Health Care Counsel Blog
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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
The highly anticipated coronavirus relief package was passed by Congress late on December 21, 2020, and is expected to be signed into law in the coming days.
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.
Headlines that Matter for Companies and Executives in Regulated Industries
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.
Headlines that Matter for Companies and Executives in Regulated Industries
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.
Headlines that Matter for Companies and Executives in Regulated Industries
Since California first legalized medical marijuana in 1996, approximately thirty-two other states and the District of Columbia have followed its lead and approved marijuana use for medical purposes.
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.
Most Favored Nations Model will alter how certain Medicare Part B drugs are reimbursed.
Headlines that Matter for Companies and Executives in Regulated Industries
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.
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.”
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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
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On November 3rd, the Department of Labor’s Wage and Hour Division published an opinion letter addressing whether the FLSA requires employers to pay non-exempt employees for time that they spend in voluntary training programs.
In a Public Notice released today, the FCC announced that its “Connected Care Pilot Program” (Pilot Program) application filing window will open on Friday, November 6, 2020, at 12:00 pm ET and will close on Monday, December 7, 2020, at 11:59 pm ET.
Headlines that Matter for Companies and Executives in Regulated Industries
The Federal government is warning that the threat of cybercrime, and especially ransomware, to US hospitals and healthcare providers has increased.
The Sixth Circuit has issued an important decision that condemns plan provisions that provide different benefits based on a patient’s need for continued dialysis, even if the provision applies to all dialysis patients and not just those with end-stage renal disease (ESRD).
Headlines that Matter for Companies and Executives in Regulated Industries