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 …
By Delia A. Stubbs & Alan M. Kirschenbaum – Yesterday, in a letter to Representative Jim McDermott, Secretary of Health and Human Services (“HHS”) Kathleen Sebelius stated that qualified health plans (“QHPs”) and other programs related to health insurance exchanges under Title I of the …
By Jeffrey N. Wasserstein and Alexander J. Varond – On September 11, 2013, Adheris, Inc. (“Adheris”) and the Department of Health and Human Services (“HHS”) filed a joint motion requesting the suspension of Adheris’s motion for a preliminary injunction seeking to prohibit HHS from enforcing its …
By Jeffrey N. Wasserstein & Alexander J. Varond – Several months ago, when HHS released the final HITECH rule, we noted that several of the provisions represented a sea change from prior practice (see our previous post here). Well, the seas have gotten rougher and …
By Jessica A. Ritsick – The Fifth Circuit earlier this month, in Elgin Nursing and Rehab Ctr. v. U.S. Dep’t of Health and Human Servs., No. 12-60086, 2013 WL 2149873 (5th Cir. May 17, 2013), struck down a decision by the Department of Health and …
By Delia A. Stubbs & Alan M. Kirschenbaum – Yesterday the OIG issued a Special Fraud Alert on physician owned distributorships, or PODs. The OIG describes these entities as “physician owned entities that derive revenue from selling, or arranging for the sale of, implantable medical …
By Alan M. Kirschenbaum & Jennifer D. Newberger – Sixteen months past its statutory deadline, CMS issued last Friday a pre-publication version of its final regulation implementing the physician payment transparency provisions of the Patient Protection and Affordable Care Act. The rule is scheduled for publication in …
