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 practitioners (“NPPs”) to meet the presence and “immediate availability” requirement via real-time, two-way audio and
Health Industry Washington Watch
Updates by Reed Smith on U.S. legislative & regulatory developments affecting the health care industry
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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 core, SB 41 prohibits spread-pricing and rebate-retention models in favor of fee-for-service and pass-through costs,…
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 3 through November 7, 2025.
This week-long event will feature a series of timely and…
New California Law Expanding Health Care Transaction Oversight Impacts Private Equity and MSOs
By Paul W. Pitts & Smita Patil
Governor Newsom signed California Assembly Bill 1415 (AB 1415) into law, which significantly expands the state’s health care transaction oversight and strengthens the authority of the Office of Health Care Affordability (OHCA) to monitor, review, and publicly report on deals impacting cost, competition, quality, and equity. This law takes effect on January 1, 2026.
The…
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 control over clinical decision-making, voids certain contractual provisions, and empowers the California Attorney General with…
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 will shut down with many federal workers being forced out on furlough and many federal…
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 generate remuneration that would be prohibited under the Federal Anti-Kickback Statute (AKS) if the requisite…
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 the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC).…
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 delay on the electronic release of test results related to positive or suspected malignancy and…
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 B (the section that covers physician office visits and services ancillary to those visits).
The…