As we and others closely following drug pricing have predicted, multiple additional lawsuits have followed in the wake of Merck’s challenge to the Inflation Reduction Act (IRA) price negotiation provisions in the D.C. federal district court on June 6 (see our post here). Since then, …
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 …
In the Spring of 2021, the Health Resources and Services Administration (HRSA) threatened six drug companies with billions of dollars in penalties for not providing 340B discounts to covered entities that sell drugs through vast networks of contract pharmacies (more background on earlier posts). The drug …
Last week, the Centers for Medicare & Medicaid Services (CMS) released a memorandum on how it intends to implement the Medicare Drug Price Negotiation Program, passed under the Inflation Reduction Act (IRA) (see our blog post and slide deck on IRA). The memorandum also introduced …
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 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. …
Last June, we blogged about a lawsuit brought by the Pharmaceutical Research and Manufacturers of America (PhRMA) challenging CMS’s ill-conceived Accumulator Adjustment Rule (“final rule”), which amended the Medicaid Rebate best price regulation. The final rule, which was set to go into effect on January …
Hyman, Phelps & McNamara, P.C. is pleased to announce that Sophia Gaulkin will be presenting and speaking on an expert panel at Informa Connect’s Drug Pricing Transparency Congress, which is being held virtually and in-person in Philadelphia on March 28-29, 2022. Ms. Gaulkin’s presentation on Changes …
There’s a lot of things packed (and that need to be unpacked to understand) into the latest version (as amended) of H.R. 5376, the 2100-plus page bill better known as the “Build Back Better Act.” The bill has gone through the House Committee on Rules …
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 …
A flourish of drug regulatory actions have issued from the Trump Administration during its waning days. Within the past two weeks, HHS has terminated FDA’s Unapproved Drug Initiative by withdrawing two guidances, finalized a proposed OIG safe harbor regulation on PBM rebates that HHS had …
Beginning February 15, drug manufacturers will have a new price to report to the Federal government: 340B ceiling price. Under Section 340B of the Public Health Service Act, a manufacturer of covered outpatient drugs, as a condition of having its drugs be eligible for federal …
As we previously reported, Nevada enacted a law on June 15, 2017 addressing drug prices. S.B. 539 imposed new reporting requirements on pharmaceutical manufacturers and pharmacy benefit managers (“PBMs”) related to diabetes treatments and health care provider payments (also see related posts here and here). …
By Alan M. Kirschenbaum – Just ahead of a predicted snow storm in the Baltimore-Washington area, CMS yesterday issued a blizzard of 658 pages constituting its final regulation implementing changes to the Medicaid Drug Rebate Program. Although this is a final rule, CMS will be accepting comments …
