The Centers for Medicare & Medicaid Services (CMS) has published its final rule that requires nursing homes enrolled in Medicare and Medicaid to disclose additional ownership and management information to CMS and state Medicaid agencies. The rule finalizes CMS’s proposed
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 10
No Criminal Charges for Cooperative Medicare Advantage Organization
On October 26, 2023, the Department of Justice (“DOJ”) announced that a Miami federal grand jury returned an indictment charging a Medicare Advantage Organization’s (“MAO”) former director of Medicare risk adjustment analytics with six counts of criminal fraud. DOJ alleged…
California labor code development: Covered health care employees to receive increase in minimum wage
New minimum wage requirements have been signed into law by Governor Gavin Newsom, establishing five comprehensive minimum wage schedules for “covered health care employees,” which includes both contracted and subcontracted employees. Effective June 1, 2024, “covered health care facilities” will…
HHS OIG Issues General Guidance as First Step in Effort to Modernize Compliance Guidance
As promised back in April in an announcement of its plans to modernize compliance program guidance, the Department of Health and Human Services Office of Inspector General (OIG) issued the first of its new guidance documents for the health care…
OIG Issues Unfavorable Advisory Opinion Concerning Pathology Lab’s Proposed Purchased Services Arrangements
On September 28, 2023, the Office of Inspector General of the Department of Health and Human Services (OIG) issued Advisory Opinion 23-06, involving a proposed services arrangement between a pathology laboratory (the Requestor) and third-party referring pathology laboratories.
The…
OIG Permits Multi-Specialty Practice to Pay Doctors Bonuses for Outpatient Procedures
In an advisory opinion released on October 13, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) approved a plan by a muti-specialty practice to pay its employed physicians bonuses related to outpatient procedures performed by…
The Latest Episode of the LDT Drama: FDA Issues Long-Awaited Proposed Rule for Laboratory Developed Tests
On October 31, FDA will be offering a webinar on its proposed rule ”Medical Devices; Laboratory Developed Tests.”
This webinar comes about a month after FDA issued a proposed rule revising 21 C.F.R. Part 809 (specifically, 21 C.F.R, § 809.3…
The Latest Episode of the LDT Drama: FDA Issues Long-Awaited Proposed Rule for Laboratory Developed Tests
On October 31, FDA will be offering a webinar on its proposed rule ”Medical Devices; Laboratory Developed Tests.”
This webinar comes about a month after FDA issued a proposed rule revising 21 C.F.R. Part 809 (specifically, 21 C.F.R, § 809.3…
FDA Updates Breakthrough Device Guidance
On September 15, 2023, FDA published an update to the guidance document – “Breakthrough Devices Program, Guidance for Industry and Food and Drug Administration Staff.” Notably, FDA states that it may consider a medical device’s ability to improve…
GOP House Bill Proposes Repeal of Retail Pharmacy Dispensing of Mifepristone
UPDATE: Late in the evening of September 28, the House defeated H.R. 4368 by a vote of 191-237, with 27 Republicans voting against the bill. It was the only one of the four appropriations bills to fail.
Editor’s Note: This…