Medicaid Enrollment & CMS 2025 Payment Rules: Healthcare Update

On Apr 1, 2024

TL/DR –

The Centers for Medicare & Medicaid Services (CMS) has proposed its fiscal year 2025 payment rules for inpatient psychiatric facilities, skilled nursing facilities, and hospice providers, streamlining Medicaid enrollment and limiting short-term insurance. The Food and Drug Administration (FDA) is withdrawing approval for AstraZeneca’s new drug application for LYNPARZA (olaparib) capsules, and has approved the ISUPREL (isoproterenol hydrochloride) injection, allowing for new drug applications. The FDA is also proposing a ban on electrical stimulation devices intended for self-injurious or aggressive behavior due to their unreasonable risk.

Health Care Weekly Review

Our Health Care Week in Review furnishes a round-up of recent developments in health care regulations, federal legislation, congressional committee initiatives, reports, studies, and health policy news.

Highlight of the Week:

This week, CMS has proposed FY 2025 payment regulations for inpatient psychiatric facilities, skilled nursing facilities, and hospice providers. They have also finalized regulations to streamline Medicaid enrollment and limit short-term, limited-duration insurance.

I. Regulations, Notices, & Guidance

The FDA released a notice on March 25, 2024, withdrawing approval for AstraZeneca Pharmaceuticals’ New Drug Application for LYNPARZA (Olaparib) Capsules.
On the same day, the FDA issued a notice regarding ISUPREL (Isoproterenol Hydrochloride) Injection, confirming it was not withdrawn from sale due to safety or effectiveness concerns.
The FDA also proposed a rule to ban Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior.
The FDA released a notice on March 26, 2024, regarding the Handling and Retention of Bioavailability and Bioequivalence Testing Samples.
On March 27, 2024, CMS finalized a rule to Streamline the Medicaid, Children’s Health Insurance Program, and Basic Health Program Application, Eligibility Determination, Enrollment, and Renewal Processes.
On the same day, CMS proposed a rule to update the Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2025.
On March 28, 2024, HHS issued a final rule that amends the definition of Short-term, Limited-Duration Insurance and Independent, Noncoordinated Excepted Benefits Coverage.

Event Notices

From April 2-4, 2024, the Advisory Committee on Infant and Maternal Health will hold a hybrid meeting, announced by HRSA.
On April 4-5, 2024, NIH will hold a hybrid meeting of the Sleep Disorders Research Advisory Board, announced by NIH.

II. Reports, Studies, & Analyses

The GAO released a report on March 25, 2024, titled Clinical Research: FDA Should Evaluate Its Efforts to Recruit and Retain Its Inspection Workforce.
The GAO
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