03/20/2026

[Duplicate] CMS-Medicare

Recent Oncology Related Articles

Hospitals: Submit Data for OPPS Drug Acquisition Cost Survey by March 31 

The Outpatient Prospective Payment System (OPPS) Drug Acquisition Cost Survey (ODACS) is live. Hospitals paid under OPPS and listed on this ODACS provider table (PDF) must submit their drug acquisition cost data to CMS by March 31, 2026, at 11:59 pm ET.

To complete the survey, you must:

• Follow the steps in the Registration User Guide (PDF) to register for the online system
• Upload your drug acquisition cost data using this template (ZIP)
• Follow the steps in the Submitter User Guide (PDF) to complete the online attestation form
• Submit your data by March 31

More Information:

• Visit the ODACS webpage for official guidance on the survey
• Read FAQs (PDF)
• Contact OPPSDrugSurvey@cms.hhs.gov with questions

Hospital Price Transparency: Enforcement of 2026 Requirements Starts April 1 

Enforcement of new and updated Hospital Price Transparency (HPT) requirements finalized in the CY 2026 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System final rule starts April 1, 2026. Make sure your hospital’s machine-readable file conforms to these requirements. See the updated HPT (PDF) fact sheet to learn more. 

CMS has resources to help hospitals understand and comply with the new requirements:

• CY 2026 OPPS and ASC Final Rule – HPT Policy Changes fact sheet
• HPT: Reviewing the CY 2026 OPPS and ASC Payment System Final Rule (PDF) webinar slides
• HPT FAQs (PDF)

CMS to Lower Drug Costs & Improve Care by Extending Deadline for GENEROUS Model Application 

CMS extended the application deadline for prescription drug manufacturers to apply to the GENErating cost Reductions fOr U.S. Medicaid (GENEROUS) Model—a landmark Innovation Center initiative designed to lower drug spending in Medicaid, improve quality of care and health outcomes by increasing access to critical medications, and strengthen the Medicaid program overall. The extension from March 31 to April 30, 2026, will provide interested drug manufacturers more opportunity to join the model. 

More Information:

• Full press release
• GENEROUS Model webpage
• Request for Applications for drug manufacturers (PDF)

Clinical Diagnostic Laboratories: Get Ready to Report Starting May 1 

Are you an independent laboratory, physician office laboratory, or hospital outreach laboratory that meets the definition of an applicable laboratory under the Clinical Laboratory Fee Schedule (CLFS)? If so, you must report data from May 1 – July 31, 2026, based on an updated data collection period of January 1 – June 30, 2025, including:

• Applicable HCPCS codes (ZIP)
• Associated private payor rates 
• Volume data 

For more information, visit the CLFS Reporting webpage.

HCPCS Application Summaries & Coding Determinations: Non-Drug and Non-Biological Items & Services

CMS published the second biannual 2025 HCPCS Level II coding, Medicare benefit category, and Medicare payment determinations for non-drug and non-biological items and services. Visit the HCPCS Level II Coding Decisions webpage for more information.

Medicare Coverage Determination Process

The National Coverage Determination (NCD) Dashboard has been updated to reflect current lists of open NCDs, finalized NCDs, pending Transitional Coverage for Emerging Technologies (TCET) topics, and accepted NCD requests. https://www.cms.gov/files/document/ncddashboard.pdf

Trump Administration Prioritizes Affordability by Announcing Major Crackdown on Health Care Fraud

On February 25, at the White House, Vice President J.D. Vance, HHS Secretary Robert F. Kennedy, Jr., and CMS Administrator Dr. Mehmet Oz announced new steps to crack down on fraud in Medicare and Medicaid to protect patients and taxpayers and improve affordability. The actions include deferring $259.5M of quarterly federal Medicaid funding in Minnesota to prevent payment of questionable claims while further investigation is completed; a nationwide moratorium on Medicare enrollment for certain DMEPOS suppliers; and a nationwide call to action for Americans to support fraud prevention, including stakeholder input on how CMS can continue to expand and strengthen its efforts. Together, these steps reflect a coordinated, data-driven strategy to prevent fraud before it occurs, hold bad actors accountable, and protect taxpayer dollars. 

More Information:

• Full press release
• Nationwide Temporary Moratoria on Enrollment of DMEPOS Supplier Medical Supply Companies notice
• Request for Information: Comprehensive Regulations to Uncover Suspicious Healthcare proposed rule: Submit comments by March 20

Crushing Fraud, Waste, & Abuse webpage

CMS Announces Manufacturer Participation in Third Cycle of Medicare Drug Price Negotiation

Under the Medicare Drug Price Negotiation Program (“Negotiation Program”), the Centers for Medicare & Medicaid Services (CMS) directly negotiates the prices of certain high expenditure, single source drugs without generic or biosimilar competition. Today, the Centers for Medicare & Medicaid Services (CMS) announced that the drug companies that manufacture the 15 drugs payable under Medicare Part B and/or covered under Medicare Part D selected for the third cycle of negotiations in the Negotiation Program have chosen to participate in the Negotiation Program.

The below list indicates the drug companies that manufacture all 15 drugs selected for the third cycle of the Negotiation Program that have chosen to participate in the Negotiation Program. Also, in the below list is the drug company that manufactures the one drug selected for renegotiation that is participating in the Negotiation Program.

1. This drug was selected for renegotiation for the third cycle of negotiations in the Negotiation Program.

 Key Milestones to Date

• On May 12, 2025, CMS issued draft guidance for the third cycle of negotiations, including requests for public comment.
• On September 30, 2025, CMS issued final guidance detailing the requirements and parameters of the Negotiation Program for the third cycle of negotiations, which will occur during 2026. Any negotiated prices will be effective beginning in 2028.
• On January 27, 2026, CMS announced the 15 drugs payable under Medicare Part B and/or covered under Medicare Part D selected for the third cycle of negotiations. Also, on January 27, 2026, CMS announced the one drug selected for renegotiation. For a list of these drugs, please click here. For a list of the top 50 negotiation-eligible drugs for initial price applicability year 2028, please click here.
• On February 28, 2026, drug companies that manufacture the drugs selected for the third cycle of the Negotiation Program had a statutory deadline to choose to sign agreements to participate in the Negotiation Program.
• Participating drug companies with a selected drug for the Negotiation Program and the public had an opportunity to submit data and information on the selected drugs and their therapeutic alternative(s) to CMS no later than March 1, 2026.
• On March 13, 2026, CMS announced the drug companies that manufacture the 15 drugs selected for the Negotiation Program that have chosen to participate in the third cycle of the Negotiation program, along with the drug company that manufactures the one drug selected for renegotiation.

CMS’ process for the third round of negotiations engages drug companies and the public throughout. Some of the next steps in the process include the following:

• Invite each participating drug company with a selected drug to engage in a meeting on its data submission.
• Host 16 patient-focused roundtable events (one dedicated to each selected drug) that will be open to patients, patient advocacy organizations, and caregivers. These events are intended to collect patient-focused input on topics such as patient experience, therapeutic alternative(s) to the selected drugs, the extent to which the selected drugs address unmet medical needs, and the impact of selected drugs on specific populations. For additional information, please click here.
• Host town hall meetings for all selected drugs, focused on the clinical considerations related to the selected drugs. CMS encourages practicing clinicians and researchers, as well as other interested parties, to participate. For additional information, please click here.
• Send an initial offer for each selected drug for which the drug company is participating in the Negotiation Program with CMS’ proposal for the maximum fair price and concise justification no later than June 1, 2026. The drug company will have 30 days to respond to the initial offer by accepting the offer or providing a counteroffer, if desired. In developing an initial offer, CMS will consider evidence related to the selected drugs and their therapeutic alternatives as well as other factors, such as research and development costs and unit costs of production and distribution of the selected drug. CMS will invite the drug company to a negotiation meeting to take place during the 30-day period after CMS sends the initial offer and before the response from the drug company is due to begin negotiation discussions.
• If agreement on a maximum fair price is not reached through the initial offer or counteroffer, CMS will invite each participating drug company for up to two additional negotiation meetings during Summer and Fall 2026 before the negotiation period ends on November 1, 2026.

For more information on the Medicare Drug Price Negotiation Program, including the final guidance and the negotiation process, please click here.