Pharmaceuticals and Biologics

On September 27, 2023, the Health Resources and Services Administration (HRSA) issued a Notice in the Federal Register applicable to all 340B Program hospitals that formally ends a COVID-era waiver of the long-standing HRSA requirement that off-site, outpatient facilities be (1) listed as reimbursable on the hospital’s Medicare Cost Report (MCR) prior to participating in the 340B Program; and (2) registered and listed in the Office of Pharmacy Affairs Information System (OPAIS) prior to participating in the 340B Program.Continue Reading HRSA Confirms End of COVID Waiver of Advance Registration Requirement for Provider-Based Clinics

On June 27, 2023, Connecticut Governor Ned Lamont signed into law Public Act 23-171“An Act Protecting Patients and Prohibiting Unnecessary Health Care Costs” (Act), which includes changes to the state’s implementation of the federal 340B Drug Pricing Program. The Act: (a) requires the Commissioner of Social Services to convene a working group to evaluate the myriad issues affecting the 340B Program and opportunities for the state to support the 340B Program; and (b) prevents pharmacy benefit managers (PBMs) from incorporating certain contract provisions in agreements with qualifying Covered Entities under the 340B Program that lower reimbursement to such Covered Entities, among other restrictions.Continue Reading Connecticut Places Checks on PBM Contracts in Support of 340B Covered Entities

On May 2, 2023, legislators approved the $229 billion New York State FY 2023-2024 Budget Bill (“the Budget”), which was signed by Governor Hochul on May 3, 2023. Article VII of the Budget touches almost every aspect of the New York healthcare system, including home health, hospitals, laboratories, and reproductive health. It contains wide-ranging provisions that expand access to care, allow clinicians to provide more services, and allocate needed resources to providers. It targets Medicaid in multiple ways, including an extension of the Medicaid Global Cap on system-wide spending growth through FY 2025.[i] Here, we outline some of the key provisions that this Budget contains.Continue Reading New York Enacts Long Negotiated Budget Bill with Sweeping Implications for Health Care

On February 24, 2023, the federal Drug Enforcement Administration (DEA) issued a pair of proposed rules to make permanent certain “telemedicine flexibilities” related to the prescribing of controlled substances via telehealth that have been relied upon by prescribers and patients during the COVID-19 pandemic.  The proposed rules respectively address (1) telemedicine prescribing of certain controlled substances without an in-person medical examination (Tele-Prescribing Rule), and (2) expansion of buprenorphine prescribing via telemedicine encounters (Buprenorphine Rule).  Below please find a high-level summary of the Tele-Prescribing Rule.  A separate post will follow addressing the Buprenorphine Rule in detail.Continue Reading As COVID-19 Emergency Waivers End, DEA Proposes to Expand Tele-Prescribing of Controlled Substances

On October 5, 2022, the Office of Inspector General (OIG) published Advisory Opinion 22-19 (Advisory Opinion), in which it determined that a proposed oncology drug discount arrangement could constitute grounds for the imposition of sanctions under the federal anti-kickback statute (AKS). The OIG concluded that while beneficiary access to potentially life-saving medications is essential, the provisions of the proposed arrangement “would present more than a minimal risk of fraud and abuse” under the AKS.Continue Reading Advisory Opinion 22-19: OIG Warns That Proposed Drug Cost Subsidization Arrangement May Warrant Sanctions

Below is an excerpt of a contributed article co-authored with Robinson+Cole Business Litigation Group lawyer Ben Daniels published in Physicians Practice on September 16, 2022.

On July 25, 2022, the U.S. Court of Appeals for the Second Circuit rejected an appeal brought by Pfizer, Inc. in a case that examines whether a “corrupt” intent is

On March 30, 2022, the United States Department of Justice (DOJ) announced that Manual J. Bojorquez, the owner of a marketing company, was sentenced to 36 months’ probation and ordered to pay restitution of $3.3 million for his role in a kickback scheme. The sentencing follows a plea agreement by Mr. Bojorquez in which he pleaded guilty to conspiracy to violate the federal anti-kickback statute. According to the DOJ and court documents, Mr. Bojorquez, through his company, provided marketing services to various compounding pharmacies. Mr. Bojorquez’s company conspired with the compounding pharmacies to pay kickbacks to physicians in exchange for those physicians referring prescriptions to the compounding pharmacies. The compounding pharmacies then paid Mr. Bojorquez (through various shell companies) a percentage (approximately 45%) of the fees generated from the prescriptions referred by the physicians. The pharmacies billed and received payment from the US Department of Labor’s (DOL) Office of Workers Compensation Program, which is a federal health care benefit program. Over the course of the conspiracy, the DOL paid over $8 million for the kickback-induced prescriptions.
Continue Reading Marketer in Kickback Scheme Involving Compound Pharmacies Sentenced to Probation and Order to Pay $3.3 Million

The Food and Drug Administration (FDA) has recently undertaken a number of notable actions with respect to vaccines in response to the ongoing COVID-19 pandemic. Below is an overview of these actions and related COVID-19 vaccine information:

Full Approval of the Moderna COVID-19 Vaccine for 18+

On January 31, 2022, the FDA announced its full approval (licensing) of the Moderna COVID-19 Vaccine for individuals 18 and older. The Moderna vaccine had been administered under an Emergency Use Authorization (EUA) from the FDA since December 18, 2020.  This is the second COVID-19 vaccine to be approved by the FDA following approval of Pfizer-BioNTech’s COVID-19 vaccine on August 23, 2021. Notably, the approved Moderna COVID-19 vaccine will be marketed and known as the ‘Spikevax.’Continue Reading COVID-19 Vaccine Update – February 2022

On Monday, November 15, 2021, the Food and Drug Administration (FDA) announced that the U.S. Department of Health and Human Services (HHS) repealed a policy established by the Trump administration that directed the FDA not to enforce premarket review requirements for COVID-19 laboratory developed tests (LDTs). This prior policy, which waived premarket review requirements aimed at increasing broad public access to COVID-19 tests, was generally consistent with the FDA’s historical stance allowing laboratories to not seek approval of LDTs. With the policy announced by the Trump administration, laboratories again began offering their tests prior to or without an emergency use authorization (EUA) after the test was validated and a notification was provided to the FDA. While this policy expedited the availability of tests, the FDA contends that the policy also led to some poorly-performing tests being offered prior to FDA review. Notably, this prior policy did not apply to at-home or point of care collection tests, which have always required FDA review.
Continue Reading HHS Again Requires FDA Premarket Review for COVID-19 Tests

On August 19, 2021, Connecticut Governor Ned Lamont issued Executive Order No. 13C (the “Order”) to expand access to COVID-19 vaccination information for patients and providers (and school nurses) as public health authorities continue to promote vaccination efforts, implement recommendations for vaccine booster shots, and as schools adopt COVID-19 control measures for returning students and