This term, the Supreme Court of the United States is set to rule in a Medicare reimbursement case that has sparked a fresh look at the historical deference often granted to agencies and whether it should remain, be modified,...more
Federal and state cannabis regulation and enforcement appear to be moving in different directions. While the Food and Drug Administration ("FDA") has broadened its net to target businesses making claims that their products...more
6/3/2021
/ Cannabidiol (CBD) oil ,
Cannabis Products ,
Cannabis-Related Businesses (CRBs) ,
Decriminalization of Marijuana ,
Drug Testing ,
FDA Warning Letters ,
Federal v State Law Application ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Recreational Use ,
Retailers
This Diagnosing Health Care episode focuses on the growing opportunity for providers to integrate telehealth into their practice through a compliant and forward-thinking approach. The episode is hosted by Megan Robertson and...more
Two announcements made by FDA in late October signal a marked change to FDA’s regulatory approach to “homeopathic” drugs. On October 25, 2019, FDA withdrew the 1988 Compliance Policy Guide (“CPG”) 400.400 Conditions Under...more
12/4/2019
/ Adverse Events ,
Comment Period ,
Direct to Consumer Sales ,
Draft Guidance ,
Enforcement Actions ,
Enforcement Authority ,
FDA Warning Letters ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Homeopathic Remedies ,
Marketing ,
New Guidance ,
Pharmaceutical Industry ,
Product Labels ,
Public Health ,
Regulatory Oversight ,
Retail Market ,
Safe Harbors
On July 31, 2018, the Office of Inspector General (“OIG”) of the U.S. Department of Health and Human Services released a portfolio titled “Vulnerabilities in the Medicare Hospice Program Affect Quality Care and Program...more
Recognizing that gene therapy products are now a “therapeutic reality” for some patients, the U.S. Food and Drug Administration (“FDA”) recently unveiled six draft guidance documents intended to foster the development of...more
A controversial new Medicare national coverage determination (“Medicare NCD”) for certain next-generation sequencing (“NGS”) tests published by the Centers for Medicare & Medicaid Services (“CMS”) on March 16, 2018, could...more