Your prescribed dose of health law news
On September 28, Rivkin Radler’s Jeff Kaiser will be a panelist at the Practising Law Institute’s program, Life Sciences 2022: Navigating Legal Challenges in Drug and Device Industries. The program is designed for attorneys and allied professionals who counsel pharmaceutical and life sciences companies.
Entitled “Enforcement Trends Impacting the Drug and Device Industries,” Jeff’s…
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The Centers for Medicare & Medicaid Services’ Transparency in Coverage Final Rule took effect on July 1, following a six-month delay in implementation to allow payers to come into compliance.
The Final Rule requires group health plans and health insurance issuers offering non-grandfathered coverage in the group and individual markets to disclose online, in machine-readable…
On July 13, the New York Office of Medicaid Inspector General (OMIG) published proposed regulations implementing 2020 changes to law relating to provider compliance programs, Medicaid managed care fraud, waste and abuse prevention programs, and OMIG’s self-disclosure program. The proposed changes will significantly affect both payers and providers alike.
In the next installment of Rivkin…
On May 27, the U.S. District Court for the Northern District of California refused to dismiss a lawsuit[1] brought against Envision Healthcare Corp. alleging violations of California’s corporate practice of medicine (CPOM) prohibition, as well as state fee-splitting and kickback prohibitions. The action was brought by the American Academy of Emergency Medicine Physician Group…
On June 13, the U.S. Department of Health and Human Services (HHS) issued guidance to explain how audio-only telehealth can comply with HIPAA, while also emphasizing that this mode of telehealth services can expand healthcare access to individuals who may have limited internet and broadband capabilities.
In response to the COVID-19 pandemic in March 2020,…
On May 9, New York Gov. Kathy Hochul signed into law a dental hygiene bill that allows dental hygienists to use nitrous oxide and local infiltration anesthesia to assist dentists with all dental procedures. The bill, which was originally introduced in the State Senate in May 2021, amends section 6605-b of the Education Law effective…
In a recent Advisory Opinion, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) determined that an arrangement involving certain physicians who have an ownership interest in a medical device company that manufactures products that may be ordered by the physician owners (the “Company”) was not considered a suspect physician-owned…
On May 11, New York Gov. Kathy Hochul announced the establishment of the Pharmacy Benefits Bureau within the State’s Department of Financial Services (DFS). The Bureau will handle the licensing and supervision of pharmacy benefit managers (PBMs), and in particular their impact on consumers and the cost of healthcare. The Bureau will also have authority…
With the proliferation of precision and individualized medicine, genetic testing and counseling will likely remain on the radar of the Department of Health and Human Services’ Office of Inspector General (OIG) and the Department of Justice for years to come. Biopharma companies and manufacturers must carefully consider the facts and safeguards applicable to any sponsored…
