Thursday, May 15, 2025
News
- CMS Releases Draft Guidance for the Third Cycle of Medicare Drug Price Negotiation Program to Lower Drug Prices for American Patients
- Opioid Treatment Programs: CY 2025 Updates
- Laboratories: Switch to Electronic Fee Coupons & CLIA Certificates
- National Mental Health Awareness Month
Compliance
Events
MLN Matters® Articles
News
CMS Releases Draft Guidance for the Third Cycle of Medicare Drug Price Negotiation Program to Lower Drug Prices for American Patients
CMS issued draft guidance for public comment on the third cycle of negotiations under the Medicare Drug Price Negotiation Program (Negotiation Program). The draft guidance includes policies that will:
- Improve the transparency of the Negotiation Program
- Prioritize the selection of prescription drugs with high costs to the Medicare Program
- Minimize any negative impacts of the negotiated maximum fair price on pharmaceutical innovation within the U.S.
Comments received by 11:59 pm PT, June 26, 2025, will be considered during the development of final guidance.
More information:
Opioid Treatment Programs: CY 2025 Updates
Learn about updates to the Opioid Treatment Program from the CY 2025 Physician Fee Schedule final rule:
- Medicare Benefit Policy Manual, Chapter 17 (PDF); see the instruction to your Medicare Administrative Contractor (MAC) (PDF)
Medicare Claims Processing Manual, Chapter 39 (PDF); see the instruction to your MAC (PDF)
Laboratories: Switch to Electronic Fee Coupons & CLIA Certificates
CMS is improving the Clinical Laboratory Improvement Amendments (CLIA) program by switching to electronic fee coupons and CLIA certificates. To continue getting these, eligible laboratories and providers that perform laboratory testing must switch to electronic email notifications by March 1, 2026; we’ll stop mailing paper versions after this date.
There are 2 ways to switch:
- Email your state agency (PDF)
- Fill out the CLIA Application for Certification (PDF) (form CMS-116), and check the box next to “Receive notifications including electronic certificates via email” in section I
Note: This doesn’t apply to CLIA-exempt states.
National Mental Health Awareness Month
During National Mental Health Awareness Month, we recognize the millions of Americans affected by mental health challenges. Mental illnesses can affect anyone, regardless of their background or circumstances (see Presidential Proclamation). Recommend appropriate Medicare Preventive Services.
Medicare covers preventive services, and your patients pay nothing if you accept assignment. Find out when your patient is eligible for these services. If you need help, contact your eligibility service provider.
More Information:
- Medicare & Mental Health Coverage booklet
- Behavioral Health Integration Services (PDF) booklet
- Preventive & screening services information for your patients
Compliance
Remote Patient Monitoring: Use & Bill Correctly
In a report, the Office of the Inspector General recommended additional oversight of remote patient monitoring in Medicare. About 43% of enrollees who received remote patient monitoring didn’t receive all 3 components, raising questions about whether it’s being used as intended.
Learn how to correctly use and bill for remote patient monitoring:
Events
Improving Technology to Empower Medicare Beneficiaries RFI Q&A Call
Your Input Matters
Register now for our upcoming Q&A Session
Date: Tuesday, May 20, 2025
Time: 1 pm ET
Location: Virtual via Zoom (link will be provided following registration)
Who Should Attend:
Technology developers, patients, caregivers, providers, payers, and other healthcare stakeholders.
Event Description:
We want YOUR ideas. Help create modern digital technologies to empower seniors to manage their health journey. Please join CMS for a Q&A session on the recent Request for Information (RFI) on Improving Technology to Empower Medicare Beneficiaries. The session will also review how to submit responses to the RFI.
The CMS Office of the Administrator team will be present to hear your valuable input as we shape the future for Medicare beneficiaries. Our panel includes:
- Stephanie Carlton, Chief of Staff and Deputy Administrator
- Amy Gleason, Strategic Advisor to HHS/CMS & Acting Administrator, U.S. DOGE Service
- Arda Kara, Senior Advisor for Technology
- Alberto Colon Viera, Senior Advisor for Technology
Why Attend:
Your insights will directly contribute to improving technology solutions for Medicare beneficiaries. This is your opportunity to help shape the future of Medicare.
Registration:
https://cms.zoomgov.com/webinar/register/WN_oNg1_jxNRaulMBeMxD6Ibw
Note: Space is limited. Please register early to secure your spot. Official comment should be made in the Federal Register by June 16 https://public-inspection.federalregister.gov/2025-08701.pdf
MLN Matters® Articles
New Waived Tests
Learn about these updates (PDF):
- Clinical Laboratory Improvement Amendments requirements
- New FDA-approved waived tests
Codes, effective dates, and descriptions
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