The Inflation Reduction Act’s price negotiation program for drugs covered under Medicare Parts B and D (“Negotiation Program”) has been challenged in federal court. Yesterday, Merck filed a complaint in the D.C. District Court challenging the Negotiation Program as a “sham,” an “extortion,” and a violation …
Last Friday, May 26, CMS published in the Federal Register an assortment of proposals to change the regulations governing the Medicaid Drug Rebate Program. Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to …
On March 31, the Federal District Court for the District of Maryland upheld CMS’s definition of a “new formulation” under the Medicaid Drug Rebate Program (MDRP). Vanda Pharmaceuticals, Inc. v. CMS, Civ. No. MJM-22-977 (Dist. Md. 2023). By way of background, manufacturers are subject to …
On Friday, November 4, CMS finalized a rule to implement mandatory rebates (called “refunds”) for discarded amounts of separately paid Medicare Part B single-source drugs packaged in single-dose or single-use containers. For a summary of the rule, we refer readers to our July 2022 post …
In November 2020, we blogged about a decision by the Federal District Court of Maryland dismissing a Federal False Claims Act (FCA) qui tam suit alleging that Forest Laboratories knowingly reported inflated best prices under the Medicaid Drug Rebate Program (MDRP), resulting in underpayment of rebates. The …
The Inflation Reduction Act of 2022 (“IRA”) has now passed both the Senate (on August 7) and the House (on August 12), and is headed to President Biden for signature. We have prepared a slide deck that summarizes Subtitle B of the IRA, entitled “Prescription Drug …
In a recent decision, the Second Circuit upheld the HHS Office of the Inspector General (OIG)’s position that Pfizer’s proposed copay assistance program for its high-cost heart treatment would violate the Federal Anti-Kickback Statute (AKS). Pfizer, Inc. v. U.S. Department of Health and Human Services …
Last November, we blogged about a provision of the Infrastructure Investment and Jobs Act that requires new rebates for discarded amounts of drugs that are covered under Medicare Part B, and that are packaged in a single-dose container or single-use package. An example of such …
We have blogged before (for example, here and here) on amendments to the Federal health care program antikickback law safe harbor regulations that were finalized by the Trump Department of Health and Human Services in November 2020. If and when implemented, the amendments will likely …
In 2017, the Centers for Medicare & Medicaid Services (“CMS”) issued a final rule to significantly decrease the rate the government will reimburse 340B hospitals in 2018 for outpatient prescription drugs from average sales price (“ASP”) plus 6% to ASP minus 22.5%. 82 Fed. Reg. …
In January 2021, we reported on a CMS rule that, among other things, revised the Medicaid rebate best price regulation to remove impediments to value-based purchasing (VBP) arrangements in Medicaid. The rule, which will go into effect on July 1, 2022, defined a VBP is …
We reported in August that CMS proposed to rescind the Most Favored Nation (MFN) drug pricing interim final rule issued in the latter days of the Trump regime. Today, CMS finalized that proposal, effectively putting an end to the concept of international reference pricing as …
While most of the Congressional focus on drug pricing has centered on the reconciliation bill currently being hammered out in the House and Senate, the Infrastructure Investment and Jobs Act (the “Act”), which was signed by President Biden yesterday, contains two provisions relating to drug …
On September 30, we blogged about the ongoing dispute and litigation around the use of contract pharmacies under the 340B Drug Discount Program (click here). We reported that HRSA was proceeding with enforcement actions against drug manufacturers that have declined to sell to 340B covered …
Drug pricing and payment reform is a three-legged stool drawing support from the Administration, the House, and the Senate. Yesterday our post focused on the Administration’s priorities and initiatives, as described in HHS’s recent Comprehensive Plan for Addressing High Drug Prices. Today we focus on …
