UK Looks To Modernize Medicines And Medical Device Regulation In The Era Of AI
A landmark program designed to deepen the regulatory partnership between the UK and the U.S., a regulatory ‘sandbox’ for AI as a medical device, evidence-gathering on AI regulation in healthcare, a consultation on a draft Rare Disease Therapies Regulatory Framework and the launch of the largest package of UK clinical trial reforms in over 20 years – Sidley’s Dr. Chris Boyle and Zina Chatzidimitriadou bring you up to date with developments at the UK Medicines and Healthcare products Regulatory Agency (MHRA) in the first half of 2026.
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.
