Alston & Bird Health Care Week in Review, August 20, 2021

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare 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, the Department of Health and Human Services (HHS) released its plan to offer COVID-19 vaccine booster shots to eligible Americans and the Centers for Medicare & Medicaid Services (CMS) announced it will issue new regulations requiring COVID-19 vaccinations for nursing home staff. Read more about these announcements and other news below.

I. Regulations, Notices & Guidance

• On August 13, 2021, the Centers for Medicare & Medicaid Services (CMS) issued guidance entitled, Updated Guidance Related to Planning for the Resumption of Normal State Medicaid, Children’s Health Insurance Program (CHIP), and Basic Health Program (BHP) Operations Upon Conclusion of the COVID-19 Public Health Emergency. This State Health Official (SHO) letter outlines policy changes CMS is making to better support states as they address the large volume of pending eligibility and enrollment actions they will need to take after the public health emergency (PHE) ends and minimize beneficiary burden.
• On August 19, 2021, the Executive Office of the President (EOP) issued an administrative order entitled, Maximizing Assistance to Respond to COVID-19. The order states that that the Federal Emergency Management Agency (FEMA) shall provide a 100 percent Federal cost share for all work eligible for assistance under Public Assistance Category B, pursuant to sections 403 (42 U.S.C. 5170b), 502 (42 U.S.C. 5192), and 503 (42 U.S.C. 5193) of the Stafford Act, including work described in section 3(a) of the Presidential Memorandum of January 21, 2021 (Memorandum to Extend Federal Support to Governors’ Use of the National Guard to Respond to COVID-19 and to Increase Reimbursement and Other Assistance Provided to States), and in section 2 of that memorandum on the Governors’ use of the National Guard, performed from January 20, 2020, through December 31, 2021.
• On August 19, 2021, the Health Resources and Services Administration (HRSA) issued guidance entitled, Updated HRSA-supported Women’s Preventive Services Guidelines: Well-Women Preventive Visits, Counseling for Sexually Transmitted Infections, and Breastfeeding Services and Supplies. This notice seeks comments on an updated draft recommendation for Well-Woman Preventive Visits, Counseling for Sexually Transmitted Infections, and Breastfeeding Services and Supplies, as part of the HRSA-supported Women’s Preventive Services Guidelines. This updated draft recommendation has been developed through a national cooperative agreement, the Women’s Preventive Services Initiative (WPSI), by the American College of Obstetricians and Gynecologists (ACOG).
• On August 20, 2021, the Food and Drug Administration (FDA) issued draft guidance entitled, Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application. This revised draft supersedes the draft guidance entitled “Bioequivalence Studies With Pharmacokinetic Endpoints for Drug Products Submitted Under an ANDA,” which was announced in the Federal Register on December 5, 2013. This revised draft guidance provides recommendations to applicants planning to include bioequivalence (BE) information in abbreviated new drug applications (ANDAs) and ANDA supplements. In addition, this guidance describes how to meet the BE requirements set forth in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA regulations.
• On August 20, 2021, FDA issued draft guidance entitled, Product-Specific Guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support ANDAs. In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled “Bioequivalence Recommendations for Specific Products” that explained the process that would be used to make product-specific guidances available to the public on FDA’s website. The guidances identified in this notice were developed using the process described in that guidance.
• On August 20, 2021, the EOP issued an administrative order entitled, School for the Nation's Children; Efforts To Ensure a Safe Return to In-Person. The order directs the Secretary of Education to assess all available tools in taking action, as appropriate and consistent with applicable law, to ensure that: (i) Governors and other officials are taking all appropriate steps to prepare for a safe return to school for our Nation's children, including not standing in the way of local leaders making such preparations; and (ii) Governors and other officials are giving students the opportunity to participate and remain in safe full-time, in-person learning without compromising their health or the health of their families or communities.

Event Notices

• August 24, 2021: The Centers for Disease Control and Prevention (CDC) announced a virtual public meeting of the Advisory Committee on Immunization Practices (ACIP). The agenda will include discussions on additional doses of COVID-19 vaccine, including booster doses.
• August 31-September 1, 2021: The National Institutes of Health (NIH) announced a virtual public meeting of the National Cancer Institute’s National Cancer Advisory Board (NCAB). The meeting will discuss the NCAB Subcommittee Meetings, including the Subcommittee on Planning and Budget and Ad Hoc Subcommittee on Global Cancer Research; the Director’s and Program reports and presentations; business of the Board; and review and evaluation of grant applications.
• September 1, 2021: NIH announced a change in the meeting of the HEAL (Helping to End Addiction Long-Term) Multi-Disciplinary Working Group. This notice is being amended to update the meeting times for the HEAL Multi-Disciplinary Working Group Meeting on September 1-2, 2021.
• September 9, 2021: The Department of Health and Human Services (HHS) announced a meeting of the National Committee on Vital and Health Statistics (NCVHS). NCVHS assists and advises the Secretary of HHS on health data, data standards, statistics, privacy, national health information policy, and the Department’s strategy to best address those issues. At this meeting, the Committee will receive updates from HHS officials, hold discussions on current health data policy topics, and discuss its work plan for the upcoming period.
• September 9-10, 2021: NIH announced an amended notice of meeting of the National Institute of Diabetes and Digestive and Kidney Diseases. The meeting notice is amended to change and adjust the Opening and Closing times on the Subcommittees and Executive Sessions.
• September 13, 2021: NIH announced an amended notice of meeting of the National Advisory Environmental Health Sciences Council. This notice is being amended to change the meeting date from September 13-14, 2021 to September 13, 2021. The start time for open session is also amended and will now start at 11:45 AM and adjourn at 5:15 PM.
• September 14, 2021: NIH announced a virtual public meeting of the National Advisory Council for Nursing Research. The meeting will include a discussion of Program policies and issues and review and evaluation of grant applications.
• September 17, 2021: NIH announced a virtual public meeting of the Council of Councils. The meeting will include announcements and updates; NIH program updates; scientific talks and other business of the Committee; and a review of grant applications.
• October 20-21, 2021: CDC announced a virtual public meeting of the Community Preventive Services Task Force (CPSTF). The agenda will consist of deliberation on systematic reviews of literature and is open to the public. Topics will include Cancer Screening; HIV Prevention; Nutrition, Physical Activity, and Obesity; Social Determinants of Health, and Violence Prevention.
• November 10, 2021: NIH announced a virtual public meeting of the National Cancer Institute Clinical Trials and Translational Research Advisory Committee. This meeting will include a strategic discussion of NCI’s Clinical and Translational Research Programs.
• Various Dates: HHS announced the Health Information Technology Advisory Committee 2021 Schedule of Meetings. The HITAC, among other things, identifies priorities for standards adoption and makes recommendations to the National Coordinator for Health Information Technology (National Coordinator). The HITAC will hold public meetings throughout 2021.

II. Congressional Hearings

There were no Congressional hearings held this week.

III. Reports, Studies & Analyses

• On August 17, 2021, the Kaiser Family Foundation (KFF) released an issue brief entitled, Higher and Faster Growing Spending Per Medicare Advantage Enrollee Adds to Medicare's Solvency and Affordability Challenges. The brief examines Medicare spending per person for beneficiaries in Medicare Advantage, relative to traditional Medicare. KFF finds that Medicare spending for Medicare Advantage enrollees was $321 higher per person in 2019 than if enrollees had instead been covered by traditional Medicare; and the higher Medicare spending per Medicare Advantage enrollee contributed an estimated $7 billion in additional spending in 2019.
• On August 18, 2021, the RAND Corporation issued a press release entitled, Early COVID-19 Vaccine Campaign in the United States Prevented Nearly 140,000 Deaths. The release discussed a study published in Health Affairs, which found that the early COVID-19 vaccination campaign in the United States prevented nearly 140,000 deaths and 3 million cases of COVID-19 by the second week of May.
• On August 18, 2021, Alston & Bird published a new edition of Healthy Byte, offering insight into what health care regulators and industry leaders shared with attendees at the annual Healthcare Information and Management Systems Society (HIMSS) conference in August 2021.
• On August 20, 2021, KFF released an issue brief entitled, Funding for Health Care Providers During the Pandemic: An Update. Congress, states, and the Administration adopted a number of policies to ease financial pressure on hospitals and other health care providers. The infusion of funds was intended to help alleviate the fiscal impact of revenue loss due to patients delaying non-urgent care, coupled with new costs associated with COVID-19. This brief describes the main sources of federal funds for health care providers and how those funds have been allocated.

IV. Other Health Policy News

• On August 13, 2021, HHS announced that the Biden-Harris Administration is providing $20 million to support Native Hawaiian health care entities to aid their response to COVID-19. This funding is being distributed through HRSA. It provides six Native Hawaiian Health Care Improvement Act (NHHCIA) award recipients resources to strengthen vaccination efforts, respond to and mitigate the spread of COVID-19, and enhance health care services and infrastructure in their communities. More information about the announcement can be found here.
• On August 18, 2021, HHS released a statement on the Administration’s plan for COVID-19 booster shots for the American people. More information on the statement can be found here.
• On August 18, 2021, CMS announced it is developing an emergency regulation requiring staff vaccinations within the nation’s more than 15,000 Medicare and Medicaid-participating nursing homes. More information about this regulation can be found here.
• On August 18, 2021, HHS announced that the Biden-Harris Administration is investing over $19 million to expand telehealth innovation and quality nationwide and improve health in rural and underserved communities. These investments are being distributed to 36 award recipients through HRSA. More information about the announcement can be found here.

Click here to view the members of our Health Care Legislative & Public Policy team.