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 …
By Michelle L. Butler – On July 21, 2014, the Department of Health and Human Services (“HHS”)/Health Resources and Services Administration (“HRSA”) announced the availability of an interpretive rule titled “Implementation of the Exclusion of Orphan Drugs for Certain Covered Entities Under the 340B Program,” which …
By Alan M. Kirschenbaum – Today the Office of the Inspector General (OIG) of the Department of Health and Human Services issued a “Special Fraud Alert on Laboratory Payments to Referring Physicians.” Despite the focus of the Special Fraud Alert on activities of laboratories, drug and …
By Jay W. Cormier & Alan M. Kirschenbaum – Last summer, the Health Resources and Services Administration (“HRSA”) promulgated a final regulation to implement a statutory provision, added by the Affordable Care Act, that excludes orphan drugs from the ceiling price limitations of the 340B Program …
By Alan M. Kirschenbaum – CMS has posted relevant dates, instructions and other information regarding “Phase 2” of the 2014 reporting process under the Physician Payment Sunshine Act. (Background on this law and the 2014 reporting process can be found here.) CMS announced that Phase 2 of …
By James C. Shehan – According to St Francis of Assisi, “where there is charity and wisdom, there is neither fear nor ignorance.” As we contemplate the policy changes announced in the just-issued OIG Supplemental Special Advisory Bulletin on Independent Charity Patient Assistance Programs (PAPs), we …
By Jeffrey N. Wasserstein – Either Senator Lamar Alexander (R-Tenn) reads the FDA Law Blog, or great minds truly think alike. On February 20, 2014, Senator Alexander wrote to Secretary of Health and Human Services (HHS) Kathleen Sebelius asking her to clarify HHS’s position regarding patient …
By Jennifer D. Newberger & Alan M. Kirschenbaum – Last Friday, CMS issued a notice announcing the opening of registration for electronic Open Payments reporting under the physician payment sunshine provisions of the Affordable Care Act. (A previous post on the sunshine provisions and our memo …
By Jeffrey N. Wasserstein & Jennifer M. Thomas – Yesterday, the Department of Health and Human Services (HHS), announced a final rule (published in the Federal Register on February 6, 2014 – here) amending the Department’s Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations, and the …
