On December 29, 2022, President Biden signed into law the Consolidated Appropriations Act, 2023, which includes the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). MoCRA significantly changes the current regulatory framework for cosmetics in place since the enactment of
Health Care Law Today
Blog Authors
Latest from Health Care Law Today
Physician Recapitalization Transactions: Three Common Business and Legal Issues
With the pace of health care transactions showing no signs of slowing, we, at Foley, regularly counsel both investors and sellers of physician practices.
The typical physician practice transaction involves the sale of all the nonclinical assets of the practice…
Medicare Advantage Plans: The Investor’s View for Building Tech Enabled Home Health Models That Deliver Value
A panel of top investors comprised of Nancy Brown, Managing Director at Oak HC/FT, Dan Gebremehdin, Managing Director at Flare Capital, and Laura Veroneau, Managing Director at Optum Ventures, convened in a webcast on January 17, 2023 sponsored by HomeCare100…
DEA Chopping Block: DATA-Waiver Requirement
On January 12, 2023, the Drug Enforcement Administration (DEA) confirmed in a letter to registrants that the Consolidated Appropriations Act of 2023 (P.L. 117-328) (the Act), which was signed into law on December 29, 2022, eliminated the “DATA-Waiver Program”. The removal…
Migraine Company Fails to Avoid Own Headache: Jet Medical and Others to Pay $745,000 to Resolve Allegations that Medical Device was not Approved or Cleared before Commercialization
On January 4, 2023, the Department of Justice issued a press release stating that Jet Medical Inc. has agreed to pay $200,000 to resolve criminal allegations relating to a migraine headache treatment. Jet Medical and two related companies also agreed…
Court Calls Underlying Legal Standards “No Model of Clarity” but Allows False Claims Act Case To Proceed Anyway
By Kara Sweet & Lori A. Rubin
Does violating requirements amount to fraud under the False Claims Act (FCA) when the requirements allegedly violated are unclear? There is currently a circuit split and petitions for review pending to the Supreme Court as to when the purported violation…
2023 Forecast for Digital Health Startups and Telemedicine Law
With 2022 closed, there is growing anticipation (trepidation?) about what is in store for digital health in the new year. Will venture funding trickle or will 2023 see more liquidity in the markets? What legal and policy changes can we…
FTC Proposes Sweeping Federal Ban on Employee Noncompetes
On January 5, 2023, the Federal Trade Commission (FTC) announced a proposed regulation that, if adopted, would essentially abolish employee noncompetes across the United States. A proposed FTC regulation on employee noncompetes has been anticipated since July 2021, when President…
“Acute Hospital Care at Home”: Omnibus Bill Extends Flexibility Period to December 31, 2024
As part of the $1.7 million omnibus spending bill that became law December 29, 2022, the Centers for Medicare & Medicaid Services (CMS) extended, through December 31, 2024, the Acute Hospital Care at Home (H@H) initiative whereby individual hospitals may…
Accredited Health Care Providers Rejoice: The Joint Commission is Eliminating 14% of its Standards Across Accreditation Programs
On Wednesday, December 21, 2022, The Joint Commission announced that, effective January 1, 2023, it is eliminating 168 (or 14%) of its accreditation standards across its accreditation programs, and revising 14 more. The Joint Commission accredits many different categories of…