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, HHS extended the COVID-19 PHE for an additional 90 days and President Biden issued an Executive Order directing HHS to explore actions it can take to lower prescription drug costs. Read more about these actions and other news below.
I. Regulations, Notices & Guidance
- On October 11, 2022, the Food and Drug Administration (FDA) issued a notice entitled, Medical Devices; Voluntary Total Product Life Cycle Advisory Program Pilot. FDA’s Center for Devices and Radiological Health (CDRH) is announcing its voluntary Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot that will begin in fiscal year (FY) 2023 with the initial phase. The TAP Pilot is one of the commitments agreed to between FDA and industry as part of the reauthorization of the Medical Device User Fee Amendments for FY 2023 through FY 2027 (MDUFA V). The long-term vision for TAP is to spur more rapid development and more rapid and widespread patient access to safe, effective, high-quality medical devices of public health importance. Over the course of MDUFA V, the voluntary TAP Pilot is intended to demonstrate the feasibility and benefits of process improvements to FDA’s early interactions with participants and of FDA’s facilitation of interactions between participants and stakeholders that support the vision for TAP.
- On October 11, 2022, the Department of the Treasury issued a final rule entitled, Affordability of Employer Coverage for Family Members of Employees. This rule contains final regulations under section 36B of the Internal Revenue Code (IRC) that amend the regulations regarding eligibility for the premium tax credit (PTC). The changes provide that affordability of employer-sponsored minimum essential coverage for family members of an employee is determined based on the employee’s share of the cost of covering the employee and those family members, not the cost of covering only the employee. The final regulations also add a minimum value rule for family members of employees based on the benefits provided to the family members. The final regulations affect taxpayers who enroll, or enroll a family member, in individual health insurance coverage through a Health Insurance Exchange and who may be allowed a PTC for the coverage.
- On October 12, 2022, the Centers for Disease Control and Prevention (CDC) issued a notice entitled, Solicitation of Nominations for Appointment to the World Trade Center Health Program Scientific/Technical Advisory Committee (WTCHP-STAC). The WTCHP-STAC consists of 17 members including experts in fields associated with occupational medicine, pulmonary medicine, environmental medicine, environmental health, industrial hygiene, epidemiology, toxicology, and mental health; representatives of World Trade Center (WTC) responders; and representatives of certified-eligible WTC survivors. Nominations for membership on the WTCHP-STAC must be received no later than November 14, 2022.
- On October 12, 2022, the Department of Health and Human Services (HHS) issued a notice entitled, Establishment of the Medicare Drug Rebate and Negotiations Group within the Center for Medicare (CM). This notice announces the establishment of the Medicare Drug Rebate and Negotiations Group within CM to implement the Drug Price Negotiation Program and the Inflation Rebate Program in Medicare Part B and Part D as authorized under the Inflation Reduction Act (IRA) of 2022. The Centers for Medicare & Medicaid Services (CMS) is responsible for implementing these new programs.
- On October 13, 2022, FDA issued a notice entitled, Request for Nominations for Individuals and Consumer Organizations for Advisory Committees. FDA is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on FDA’s advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to open in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. Nominations will be accepted for current vacancies and for those that may occur through December 31, 2023.
- On October 13, 2022, FDA issued a notice entitled, Discussion Paper: Distributed Manufacturing and Point-of-Care Manufacturing of Drugs; Request for Information and Comments. FDA announced the publication of a discussion paper providing information for stakeholders and soliciting public comments on specific areas of emerging and advanced manufacturing technologies. The discussion paper presents areas for consideration and policy development identified by the Center for Drug Evaluation and Research (CDER) scientific and policy experts associated with distributed manufacturing (DM) and point-of-care (POC) manufacturing for drugs, including biological products regulated by CDER and the Center for Biologics Evaluation and Research (CBER). FDA recognizes that regulatory policies and programs may need to evolve to enable the timely adoption of these technologies. The discussion paper includes a series of questions for each technology to stimulate feedback from the public.
- On October 13, 2022, FDA issued a notice entitled, Prescription Drug User Fee Act VII; Independent Assessment of Communication Through Product Quality Information Requests During Application Review; Statement of Work; Request for Comments. FDA announced an opportunity for public comment on the statement of work to assess communication between FDA and sponsors through product quality information requests during application review and to identify best practices and areas of improvement. The independent assessment is part of FDA performance commitments under the recent reauthorization of the Prescription Drug User Fee Act (PDUFA). FDA is providing for public comment on the statement of work before revising as needed and requesting contractor proposals.
- On October 13, 2022, FDA issued final guidance entitled, Comparability Protocols for Post-approval Changes to the Chemistry, Manufacturing, and Controls Information in a New Drug Application, Abbreviated New Drug Application, or Biologics License Application; Guidance for Industry; Availability. This final guidance is intended to assist original applicants and holders of approved new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs) on implementing a chemistry, manufacturing, and controls (CMC) post-approval change(s) through the use of a comparability protocol (CP). In many cases, submission and approval of a CP will facilitate the subsequent implementation and reporting of CMC changes. This could result in moving a drug or biological product into distribution or facilitating a proactive approach to reinforcing the supply of a product sooner than if a CP were not used. This final guidance recommends a framework to promote continuous improvement in the manufacturing of quality drug and biological products.
- On October 14, 2022, CDC issued a notice entitled, Solicitation of Nominations for Appointment to the Advisory Board on Radiation and Worker Health for the Energy Employees Occupational Illness Compensation Program Act of 2000. CDC is seeking nominations for membership on the Advisory Board on Radiation and Worker Health (ABRWH) as authorized by the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA). Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishments of the ABRWH’s objectives. Nominees will be appointed based on their demonstrated qualifications, professional experience, and knowledge of issues the ABRWH may be asked to consider.
- October 20, 2022: The National Institutes of Health (NIH) announced a public meeting of the National Advisory Child Health and Human Development Council Stillbirth Working Group. The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Stillbirth Working Group of Council is tasked with providing a report to the National Advisory Child Health and Human Development Council focusing on the current barriers to collecting data on stillbirths throughout the U.S., communities at higher risk of stillbirth, the psychological impact and treatment for mothers following stillbirth, and known risk factors for stillbirth.
- November 2-3, 2022: CDC announced a public meeting of the Advisory Committee to the Director (ACD). The agenda will include discussions regarding CDC’s current and future work in the following topic areas: (1) data modernization; (2) laboratory quality; and (3) health equity. ACD will hear reports from its working groups on these three topics. In addition, ACD will have presentations on the COVID-19 and Monkeypox responses, social determinants of health (SDOH), and CDC’s Moving Forward initiative.
- November 7-8, 2022: NIH announced a public meeting of the National Institute on Deafness and Other Communication Disorders (NIDCD) Board of Scientific Counselors. The meeting agenda will include staff reports on divisional, programmatical, and special activities.
- November 15-16, 2022: The Biomedical Advanced Research and Development Authority (BARDA) announced its 2022 BARDA Industry Day (BID). BID is a two-day conference with industry and government partners to share BARDA’s goals and objectives, increase awareness of U.S. government medical countermeasure (MCM) priorities, and facilitate coordination and collaboration between public and private sectors within the health security space.
- November 15-16, 2022: CDC announced a public meeting of the Board of Scientific Counselors, Center for Preparedness and Response (BSC, CPR). The agenda for day one will include CPR division updates and discussion; a CPR diversity, equity, inclusion and accessibility update; and data modernization and outbreak forecasting analytics. The agenda for day 2 will include CDC response updates; a U.S. National Authority for Containment of Poliovirus (NAC) and Polio Containment Workgroup update; a Strategic Capacity Building and Innovation Program Review Working Group update; risk communications during public health emergencies (PHEs); and a BSC discussion of future meeting topics.
- December 2, 2022: The Health Resources and Services Administration (HRSA) announced a public meeting of the Advisory Commission on Childhood Vaccines (ACCV). ACCV provides advice and recommendations to the Secretary of HHS on policy, program development, and other issues related to the implementation of the National Vaccine Injury Compensation Program (VICP) and concerning other matters as described under the Public Health Service Act. This meeting will include updates from various federal agencies.
- December 8, 2022: CDC announced a public meeting of the Mine Safety and Health Research Advisory Committee (MSHRAC). The agenda will include discussions on the National Institute for Occupational Safety and Health (NIOSH) mining safety and health research organizational structure, capabilities, projects, and outcomes. The meeting will also include an update from the NIOSH Associate Director for Mining.
II. Reports, Studies & Analyses
- On October 11, 2022, the Bipartisan Policy Center (BPC) published a report entitled, The Future of Telehealth After COVID-19. In this report, BPC details its findings from telehealth research and Medicare data analysis to inform future policy decisions regarding telehealth. BPC concluded that telehealth flexibilities afforded during the PHE substantially improved access to care, convenience, user experience, and utility of virtual care. BPC also provided detailed recommendations on telehealth policy for tele-specialty services, primary care, behavioral health, as well as for telehealth services overall. Specifically, BPC recommended that Congress and the Biden Administration work to extend most of the telehealth flexibilities for Medicare beneficiaries for two years after the end of the PHE, and formally evaluate their impact.
- On October 12, 2022, the Kaiser Family Foundation (KFF) published a report entitled, KFF Health Tracking Poll October 2022: The Issues Motivating Voters One Month Before The Midterm Elections. KFF’s Health Tracking Poll examines what health care issues may be motivating small groups of voters that could shift some key races in the upcoming 2022 midterm elections. Overall, KFF found that half of registered voters are more motivated to vote in the upcoming elections compared to past elections. Polling also found that abortion access and reproductive health is motivating majorities of Democratic women, women of reproductive age, and Democratic and Democratic-leaning voters in states where abortion is currently illegal. KFF also found that reducing the price of prescription drugs for Medicare enrollees was a key issue that resonated with older voters.
- On October 13, 2022, the Robert Wood Johnson Foundation (RWJF) published a report entitled, A Review of State Efforts to Enforce Mental Health Parity: Lessons for Policymakers and Regulators. The Mental Health Parity and Addiction Equity Act (MHPAEA) aims to remove insurance-related obstacles to mental health and substance use disorder (SUD) treatment. This report provides an overview of the MHPAEA and explains how federal and state regulators are having difficulty enforcing the law. Among their key findings, RWJF found that states have limited resources to enforce federal mental health protections, a lack of awareness about federal mental health protections hinders enforcement, and that more federal support for parity requirements is needed. RWJF made recommendations to policy makers including conducting targeted benefit reviews, providing additional federal resources, and clarifying federal guidance around mental health protections.
IV. Other Health Policy News
- On October 12, 2022, the Department of Agriculture (USDA) announced that it was awarding $110 million in American Rescue Plan (ARP) grants to 208 rural health care organizations across 43 states. The investments are designed to help build, renovate, and equip health care facilities such as hospitals and clinics located in rural areas that may not be able to fund projects without grant support. The funding will support various projects such as, helping providers implement telehealth technologies, establishing nutrition assistance programs, purchasing medical supplies, and increasing staffing. More information on this funding can be found here.
- On October 13, 2022, HHS, through the Administration for Strategic Preparedness and Response (ASPR), renewed its determination that a public health emergency (PHE) exists in regard to the COVID-19 pandemic. This is HHS Secretary Xavier Becerra’s seventh renewal of the COVID-19 PHE since President Biden took office. More information on this announcement can be found here.
- On October 14, 2022, President Biden issued an Executive Order (EO) that directs HHS to explore additional actions it can take to lower prescription drug costs. Specifically, the EO cites the Center for Medicare & Medicaid Innovation (CMMI) as an entity that can work to lower drug costs by testing models and new methods for paying Medicare services, including prescription drug coverage. HHS will have 90 days to submit a formal report outlining any plans to use CMMI’s authorities to lower drug costs and promote access to innovative drug therapies for Medicare beneficiaries. More information about this action can be found here.
Click here to view the members of our Health Care Legislative & Public Policy team.