Regulatory

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.
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…
President Biden October 30 issued an Executive Order (EO) on the use of artificial intelligence (AI) that attempts to strike a balance between managing the risks and encouraging innovation.
The Centers for Medicare & Medicaid Services (CMS) Nov. 15 issued a final rule requiring the disclosure of ownership, managerial and other information for skilled-nursing facilities (SNFs) and nursing facilities (NFs).
The AHA strongly urges the FDA to work with Congress to enact an updated version of the Verifying Accurate Leading-Edge IVCT Development (VALID) Act. This legislation would establish a diagnostic-specific, risk-based framework that recognizes the essential role of clinical laboratories in…
Waivers allowed practitioners to render telehealth services from their home without having to report their home address on Medicare enrollment or claims forms. Beginning Jan. 1, 2024, these providers will be required to report their home address on enrollment and claims forms.
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…
FDA last month approved a new long-acting monoclonal antibody to prevent RSV in this age group.
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.