As we take a breather during the holiday whirlwind, we wanted to flag for readers a recent development in advertising and promotion regulation that FDA quietly released nearly a month ago. In a Memorandum issued on October 27...more
On October 5, 2022, the Office of Inspector General (“OIG”) posted Advisory Opinion No. 22-19 (the “Opinion”), which limits the ability of pharmaceutical manufacturers to offer cost-sharing subsidies to Medicare Part D (“Part...more
10/13/2022
/ Advisory Opinions ,
Anti-Kickback Statute ,
Civil Monetary Penalty ,
Cost-Sharing ,
Department of Justice (DOJ) ,
Drug Pricing ,
Enforcement ,
Manufacturers ,
Medicare Part D ,
OIG ,
Pharmaceutical Industry
On July 25, 2022, the U.S. Department of Health and Human Services (“HHS”) issued a proposed new rule that significantly expands the scope of protection available to vulnerable populations under Section 1557 of the Affordable...more
8/23/2022
/ Affordable Care Act ,
Biden Administration ,
Department of Health and Human Services (HHS) ,
Discrimination ,
Executive Orders ,
Gender Identity ,
Proposed Rules ,
Rulemaking Process ,
Section 1557 ,
Sexual Orientation Discrimination ,
Women's Rights
With a September 24, 2022 compliance date looming, the U.S. Food and Drug Administration (FDA) announced that it will delay enforcement of its requirement to submit Unique Device Identifier (UDI) data for low-risk consumer...more
On July 15, 2022, the Food and Drug Administration (FDA) issued its final guidance on developing the content and format of patient Instructions for Use (IFU) for human prescription drug and biological products, as well as...more
Last month, in Cummings v. Premier Rehab Keller, P.L.L.C., the Supreme Court denied a petitioner’s right to emotional distress damages in a private action brought under federal anti-discrimination laws. The Petitioner, a...more
5/26/2022
/ Affordable Care Act ,
Civil Rights Act ,
Compensatory Damages ,
Cummings v Premier Rehab Keller PLLC ,
Disability Discrimination ,
Emotional Distress Damages ,
OCR ,
Rehabilitation Act ,
SCOTUS ,
Section 1557 ,
Section 504
Texas HB 1445, which went into effect on January 1, 2022, exempts medical billing services performed before the submission of the relevant insurance claim from state sales tax. The new legislation legally exempts medical...more