Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.
Week in Review Highlight of the Week:
This week, Congress is expected to pass the Inflation Reduction Act of 2022, which includes numerous health-related provisions such as prescription drug inflation rebates; out-of-pocket caps for Medicare Part D; and drug price negotiation. Read more about this action and other news below.
I. Regulations, Notices & Guidance
- On August 9, 2022, the Food and Drug Administration (FDA) issued a notice entitled, Food and Drug Administration Modernization Act: Modifications to the List of Recognized Standards, Recognition List Number: 058. This notice announced the publication of modifications FDA is making to the list of standards it uses in premarket reviews (FDA Recognized Consensus Standards) and other requirements for devices. The notice will assist manufacturers in meeting the requirements under the consensus standards, which will be maintained on the FDA website.
- On August 9, 2022, the Centers for Medicare & Medicaid Services (CMS) issued a payment advisory entitled, Medicare Program: Alternative Payment Model Incentive Payment Advisory for Clinicians – Request for Current Billing Information for Qualifying Participants. This advisory alerts clinicians who are Qualifying APM participants (QPs) and eligible to receive an Alternative Payment Model (APM) Incentive Payment that CMS does not have the current billing information needed to disburse the payment. This advisory provides information on how QPs should update their billing information by November 1, 2022, to receive payment.
- On August 9, 2022, CMS issued a notice entitled, Medicare Program: Suspension of Required Prior Authorization for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Items under Certain Circumstances. This suspension of prior authorization applies to specified orthoses items that require prior authorization as a condition of payment. Due to the need for certain patients to receive an orthoses item that may otherwise be subject to prior authorization that may delay care and risk the health or life of the beneficiary, CMS is suspending prior authorization requirements indefinitely when the orthoses item is furnished urgently or due to medical necessity. Specific conditions are detailed further in the notice.
- On August 11, 2022, the Agency for Healthcare Research and Quality (AHRQ) issued a notice entitled, Supplemental Evidence and Data Request on Cervical Degenerative Disease Treatment. AHRQ seeks scientific information submissions from the public to inform the agency’s review on Cervical Degenerative Disease Treatment, which is currently being conducted by AHRQ’s Evidence-based Practice Centers (EPC) Program. The EPC program is specifically seeking to collect studies so it may conduct a systematic review to answer 13 key questions and two contextual questions detailed further in this notice. Submissions are due by September 11, 2022.
- On August 11, 2022, the Indian Health Service (IHS) issued a notice entitled, Healthy Lifestyles in Youth (HLY) Project. This notice announced that IHS is accepting applications for a cooperative agreement for the HLY Program. The HLY Program aims to improve the health of American Indian and Alaska Native (AI/AN) youth through health promotion and health education programs. The goal of this IHS five-year cooperative agreement is to address healthy lifestyle development and emphasize nutrition and physical activity for AI/AN children and youth 7 through 11 years of age. This notice further details eligibility requirements and program expectations. The total funding awarded to one organization for the first budget year, starting in fiscal year (FY) 2022, is approximately $1,250,000. Applications are due September 15, 2022.
- On August 12, 2022, FDA issued a notice entitled, Abbreviated New Drug Application Submissions–Amendments to Abbreviated New Drug Applications Under Generic Drug User Fee Amendments. This notice announces the agency’s solicitation of comments on the content of Appendix A in the July 2018 guidance for industry entitled “ANDA Submissions–Amendments to Abbreviated New Drug Applications Under GDUFA” (ANDA Amendments Guidance). FDA is specifically seeking comments on the examples of major deficiencies listed in Appendix A of the ANDA amendments guidance, as well as comments on how any proposed revisions to that list could be beneficial to industry in understanding ANDA amendment classification. Comments are due October 14, 2022.
- August 30-31, 2022: The National Institutes of Health (NIH) announced a partially open meeting of the National Institute of Neurological Disorders and Stroke (NINDS) Helping to End Addiction Long-Term (HEAL) Multi-Disciplinary Working Group. The agenda will include discussions to review and evaluate HEAL Initiative projects as well as to obtain expertise of the HEAL working group on the NIH HEAL Initiative and on specific HEAL projects.
- August 31, 2022: NIH announced a partially open meeting of the National Cancer Advisory Board (NCAB). The open session agendas will include a NCAB Ad Hoc Subcommittee on Experimental Therapeutics and Subcommittee on Planning and Budget meeting, discussions on the Acting Director’s and Program reports and presentations, as well as business of NCAB. The closed session agenda will include review and evaluation of grant applications.
- September 6, 2022: The Centers for Disease Control and Prevention (CDC) announced a meeting of the Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH), National Firefighter Registry Subcommittee. The agenda will address issues related to: The National Firefighter Registry project overview and status, protocol updates, enrollment system demonstration, project launch, and future planning applicable to stakeholders.
- September 13, 2022: NIH announced a partially open meeting of the National Advisory Council for Nursing Research (NACNR). The open agenda will include discussion of program policies and issues. The closed agenda will include review and evaluation of grant applications.
- September 13-14, 2022: NIH announced a partially open meeting of the National Advisory Environmental Health Sciences Council (NAEHSC). The open sessions agendas will include discussions of program policies and issues as well as NAEHSC discussions. The closed session agenda will include review and evaluation of grant applications.
- September 13-15, 2022: The Health Resources and Services Administration (HRSA) announced a meeting of the Advisory Committee on Infant and Maternal Mortality (ACIMM). The agenda may include discussions on the following topics: infant and maternal mortality among AI/AN women and infants; indigenous health; federal program updates; and recommendations by the ACIMM to the Secretary of the Department of Health and Human Services (HHS) on improving birth outcomes among AI/AN mothers and infants.
- September 15, 2022: CMS announced a public meeting of the Advisory Panel on Outreach and Education (APOE). The agenda will include a welcome and listening session with CMS leadership; a recap of the previous meeting on June 23, 2022; a discussion of CMS programs, initiatives, and priorities; an opportunity for public comment; and a summary of the meeting, review of recommendations, and discussion on next steps.
- September 19-20, 2022: NIH announced a partially open meeting of the National Advisory Council for Human Genome Research (NACHGR). The open session agenda will include a report from the National Human Genome Research Institute (NHGRI) director and staff. The closed session agenda will include review and evaluation of grant applications.
- September 22, 2022: FDA announced a public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). The agenda will include a discussion on BLA 125739 from Rebiotix Inc., for a product REBYOTA (Fecal Microbiota, Live), with a requested indication to “reduce the recurrence of Clostridioides difficile infection (CDI) in adults following antibiotic treatment for recurrent Clostridioides difficile”
- September 29, 2022: HHS announced a public meeting of the National Biodefense Science Board (NBSB). The agenda will include discussions regarding current and future chemical, biological, radiological, and nuclear threats, as well as other matters related to disaster preparedness and response.
II. Reports, Studies & Analyses
- On August 8, 2022, the Congressional Research Service (CRS) released a report entitled, Health Savings Accounts (HSAs). This report provides an overview of HSA eligibility, contributions, withdrawals, and tax advantages. This report also discusses data on HSA-qualified high-deductible health plan (HDHP) enrollment and data on HSA access and use. However, the authors note there is limited information on the population of those who are eligible and contribute to an HSA because of fragmented data sources, a lack of representative national data, and other methodological limitations. Despite the limited data sources, key findings of this report include: (1) the rate of growth in HSA-qualified HDHP enrollment has more recently fluctuated; (2) access generally increased as firm size increased and was higher for higher-paying occupations; (3) HSA contributions are generally increasing overall, although employer contributions are growing faster than individual contributions; (4) HSA contributions are generally less for individuals under 26 or over 65 years of age and for individuals with lower incomes; (5) individuals between 26-34 years of age generally have lower withdrawal rates among those aged 26-34; and (6) individuals with greater incomes generally had higher rates of non-rollover HSA withdrawals.
- On August 11, 2022, CRS updated its report entitled, State Laws Restricting or Prohibiting Abortion. This report provides an overview of existing or recently passed state laws prohibiting or limiting abortion prior to 24 weeks’ gestational age (which is considered the point of viability but may change given medical advancements) in light of the recent Supreme Court decision Dobbs v. Jackson Women’s Health Organization which overruled Roe v. Wade. The report also discusses “trigger laws” which restrict access to abortion and go into effect following the overturning of Roe.
- On August 11, 2022, the Congressional Budget Office (CBO) issued a cost estimate entitled, Information About Reconciliation Legislation Passed by the Senate on August 7, 2022. This cost estimate is issued in the form of a letter to Senator Bernie Sanders (D-VT) to update information about the budgetary effects of the Senate amendment to H.R. 5376, the Inflation Reduction Act, that passed on August 7, 2022. This analysis estimates the budgetary effects for 2022, the 2022-2026 period, and the 2022-2031 period of Titles I – VIII. The greatest net increases in the deficit are estimated in Titles V (the Committee on Energy and Natural Resources), Title VI (the Committee on Environment and Public Works), and Title II (the Committee on Agriculture, Nutrition, and Forestry. CBO expects the full analysis of the cost estimate to be ready in a few weeks.
- On August 11, 2022, the Office of Inspector General (OIG) issued a report entitled, Part D Plan Preference for Higher-Cost Hepatitis C Drugs Led to Higher Medicare and Beneficiary Spending. This report addresses concerns that despite the availability of authorized generics for hepatitis C drugs, Part D beneficiaries continue to use higher-cost hepatitis C drugs than Medicaid beneficiaries, resulting in higher Part D spending. OIG found similar trends when analyzing 2019 and 2020 claims data. OIG also found that some Part D plans did not cover the authorized generics and that Part D beneficiaries paid about $2,200 more out of pocket for higher-cost hepatitis C drugs. OIG recommends that CMS encourage Part D plans to increase access and use of the authorized generic hepatitis C drugs, and pursue strategies such as education providers and pharmacies on the use of alternative and lower-cost hepatitis C drugs in Part D.
- On August 11, 2022, CBO issued a cost estimate entitled, Estimated Budgetary Effects of H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act. This legislation, H.R. 2884, would limit the number of patents that could be included in infringement claims for biological products. CBO estimates a net decrease in the deficit from changes in direct spending and revenues to be about $233 million in the next five years and $511 million in the next 10 years.
- On August 11, 2022, CBO issued another cost estimate entitled, Estimated Budgetary Effects of H.R. 2891, the Preserve Access to Affordable Generics and Biosimilars Act. Under this legislation, H.R. 2891, certain agreements that are used to settle claims of patent infringement between sponsors of brand-name, generic, or biosimilar drugs and relating to the sale of a drug or biological product would presumptively be considered illegal under antitrust law. CBO estimates a net decrease in the deficit from changes in direct spending and revenues to be about $258 million in the next five years and $685 million in the next 10 years.
III. Other Health Policy News
- On August 8, 2022, HHS, through HRSA, announced investments of nearly $60 million to grow the health workforce and increase access to quality health care in rural communities. $46 million in American Rescue Plan (ARP) Act funding will support 31 awardees to expand health care capacity in rural and tribal communities through health care job development, training, and placement. Additionally, $10 million will support 13 organizations through the Rural Residency Planning and Development Program to establish new medical residency programs and $4 million will support 18 awards to improve patient health and access to quality care for rural veterans. More information on this announcement can be found here.
- On August 8, 2022, HHS awarded $90 million in ARP Act funding to nearly 1,400 community health centers across the country to advance health equity through better data collection and reporting. The funding will support data modernization efforts to better respond to the specific needs of patients and communities; advanced COVID-19 response efforts; and preparation for future public health emergencies. More information on this announcement can be found here.
- On August 9, 2022, HHS Secretary Xavier Becerra issued a determination under Section 564 of the Federal Food, Drug and Cosmetic Act (FD&C) that will allow FDA to grant emergency use authorizations (EUA) for monkeypox vaccines. This determination follows the public health emergency (PHE) declaration for monkeypox on August 4, 2022 and will allow for increased availability of vaccines to prevent monkeypox. More information on this announcement can be found here.
- On August 10, 2022, CDC and the Agency for Toxic Substances and Disease Registry (ATSDR), along with HHS’ Office of Environmental Justice, announced the release of the Environmental Justice Index (EJI), which provides a single score for local communities so public health officials can identify areas most at risk for the health impacts of environmental hazards. The EJI also breaks out three separate scores on social vulnerability, environmental burden, and health vulnerability for each community. EJI databases and maps can help educate public health officials and the public, inform policy, and advance health equity. More on this announcement can be found here.
- On August 11, 2022, HHS announced a new prize competition from the Kidney Innovation Accelerator (KidneyX) that seeks to further the development of a fully functional bioartificial kidney. The competition invites submissions from innovators in the fields of regenerative medicine, cellular engineering, tissue engineering, systems biology, and synthetic biology, who are working to develop bioartificial kidneys. This innovation can help alleviate the burden of expensive and limited treatment available to the 37 million Americans with kidney diseases. Currently, the best treatment is a kidney transplant, and data shows that 13 people die each day waiting for their transplant while those on dialysis face a 50 percent mortality rate during the first five years of treatment. Poor outcomes also disproportionately affect communities of color. Deadlines for submission are October 28, 2022 and January 28, 2023. More on this announcement can be found here.
- On August 12, 2022, Congress is expected to pass H.R. 5376, the Inflation Reduction Act of 2022. Previously known as the Build Back Better Act, the legislation includes numerous health-related provisions such as prescription drug inflation rebates; out-of-pocket caps for Medicare Part D; and drug price negotiation. Specific notable provisions in the bill: (1) cap out-of-pocket costs of prescription drugs under Medicare Part D to $2,000; (2) lower Affordable Care Act (ACA) health care premiums; (3) cap out-of-pocket Medicare costs of insulin to $35; (4) allow for negotiations of a maximum price of high-cost prescription drugs in Medicare; (5) require drugmakers to pay Medicare a rebate for prices that increase faster than inflation; and (6) require coverage of vaccines with no cost-sharing or deductible under Medicare Part D. The bill, H.R. 5375, recently passed the Senate on August 7, 2022 with several amendments. The House of Representatives is expected to pass H.R. 5375 on August 12, 2022, after which the bill will advance to the President’s desk to be signed into law. More information on this legislation can be found here.