Health Care Counsel Blog

This is the latest in a series of articles discussing selected updates to the Department of Consumer Affairs’ (DCA) waivers issued in response to Governor Newsom’s March 30, 2020 Executive Order N-39-20.

Headlines that Matter for Companies and Executives in Regulated Industries

Headlines that Matter for Companies and Executives in Regulated Industries

Headlines that Matter for Companies and Executives in Regulated Industries

Fraud and abuse regulations have been adapted to meet today’s technology for electronic data, promoting cooperation among health care providers for the exchange of health information and the protection of such information from cyberattacks.

The Department of Health and Human Services (HHS) is working to dramatically increase the number of available vaccinators who may administer COVID-19 shots.

As part of its recent rulemaking process, the Centers for Medicare and Medicaid Services (CMS) finalized a new exception to the Physician Self-Referral Law (the Stark Law) to protect arrangements where limited remuneration is provided to a physician in exchange for items or services provided by the

Headlines that Matter for Companies and Executives in Regulated Industries

In its first significant Stark Law rulemaking since 2015, the Centers for Medicare and Medicaid Services (CMS) recently issued a new final rule (Final Rule) intending to provide physicians and designated health services (DHS) entities with additional flexibility in complying with the law’s stringent

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). 

Headlines that Matter for Companies and Executives in Regulated Industries

Enrolling in such a CMS-sponsored innovation model now has an added benefit: a new Anti-Kickback Statute (AKS) safe harbor.

Headlines that Matter for Companies and Executives in Regulated Industries

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

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. 

Headlines that Matter for Companies and Executives in Regulated Industries

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.

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.