After DEA’s of its draft temporary rule last week, the Drug Enforcement Administration (“DEA”) has officially published a temporary rule expanding COVID-19 related flexibilities for prescribing controlled substances via telehealth. The... Read More
Last month, HHS Office for Civil Rights (“OCR”) announced that its COVID-19 related enforcement discretion regarding the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) will end on May 11, 2023, coinciding with the... Read More
Last month, Cerebral, Inc., notified the Department of Health and Human Services Office for Civil Rights (“OCR”), and issued a public notice, that nearly 3.2 million individuals may have been affected by a breach of data, including protected... Read More
In February, the Office of Inspector General (“OIG”) issued an advisory opinion regarding a pharmaceutical manufacturer’s proposal to provide a free 14-day supply of its drug to patients experiencing delays in the insurance approval process.... Read More
In the wake of the Federal Trade Commission (“FTC”) enforcement action against GoodRx last month, the agency has issued another proposed consent order against virtual mental health platform BetterHelp on a similar basis. Namely, the... Read More
The Federal Trade Commission (“FTC”) recently enforced its Health Breach Notification Rule (“Rule”) for the very first time. The FTC issued a $1.5 million civil penalty to GoodRx and imposed restrictions on the company’s future handling of... Read More
On Friday, February 24, 2023, the Drug Enforcement Agency (“DEA”) issued long awaited proposed rules for prescribing controlled substances via telehealth after the conclusion of the COVID-19 Public Health Emergency (“PHE”). The Controlled... Read More
On January 30, 2023, the Biden Administration announced that the COVID-19 Public Health Emergency (“PHE”), which has been in effect since January 2020, is set to expire on May 11, 2023. Considering the impending end to the PHE, healthcare... Read More
In its campaign against the corruption of medical decision making and illegal kickbacks, the Department of Justice (“DOJ”) has increasingly come to rely upon two pieces of legislation together with the Federal Anti-Kickback Statute (“AKS”):... Read More
If your organization is challenged by the limitations on physician compensation imposed by the Stark Law (“Stark”) and the federal Anti-Kickback Statute (“AKS”), a Value Based Enterprise (“VBE”) may provide relief from those constraints.... Read More
