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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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. …
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 …
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 …
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 …
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 …
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 …
By Jay W. Cormier & Alan M. Kirschenbaum – In an advisory opinion posted on Monday, July 28, 2014, the Office of the Inspector General of the Department of Health and Human Services (“OIG”) determined that no enforcement action would be taken against a drug manufacturer’s …
