, are untested and whose HIV status is unknown), and younger adolescents and older adults who are at increased risk for the disease. AHIP and our members have been in support of the recommendations since their release in April 2013. Our members agreed with the NCA reconsideration request for CMS to review new scientific evidence and to adopt the USPSTF most current evidence-based recommendations, and are in agreement with the Proposed Decision Memo. Members did express some concern regarding testing an individual annually who is outside of the high risk categories (listed in statements 2 and 3) if that person initially screens negative for HIV. The CMS proposed decision memo appears to recommend annual screening for this low-risk group, even if the risk has not changed. AHIP encourages CMS to consider a broader interval (such as every 2 to 5 years) for re-testing low risk individuals that is in line with the USPSTF recommendation. Thank you for the opportunity to comment on this important issue. Sincerely, Carmella Bocchino Executive Vice President Less RE: Centers for Medicare and Medicaid Services (CMS) Proposed Decision Memo for Screening for the Human Immunodeficiency Virus (HIV) Infection (CAG-00409R) Dear Mr. Caplan: Thank you for the opportunity to comment on the Centers for Medicare and Medicaid Services (CMS) Proposed Decision Memo for Screening for the Human Immunodeficiency Virus (HIV) Infection (CAG-00409R). America’s Health Insurance Plans (AHIP) is the national association for the health insurance More
Maril, Robin	Organization: Human Rights Campaign Date: 02/26/2015 Comment: February 26, 2015 Stuart Caplan Office of Clinical Standards and Quality Centers for Medicare & Medicaid Services 7500 Security Blvd. Baltimore, MD 21244 Re: National Coverage Determination – Proposed Decision Memorandum for Screening for HIV Infection Dear Mr. Caplan: On behalf of the Human Rights Campaign’s more than 1.5 million members and supporters nationwide, I write in response to the proposed expansion of Medicare coverage for HIV screening published January 30. We applaud the Center for Medicare and Medicaid Services for revisiting this issue, and we strongly support the proposal to update the National Coverage Determination (NCD) to allow for reimbursement of routine screening in healthcare settings for all beneficiaries age 15 to 65. The HIV/AIDS epidemic continues to disproportionately impact gay and bisexual men and transgender women. In recent years, there has been a marked and steady increase in new HIV diagnoses among youth ages 13-24 and in communities of color, particularly in the southern United States. While tremendous medical advances have helped HIV-positive individuals live longer, healthier lives, there remains no cure and tens of thousands of new infections occur every year. Increased screening is key to reducing new infections and bringing us closer to ending this disease. Currently, Medicare coverage for HIV screening is only available to pregnant women and individuals considered at-risk for developing the disease. The proposed update meets the current recommended guidelines for HIV screening adopted by the Center for Disease Control and Prevention and the U.S. Preventive Services Task Force. Screening adults, regardless of perceived risk, is critical for early diagnosis and a vital tool for reducing the risk for progression of the virus to AIDS. Diagnosis is the first step towards connecting infected individuals to treatment options, which reduce viral load thereby lessening the likelihood of transmission. According to CDC, there are 1.2 million people in the U.S. living with HIV, with 86 percent already diagnosed. The remaining 14 percent are unaware of their infection and are at risk of passing the virus to their partners. Expanding reimbursement for testing will open the door for many more individuals to be screened, diagnosed, linked to life-saving treatment, and in the process bend the curve on new infections. We appreciate the opportunity to provide these comments and look forward to sharing this new coverage option with our members. Sincerely, David Stacy Government Affairs Director Less February 26, 2015 Stuart Caplan Office of Clinical Standards and Quality Centers for Medicare & Medicaid Services 7500 Security Blvd. Baltimore, MD 21244 Re: National Coverage Determination – Proposed Decision Memorandum for Screening for HIV Infection Dear Mr. Caplan: On behalf of the Human Rights Campaign’s more than 1.5 million members and supporters nationwide, I write in response to the proposed expansion of Medicare coverage More
Anderson, Denise	Title: Program Manager, HIV Prevention Services Organization: Rutgers, New Jersey Medical School Date: 02/26/2015 Comment: Rutgers New Jersey Medical School (NJMS) is pleased that the Center for Medicare and Medicaid Services (CMS) has proposed to cover routine HIV testing for its beneficiaries. NJMS has been offering and providing HIV testing for many years. At the end of 2014, NJMS received the On the Frontlines of Communities in the United States (FOCUS) award by Gilead Sciences, Inc. to implement routine HIV screening in the Emergency Department (ED) at University Hospital (UH) in Newark, NJ as per the Centers for Disease Control and Prevention (CDC) recommendations. The city of Newark continues to be one of the most severely impacted communities by HIV/AIDS within the U.S. As such, implementing routine HIV testing in the ED of a major hospital serving the Newark community is an opportunity to increase the number of people that know their HIV status, connect them to care and treatment, and decrease the patient’s viral load. Therefore, we anticipate that this change will have a significant impact on the HIV epidemic in Newark and the surrounding communities we serve. Routinizing HIV testing in the ED will increase the number of individuals screened for HIV by 700%. Our payor data indicates that 16% of our ED patients are Medicare beneficiaries. By receiving reimbursement from Medicare for these services this CMS initiative strengthens our ability to sustain routine HIV screening efforts in the ED. Less Rutgers New Jersey Medical School (NJMS) is pleased that the Center for Medicare and Medicaid Services (CMS) has proposed to cover routine HIV testing for its beneficiaries. NJMS has been offering and providing HIV testing for many years. At the end of 2014, NJMS received the On the Frontlines of Communities in the United States (FOCUS) award by Gilead Sciences, Inc. to implement routine HIV screening in the Emergency Department (ED) at University Hospital (UH) in Newark, NJ as per the More
Wilson, Nonda	Organization: College of American Pathologists Date: 02/25/2015 Comment: The College of American Pathologists (CAP), which represents more than 18,000 pathologists who practice anatomic pathology and laboratory medicine in laboratories worldwide, supports the Centers for Medicare and Medicaid proposal to update its national coverage policy for routing testing for the Human Immunodeficiency Virus (HIV) Infection. Routine testing for adolescents and adults without regard to perceived risk is an important strategy for helping more people know their status so that they can seek the treatment they need. By aligning Medicare national policy with the well supported scientific evidence cited by the Centers for Disease Control and Prevention and the US Preventative Services Task Force, will help prevent the spread of HIV and improve health outcomes for those who are already infected. Thank you for the opportunity to comment on this important issue. College of American Pathologists 1350 I Street, NW Wasington, DC 20005 Less The College of American Pathologists (CAP), which represents more than 18,000 pathologists who practice anatomic pathology and laboratory medicine in laboratories worldwide, supports the Centers for Medicare and Medicaid proposal to update its national coverage policy for routing testing for the Human Immunodeficiency Virus (HIV) Infection. Routine testing for adolescents and adults without regard to perceived risk is an important strategy for helping more people know their status More
McClain, Angelo	Title: Chief Executive Officer Organization: National Association of Social Workers Date: 02/24/2015 Comment: Re: Proposed Decision Memo for Screening for the Human Immunodeficiency Virus (HIV) Infection (CAG-00409R), Centers for Medicare & Medicaid Services (CMS) Dear Ms. Tamara Syrek Jensen, Dr. Joseph Chin, Ms. Lori Ashby, Dr. James Rollins, Mr. Stuart Caplan, and Dr. Susan Miller: I am writing on behalf of the 132,000 members of the National Association of Social Workers (NASW), the largest membership organization of professional social workers in the United States. NASW works to enhance the professional growth and development of its members, to create and maintain standards for the profession, and to advance sound social policies. NASW also contributes to the well-being of individuals, families and communities through its work and advocacy. The National Association of Social Workers (NASW) supports the recommendation by the Centers for Medicare & Medicaid Services (CMS) to expand coverage in section 210.7 of the Medicare National Coverage Determinations (NCD) Manual to include routine screening and testing for HIV infection for all individuals between the ages of 15 and 65 years. Changing guidelines from “perceived risk” to “routine” HIV testing will bring Medicare coverage policies more in line with the Center for Disease Control and Prevention (CDC) HIV Testing Recommendations and the U.S. Preventive Services Task Force (USPSTF) Recommendations for Screening for HIV. NASW encourages CMS to further expand coverage of routine screening and testing for HIV infection to people older than 65 years of age. The proposed change supports the goals of U.S. National HIV/AIDS Strategy (NHAS) by increasing the number of persons living with HIV, as well as recommendations within the NHAS to support this goal through implementation of testing guidance based on the USPSTF recommendations.¹ Increased access to testing supports the NHAS goal to ensure that all those diagnosed with HIV or AIDS enter into and engage in medical and behavioral health care services. NASW is committed to elimination of policies that contribute discrimination and health disparities among older adults.² Therefore, NASW recommends expanded coverage to persons older than 65 years of age. Research shows that older adults are more likely to be diagnosed with HIV infection late in the course of their disease. According to the Centers for Disease Control and Prevention (CDC), disease progression from HIV to AIDS in persons 65 years and older accounts for 53% of those diagnosed with HIV.³ Expanding routine screening and testing to persons 15 years of age and older will enhance prevention efforts, increase early diagnosis, and facilitate access to necessary health and behavioral health services. Research has also shown that people who are aware of their HIV status may be more likely to take steps to prevent transmitting the virus to others.⁴ In practical terms, expanded coverage will provide clients and patients’ ages 15 years and older easier access to testing, treatment, and resources through services based within their own community (e.g., Federally Qualified Health Centers or Rural Health Centers). Expanded coverage further supports the NHAS through increasing the opportunity to provide prevention and harm reduction information to clients, and to increase the numbers of persons living with HIV or AIDS that are engaged and retained in care. Professional social workers in agencies and clinics providing Medicare eligible services have a critical role in providing prevention and early intervention services to persons living with or at-risk for HIV or AIDS. Social workers provide the link to community through outreach and case management, and are a critical link to reaching and providing services to the underserved communities increasingly at risk for HIV and at-risk populations. We appreciate the opportunity to make comments on the proposed rule, and welcome your questions. If you have questions about NASW’s comments, please contact my office at naswceo@naswdc.org or (202) 336-8200. Angelo McClain, Ph.D., LICSW Chief Executive Officer National Association of Social Workers 1 Office of AIDS Policy. (2014) National HIV/AIDS Strategy: Update 2014 to Implement Federal Actions http://www.whitehouse.gov/sites/default/files/docs/nhas_2014_progress_report_final_2.pdf 2 Policy on Older Adults. (2008). In Social Work Speaks, 9th Edition. National Association of Social Workers: Washington, DC. 3 HIV Among Older Americans. Factsheet. Centers for Disease Control and Prevention (CDC). http://www.cdc.gov/hiv/risk/age/olderamericans/ 4 Policy on HIV/AIDS. (2008). In Social Work Speaks, 9th Edition. National Association of Social Workers: Washington, DC. Less Re: Proposed Decision Memo for Screening for the Human Immunodeficiency Virus (HIV) Infection (CAG-00409R), Centers for Medicare & Medicaid Services (CMS) Dear Ms. Tamara Syrek Jensen, Dr. Joseph Chin, Ms. Lori Ashby, Dr. James Rollins, Mr. Stuart Caplan, and Dr. Susan Miller: I am writing on behalf of the 132,000 members of the National Association of Social Workers (NASW), the largest membership organization of professional social workers in the United States. NASW More
Buitron, Michael	Title: Linkage to Care Project Coordinator Organization: St. Mary Medical Center Date: 02/23/2015 Comment: February 23, 2015 Stuart Caplan Office of Clinical Standards and Quality Centers for Medicare & Medicaid Services 7500 Security Blvd. Baltimore, MD 21244 Re: National Coverage Determination – Proposed Decision Memorandum for Screening for HIV Infection Dear Mr. Caplan, I would like to provide comments on the proposed expansion of Medicare coverage for HIV screening. I support the proposal to update the National Coverage Determination (NCD) to allow for reimbursement of routine screening in healthcare settings for all beneficiaries age 15 to 65. I also believe that in addition to coverage for annual screenings, there should also be coverage for at least one lifetime test for everyone, regardless of age. As the linkage to care for the HIV testing program we have in our hospital’s emergency department, I regularly see individuals who test positive for the first time who are older than 65. In the past week, we had a 68-year-old who hadn’t had sex or any other risk for HIV in the past ten years. The patients visit to the ED was completely unrelated to anything that would warrant testing for HIV. By getting her into HIV care before she becomes symptomatic, we can hopefully avoid the cost and stress to the patient from having to treat opportunistic infections, HIV-related cancers, and the like. We can also avoid the complexities of treating a geriatric patient, controlling common age-related illnesses and drug-drug interactions on top of HIV treatments and treatments for AIDS-related illnesses. As we work to expand HIV testing to all persons between 15 and 65, I expect we will find—like the testing program in our emergency department—individuals who do not perceive themselves at risk and otherwise would not visit an HIV testing site. These are the persons who will most benefit, receiving care before their infection becomes problematic, and allow them to take precautions that would reduce the chances that they pass along their virus to others. Thank you for your consideration. Sincerely, Michael Buitrón Linkage to Care Project Coordinator Less February 23, 2015 Stuart Caplan Office of Clinical Standards and Quality Centers for Medicare & Medicaid Services 7500 Security Blvd. Baltimore, MD 21244 Re: National Coverage Determination – Proposed Decision Memorandum for Screening for HIV Infection Dear Mr. Caplan, I would like to provide comments on the proposed expansion of Medicare coverage for HIV screening. I support the proposal to update the National Coverage More
Yao, Dr. Joseph	Title: Associate Professor, College of Medicine Organization: Mayo Clinic Date: 02/23/2015 Comment: February 23, 2015 Joseph Chin, MD, Director Tamara Syrek Jensen, JD, Director Centers for Medicare and Medicaid Services 7500 Security Boulevard Baltimore, MD 21244 RE: Proposed Decision Memo for Screening for the Human Immunodeficiency Virus (HIV) Infection (CAG-00409R) Dear Dr. Chin and Ms. Syrek Jensen, Thank you for the opportunity to comment on the proposed decision memo for screening for the Human Immunodeficiency Virus (HIV) infection (CAG-00409R). Mayo Clinic is a not-for-profit health care system dedicated to medical care, research and education. With more than 3,600 physicians and 60,000 employees, Mayo Clinic demonstrates a relentless and unwavering commitment to excellence which has spawned a rich history of health care innovation. Each year, more than one million people from all 50 states and 140 countries come to Mayo Clinic to receive the highest quality care at sites in Minnesota, Arizona and Florida. In addition, Mayo Clinic Health System, a family of clinics, hospitals and health care facilities, serves communities in Iowa, Georgia, Minnesota and Wisconsin. Mayo Clinic agrees with the Centers for Medicare & Medicaid Services’ (CMS) proposal to expand coverage of the Medicare National Coverage Determination Manual, allowing coverage for HIV screening for all individuals between the ages of 15 and 65 years. Mayo Clinic supports the decision to cover screening for HIV with the appropriate U.S. Food and Drug Administration (FDA) approved laboratory tests and point of care tests used consistent with FDA-approved labeling and in compliance with Clinical Laboratory Improvement Act (CLIA) regulations. When the coverage is limited to Medicare beneficiaries at an increased risk of HIV infection, pregnant Medicare beneficiaries: 1) when the diagnosis of pregnancy is known, 2) during the third trimester, and 3) at labor, if ordered by the women’s clinician, there remains a question of the appropriate coding to reflect that the individual receiving the screen meets the coverage requirements. Though coding decisions are not made during the comment process, Mayo Clinic strongly urges CMS to require the use of only a single CPT code to reflect the provision of HIV testing for both screening and diagnostic purposes. The introduction of a new HCPCS code would place a significant burden on the clinical laboratories in U.S., consuming personnel resources to create processes to differentiate between the two different indications for HIV testing with the correct CPT code(s). Mayo Clinic respectfully requests a coverage analysis conclusion favoring the coverage for these individuals so that health care providers across the country can identify and provide treatment to those with HIV and can continue to put the needs of the patient first. Thank you, Joseph D. Yao, MD Department of Laboratory Medicine and Pathology, Associate Professor, College of Medicine Mayo Clinic Less February 23, 2015 Joseph Chin, MD, Director Tamara Syrek Jensen, JD, Director Centers for Medicare and Medicaid Services 7500 Security Boulevard Baltimore, MD 21244 RE: Proposed Decision Memo for Screening for the Human Immunodeficiency Virus (HIV) Infection (CAG-00409R) Dear Dr. Chin and Ms. Syrek Jensen, Thank you for the opportunity to comment on the proposed decision memo for screening for the Human Immunodeficiency Virus (HIV) More
Adimora, MD, MPH, FIDSA, Adaora	Title: Chair, HIVMA Board of Directors Organization: The HIV Medicine Association (HIVMA) Date: 02/20/2015 Comment: February 20, 2015 Submitted Electronically via: CAGinquiries@cms.hhs.gov Mr. Stuart Caplan Office of Clinical Standards and Quality Centers for Medicare and Medicaid Services (CMS) 7500 Security Blvd. Baltimore, MD 21244 Subject: Proposed Decision Memo for Screening for the Human Immunodeficiency Virus (HIV) Infection (CAG-00409R) Dear Mr. Caplan: The HIV Medicine Association (HIVMA) is pleased to comment in support of CMS’s proposal to update Medicare’s National Coverage Determination (NCD) for routine testing for HIV. HIVMA represents nearly 5,000 HIV clinicians and researchers that work on the frontlines of the HIV epidemic across the U.S. This change is an important step forward to expand Medicare beneficiaries’ access to HIV screening and other preventive services, as intended by health care reform. Specifically, Medicare is authorized to cover, on a national basis, preventive services that have been graded “A” or “B” by the U.S. Preventive Services Task Force (USPSTF) without costsharing. Since 2009, Medicare national coverage for HIV screening has been limited to at-risk individuals and all pregnant women, based on 2007 recommendations of the USPSTF. In 2013, the USPSTF revised its recommendation, in favor of routine testing for all individuals up to age 65, regardless of their risk or perceived risk. The Centers for Disease Control and Prevention has recommended routine HIV testing since 2006. A final NCD that is aligned with both the USPSTF and CDC will promote earlier detection of HIV among Medicare beneficiaries. In our experience as HIV providers, routine testing is critical to identify individuals with HIV and getthem into care in a timely manner, ideally before developing late stage symptomatic disease. A large proportion of people with HIV – up to 20 percent – are not aware of their infection. The proposed coverage of routine HIV testing will have a significant benefit for younger disabled Medicare beneficiaries under age 65, representing nearly 17% of the Medicare beneficiary population. Further, it is estimated that within the next decade 10% of persons with HIV/AIDS will be in their sixth decade or older. Updating Medicare’s national coverage policy is well supported by the wealth of scientific evidence cited by the CDC and the USPSTF in their HIV screening recommendations, and will advance national efforts to diagnose patients with HIV earlier and to improve access to HIV care and treatment. Thank you for your consideration of our views and for your important work on this issue. Please count on us as a resource if we can be of any assistance. We can be reached through HIVMA Policy Officer, Kimberly Miller at kmiller@hivma.org, or (703) 740-4957. Sincerely, /s/ Adaora Adimora, MD, MPH, FIDSA Chair, HIVMA Board of Directors ______________________________________ 1Medicare Resource Center, “What is Medicare? A look at the plans and who's eligible for them,” accessed online 2/19/2015 at: http:// www.medicareresources.org/basic-medicare-information/what-is-medicare/ 2McCormick WC, Wood RW. Clinical decisions in the care of elderly persons with AIDS. J Am Geriatr Soc. 1992;40:917-921. Less February 20, 2015 Submitted Electronically via: CAGinquiries@cms.hhs.gov Mr. Stuart Caplan Office of Clinical Standards and Quality Centers for Medicare and Medicaid Services (CMS) 7500 Security Blvd. Baltimore, MD 21244 Subject: Proposed Decision Memo for Screening for the Human Immunodeficiency Virus (HIV) Infection (CAG-00409R) Dear Mr. Caplan: The HIV Medicine Association (HIVMA) is pleased to comment in support of More
Parker, Scott	Organization: Western NC Community Health Services Date: 02/19/2015 Comment: I support yearly HIV screening for Medicare beneficiaries. Thank you.
Blackwelder, MD, FAAFP, Reid B.	Title: Board Chair Organization: American Academy of Family Physicians (AAFP) Date: 02/18/2015 Comment: February 18, 2015 Marilyn Tavenner Administrator Centers for Medicare & Medicaid Services 200 Independence Ave., SW Washington, DC 20201 RE: Proposed decision memo for screening for the HIV infection (CAG-00409R) Dear Administrator Tavenner: On behalf of the American Academy of Family Physicians (AAFP), which represents 115,900 family physicians and medical students across the country, I write in response to the proposed decision memo for the screening for the human immunodeficiency virus (HIV) infection as announced by the Centers for Medicare & Medicaid Services (CMS) on January 29, 2015. Although the AAFP believes the evidence does not support screening prior to age 18, the AAFP supports the CMS proposal to recommend screening for HIV infection as is recommended with a grade of A by the United States Preventive Services Task Force (USPSTF), is reasonable and necessary for the early detection of HIV and is therefore appropriate for individuals entitled to benefits under Medicare Part A or enrolled under Part B. We urge CMS to finalize this policy promptly. CMS proposes to cover screening for HIV with the appropriate U.S. Food and Drug Administration (FDA) approved laboratory tests and point of care tests, used consistent with FDA approved labeling and in compliance with the Clinical Laboratory Improvement Act (CLIA) regulations, when ordered by the beneficiary’s physician or practitioner within the context of a healthcare setting and performed by an eligible Medicare provider or supplier for these services, for beneficiaries who meet one of the following conditions: Except for pregnant Medicare beneficiaries addressed below, a maximum of one, annual voluntary screening for all adolescents and adults between the age of 15 and 65, without regard to perceived risk. Except for pregnant Medicare beneficiaries addressed below, a maximum of one, annual voluntary screening for adolescents younger than 15 and adults older than 65 who are at increased risk for HIV infection. Increased risk for HIV infection is defined as follows: Men who have sex with men Men and women having unprotected vaginal or anal intercourse Past or present injection drug users Men and women who exchange sex for money or drugs, or have sex partners who do Individuals whose past or present sex partners were HIV-infected, bisexual or injection drug users Persons who have acquired or request testing for other sexually transmitted infectious diseases Persons with a history of blood transfusions between 1978 and 1985 Persons who request an HIV test despite reporting no individual risk factors Persons with new sexual partners Persons who based on individualized physician interview and examination are deemed to be at increased risk for HIV infection. The determination of “increased risk” for HIV infection is identified by the health care 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 recommendation should be a reflection of the service provided. A maximum of three, voluntary HIV screenings of pregnant Medicare beneficiaries: (1) when the diagnosis of pregnancy is known, (2) during the third trimester, and (3) at labor, if ordered by the woman’s clinician. We appreciate the opportunity to comment in support of this national coverage determination. For any questions you might have please contact Robert Bennett, Federal Regulatory Manager, at 202-232-9033 or rbennett@aafp.org. Sincerely, /s/ Reid B. Blackwelder, MD, FAAFP Board Chair CC: Tamara Syrek Jensen, JD, Director, Coverage and Analysis Group Joseph Chin, MD, MS, Acting Deputy Director, Coverage and Analysis Group Lori Ashby, Acting Director, Division of Medical and Surgical Services James Rollins, MD, PhD, Director, Division of Items and Devices Stuart Caplan, RN, MAS, Lead Analyst, Division of Items and Devices Susan Miller, MD, Lead Medical Officer Less February 18, 2015 Marilyn Tavenner Administrator Centers for Medicare & Medicaid Services 200 Independence Ave., SW Washington, DC 20201 RE: Proposed decision memo for screening for the HIV infection (CAG-00409R) Dear Administrator Tavenner: On behalf of the American Academy of Family Physicians (AAFP), which represents 115,900 family physicians and medical students across the country, I write in response to the proposed decision More
Weiss, Michael	Title: Program Services Coordinator Organization: Humboldt County DHHS - North Coast AIDS Project Date: 02/05/2015 Comment: I support the proposed decission to include HIV screening in clinic lab testing. This is so important for early dection which will help stop the risk of transmission to new people. HIV is highly infectious in the beginning stages of infection when a person does not know their status and are not on medications. Most new infections happen at this time.
Barry, Elizabaeth J	Date: 01/30/2015 Comment: Why use Medicare money that is supposed to be earmarked for the elderly to test people in the teens, 20's, 30's and 40's. We keep using Meidiare money for every propram under the sun then we wonder if there will be money for our elderly. The medicare fund has become a "slush" fund for the government and I for one that has been paying since I was 16 is not thrilled that it is being used that way. More people should be ticked off this is happening.
Earl, CCS-P, Darlene	Title: Certified Coding Specialist-Physician Based Organization: AHIMA Date: 01/30/2015 Comment: I have worked in healthcare since 1968. I was working in a Family Practice group when we saw our first HIV positive patient. To watch the cruel advancement of this dreadful disease was horrific to say the least. I was then lucky to later work with Providers who took on these special patients and work for a longer, somewhat better life span and rally for studies and funding to curb and treat this terribly devastating disease. Knowing that this virus may lay dormant in most individuals, it is essential to test all age groups for possible infection. The sooner we can begin to eradicate HIV/AIDS from the people, the better. Less I have worked in healthcare since 1968. I was working in a Family Practice group when we saw our first HIV positive patient. To watch the cruel advancement of this dreadful disease was horrific to say the least. I was then lucky to later work with Providers who took on these special patients and work for a longer, somewhat better life span and rally for studies and funding to curb and treat this terribly devastating disease. Knowing that this virus may lay dormant in most individuals, it is More

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