Health Care Counsel Blog
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Texas Health and Human Services announced that beginning April 1, 2021, drug manufacturers who wish for their products to be added to the Texas Drug Code Index (the Texas Medicaid formulary) must create an electronic account.
Immediately at issue was Lilly and Company and Lilly USA’ refusal to sell covered outpatient drugs at the 340B Ceiling Price to contract pharmacies acting as agents for 340B Covered Entities. Several 340B Covered Entities had petition for a hearing by the ADR panel.
Headlines that Matter for Companies and Executives in Regulated Industries
The American Rescue Plan Act of 2021, signed into law by President Biden on March 11, 2021, is a $1.9 trillion aid package that provides assistance to businesses and individuals experiencing financial hardship due to COVID-19.
Headlines that Matter for Companies and Executives in Regulated Industries
Our Health Care team has a complete analysis of recent updates to the Stark Law and Anti-Kickback Statute and their impact on health care providers.
Headlines that Matter for Companies and Executives in Regulated Industries
Headlines that Matter for Companies and Executives in Regulated Industries
Recent updates to the federal Anti-Kickback Statute give providers additional flexibility to enter into innovative arrangements, but before doing so, providers must ensure they understand the safe harbor requirements necessary to protect those arrangements.
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
Headlines that Matter for Companies and Executives in Regulated Industries
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.
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.