Screening for Hepatitis B Virus (HBV) Infection

August 5, 2016

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Blvd. Baltimore, MD 21244

RE: Centers for Medicare and Medicaid Services National Coverage Analysis for Screening for Hepatitis B Virus (HBV) Infection (CAG-00447N)

Dear Ms. Jensen:

The National Viral Hepatitis Roundtable (NVHR), a coalition of over 380 organizations working to fight, and ultimately end, the hepatitis B and C epidemics in the United States, strongly supports the Centers for Medicare & Medicaid Services’ (CMS) Proposed Decision Memo for hepatitis B virus (HBV) screening of persons at high risk for infection, as defined by the United States Preventive Services Task Force (USPSTF). We appreciate your leadership in ensuring that Medicare beneficiaries at highest risk for hepatitis B infection have access to screening without cost-sharing as allowed by the Patient Protection and Affordable Care Act (ACA).

As you know, up to 2.2 million Americans have chronic hepatitis B infection. Unfortunately, up to 67% are unaware of their infection, placing them at significant risk for advanced liver disease, liver cancer, and/or in need of a liver transplant. Hepatitis B is a primary risk factor for liver cancer -the 2nd deadliest cancer for men and women. Liver cancer incidence rates are highest among American Indians/Alaska Natives, and Asian Americans and Pacific Islanders (AAPIs), and increase with age among almost all ethnic groups, until age 85.

Of the identified and reported cases of hepatitis B in the United States between 2007 and 2012, 15.6% were over the age of 65 and part of the Medicare-covered population. Medicare beneficiaries who are unaware of their hepatitis B infection are likely to have been living with the disease for a very long time so it is vital to ensure they are linked to care and treatment before developing advanced liver disease or liver cancer. Additionally, those with end stage renal disease are at higher risk for hepatitis B infection and are less likely to respond to the hepatitis B vaccine, and would benefit greatly from screening and subsequent linkage to care.

Hepatitis B is also associated with significant health inequities in the United States. Both chronic hepatitis B and liver cancer disproportionately affect Asian Americans and Pacific Islanders, who make up 50% of the hepatitis B infection burden in the United States – yet represent only 4% of the population – and have liver cancer rates up to 13 times higher than Caucasian populations.

While we are supportive of the proposed decision, we strongly urge CMS to reconsider the limitation of coverage to screening ordered by a beneficiary’s primary care provider or practitioner within the context of a primary care setting. This restriction would create obstacles to identify those who are chronically infected who could be screened in a broad array of settings, such as emergency departments. CMS acknowledges in your HIV screening determination that Medicare beneficiaries seek services in a continuum of settings and rightfully allows screenings to be covered in settings other than primary care as long as the test is ordered by a Medicare provider. We urge you to include the same flexibility with health care settings in your final decision. By extending screening coverage to a broader array of providers and settings, CMS would ensure that hepatitis B screenings are a true preventive service.

Thank you again for the opportunity to comment. If you have any questions or need additional information, please contact me at (202) 407-2391 or rclary@nvhr.org.

Sincerely,

Ryan Clary
Executive Director

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August 6, 2016

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Blvd. Baltimore, MD 21244

RE: Centers for Medicare and Medicaid Proposed Decision Memo for Screening for Hepatitis B Virus (HBV) Infection (CAG-00447N)

Dear Ms. Jensen:

On behalf of the National Center for Reducing Asian American Cancer Health Disparities (otherwise known as "AANCART", we write to express our appreciation and strong support of the Centers for Medicare and Medicaid Servicesf (CMS) Proposed National Coverage Determination Decision Memo for hepatitis B virus (HBV) screening in persons at high risk for infection, as defined by the United States Preventive Services Task Force (USPSTF). Up to 2.2 million Americans have chronic HBV infection.ⁱ Unfortunately, 67% are unaware of their infection, placing them at significant risk for advanced liver disease, liver cancer, and/or in need of a liver transplant. HBV is a primary risk factor for liver cancer -the 2nd deadliest cancer for men and women. Liver cancer incidence rates are highest among American Indians/Alaska Natives, and Asian Americans and Pacific Islanders (AAPIs), and increase with age among almost all ethnic groups, until age 85.ⁱⁱ

We are incredibly thankful that CMS's National Coverage Analysis acknowledges that the body of evidence is sufficient to cover HBV screening for Medicare beneficiaries. This is in line with both United States Preventive Services Task Force (USPSTF) and the Centers for Disease Control and Prevention's (CDC) recommendations. USPSTF gave a grade of "B" for risk-based HBV screening, identifying those born in countries and regions with a high prevalence of HBV infection (≥2%) as the most important risk factor of HBV. People born in the U.S. who were not vaccinated as infants and whose parents were born in a region with high prevalence of hepatitis B infection (≥8%), as well as HIV-positive individuals, injection drug users, men who have sex with men, and household partners and sexual partners of people who are HBV infected are also significant risk factors/populations.

As the National Center for Reducing Asian American Cancer Health Disparities, we recognize that HBV-linked liver cancer is the most significant cancer health disparities affecting Asian Americans. Hence, over the past decade, we have been among the national scientific and research leaders in addressing through various community-based and clinical interventions focused on Chinese, Hmong, Korean, and Vietnamese Americans. We have demonstrated that in-language, community-based interventions, including use of electronic health record messages targeting providers have resulted in statistically significant increases in screening for HBV over control conditions. To date we have screened approximately 2500 Asian Americans including those ages 65 and older. We believe we are doing our part and it is just that experience that we urge CMS to broaden coverage to all settings and providers (beyond primary care] to include community and clinical entities who adhere to CDC guidelines to have their screening for HBV covered as a reimbursable CMS item. We base this request on the evidence that indeed if it were not for our in-language community-based outreach that large segments of Asians with limited English proficiency would not have been screened for HBV and linked to care or to vaccination if they were not naturally immune. According to a study published in the American Journal of Public Health, "Is there enough time for prevention?", which we append to this letter provided by the Director of our Primary Care Network, there is simply not enough time (7.4 hours/day) if everything were left to the primary care provider. We are fortunate that we have committed gastroenterologists/hepatologists and other specialists working in concert with our community-based outreach to assure that no at-risk Asian American is left unscreened. Only then do we have the opportunity to mitigate this unnecessary and unequal cancer burden.

HBV is associated with significant health disparities in the U.S. Both chronic HBV and HCC disproportionately affect AAPIs, who make up 50% of the HBV infection burden in the U.S., and have liver cancer rates that are up to 13 times higher than Caucasian populations in the U.S. The revised USPSTF hepatitis B screening recommendations are a significant advance in efforts to identify those with chronic HBV and link them to care, and a National Coverage Determination from CMS stating the same would have similar benefits. We urge CMS to finalize the addition of hepatitis B screening as an "additional preventive servic" in light of the new USPSTF evidence-based recommendations.

Of the identified and reported cases of HBV in the U.S. between 2007 and 2012, 15.6% were over the age of 65 and part of the Medicare covered population. Those who are Medicare beneficiaries and are unaware of their HBV infection are likely to have been living with the disease for a very long time. It is vital to ensure they are screened and linked to care and treatment, before they develop advanced liver disease or liver cancer. Those with end stage renal disease are at higher risk for HBV infection and are less likely to respond to the HBV vaccine, and would benefit greatly from screening and subsequent linkage to care.

The limitation of coverage to screenings recommended by primary care practitioners in a primary care setting is inconsistent with Medicare regulations permitting the provision of preventive health assessments and care plan development in a broader array of settings. To clarify and strengthen the draft decision memo, we offer the following viewpoint for your consideration.

We support the recommendation that the determination of whether an individual is "high-risk" for the purposes of HBV screening ideally be made in conjunction with an assessment of the patientfs history, "typically part of an annual wellness visit and considered in the development of a comprehensive prevention plan." To this end, Medicare covers both an Initial Primary Preventive Exam (IPPE) and/or subsequent annual wellness visits (AWV) that include the creation of personalized prevention plan services (PPPS), and a health risk assessment (HRA). However, neither the IPPE or AWV are limited to performance by primary care providers or in primary care settings.ⁱⁱⁱ Therefore, if the NCD is adopted as written, it is possible that a medical provider (or team of providers) could perform an enrollee's IPPE or AWV but not have authorization to recommend screening for HBV. This could then require a separate appointment with a different provider for that purpose, working against the promotion of care coordination and efficiency. By extending screening coverage to a broader array of providers and settings, CMS could ensure that HBV screenings are a true preventive service.

CMS's own analysis does not provide any data or studies to support its determination that these screenings must be done in a primary care setting. Although there is no statutory or regulatory requirement to limit HBV screening to primary care, there is also no analysis of data or research in the NCD that would justify why this service should be so limited. The CDC's recommendations for screening both at-risk individuals, for example, are not limited to primary care -identifying other settings such as obstetrician and other physician offices, refugee clinics, substance use treatment clinics, and dialysis clinics.^iv In addition, while the USPSTF makes recommendations based on primary care populations, there is not an explicit requirement in the their recommendation that these screenings be performed by a primary care provider in a primary care setting. Additionally, there is no statutory requirement that services recommended by the USPSTF with an A or B grade rating be covered by insurers under only these circumstances.^v

We thank you for including HBV screening under Medicarefs Preventive Services, leading to improved health outcomes for Medicare beneficiaries. However, we strongly encourage CMS to expand the definition of screening settings to beyond primary care. We look forward to the finalization of these recommendations and encourage CMS to issue its final recommendation.

Sincerely,

Moon S. Chen, Jr., Ph.D., M.P.H.
Professor, Div. of Hematology & Oncology, Department of Internal Medicine,
Lead Principal Investigator, AANCART: The National Center
for Reducing Asian American Cancer Health Disparities
Associate Director for Cancer Control, UC Davis Comprehensive Cancer Center
4800 2nd Avenue, Suite 2207, Sacramento, CA 95817
Tel. (916) 734-1191
i Kowdley KV, Wang CC, Welch S, Roberts H, Brosgart CL. Prevalence of chronic hepatitis B among foreign-born persons living in the United States by country of origin. Hepatology 2012. 56(2): 422-433.
ii Ryerson AB, Eheman CR, Altekruse SF, Ward JW, Jemal A, Sherman RL, Henley SJ, Holtzman D, Lake A, Noone A-M, Anderson RN, Ma J, Ly KN, Cronin KA, Penburthy L, Kohler BA. Annual Report to the Nation on the Status of Cancer, 1975-2012, featuring the increasing incidence of liver cancer. Cancer 2016. 122(9): 1312-1337.
iii Regulations require that both the Initial Preventive Physical Exam (IPPE) and Annual Wellness Visits (AWVs) be performed by qualified health professionals, including physicians and/or other qualified non-physician practitioners. Physician in this context is defined by statute as a doctor of medicine or osteopathy, with no specification related to primary care as would be found in ˜1883(u)(6), ˜1833(x)(2)(A)(i)(I) or ˜ 1833(x)(2)(A)(i)(II) of the Social Security Act. (See 42 CFR ˜˜ 410.15-16).
iv Weinbaum CM, Williams I, Mast EE, Wang SA, Finelli L, Wasley A, Neitzel SM, Ward JW. Recommendations for Identification and Public Health Management of Persons with Chronic Hepatitis B Virus Infection. MMWR 2008. 57(RR08): 1-20.
v For instance, insurers may use gestablished techniques and the relevant evidence baseh to implement greasonable medical management techniques to determine the frequency, method, treatment, or settingh for a preventive service recommended by the USPSTF, ACIP, or HRSA to the extent not specified by those bodies. This regulation therefore implies that there is not a pre-established setting in which USPSTF guidelines must be implemented. (See 75 FR 41726 (Jul. 19, 2010), 41728-9; 45 CFR ˜147.130(a)(iv)(B)(4)(4)). Moreover, CMS has not provided any reference to a grelevant evidence baseh with respect to its primary care restriction.

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August 5, 2016

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Blvd. Baltimore, MD 21244

RE: Proposed Decision Memorandum for Screening for Hepatitis B Virus (HBV) Infection (CAG-00447N)

Dear Ms. Jensen:

The New York City Department of Health and Mental Hygiene (NYC DOHMH) fully supports the Centers for Medicare and Medicaid Services’ (CMS) decision memo proposing to cover hepatitis B screening at no cost to Medicare beneficiaries who are at high risk as defined by the United States Preventive Services Task Force. Adding hepatitis B screening as a covered Medicare preventive service would significantly improve efforts to identify people living with hepatitis B and link them to lifesaving care and treatment.

Rather than limiting this benefit to those whose tests were ordered by the beneficiary's primary care physician or practitioner within the context of a primary care setting, however, we request that CMS expand coverage beyond the primary care into a variety of settings where vulnerable populations seek culturally competent healthcare services. By limiting coverage to primary care, CMS would be creating barriers to hepatitis B screening in other vital health care settings, such as emergency departments. Similar restrictions have created significant challenges in hepatitis C screening and other covered preventive services.

Up to 2 million Americans have chronic HBV infection. Between 2011 and 2014, 83,494 unique individuals were reported with chronic HBV in NYC alone¹, and the prevalence is estimated to be 1.2%, which is two to four times higher than the U.S overall². Unfortunately, 67% of persons with chronic HBV are unaware of their infection, placing them at significant risk for advanced liver disease, liver cancer, and/or in need of a liver transplant. HBV is the leading cause of hepatocellular carcinoma (HCC), which is the only cancer that continues to rise in both incidence and mortality in the U.S.

Of the 7,459 New Yorkers identified with chronic HBV in 2014, 7.4% of them were age 65 and over and part of the Medicare covered population. Seniors who are Medicare beneficiaries and are unaware of their HBV infection are likely to have been living with the disease for decades, and it is vital that they are linked to care and treatment before they develop advanced liver disease or liver cancer. Additionally, those with end stage renal disease are at higher risk for HBV infection and are less likely to respond to the HBV vaccine, and would benefit greatly from screening and subsequent linkage to care.

Furthermore, minority populations in the U.S. are disproportionately affected by chronic HBV; in particular, African immigrants and Asian Americans and Pacific Islanders (AAPI), who make up over 50% of the HBV infection burden in the U.S., and have higher liver cancer rates than Caucasian populations. The NYC area has the third largest Asian elderly population in the US, with over 100,000 Asian seniors, and nearly a quarter of elderly Asians live in poverty³. DOHMH serves an area with one of the highest populations of people at risk for or infected with hepatitis B due to the large population of immigrants from HBV-endemic regions. According to the 2010 U.S. Census, the population of non-Hispanic Asians showed the greatest growth among foreign-born NYC residents, which now make up over one million, or 1 in 8 New Yorkers.

We believe that including HBV screening under Medicare Preventive Services would lead to improved health outcomes for Medicare beneficiaries, and have a particularly beneficial impact on improving health equity among our immigrant populations. We thank CMS for releasing this decision memo and appreciate the opportunity to comment on this process.

Sincerely,

Mary T. Bassett, MD, MPH
Commissioner

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1 NYC DOHMH 2014 Hepatitis Band C Annual Report. Published 2016. http://wwwl.nyc.gov/asscts/doh/downloads/pdf/cd/hepatitis-b-and-c-annual-report.pdf
2 Estimating the prevalence of chronic hepatitis B virus infection New York City, 2008. A.M. France, et al., J Urban Health. 2012 Apr: 89(2): 373-83. http://www.ncbi.nlm.nih.gov/pubmed/22246675
3 Asian American Federation of New York Census Info1mation Center. Census Profile: New York City's Asian American Elderly Population.

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August 5, 2016

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Blvd.
Baltimore, MD 21244

RE: Proposed Decision Memorandum for Screening for Hepatitis B Virus (HBV) Infection

Dear Ms. Jensen:

On behalf of the National Association of County and City Health Officials (NACCHO), I appreciate the opportunity to provide comments on the proposed decision memorandum for adding hepatitis B screening as a covered Medicare preventive service.

NACCHO is the national organization representing the 2,800 local health departments (LHDs) across the country. These city, county, metropolitan, district, and tribal departments work every day to protect and promote health and well-being for all people in their communities. LHDs play a critical role in responding to viral hepatitis. In their capacity at the local level, LHDs are on the frontlines of efforts to achieve the goals of the Action Plan for the Prevention, Care, & Treatment of Viral Hepatitis. LHDs lead and support an array of services and activities to address viral hepatitis, including surveillance, prevention, outbreak control, education and outreach, vaccination for hepatitis A and B virus, and provision of or referral to diagnosis, care, and treatment. A number of LHDs house perinatal hepatitis B prevention coordinators and work closely with their state on hepatitis B prevention activities. Additionally, LHDs are critical safety net providers for populations disproportionately affected by viral hepatitis, and are committed to addressing health inequities and reducing health disparities related to viral hepatitis outcomes.

An estimated 700,000 to 2.2 million people in the United States have chronic hepatitis B virus (HBV) infection. Alarmingly, an estimated 67% are unaware of their chronic HBV infection, placing them at significant risk for advanced liver disease, liver cancer, and/or in need of a liver transplant. HBV is the leading cause of primary liver cancer (hepatocellular carcinoma, HCC), and remains the only cancer that continues to rise in both incidence and mortality among men and women in the U.S. Both chronic HBV and HCC disproportionately affect Asians and Pacific Islanders, who make up 50% of the HBV infection burden in the U.S., and have liver cancer rates that are up to 13 times higher than Caucasian populations in the U.S. In fact, HCC has recently become the number one cause of cancer death in Vietnamese men in the U.S.

Chronic HBV is also a major global health problem with an estimated 350-400 million persons affected worldwide. Studies have found that as many 2.2 million foreign-born residents of the U.S. are living with chronic HBV and the prevalence of chronic HBV among foreign-born U.S. residents is about 10 times higher than among US born residents. About 58% of immigrants living with chronic HBV come from Asia, 11% from Africa, and 7% from Central America.

There are significant barriers to HBV screening in the U.S., including the silent nature of the disease and the lack of HBV screening currently being conducted at the primary care level. Increasing HBV screening is critical to saving lives, as those who are diagnosed can take advantage of lifestyle changes and FDA approved medications that can help prevent end-stage liver disease and liver cancer. In addition, many new treatments are now in development promising a bright future for preventing morbidity and mortality among infected individuals.

Adding hepatitis B screening as a covered Medicare preventive service would significantly improve efforts to identify people living with hepatitis B and link them to lifesaving care and treatment. We believe that including HBV screening under Medicare Preventive Services would lead to improved health outcomes for Medicare beneficiaries. Studies have shown that adults older than 50 years of age have on average a 1.5 to twofold higher prevalence of chronic HBV across different ethnic groups compared to with younger individuals. Of the identified and reported cases of HBV in the U.S. between 2007 and 2012, 15.6% were over the age of 65 and part of the Medicare covered population. Seniors who are Medicare beneficiaries and are unaware of their HBV infection are likely to have been living with the disease for a very long time and it is vital to ensure they are linked to care and treatment before they develop advanced liver disease or liver cancer.

Additionally, we recommend that coverage for hepatitis B screening be expanded beyond the primary care setting. By limiting coverage to primary care, barriers will be created to hepatitis B screening in other vital health care settings, such as emergency departments. Similar restrictions have created significant challenges in hepatitis C screening and other covered preventive services. Hepatitis B screening should be a covered service in a variety of health care settings. NACCHO also recognizes the need for linguistically and culturally competent HBV screening and care services for Medicare-eligible immigrant populations. Currently HBV screening has not been an integrated practice in routine care for underserved foreign born Asian and African immigrant populations. Expanding holistic Medicare covered screening at community-based health care settings can greatly improve the quality of life for these populations.

We thank the Centers for Medicare and Medicaid Services for initiating this National Coverage Analysis and proposing the decision memorandum for screening for HBV infection. Thank you for the opportunity to comment on this process. If you have any questions, please contact Gretchen Weiss, Director, HIV, STI, and Viral Hepatitis, at 202-507-4326 or gweiss@naccho.org.

Sincerely,

LaMar Hasbrouck, MD, MPH
Executive Director

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August 4, 2016

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Blvd. Baltimore, MD 21244

RE: Centers for Medicare and Medicaid Proposed Decision Memo for Screening for Hepatitis B Virus (HBV) Infection (CAG-00447N)

Dear Ms. Jensen:

On behalf of the San Francisco Department of Public Health (SFDPH), we appreciate the opportunity to provide comments on the Centers for Medicare and Medicaid Proposed Decision Memo for Screening for Hepatitis B Virus (HBV) Infection (CAG-00447N). Our local health department plays a critical role in responding to HBV and ending this disease is an important goal for the SFDPH and for the City and County of San Francisco as a whole.

While the SFDPH supports the intent of the proposed CMS Screening for Hepatitis B Virus (HBV) Infection memo, we have significant concerns that the new recommendations do not go far enough to support local health department services and activities to address HBV. We applaud CMS coverage of HBV testing by primary care providers and recognize that this decision is an important step forward in expanding HBV screening and coverage to those individuals at high-risk. However, the new recommendation only includes reimbursement for HBV screening in primary care providers' offices and we are very concerned that the recommendation does not include reimbursement for specialty care, emergency room, public health department, or community screening opportunities. We urge CMS to expand coverage to these other settings.

San Francisco has the highest rate of liver cancer in the country. Asian Pacific Islanders (APIs) in San Francisco are disproportionately affected by HBV, comprising one-third of the City’s population but representing 88% of reported cases. HBV is a serious health equity issue and as such, significant resources have been devoted to end HBV through the San Francisco Hep B Free Campaign and the SFDPH Hepatitis Surveillance Program. These two programs have been a safety net for populations disproportionately affected by HBV and are critical to reducing health disparities.

From our experience as a local health department, we have evidence that HBV screenings occur in specialty care settings, emergency rooms, and at on-site community events. The San Francisco Hep B Free Campaign is a nationally-respected program with a goal of turning San Francisco into the first hepatitis B free city in the nation. This campaign provides free and low-cost hepatitis B testing and vaccinations to Asian and Pacific Islander adults at locations throughout San Francisco. From 2012-2014, the campaign tested over 9,000 people in the community for HBV and was able to link many of those who tested positive to care options. The SF Hep B Free Campaign frequently provides screenings at community events throughout the City and expanding CMS coverage to this setting would enable this program to reimburse for these key services.

The SFDPH Hepatitis Surveillance Program provides HBV surveillance data to assist community partners and advocates in the identification of at-risk populations. The program contacts newly-reported cases to provide education on transmission prevention methods, and works with the Perinatal Program to ensure mothers do not transmit HBV to their newborn children. The Program also provides counseling and information about community resources for testing and vaccination. Reporting of positive HBV lab results to SFDPH’s Hepatitis Surveillance Program indicates that tests are conducted in the emergency room. Expanding CMS coverage to the emergency room setting would enable hospitals to reimburse for these much-needed services that they are already providing.

While we understand that screenings often occur in a primary care setting, our direct experience with programs and individuals in the community indicates that HBV screening can and does occur in many non-primary care settings, and that these alternative settings are critical access points for high-risk residents of our City. We strongly believe that CMS broadening this coverage will accelerate the diagnoses of chronically infected HBV individuals and link them to care, as well as accelerate the identification of individuals who do not have immunity to HBV so they may avail themselves of the HBV vaccination. With these facts in mind, we respectfully request that CMS expand coverage of HBV screening to specialty care, emergency rooms, public health departments, community-based organizations and any other entity that adheres to CDC recommendations for HBV testing. This expansion in coverage will help to ensure that San Francisco, and other cities and states, can effectively address this pressing public health concern.

Thank you for the opportunity to comment.

Sincerely,

Barbara A. Garcia, MPA
Director of Health
San Francisco Department of Public Health

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August 5, 2016

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Blvd. Baltimore, MD 21244

RE: Centers for Medicare and Medicaid Proposed Decision Memo for Screening for Hepatitis B Virus (HBV) Infection (CAG-00447N)

Dear Ms. Jensen:

On behalf of the over 30 hepatitis B community coalitions and organizations representing Hep B United we write to express our appreciation and strong support of the Centers for Medicare and Medicaid Services’ (CMS) Proposed National Coverage Determination Decision Memo for hepatitis B virus (HBV) screening in persons at high risk for infection, as defined by the United States Preventive Services Task Force (USPSTF). Up to 2.2 million Americans have chronic HBV infection. Unfortunately, 67% are unaware of their infection, placing them at significant risk for advanced liver disease, liver cancer, and/or in need of a liver transplant. HBV is a primary risk factor for liver cancer -the 2nd deadliest cancer for men and women. According to the 2016 Annual Report to the Nation on the Status of Cancer, unlike most other kinds of cancer, liver cancer incidence and death rates are increasing.

We appreciate that CMS’ National Coverage Analysis acknowledges that the body of evidence is sufficient to cover HBV screening for Medicare beneficiaries. This is in line with both United States Preventive Services Task Force (USPSTF) and the Centers for Disease Control and Prevention’s (CDC) recommendations. USPSTF gave a grade of “B” for risk-based HBV screening, identifying those born in countries and regions with a high prevalence of HBV infection (≥2%) as the most important risk factor of HBV. People born in the U.S. who were not vaccinated as infants and whose parents were born in a region with high prevalence of hepatitis B infection (≥8%), as well as HIV-positive individuals, injection drug users, men who have sex with men, and household partners and sexual partners of people who are HBV infected are also significant risk factors/populations.

Hep B United is a national coalition comprised of over 30 community-based multisectoral coalitions and national partner organizations with a reach of over 4 million, working across 15 states and 25 cities to address and eliminate hepatitis B. Our goals are to 1) raise the profile of hepatitis B and liver cancer as an urgent public health priority; 2) increase hepatitis B testing and vaccination, particularly among Asian Americans and other at-risk communities; and 3) improve access to care and treatment for individuals living with hepatitis B to prevent end-stage liver disease and liver cancer.

HBV is associated with significant health disparities in the U.S. Both chronic HBV and hepatocellular carcinoma (HCC) disproportionately affect AAPIs, who make up 50% of the HBV infection burden in the U.S., and have liver cancer rates that are up to 13 times higher than Caucasian populations in the U.S.

The revised USPSTF hepatitis B screening recommendations are a significant advance in efforts to identify those with chronic HBV and link them to care, and a National Coverage Determination (NCD) from CMS stating the same would have similar benefits. We urge CMS to finalize the addition of hepatitis B screening as an “additional preventive service” in light of the new USPSTF evidence-based recommendations. Of the identified and reported cases of HBV in the U.S. between 2007 and 2012, 15.6% were over the age of 65 and part of the Medicare covered population. Those who are Medicare beneficiaries and are unaware of their HBV infection are likely to have been living with the disease for a very long time. It is vital to ensure they are screened and linked to care and treatment, before they develop advanced liver disease or liver cancer. Those with end stage renal disease are at higher risk for HBV infection and are less likely to respond to the HBV vaccine, and would benefit greatly from screening and subsequent linkage to care.

The limitation of coverage to screenings recommended by primary care practitioners in a primary care setting is inconsistent with Medicare regulations permitting the provision of preventive health assessments and care plan development in a broader array of settings. To clarify and strengthen the proposed decision on HBV screening coverage, we offer the following viewpoint for your consideration.

As a coalition representing community-based organizations, health clinics, community leaders, and physicians, we provide a number of HBV screenings in community-based settings. Conducting these screenings outside of the primary care provider space is essential in order to effectively address the needs of AAPI communities many of those in our communities do not see a primary care provider (PCP) regularly if at all, and setting up a system in which these community-based screenings would be covered, following the Centers for Disease Control and Prevention’s and USPSTF’s guidelines would be incredibly beneficial to these patients most at risk. In 2014 alone, Hep B United partners combined, screened over 40,000 high-risk individuals for HBV infection, including many outside of the traditional primary care setting. Additionally, screenings conducted by specialists (i.e. gastroenterologists, hepatologists) need to also be covered. Currently, the average PCP is incredibly burdened and may not have the time to conduct HBV screenings along with the many other services that they provide in a short visit.

We support the recommendation that the determination of whether an individual is “high-risk” for the purposes of HBV screening ideally be made in conjunction with an assessment of the patient’s history, “typically part of an annual wellness visit and considered in the development of a comprehensive prevention plan.” To this end, Medicare covers both an initial primary preventive exam (IPPE) and/or subsequent annual wellness visits (AWV) that include the creation of personalized prevention plan services (PPPS), and a health risk assessment (HRA). However, neither the IPPE or AWV are limited to performance by primary care providers or in primary care settings. Therefore, if the NCD is adopted as written, it is possible that a medical provider (or team of providers) could perform an enrollee’s IPPE or AWV but not have authorization to recommend screening for HBV. This could then require a separate appointment with a different provider for that purpose, working against the promotion of care coordination and efficiency. By extending screening coverage to a broader array of providers and settings, CMS could ensure that HBV screenings are a true preventive service.

CMS’s own analysis does not provide any data or studies to support its determination that these screenings must be done in a primary care setting. Although there is no statutory or regulatory requirement to limit HBV screening to primary care, there is also no analysis of data or research in the NCD that would justify why this service should be so limited. The CDC’s recommendations for screening both at-risk individuals, for example, are not limited to primary care -identifying other settings such as obstetrician and other physician offices, refugee clinics, substance use treatment clinics, and dialysis clinics. In addition, while the USPSTF makes recommendations based on primary care populations, there is not an explicit requirement in their recommendation that these screenings be performed by a primary care provider in a primary care setting. Additionally, there is no statutory requirement that services recommended by the USPSTF with an A or B grade rating be covered by insurers under only these circumstances.

We thank and applaud CMS for including HBV screening under Medicare’s Preventive Services, leading to improved health outcomes for Medicare beneficiaries. However, we strongly encourage CMS to expand the definition of screening settings to beyond primary care. We look forward to the finalization of these recommendations and encourage CMS to issue its final recommendation.

Sincerely,
Hep B United
Hepatitis B Foundation (Co-Chair)
Association of Asian Pacific Community Health Organizations (Co-Chair)
Asian and Pacific Islander American Health Forum
Immunization Action Coalition
National Center for Reducing Asian American Cancer Health Disparities
National Task Force on Hepatitis B
National Viral Hepatitis Roundtable
Asian American Health Coalition (HOPE Clinic), Houston, TX
Asian American Community Services, Arlington, OH
Asian Health Coalition, Chicago, IL
Asian Pacific Community in Action, Phoenix, AZ
Asian Pacific Health Foundation, San Diego, CA
Asian Pacific Liver Center at St. Vincent Medical Center, Los Angeles, CA
Asian Services in Action, Inc., Cleveland, OH
Center for Asian Health, St. Barnabas Medical Center, Livingston, NJ
Center for Pan Asian Community Services, Atlanta, GA
Charles B. Wang Community Health Center, New York, NY
Dallas-Fort Worth Hepatitis B Free Project, Dallas, TX
Hepatitis Education Project, Seattle, WA
Hep B Project, Oakland, CA
Hep B United Philadelphia, Philadelphia, PA
Hep B United - Twin Cities (Lao Assistance Center of MN), Minneapolis, MN
Hep Free Hawaii, Honolulu, HI
Hep B Free Las Vegas, Las Vegas, NV
Hep B Free Los Angeles, Los Angeles, CA
Hepatitis B Initiative of Washington DC, Washington, DC
Midwest Asian Health Association, Chicago, IL
North East Medical Services, San Francisco, CA
New York City Hepatitis B Coalition, New York, NY
New Jersey Hepatitis B Coalition, Trenton, NJ
NYU Center for the Study of Asian American Health, New York, NY
Ohio Asian American Health Coalition, Columbus, OH
Project Prevention, Merced, CA
San Francisco Hep B Free, San Francisco, CA

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August 4th, 2016

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Blvd. Baltimore, MD 21244

RE: Centers for Medicare and Medicaid Proposed Decision Memo for Screening for Hepatitis B Virus (HBV) Infection (CAG-00447N)

Dear Ms. Jensen:

On behalf of the Association of Asian Pacific Community Health Organizations (AAPCHO), we write to express our appreciation and strong support of the Centers for Medicare and Medicaid Services’ (CMS) Proposed National Coverage Determination Decision Memo for hepatitis B virus (HBV) screening in persons at high risk for infection, as defined by the United States Preventive Services Task Force (USPSTF). Up to 2.2 million Americans have chronic HBV infection.ⁱ Unfortunately, 67% are unaware of their infection, placing them at significant risk for advanced liver disease, liver cancer, and/or in need of a liver transplant. HBV is a primary risk factor for liver cancer -the 2nd deadliest cancer for men and women. Liver cancer incidence rates are highest among American Indians/Alaska Natives, and Asian Americans and Pacific Islanders (AAPIs), and increase with age among almost all ethnic groups, until age 85.ⁱⁱ

We are incredibly thankful that CMS’s National Coverage Analysis acknowledges that the body of evidence is sufficient to cover HBV screening for Medicare beneficiaries. This is in line with both United States Preventive Services Task Force (USPSTF) and the Centers for Disease Control and Prevention’s (CDC) recommendations. USPSTF gave a grade of “B” for risk-based HBV screening, identifying those born in countries and regions with a high prevalence of HBV infection (≥2%) as the most important risk factor of HBV. People born in the U.S. who were not vaccinated as infants and whose parents were born in a region with high prevalence of hepatitis B infection (≥8%), as well as HIV-positive individuals, injection drug users, men who have sex with men, and household partners and sexual partners of people who are HBV infected are also significant risk factors/populations.

AAPCHO, based in San Leandro, CA, with an office in Washington, DC, represents 35 community health centers across the country, 29 of which are Federally Qualified Health Centers (FQHCs). AAPCHO members are dedicated to promoting advocacy, collaboration, and leadership to improve the health status and access of medically underserved Asian Americans, Native Hawaiians, and Pacific Islanders (AA & NHPIs) in the U.S., its territories, and its freely associated states. Since a number of AAPCHO member centers have patient populations infected with and with increased risk for hepatitis B, AAPCHO prioritizes education, awareness, and policy objectives around hepatitis B. AAPCHO is also a founding member of Hep B United, a national coalition to address the public health challenge of hepatitis B, the leading cause of liver cancer and a major health disparity among Asian Americans and Pacific Islanders (AAPIs). Hep B United works with 30 community coalitions in 24 cities and 14 states across the U.S. to increase hepatitis B awareness, screening, vaccination and linkage to care, particularly for high-risk AAPIs who are disproportionately impacted.

HBV is associated with significant health disparities in the U.S. Both chronic HBV and HCC disproportionately affect AAPIs, who make up 50% of the HBV infection burden in the U.S., and have liver cancer rates that are up to 13 times higher than Caucasian populations in the U.S. This is why it is critical that we improve opportunity and access to HBV screening. Patients experience cultural and linguistic barriers, which often impact their access to care, and therefore impede HBV screening levels. Older Limited English proficient populations many times have issues with transportation as well, creating barriers to get them to their local clinic.

The revised USPSTF hepatitis B screening recommendations are a significant advance in efforts to identify those with chronic HBV and link them to care, and a National Coverage Determination from CMS stating the same would have similar benefits. We urge CMS to finalize the addition of hepatitis B screening as an “additional preventive service” in light of the new USPSTF evidence-based recommendations. A number of our members screen for hepatitis B, and some of those members have provided comments separately. Because Federally Qualified Health Center (FQHC) data, included in the Uniform Data System (UDS), does not require reporting for hepatitis B screening, we do not have data across our member centers. However, we have data in the aggregate from seventeen centers, of which four of our centers participate: Asian Health Services Community Health Center in Oakland, CA, Charles B. Wang Community Health Center in New York, NY, Waianae Coast Comprehensive Health Center and Waimanalo Health Center in Oahu, HI, who participate in the Community Health Applied Research Network (CHARN). Of the 121,346 patients screened among all seventeen sites that are part of CHARN, 58.84% (n= 71,401) were AAPIs. Of all patients screened, 9.72% (n= 11,793) were infected with HBV, and 21.71% (n= 26,347) found to be susceptible for HBV. Of those infected, 2.32% (n= 1,063) are older than 64, and of those susceptible for HBV, 4.55% (n= 2,087) are older than 64.

It is vital to ensure that these populations at risk are screened and linked to care and treatment, before they develop advanced liver disease or liver cancer. Those with end stage renal disease are at higher risk for HBV infection and are less likely to respond to the HBV vaccine, and would benefit greatly from screening and subsequent linkage to care.

The limitation of coverage to screenings recommended by primary care practitioners in a primary care setting is inconsistent with Medicare regulations permitting the provision of preventive health assessments and care plan development in a broader array of settings. To clarify and strengthen the draft decision memo, we offer the following for your consideration. As an association representing community health centers, our members provide a number of HBV screenings in community-based settings as well. Conducting these screenings outside of the primary care provider space is essential in order to effectively address the needs of AAPI communities many of those in our communities do not see a primary care provider (PCP) regularly if at all, and setting up a system in which these community-based screenings would be covered, following the Centers for Disease Control and Prevention’s and USPSTF’s guidelines would be incredibly beneficial to these patients most at risk. Additionally, screenings conducted by specialists (i.e. gastroenterologists, hepatologists) need to also be covered. Currently, the average PCP is incredibly burdened, and may not have the time to conduct HBV screenings along with the many other services that they provide in a short visit.

We support the recommendation that the determination of whether an individual is “high-risk” for the purposes of HBV screening ideally be made in conjunction with an assessment of the patient’s history, “typically part of an annual wellness visit and considered in the development of a comprehensive prevention plan.” To this end, Medicare covers both an Initial Primary Preventive Exam (IPPE) and/or subsequent annual wellness visits (AWV) that include the creation of personalized prevention plan services (PPPS), and a health risk assessment (HRA). However, neither the IPPE or AWV are limited to performance by primary care providers or in primary care settings.ⁱⁱⁱ Therefore, if the NCD is adopted as written, it is possible that a medical provider (or team of providers) could perform an enrollee’s IPPE or AWV but not have authorization to recommend screening for HBV. This could then require a separate appointment with a different provider for that purpose, working against the promotion of care coordination and efficiency. By extending screening coverage to a broader array of providers and settings, CMS could ensure that HBV screenings are a true preventive service.

CMS’s own analysis does not provide any data or studies to support its determination that these screenings must be done in a primary care setting. Although there is no statutory or regulatory requirement to limit HBV screening to primary care, there is also no analysis of data or research in the NCD that would justify why this service should be so limited. The CDC’s recommendations for screening both at-risk individuals, for example, are not limited to primary care -identifying other settings such as obstetrician and other physician offices, refugee clinics, substance use treatment clinics, and dialysis clinics.^iv In addition, while the USPSTF makes recommendations based on primary care populations, there is not an explicit requirement in the their recommendation that these screenings be performed by a primary care provider in a primary care setting. Additionally, there is no statutory requirement that services recommended by the USPSTF with an A or B grade rating be covered by insurers under only these circumstances.^v

We thank you for including HBV screening under Medicare’s Preventive Services, leading to improved health outcomes for Medicare beneficiaries. However, we strongly encourage CMS to expand the definition of screening settings to beyond primary care. We look forward to the finalization of these recommendations and encourage CMS to issue its final recommendation.

Sincerely,

Jeffrey Caballero, MPH
Association of Asian Pacific Community Health Organizations
jeffc@aapcho.org

i Kowdley KV, Wang CC, Welch S, Roberts H, Brosgart CL. Prevalence of chronic hepatitis B among foreign-born persons living in the United States by country of origin. Hepatology 2012. 56(2): 422-433.
ii Ryerson AB, Eheman CR, Altekruse SF, Ward JW, Jemal A, Sherman RL, Henley SJ, Holtzman D, Lake A, Noone A-M, Anderson RN, Ma J, Ly KN, Cronin KA, Penburthy L, Kohler BA. Annual Report to the Nation on the Status of Cancer, 1975- 2012, featuring the increasing incidence of liver cancer. Cancer 2016. 122(9): 1312-1337.
iii Regulations require that both the Initial Preventive Physical Exam (IPPE) and Annual Wellness Visits (AWVs) be performed by qualified health professionals, including physicians and/or other qualified non-physician practitioners. Physician in this context is defined by statute as a doctor of medicine or osteopathy, with no specification related to primary care as would be found in §1883(u)(6), §1833(x)(2)(A)(i)(I) or § 1833(x)(2)(A)(i)(II) of the Social Security Act. (See 42 CFR §§ 410.15-16).
iv Weinbaum CM, Williams I, Mast EE, Wang SA, Finelli L, Wasley A, Neitzel SM, Ward JW. Recommendations for Identification and Public Health Management of Persons with Chronic Hepatitis B Virus Infection. MMWR 2008. 57(RR08): 1-20.
v For instance, insurers may use “established techniques and the relevant evidence base” to implement “reasonable medical management techniques to determine the frequency, method, treatment, or setting” for a preventive service recommended by the USPSTF, ACIP, or HRSA to the extent not specified by those bodies. This regulation therefore implies that there is not a pre-established setting in which USPSTF guidelines must be implemented. (See 75 FR 41726 (Jul. 19, 2010), 41728-9; 45 CFR §147.130(a)(iv)(B)(4)(4)). Moreover, CMS has not provided any reference to a “relevant evidence base” with respect to its primary care restriction.

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August 5, 2016

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Blvd. Baltimore, MD 21244

RE: Centers for Medicare and Medicaid Proposed Decision Memo for Screening for Hepatitis B Virus (HBV) Infection (CAG-00447N)

Dear Ms. Jensen:

On behalf of North East Medical Services we write to express our appreciation and strong support of the Centers for Medicare and Medicaid Services’ (CMS) Proposed National Coverage Determination Decision Memo for hepatitis B virus (HBV) screening in persons at high risk for infection, as defined by the United States Preventive Services Task Force (USPSTF). Up to 2.2 million Americans have chronic HBV infection.ⁱ Unfortunately, 67% are unaware of their infection, placing them at significant risk for advanced liver disease, liver cancer, and/or in need of a liver transplant. HBV is a primary risk factor for liver cancer -the 2nd deadliest cancer for men and women. Liver cancer incidence rates are highest among American Indians/Alaska Natives, and Asian Americans and Pacific Islanders (AAPIs), and increase with age among almost all ethnic groups, until age 85.ⁱⁱ

We are incredibly thankful that CMS’s National Coverage Analysis acknowledges that the body of evidence is sufficient to cover HBV screening for Medicare beneficiaries. This is in line with both United States Preventive Services Task Force (USPSTF) and the Centers for Disease Control and Prevention’s (CDC) recommendations. USPSTF gave a grade of “B” for risk-based HBV screening, identifying those born in countries and regions with a high prevalence of HBV infection (>2%) as the most important risk factor of HBV. People born in the U.S. who were not vaccinated as infants and whose parents were born in a region with high prevalence of hepatitis B infection (>8%), as well as HIV-positive individuals, injection drug users, men who have sex with men, and household partners and sexual partners of people who are HBV infected are also significant risk factors/populations.

North East Medical Services (NEMS) is one of the largest community health centers in the United States targeting the medically underserved Asian population. Based in San Francisco, the non-profit community health center offers comprehensive health care services to a variety of patients, a majority of whom are uninsured or low-income. NEMS offers linguistically-competent and culturally-sensitive health care services in many languages and dialects, including Cantonese, Mandarin, Toishan, Vietnamese, Burmese, Korean, Spanish, and Hindi.

HBV is associated with significant health disparities in the U.S. Both chronic HBV and HCC disproportionately affect AAPIs, who make up 50% of the HBV infection burden in the U.S., and have liver cancer rates that are up to 13 times higher than Caucasian populations in the U.S.

The revised USPSTF hepatitis B screening recommendations are a significant advance in efforts to identify those with chronic HBV and link them to care, and a National Coverage Determination from CMS stating the same would have similar benefits. We urge CMS to finalize the addition of hepatitis B screening as an “additional preventive service” in light of the new USPSTF evidence-based recommendations. As many as 1 in 10 Asian and Pacific Islanders are chronically infected with hepatitis B, world-wide. Of these, 2 out of 3 don’t know they are infected and 1 in 4 will develop liver cancer or liver disease if untreated. Nearly 80% of all liver cancer cases are directly associated with chronic hepatitis B. Across the globe, approximately 1 million people die from liver cancer or liver disease each year as a direct result of hepatitis B. Of the identified and reported cases of HBV in the U.S. between 2007 and 2012, 15.6% were over the age of 65 and part of the Medicare covered population. Those who are Medicare beneficiaries and are unaware of their HBV infection are likely to have been living with the disease for a very long time. It is vital to ensure they are screened and linked to care and treatment, before they develop advanced liver disease or liver cancer. Those with end stage renal disease are at higher risk for HBV infection and are less likely to respond to the HBV vaccine, and would benefit greatly from screening and subsequent linkage to care.

The limitation of coverage to screenings recommended by primary care practitioners in a primary care setting is inconsistent with Medicare regulations permitting the provision of preventive health assessments and care plan development in a broader array of settings. To clarify and strengthen the draft decision memo, we offer the following viewpoint for your consideration. As a community leader, we provide a number of HBV screenings in community-based settings. Conducting these screenings outside of the primary care provider space is essential in order to effectively address the needs of AAPI communities many of those in our communities do not see a primary care provider (PCP) regularly if at all, and setting up a system in which these community-based screenings would be covered, following the Centers for Disease Control and Prevention’s and USPSTF’s guidelines would be incredibly beneficial to these patients most at risk. Additionally, screenings conducted by specialists (i.e. gastroenterologists, hepatologists) need to also be covered. Currently, the average PCP is incredibly burdened, and may not have the time to conduct HBV screenings along with the many other services that they provide in a short visit.

We support the recommendation that the determination of whether an individual is “high-risk” for the purposes of HBV screening ideally be made in conjunction with an assessment of the patient’s history, “typically part of an annual wellness visit and considered in the development of a comprehensive prevention plan.” To this end, Medicare covers both an Initial Primary Preventive Exam (IPPE) and/or subsequent annual wellness visits (AWV) that include the creation of personalized prevention plan services (PPPS), and a health risk assessment (HRA). However, neither the IPPE or AWV are limited to performance by primary care providers or in primary care settings.ⁱⁱⁱ Therefore, if the NCD is adopted as written, it is possible that a medical provider (or team of providers) could perform an enrollee’s IPPE or AWV but not have authorization to recommend screening for HBV. This could then require a separate appointment with a different provider for that purpose, working against the promotion of care coordination and efficiency. By extending screening coverage to a broader array of providers and settings, CMS could ensure that HBV screenings are a true preventive service.

CMS’s own analysis does not provide any data or studies to support its determination that these screenings must be done in a primary care setting. Although there is no statutory or regulatory requirement to limit HBV screening to primary care, there is also no analysis of data or research in the NCD that would justify why this service should be so limited. The CDC’s recommendations for screening both at-risk individuals, for example, are not limited to primary care -identifying other settings such as obstetrician and other physician offices, refugee clinics, substance use treatment clinics, and dialysis clinics.^iv In addition, while the USPSTF makes recommendations based on primary care populations, there is not an explicit requirement in the their recommendation that these screenings be performed by a primary care provider in a primary care setting. Additionally, there is no statutory requirement that services recommended by the USPSTF with an A or B grade rating be covered by insurers under only these circumstances.^v

We thank you for including HBV screening under Medicare’s Preventive Services, leading to improved health outcomes for Medicare beneficiaries. However, we strongly encourage CMS to expand the definition of screening settings to beyond primary care. We look forward to the finalization of these recommendations and encourage CMS to issue its final recommendation.

Sincerely,

Eddie Chan, President & CEO
North East Medical Services
Eddie.Chan@nems.org

i Kowdley KV, Wang CC, Welch S, Roberts H, Brosgart CL. Prevalence of chronic hepatitis B among foreign-born persons living in the United States by country of origin. Hepatology 2012. 56(2): 422-433.
ii Ryerson AB, Eheman CR, Altekruse SF, Ward JW, Jemal A, Sherman RL, Henley SJ, Holtzman D, Lake A, Noone A-M, Anderson RN, Ma J, Ly KN, Cronin KA, Penburthy L, Kohler BA. Annual Report to the Nation on the Status of Cancer, 1975- 2012, featuring the increasing incidence of liver cancer. Cancer 2016. 122(9): 1312-1337.
iii Regulations require that both the Initial Preventive Physical Exam (IPPE) and Annual Wellness Visits (AWVs) be performed by qualified health professionals, including physicians and/or other qualified non-physician practitioners. Physician in this context is defined by statute as a doctor of medicine or osteopathy, with no specification related to primary care as would be found in §1883(u)(6), §1833(x)(2)(A)(i)(I) or § 1833(x)(2)(A)(i)(II) of the Social Security Act. (See 42 CFR §§ 410.15-16).
iv Weinbaum CM, Williams I, Mast EE, Wang SA, Finelli L, Wasley A, Neitzel SM, Ward JW. Recommendations for Identification and Public Health Management of Persons with Chronic Hepatitis B Virus Infection. MMWR 2008. 57(RR08): 1-20.
v For instance, insurers may use “established techniques and the relevant evidence base” to implement “reasonable medical management techniques to determine the frequency, method, treatment, or setting” for a preventive service recommended by the USPSTF, ACIP, or HRSA to the extent not specified by those bodies. This regulation therefore implies that there is not a pre-established setting in which USPSTF guidelines must be implemented. (See 75 FR 41726 (Jul. 19, 2010), 41728-9; 45 CFR §147.130(a)(iv)(B)(4)(4)). Moreover, CMS has not provided any reference to a “relevant evidence base” with respect to its primary care restriction.

Less

August 5, 2016

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Blvd. Baltimore, MD 21244

RE: Centers for Medicare and Medicaid Proposed Decision Memo for Screening for Hepatitis B Virus (HBV) Infection (CAG-00447N)

Dear Ms. Jensen:

On behalf of the Coalition Against Hepatitis for People of African Origin (CHIPO), I write to express our appreciation and strong support of the Centers for Medicare and Medicaid Services’ (CMS) Proposed National Coverage Determination Decision Memo for hepatitis B virus (HBV) screening in persons at high risk for infection, as defined by the United States Preventive Services Task Force (USPSTF). Up to 2.2 million Americans have chronic HBV infection.1 Unfortunately, 67% are unaware of their infection, placing them at significant risk for advanced liver disease, liver cancer, and/or in need of a liver transplant. HBV is a primary risk factor for liver cancer -the 2nd deadliest cancer for men and women. According to the 2016 Annual Report to the Nation on the Status of Cancer, unlike most other kinds of cancer, liver cancer incidence and death rates are increasing.¹

CHIPO appreciates that CMS’ National Coverage Analysis acknowledges that the body of evidence is sufficient to cover HBV screening for Medicare beneficiaries. This is in line with both United States Preventive Services Task Force (USPSTF) and the Centers for Disease Control and Prevention’s (CDC) recommendations. USPSTF gave a grade of “B” for risk-based HBV screening, identifying those born in countries and regions with a high prevalence of HBV infection (≥2%) as the most important risk factor of HBV. People born in the U.S. who were not vaccinated as infants and whose parents were born in a region with high prevalence of hepatitis B infection (≥8%), as well as HIV-positive individuals, injection drug users, men who have sex with men, and household partners and sexual partners of people who are HBV infected are also significant risk factors/populations.

CHIPO, meaning “gift” in the Shona language, seeks to promote hepatitis B education and prevention among African immigrants, healthcare providers and organizations serving this community, through raising awareness, developing local and national partnerships, and advocating for increased screening and improved linkage to care services. We currently have over 30 coalition partners around the U.S., dedicated to addressing viral hepatitis in African communities.

The primary goals of CHIPO are to discuss issues around the diagnosis and treatment of HBV among African immigrants; engage and educate providers about the importance of hepatitis B testing, prevention, and timely treatment; and ensure that the African immigrant population is represented in HBV programs regionally and nationally.

CHIPO strategies and activities include coordinating and conducting awareness and educational presentations; sharing relevant topics, research and interventions via presentations, conference calls and webinars; and promoting the coalition and the work of coalition members, locally and nationwide.

As our partners are aware, people of African origin are disproportionately affected by hepatitis B infection. In fact, in some African communities in the U.S., between 5%-15% of people have chronic HBV infection. Unfortunately, due to the silent nature of the disease, lack of disease awareness, and limited health care access, most African community members who have hepatitis B DO NOT KNOW that they are infected. This puts them much greater risk for premature death from cirrhosis or liver cancer.

The key to addressing the high burden of hepatitis B infection in people of African origin is to improve hepatitis B screening, so that infected individuals can seek appropriate followup care. The revised USPSTF hepatitis B screening recommendations are a significant advance in efforts to identify those with chronic HBV and link them to care, and a National Coverage Determination from CMS stating the same would have similar benefits. We urge CMS to finalize the addition of hepatitis B screening as an “additional preventive service” in light of the new USPSTF evidence-based recommendations. Of the identified and reported cases of HBV in the U.S. between 2007 and 2012, 15.6% were over the age of 65 and part of the Medicare covered population. Those who are Medicare beneficiaries and are unaware of their HBV infection are likely to have been living with the disease for a very long time. It is vital to ensure they are screened and linked to care and treatment, before they develop advanced liver disease or liver cancer. Those with end stage renal disease are at higher risk for HBV infection and are less likely to respond to the HBV vaccine, and would benefit greatly from screening and subsequent linkage to care.

The limitation of coverage to screenings recommended by primary care practitioners (PCP) in a primary care setting is inconsistent with Medicare regulations permitting the provision of preventive health assessments and care plan development in a broader array of settings. To clarify and strengthen the proposed decision on HBV screening coverage, we offer the following viewpoint for your consideration.

CHIPO partners are aware that much of the hepatitis B screening that occurs in the U.S. happens outside of the primary care setting. African immigrant communities face a significant number of barriers to health care, and therefore, they are often screened for HBV in community-based settings. Conducting these screenings outside of the primary care provider space is essential in order to effectively address the needs of African immigrant communities - many of those in our communities do not see a primary care provider (PCP) regularly if at all, and setting up a system in which these community-based screenings would be covered, following the CDC and USPSTF’s guidelines, would be incredibly beneficial to these patients most at risk. Additionally, for many people of African origin with health care access barriers, the Emergency Room is often the sole source of health care, and many people are screened in that setting, as well as others (such as pharmacies and specialty offices). Currently, the average PCP is incredibly burdened, and may not have the time to conduct HBV screenings along with the many other services that they provide in a short visit. Relying only on primary health care providers puts an undue burden on them, and realistically, will limit the amount of screening that is done in high-risk communities across the U.S.

We support the recommendation that the determination of whether an individual is “high-risk” for the purposes of HBV screening ideally be made in conjunction with an assessment of the patient’s history, “typically part of an annual wellness visit and considered in the development of a comprehensive prevention plan.” To this end, Medicare covers both an Initial Primary Preventive Exam (IPPE) and/or subsequent annual wellness visits (AWV) that include the creation of personalized prevention plan services (PPPS), and a health risk assessment (HRA). However, neither the IPPE nor AWV are limited to performance by primary care providers or in primary care settings.ⁱ Therefore, if the NCD is adopted as written, it is possible that a medical provider (or team of providers) could perform an enrollee’s IPPE or AWV but not have authorization to recommend screening for HBV. This could then require a separate appointment with a different provider for that purpose, working against the promotion of care coordination and efficiency. By extending screening coverage to a broader array of providers and settings, CMS could ensure that HBV screenings are a true preventive service.

CMS’s own analysis does not provide any data or studies to support its determination that these screenings must be done in a primary care setting. Although there is no statutory or regulatory requirement to limit HBV screening to primary care, there is also no analysis of data or research in the NCD that would justify why this service should be so limited. The CDC’s recommendations for screening both at-risk individuals, for example, are not limited to primary care -identifying other settings such as obstetrician and other physician offices, refugee clinics, substance use treatment clinics, and dialysis clinics.ⁱⁱ In addition, while the USPSTF makes recommendations based on primary care populations, there is not an explicit requirement in the their recommendation that these screenings be performed by a primary care provider in a primary care setting. Additionally, there is no statutory requirement that services recommended by the USPSTF with an A or B grade rating be covered by insurers under only these circumstances.ⁱⁱⁱ

We thank and applaud CMS for including HBV screening under Medicare’s Preventive Services, leading to improved health outcomes for Medicare beneficiaries. However, we strongly encourage CMS to expand the definition of screening settings to beyond primary care. We look forward to the finalization of these recommendations and encourage CMS to issue its final recommendation.

Sincerely,

Chari Cohen
Chairperson, CHIPO

Less

August 5, 2016

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Blvd. Baltimore, MD 21244

RE: Centers for Medicare and Medicaid Proposed Decision Memo for Screening for Hepatitis B Virus (HBV) Infection (CAG00447N)

Dear Ms. Jensen:

On behalf of the over 70 coalition partners and organizations within Hep B United Philadelphia we write to express our appreciation and strong support of the Centers for Medicare and Medicaid Services' (CMS) Proposed National Coverage Determination Decision Memo for hepatitis B virus (HBV) screening in persons at high risk for infection, as defined by the United States Preventive Services Task Force (USPSTF). Up to 2.2 million Americans have chronic HBV infection.ⁱ Unfortunately, 67% are unaware of their infection, placing them at significant risk for advanced liver disease, liver cancer, and/or in need of a liver transplant. HBV is a major risk factor for primary liver cancer (HCC) the 2nd deadliest cancer for men and women. According to the 2016 Annual Report to the Nation on the Status of Cancer, unlike most other kinds of cancer, liver cancer incidence and death rates are increasing.ⁱⁱ

We appreciate that CMS' National Coverage Analysis acknowledges that the body of evidence is sufficient to cover HBV screening for Medicare beneficiaries. This is in line with both United States Preventive Services Task Force (USPSTF) and the Centers for Disease Control and Prevention's (CDC) recommendations. USPSTF gave a grade of 'B' for risk-based HBV screening, identifying those born in countries and regions with a high prevalence of HBV infection (≥2%) as the most important risk factor of HBV. People born in the U.S. who were not vaccinated as infants and whose parents were born in a region with high prevalence of hepatitis B infection (≥8%), as well as HIV positive individuals, injection drug users, men who have sex with men, and household partners and sexual partners of people who are HBV infected are also significant risk factors/populations.

Hep B United Philadelphia is a coalition comprised of over 70 community-based multisectoral organizations with a reach of over 10,000 Philadelphians. Since 2008, we have provided in-person education for over 5,000; offered free hepatitis B screening to 3,500; administered over 500 free doses of hepatitis B vaccine; and found medical homes for 85% of infected individuals in our program. Our goals are to 1) raise the profile of hepatitis B and liver cancer as an urgent public health priority; 2) increase hepatitis B testing and vaccination, particularly among at-risk populations; and 3) stimulate community engagement and involvement to improve access to care for both prevention and treatment to reduce the local burden of hepatitis B and liver cancer.

HBV is associated with significant health disparities in the U.S. Both chronic HBV and HCC disproportionately affect Asian Americans, Pacific Islanders (AAPI), and people of African Origin, who make up over 50% of the HBV infection burden in the U.S., and have liver cancer rates that are significantly higher than Caucasian populations in the U.S.

The revised USPSTF hepatitis B screening recommendations are a significant advance in efforts to identify those with chronic HBV and link them to care, and a National Coverage Determination from CMS stating the same would have similar benefits. We urge CMS to finalize the addition of hepatitis B screening as an 'additional preventive service' in light of the new USPSTF evidence-based recommendations. Of the identified and reported cases of HBV in the U.S. between 2007 and 2012, 15.6% were over the age of 65 and part of the Medicare covered population. Within Philadelphia alone, our coalition recently screened 2,400 high-risk members of the Asian Pacific Islander community. Those screened aged 65 or older had a 5% infection rate for hepatitis B. Those who are Medicare beneficiaries and are unaware of their HBV infection are likely to have been living with the disease for a very long time. It is vital to ensure they are screened and linked to care and treatment, before they develop advanced liver disease or liver cancer. Those with end stage renal disease are at higher risk for HBV infection, are less likely to respond to the HBV vaccine, and would benefit greatly from screening and subsequent linkage to care.

The limitation of coverage to screenings recommended by primary care practitioners in a primary care setting is inconsistent with Medicare regulations permitting the provision of preventive health assessments and care plan development in a broader array of settings. To clarify and strengthen the proposed decision on HBV screening coverage, we offer the following viewpoint for your consideration.

As a coalition representing community-based organizations, health clinics, community leaders, and physicians, we provide a number of HBV screenings in community-based settings. Conducting these screenings outside of the primary care provider space is essential in order to effectively address the needs of AAPI communities many of those in our communities do not see a primary care provider (PCP) regularly if at all, and setting up a system in which these community-based screenings would be covered, following the Centers for Disease Control and Prevention's and USPSTF's guidelines would be incredibly beneficial to these patients most at risk. Since 2008, Hep B United Philadelphia has screened over 3,500 high-risk individuals for HBV infection, including many outside of the traditional primary care setting. Additionally, screenings conducted by specialists (i.e. gastroenterologists, hepatologists) need to also be covered. Currently, the average PCP is incredibly burdened, and may not have the time to conduct HBV screenings along with the many other services that they provide in a short visit.

We support the recommendation that the determination of whether an individual is 'high risk' for the purposes of HBV screening ideally be made in conjunction with an assessment of the patient's history, 'typically part of an annual wellness visit and considered in the development of a comprehensive prevention plan.'' To this end, Medicare covers both an Initial Primary Preventive Exam (IPPE) and/or subsequent annual wellness visits (AWV) that include the creation of personalized prevention plan services (PPPS), and a health risk assessment (HRA). However, neither the IPPE or AWV are limited to performance by primary care providers or in primary care settings.ⁱⁱⁱ Therefore, if the NCD is adopted as written, it is possible that a medical provider (or team of providers) could perform an enrollee's IPPE or AWV but not have authorization to recommend screening for HBV. This could then require a separate appointment with a different provider for that purpose, working against the promotion of care coordination and efficiency. By extending screening coverage to a broader array of providers and settings, CMS could ensure that HBV screenings are a true preventive service.

CMS's own analysis does not provide any data or studies to support its determination that these screenings must be done in a primary care setting. Although there is no statutory or regulatory requirement to limit HBV screening to primary care, there is also no analysis of data or research in the NCD that would justify why this service should be so limited. The CDC's recommendations for screening both at-risk individuals, for example, are not limited to primary care identifying other settings such as obstetrician and other physician offices, refugee clinics, substance use treatment clinics, and dialysis clinics.^iv In addition, while the USPSTF makes recommendations based on primary care populations, there is not an explicit requirement in the their recommendation that these screenings be performed by a primary care provider in a primary care setting. Additionally, there is no statutory requirement that services recommended by the USPSTF with an A or B grade rating be covered by insurers under only these circumstances.^v

We thank and applaud CMS for including HBV screening under Medicare's Preventive Services, leading to improved health outcomes for Medicare beneficiaries. However, we strongly encourage CMS to expand the definition of screening settings to beyond primary care. We look forward to the finalization of these recommendations and encourage CMS to issue its final recommendation.

Sincerely,

Hep B United Philadelphia
African Family Health Organization (AFAHO)
AIDS Services in Asian Communities (ASIAC)
Albert Einstein Center for Liver Disease and Transplant
American Cancer Society, SE Pennsylvania
American Liver Foundation, Mid-Atlantic Division
AmeriCare Pharmacy
Asian American Lions Club
Asian Americans United
Asian Arts Initiative (AAI)
Asian Community Health Coalition
Bethany Indonesian Church of God
Boat People SOS, Philadelphia
Cambodian Association of Greater Philadelphia
Center for Asian Health at Temple University
Children's Hospital of Philadelphia
China News Weekend
Chinatown Health and Information Center
Chinatown Medical Services
Chinese Asian Women Sisterhood Society of Philadelphia
Chinese Benevolent Association
Chinese Christian Church and Center
Chinese Benevolent Association
CoventryCares from HealthAmerica
CTE Healthcare Communications
Drexel University Circle K
Drexel University College of Medicine & APAMSA
Drexel University Pre-PA Club
Drexel University School of Public Health
Fox Chase Cancer Center
Furia Rubel Communications
GeneroCity.com
Gilead Sciences
GlaxoSmithKline
Governor's Advisory Commission on Asian American Affairs
Greater Philadelphia Chinese Restaurants Association
Greater Philadelphia Health Action
HBV Team, UPenn
HBV Team, Princeton
Health Partners
Health Promotion Council of Southeast PA
Hepatitis B Foundation
Hepatitis C Allies of Philadelphia (HepCAP)
HepTREC
Independence Dragon Boat Regatta
Indochinese-American Council (IAC)
Intercultural Family Services
Liver Disease Prevention Center
Lourdes Medical Associates
Mayor's Commission on Asian American Affairs
MetroChinese News
MetroVietnamese News
Nationalities Service Center
New Times Journal
North Penn Korean Coalition
Penn Asian Senior Services
Philadelphia Asian American Film Festival
Philadelphia Chinatown Development Corporation (PCDC)
Philadelphia College of Osteopathic Medicine APAMSA
Philadelphia Corporation for Aging
Philadelphia Hepatitis Outreach Project
Philadelphia Praise Center
Philadelphia Viral Hepatitis Alliance
Philip Jaisohn Memorial Center
Planned Motherhood, SE Pennsylvania
Project Shine at Temple University
Public Health Management Corporation (PHMC)
Refugee Health Partners
Robert Wood Johnson University Medical Center APAMSA
Southeast Asian Mutual Assistance Associations Coalition (SEAMAAC)
Temple University School of Medicine & APAMSA
Thomas Jefferson University Hospital & APAMSA
United Healthcare
University of Medicine and Dentistry of NJ APAMSA
University of Pennsylvania Asian Health Initiatives, Asian Heritage Week, & APAMSA
University of the Sciences in Philadelphia
Vietnamese Mennonite Church
Wedge Medical Center
WES Health Center
Women's Christian Alliance

i Kowdley KV, Wang CC, Welch S, Roberts H, Brosgart CL. Prevalence of chronic hepatitis B among foreign-born persons living in the United States by country of origin. Hepatology 2012. 56(2): 422-433.
ii Ryerson AB, Eheman CR, Altekruse SF, Ward JW, Jemal A, Sherman RL, Henley SJ, Holtzman D, Lake A, Noone A-M, Anderson RN, Ma J, Ly KN, Cronin KA, Penburthy L, Kohler BA. Annual Report to the Nation on the Status of Cancer, 1975-2012, featuring the increasing incidence of liver cancer. Cancer 2016. 122(9): 1312-1337.
iii Regulations require that both the Initial Preventive Physical Exam (IPPE) and Annual Wellness Visits (AWVs) be performed by qualified health professionals, including physicians and/or other qualified non-physician practitioners. Physician in this context is defined by statute as a doctor of medicine or osteopathy, with no specification related to primary care as would be found in ˜1883(u)(6), ˜1833(x)(2)(A)(i)(I) or ˜ 1833(x)(2)(A)(i)(II) of the Social Security Act. (See 42 CFR ˜˜ 410.15-16).
iv Weinbaum CM, Williams I, Mast EE, Wang SA, Finelli L, Wasley A, Neitzel SM, Ward JW. Recommendations for Identification and Public Health Management of Persons with Chronic Hepatitis B Virus Infection. MMWR 2008. 57(RR08): 1-20.
v For instance, insurers may use 'established techniques and the relevant evidence base' to implement 'reasonable medical management techniques to determine the frequency, method, treatment, or setting' for a preventive service recommended by the USPSTF, ACIP, or HRSA to the extent not specified by those bodies. This regulation therefore implies that there is not a pre-established setting in which USPSTF guidelines must be implemented. (See 75 FR 41726 (Jul. 19, 2010), 41728-9; 45 CFR ˜147.130(a)(iv)(B)(4)(4)). Moreover, CMS has not provided any reference to a 'relevant evidence base' with respect to its primary care restriction.

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AACS
ASIAN AMERICAN COMMUNITY SERVICES

August 4, 2016

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Blvd. Baltimore, MD 21244

RE: Centers for Medicare and Medicaid Proposed Decision Memo for Screening for Hepatitis B Virus (HBV) Infection (CAG-00447N)

Dear Ms. Jensen:

On behalf of Asian American Community Services we write to express our appreciation and strong support of the Centers for Medicare and Medicaid Services' (CMS) Proposed National Coverage Determination Decision Memo for hepatitis B virus (HBV) screening in persons at high risk for infection, as defined by the United States Preventive Services Task Force (USPSTF). Up to 2.2 million Americans have chronic HBV infection.ⁱ Unfortunately, 67% are unaware of their infection, placing them at significant risk for advanced liver disease, liver cancer, and/ or in need of a liver transplant. HBV is a primary risk factor for liver cancer -the znct deadliest cancer for men and women. Liver cancer incidence rates are highest among American Indians/ Alaska Natives, and Asian Americans and Pacific Islanders (AAPis ), and increase with age among almost all ethnic groups, until age 85.ⁱⁱ.

We are incredibly thankful that CMS's National Coverage Analysis acknowledges that the body of evidence is sufficient to cover HBV screening for Medicare beneficiaries. This is in line with both United States Preventive Services Task Force (USPSTF) and the Centers for Disease Control and Prevention's (CDC) recommendations. USPSTF gave a grade of "B" for risk-based HBV screening, identifying those born in countries and regions with a high prevalence of HBV infection (≥2%) as the most important risk factor of HBV. People born in the U.S. who were not vaccinated as infants and whose parents were born in a region with high prevalence of hepatitis B infection (≥8%), as well as HIV-positive individuals, injection drug users, men who have sex with men, and household partners and sexual partners of people who are HBV infected are also significant risk factors/populations.

Asian American Community Services (AACS) is the premier non-profit community-based organization serving needs of all Asian Pacific Islanders in Central Ohio. Since 1976, AACS has led efforts to empower and develop the local Asian community through its expansive and proactive programs and services. HBV is associated with significant health disparities in the U.S. Both chronic HBV and HCC disproportionately affect AAPis, who make up 50% of the HBV infection burden in the U.S., and have liver cancer rates that are up to 13 times higher than Caucasian populations in the U.S.

The revised USPSTF hepatitis B screening recommendations are a significant advance in efforts to identify those with chronic HBV and link them to care, and a National Coverage Determination from CMS stating the same would have similar benefits. We urge CMS to finalize the addition of hepatitis B screening as an "additional preventive service" in light of the new USPSTF evidence-based recommendations. We had an analysis of our local statistics published in the Journal of Investigative Medicine, Volume 61, Number 7, October 2013, "Racial Disparities in Hepatitis B Infection in Ohio: Screening and Immunization are Critical for Early Clinical Management", Ranjita Misra, PhD, CHES, PASHA,* Karen Jiobu, BA, MA, DLM (ASCP), Johnathan Zhang, MD, Qihui Liu, MD, Feng Li, MD, Robert Kirkpatrick, MD,§ and Jason Ho, MDp. Our prevalence data for chronic hepatitis Bin the age group 60-69 as 5.6% and ≥ 70 as 4.3%. Of the identified and reported cases of HBV in the U.S. between 2007 and 2012, 15.6% were over the age of 65 and part of the Medicare covered population. Those who are Medicare beneficiaries and are unaware of their HBV infection are likely to have been living with the disease for a very long time. It is vital to ensure they are screened and linked to care and treatment, before they develop advanced liver disease or liver cancer. Those with end stage renal disease are at higher risk for HBV infection and are less likely to respond to the HBV vaccine, and would benefit greatly from screening and subsequent linkage to care.

The limitation of coverage to screenings recommended by primary care practitioners in a primary care setting is inconsistent with Medicare regulations permitting the provision of preventive health assessments and care plan development in a broader array of settings. To clarify and strengthen the draft decision memo, we offer the following viewpoint for your consideration. As a community based organization, we have provided a number of HBV screenings in community-based settings. Conducting these screenings outside of the primary care provider space is essential in order to effectively address the needs of AAPI communities many of those in our communities do not see a primary care provider (PCP) regularly if at all, and setting up a system in which these communitybased screenings would be covered, following the Centers for Disease Control and Prevention's and USPSTF's guidelines would be incredibly beneficial to these patients most at risk. Additionally, screenings conducted by specialists need to also be covered. Some Medicare recipients belong to a PPO and go directly to specialists. Also, some Medicare recipients do not have a primary care physicians and when really sick go to the emergency room. We have heard of a case, where a person traveling in another state on business went to an emergency room complaining of abdominal pain. He was released and died shortly after. His family only became aware that he had liver cancer upon being contacted to be screened for hepatitis B.

We support the recommendation that the determination of whether an individual is "high-risk'' for the purposes of HBV screening ideally be made in conjunction with an assessment of the patient's history, "typically part of an annual wellness visit and considered in the development of a comprehensive prevention plan." To this end, Medicare covers both an Initial Primary Preventive Exam (IPPE) and/or subsequent annual wellness visits (AWV) that include the creation of personalized prevention plan services (PPPS), and a health risk assessment (HRA). However, neither the IPPE or AWV are limited to performance by primary care providers or in primary care settings.m Therefore, if the NCD is adopted as written, it is possible that a medical provider ( or team of providers) could perform an enrollee's IPPE or A WV but not have authorization to recommend screening for HBV. This could then require a separate appointment with a different provider for that purpose, working against the promotion of care coordination and efficiency. By extending screening coverage to a broader array of providers and settings, CMS could ensure that HBV screenings are a true preventive service.

CMS's own analysis does not provide any data or studies to support its determination that these screenings must be done in a primary care setting. Although there is no statutory or regulatory requirement to limit HBV screening to primary care, there is also no analysis of data or research in the NCD that would justify why this service should be so limited. The CDC's recommendations for screening both at-risk individuals, for example, are not limited to primary care -identifying other settings such as obstetrician and other physician offices, refugee clinics, substance use treatment clinics, and dialysis clinics.^iv In addition, while the USPSTF makes recommendations based on primary care populations, there is not an explicit requirement in the their recommendation that these screenings be performed by a primary care provider in a primary care setting. Additionally, there is no statutory requirement that services recommended by the USPSTF with an A or B grade rating be covered by insurers under only these circumstances.^v

We thank you for including HBV screening under Medicare's Preventive Services, leading to improved health outcomes for Medicare beneficiaries. However, we strongly encourage CMS to expand the definition of screening settings to beyond primary care. We look forward to the finalization of these recommendations and encourage CMS to issue its final recommendation.

Sincerely,

Karen Jiobu, DLM(ASCP), Health Care Consultant
Asian American Community Services,
Upper Arlington, Ohio 43220
kjiobu@gmail.com. or kjiobu@aacsohio.org

Kathy Chen, Executive Director
Asian American Community Services,
Upper Arlington, Ohio 43220
kchen@aacsohio.org

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August 5, 2016

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Blvd. Baltimore, MD 21244

RE: Centers for Medicare and Medicaid Proposed Decision Memo for Screening for Hepatitis B Virus (HBV) Infection (CAG-00447N)

Dear Ms. Jensen:

On behalf of the National Council of Asian Pacific Americans (NCAPA), we write to express our appreciation and strong support of the Centers for Medicare and Medicaid Services’ (CMS) Proposed National Coverage Determination Decision Memo for hepatitis B virus (HBV) screening in persons at high risk for infection, as defined by the United States Preventive Services Task Force (USPSTF). Up to 2.2 million Americans have chronic HBV infection.ⁱ Unfortunately, 67% are unaware of their infection, placing them at significant risk for advanced liver disease, liver cancer, and/or in need of a liver transplant. HBV is a primary risk factor for liver cancer -the 2nd deadliest cancer for men and women. Liver cancer incidence rates are highest among American Indians/Alaska Natives, and Asian Americans and Pacific Islanders (AAPIs), and increase with age among almost all ethnic groups, until age 85.ⁱⁱ

We are incredibly thankful that CMS’s National Coverage Analysis acknowledges that the body of evidence is sufficient to cover HBV screening for Medicare beneficiaries. This is in line with both United States Preventive Services Task Force (USPSTF) and the Centers for Disease Control and Prevention’s (CDC) recommendations. USPSTF gave a grade of “B” for risk-based HBV screening, identifying those born in countries and regions with a high prevalence of HBV infection (≥2%) as the most important risk factor of HBV. People born in the U.S. who were not vaccinated as infants and whose parents were born in a region with high prevalence of hepatitis B infection (≥8%), as well as HIV-positive individuals, injection drug users, men who have sex with men, and household partners and sexual partners of people who are HBV infected are also significant risk factors/populations.

The National Council of Asian Pacific Americans (NCAPA), founded in 1996, is a coalition of thirty-five national Asian American, Native Hawaiian and Pacific Islander organizations around the country. NCAPA, located in Washington, D.C., serves to represent the interests of the greater Asian American (AA) and Native Hawaiian Pacific Islander (NHPI) communities and to provide a national voice for AA and NHPI issues.

HBV is associated with significant health disparities in the U.S. Both chronic HBV and HCC disproportionately affect AAPIs, who make up 50% of the HBV infection burden in the U.S., and have liver cancer rates that are up to 13 times higher than Caucasian populations in the U.S.

The revised USPSTF hepatitis B screening recommendations are a significant advance in efforts to identify those with chronic HBV and link them to care, and a National Coverage Determination from CMS stating the same would have similar benefits. We urge CMS to finalize the addition of hepatitis B screening as an “additional preventive service” in light of the new USPSTF evidence-based recommendations. Of the identified and reported cases of HBV in the U.S. between 2007 and 2012, 15.6% were over the age of 65 and part of the Medicare covered population. Those who are Medicare beneficiaries and are unaware of their HBV infection are likely to have been living with the disease for a very long time. It is vital to ensure they are screened and linked to care and treatment, before they develop advanced liver disease or liver cancer. Those with end stage renal disease are at higher risk for HBV infection and are less likely to respond to the HBV vaccine, and would benefit greatly from screening and subsequent linkage to care.

The CDC’s recommendations for screening both at-risk individuals, for example, are not limited to primary care -identifying other settings such as obstetrician and other physician offices, refugee clinics, substance use treatment clinics, and dialysis clinics.ⁱⁱⁱ In addition, while the USPSTF makes recommendations based on primary care populations, there is not an explicit requirement in the their recommendation that these screenings be performed by a primary care provider in a primary care setting. Additionally, there is no statutory requirement that services recommended by the USPSTF with an A or B grade rating be covered by insurers under only these circumstances.^iv

We thank you for including HBV screening under Medicare’s Preventive Services, leading to improved health outcomes for Medicare beneficiaries. However, we strongly encourage CMS to expand the definition of screening settings to beyond primary care. We look forward to the finalization of these recommendations and encourage CMS to issue its final recommendation.

Sincerely,

Nisha Ramachandran
National Council of Asian Pacific Americans (NCAPA)
nisha@ncapaonline.org

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San Francisco Department of Public Health
Barbara A. Garcia, MPA
Director of Health

City and County of San Francisco
Edwin M. Lee
Mayor

August 4, 2016

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Blvd. Baltimore, MD 21244

RE: Centers for Medicare and Medicaid Proposed Decision Memo for Screening for Hepatitis B Virus (HBV) Infection (CAG-00447N)

Dear Ms. Jensen:

On behalf of the San Francisco Department of Public Health {SFDPH), we appreciate the opportunity to provide comments on the Centers for Medicare and Medicaid Proposed Decision Memo for Screening for Hepatitis B Virus {HBV) Infection {CAG-00447N). Our local health department plays a critical role in responding to HBV and ending this disease is an important goal for the SFDPH and for the City and County of San Francisco as a whole.

While the SFDPH supports the intent of the proposed CMS Screening for Hepatitis B Virus {HBV) Infection memo, we have significant concerns that the new recommendations do not go far enough to support local health department services and activities to address HBV. We applaud CMS coverage of HBV testing by primary care providers and recognize that this decision is an important step forward in expanding HBV screening and coverage to those individuals at high-risk. However, the new recommendation only includes reimbursement for HBV screening in primary care providers' offices and we are very concerned that the recommendation does not include reimbursement for specialty care, emergency room, public health department, or community screening opportunities. We urge CMS to expand coverage to these other settings.

San Francisco has the highest rate of liver cancer in the country. Asian Pacific Islanders (APIs) in San Francisco are disproportionately affected by HBV, comprising one-third of the City's population but representing 88% of reported cases. HBV is a serious health equity issue and as such, significant resources have been devoted to end HBV through the San Francisco Hep B Free Campaign and the SFDPH Hepatitis Surveillance Program. These two programs have been a safety net for populations disproportionately affected by HBV and are critical to reducing health disparities.

From our experience as a local health department, we have evidence that HBV screenings occur in specialty care settings, emergency rooms, and at on-site community events. The San Francisco Hep B Free Campaign is a nationally-respected program with a goal of turning San Francisco into the first hepatitis B free city in the nation. This campaign provides free and low-cost hepatitis B testing and vaccinations to Asian and Pacific Islander adults at locations throughout San Francisco. From 2012-2014, the campaign tested over 9,000 people in the community for HBV and was able to link many of those who tested positive to care options. The SF Hep B Free Campaign frequently provides screenings at community events throughout the City and expanding CMS coverage to this setting would enable this program to reimburse for these key services.

The SFDPH Hepatitis Surveillance Program provides HBV surveillance data to assist community partners and advocates in the identification of at-risk populations. The program contacts newly-reported cases to provide education on transmission prevention methods, and works with the Perinatal Program to ensure mothers do not transmit HBV to their newborn children. The Program also provides counseling and information about community resources for testing and vaccination. Reporting of positive HBV lab results to SFDPH's Hepatitis Surveillance Program indicates that tests are conducted in the emergency room. Expanding CMS coverage to the emergency room setting would enable hospitals to reimburse for these much-needed services that they are already providing.

While we understand that screenings often occur in a primary care setting, our direct experience with programs and individuals in the community indicates that HBV screening can and does occur in many non-primary care settings, and that these alternative settings are critical access points for high-risk residents of our City. We strongly believe that CMS broadening this coverage will accelerate the diagnoses of chronically infected HBV individuals and link them to care, as well as accelerate the identification of individuals who do not have immunity to HBV so they may avail themselves of the HBV vaccination. With these facts in mind, we respectfully request that CMS expand coverage of HBV screening to specialty care, emergency rooms, public health departments, community-based organizations and any other entity that adheres to CDC recommendations for HBV testing. This expansion in coverage will help to ensure that San Francisco, and other cities and states, can effectively address this pressing public health concern.

Thank you for the opportunity to comment.

Barbara A. Garcia, MPA
Director of Health

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prevent cancer foundation

August 4, 2016

Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CAG-00447N
7500 Security Boulevard
Baltimore, MD 21244

Re: Proposed Decision Memo for Screening for Hepatitis B Virus (HBV) Infection

Dear Acting Administrator Slavitt:

Thank you for the opportunity to comment on the Proposed Decision Memo for Screening for Hepatitis B Virus (HBV) Infection. The Prevent Cancer Foundation strongly supports CMS’ proposal to cover annual HBV screenings for asymptomatic, high-risk individuals, as well as screenings for all pregnant women at their first prenatal visit.

As you know, at this time, approximately 700,000 to 1.4 million people in the United States have a chronic hepatitis B infection, making it second only to tobacco as a known human carcinogen (World Health Organization). Many of those who are infected are exhibiting no symptoms and are unaware that they have contracted HBV. Due to the long term consequences of a hepatitis B infection, including liver cancer, it is important that hepatitis B is identified and treated as early as possible. Early screening and treatment will greatly reduce the long-term health effects of the disease and help prevent liver cancer. Additionally, studies by the National Center for Biotechnology Information have shown that screening for hepatitis B in pregnant women and asymptomatic, high-risk individuals is highly cost effective.

Covering hepatitis B testing will hopefully lead to the identification and treatment of more people with HBV, and ultimately result in fewer cases of liver cancer in the United States. This proposal has positive health consequences and will ultimately provide cost savings. For these reasons, we strongly support this proposal.

Sincerely,

Carolyn Aldigé
President and Founder

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August 4, 2016

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: Proposed Decision Memorandum for Screening for Hepatitis B Virus (HBV) Infection (CAG-00447N)

Dear Ms. Jensen:

I am writing on behalf of the California Department of Public Health (CDPH), Office of Viral Hepatitis Prevention (OVHP), to comment on the CMS proposed decision regarding coverage of hepatitis B screening for Medicare Part A and/or B beneficiaries. CDPH appreciates the planned adoption of coverage for this important preventive service among Medicare beneficiaries at high risk for hepatitis B infection to appropriately vaccinate or link individuals to clinical management.

Medicare beneficiaries comprise 14 percent of California’s total population, 37 percent of whom have earnings under 200 percent of the federal poverty level. CDPH surveillance data indicate that at least 1,099 cases of chronic hepatitis B among persons ages 65 and older were newly reported in 2013. Of note, there were also at least 1,542 newly reported cases of chronic hepatitis B in 2013 among persons ages 55-64 who will soon, or have already since 2013, become Medicare-eligible. More than two-thirds of reported cases were among Asians and Pacific Islanders, who are disproportionately affected by chronic hepatitis B infection. Due to the asymptomatic nature of infection and variable surveillance capacity across the state, this is likely an underestimate of the true chronic hepatitis B burden in California.

CDPH also wishes to encourage coverage for the broadest possible (“no wrong door”) approach to screening, including in settings other than primary care and with a wider range of eligible providers without compromising quality of care. The Initial Primary Preventive Exam (IPPE) and/or subsequent annual wellness visits (AWV) offered as Medicare benefits, which include the creation of personalized prevention plan services and a health risk assessment, represent valuable opportunities for integrating screening. However, neither the IPPE nor the AWV are limited to performance by primary care providers or in primary care settings. Therefore, if the proposed decision is adopted as written, it is possible that a medical provider (or team of providers) could perform an enrollee’s IPPE or AWV without authorization to recommend hepatitis B screening, creating a potential additional barrier to care.

Anecdotally, primary care providers in California have expressed to CDPH that the considerable volume of USPSTF-recommended services is overwhelming and impossible to accommodate in a standard 15-minute patient visit. For this reason, they rely heavily on colleagues across their health systems to also deliver preventive services where appropriate, including through standing orders (such as for pharmacy-based screening).

Hepatitis B screening without cost-sharing would be a welcome development for California’s over five million Medicare beneficiaries, and would help to advance the goals of both the HHS Action Plan for the Prevention, Care, & Treatment of Viral Hepatitis and California's efforts to reduce the impact of viral hepatitis morbidity and mortality, particularly among Asians and Pacific Islanders.

Thank you for your consideration of these comments and for CMS’ ongoing commitment to achieving a high quality health care system for all beneficiaries.

Sincerely,

Rachel McLean, MPH
Chief, Office of Viral Hepatitis Prevention

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August 04, 2016

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Blvd. Baltimore, MD 21244

RE: Centers for Medicare and Medicaid Proposed Decision Memo for Screening for Hepatitis B Virus (HBV) Infection (CAG-00447N)

Dear Ms. Jensen:

On behalf of Ohio Asian American Health coalition, we write to express our appreciation and strong support of the Centers for Medicare and Medicaid Services’ (CMS) Proposed National Coverage Determination Decision Memo for hepatitis B virus (HBV) screening in persons at high risk for infection, as defined by the United States Preventive Services Task Force (USPSTF). Up to 2.2 million Americans have chronic HBV infection. Unfortunately, 67% are unaware of their infection, placing them at significant risk for advanced liver disease, liver cancer, and/or in need of a liver transplant. HBV is a primary risk factor for liver cancer -the 2nd deadliest cancer for men and women. Liver cancer incidence rates are highest among American Indians/Alaska Natives, and Asian Americans and Pacific Islanders (AAPIs), and increase with age among almost all ethnic groups, until age 85.

We are incredibly thankful that CMS’s National Coverage Analysis acknowledges that the body of evidence is sufficient to cover HBV screening for Medicare beneficiaries. This is in line with both United States Preventive Services Task Force (USPSTF) and the Centers for Disease Control and Prevention’s (CDC) recommendations. USPSTF gave a grade of “B” for risk-based HBV screening, identifying those born in countries and regions with a high prevalence of HBV infection (>2%) as the most important risk factor of HBV. People born in the U.S. who were not vaccinated as infants and whose parents were born in a region with high prevalence of hepatitis B infection (>8%), as well as HIV-positive individuals, injection drug users, men who have sex with men, and household partners and sexual partners of people who are HBV infected are also significant risk factors/populations.

Ohio Asian American Health Coalition, is located in Columbus, Ohio serving Asian Community Based Organizations throughout State of Ohio. HBV is associated with significant health disparities in the U.S. Both chronic HBV and HCC disproportionately affect AAPIs, who make up 50% of the HBV infection burden in the U.S., and have liver cancer rates that are up to 13 times higher than Caucasian populations in the U.S. The revised USPSTF hepatitis B screening recommendations are a significant advance in efforts to identify those with chronic HBV and link them to care, and a National Coverage Determination from CMS stating the same would have similar benefits. We urge CMS to finalize the addition of hepatitis B screening as an “additional preventive service” in light of the new USPSTF evidence-based recommendations. Of the identified and reported cases of HBV in the U.S. between 2007 and 2012, 15.6% were over the age of 65 and part of the Medicare covered population. Those who are Medicare beneficiaries and are unaware of their HBV infection are likely to have been living with the disease for a very long time. It is vital to ensure they are screened and linked to care and treatment, before they develop advanced liver disease or liver cancer. Those with end stage renal disease are at higher risk for HBV infection and are less likely to respond to the HBV vaccine, and would benefit greatly from screening and subsequent linkage to care.

The limitation of coverage to screenings recommended by primary care practitioners in a primary care setting is inconsistent with Medicare regulations permitting the provision of preventive health assessments and care plan development in a broader array of settings. To clarify and strengthen the draft decision memo, we offer the following viewpoint for your consideration.

Conducting these screenings outside of the primary care provider space is essential in order to effectively address the needs of AAPI communities many of those in our communities do not see a primary care provider (PCP) regularly if at all, and setting up a system in which these community-based screenings would be covered, following the Centers for Disease Control and Prevention’s and USPSTF’s guidelines would be incredibly beneficial to these patients most at risk. As Coaltiion we have performed screened over two year period for growing Immigrant African and Asian Population in Central Ohio. The number screened are 3,00 people over two year period. Additionally, screenings conducted by specialists (i.e. gastroenterologists, hepatologists) need to also be covered. Currently, the average PCP is incredibly burdened, and may not have the time to conduct HBV screenings along with the many other services that they provide in a short visit.

We support the recommendation that the determination of whether an individual is “high-risk” for the purposes of HBV screening ideally be made in conjunction with an assessment of the patient’s history, “typically part of an annual wellness visit and considered in the development of a comprehensive prevention plan.” To this end, Medicare covers both an Initial Primary Preventive Exam (IPPE) and/or subsequent annual wellness visits (AWV) that include the creation of personalized prevention plan services (PPPS), and a health risk assessment (HRA). However, neither the IPPE or AWV are limited to performance by primary care providers or in primary care settings. Therefore, if the NCD is adopted as written, it is possible that a medical provider (or team of providers) could perform an enrollee’s IPPE or AWV but not have authorization to recommend screening for HBV. This could then require a separate appointment with a different provider for that purpose, working against the promotion of care coordination and efficiency. By extending screening coverage to a broader array of providers and settings, CMS could ensure that HBV screenings are a true preventive service.

CMS’s own analysis does not provide any data or studies to support its determination that these screenings must be done in a primary care setting. Although there is no statutory or regulatory requirement to limit HBV screening to primary care, there is also no analysis of data or research in the NCD that would justify why this service should be so limited. The CDC’s recommendations for screening both at-risk individuals, for example, are not limited to primary care -identifying other settings such as obstetrician and other physician offices, refugee clinics, substance use treatment clinics, and dialysis clinics. In addition, while the USPSTF makes recommendations based on primary care populations, there is not an explicit requirement in the their recommendation that these screenings be performed by a primary care provider in a primary care setting. Additionally, there is no statutory requirement that services recommended by the USPSTF with an A or B grade rating be covered by insurers under only these circumstances.

We thank you for including HBV screening under Medicare’s Preventive Services, leading to improved health outcomes for Medicare beneficiaries. However, we strongly encourage CMS to expand the definition of screening settings to beyond primary care. We look forward to the finalization of these recommendations and encourage CMS to issue its final recommendation.

Sincerely,
Manju Sankarappa
Executive Director
Ohio Asian American Health Coalition

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Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Blvd. Baltimore, MD 21244

Re: Proposed Decision Memorandum for Screening for Hepatitis B Virus (HBV) Infection

Dear Ms. Jensen,

On behalf of the American Society of Addiction Medicine (ASAM), a national medical specialty organization representing more than 4,000 physicians and other clinicians who specialize in the treatment of addiction, I’d like to thank you for the opportunity to provide comments on the proposed policy to cover hepatitis B screening with no cost to Medicare beneficiaries.

Hepatitis B is a viral infection that is especially common in injection drug users. As rates of injection drug use are increasing, it is likely that rates of hepatitis B infection will also increase in the coming years. No-cost screening for this infectious disease will help patients access timely treatment and possibly prevent transmission to others. High-risk patients without infection can receive the hepatitis B vaccine at no cost, therefore extending the policy to cover screening for this disease makes sense.

We urge you to consider adding no-cost coverage for hepatitis B screening when performed by non-primary care providers. Many patients with substance use disorder or otherwise at high risk of infection may initially be treated by an addiction physician, emergency medicine physician, psychiatrist, or non-primary care provider. Patient cost for an important screening should not be determined by which provider orders the test, especially for patients who may be reconnecting with the health care system for the first time in many years.

Screening for hepatitis C is already a no-cost service for Medicare beneficiaries as a preventive service. Adding hepatitis B screening to the list of no-cost preventive services will benefit many of the same patients that are receiving the hepatitis C screening and we support adding it to the list of no-cost preventive services.

Sincerely,

R. Jeffrey Goldsmith
President, American Society of Addiction Medicine

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August 4, 2016

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Blvd. Baltimore, MD 21244

RE: Centers for Medicare and Medicaid Proposed Decision Memo for Screening for Hepatitis B Virus (HBV) Infection (CAG-00447N)

Dear Ms. Jensen:

The Asian & Pacific Islander American Health Forum (APIAHF) writes to express our appreciation and strong support of the Centers for Medicare and Medicaid Services’ (CMS) Proposed National Coverage Determination Decision Memo for hepatitis B virus (HBV) screening in persons at high risk for infection, as defined by the United States Preventive Services Task Force (USPSTF). APIAHF is the oldest and largest health policy and public health organization working with Asian American (AA), Native Hawaiian and Pacific Islander (NHPI) communities across the nation and its Pacific jurisdictions. APIAHF influences policy, mobilizes communities and strengthens programs and organizations to improve the health of AAs and NHPIs. With more than 30 community-based organizational partners in over 20 states and territories, APIAHF provides a voice in the nation’s capital for underserved AA and NHPI communities and works toward health equity and health justice for all communities.

Up to 2.2 million Americans have chronic HBV infection.¹ Unfortunately, 67% are unaware of their infection, placing them at significant risk for advanced liver disease, liver cancer, and/or in need of a liver transplant. HBV is a primary risk factor for liver cancer -the 2nd deadliest cancer for men and women. Liver cancer incidence rates are highest among American Indians/Alaska Natives, and Asian Americans and Pacific Islanders (AAPIs), and increase with age among almost all ethnic groups, until age 85.

We are incredibly thankful that CMS’s National Coverage Analysis acknowledges that the body of evidence is sufficient to cover HBV screening for Medicare beneficiaries. This is in line with both USPSTF and the Centers for Disease Control and Prevention’s (CDC) recommendations. USPSTF gave a grade of “B” for risk-based HBV screening, identifying those born in countries and regions with a high prevalence of HBV infection (>2%) as the most important risk factor of HBV. People born in the U.S. who were not vaccinated as infants and whose parents were born in a region with high prevalence of hepatitis B infection (>8%), as well as HIV-positive individuals, injection drug users, men who have sex with men, and household partners and sexual partners of people who are HBV infected are also significant risk factors/populations.

HBV is associated with significant health disparities in the U.S. Both chronic HBV and HCC disproportionately affect AAPIs, who make up 50% of the HBV infection burden in the U.S., and have liver cancer rates that are up to 13 times higher than Caucasian populations in the U.S.

The revised USPSTF hepatitis B screening recommendations are a significant advance in efforts to identify those with chronic HBV and link them to care, and a National Coverage Determination from CMS stating the same would have similar benefits. We urge CMS to finalize the addition of hepatitis B screening as an “additional preventive service” in light of the new USPSTF evidence-based recommendations.

Of the identified and reported cases of HBV in the U.S. between 2007 and 2012, 15.6% were over the age of 65 and part of the Medicare covered population. Those who are Medicare beneficiaries and are unaware of their HBV infection are likely to have been living with the disease for a very long time. It is vital to ensure they are screened and linked to care and treatment, before they develop advanced liver disease or liver cancer. Those with end stage renal disease are at higher risk for HBV infection and are less likely to respond to the HBV vaccine, and would benefit greatly from screening and subsequent linkage to care.

The limitation of coverage to screenings recommended by primary care practitioners in a primary care setting is inconsistent with Medicare regulations permitting the provision of preventive health assessments and care plan development in a broader array of settings. Conducting these screenings outside of the primary care provider space is essential in order to effectively address the needs of AAPI communities. Many of AAPIs do not see a primary care provider (PCP) regularly, if at all, and setting up a system in which these community-based screenings would be covered, following the CDC and USPSTF guidelines would be incredibly beneficial to these patients most at risk. Additionally, screenings conducted by specialists (i.e. gastroenterologists, hepatologists) need to be covered. Currently, the average PCP is incredibly burdened and may not have the time to conduct HBV screenings along with the many other services that they provide in a short visit.

We support the recommendation that the determination of whether an individual is “high-risk” for the purposes of HBV screening ideally be made in conjunction with an assessment of the patient’s history, “typically part of an annual wellness visit and considered in the development of a comprehensive prevention plan.” To this end, Medicare covers both an Initial Primary Preventive Exam (IPPE) and/or subsequent annual wellness visits (AWV) that include the creation of personalized prevention plan services (PPPS), and a health risk assessment (HRA). However, neither the IPPE or AWV are limited to performance by primary care providers or in primary care settings.³ Therefore, if the NCD is adopted as written, it is possible that a medical provider (or team of providers) could perform an enrollee’s IPPE or AWV, but not have authorization to recommend screening for HBV. This could then require a separate appointment with a different provider for that purpose, working against the promotion of care coordination and efficiency. By extending screening coverage to a broader array of providers and settings, CMS could ensure that HBV screenings are a true preventive service.

CMS’s own analysis does not provide any data or studies to support its determination that these screenings must be done in a primary care setting. Although there is no statutory or regulatory requirement to limit HBV screening to primary care, there is also no analysis of data or research in the NCD that would justify why this service should be so limited. The CDC’s recommendations for screening both at-risk individuals, for example, are not limited to primary care -identifying other settings such as obstetrician and other physician offices, refugee clinics, substance use treatment clinics, and dialysis clinics.⁴ In addition, while the USPSTF makes recommendations based on primary care populations, there is not an explicit requirement in the their recommendation that these screenings be performed by a primary care provider in a primary care setting. Additionally, there is no statutory requirement that services recommended by the USPSTF with an A or B grade rating be covered by insurers under only these circumstances.

We thank you for including HBV screening under Medicare’s Preventive Services, leading to improved health outcomes for Medicare beneficiaries. However, we strongly encourage CMS to expand the definition of screening settings beyond primary care. We encourage CMS to issue its final recommendation. Please direct any questions about our comments to Amina Abbas, APIAHF Director of Government Relations at aabbas@apiahf.org.

Sincerely,

Kathy Ko Chin
President/Chief Executive Officer

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August 02, 2016

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Blvd. Baltimore, MD 21244

RE: Centers for Medicare and Medicaid Proposed Decision Memo for Screening for Hepatitis B Virus (HBV) Infection (CAG-00447N)

Dear Ms. Jensen:

On behalf of the International Community Health Service (ICHS), we write to express our appreciation and strong support of the Centers for Medicare and Medicaid Services' (CMS) Proposed National Coverage Detennination Decision Memo for hepatitis B virus (HBV) screening in persons at high risk for infection, as defined by the United States Preventive Services Task Force (USPSTF). Up to 2.2 million Americans have chronic HBV infection. Unfortunately, 67% are unaware of their infection, placing them at significant risk for advanced liver disease, liver cancer, and/or in need of a liver transplant. HBV is a primary risk factor for liver cancer -the 2nd deadliest cancer for men and women. Liver cancer incidence rates are highest among American Indians/ Alaska Natives, and Asian Americans and Pacific Islanders (AAPis), and increase with age among almost all ethnic groups, until age 85.We are incredibly thankful that CMS's National Coverage Analysis acknowledges that the body of evidence is sufficient to cover HBV screening for Medicare beneficiaries. This is in line with both United States Preventive Services Task Force (USPSTF) and the Centers for Disease Control and Prevention's (CDC) recommendations. USPSTF gave a grade of "B'' for risk-based HBV screening, identifying those born in countries and regions with a high prevalence of HBV infection (≥2%) as the most important risk factor of HBV. People born in the U.S. who were not vaccinated as infants and whose parents were born in a region with high prevalence of hepatitis B infection (≥8%), as well as HIV-positive individuals, injection drug users, men who have sex with men, and household partners and sexual partners of people who are HBV infected are also significant risk factors/populations.

ICHS is a non-pro.fit Federally Qualified Health Center (FQHC) offering affordable, culturally appropriate, comprehensive primary health care to Asian, Native Hawaiian, and Pacific Islander communities and the broader community, including refugees and immigrants from East Africa, Eastern Europe, and Latino communities in Seattle and King County in Washington State. Since these communities carry a disproportionate burden of chronic Hepatitis B, ICHS, bas supported the Hepatitis B Coalition of Washington (HBCW) since its inception in 1997. Since 2013, ICIIS assumed the leadership of the HBCW, which brings together an innovative partnership of health care providers, non-profit and government leaders, educators, and community members to address the medical and social disparities of hepatitis B.

HBV is associated with significant health disparities in the U.S. Both chronic HBV and HCC disproportionately affect AAPis, who make up 50% of the HBV infection burden in the U.S., and have liver cancer rates that are up to 13 times higher than Caucasian populations in the U.S.

The revised USPSTF hepatitis B screening recommendations are a significant advance in efforts to identify those with chronic HBV and link them to care, and a National Coverage Determination from CMS stating the same would have similar benefits. We urge CMS to finalize the addition of hepatitis B screening as an "additional preventive service" in light of the new USPSTF evidence-based recommendations. As of February 20, 2016 our Asian American and Pacific Islander (AAPI) patients age 65 and older, 1,981 have hepatitis B surface antigen (HBsAg) results in ICHS' electronic health record. Among those patients 128 are surface antigen positive, resulting in a chronic hepatitis B (CHBV) prevalence of 6.46%, which is substantially higher than that of the general population. The majority of these patients are ethnic Chinese (n=l,164) or Vietnamese (n=549), with surface antigen positive prevalence of 6. 79% (n=79) and 6.56 % (n=36), respectively. In total, ICHS currently provides primary care to 191 Medicare recipients living with chronic hepatitis B. These patients are 20% of ICHS' total CHBV patient population, and demonstrate the high burden of disease among our elderly AAPI patients. Although, ICHS makes considerable efforts to test patients at risk for hepatitis B, a substantial number of our elderly patients have not been tested for hepatitis B, with the cost of testing cited as a major barrier for our patients most of whom are low income. It is also important to consider the large cohort of adults who will be aging into Medicare eligibility within the next decade. Among our AAPI patients age 55-64, 1,781 have surface antigen results reported in their electronic health records and 126 are surface antigen positive with a prevalence rate of 7.07%, indicating that CHBV will remain a health disparity for AAPis for decades to come and testing for CHBV among older adults will remain an essential and important preventive service.

Of the identified and reported cases of HBV in the U.S. between 2007 and 2012, 15.6% were over the age of 65 and part of the Medicare covered population. Those who are Medicare beneficiaries and are unaware of their 1-IBV infection are likely to have been living with the disease for a very long time. It is vital to ensure they are screened and linked to care and treatment, before they develop advanced liver disease or liver cancer. Those with end stage renal disease are at higher risk for HBV infection and are less likely to respond to the HBV vaccine, and would benefit greatly from screening and subsequent linkage to care.

The limitation of coverage to screenings recommended by primary care practitioners in a primary care setting is inconsistent with Medicare regulations permitting the provision of preventive health assessments and care plan development in a broader array of settings. To clarify and strengthen the draft decision memo, we offer the following viewpoint for your consideration. Any member of the health care team, following approved protocols for risk assessment should be able to order the HBV screening test and have it covered. Additionally, screenings conducted by specialists (i.e. gastroenterologists, hepatologists) need to also be covered. Currently, the average PCP is incredibly burdened, and may not have the time to conduct HBV screenings along with the many other services that they provide in a short visit.

We support the recommendation that the determination of whether an individual is "high-risk" for the purposes of HBV screening ideally be made in conjunction with an assessment of the patient's history, "typically part of an annual wellness visit and considered in the development of a comprehensive prevention plan." To this end, Medicare covers both an Initial Primary Preventive Exam (IPPE) and/or subsequent annual wellness visits (AWV) that include the creation of personalized prevention plan services (PPPS), and a health risk assessment (HRA). However, neither the IPPE or AWV are limited to performance by primary care providers or in primary care settings. Therefore, if the NCD is adopted as written, it is possible that a medical provider ( or team of providers) could perform an enrollee's IPPE or A WV but not have authorization to recommend screening for HBV. This could then require a separate appointment with a different provider for that purpose, working against the promotion of care coordination and efficiency. By extending screening coverage to a broader array of providers and settirnrs. CMS could ensure that HBV screenings are a true preventive service.

CMS's own analysis does not provide any data or studies to support its determination that these screenings must be done in a primary care setting. Although there is no statutory or regulatory requirement to limit HBV screening to primary care, there is also no analysis of data or research in the NCD that would justify why this service should be so limited. The CDC's recommendations for screening both at-risk individuals, for example, are not limited to primary care -identifying other settings such as obstetrician and other physician offices, refugee clinics, substance use treatment clinics, and dialysis clinics. In addition, while the USPSTF makes recommendations based on primary care populations, there is not an explicit requirement in the their recommendation that these screenings be performed by a primary care provider in a primary care setting. Additionally, there is no statutory requirement that services recommended by the USPSTF with an A or B grade rating be covered by insurers under only these circumstances.

We thank you for including HBV screening under Medicare's Preventive Services, leading to improved health outcomes for Medicare beneficiaries. However, we strongly encourage CMS to expand the definition of screening settings to beyond primary care. We look forward to the finalization of these recommendations and encourage CMS to issue its final recommendation.

Sincerely,

Teresita Batayola
CEO

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8/4/2016

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Blvd. Baltimore, MD 21244

RE: Centers for Medicare and Medicaid Proposed Decision Memo for Screening for Hepatitis B Virus (HBV) Infection (CAG-00447N)

Dear Ms. Jensen:

On behalf of the Hepatitis Education Project (HEP) we write to express our appreciation and strong support of the Centers for Medicare and Medicaid Services’ (CMS) Proposed National Coverage Determination Decision Memo for hepatitis B virus (HBV) screening in persons at high risk for infection, as defined by the United States Preventive Services Task Force (USPSTF). Up to 2.2 million Americans have chronic HBV infection.ⁱ Unfortunately, 67% are unaware of their infection, placing them at significant risk for advanced liver disease, liver cancer, and/or in need of a liver transplant. HBV is a primary risk factor for liver cancer -the 2nd deadliest cancer for men and women. Liver cancer incidence rates are highest among American Indians/Alaska Natives, and Asian Americans and Pacific Islanders (AAPIs), and increase with age among almost all ethnic groups, until age 85.ⁱⁱ

We are incredibly thankful that CMS’s National Coverage Analysis acknowledges that the body of evidence is sufficient to cover HBV screening for Medicare beneficiaries. This is in line with both United States Preventive Services Task Force (USPSTF) and the Centers for Disease Control and Prevention’s (CDC) recommendations. USPSTF gave a grade of “B” for risk-based HBV screening, identifying those born in countries and regions with a high prevalence of HBV infection (≥2%) as the most important risk factor of HBV. People born in the U.S. who were not vaccinated as infants and whose parents were born in a region with high prevalence of hepatitis B infection (≥8%), as well as HIV-positive individuals, injection drug users, men who have sex with men, and household partners and sexual partners of people who are HBV infected are also significant risk factors/populations.

HEP is committed to providing support, education, advocacy and direct services for people affected by hepatitis and to helping raise hepatitis awareness among patients, medical providers and the general public. We are based out of Seattle, Washington, and provide services across the state and participate in advocacy on a local and national level. HBV is associated with significant health disparities in the U.S. Both chronic HBV and HCC disproportionately affect AAPIs, who make up 50% of the HBV infection burden in the U.S., and have liver cancer rates that are up to 13 times higher than Caucasian populations in the U.S.

The revised USPSTF hepatitis B screening recommendations are a significant advance in efforts to identify those with chronic HBV and link them to care, and a National Coverage Determination from CMS stating the same would have similar benefits. We urge CMS to finalize the addition of hepatitis B screening as an “additional preventive service” in light of the new USPSTF evidence-based recommendations. Of the identified and reported cases of HBV in the U.S. between 2007 and 2012, 15.6% were over the age of 65 and part of the Medicare covered population. Those who are Medicare beneficiaries and are unaware of their HBV infection are likely to have been living with the disease for a very long time. It is vital to ensure they are screened and linked to care and treatment, before they develop advanced liver disease or liver cancer. Those with end stage renal disease are at higher risk for HBV infection and are less likely to respond to the HBV vaccine, and would benefit greatly from screening and subsequent linkage to care.

The limitation of coverage to screenings recommended by primary care practitioners in a primary care setting is inconsistent with Medicare regulations permitting the provision of preventive health assessments and care plan development in a broader array of settings. To clarify and strengthen the draft decision memo, we offer the following viewpoint for your consideration. As a community based organization, we provide a number of HBV screenings in community-based settings. Conducting these screenings outside of the primary care provider space is essential in order to effectively address the needs of AAPI communities many of those in our communities do not see a primary care provider (PCP) regularly if at all, and setting up a system in which these community-based screenings would be covered, following the Centers for Disease Control and Prevention’s and USPSTF’s guidelines would be incredibly beneficial to these patients most at risk. However, it has been difficult to provide these screenings due to the costs involved and the general lack of support. With further funding for CBOs to be able to conduct HBV screenings, significantly more community members would be reached in a culturally appropriate and supportive manner. Additionally, screenings conducted by specialists (i.e. gastroenterologists, hepatologists) need to also be covered. Currently, the average PCP is incredibly burdened, and may not have the time to conduct HBV screenings along with the many other services that they provide in a short visit.

We support the recommendation that the determination of whether an individual is “high-risk” for the purposes of HBV screening ideally be made in conjunction with an assessment of the patient’s history, “typically part of an annual wellness visit and considered in the development of a comprehensive prevention plan.” To this end, Medicare covers both an Initial Primary Preventive Exam (IPPE) and/or subsequent annual wellness visits (AWV) that include the creation of personalized prevention plan services (PPPS), and a health risk assessment (HRA). However, neither the IPPE or AWV are limited to performance by primary care providers or in primary care settings.iii Therefore, if the NCD is adopted as written, it is possible that a medical provider (or team of providers) could perform an enrollee’s IPPE or AWV but not have authorization to recommend screening for HBV. This could then require a separate appointment with a different provider for that purpose, working against the promotion of care coordination and efficiency. By extending screening coverage to a broader array of providers and settings, CMS could ensure that HBV screenings are a true preventive service.

CMS’s own analysis does not provide any data or studies to support its determination that these screenings must be done in a primary care setting. Although there is no statutory or regulatory requirement to limit HBV screening to primary care, there is also no analysis of data or research in the NCD that would justify why this service should be so limited. The CDC’s recommendations for screening both at-risk individuals, for example, are not limited to primary care -identifying other settings such as obstetrician and other physician offices, refugee clinics, substance use treatment clinics, and dialysis clinics.^iv In addition, while the USPSTF makes recommendations based on primary care populations, there is not an explicit requirement in the their recommendation that these screenings be performed by a primary care provider in a primary care setting. Additionally, there is no statutory requirement that services recommended by the USPSTF with an A or B grade rating be covered by insurers under only these circumstances.^v

We thank you for including HBV screening under Medicare’s Preventive Services, leading to improved health outcomes for Medicare beneficiaries. However, we strongly encourage CMS to expand the definition of screening settings to beyond primary care. We look forward to the finalization of these recommendations and encourage CMS to issue its final recommendation.

Sincerely,
Arman Altug, MSW

Hepatitis Education Project
911 Western Avenue #302, Seattle, WA 98104
P: 206-732-0311
F: 206-732-0312
Email: arman@hepeducation.org

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August 5, 2016

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Blvd. Baltimore, MD 21244

RE: Centers for Medicare and Medicaid Proposed Decision Memo for Screening for Hepatitis B Virus (HBV) Infection (CAG-00447N)

Dear Ms. Jensen:

On behalf of the Hepatitis B Foundation (HBF), I write to express our appreciation and strong support of the Centers for Medicare and Medicaid Services’ (CMS) Proposed National Coverage Determination Decision Memo for hepatitis B virus (HBV) screening in persons at high risk for infection, as defined by the United States Preventive Services Task Force (USPSTF). Up to 2.2 million Americans have chronic HBV infection.ⁱ Unfortunately, 67% are unaware of their infection, placing them at significant risk for advanced liver disease, liver cancer, and/or in need of a liver transplant. HBV is a primary risk factor for liver cancer -the 2nd deadliest cancer for men and women. According to the 2016 Annual Report to the Nation on the Status of Cancer, unlike most other kinds of cancer, liver cancer incidence and death rates are increasing.ⁱⁱ

HBF appreciates that CMS’ National Coverage Analysis acknowledges that the body of evidence is sufficient to cover HBV screening for Medicare beneficiaries. This is in line with both United States Preventive Services Task Force (USPSTF) and the Centers for Disease Control and Prevention’s (CDC) recommendations. USPSTF gave a grade of “B” for risk-based HBV screening, identifying those born in countries and regions with a high prevalence of HBV infection (>2%) as the most important risk factor of HBV. People born in the U.S. who were not vaccinated as infants and whose parents were born in a region with high prevalence of hepatitis B infection (>8%), as well as HIVpositive individuals, injection drug users, men who have sex with men, and household partners and sexual partners of people who are HBV infected are also significant risk factors/populations.

HBF is the nation’s leading nonprofit research and disease advocacy organization dedicated to finding a cure for hepatitis B and improving the lives of those affected worldwide. Our commitment includes funding focused research, promoting disease awareness, supporting testing, immunization and treatment initiatives, and serving as the primary source of information for patients and families, the medical and scientific community, and the general public. Through our public health and outreach programs, we have seen firsthand the devastative impact of the disease on those who were not screened early enough to prevent end-stage liver disease or HCC. The illnesses associated with chronic hepatitis B infection can largely be prevented with improved access to screening for those who are at high-risk.

HBV is associated with significant health disparities in the U.S. Both chronic HBV and HCC disproportionately affect Asian Americans and Pacific Islanders (AAPI) and African immigrants, who make up over 50% of the HBV infection burden in the U.S., and have liver cancer rates that are up to 13 times higher than Caucasian populations in the U.S.

The revised USPSTF hepatitis B screening recommendations are a significant advance in efforts to identify those with chronic HBV and link them to care, and a National Coverage Determination from CMS stating the same would have similar benefits. We urge CMS to finalize the addition of hepatitis B screening as an “additional preventive service” in light of the new USPSTF evidence-based recommendations. Of the identified and reported cases of HBV in the U.S. between 2007 and 2012, 15.6% were over the age of 65 and part of the Medicare covered population. Those who are Medicare beneficiaries and are unaware of their HBV infection are likely to have been living with the disease for a very long time. It is vital to ensure they are screened and linked to care and treatment, before they develop advanced liver disease or liver cancer. Those with end stage renal disease are at higher risk for HBV infection and are less likely to respond to the HBV vaccine, and would benefit greatly from screening and subsequent linkage to care.

The limitation of coverage to screenings recommended by primary care practitioners in a primary care setting is inconsistent with Medicare regulations permitting the provision of preventive health assessments and care plan development in a broader array of settings. To clarify and strengthen the proposed decision on HBV screening coverage, we offer the following viewpoint for your consideration.

HBF is acutely aware that much of the hepatitis B screening that occurs in the U.S. happens outside of the primary care setting. AAPI and African immigrant communities face a significant number of barriers to health care, and therefore, these communities are often screened number of HBV screenings in community-based settings. Conducting these screenings outside of the primary care provider space is essential in order to effectively address the needs of AAPI communities many of those in our communities do not see a primary care provider (PCP) regularly if at all, and setting up a system in which these community-based screenings would be covered, following the Centers for Disease Control and Prevention’s and USPSTF’s guidelines would be incredibly beneficial to these patients most at risk. Additionally, for many people with health care access barriers, the emergency Room or the pharmacy is often the sole source of health care, and many people are screened in those settings. Screenings are also conducted by specialists (i.e. gastroenterologists, hepatologists), and need to also be covered. Currently, the average PCP is incredibly burdened, and may not have the time to conduct HBV screenings along with the many other services that they provide in a short visit. Relying only on primary health care providers puts an undue burden on them, and realistically, will limit the amount of screening that is done in high-risk communities across the U.S.

We support the recommendation that the determination of whether an individual is “high-risk” for the purposes of HBV screening ideally be made in conjunction with an assessment of the patient’s history, “typically part of an annual wellness visit and considered in the development of a comprehensive prevention plan.” To this end, Medicare covers both an Initial Primary Preventive Exam (IPPE) and/or subsequent annual wellness visits (AWV) that include the creation of personalized prevention plan services (PPPS), and a health risk assessment (HRA). However, neither the IPPE or AWV are limited to performance by primary care providers or in primary care settings.ⁱⁱⁱ Therefore, if the NCD is adopted as written, it is possible that a medical provider (or team of providers) could perform an enrollee’s IPPE or AWV but not have authorization to recommend screening for HBV. This could then require a separate appointment with a different provider for that purpose, working against the promotion of care coordination and efficiency. By extending screening coverage to a broader array of providers and settings, CMS could ensure that HBV screenings are a true preventive service.

CMS’s own analysis does not provide any data or studies to support its determination that these screenings must be done in a primary care setting. Although there is no statutory or regulatory requirement to limit HBV screening to primary care, there is also no analysis of data or research in the NCD that would justify why this service should be so limited. The CDC’s recommendations for screening both at-risk individuals, for example, are not limited to primary care -identifying other settings such as obstetrician and other physician offices, refugee clinics, substance use treatment clinics, and dialysis clinics.^iv In addition, while the USPSTF makes recommendations based on primary care populations, there is not an explicit requirement in the their recommendation that these screenings be performed by a primary care provider in a primary care setting. Additionally, there is no statutory requirement that services recommended by the USPSTF with an A or B grade rating be covered by insurers under only these circumstances.v

We thank and applaud CMS for including HBV screening under Medicare’s Preventive Services, leading to improved health outcomes for Medicare beneficiaries. However, we strongly encourage CMS to expand the definition of screening settings to beyond primary care. We look forward to the finalization of these recommendations and encourage CMS to issue its final recommendation.

Sincerely,

Joan Block, RN, BSN
Executive Director
Hepatitis B Foundation

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National Task Force on Hepatitis B Focus on Asian Pacific Islander Americans

www.hepbtaskforce.org

August 3, 2016

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Blvd. Baltimore, MD 21244

RE: Centers for Medicare and Medicaid Proposed Decision Memo for Screening for Hepatitis B Virus (HBV) Infection (CAG-00447N)

Dear Ms. Jensen:

On behalf of The National Task Force on Hepatitis B: Focus on Asian and Pacific Islander Americans, we write to express our appreciation and strong support of the Centers for Medicare and Medicaid Services’ (CMS) Proposed National Coverage Determination Decision Memo for hepatitis B virus (HBV) screening in persons at high risk for infection, as defined by the United States Preventive Services Task Force (USPSTF). Up to 2.2 million Americans have chronic HBV infection.ⁱ Unfortunately, 67% are unaware of their infection, placing them at significant risk for advanced liver disease, liver cancer, and/or in need of a liver transplant. HBV is a primary risk factor for liver cancer, and liver cancer incidence rates are highest among Asian Americans and Pacific Islanders (AAPIs).

We are thankful that CMS’s National Coverage Analysis acknowledges that the body of evidence is sufficient to cover HBV screening for Medicare beneficiaries. This is in line with both United States Preventive Services Task Force (USPSTF) and the Centers for Disease Control and Prevention’s (CDC) recommendations. USPSTF gave a grade of “B” for risk-based HBV screening, identifying those born in countries and regions with a high prevalence of HBV infection (>2%) as the most important risk factor of HBV. People born in the U.S. who were not vaccinated as infants and whose parents were born in a region with high prevalence of hepatitis B infection (>8%), as well as HIV-positive individuals, injection drug users, men who have sex with men, and household partners and sexual partners of people who are HBV infected are also significant risk factors/populations.

The National Task Force on Hepatitis B: Focus on Asians and Pacific Islander Americans is comprised of a number of diverse groups, founded by and funded in part by the Centers for Disease Control and Prevention (CDC). As the Task Force, we represent more than 75 organizations nationally, and work very closely with other national partners who focus on hepatitis B in AAPI and other at-risk communities. Members include government agencies, nonprofit organizations, health care providers, and individuals who are interested in learning more about hepatitis B resources. Our mission is to eliminate hepatitis B and hepatitis B related liver disease and liver cancer in the United States by empowering and mobilizing communities, enabling national networking and policy development, and by advocating for education and access to comprehensive care and affordable treatment for all Asian and Pacific Islander Americans.

The revised USPSTF hepatitis B screening recommendations are a significant advance in efforts to identify those with chronic HBV and link them to care, and a National Coverage Determination from CMS stating the same would have similar benefits. We urge CMS to finalize the addition of hepatitis B screening as an “additional preventive service” in light of the new USPSTF evidence-based recommendations. Of the identified and reported cases of HBV in the U.S. between 2007 and 2012, 15.6% were over the age of 65 and part of the Medicare covered population. Those who are Medicare beneficiaries and are unaware of their HBV infection are likely to have been living with the disease for a very long time. It is vital to ensure they are screened and linked to care and treatment, before they develop advanced liver disease or liver cancer. Those with end stage renal disease are at higher risk for HBV infection and are less likely to respond to the HBV vaccine, and would benefit greatly from screening and subsequent linkage to care.

To clarify and strengthen the draft decision memo, we offer the following viewpoint for your consideration. As a physician group, we collectively provide a number of HBV screenings in community-based settings. Conducting these screenings outside of the primary care provider space is essential in order to effectively address the needs of AAPI communities many of those in our communities do not see a primary care provider (PCP) regularly if at all, and setting up a system in which these community-based screenings would be covered, following the Centers for Disease Control and Prevention’s and USPSTF’s guidelines would be incredibly beneficial to these patients most at risk. Additionally, screenings conducted by specialists (i.e. gastroenterologists, hepatologists) need to also be covered. Currently, the average PCP is incredibly burdened, and may not have the time to conduct HBV screenings along with the many other services that they provide in a short visit.

We support the recommendation that the determination of whether an individual is “high-risk” for the purposes of HBV screening ideally be made in conjunction with an assessment of the patient’s history, “typically part of an annual wellness visit and considered in the development of a comprehensive prevention plan.” To this end, Medicare covers both an Initial Primary Preventive Exam (IPPE) and/or subsequent annual wellness visits (AWV) that include the creation of personalized prevention plan services (PPPS), and a health risk assessment (HRA). However, neither the IPPE or AWV are limited to performance by primary care providers or in primary care settings.ⁱⁱ Therefore, if the NCD is adopted as written, it is possible that a medical provider (or team of providers) could perform an enrollee’s IPPE or AWV but not have authorization to recommend screening for HBV. This could then require a separate appointment with a different provider for that purpose, working against the promotion of care coordination and efficiency. By extending screening coverage to a broader array of providers and settings, CMS could ensure that HBV screenings are a true preventive service.

CMS’s analysis does not provide any data or studies to support its determination that these screenings must be done in a primary care setting. Although there is no statutory or regulatory requirement to limit HBV screening to primary care, there is also no analysis of data or research in the NCD that would justify why this service should be limited. The CDC’s recommendations for screening both at-risk individuals, for example, are not limited to primary care -identifying other settings such as obstetrician and other physician offices, refugee clinics, substance use treatment clinics, and dialysis clinics.ⁱⁱⁱ In addition, while the USPSTF makes recommendations based on primary care populations, there is not an explicit requirement in the their recommendation that these screenings be performed by a primary care provider in a primary care setting. Additionally, there is no statutory requirement that services recommended by the USPSTF with an A or B grade rating be covered by insurers under only these circumstances.

We thank you for including HBV screening under Medicare’s Preventive Services, leading to improved health outcomes for Medicare beneficiaries. However, we strongly encourage CMS to expand the definition of screening settings to beyond primary care. We welcome the opportunity to discuss our concerns and comments further. If you have any questions or concerns, please do not hesitate to contact us.

Sincerely,

Doan Dao, M.D.
Chairperson, National Task Force on Hepatitis B:
Focus on Asian and Pacific Islander Americans
Doan.Dao@utsouthwestern.edu

Isha Weerasinghe, MSc
Vice chairperson, National Task Force on Hepatitis B:
Focus on Asian and Pacific Islander Americans
iweerasinghe@aapcho.org

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August 4, 2016

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services (CMS)
7500 Security Blvd.
Baltimore, MD 21244

RE: CMS’s Proposed Decision Memo for Screening for Hepatitis B Virus (HBV) Infection (CAG-00447N)

Dear Ms. Jensen:

The Infectious Diseases Society of America (IDSA) and the HIV Medicine Association (HIVMA) appreciate the opportunity to comment on CMS’s proposed addition of HBV screening for high risk individuals as a covered Medicare preventive service. Our societies represent more than 10,000 infectious diseases physicians and scientists devoted to patient care, prevention, public health, education, and research in the area of infectious diseases, including viral hepatitis and HIV.

We support CMS’s determination that coverage of screening for Hepatitis B Virus (HBV), consistent with the grade A and B recommendations by the U.S. Preventive Services Task Force (USPSTF), will improve the prevention or early detection of HBV infection among Medicare beneficiaries. However, while this represents an important step forward, we are concerned about restricting the ordering of HBV tests to primary care providers, which effectively excludes coverage of HBV tests that are ordered by infectious diseases physicians or HIV providers. While primary care providers play an important role in such screening, there are circumstances when infectious diseases physicians, including HIV providers, may be playing a primary role in managing the patient’s health and it would be appropriate and important for an HBV test ordered by them to be covered. As has been demonstrated with the expanded implementation of HIV screening, infectious diseases physicians often serve as champions within their institutions for programs to promote infectious diseases related screenings and immunizations and it would be short-sighted to exclude them as covered physicians.

Although HBV is a vaccine-preventable infection, it remains common, with an estimated 1 to 1.25 million people chronically infected with HBV in the United States.1,2 These carriers are at risk for progression to end-stage liver disease, hepatocellular carcinoma, and transmission of HBV to others. Medicare coverage of HBV screening is important considering that HBV vaccination rates among age-eligible Medicare beneficiaries are likely low, so there is a higher possibility that they may have undiagnosed and unsuspected HBV infection.

In addition, because HIV and HBV have similar modes of transmission (blood and sexual transmission) and fewer patients with HIV clear HBV infection, HIV-infected persons have a higher prevalence of chronic HBV infection than the general population. Although these rates vary depending on the population studied, estimates in some populations are as high as 5%-10%.3,4,5 We also note that current primary care guidelines for the management of persons infected with HIV call for patients to be screened for evidence of hepatitis B virus (HBV) infection upon initiation of care by detection of hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), and antibody to hepatitis B total core antigen (anti-HBc or HBcAb).

We believe that including HBV screening under Medicare Preventive Services will lead to improved health outcomes for Medicare beneficiaries, although we urge that HBV tests ordered by Medicare eligible infectious diseases physicians also be covered.

Thank you for your consideration of our views.

Sincerely,

Johan S. Bakken, MD, PhD, FIDSA
IDSA President
Carlos del Rio, MD, FIDSA
Chair, HIV Medicine Association Board of Directors

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Amy Shen Tang, MD
268 Canal Street
New York, NY 10013

astang@cbwchc.org
Tel: 212-379-6999

August 3, 2016

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Blvd. Baltimore, MD 21244

RE: Centers for Medicare and Medicaid Proposed Decision Memo for Screening for Hepatitis B Virus (HBV) Infection (CAG-00447N)

Dear Ms. Jensen:

On behalf of Charles B. Wang Community Health Center we write to express our appreciation and strong support of the Centers for Medicare and Medicaid Services’ (CMS) Proposed National Coverage Determination Decision Memo for hepatitis B virus (HBV) screening in persons at high risk for infection, as defined by the United States Preventive Services Task Force (USPSTF). Up to 2.2 million Americans have chronic HBV infection.ⁱ Unfortunately, 67% are unaware of their infection, placing them at significant risk for advanced liver disease, liver cancer, and/or in need of a liver transplant. HBV is a primary risk factor for liver cancer, the 2nd deadliest cancer for men and women. Liver cancer incidence rates are highest among American Indians/Alaska Natives, and Asian Americans and Pacific Islanders (AAPIs), and increase with age among almost all ethnic groups, until age 85.ⁱⁱ

We are incredibly thankful that CMS’s National Coverage Analysis acknowledges that the body of evidence is sufficient to cover HBV screening for Medicare beneficiaries. This is in line with both the United States Preventive Services Task Force’s (USPSTF) and the Centers for Disease Control and Prevention’s (CDC) recommendations. USPSTF gave a grade of “B” for risk-based HBV screening, identifying those born in countries and regions with a high prevalence of HBV infection (>2%) as the most important risk factor of HBV. People born in the U.S. who were not vaccinated as infants and whose parents were born in a region with high prevalence of hepatitis B infection (>8%), as well as HIV-positive individuals, injection drug users, men who have sex with men, and household partners and sexual partners of people who are HBV infected are also significant risk factors/populations.

HBV is associated with significant health disparities in the U.S. Both chronic HBV and HCC disproportionately affect AAPIs, who make up 50% of the HBV infection burden in the U.S., and have liver cancer rates that are up to 13 times higher than Caucasian populations in the U.S. The Charles B. Wang Community Health Center (CBWCHC), an FQHC serving predominantly underserved Asian Americans in New York City, is at the forefront of treating patients with chronic hepatitis B infection in a primary care setting. We have seen many cases of advanced liver disease or even cancer in the community; tragically, many patients did not even know they were infected with hepatitis B. Despite high vaccination rates in the U.S. and increased universal vaccination in other countries, we continue to see high rates of infection.

At CBWCHC, we saw 4046 adult patients (over age 18) with chronic hepatitis B infection in the last three years. Of those, 338 (8.35%) patients are 65 and older. In 2015, we screened a total of 6,448 patients for hepatitis B, including 394 patients 65 and older. We found 7.83% of our patients to have chronic hepatitis B infection overall and 4.57% of our patients 65 and over (over 10 times the national average for seniors 65 and over). Furthermore, we have started testing for Hepatitis B core antibody, in addition to hepatitis B surface antigen and antibody, and found a positivity rate of 44.67% for prior infection (hepatitis B core Ab positive). This supplemental information expands our thinking to recognize the high prevalence of past or present disease in our patient population. As more biologic modifiers, immunosuppressive therapies, and chemotherapies become available as new treatments for diseases, it will be even more important to screen for HBV infection to prevent hepatitis failures and even liver failure.

The revised USPSTF hepatitis B screening recommendations are a significant advancement in efforts to identify those with chronic HBV and link them to care, and a National Coverage Determination from CMS stating the same would have similar benefits. We urge CMS to finalize the addition of hepatitis B screening as an “additional preventive service” in light of the new USPSTF evidence-based recommendations. Of the identified and reported cases of HBV in the U.S. between 2007 and 2012, 15.6% were over the age of 65 and part of the Medicare covered population. Those who are Medicare beneficiaries and are unaware of their HBV infection are likely to have been living with the disease for a very long time. It is vital to ensure they are screened and linked to care and treatment, before they develop advanced liver disease or liver cancer. Those with end stage renal disease are at higher risk for HBV infection and are less likely to respond to the HBV vaccine, and would benefit greatly from screening and subsequent linkage to care.

The limitation of coverage to screenings recommended by primary care practitioners in a primary care setting is inconsistent with Medicare regulations permitting the provision of preventive health assessments and care plan development in a broader array of settings. To clarify and strengthen the draft decision memo, we offer the following viewpoint for your consideration. As a community health center, CBWCHC provides a number of HBV screenings in community-based settings. Conducting these screenings outside of the primary care provider space is essential in order to effectively address the needs of AAPI communities; many of those in our communities do not see a primary care provider (PCP) regularly if at all, and setting up a system in which these community-based screenings would be covered, following the Centers for Disease Control and Prevention’s and USPSTF’s guidelines would be incredibly beneficial to these patients most at risk.

We support the recommendation that the determination of whether an individual is “high-risk” for the purposes of HBV screening ideally be made in conjunction with an assessment of the patient’s history, “typically part of an annual wellness visit and considered in the development of a comprehensive prevention plan.” To this end, Medicare covers both an Initial Primary Preventive Exam (IPPE) and/or subsequent annual wellness visits (AWV) that include the creation of personalized prevention plan services (PPPS), and a health risk assessment (HRA). However, neither the IPPE or AWV are limited to performance by primary care providers or in primary care settings.ⁱⁱⁱ Therefore, if the NCD is adopted as written, it is possible that a medical provider (or team of providers) could perform an enrollee’s IPPE or AWV but not have authorization to recommend screening for HBV. This could then require a separate appointment with a different provider for that purpose, working against the promotion of care coordination and efficiency. By extending screening coverage to a broader array of providers and settings, CMS could ensure that HBV screenings are a true preventive service.

CMS’s own analysis does not provide any data or studies to support its determination that these screenings must be done in a primary care setting. Although there is no statutory or regulatory requirement to limit HBV screening to primary care, there is also no analysis of data or research in the NCD that would justify why this service should be so limited. The CDC’s recommendations for screening both at-risk individuals, for example, are not limited to primary care, identifying other settings such as obstetrician and other physician offices, refugee clinics, substance use treatment clinics, and dialysis clinics.^iv In addition, while the USPSTF makes recommendations based on primary care populations, there is not an explicit requirement in the their recommendation that these screenings be performed by a primary care provider in a primary care setting. Additionally, there is no statutory requirement that services recommended by the USPSTF with an A or B grade rating be covered by insurers under only these circumstances.^v

We thank you for including HBV screening under Medicare’s Preventive Services, leading to improved health outcomes for Medicare beneficiaries. However, we strongly encourage CMS to expand the definition of screening settings to beyond primary care. We look forward to the finalization of these recommendations and encourage CMS to issue its final recommendation.

Sincerely,

Amy Shen Tang, MD
Hepatitis B Program Director

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August 3, 2016

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Blvd. Baltimore, MD 21244

RE: Centers for Medicare and Medicaid Proposed Decision Memo for Screening for Hepatitis B Virus (HBV) Infection (CAG-00447N)

Dear Ms. Jensen:

On behalf of Asian Pacific Health Foundation we write to express our appreciation and strong support of the Centers for Medicare and Medicaid Services’ (CMS) Proposed National Coverage Determination Decision Memo for hepatitis B virus (HBV) screening in persons at high risk for infection, as defined by the United States Preventive Services Task Force (USPSTF). Up to 2.2 million Americans have chronic HBV infection.i Unfortunately, 67% are unaware of their infection, placing them at significant risk for advanced liver disease, liver cancer, and/or in need of a liver transplant. HBV is a primary risk factor for liver cancer -the 2nd deadliest cancer for men and women. Liver cancer incidence rates are highest among American Indians/Alaska Natives, and Asian Americans and Pacific Islanders (AAPIs), and increase with age among almost all ethnic groups, until age 85.ⁱⁱ

We are incredibly thankful that CMS’s National Coverage Analysis acknowledges that the body of evidence is sufficient to cover HBV screening for Medicare beneficiaries. This is in line with both United States Preventive Services Task Force (USPSTF) and the Centers for Disease Control and Prevention’s (CDC) recommendations. USPSTF gave a grade of “B” for risk-based HBV screening, identifying those born in countries and regions with a high prevalence of HBV infection (>2%) as the most important risk factor of HBV. People born in the U.S. who were not vaccinated as infants and whose parents were born in a region with high prevalence of hepatitis B infection (>8%), as well as HIV-positive individuals, injection drug users, men who have sex with men, and household partners and sexual partners of people who are HBV infected are also significant risk factors/populations.

Asian Pacific Health Foundation (APHF), a 501 C(3) organization located in San Diego, California. Along with the former Asian Pacific Health Center, we have served Asian populations in San Diego for over 15 years, and as Regional Director of the National Hepatitis B Task Force, I have been working in the area of Hepatitis B prevention and screening since 2003.

In response to the Hepatitis B epidemic, we have collaborated with many entities and funders including the California Endowment, the Tzu-Chi Foundation, the Vietnamese Federation of San Diego and the UCSD School of Pharmacy to bring these activities to fruition in the Asian communities that we serve.

HBV is associated with significant health disparities in the U.S. Both chronic HBV and HCC disproportionately affect AAPIs, who make up 50% of the HBV infection burden in the U.S., and have liver cancer rates that are up to 13 times higher than Caucasian populations in the U.S.

The revised USPSTF hepatitis B screening recommendations are a significant advance in efforts to identify those with chronic HBV and link them to care, and a National Coverage Determination (NCD) from CMS stating the same would have similar benefits. We urge CMS to finalize the addition of hepatitis B screening as an “additional preventive service” in light of the new USPSTF evidence-based recommendations. APHF has engaged in many screening drives, screening 4613 individuals for hepatitis B infection, with a prevalence of about 5-6%. Most of the persons screened are among those 65 years and older. Of the identified and reported cases of HBV in the U.S. between 2007 and 2012, 15.6% were over the age of 65 and part of the Medicare covered population. Those who are Medicare beneficiaries and are unaware of their HBV infection are likely to have been living with the disease for a very long time. It is vital to ensure they are screened and linked to care and treatment, before they develop advanced liver disease or liver cancer. Those with end stage renal disease are at higher risk for HBV infection and are less likely to respond to the HBV vaccine, and would benefit greatly from screening and subsequent linkage to care.

The limitation of coverage to screenings recommended by primary care practitioners in a primary care setting is inconsistent with Medicare regulations permitting the provision of preventive health assessments and care plan development in a broader array of settings. To clarify and strengthen the draft decision memo, we offer the following viewpoint for your consideration. As a Community Based Organization, we provide a number of HBV screenings in community-based settings. Conducting these screenings outside of the primary care provider space is essential in order to effectively address the needs of AAPI communities many of those in our communities do not see a primary care provider (PCP) regularly if at all, and setting up a system in which these community-based screenings would be covered, following the Centers for Disease Control and Prevention’s and USPSTF’s guidelines would be incredibly beneficial to these patients most at risk. Additionally, screenings conducted by specialists (i.e. gastroenterologists, hepatologists) need to also be covered. Currently, the average PCP is incredibly burdened, and may not have the time to conduct HBV screenings along with the many other services that they provide in a short visit.

We support the recommendation that the determination of whether an individual is “high-risk” for the purposes of HBV screening ideally be made in conjunction with an assessment of the patient’s history, “typically part of an annual wellness visit and considered in the development of a comprehensive prevention plan.” To this end, Medicare covers both an Initial Primary Preventive Exam (IPPE) and/or subsequent annual wellness visits (AWV) that include the creation of personalized prevention plan services (PPPS), and a health risk assessment (HRA). However, neither the IPPE nor AWV are limited to performance by primary care providers or in primary care settings.ⁱⁱⁱ Therefore, if the NCD is adopted as written, it is possible that a medical provider (or team of providers) could perform an enrollee’s IPPE or AWV but not have authorization to recommend screening for HBV. This could then require a separate appointment with a different provider for that purpose, working against the promotion of care coordination and efficiency. By extending screening coverage to a broader array of providers and settings, CMS could ensure that HBV screenings are a true preventive service.

CMS’s own analysis does not provide any data or studies to support its determination that these screenings must be done in a primary care setting. Although there is no statutory or regulatory requirement to limit HBV screening to primary care, there is also no analysis of data or research in the NCD that would justify why this service should be so limited. The CDC’s recommendations for screening both at-risk individuals, for example, are not limited to primary care -identifying other settings such as obstetrician and other physician offices, refugee clinics, substance use treatment clinics, and dialysis clinics.^iv In addition, while the USPSTF makes recommendations based on primary care populations, there is not an explicit requirement in the their recommendation that these screenings be performed by a primary care provider in a primary care setting. Additionally, there is no statutory requirement that services recommended by the USPSTF with an A or B grade rating be covered by insurers under only these circumstances.^v

We thank you for including HBV screening under Medicare’s Preventive Services, leading to improved health outcomes for Medicare beneficiaries. However, we strongly encourage CMS to expand the definition of screening settings to beyond primary care. We look forward to the finalization of these recommendations and encourage CMS to issue its final recommendation.

Sincerely,

Binh Tran, PharmD, MS, MBA

Asian Pacific Health Foundation
4844 University Ave, Suite C
San Diego, CA 92105

btran.aphf@sbcglobal.net

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August 5, 2016

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Blvd. Baltimore, MD 21244

RE: Centers for Medicare and Medicaid Proposed Decision Memo for Screening for Hepatitis B Virus (HBV) Infection (CAG-00447N)

Dear Ms. Jensen:

As a primary care physician who has screened and cared for many individuals at-risk for hepatitis B, I am glad to see the Centers for Medicare and Medicaid Services’ (CMS) Proposed National Coverage Determination Decision Memo for hepatitis B virus (HBV) screening in persons at high risk for infection, as defined by the United States Preventive Services Task Force (USPSTF).

Up to 2.2 million Americans have chronic HBV infection. Unfortunately, 67% are unaware of their infection, placing them at significant risk for advanced liver disease, liver cancer, and/or in need of a liver transplant. HBV is a primary risk factor for liver cancer -the 2nd deadliest cancer for men and women. According to the 2016 Annual Report to the Nation on the Status of Cancer, unlike most other kinds of cancer, liver cancer incidence and death rates are increasing.

It is timely that CMS’ National Coverage Analysis acknowledges that the body of evidence is sufficient to cover HBV screening for Medicare beneficiaries. This is in line with both United States Preventive Services Task Force (USPSTF) and the Centers for Disease Control and Prevention’s (CDC) recommendations. USPSTF gave a grade of “B” for risk-based HBV screening, identifying those born in countries and regions with a high prevalence of HBV infection (>2%) as the most important risk factor of HBV. People born in the U.S. who were not vaccinated as infants and whose parents were born in a region with high prevalence of hepatitis B infection (>8%), as well as HIV-positive individuals, injection drug users, men who have sex with men, and household partners and sexual partners of people who are HBV infected are also significant risk factors/populations.

The revised USPSTF hepatitis B screening recommendations are a significant advance in efforts to identify those with chronic HBV and link them to care, and a National Coverage Determination from CMS stating the same would have similar benefits. I urge CMS to finalize the addition of hepatitis B screening as an “additional preventive service” in light of the new USPSTF evidence-based recommendations. Of the identified and reported cases of HBV in the U.S. between 2007 and 2012, 15.6% were over the age of 65 and part of the Medicare covered population. Those who are Medicare beneficiaries and are unaware of their HBV infection are likely to have been living with the disease for a very long time. It is vital to ensure they are screened and linked to care and treatment, before they develop advanced liver disease or liver cancer. Those with end stage renal disease are at higher risk for HBV infection and are less likely to respond to the HBV vaccine, and would benefit greatly from screening and subsequent linkage to care.

The limitation of coverage to screenings recommended by primary care practitioners in a primary care setting is inconsistent with Medicare regulations permitting the provision of preventive health assessments and care plan development in a broader array of settings.

I believe that limiting the screenings to primary settings will be a hindrance to truly decrease the morbidity and mortality from hepatitis B. From my experience as an internist, many patients access healthcare through other settings (senior centers, emergency departments, specialists) and Hep B screening should be covered in these settings as well. There is much data now showing that Hep C screening in emergency departments has led to identifying many HCV infected individuals not previously diagnosed or linked in care and even other community organizations, such as senior centers, can provide crucial screening to at-risk populations .

We support the recommendation that the determination of whether an individual is “high-risk” for the purposes of HBV screening ideally be made in conjunction with an assessment of the patient’s history, “typically part of an annual wellness visit and considered in the development of a comprehensive prevention plan.” To this end, Medicare covers both an Initial Primary Preventive Exam (IPPE) and/or subsequent annual wellness visits (AWV) that include the creation of personalized prevention plan services (PPPS), and a health risk assessment (HRA). However, neither the IPPE or AWV are limited to performance by primary care providers or in primary care settings. Therefore, if the NCD is adopted as written, it is possible that a medical provider (or team of providers) could perform an enrollee’s IPPE or AWV but not have authorization to recommend screening for HBV. This could then require a separate appointment with a different provider for that purpose, working against the promotion of care coordination and efficiency. By extending screening coverage to a broader array of providers and settings, CMS could ensure that HBV screenings are a true preventive service.

CMS’s own analysis does not provide any data or studies to support its determination that these screenings must be done in a primary care setting. Although there is no statutory or regulatory requirement to limit HBV screening to primary care, there is also no analysis of data or research in the NCD that would justify why this service should be so limited. The CDC’s recommendations for screening both at-risk individuals, for example, are not limited to primary care -identifying other settings such as obstetrician and other physician offices, refugee clinics, substance use treatment clinics, and dialysis clinics. In addition, while the USPSTF makes recommendations based on primary care populations, there is not an explicit requirement in the their recommendation that these screenings be performed by a primary care provider in a primary care setting. Additionally, there is no statutory requirement that services recommended by the USPSTF with an A or B grade rating be covered by insurers under only these circumstances.

I thank and applaud CMS for including HBV screening under Medicare’s Preventive Services, leading to improved health outcomes for Medicare beneficiaries. However, I strongly encourage CMS to expand the definition of screening settings to beyond primary care. I look forward to the finalization of these recommendations and encourage CMS to issue its final recommendation and not limit it to certain healthcare settings.

Sincerely,

Su Wang, MD MPH
Medical Director, Center for Asian Health
Saint Barnabas Medical Center
101 Old Short Hills Road, Suite 408
West Orange NJ 07052
973.322.6885 Fax: 973.322.6886 Suwang@rwjh.org

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August 6, 2016

Centers for Medicare and Medicaid Services (CMS)
Attention: Proposed Decision Memo for Screening for Hepatitis B Virus (HBV) Infection
(CAG-00447N)

To Whom It May Concern:

Trust for America’s Health (TFAH) appreciates the opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS) proposed decision memo regarding the inclusion of Hepatitis B virus (HBV) screening into the group of preventive services covered under Medicare. As a non-profit, non-partisan organization dedicated to saving lives and working to make disease prevention a national priority, TFAH believes the proposed decision could result in significant progress in disease prevention and early detection.

In 2010, TFAH and the American Association for the Study of Liver Diseases published a report, “HBV & HCV: America’s Hidden Epidemics,” which recommended steps to preventing and containing viral hepatitis in our country. These steps include identifying the millions of Americans who may be infected with HBV but not know it. According to the Hepatitis B Foundation, 1 out of every 20 Americans is infected with Hepatitis B, for a total of 12 million. Yet, as many as two out of three people with HBV do not know they have it, according to the Centers for Disease Control and Prevention. In addition, as many as 40,000 Americans become infected with the virus yearly and between 2,000 and 4,000 Americans die from liver disease complications associated with Hepatitis B yearly. Further, some populations are at disproportionately higher risk of becoming infected with Hepatitis B, including: individuals who are born in areas with high prevalence of Hepatitis B, those whose parents are from areas with high prevalence of Hepatitis B, and pregnant women.

Screening is a crucial component of public health promotion and disease prevention, and is an integral tool in addressing Hepatitis B. According to the United States Preventive Services Task Force (USPSTF), screening not only correctly identifies those living with Hepatitis B, but also can reduce transmission and development of complications, such as liver cancer. Thus, given the significant health impact that Hepatitis B has on American communities, and the crucial role screening tests have in prevention and disease management efforts, Trust for America’s Health supports CMS’ proposed decision memo.

-TFAH supports the decision to cover Hepatitis B screening under Medicare.
Hepatitis B screening strives to prevent the advancement of HBV by identifying infections sooner. Given that approximately one-third of those living with chronic hepatitis are asymptomatic, screening is a vital tool to achieve linkage to necessary care sooner and limit unintentional transmission. Far too many cases of HBV go undetected until the disease progresses to cause serious complications, such as liver cancer or liver failure. By covering screening, CMS ensures that more individuals can have access to this health resource, and thus have the opportunity to, if necessary, be connected to relevant health resources to manage the disease and protect the health of their communities.

-TFAH supports improving healthcare disparities by screening those at high risk for infection and pregnant women.
Hepatitis B disproportionately affects particular American subpopulations, such as the Asian American and Pacific Islander (AAPI) community. Half of the population living with Hepatitis B in the U.S. is AAPI, yet this population makes up only 5 percent of the country’s population. In addition, the Hepatitis B virus can be transmitted from infected pregnant women to their children perinatally, and 30-40 percent of chronic Hepatitis B cases are due to perinatal transmission. Thus, coverage of Hepatitis B screening for these populations in particular is important in improving their health, linking access to necessary healthcare resources, providing preventive vaccinations when needed, and addressing health disparities. For “asymptomatic, nonpregnant adolescents and adults at high risk,” screening not only allows for earlier detection of Hepatitis B, but also improved care management to prevent development of chronic disease. For pregnant women, screening not only links the mother to relevant health resources, but also can virtually eliminate the risk she will transmit the virus to her baby if proper care is provided.

-TFAH encourages CMS to extend coverage of Hepatitis B screening to other health care settings.
CMS’ proposed decision restricts coverage of Hepatitis B screening under Medicare to primary care settings. This setting limitation may unintentionally hinder access to Hepatitis B screening in other health care settings for example emergency departments, which often are entry points for care. By extending coverage of Hepatitis B screening to other health care settings, CMS can ensure that populations who may not have access to primary care resources, but still face high risk of infection, do not face unnecessary obstacles to vital screenings simply because of the setting in which care is delivered. Further, by extending coverage to other health care settings, CMS can reach a broader scope of the patient population, and thus have a greater impact on disparities in care.

Thank you again for issuing this important decision memo. We hope to see it finalized and implemented very soon. If you have any questions, please contact Dara Lieberman, TFAH’s Senior Government Relations Manager, at dlieberman@tfah.org.

Sincerely,

Richard Hamburg
Interim President & Chief Executive Officer

Sources:
HBV & HCV: America’s Hidden Epidemics. Trust for America’s Health and AASLD. (2010, September). http://healthyamericans.org/report/76/hepatitis-report
Statistics. (2016, January 15). Hepatitis B Foundation. Retrieved July 21, 2016, from http://www.hepb.org/hepb/statistics.htm
Know Hepatitis B FAQs, Centers for Disease Control and Prevention. Retrieved August 1, 2016 from: http://www.cdc.gov/knowhepatitisb/faqs.htm.
Chronic Viral Hepatitis and Health Care Reform. (n.d.). Retrieved July 21, 2016, from http://nvhr.org/sites/default/files/docs/Viral_Hepatitis_Reform.pdf
High Risk Groups. (2014, March). Retrieved July 21, 2016, from http://www.hepb.org/professionals/high-risk_groups.htm
Screening for Hepatitis B Infection in Nonpregnant Adolescents and Adults: Consumer Guide. (2014, May). Retrieved July 21, 2016, from http://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/hepatitis-b-virus-infection-screening-2014
Chronic Viral Hepatitis Prevention Principles for Sound Health Care Reform. (2008, July). Retrieved July 21, 2016, from http://nvhr.org/sites/default/files/docs/intro-to prevention-7-28-09.pdf
Closing the Gap in Hepatitis B Prevention, Screening and Care. (2011, June). Retrieved July 21, 2016, from http://nvhr.org/sites/default/files/NVHR_HBV_Advocacy_Brief_June_2011.pdf
Testing Asian Americans and Pacific Islanders for Hepatitis B. (2013, September). Retrieved July 21, 2016, from http://www.cdc.gov/hepatitis/hbv/pdfs/hepb-api.pdf
Perinatal Transmission. (2016, January 25). Retrieved July 21, 2016, from http://www.cdc.gov/hepatitis/hbv/perinatalxmtn.htm
Final Recommendation Statement. (2009, June). Retrieved July 21, 2016, from http://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/hepatitis-b-in-pregnant-women-screening
Proposed Decision Memo for Screening for Hepatitis B Virus (HBV) Infection (CAG-00447N). (2016, July 7). Retrieved July 25, 2016, from https://www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=283

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August 3, 2016

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Blvd. Baltimore, MD 21244

RE: Centers for Medicare and Medicaid Proposed Decision Memo for Screening for Hepatitis B Virus (HBV) Infection (CAG-00447N)

Dear Ms. Jensen:

Arrowhead Pharmaceuticals, Inc. is a clinical-stage research and development company that is a leader in the search for curative therapies to treat chronic hepatitis B infection. We strongly support the Center for Medicare & Medicaid Services (CMS) proposal to provide coverage for hepatitis B infection screening in beneficiaries at high risk for hepatitis B infection.

However, based on our experience we believe limiting coverage to providers meeting a definition of "primary care provider" and only in a primary care setting may undermine the goal of identifying and treating people infected with hepatitis B. Many high risk patients encounter non-primary care providers who are capable of identifying and treating high risk patients found to be infected with hepatitis B. We do not read the well-researched draft coverage memorandum to provide evidence of a public health benefit to the primary care limitation. For this reason, we believe the final coverage memorandum should clarify that claims for hepatitis B screening in high risk patients will be covered for all providers who can accommodate follow­up communication and treatment of infected patients.

We thank CMS for conducting this important National Coverage Analysis and hope our comments are helpful.

Sincerely

General Counsel

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August 2, 2016

Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Attention: Screening for Hepatitis B Virus (HBV) Infection

On behalf of the National Alliance of State and Territorial AIDS Directors (NASTAD), the association which represents public health officials who administer HIV and hepatitis health care, prevention, education, and supportive service programs funded by state and federal governments, I write to thank the Centers for Medicare and Medicaid Services (CMS) on the Proposed Decision Memorandum for Screening for Hepatitis B Virus (HBV) Infection. Based on this proposed decision, I strongly urge CMS to cover HBV screening for Medicare beneficiaries who are at high risk for infection, as defined by the United States Preventive Services Task Force (USPSTF), in all public health settings.

In the current proposed decision memorandum, CMS proposes to only cover screening for HBV infection when ordered “within the context of a primary care setting.” This prohibitive coverage based upon setting limits the scope where individuals can seek covered screening for HBV. At a time when there are as many as two million people living chronic HBV infection in the U.S. and an estimated 67% are unaware of their infection, CMS should cover screening in all appropriate healthcare settings, including health department and STD clinics. These two settings, in particular, often serve populations that are disproportionately impacted by HBV and have practitioners who are experienced in screening, testing, and treating HBV.

Incorporating HBV screening into Medicare will fulfill a key action in the U.S. Department of Health and Human Services Action Plan for the Prevention, Care, and Treatment of Viral Hepatitis. CMS’ leadership is urgently needed to make sure the goals of the Action Plan are realized and that the necessary screening coverage is in place to identify people living with HBV in all public health settings.

We appreciate your attention and consideration of these comments. Please do not hesitate to contact me at (202) 434-8090 or by email at mpenner@NASTAD.org if you have questions related to these comments.

Sincerely,
Murray C. Penner
Executive Director

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July 26, 2016

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Blvd. Baltimore, MD 21244

RE: Proposed Decision Memo for Screening for Hepatitis B Virus (HBV) Infection (CAG-00447N)

Dear Ms. Jensen,

On behalf of the Hepatitis Foundation International (HFI), we are pleased to share our comments with the Centers for Medicare & Medicaid Services (CMS) on the Proposed Decision Memo for Screening for Hepatitis B Infection. By way of background, HFI is a 501(c) 3 non-profit organization established in 1994 to eradicate viral hepatitis for 550 million people globally. HFI is also dedicated to increasing and promoting health and wellness, as well as, reducing the incidence of preventable liver-related chronic diseases and lifestyles that negatively impact the liver. Some of these diseases include obesity, diabetes, hepatitis, substance abuse, HIV/AIDS, cardiovascular disease, fatty liver disease and liver cancer. We implement our mission through our touchstones to educate, prevent, serve, support, and reach well over 5 million patients and health care professionals annually.

To this end, as a patient advocacy organization, the patient and their quality of life must be protected first and foremost. For this reason, we strongly believe that hepatitis B (HBV) screening should be covered as a Medicare preventive service. HBV is a silent killer, which deems it appropriate for Medicare to cover HBV screening for individuals enrolled under Part A or Part B. CMS proposes that to be covered by Medicare, the test would need to be ordered by the beneficiary’s primary care physician or within a primary care setting and performed by an eligible Medicare provider. However, Medicare coverage should be expanded beyond the primary care setting into other health care settings such as emergency departments. By limiting the coverage to primary care only, barriers are created for Medicare patients that wish to receive hepatitis B screenings in other departments. We believe that including HBV screening under Medicare Preventive Services would lead to improved health outcomes for Medicare beneficiaries. We thank CMS for initiating this Proposed Decision Memo and appreciate the opportunity to comment on this process.

Thank you for the opportunity to comment on this critical issue. The Hepatitis Foundation International looks forward to assisting further as this process continues. Please do not hesitate to contact me directly at ifcameron@hepatitisfoundation.org or by telephone at (301)-565-9410 if we can be of further assistance.

Sincerely,

Ivonne Fuller Cameron
President & CEO

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CMS has proposed to cover the Hepatitis B screening test “when ordered by the beneficiary's primary care physician or practitioner within the context of a primary care setting.” The proposal goes on to define primary care practitioners and primary care settings.

We are concerned that the definition of primary care practitioner does not include certified nurse-midwives (CNMs) and we strongly recommend that CMS modify its proposal to include these providers. Under Section 1861(gg), services of CNMs are a required Medicare benefit. Further, the proposal notes that the HBV screening test would be ordered at the first prenatal visit for pregnant women. In several states CNMs attend 20-25% of all births. CNMs clearly are important providers of maternity care and will see Medicare covered women for prenatal care. If they are unable to order this important test for their patients these Medicare beneficiaries would be forced to go to some other provider for these services, which may result in redundant costs because the patient will have to set up what is essentially a redundant office visit purely for purposes of securing the HBV test. Alternatively, patients of CNMs may opt to simply skip the test, which would not be in their best interest either.

We are likewise concerned about the fashion in which “primary care setting” has been defined. It is not clear to us that this definition would encompass the clinic of a CNM who is providing prenatal and postpartum care to Medicare beneficiaries. We believe that it should and we strongly recommend that CMS make clear in its definition of primary care setting that this location would include the clinics or facilities of maternity care providers, including CNMs, during and just after a woman’s pregnancy.

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On behalf of the Asian Liver Center at Stanford University, I strongly support the proposed Medicare coverage for hepatitis B screening. Medicare's coverage would help accelerate the adoption of USPSTF recommended hepatitis B screening guidelines by both private and public healthcare entities. Current evidence suggests that as many as two thirds of those living with chronic HBV infection in the country are not aware of their disease because they have not been screened. This important policy change would lead to an increase the number of infected persons diagnosed and connected to care and effective treatment and a reduction in complications and deaths from cirrhosis and liver disease related to chronic hepatitis B infection.

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Project Inform is in strong support of the CMS proposal. Adding hepatitis B screening as a covered Medicare preventive service would significantly improve efforts to identify people living with hepatitis B and link them to lifesaving care and treatment.

We request that coverage be expanded beyond the primary care setting. By limiting coverage to primary care, CMS would be creating barriers to hepatitis B screening in other vital health care settings, such as emergency departments. Similar restrictions have created significant challenges in hepatitis C screening and other covered preventive services. A number of studies and professional group analyses have shown the effectiveness of screening for similar infectious diseases, like hepatitis C and HIV, in emergency department settings. See below for examples:

http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0150546
http://cid.oxfordjournals.org/content/early/2015/12/24/cid.civ984.abstract
http://www.natap.org/2015/HCV/PIIS0196064415005296(2).pdf
https://www.acep.org/clinical -practice-management/hiv-testing-and-screening-in-the-emergency-department/
http://www.annemergmed.com/issue/S0196-0644(11)X0013-6
https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5624a2.htm

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I strongly support the idea of screening for high risk patient such as Chinese and Asian people. So far, I screen all new patients of Asian ethnicity. I have been treating these patients to prevent cirrhosis and liver cancer so successfully that none of my patient died of liver cancer from HBV though I found probably 6 to 8 of them and none of the patient with cirrhosis from HBV died except one who refused the treatment. The now a day understand and diagnosis and management of HBV are so effective and life saving.

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