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    • 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 …

    • A Round Up of New State Laws to Control Drug PricesJuly 8th, 2019

      While the federal government continues to debate the hot topic of drug prices, states continue to pass new laws designed to tackle drug pricing, price reporting, and discounting.  We’ve previously reported on the laws passed in California, Connecticut, Louisiana, Maryland, Nevada, New York, Oregon, Vermont …

    • Federal Court Punts Regarding Remedy Related to CMS’ Invalidated Rule Concerning Medicare Hospital Outpatient Payment Rates for 340B DrugsMay 17th, 2019

      On May 6, 2019, the United States District Court for the District of Columbia issued a Memorandum and Opinion concerning the remedy available to Plaintiffs following the same court’s earlier decision (see our previous post regarding the court’s earlier decision here) invalidating a final rule …

    • Two More States Seek to Establish Prescription Drug Importation ProgramsMay 12th, 2019

      Colorado and Florida have joined Vermont in the list of states seeking to combat high prescription drug prices by establishing programs to import drugs from Canada.  On April 29, 2019, the Florida legislature passed CS/HB 19, which directs the state’s Agency for Health Care Administration …

    • New Jersey Attorney General Loosens Rules on the Acceptance by Prescribers of Remuneration from Drug ManufacturersMay 9th, 2019

      Responding to objections from New Jersey healthcare practitioners, hospitality and restaurant businesses, and the pharmaceutical industry, the New Jersey Attorney General published an amendment to the state’s rules restricting the acceptance of remuneration by prescribers from pharmaceutical manufacturers.  The final amendment, which appeared in the …

    • Post Script on “Right Rebate” LawApril 24th, 2019

      As expected, Donald Trump has signed the Medicaid Services Investment and Accountability Act of 2019 (H.R. 1839), which, among other things, amends the Medicaid Drug Rebate statute to impose penalties for misclassifying innovator drugs as non-innovator drugs to reduce rebates.  We previously posted on this …

    • Medicaid “Right Rebate” Provisions Clear CongressApril 5th, 2019

      The Senate on Tuesday passed H.R. 1839, a bill of Medicaid amendments that included new penalties for mis-categorizing a drug under the Medicaid Drug Rebate Program (MDRP).  The bill already cleared the House on March 25, and is now headed to Donald Trump for signature.  …

    • Laboratories Beware of EKRAMarch 5th, 2019

      On October 24, 2018, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (“SUPPORT”) for Patients and Communities Act was signed into law (the Act’s text is available here).  The SUPPORT Act includes a number of provisions to address the ongoing opioid crisis, such …

    • Telemedicine Lunch-and-Learn at HP&MFebruary 25th, 2019

      Hyman, Phelps & McNamara, P.C. (HP&M) is proud to announce that two associates, Serra Schlanger and Rachael Hunt, will be hosting a program on telemedicine for FDLI’s New to Food and Drug Law Group (NFDL). Telemedicine: Key Issues to Consider When Advising Clients, will take place …