Health Care Counsel Blog
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On Thursday, the Senate Finance Committee held a confirmation hearing for two of the most important health policy officials nominated by President Biden, Chiquita Brooks-LaSure (Administrator, Centers for Medicare and Medicaid Services) and Andrea Palm (Deputy Secretary).
Congress recently passed two bills that are designed to educate patients and prescribers about biosimilars and thereby encourage their use and to close a loophole in existing law that allows certain branded drugs to retain longer market exclusivity.
Headlines that Matter for Companies and Executives in Regulated Industries
Hospitals everywhere in the United States should take note: CMS announced on March 26, 2020, that it is lifting its extended 30-day survey suspension for hospitals. Survey activity will now resume.
Headlines that Matter for Companies and Executives in Regulated Industries
Applicable drug manufacturers and group purchasing organizations that are subject to the reporting rules under the Open Payments System are reminded that March 31, 2021, is the final day to submit and attest to data for the June 2021 publication of Program Year 2020 data.
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.
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
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
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.
Headlines that Matter for Companies and Executives in Regulated Industries
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