Podcast — Drug Pricing: What’s in the New CMS Medicaid Final Rule?
Podcast — Drug Pricing: Takeaways From the Chicago Medicaid Drug Rebate Program Summit
Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more
Ropes & Gray attorneys share their analysis of administrative and court litigation, regulatory developments, key developments affecting federal program payments to hospitals and health systems, and other reimbursement-related...more
Congress Votes on CR, Health-Related Legislation. After reaching a deal over the weekend, both chambers passed a CR to avoid a government shutdown and fund the federal government through December 20, 2024. This tees up a push...more
The following is a summary of selected federal Department of Health and Human Services’ Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported...more
As discussed throughout this Update, the implementation of the Medicare Drug Price Negotiation Program (the “Negotiation Program” or “Program”) has been subject to a number of legal challenges. To date, six manufacturers and...more
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 May 26, 2023, the Centers for Medicare and Medicaid Services (CMS) proposed an update to the Medicaid Drug Rebate Program (MDRP) rules, which includes provisions aimed at preventing 340B duplicate discounts on claims...more
On February 7, 2023, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published a report entitled, “Technical Assistance Brief: Implementation of Inflation-Indexed Rebates for Part B Drugs.” ...more
The Centers for Medicare & Medicaid Services (CMS) and the US Department of Health and Human Services Office of Inspector General (OIG) continue to issue guidance regarding the implementation of the drug pricing provisions of...more
After almost a year of negotiations among congressional Democrats and the White House, the Inflation Reduction Act of 2022 (IRA) was signed into law by President Biden on August 16, 2022. It passed in the US Senate by a vote...more
After many years of policy debate and attempts at proposed legislation, some of the most meaningful changes to the ways in which Medicare pays for prescription drugs – and the obligations of manufacturers selling drugs to...more
Key Drug Pricing Implications of the Inflation Reduction Act of 2022 - I. Introduction - On Sunday, August 7, 2022, the United States Senate passed the most consequential drug and biologics pricing legislation in almost...more
Litigation involving drug price reporting under the Medicaid Drug Rebate Program (MDRP) has been very active in 2022. Most recently, on August 3, 2022, an Illinois federal jury levied a $61 million verdict against Eli...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
Biden Administration Releases FY 2023 Budget - The Biden Administration’s proposed Budget of the U.S. Government for FY 2023 (see also the accompanying fact sheet) includes proposals relevant to drug manufacturers....more
While Congress continues to consider significant drug pricing legislation, separate regulatory and statutory changes have been finalized this week with potential implications for manufacturers that report prices into the...more
2021 Medicaid Drug Rebate Program Conference Concludes: The conference took place in New Brunswick, N.J., Oct. 11-13 and virtually Oct. 18-20. Christopher H. Schott spoke in person as part of the “Fireside Chat: External...more
On October 13, 2021, the in-person portion of the annual informaconnect Medicaid Drug Rebate Program (MDRP) Conference concluded in New Brunswick, New Jersey. A day earlier, on October 12, 2021, a joint hearing was held in...more
Drug Pricing Initiatives: The fate of the reconciliation package that contains many of President Biden’s domestic policy initiatives, including with respect to drug pricing, remains in limbo as Democrats continue to debate...more
It’s finally here – the Drug Pricing Plan that President Biden ordered the Department of Health and Human Services (HHS) to produce by the end of August (the “Plan”) was released publicly by the Administration on September 9,...more
Drug Pricing Initiatives: On Aug. 24, 2021, the House of Representatives approved a $3.5 trillion budget framework, S. Cons. Res. 14, while also voting to advance the $1 trillion infrastructure bill. The deadline for the...more
Like the Brood X cicadas emerging from their 17-year chthonic slumber, summer 2021 saw the reemergence of something else set to dominate headlines: 340B contract pharmacies. Given the link between the Medicaid drug rebate...more
The U.S. House of Representatives is considering dueling proposals related to drug pricing under Medicaid and Medicare, including the Republican-led H.R. 19, the “Lower Costs, More Cures Act of 2021” and a reintroduced...more
Pharmaceutical Care Management Association (“PCMA”) lawsuit results in delayed implementation of Final Rule while Biden Administration review is ongoing - Pursuant to a Court Order, implementation of the U.S. Dept. Health...more
On November 20, 2020, the Centers for Medicare & Medicaid Services (“CMS”) and the Department of Health and Human Services Office of the Inspector General (“OIG”) released their highly-anticipated final rules to modernize and...more