CMS’ CY 2027 OPPS and PFS Proposed Rules Include Major Changes to Reimbursement for 340B Hospitals, Data Reporting, and Digital Health
In July 2026, the Centers for Medicare & Medicaid Services (CMS or Agency) published two of their annual proposed rules: the CY 2027 Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Proposed Rule (OPPS-ASC Proposed Rule) and the CY 2027 Medicare Physician Fee Schedule Proposed Rule (PFS Proposed Rule). These proposals include several significant policy and payment changes, including substantial reductions in reimbursement for 340B-acquired drugs in the hospital outpatient setting and changes to Medicare reimbursement methodologies for Evaluation and Management (E/M) services and digital health services, including remote patient monitoring services and telehealth, among other items. The Agency also proposes several changes to CPT codes, PFS practice expense inputs, and OPPS Ambulatory Payment Classification (APC) assignments and payment rates for established services. Stakeholders should review relevant proposals, including changes to APC assignments and payment rates in the OPPS Addendum, and consider providing input through comments. Comments on the OPPS-ASC Proposed Rule are due August 31, and comments on the PFS Proposed Rule are due September 14.
Forthcoming HHS Regulatory Actions and Opportunities Relevant for Pharmaceutical Manufacturers for the Rest of this Year and Next
Pharmaceutical manufacturers need to note some key forthcoming regulatory actions and opportunities which the Department of Health and Human Services (“HHS”) has recently published. Meena Datta and Catherine Starks give a bird’s eye view of the key points, the key dates and the stage which each new rule has reached.
HHS-OIG Rejects Calls for New Safe Harbors for Financial Support to Patients Enrolled in Clinical Trials
Earlier this month, the U.S. Department of Health and Human Services Office of the Inspector General (HHS-OIG) declined to establish new safe harbors that would protect arrangements under which clinical trial sponsors provide financial support to participants. Catherine Starks, Deeona Gaskin, Meenakshi Datta, and Taylor Andelman report.
