Medicare Prescription Drug Inflation Rebate Program (section III.E.)
- For the Medicare Part D Inflation Rebate Program:
-CMS proposes that for claims filed on or after January 1, 2026, the agency will exclude units of Part D relatable drugs that received a 340B discount from the total rebate unit calculation.
-CMS proposes the creation of a “340B Repository” to receive voluntary data submissions from 340B covered entities for certain data elements related to Part D 340B claims.
- For the Medicare Part B Inflation Rebate Program, CMS proposes methodologies to:
-Identify the payment amount benchmark quarter if data needed to calculate the payment amount in the payment amount benchmark quarter are not available.
-Calculate the payment amount in the payment amount benchmark quarter if a published payment limit is not available
-Calculate the payment amount in the payment amount benchmark quarter if there is no published payment limit, and neither a positive Average Sale Price (ASP) nor a positive Wholesale Acquisition Cost (WAC) data is available in the ASP Data Collection System.
Average Sales Price: Price concessions and bona fide service fees
- CMS proposes a new definition for “bundled arrangements” to further clarify how bundled sales price concessions should be incorporated into manufacturers’ ASP calculations.
- CMS proposes two changes to Bona Fide Service Fees (BFSFs) payment standards; BFSFs are not considered price concessions under the ASP methodology. CMS is proposing to tighten Fair Market Value (FMV) standards for payments to be considered BFSFs.
-CMS is changing language to clarify that a fee may not be considered a BFSF if it is “passed on to an affiliate, client, or customer of any entity,” and that manufacturers are “responsible for obtaining a certification or warranty from the entity receiving the fee” that it will not be passed on.
Autologous Cell-based Immunotherapy and Gene Therapy Payment
- CMS proposes that preparatory procedures for tissue procurement required for manufacturing an autologous cell-based immunotherapy, or gene therapy, be included in the payment of the product itself rather than separate Medicare payments.
Medicare Diabetes Prevention Program (MDPP)
- CMS proposes a 4-year test period (Jan 1, 2026 – Dec 31, 2029) to allow MDPP suppliers to deliver services via asynchronous online delivery. Reimbursement for these sessions would be facilitated by a new G-code.
- CMS proposes extending PHE-era virtual delivery flexibilities through 2029 (currently set to expire Dec 31, 2027) and supporting both live and asynchronous sessions with a new G-code.
- Other changes:
-CMS proposes letting beneficiaries self-report weight from any reasonable location, not just their primary residence.
-CMS proposes allowing MDPP suppliers to use the weight documented in a beneficiary’s medical record (e.g., from a provider visit) within 2 days of the MDPP session.
Miscellaneous Highlights
• CMS is proposing the Ambulatory Specialty Model (ASM), a mandatory payment model through the Innovation Center which aims to improve prevention and upstream management of chronic disease.
• CMS is proposing to add Group Behavioral Counseling for Obesity (G0473) to the CY 2026 Medicare Telehealth Services List.
CY 2026 Outpatient Prospective Payment System Proposed Rule
Method to Control Unnecessary Increases in the Volume of Outpatient Services Furnished in Excepted Off-Campus Provider-Based Departments (PBDs)
- CMS is proposing to expand site-neutral payment policies (established through the CY 2019 OPPS/ASC final rule through a PFS-equivalent payment rate for drug administration services furnished in excepted off-campus PBDs.
-CMS is proposing to reduce payment for these services across the drug administration APC family.
-CMS is proposing to incorporate an exception to PBDs affiliated with rural Sole Community Hospitals.
Notice of Intent to Conduct Medicare OPPS Drugs Acquisition Cost Survey
- CMS proposes to survey the acquisition costs for each separately payable drug acquired by all hospitals paid under the OPPS, including specified covered outpatient drugs (SCODs), and drugs and biologicals CMS historically treats as SCODs.
-The survey will be open starting at the end of CY 2025 to early CY 2026.
Miscellaneous Highlights
- CMS proposes to phase out the Medicare Inpatient Only List (IPO) over 3 years, beginning with the removal of 285 mostly musculoskeletal procedures for CY 2026.
- CMS proposes to require, beginning January 1, 2026, hospitals disclose the tenth, median, and ninetieth percentile allowed amounts in machine-readable files (MRFs) when payer-specific negotiated charges are based on percentages or algorithms, as well as the count of allowed amounts used to determine these percentiles.
- CMS is soliciting comments from the public on payment policies for software as a service (SaaS) under the OPPS.
By Zack Friend
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