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    • 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 …

    • HRSA’s 340B “Mega-Rule” Becomes Casualty of PhRMA Lawsuit Against Orphan Drug RuleNovember 18th, 2014

      By Michelle L. Butler & Alan M. Kirschenbaum – On November 13, 2014, the Health Resources and Services Administration (“HRSA”) withdrew the 340B program “mega-rule” it had submitted for review to the Office of Management and Budget.  In a previous blog post we reported on a …

    • CMS Eliminates CME Exclusion Under Sunshine RuleNovember 4th, 2014

      By Jennifer D. Newberger & Alan M. Kirschenbaum – On October 31, 2014, the Centers for Medicare & Medicaid Services ("CMS") finalized changes to the regulations implementing the Affordable Care Act’s transparency reporting provisions, otherwise known as the Physician Payment Sunshine Act ("Sunshine Act").  The original Sunshine …

    • OIG Proposes Antikickback Law Safe Harbors and CMP Rules that Would Offer Additional Protections for Pharmaceutical and Device ManufacturersOctober 13th, 2014

      By Alan M. Kirschenbaum & David C. Gibbons – On October 3, 2014, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) published a Proposed Rule to amend the safe harbor regulations under the Federal health care program antikickback statute (“AKS”) (42 …

    • Mostly Cloudy with a Little Bit of Sunshine—Accuracy of CMS’s Release of “Sunshine” Data QuestionedOctober 2nd, 2014

      By Jennifer D. Newberger – On September 30, 2014, the Centers for Medicare & Medicaid Services (“CMS”) released for public review the first round of Open Payments (more commonly known as “Sunshine”) data.  According to CMS, the Sunshine data is intended to “help consumers understand the …