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 …
By Bill Koustas & Alan Kirschenbaum – In July, we reported that Massachusetts had amended its prescription drug and device marketing law to (among other things) allow pharmaceutical and medical device companies to provide “modest meals and refreshments” as part of an informational presentation to …
By Nisha P. Shah – On July 8, 2012, Massachusetts Governor Deval Patrick signed H. 4200, which, in part, relaxes: (1) the state anti-kickback law to permit the offering of coupons for prescription drug and biological products, and (2) the marketing laws to allow prescription drug …
By Alan M. Kirschenbaum – On May 3, 2012, CMS posted on its website a notice announcing that manufacturers will not be required to collect data under the physician payment sunshine provisions of the Patient Protection and Affordable Care Act before January 1, 2013. As we have …
By Alan M. Kirschenbaum & Michelle L. Butler - A long anticipated proposed revision to CMS regulations governing the Medicaid Drug Rebate Program ("MDRP") appeared in the Federal Register on Thursday, February 2, 2012. As expected, the proposal implements amendments to the MDRP that were enacted …
By Peter M. Jaensch & Alan M. Kirschenbaum – The Office of the Inspector General (“OIG”) of the Department of Health and Human Services has issued a favorable Advisory Opinion on a manufacturer-sponsored patient reminder program for a vaccine, concluding that OIG will not seek penalties under …
By Alan M. Kirschenbaum – Exclusion from Medicare and Medicaid is a potent weapon used by the government against program-related fraud, but it can be a double edged sword when wielded against drug and medical device companies. Exclusion of a drug or device company means that …
