The U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued Advisory Opinion No. 25-09 on August 12, 2025. The favorable opinion that found that a medical device manufacturer that was partly physician-owned qualified for the small
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 - Page 2
CMS Announces Health Tech Ecosystem Initiative
The Centers for Medicare & Medicaid Services (“CMS”) has announced a Health Tech Ecosystem initiative, developed in response to a May 2025 request for information (“RFI”) to solicit suggestions from stakeholders on ways to modernize the nation’s digital health ecosystem.…
CMS makes changes to Medicare Part D bid parameters for 2026
By Taber Rueter
The Centers for Medicare & Medicaid Services (“CMS”) announced preliminary Medicare Part D bid parameters for year 2026 to help plan sponsors finalize plan offerings and prepare for Medicare open enrollment in 2026.
Notably, the announcement includes various updates to…
Sixth Circuit Likely Next to Consider FCA’s Constitutionality Under Article II
On July 28, 2025, the U.S. District Court for the Southern District of Ohio certified for interlocutory appeal to the U.S. Court of Appeals for the Sixth Circuit the question of whether the False Claims Act’s qui tam provisions violate…
New California Medical Debt Disclosure Law Now in Effect—What Providers Need to Know Now
CMS Launches WISeR Model to Target Waste by Leveraging (Broken) Prior Authorization System
The Centers for Medicare & Medicaid Services (CMS) recently announced the launch of the Wasteful and Inappropriate Service Reduction (WISeR) Model – a six-year pilot program designed to reduce Medicare spending on select “wasteful (low-value) services shown to have little…
OIG Approves Free Companion Diagnostic Testing Program for Enzyme Inhibitor Drug
The Department of Health and Human Services, Office of Inspector General (OIG) recently issued a favorable advisory opinion (Advisory Opinion 25-07) regarding a pharmaceutical manufacturer’s program to sponsor free companion diagnostic testing for certain oncology patients.
Though the…
More in-depth analysis from Reed Smith on new Oregon Corporate Practice of Medicine law
On June 9, 2025, Oregon Governor Tina Kotek signed Senate Bill 951 into law, establishing some of the strictest corporate practice of medicine prohibitions in the country. The new law directly targets management services organizations (MSOs) and the ways in…
Recent Legislative and Regulatory Updates for Long-Term Care Facilities
Recent guidance from the Centers for Medicare & Medicaid Services (CMS), along with the passage of the 2025 Reconciliation Law (colloquially known as the “One Big Beautiful Bill Act” or OBBA), have led to several significant developments for nursing homes…
CMS Proposes Permanent Virtual Direct Supervision of Diagnostic Tests
On July 14, 2025, the Centers for Medicare & Medicaid Services (“CMS”) issued the proposed Medicare Physician Fee Schedule Rule for Calendar Year (“CY”) 2026. Building on the temporary flexibility first introduced during the COVID-19 public health emergency and…