Although most of the recent focus around the implementation of the Inflation Reduction Act (“IRA”) by the press and industry stakeholders has been on the Medicare Drug Price Negotiation Program, the IRA has several other...more
On January 9, 2023, the U.S. Supreme Court denied Pfizer Inc.’s petition for a writ of certiorari. The denial brought the pharmaceutical company’s lawsuit challenging the breadth of the federal Anti-Kickback Statute (AKS) to...more
Key Points - A new legal challenge to OIG on Medicare Beneficiaries’ ability to receive co-pay assistance has emerged. The Supreme Court has been asked to review HHS’s prohibition of co-pay assistance programs under the...more
Pharmacies have long been a focus of enforcement actions brought by the Department of Justice (DOJ) and Department of Health and Human Services Office of Inspector General (OIG). This summer has been no exception, with the...more
This special inaugural issue of McDermott’s Healthcare Regulatory Check-Up highlights noticeable enforcement activity, OIG regulatory developments, CMS regulatory developments and other key developments for healthcare...more
In a previous post published on the Washington Legal Foundation’s Legal Pulse blog, Goodwin Partners Matt Wetzel and William Jackson discussed the potential implications of a high-profile recent lawsuit lodged by Pfizer...more
On September 23, 2020, the Office of Inspector General of the United States Department of Health and Human Services (OIG) publicly released Advisory Opinion 20-05 (AO 20-05), a significant, adverse opinion rejecting a...more
On September 23, the HHS OIG published Advisory Opinion No. 20-05, advising that OIG found “highly suspect” a manufacturer’s proposal to create a copay subsidy program to help certain financially eligible Medicare...more
On March 24, 2020, the US Department of Health and Humans Services Office of Inspector General (OIG) issued guidance regarding OIG’s March 17, 2020, policy statement on reductions or waivers of cost-sharing obligations owed...more
On October 22, 2019, Skadden hosted our Ninth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York, which focused on U.S. enforcement issues companies face throughout the industry. The key...more
More than two years since issuing the proposed rule, the HHS Office of the Inspector General (OIG) issued the long-awaited and highly anticipated final rule (the Final Rule) that provides amendments to the Anti-Kickback...more
A New York State hematology-oncology medical practice (the Practice), has agreed to pay $5.3 million to resolve allegations that, over an approximate five-year period, it provided kickbacks to patients in the form of waived...more
Arizona seeks Medicaid Waiver to implement new coverage restrictions for Medicaid expansion enrollees and delivery system reform; Tennessee’s uninsured rate continues to drop; and Louisiana gubernatorial candidates line up...more
“You scratch my back, I scratch yours” arrangements are common in business transactions. These agreements are risky in the healthcare space, however, with the potential to implicate civil and criminal sanctions. Whether...more
In This Issue: - Connecticut Supreme Court Rules State Does Not Recognize Mature Minor Doctrine - OIG Issues Advisory Opinion Permitting Copayment Assistance - CMS Announces Recovery Audit Program...more
On January 5, 2015, the OIG posted a favorable advisory opinion, OIG Advisory Opinion 14-11, regarding a 501(c)(3) charitable foundation’s (Foundation) proposal to establish a patient assistance program that would provide...more
Earlier this week the OIG released an advisory opinion stating that a nonprofit organization’s proposed arrangement to provide copayment assistance to financially needy patients would not result in civil monetary penalties or...more
The Office of Inspector General of the Department of Health and Human Services recently issued a warning to pharmaceutical manufacturers, reminding them that copay coupons used for drugs purchased through federal healthcare...more
In This Issue: - CMS Updates Guidance on Hospital Governing Body and Medical Staff Conditions of Participation (CoPs) - DOL Announces Delay of Home Care Minimum Wage Enforcement - OIG Releases Special...more
In recent years, copayment coupon programs have become standard promotional practices for both large and small pharmaceutical manufacturers. Copayment coupons are typically offered to commercially insured patients in order...more
On September 18, 2014, the OIG simultaneously issued a Report [PDF] and Special Advisory Bulletin [PDF] warning about the potential fraud and abuse risks posed by coupons offered by pharmaceutical manufacturers when those...more
Brand name drugs cost a lot. So to make them more attractive, drug manufacturers issue coupons for discounts on the copayment portion of the price. They work the same as the dollar-off coupons offered by cereal manufacturers....more
For years, many drug manufacturers have issued coupons to help cover some or all of the cost of copayments (commonly referred to as a “copay”) for prescription medications. While the Department of Health and Human Services...more
Last week, the U.S. Department of Health and Human Services Office of Inspector General (OIG) released a Special Advisory Bulletin titled, Pharmaceutical Manufacturer Copayment Coupons (Bulletin), and a report titled,...more