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 Senate passed the bipartisan infrastructure bill (H. R. 3684) and the Fiscal Year (FY) 2022 Budget Resolution (S. Con. Res. 14). Read more about these legislative actions and other news below.
I. Regulations, Notices & Guidance
- On August 10, 2021, the Drug Enforcement Administration (DEA) issued a proposed rule entitled, Schedules of Controlled Substances: Placement of Mesocarb in Schedule I. The Drug Enforcement Administration proposes placing the substance mesocarb (chemical name: N-phenyl-N'-(3-(1-phenylpropan-2-yl)-1,2,3-oxadiazol-3-ium5-yl)carbamimidate), including its salts, isomers, and salts of isomers, in schedule I of the Controlled Substances Act. If finalized, this action would impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess), or propose to handle, mesocarb.
- On August 11, 2021, DEA issued a final rule entitled, Schedules of Controlled Substances: Placement of 4,4’-DMAR in Schedule I. The rule places 4,4’-dimethylaminorex (common name: 4,4’-DMAR) including its salts, isomers, and salts of isomers, in schedule I of the Controlled Substances Act. This action imposes the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle 4,4’- DMAR.
- On August 11, 2021, the Rural Housing Services (RHS) issued a notice entitled, The American Rescue Plan Act Emergency Rural Health Care Grant Program. RHS announces the availability of up to $500 million in grant funding, appropriated under the American Rescue Plan Act of 2021, for the establishment of the Emergency Rural Health Care (ERHC) Grant Program.
- On August 13, 2021, the Department of Health and Human Services (HHS) issued a final rule entitled, Countermeasures Injury Compensation Program: Smallpox Countermeasures Injury Table. The rule adds the Smallpox Countermeasures Injury Table to HHS’s regulations. The Table includes a list of covered smallpox countermeasures, required time intervals for the first symptom or manifestation of onset of injuries, and the accompanying Qualifications and Aids to Interpretation (QAI), which set forth definitions and other requirements necessary to establish Table injuries.
- September 1-2, 2021: The National Institutes of Health (NIH) announced a virtual public meeting of the Helping to End Addiction Long-Term (HEAL) Multi-Disciplinary Working Group (MDWG). The meeting will provide an update on Helping to End Addiction Long-Term (HEAL) Initiative projects and obtain expertise from MDWG relevant to the NIH HEAL Initiative and to specific HEAL projects.
- September 9, 2021: NIH announced a virtual public meeting of the National Advisory Dental and Craniofacial Research Council. The meeting will discuss the report of the Director, NICDR and concept clearances, as well as review and evaluate grant applications and proposals.
- September 13-14, 2021: NIH announced a virtual public meeting of the National Advisory Environmental Health Sciences Council. The meeting will review and evaluate grant applications and proposals and discuss program policies and issues.
- September 14-15, 2021: NIH announced a virtual public meeting of the National Advisory Mental Health Council of the National Institute of Mental Health (NIMH). The meeting will include a presentation of the NIMH Director's Report and discussion of NIMH program, as well as reviewing and evaluating grant applications and proposals.
- September 17, 2021: FDA announced a public advisory committee meeting of the Pediatric Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. FDA is establishing a docket for public comment on this meeting.
- September 27, 2021: NIH announced a public meeting of the Center for Scientific Review Advisory Council. The meeting will provide advice to the Director, Center for Scientific Review (CSR), on matters related to planning, execution, conduct, support, review, evaluation, and receipt and referral of grant applications at CSR.
- October 5, 2021: CDC announced a virtual public meeting of the Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH). The meeting will address progress on the NIOSH Evaluation Capacity Building Plan; mental health initiative for health workers; and National Firefighter Registry.
- October 6, 2021: FDA announced a virtual public advisory committee meeting of the Patient Engagement Advisory Committee. The general function of the committee is to provide advice to the Commissioner of Food and Drugs, or designee, on complex scientific issues relating to medical devices, the regulation of devices, and their use by patients.
II. Congressional Hearings
There were no Congressional hearings held this week.
III. Reports, Studies & Analyses
- On August 9, 2021, the Government Accountability Office (GAO) published a report entitled, Medicare: Additional Reporting on Key Staffing Information and Stronger Payment Incentives Needed for Skilled Nursing Facilities. This report examines skilled nursing facilities (SNF) performance on staffing measures, CMS reporting of staffing information on Care Compare, and Medicare payments for critical incidents. GAO analyzed CMS staffing and critical incidents data, information on Care Compare, and Medicare claims data for 2018 and 2019. GAO also interviewed CMS officials and other stakeholders such as key researchers and beneficiary groups.
- On August 10, 2021, the Kaiser Family Foundation (KFF) published an issue brief entitled, State Medicaid Home-& Community-Based Services (HCBS) Programs Respond to COVID-19: Early Findings from a 50-State Survey. This issue brief focuses on state policies adopted in response to challenges posed by the pandemic, the pandemic’s impact on Medicaid home-and community-based services (HCBS) enrollees and providers, and states’ early plans for the new American Rescue Plan Act 10 percentage point temporary increase in federal Medicaid matching funds for HCBS.
- On August 11, 2021, the Office of Inspector General (OIG) published a report entitled, Medicare Continues To Make Overpayments for Chronic Care Management Services, Costing the Program and Its Beneficiaries Millions of Dollars. The report finds that not all payments made by CMS to providers for noncomplex and complex Chronic Care Management services rendered during CYs 2017 and 2018 complied with Federal requirements, resulting in $1.9 million in overpayments associated with 50,192 claims.
- On August 12, 2021, KFF published an issue brief entitled, How Would Drug Price Negotiation Affect Medicare Part D Premiums?. The brief finds that drug price negotiation proposals lowering Medicare spending for Part D, which covers retail prescription drugs, would also be expected to lower premiums that beneficiaries pay for Part D coverage.
IV. Other Health Policy News
- On August 9, 2021, the Congressional Budget Office (CBO) announced the members of the Panel of Health Advisers for 2021. More information about the panel can be found here.
- On August 10, 2021, the Executive Office of the President (EOP) issued a proclamation entitled, Special Observance: National Health Center Week. Joseph R. Biden, Jr., President of the United States of America, proclaimed the week of August 8 through August 14, 2021, as National Health Center Week. National Health Center Week recognizes the importance of federally-supported health centers and the role they play as a beacon of strength, service, and care in communities. More information about the proclamation can be found here.
- On August 10, 2021, HHS announced that more than 2.5 million people enrolled in health coverage on HealthCare.gov and state Marketplaces during the Biden-Harris Administration’s 2021 Special Enrollment Period (SEP). It also announced that a record high of nearly 81.7 million people are now receiving coverage through Medicaid and the Children’s Health Insurance Program (CHIP) as of March 2021. More information about coverage can be found here.
- On August 12, 2021, HHS announced it will require more than 25,000 members of its health care workforce to be vaccinated against COVID-19. Staff at the Indian Health Service (IHS) and National Institutes of Health (NIH) who serve in federally-operated health care and clinical research facilities and interact with, or have the potential to come into contact with, patients will be required to receive the COVID-19 vaccine. Members of the U.S. Public Health Service Commissioned Corps will also be required to be vaccinated against COVID-19. More information about the announcement can be found here.