On November 1, 2023, a bipartisan group of senators announced that they had reintroduced legislation to expand and eliminate barriers to treat opioid use disorder (OUD) through telehealth. Specifically, the Telehealth Response for E-prescribing... Read More
This summer, the Office for Civil Rights (OCR) and the Federal Trade Commission (FTC) issued and published warnings to over 120 hospitals and telehealth providers regarding third-party online tracking technologies that may be integrated into their... Read More
On October 3rd, 2023, the U.S. Food and Drug Administration (FDA) published a proposed rule to clarify and confirm that in vitro diagnostic products (IVDs), including certain laboratory developed tests (LDTs), are considered devices under the... Read More
In June, the United States Supreme Court evaluated the False Claims Act’s (FCA) scienter element to determine whether the existence of an objectively reasonable interpretation that a claim was not false could be presented as a valid defense to the... Read More
On October 10th, the Department of Health and Human Services (HHS) jointly with the Drug Enforcement Administration (DEA) published a second temporary rule extending the full set of telemedicine flexibilities applicable to prescribing controlled... Read More
Recently, there has been an increase in the emergence of third-party companies specializing in assisting physicians and facilities obtain access to “unclaimed” rebates from manufacturers for prescription drugs. These rebates pertain to drugs... Read More
On April 17, 2023, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) published its proposed rules to modify the Health Insurance Portability and Accountability Act (HIPAA). The proposed changes impact HIPAA’s... Read More
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
