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With Congressional Action Limited, Administration Releases Flurry of Health Care Regulations

During the last two weeks we have seen a flurry of regulatory activity affecting hospitals and health care providers, and we expect that trend to continue for the next several months.

CMS proposes changes to requirements for accrediting organizations

The Centers for Medicare & Medicaid Services Feb. 8 released a proposed rule intended to strengthen oversight of organizations that accredit health care providers certified by the Medicare and Medicaid programs and prevent conflicts of interest.

OCR issues FAQs on patient visitation rights

The Department of Health and Human Services’ Office for Civil Rights Jan. 25 released guidance reminding hospitals, critical access hospitals and long-term care facilities of their obligation under Centers for Medicare & Medicaid Services regulations to ensure that their visitation policies do not unlawfully discriminate based on religion or other protected bases under federal civil rights laws, including during a public health emergency.

CMS releases rule implementing new Medicaid renewal enforcement authorities

The Centers for Medicare & Medicaid Services Dec. 4 released an interim final rule implementing new enforcement authorities the agency will use if states fail to comply with new reporting requirements as they restore Medicaid eligibility and enrollment operations following the end of the Medicaid continuous enrollment condition.

FDA proposes enforcing requirements for laboratory developed tests

The Food and Drug Administration Sept. 29 released a proposed rule that would phase out over four years its general enforcement discretion approach for most laboratory developed tests, citing concern that some of the tests may not provide accurate results or perform as well as FDA-approved in vitro diagnostic products.

CDC recommends immunizing all infants under 8 months old against RSV

FDA last month approved a new long-acting monoclonal antibody to prevent RSV in this age group.

AHA urges appeals court to examine due process claims in FTC merger case

The 5th Circuit Court of Appeals should reverse the Federal Trade Commission’s decision in Illumina Inc. v. FTC, “a paradigmatic example” of how the agency’s practices violate the Constitution’s due process clause, AHA said in a friend-of-the-court brief filed in the case. 

FDA approves first RSV vaccine, for adults 60 and older

The Food and Drug Administration on May 3 approved the first U.S. vaccine for respiratory syncytial virus, Arexvy by GlaxoSmithKline Biologicals, for use in individuals aged 60 and older.

Supreme Court: FTC cannot preclude court review of unconstitutional actions

As urged by the AHA, the U.S. Supreme Court today unanimously reversed a 9th Circuit decision that impliedly stripped federal district courts of jurisdiction over constitutional challenges to the Federal Trade Commission structure, procedures and existence.

White House releases additional details for 2024 budget request; see AHA summary

The White House today released additional details related to President Biden’s budget request for fiscal year 2024. The main budget documents were released March 9 — today’s request provides more granular detail and historical information.