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 …
