The Healthcare Group Purchasing Organization sector has played a critical role in assisting health systems respond to supply disruptions during the pandemic.
The Centers for Medicare & Medicaid Services (CMS) published a Final Rule in the Federal Register on December 2, 2020, overhauling the regulations governing the federal Physician Self-Referral Law (Stark Law).
The Final Rule of the Stark Law revises the definitions of Fair Market Value and includes a definition of General Market Value to better align with actual practices without unduly restricting innovative relationships between physicians and entities providing designated health services.
On December 28, 2020, Judge Vince Chhabria of the US District Court for the Northern District of California joined Judge Catherine Blake of the US District Court of the District of Maryland in enjoining the application of the Medicare Part B Most Favored Nations Reimbursement Rule.
On December 23, 2020, Judge Catherine Blake of the US District Court for the District of Maryland put in place a 14-day restraining order while she considers whether to issue a preliminary injunction. She plans to consider whether the Centers for Medicare & Medicaid Services rulemaking was adequate
States seeking to regulate pharmacy benefit managers (PBMs) and prescription drug pricing received a win from the Supreme Court, which reversed an Eighth Circuit decision that had invalidated an Arkansas law governing pharmacy and PBM conduct on ERISA preemption grounds.
Nearly two years after soliciting public suggestions to modify HIPAA rules to improve the coordination of care, the Department of Health and Human Services (DHHS) issued a Proposed Rule.
OIG and CMS, through a coordinated effort, have issued sweeping and much-anticipated final changes to the Anti-kickback and Stark rules. These changes are generally industry-friendly.
Health Care Practice Co-Leader Douglas Grimm and Law Clerk Hillary Stemple presented at the Center for Telehealth & e-Health Law (CTeL) Digital Health Virtual Summit on December 3.
The Nevada Division of Public and Behavioral Health will hold an open public meeting to discuss proposed amendments to current regulations impacting the State’s drug transparency program. The meeting will take place on December 9, 2020, at 1 pm PST.
Final Rule largely tracks prior proposal to make significant changes to the Discount Safe Harbor and other regulatory safe harbors to the Federal Anti-Kickback Statute.
On November 18, the Centers for Medicare & Medicaid Services (CMS) released an alert urging nursing homes to follow established COVID guidelines for visitation and infection prevention during the upcoming holidays.
Health Care Partner Stephanie Trunk will speak at the American Conference Institute’s Proficiency Series on Rx Drug Pricing & Rebate Fundamentals on November 19.
The Department of Health and Human Services Office of the Inspector General (OIG) published a Special Fraud Alert on November 16, 2020 (the Alert) regarding a common practice within the pharmaceutical and medical device industry known as “speaker programs.”
Calling it a “straightforward inquiry,” the US Court of Appeals for the 11th Circuit recently opted to expand access to the Medicare Secondary Payer Act (the MSP Act) private right of recovery to Medicare Advantage “downstream actors.”
The Department of Consumer Affairs (DCA) continues to issue and extend waivers under Governor Newsom’s March 30, 2020 Executive Order, which authorized the DCA to temporarily modify licensing and staffing requirements for healthcare professionals licensed under the California Business and Profession
Twenty-four Arent Fox LLP practices have been recognized in the 2021 “Best Law Firms” rankings that are published annually by US News & World Report and Best Lawyers.