Buried in the 2,124-page Consolidated Appropriations Act, 2021 (the Act), which was signed by Donald Trump yesterday, was a brief provision requiring the reporting of average sales price (ASP) by manufacturers that do not have a Medicaid Drug Rebate Agreement. ASP is used by CMS …
As part of its final push to lower drug prices, the Trump administration announced that it was finalizing a January 2019 proposed rule to amend the safe harbor provisions relating to manufacturer rebates to Medicare Part D plans, Medicaid Managed Care Organizations (MCOs) and their …
To close out 2020, Hyman, Phelps & McNamara, P.C. is pleased to present the latest issue of our quarterly newsletter highlighting key postings from our nationally acclaimed FDA Law Blog. Please subscribe to the FDA Law Blog to receive contemporaneous posts on regulatory and enforcement …
On November 5, the Maryland Federal District Court dismissed a Federal False Claims Act qui tam suit alleging that Forest Laboratories knowingly reported inflated best prices under the Medicaid Drug Rebate Program (MDRP), resulting in underpayment of rebates. United States ex. rel. Sheldon et al. …
Hyman, Phelps & McNamara, P.C. is pleased to announce that Serra Schlanger will present at this year’s Drug Pricing Transparency Congress, a virtual conference, on November 16–17, 2020. This conference gathers stakeholders to examine the evolving landscape of state drug price reporting and transparency efforts. …
During these unprecedented times, Hyman, Phelps & McNamara, P.C. is pleased to bring you the next installment of our quarterly newsletter highlighting key postings from our nationally acclaimed FDA Law Blog. Please subscribe to the FDA Law Blog to receive contemporaneous posts on regulatory and …
Our post was a day too early. Yesterday, we posted an article on a D.C. Circuit decision upholding CMS’s payment cuts to hospitals for drugs purchased under the 340B Drug Discount Program. We wrote in that post that CMS was expected very soon to issue its …
In December 2018, we reported on a decision of the Federal District Court for the District of Columbia enjoining CMS from implementing a 28.5% cut in Medicare Part B drug payments to hospitals that purchase drugs under the 340B Drug Discount Program. On Friday, July …
On Friday, July 24, Donald Trump signed three Executive Orders addressing the high prices of prescription drugs, and threatened to sign a fourth if drug manufacturers do not put forward acceptable proposals for reducing prices. For the most part, these Orders recycle proposals previously issued …
CMS Proposed MDRP regulation: In the Federal Register of Friday, June 19, CMS published a proposed rule to implement statutory amendments to the Medicaid Rebate Program statute, and to add CMS’s own policy proposals to encourage value based purchasing arrangements and discourage patient copay assistance. …
Hyman, Phelps & McNamara, P.C. is pleased to publish the first FDA Law Alert of the new year. This is the fourth installment of our quarterly newsletter highlighting key postings from our nationally acclaimed FDA Law Blog. Please subscribe to the FDA Law Blog to …
Hyman, Phelps & McNamara, P.C. is pleased to announce that Serra Schlanger will present at this year’s Drug Pricing Transparency Congress, to be held in Philadelphia, PA on March 30-31, 2020. This conference gathers stakeholders to examine the evolving landscape of state drug price reporting …
On December 9, 2019, the Pharmaceutical Research and Manufacturers of America (PhRMA) filed a civil action in the United States District Court for the District of Oregon seeking declaratory and injunctive relief against the Acting Director of the Oregon Department of Consumer and Business Services …
Hyman, Phelps & McNamara, P.C. is pleased to publish the third installment of the FDA Law Alert, a quarterly newsletter highlighting key postings from our nationally acclaimed FDA Law Blog. Please subscribe to the FDA Law Blog to receive contemporaneous posts on government regulatory and …
It is generally accepted that FDA’s authority under the Federal Food, Drug, and Cosmetic Act (FDCA) does not allow for FDA to regulate the practice of medicine. FDCA § 1006 (21 U.S.C. § 396) explicitly states that FDA may not interfere with the practice of medicine …
