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, Congress passed the $1.5 trillion Consolidated Appropriations Act of 2022 to fund the government for the rest of FY 2022. Read more about this legislation and other news below.
I. Regulations, Notices & Guidance
- On March 7, 2022, the Department of Health and Human Services (HHS) issued a proposed rule entitled, National Institutes of Health Loan Repayment Programs. HHS, through the National Institutes of Health (NIH), proposes to update the existing regulation for NIH Loan Repayment Programs (LRPs) to reflect the consolidation of NIH LRPs into two programs, the Intramural Loan Repayment Program (for NIH researchers) and the Extramural Loan Repayment Program (for non-NIH researchers); the direct authority of the NIH Director to administer the NIH LRPs (formerly the duty of the Secretary, HHS); and the increase in the annual loan repayment amount from a maximum of $35,000 to a maximum of $50,000.
- On March 8, 2022, the Food and Drug Administration (FDA) issued a notice entitled, Drugs for Human Use; Drug Efficacy Study Implementation; Potassium Aminobenzoate Oral Preparations; Withdrawal of Hearing Request; Withdrawal of New Drug Application; Final Resolution of Drug Efficacy Study Implementation. FDA announced that all outstanding hearing requests regarding POTABA (potassium aminobenzoate) Tablets, Capsules, Powder, and Envules have been withdrawn. Therefore, as proposed in the notice of opportunity for hearing, FDA finds that the products subject to the application identified in this docket, or any identical, related, or similar products, have not been shown to be effective for use under the conditions of use prescribed, recommended, or suggested in the labeling, and hereby withdraws approval of the application under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
- On March 8, 2022, HHS issued a correction notice entitled, Vaccines Federal Implementation Plan, Request for Comments; Correction. The notice provides the weblink for the implementation plan.
- On March 9, 2022, FDA issued a draft guidance entitled, Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs; Draft Guidance for Industry. This draft guidance addresses the verification systems that manufacturers, repackagers, wholesale distributors, and dispensers must have in place to comply with the FD&C Act, as amended by the Drug Supply Chain Security Act (DSCSA). The draft guidance also addresses the statutory requirement for notification to the Agency of a product that has been cleared by a manufacturer, repackager, wholesale distributor, or dispenser after a suspect product investigation because it is determined that the product is not an illegitimate product. Finally, the draft guidance addresses the statutory requirement for responding to requests for verification and processing saleable returns.
- On March 9, 2022, the Department of Veterans Affairs (VA) issued an interim final rule entitled, Staff Sergeant Parker Gordon Fox Suicide Prevention Grant Program. VA is issuing this interim final rule to implement a new authority requiring VA to implement a three-year community-based grant program to award grants to eligible entities to provide or coordinate the provision of suicide prevention services to eligible individuals and their families for the purpose of reducing veteran suicide.
- On March 10, 2022, the Agency for Healthcare Research and Quality (AHRQ) issued a request for supplemental evidence and data submissions entitled, Supplemental Evidence and Data Request on Postpartum Care for Women Up to One Year After Pregnancy. In this request, AHRQ is seeking scientific information submissions from the public. Scientific information is being solicited to inform AHRQ’s review on Postpartum Care for Women Up to One Year After Pregnancy, which is currently being conducted by the AHRQ’s Evidence-based Practice Centers (EPC) Program.
- On March 10, 2022, the Health Resources and Services Administration (HRSA) issued a notice entitled, “Low Income Levels” Used for Various Health Professions and Nursing Programs Authorized in Titles III, VII, and VIII of the Public Health Service Act. In this notice, HRSA is updating income levels used to identify a “low-income family” for the purpose of determining eligibility for programs that provide health professions and nursing training to individuals from disadvantaged backgrounds. These various programs are authorized in Titles III, VII, and VIII of the Public Health Service Act.
- On March 10, 2022, HRSA issued a notice entitled, National Vaccine Injury Compensation Program: Revised Amount of the Average Cost of a Health Insurance Policy. In this notice, HRSA is publishing an updated monetary amount of the average cost of a health insurance policy as it relates to the National Vaccine Injury Compensation Program (VICP).
- On March 10, 2022, HHS issued a correction notice entitled, Impact of Health Misinformation in the Digital Information Environment in the United States Throughout the COVID–19 Pandemic Request for Information (RFI); Correction. This notice corrects the hyperlink for accessing the RFI.
- On March 11, 2022, FDA issued a final guidance entitled, Current Good Manufacturing Practice and Preventive Controls, Foreign Supplier Verification Programs, Intentional Adulteration, and Produce Safety Regulations: Enforcement Policy Regarding Certain Provisions; Guidance for Industry. This guidance states Agency policy regarding enforcement of certain requirements related to supply-chain programs for contract manufacturers/processors, the intentional adulteration regulation, and supplier approval and verification requirements in the Current Good Manufacturing Practice and Preventive Controls Regulations and the Foreign Supplier Verification Programs (FSVP) Regulation.
- On March 11, 2022, FDA issued a final rule entitled, Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Interoperable Automated Glycemic Controller. In this rule, FDA is classifying the interoperable automated glycemic controller into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the interoperable automated glycemic controller’s classification.
Event Notices
- March 30, 2022: The Department of Defense (DoD) announced a public meeting of the Defense Health Board’s (DHB) Federal Advisory Committee. The DHB provides independent advice and recommendations to maximize the safety and quality of, as well as access to, health care for DoD health care beneficiaries. The purpose of the meeting is to provide briefings to DHB members on current issues related to military medicine and upcoming DHB taskings.
- March 30, 2022: The Centers for Disease Control and Prevention (CDC) announced a public meeting of the National Committee on Vital and Health Statistics. The National Committee on Vital and Health Statistics 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.
- April 7, 2022: NIH announced a public meeting of the National Heart, Lung, and Blood Institute’s Sleep Disorders Research Advisory Board. The purpose of this meeting is to update the Advisory Board and public stakeholders on the progress of sleep and circadian research activities across NIH, and the activities of Federal stakeholders and professional societies.
- April 21-22, 2022: FDA announced a public meeting of the Oncologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. FDA is also establishing a docket for public comment.
- April 27, 2022: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a public meeting of the Center for Substance Abuse Treatment (CSAT) National Advisory Council (NAC). The meeting will include consideration of minutes from the SAMHSA CSAT NAC meeting of August 12, 2021, and a discussion with SAMHSA leadership. It will also cover updates on CSAT activities from the Office of the Director (OD); the Division of Pharmacologic Therapies (DPT); the State Opioid Response Program (SOR); the Division of State and Community Assistance (DSCA); the Division of Services Improvement (DSI), and a discussion on substance use disorder and oral health.
- Various Dates: The Federal Emergency Management Agency (FEMA) announced various dates for a series of public meetings, under the Plan of Action to Establish a National Strategy for the Coordination of National Multimodal Healthcare Supply Chains to Respond to COVID19, to implement the Voluntary Agreement for the Manufacture and Distribution of Critical Healthcare Resources Necessary to Respond to a Pandemic.
II. Congressional Hearings
U.S. House of Representatives
- On March 8, 2022, the House Committee on Financial Services held a hearing entitled, The Inflation Equation: Corporate Profiteering, Supply Chain Bottlenecks, and COVID-19. Witnesses present included: Demond Drummer, Managing Director Equitable Economy, PolicyLink; Rakeen Mabud, Chief Economist and Managing Director of Policy, Groundwork Collaborative; Sandeep Vaheesan, Legal Director, Open Markets Institute; Mark Zandi, Chief Economist, Moody’s Analytics; and Tyler Goodspeed, Kleinheinz Fellow, Hoover Institution.
III. Reports, Studies & Analyses
- On March 7, 2022, the Government Accountability Office (GAO) published a report entitled, Medicare: Information on Geographic Adjustments to Physician Payments for Physicians' Time, Skills, and Effort. Medicare adjusts the amount it pays for physician services based on the geographic area where a physician works. Specifically, Medicare will pay more for a physician's service in an area where approximate costs for a physician's time, skills, and effort are higher than the national average and less in an area where costs are lower. In this report, GAO found that Medicare's payment system generally does a good job of adjusting for differences in an area's relevant costs. In 90 of 119 areas, actual physician earnings matched the payment adjustment amount.
- On March 10, 2022, the Kaiser Family Foundation (KFF) published an issue brief entitled, How Affordability of Health Care Varies by Income among People with Employer Coverage. In this brief, KFF analyzes the Current Population Survey to look at the share of family income people with employer-based coverage pay toward their premiums and out-of-pocket payments for medical care. KFF finds that people in lower-income families with employer coverage spend a greater share of their income on health costs than those with higher incomes, and that the health status of family members is associated with higher health-related expenses.
- On March 11, 2022, KFF published an issue brief entitled, Half of Admissions in the Large Group Market Are Paid Above 150% of Medicare Rates, Excluding Maternity Admissions. The brief states that rising health care prices have led premiums and deductibles for employer-sponsored coverage to grow faster than wages and general inflation, creating affordability challenges for employers and employees. One proposal to address the high prices paid by private insurers is to cap these prices at a multiple of Medicare rates. This brief considers the potential implications for inpatient admissions and spending of applying a price cap to all private insurance hospital payments in the large employer group market.
IV. Other Health Policy News
- On March 8, 2022, HHS announced that as part of President Biden’s National COVID-19 Preparedness Plan, the Biden-Harris Administration is launching a nationwide Test to Treat Initiative this week so Americans can rapidly access needed COVID-19 treatments. Through this program, people who test positive for COVID-19 will be able to visit hundreds of local pharmacy-based clinics and federally-qualified community health centers (FHQCs), and residents of long-term care facilities will in one stop, be assessed by a qualified health care provider who can prescribe antiviral pills on the spot. The program includes a direct allocation of antiviral pills to participating clinics, centers, and facilities. More information on this initiative can be found here.
- On March 9, 2022, HHS, through SAMHSA and the Office of Minority Health (OMH), announced nearly $35 million in funding opportunities through seven grant programs to strengthen and expand community mental health services and suicide prevention programs for America’s children and young adults. The American Rescue Plan funded $9.2 million. This announcement is part of a new Administration-wide initiative to tackle the nation’s mental health crisis. More information on this announcement can be found here.
- On March 10, 2022, the Senate passed H.R. 2471, the Consolidated Appropriations Act of 2022, also referred to as the Fiscal Year (FY) 2022 Omnibus spending package. The House passed the measure on March 9, 2022. The bill contains the 12 annual appropriations bills and would fund the government for the rest of FY 2022. In particular, the spending package includes approximately $108.3 billion for HHS, a $11.3 billion increase from FY 2021. Within HHS, the spending package appropriates $1.022 trillion to the Centers for Medicare & Medicaid Services (CMS); $8.9 billion to HRSA; $6.4 billion to SAMHSA; $7.6 billion to CDC; $43.6 billion to NIH; $3.3 billion to FDA; and $1 billion to establish the Advanced Research Projects Agency for Health (ARPA-H). The bill also extends a number of COVID-19 Medicare telehealth flexibilities for 151 days after the end of the COVID-19 public health emergency (PHE) and delays several CMS regulatory policies for 151 days after the end of the PHE, among other health care-related provisions. Notably, the final measure that was passed did not include various COVID-19 supplemental appropriations, which were removed from the spending package on March 9, 2022 and introduced as a standalone supplemental bill entitled, R. 7007, the COVID Supplemental Appropriations Act of 2022. The full text of the spending package, H.R. 2471, is available here. Explanatory statements are available here. A full summary of the 12 regular appropriations bills is available here.
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