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, CMS announced Medicaid coverage of COVID-19 vaccine counseling visits for children and youth up to age 21. Read more about this development and other news below.
I. Regulations, Notices & Guidance
- On November 29, 2021, the Administration for Children and Families (ACF) issued an interim final rule with comment period entitled, Vaccine and Mask Requirements to Mitigate the Spread of COVID-19 in Head Start Programs. This interim final rule adds new provisions to the Head Start Program Performance Standards to mitigate the spread of the coronavirus disease 2019 (COVID-19) in Head Start programs. It requires effective upon publication, universal masking for all individuals two years of age and older, with some noted exceptions, and all Head Start staff, contractors whose activities involve contact with or providing direct services to children and families, and volunteers working in classrooms or directly with children to be vaccinated for COVID-19 by January 31, 2022.
- On November 29, 2021, the Department of Defense (DOD) issued a final rule entitled, TRICARE Program: TRICARE Reserve Select Coverage for Members of the Selected Reserve. This final rule implements the National Defense Authorization Act for Fiscal Year 2020 (NDAA-2020), which removes the permanent eligible exclusion for TRICARE Reserve Select (TRS) coverage for a member of the Selected Reserve of the Ready Reserve who is enrolled or eligible to enroll in a Federal Employees Health Benefits (FEHB) Program health insurance plan. The law now excludes TRS coverage for such members only during the period preceding January 1, 2030. The law was effective upon enactment of NDAA-2020 on December 20, 2019. In implementing the statutory changes, this final rule will improve TRICARE by increasing options for access to care for Federal employees.
- On November 29, 2021, the Food and Drug Administration (FDA) issued draft guidance for industry entitled, Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry. This guidance provides sponsors and other stakeholders with considerations when either proposing to design a registry or using an existing registry to support regulatory decision-making about a drug’s effectiveness or safety.
- On December 1, 2021, the Department of Health and Human Services (HHS) issued a final rule entitled, National Vaccine Injury Compensation Program: Adding the Category of Vaccines Recommended for Pregnant Women to the Vaccine Injury Table. On April 4, 2018, the HHS Secretary published in the Federal Register a notice of proposed rulemaking (NPRM) to amend the National Vaccine Injury Compensation Program (VICP) Vaccine Injury Table, consistent with the statutory requirement to include vaccines recommended by the Centers for Disease Control and Prevention (CDC) for routine administration in pregnant women. Specifically, the Secretary sought public comment regarding how the addition of this new category should be formatted on the Table. Through this final rule, the Secretary amends the Table to add “and/or pregnant women” after “children” to the existing language in Item XVII as proposed in the NPRM. This change will apply only to petitions for compensation under the VICP filed after the effective date of this final rule.
- On December 1, 2021, the Centers for Medicare & Medicaid Services (CMS) issued a request for information on a proposed rule entitled, Request for Information; Health and Safety Requirements for Transplant Programs, Organ Procurement Organizations, and End-Stage Renal Disease Facilities. This request for information solicits public comments on potential changes to the requirements that transplant programs, organ procurement organizations, and end-stage renal disease facilities must meet in order to participate in the Medicare and Medicaid programs. These providers and suppliers are integral to the transplant ecosystem in the United States and to the health of patients across the Nation. CMS is seeking public comment that will help to inform potential changes that would create system-wide improvements, which would further lead to improved organ donation, organ transplantation, quality of care in dialysis facilities, and improved access to dialysis services.
- On December 1, 2021, FDA issued a final rule entitled, Laboratory Accreditation for Analyses of Foods. FDA is amending its regulations to establish a program for the testing of food in certain circumstances by accredited laboratories, as required under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Establishing this program will help FDA improve the safety of the U.S. food supply and protect U.S. consumers by helping ensure that certain food testing of importance to public health is conducted subject to appropriate oversight and in accordance with appropriate model standards to produce reliable and valid test results.
- On December 2, 2021, the Department of Labor (DOL) Occupational Safety and Health Administration (OSHA) issued an interim final rule with extension of comment period entitled, COVID-19 Vaccination and Testing; Emergency Temporary Standard. The period for submitting public comments is being extended by 45 days to allow stakeholders interested in the COVID-19 vaccination and testing emergency temporary standard (ETS) additional time to review the ETS and collect information and data necessary for comment.
- December 7-9, 2021: The National Institutes of Health (NIH) announced amended meeting times and agendas for the public meeting of the National Cancer Institute’s (NCI) National Cancer Advisory Board and NCI Board of Scientific Advisors.
- December 9-10, 2021: ACF announced a public meeting of the National Advisory Committee on the Sex Trafficking of Children and Youth in the United States. The purpose of the meeting is for the Committee to review state self-assessment survey responses and finalize their January 2022 report. The members of the Committee request comments from the public to inform their ongoing work and January 2022 report.
- January 11-12, 2022: NIH announced a public meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development’s National Advisory Child Health and Human Development Council. The agenda will include opening remarks, administrative matters, NICHD Director's Report, presentation from Director of the Center for Scientific Review; presentation from Director of the National Eye Institute; Inclusion Triennial Report; NICHD Division of Extramural Research discussion; and other business of Council.
- January 31, 2022: NIH announced a public meeting of the National Institute of Allergy and Infectious Diseases’ AIDS Research Advisory Committee. The agenda will include a report from the Division Director and Division Staff.
- January 31, 2022: NIH announced a public meeting of the National Institute of Allergy and Infectious Diseases’ National Advisory Allergy and Infectious Diseases Council. The agenda will feature reports from the Division Director and Division Staff.
- February 3, 2022: CDC announced a public meeting of the National Institute for Occupational Safety and Health (NIOSH) Tribal Consultation Session. CDC will host American Indian and Alaska Native (AI/AN) Federally Recognized Tribes for a virtual tribal consultation session on the NIOSH draft strategic plan entitled American Indian and Alaska Native Worker Safety and Health Strategic Plan.
- February 10, 2022: CDC announced a public meeting of the Board of Scientific Counselors, National Center for Health Statistics (BSC, NCHS). The Board is charged with providing advice and making recommendations to the Secretary, Department of Health and Human Services; the Director, CDC; and the Director, NCHS, regarding the scientific and technical program goals and objectives, strategies, and priorities of NCHS.
U.S. House of Representatives
- On December 2, 2021, the House Committee on Energy & Commerce Subcommittee on Health held a hearing entitled, The Overdose Crisis: Interagency Proposal to Combat Illicit Fentanyl-Related Substances. Witnesses present included: Kemp L. Chester, Assistant Director, Executive Office of the President, Office of National Drug Control Policy; Louis J. Milione, Principal Deputy Administrator, U.S. Drug Enforcement Administration; Lisa O. Monaco, Deputy Attorney General, U.S. Department of Justice; Douglas Throckmorton, M.D., Deputy Director for Regulatory Programs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration; and Nora D. Volkow, M.D., Director, National Institute on Drug Abuse, National Institutes of Health.
III. Reports, Studies & Analyses
- On December 2, 2021, the HHS Office of Inspector General (OIG) published a report entitled, Fall 2021 Semiannual Report to Congress. This report describes OIG's work identifying significant risks, problems, abuses, deficiencies, remedies, and investigative outcomes relating to the administration of HHS programs and operations that were disclosed during the semiannual reporting period April 1, 2021, through September 30, 2021.
- On December 2, 2021, the Bipartisan Policy Center published a report entitled, Public Health Forward: Modernizing the U.S. Public Health System. This report’s focus is on governmental public health systems at the state, territorial, and local levels, where most public health policy is enacted and critical decisions are made regarding the stewardship and allocation of federal funds. The report includes recommendations to improve consultation and collaboration between U.S. and Tribal governments to support shared public health priorities.
IV. Other Health Policy News
- On December 1, 2021, HHS, through CMS, issued a Request for Information (RFI) to solicit stakeholder and public feedback that will be used to inform potential changes and future rulemaking to improve the organ transplantation system and seek to enhance the quality of life of those living with organ failure. This is part of the Biden-Harris Administration’s ongoing efforts to improve the health outcomes of the more than 106,000 people who are waiting to receive a life-saving or life-enhancing organ transplant. CMS is focused on identifying potential system-wide improvements that would increase organ donations, improve transplants, enhance the quality of care in dialysis facilities, increase access to dialysis services, and advance equity in organ donation and transplantation. More information about this RFI can be found here.
- On December 1, 2021, HHS through the Office of Chief Information Officer (OCIO) and Office of Information Security (OIS) launched a website for the HHS 405(d) Aligning Health Care Industry Security Approaches Program. The HHS 405(d) Program website was developed in partnership with the HHS 405(d) Task Group which includes more than 150 individuals from industry and the federal government. Through this new website, the 405(d) Program supports the motto that Cyber Safety is Patient Safety and provides the Healthcare and Public Health (HPH) sector with useful, impactful, and vetted resources, products, videos, and tools that help raise awareness and provide cybersecurity practices, which drive behavioral change and move toward consistency in mitigating the most relevant cybersecurity threats to the sector. More information about this website can be found here.
- On December 2, 2021, CMS announced that it is now requiring states to cover COVID-19 vaccine counseling visits through Medicaid. CMS will now consider certain COVID-19 vaccine counseling visits for children and youth to be COVID-19 vaccine administration, for which state expenditures can be federally matched at 100 percent through the last day of the first quarter that begins one year after the end of the COVID-19 public health emergency, under the ARP. CMS notes that it will match COVID-19 vaccine counseling-only visits at the ARP 100 percent federal match rate only when they are provided to children and youth under age 21 as part of the Medicaid Early and Periodic Screening, Diagnostic and Treatment (EPSDT) benefit. Moving forward, CMS will require states to cover stand-alone vaccine counseling visits related to all pediatric vaccines under the EPSDT benefit. These state expenditures will be matched at the state’s regular federal medical assistance percentage. Additional information about this decision can be accessed here.
- On December 3, 2021, HHS published a report evaluating the increase in Medicare telehealth utilization during the COVID-19 pandemic. The report found that massive increases in the use of telehealth helped maintain some health care access during the COVID-19 pandemic, with specialists like behavioral health providers seeing the highest telehealth utilization relative to other providers. The report, which was produced by researchers in HHS's Office of the Assistant Secretary for Planning and Evaluation (ASPE) and analyzes Medicare fee for service (FFS) data in 2019 and 2020, also highlights that telehealth services were accessed more in urban areas than rural communities, and Black Medicare beneficiaries were less likely than White beneficiaries to utilize telehealth. Additional information about the publication can be found here.
- On December 3, 2021, President Joe Biden signed into law H.R. 6119, the Further Extending Government Funding Act, which would keep the federal government open until February 18, 2022, and provide more time for Congress to reach a bipartisan agreement on full-year appropriations bills for fiscal year (FY) 2022. The House of Representatives and Senate passed the bill on December 2, 2021. Notably, the continuing resolution does not extend expiring health provisions and does not address looming Medicare payment cliffs. These include a 4 percent payment reduction from sequestration under the Statutory Pay-As-You-Go Act of 2010 (Statutory PAYGO), a 2 percent payment reduction from sequestration under the Budget Control Act of 2011, and the expiration of the 2021 Medicare physician payment adjustment of 3.75 percent. The legislation now goes to the President for his signature. For additional information, a section-by-section summary of the legislation is available here.
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