On August 3, 2026, the Health Resources and Services Administration (HRSA) published a Federal Register notice announcing a revised 340B Rebate Model Pilot Program, stating that, for a defined set of drugs, “rebates will be used instead of upfront discounts.” It is HRSA’s second attempt …
Hyman, Phelps & McNamara, P.C. (HPM) is pleased to announce that Abdie Santiago has joined the firm as an Associate. Mr. Santiago advises healthcare and life sciences clients on a broad range of healthcare regulatory and compliance matters, including fraud and abuse issues, federal drug pricing …
Yesterday, we posted Part I of our update on CMS’s proposed regulations to establish two most favored nation (MFN) demonstration models under Medicare Parts B and D, focusing on the Part D model, called Guarding U.S. Medicare Against Rising Drug Costs (GUARD). In this post, we …
In November, we posted that the New Year would be bringing us GENEROUS, a new Medicaid demonstration model initiated through CMS’s Center for Medicare and Medicaid Innovation (CMMI), which will permit drug manufacturers to enter into voluntary agreements with state Medicaid programs to provide most …
Last Friday, October 31, the Centers for Medicare & Medicaid Services (CMS) released the Calendar Year (CY) 2026 Medicare Physician Fee Schedule (PFS) Final Rule, which contained important changes in regulations governing the calculation of average sales price (ASP) for drugs covered under Medicare Part …
The Calendar Year 2026 Medicare Physician Fee Schedule (PFS) proposed rule (here), which was issued yesterday by CMS, contained important amendments to the regulations on Medicare Part B average sales price (ASP) reporting. One amendment would add provisions for bundled sales that are consistent with …
Following up on Donald Trump’s May 12 Executive Order on Most Favored Nation Prescription Drug Pricing (see our post here), The Department of Health and Human Services today issued a brief press release answering a few of the multitude of questions raised by the Executive …
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 annual Life Sciences Pricing & Contracting USA Summit, which is being held virtually and in-person in Philadelphia on May 19-21. Ms. Gaulkin’s presentation, Product Price …
There has been increased enforcement against medical device companies that engage in the pervasive practice of paying third party sales agents based on their volume of sales. This scrutiny was enhanced after the Fourth Circuit’s ruling in United States v. Mallory, 988 F.3d 730 (4th …
Drug manufacturers won’t be receiving their first invoices for Medicare Part B and Part D inflation rebates until later this year, but rebates have been accruing since first quarter 2023 for Part B rebates and October 2022 for Part D rebates. To help our readers …
On Wednesday, December 11, Hyman, Phelps & McNamara, P.C. (HPM) and Riparian LLC will co-host a webinar on an important CMS rule imposing penalties for misclassification of drugs and other reporting errors under the Medicaid Drug Rebate Program. (See our post on this rule here.) …
On Wednesday, December 11, Hyman, Phelps & McNamara, P.C. (HPM) and Riparian LLC will co-host a webinar on an important CMS rule imposing penalties for misclassification of drugs and other reporting errors under the Medicaid Drug Rebate Program. (See our post on this rule here.) …
In May 2023, we posted about a CMS proposed regulation that sought to make a wide variety of changes to the Medicaid Drug Rebate Program (MDRP), including a new “price verification survey,” and a controversial proposal to require “stacking” of discounts to different customers when …
Enacted in 2022, the Inflation Reduction Act (IRA) amended the Medicare provisions of the Social Security Act to impose several discount requirements on pharmaceutical manufacturers. In addition to the widely publicized drug price negotiation program, the IRA established inflation rebate programs under Medicare Part B …
Today’s email brings an interesting, and somewhat confusing settlement of what should have been an ordinary antikickback statute case, and may bring about a clash between what many companies do and what the government may be objecting to. Or, perhaps your loyal blogger is reading …
