On October 31, 2025, the Centers for Medicare & Medicaid Services (“CMS”) issued the Calendar Year 2026 Medicare Physician Fee Schedule (“PFS”) Final Rule, permanently adopting a revised definition of “direct supervision ” that allows supervising physicians or non-physician
Health Industry Washington Watch
Updates by Reed Smith on U.S. legislative & regulatory developments affecting the health care industry
Health Industry Washington Watch, published by Reed Smith LLP, focuses on legal and regulatory developments affecting the healthcare and life sciences sectors. The blog covers topics such as Medicare and Medicaid policy changes, pharmacy benefit management reforms, healthcare provider compliance, life sciences transactional and litigation issues, product liability directives, and emerging trends in healthcare fraud and abuse enforcement. It also addresses the impact of new laws on healthcare ownership and investment, telehealth supervision rules, and evolving legal challenges in areas like vaccine liability and women’s health. The content is aimed at healthcare providers, payers, manufacturers, and legal professionals navigating complex healthcare regulations and industry shifts.
Latest from Health Industry Washington Watch
A Pharmacy Benefit Overhaul In California
By Paul W. Pitts & Robert Hill
Governor Newsom signed into law Senate Bill 41 materially reshaping the regulation of pharmacy benefit management, reimbursement, contracting, and patient cost sharing in California, with significant implications for pharmacy benefit managers (PBMs), payers, pharmacies, manufacturers, and plan participants. At its…
Reed Smith to host Virtual Life Sciences CLE Week Nov. 3 through Nov. 7
For anyone working in the health and life sciences industries and looking to complete a few final CLE hours before the end of 2025, Reed Smith will be hosting its annual Virtual Life Sciences CLE Week, taking place from November…
California’s New Restrictions on Private Equity in Health Care: What Health Providers and Investors Need to Know
By Paul W. Pitts & Smita Patil
On October 6, 2025, Governor Newsom signed into law Senate Bill 351 (SB 351), introducing new restrictions on private equity and hedge fund involvement in physician and dental practices across California. Effective January 1, 2026, this law directly targets non-clinical…
What could a Government Shutdown mean for the Health Care Industry?
September 30 is the end of Fiscal Year 2025 for the federal government. If the Congress does not pass a continuing resolution or the remaining budget bills for fiscal year 2026 by that date, then parts of the federal government…
OIG Issues Favorable Opinion on Donations to Foundation to Support Therapy Services
The Department of Health and Human Services Office of Inspector General (OIG) has released a favorable advisory opinion on an arrangement involving donations from a children’s therapy provider to an independent grant foundation.
According to OIG, although the arrangement would…
HHS Announces Crackdown on Health Data Blocking
In the first week of September, the U.S. Department of Health and Human Services (HHS) announced a renewed enforcement focus on information blocking through a press release and joint enforcement alert issued by the Office of Inspector General (OIG) and…
Texas Senate Bill No. 922 – 72-Hour Hold on Electronic Release of Sensitive Test Results
Texas has enacted a groundbreaking new law – Texas Senate Bill No. 922 (“S.B. 922”) that changes the way certain sensitive medical test results are shared with patients. The law, which took effect on September 1, 2025, requires a 72-hour…
CMS Proposes Changes to Average Sales Price Calculations for Part B Drug Reimbursement
In its 2026 Medicare Physician Fee Schedule proposed rule, the Centers for Medicare & Medicaid Services (CMS) has proposed additional guidance for how manufacturers will calculate their average sales prices (ASP) for drugs that are payable under Medicare Part…
HHS issues No Surprises Act FAQs in response to Fifth Circuit vacating prior panel opinion
By Megan K. Ali
The U.S. Department of Health and Human Services (“HHS”), along with several other agencies (the Departments of Labor and Treasury, as well as the Office of Personnel Management), issued an updated “Frequently Asked Question” document on July 30, 2025 (FAQ…