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Health Care Counsel Blog

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In its recent Final Rule significantly revising the federal Physician Self-Referral Law (Stark Law), the Centers for Medicare and Medicaid Services (CMS) implements several important changes to the special rules on compensation set forth in 42 C.F.R. § 411.354(d). 
Enrolling in such a CMS-sponsored innovation model now has an added benefit: a new Anti-Kickback Statute (AKS) safe harbor.
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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).
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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.
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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.
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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.
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.
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.
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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
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.
Two surgeons in dimly lit OR reviewing patient scan
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). 
Three organizations serving primarily HIV and AIDS patients and who each are also considered “Covered Entities”.
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Home health is a $100 billion industry in the U.S., spanning more than 33,000 provider organizations.
With increased financial pressure on the health care delivery system, there is likely to be an increase in health care provider financial restructurings.
On September 24, 2020, the California Court of Appeal shed additional light on meeting the public interest requirements in anti-SLAPP motions in its opinion of Murray v. Tran (Cal. Ct. App., Sept. 24, 2020, No. D076104).
California Governor Newsom signed Senate Bill 1237 (SB 1237), broadening the certified nurse midwife (CNM) scope of practice, among other changes to the Nursing Practice Act and other Sections of the Business and Professions Code. 
For the first time, California has granted nurse practitioners who meet certain qualifications a separate scope of practice. This eventually will allow them to practice specified medical functions independently, without standardized procedures.