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    • VA Changes Course to Require Covered Drugs that are TAA Non-Compliant to be Available on the Federal Supply ScheduleApril 21st, 2016

      By Michelle L. Butler & and Alan M. Kirschenbaum – The Department of Veterans Affairs (VA) recently issued an Important Notice on its website regarding a change in policy with regard to covered drugs (drugs approved via new drug applications, including authorized generics, and biologics license …

    • Research Institution Pays $3.9 million HIPAA Settlement for BreachMarch 20th, 2016

      By David C. Gibbons & Jeffrey N. Wasserstein – On March 16, 2016, the Feinstein Institute for Medical Research, located in Manhasset, New York, (“Feinstein”) entered into an agreement with the U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) to pay $3.9 …

    • CMS Proposes Far-Reaching Pilot to Test Alternative Drug Payment Models Under Medicare Part BMarch 10th, 2016

      By David C. Gibbons & Alan M. Kirschenbaum – On March 8, 2016, CMS issued a proposed rule to test new models for payment of drugs and biologicals under Medicare Part B (“Proposed Rule”). Medicare Part B covers limited categories of drugs, including (1) those provided incident …

    • Free Webinar on the Medicaid Rebate Final RuleFebruary 16th, 2016

      In collaboration with KPMG’s government pricing leaders, Hyman, Phelps & McNamara, P.C. (“HP&M”) will conduct a free webinar on the recently published Medicaid Rebate Final Rule (see our previous post here).  The webinar, titled “A Practical Guide the Medicaid Rebate Final Rule,” will be held …

    • Medicaid Rebate Final Rule Published in Federal Register; HP&M Issues Summary, Schedules WebinarFebruary 2nd, 2016

      By Alan M. Kirschenbaum, Michelle L. Butler & David C. Gibbons – The February 1st Federal Register contains CMS’s final rule implementing changes to the Medicaid Drug Rebate Program (MDRP). The rule had been released for prepublication review on January 21. This rule, which has an effective date of …

    • CMS Releases Final Medicaid Rebate RuleJanuary 22nd, 2016

      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 …

    • Final Medicaid Rebate Regulation Clears OMB, Bound for PublicationDecember 14th, 2015

      By Alan M. Kirschenbaum – If you’re looking for Holiday reading, CMS has a gift for you! OMB’s Office of Information Regulatory Affairs (OIRA) has completed its review of a long-awaited CMS final regulation implementing significant changes to the Medicaid Drug Rebate Program.  Completion of the review …

    • Texas Proposes Repeal of Price Reporting RequirementNovember 10th, 2015

      By Alan M. Kirschenbaum – The October 30, 2015 Texas Register contained a proposed regulation published by the Health and Human Services Commission (HHSC) that would repeal a burdensome price reporting requirement for drug manufacturers.  In order to have a drug included on the Texas fee-for-service …

    • HRSA Issues Long-Awaited 340B Mega-Guidance; HP&M Issues SummarySeptember 4th, 2015

      By Alan M. Kirschenbaum, Michelle L. Butler & David C. Gibbons – On August 28, 2015, the Health Resources and Services Administration (HRSA) of the Department of Health and Human Services published an omnibus guidance document to implement the 340B Drug Discount Program (the Proposed Guidance). Since …

    • Recent OIG Advisory Opinions Involving Benefits Provided to Patients Are of Special Interest to Drug and Device ManufacturersAugust 12th, 2015

      By David C. Gibbons & Alan M. Kirschenbaum – The U.S. Department of Health and Human Services Office of Inspector General (“OIG”) has recently issued two Advisory Opinions involving patient benefits provided by drug and device manufacturers.  Advisory Opinion 15-11, posted today, involves a manufacturer’s short-term …

    • Long Awaited Medicaid Rebate Rule Under Review by OMBAugust 5th, 2015

      By Alan M. Kirschenbaum – Yesterday, CMS’s final Medicaid Drug Rebate Program rule arrived on the doorstep of OMB’s Office of Information and Regulatory Affairs (OIRA) for review under Executive Order 12866.  Under the Executive Order, OIRA ordinarily has 90 days to complete its review, with …

    • HRSA Proposes to Collect Manufacturer Pricing Data Under 340B ProgramApril 23rd, 2015

      By David C. Gibbons – On Tuesday, April 21, 2015, the U.S. Department of Health and Human Services Health Resources and Services Administration (“HRSA”) issued a Notice soliciting comments on its proposal to collect pricing data from drug manufacturers under the 340B drug discount program.  This …

    • Two Developments in Transparency ReportingApril 2nd, 2015

      By Jennifer D. Newberger – Federal Sunshine Law:  On March 31, 2015, CMS issued an email notice that the Open Payments data submission period will remain open until midnight on Friday, April 3, 2015, “to accommodate all applicable manufacturers and group purchasing organizations (GPOs) that are …

    • HRSA’s 340B Orphan Drug Exclusion Rule is Briefed for its Third Judicial ReviewMarch 15th, 2015

      By Jay W. Cormier & Alan M. Kirschenbaum – The stage is set for yet another court ruling in the battle between the Health Resources and Services Administration (HRSA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) over HRSA’s implementation of the 340B Orphan Drug Rule.  …

    • CMS Sets New Date for Final Medicaid Rebate Regulation Re-WriteDecember 11th, 2014

      By Alan M. Kirschenbaum – A CMS final regulation implementing changes to the Medicaid Drug Rebate Program (MDRP) is now scheduled to be published in April 2015, according to OMB’s updated current Unified Agenda of Regulatory and Deregulatory Actions.  Before you mark that in your calendar …