Beacon Alert 2025-047 Weekly Regulatory Updates
The Centers for Medicare & Medicaid Services (CMS) delivered several important updates this week, impacting Medicare Advantage Organizations (MAOs), Medicare-Medicaid Plans (MMPs), PACE providers, and Part D sponsors. Below is a summary of the key regulatory developments, deadlines, and operational impacts to keep your compliance and policy teams up to date.
Extension of Oral Antiviral Drug Coverage Under Part D
Effective Through January 30, 2026
CMS confirmed that COVID-19 oral antivirals with Emergency Use Authorization (EUA) will continue to be treated as Medicare Part D drugs until January 30, 2026, under the Continuing Appropriations Act, 2026. This extension is retroactive to October 1, 2025, and affects all relevant claims—even those processed before the law passed.
Action Required: Part D plans must continue treating these drugs like any other Part D medication and follow existing guidance from CMS, including memos issued in late 2024 (e.g., molnupiravir guidance) .
Medicare Advantage Q3 Encounter Data Report Cards Released
CMS has released the Q3 2025 Encounter Data Report Cards to assist MA plans in identifying data submission issues that may impact risk adjustment and payment integrity.
You can locate these reports in HPMS → Risk Adjustment → Encounter Data → Report → November 2025 Update.
Action Required: Plans with data quality concerns should contact CMS at RiskAdjustmentOperations@cms.hhs.gov with the subject line “Report Card Q3 2025 Update” .
MMP Reporting Expectations for 2025 Quality Withholds
CMS revised the Core and State-Specific Measure Reporting Expectations for Medicare-Medicaid Plans. MMPs must report:
Only the core and state-specific measures used in CY 2025 quality withhold calculations
Both standard and alternative measures per the state’s capitated model demonstration
No changes to technical specifications or value sets
Other reporting such as HEDIS® and CAHPS® remains unchanged
Contact: mmcocapsreporting@cms.hhs.gov
CMS Finalizes 2026 Program Audit Protocols
Key Changes Starting in 2026:
Audit scoring removed
New classification categories: Observation, CAR (Corrective Action Required), IDS (Invalid/Incomplete Data Submission)
Simplified CPE (Compliance Program Effectiveness) evaluations
Quarterly compliance calls will begin
Independent auditors required if more than 5 findings need validation
CMS will continue using the 2024 Final Audit Protocols but is shifting to streamlined enforcement categories and offering new support tools including webinars and checklists .
PACE: 2024 Final Part D Payment Reconciliation Reopened
CMS is reopening the 2024 final reconciliation only for PACE organizations, due to a payment error affecting Dual-Eligible cost allocations.
What’s New:
No action is required by PACE organizations
Updated reports available Dec 3, 2025, in CSSC mailboxes
Payment adjustments will be reflected in the Jan 2026 payment cycle
Appeals Deadline: December 18, 2025
Contact: PartDPaymentSupport@acumenllc.com
December 2025 Manufacturer Discount Program File Released
CMS released the December 2025 Medicare Part D Manufacturer Discount Program Files, including:
A Labeler Code File: Lists brand-name drugs covered under signed discount agreements
A Phase-In Eligible NDC-9 List: Covers drugs marketed before August 16, 2022, with eligibility details for phase-in from 2025–2031
Note: Inclusion on the list doesn’t guarantee coverage under Medicare Part D—it only indicates eligibility for phase-in pricing where applicable .
Medicaid.gov OMB Submission Updates
Numerous OMB Review submissions related to Medicare and Medicaid program data collection were posted between November 18–22, 2025. These include proposals and renewals that may affect provider reporting or compliance.
For details, visit: federalregister.gov/documents/and search for the document numbers listed in the update (e.g., 2025-20787, 2025-20486, etc.) .
Final Thoughts
These updates reflect CMS’s ongoing efforts to refine compliance structures, improve data accuracy, and adapt program rules to current public health realities. Organizations should work closely with compliance officers and legal counsel to review the implications of each update and adjust their operations accordingly.
To stay ahead of CMS policy changes, subscribe to weekly regulatory briefings or integrate updates directly into your compliance workflow using platforms like Beacon Compliance Manager.
