Articles and Blogs

On October 7, 2021, five years after issuing initial draft guidance on its enforcement approach for hospitals and health system pharmacy compounding under section 503A of the Food, Drug, and Cosmetic Act (the “Act”), the U.S. Food and Drug Administration (“FDA”) released revised draft guidance (“Draft Guidance”) that provides increased flexibility to hospitals and health... READ MORE

We continue to receive questions regarding the future of the 340B drug discount program (“340B Program”) now that its mid-term longevity is no longer in doubt. These include whether Congress will continue to focus on limiting the 340B Program’s scope as well as what effect, if any, broader efforts to reduce drug costs might... READ MORE

It’s no April Fools’ joke. On April 1, 2019, the Health Resources & Services Administration Office of Pharmacy Affairs (“HRSA”) unveiled a long-awaited website that gives providers participating in the 340B drug pricing program (“340B Program”) direct access to information about the maximum amounts that pharmaceutical companies may charge for certain drugs. This moves... READ MORE

Beginning April 1, 2019, Medicare Part C and D plans, PACE organizations and 1876 cost contract plans (“Plans”) will be required to deny payment for services rendered or prescriptions ordered by any provider on the new Centers for Medicare & Medicaid Services (“CMS”) Preclusion List. The Preclusion List, which was first made available to... READ MORE

The Department of Health and Human Services Office of Inspector General (“OIG”) recently issued a favorable Advisory Opinion, No. 16-07, of an arrangement that offers Medicare Part D beneficiaries discounts on prescriptions for an erectile dysfunction drug that is statutorily excluded from coverage under Part D (the “Arrangement”). While OIG concluded that the Arrangement... READ MORE

A recent whistleblower case could have a significant impact on Medicare Part D charge limits and corresponding reimbursement and could have ripple effects for aspects of other Medicare programs. The Seventh Circuit Court of Appeals ruled that reduced prescription prices offered by a large retail pharmacy (here Kmart) to participants enrolled in a popular discount... READ MORE

Recently, a federal District Court for the Northern District of Indiana ruled that pharmacists in Indiana are not subject to patient lawsuits for their refusal to dispense certain prescriptions but can be sued by prescribing physicians for related claims or face administrative actions by the state for improperly refusing to fill a prescription.  Therefore, pharmacies and pharmacists should carefully determine when they... READ MORE

Relator Thulin was a pharmacist in Idaho working for Shopko, a Wisconsin company. He filed an FCA claim alleging Shopko defrauded Medicaid by failing to pass along private insurance plan prices to Medicaid for dual-eligible patients. The court rejected Shopko’s claim, affirming the trial court’s grant of a motion to dismiss. Dual-eligible Medicaid recipients... READ MORE

OIG recently issued Advisory Opinion 14-06, determining that a proposed arrangement for patient referrals to a specialty pharmacy had the potential to generate prohibited remuneration under the Anti-Kickback Statute.  The proposed arrangement involved a specialty pharmacy paying a support services fee to local retail pharmacies when the local pharmacies referred patients to the specialty... READ MORE

Executive Summary On July 28, 2014, the Department of Health and Human Services Office of Inspector General (“OIG”) released Advisory Opinion No. 14-05 (“AO 14-05”), addressing one of OIG’s favorite foci, federal health care program “carve out” arrangements.  AO 14-05 was issued in response to a pharmaceutical manufacturer’s (“Company”) request for review of its... READ MORE