CMS Proposes Key Medicare Part B Pricing and Reporting Updates for 2026
The Centers for Medicare & Medicaid Services (CMS) has released its proposed rules for the 2026 Medicare Part B program, highlighted within the Physician Fee Schedule (PFS) and the Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) proposed rules. This year, these proposals include significant updates affecting the government pricing (GP) community, covering areas such as the average sales price (ASP) calculation, implementation of the Inflation Reduction Act's maximum fair price (MFP) requirement, and revisions to the bona fide service fee (BFSF) definition. The rules also address bundled sale arrangements, new ASP documentation and submission obligations, Medicare inflation rebates, and considerations related to the 340B drug pricing program.
CMS is clarifying how MFP units are incorporated into ASP calculations, particularly for selected drugs under the Drug Price Negotiation Program. In response to concerns from a 2022 Department of Health and Human Services Office of Inspector General (OIG) report, CMS proposes changes to how ASP is calculated, including updated BFSF standards and enhanced manufacturer documentation requirements. Notably, manufacturers will now be required to submit their reasonable assumptions for ASP quarterly, a shift from previous voluntary practices.
The proposed mandates for documentation expand to include two new categories under the ASP submission process, aiming to increase transparency and regulatory compliance. These changes have potential repercussions for manufacturers and providers within Medicare Part B, influencing reimbursement calculations and compliance obligations. Additionally, CMS introduces new policies for Medicare Part B and Part D inflation rebate programs, further impacting pricing and rebate dynamics within government healthcare programs.
Stakeholders in the Medicare payment ecosystem are encouraged to thoroughly review both the PFS and OPPS/ASC proposed rules, as these documents are extensive but contain critical updates for government price reporting and drug pricing policies. Comments on these proposed changes are due mid-September 2025, providing an opportunity for industry feedback ahead of final rule issuance.
These regulatory updates reflect CMS's ongoing effort to refine payment accuracy and compliance frameworks within Medicare, particularly concerning drug pricing and related services. Insurance professionals and healthcare payer organizations should evaluate the potential impacts on their operations and prepare for adjusted reporting and documentation requirements. The proposal also underscores the federal commitment to implementing reforms stemming from recent legislation such as the Inflation Reduction Act, which aims to control drug costs within public programs.