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    • FDA Law Alert – September 2020September 10th, 2020

      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 …

    • CMS Cuts in Drug Payment to Hospitals for 340B Drugs – Post ScriptAugust 5th, 2020

      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 …

    • D.C. Circuit Reverses Lower Court, Clearing the Way for CMS Cuts in Drug Payment to 340B HospitalsAugust 3rd, 2020

      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 …

    • Donald Trump Issues Executive Orders to Control Prescription Drug PricesJuly 27th, 2020

      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 …

    • Medicaid Drug Rebate Program Update: CMS Publishes Proposed Rule Addressing Value Based Purchasing Arrangements and Other Topics; D.C. District Court Opposes Base AMP ResetJune 26th, 2020

      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.  …

    • FDA Law Alert – February 2020February 10th, 2020

      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 …

    • HP&M’s Serra Schlanger to Present on State Drug Price Reporting LawsJanuary 24th, 2020

      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 …

    • PhRMA Challenges Oregon Drug Pricing Transparency LawsJanuary 2nd, 2020

      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 …

    • FDA Law Alert – November 2019November 6th, 2019

      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 …

    • When FDA and the Practice of (Tele)Medicine CollideOctober 24th, 2019

      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 …

    • CMS and OIG Propose Changes to the Stark Law, Anti-Kickback Statute and Civil Monetary Penalty RuleOctober 22nd, 2019

      In the Federal Register of Thursday, October 17, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) Office of Inspector General (OIG) both published substantial amendments to the regulations implementing the Medicare physician self-referral law (commonly referred …

    • Continuing Appropriations Act Changes Treatment of Authorized Generics in Medicaid Rebate Average Manufacturer PriceOctober 8th, 2019

      Buried in a recently enacted continuing appropriations act for FY 2020 is a provision amending the Medicaid Drug Rebate statute as it relates to authorized generics. See Continuing Appropriations Act, 2020, and Health Extenders Act of 2019, § 1603.  Under CMS regulations, NDA holders (“primary …

    • CMS Proposes Regulations to Expand Sunshine ReportingAugust 14th, 2019

      Among the provisions contained in CMS’ proposed Physician Fee Schedule revisions for 2020, which appeared in today’s Federal Register, were proposed changes to the Open Payments program (sometimes called the Physician Payment Sunshine Law).  See 84 Fed. Reg. 40482, 40713-16 (Aug. 14, 2019).  Some of …

    • Brief Updates on California and Colorado Drug Price Reporting LawsAugust 8th, 2019

      California Last week, U.S. District Court Judge Morrison C. England Jr. denied the state of California’s motion to dismiss PhRMA’s lawsuit challenging SB 17, which was signed into law in October 2017 and became effective on January 1, 2018.  (Our summary of SB 17 is available …

    • FDA Law Alert: Issue #2August 7th, 2019

      Hyman, Phelps & McNamara, P.C. is pleased to publish this second issue of the FDA Law Alert, a 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 enforcement …