In both civil and criminal enforcement proceedings, 2017 was perhaps most notable for the cases brought against individual health care providers and small physician practice owners.  Among the factors that may have resulted in the uptick in cases against individuals are the Yates Memo issued in late 2015, improved and increased reliance on sophisticated data analytics, and the aggressive focus on opioid addiction and its causes. Continue Reading Health Care Enforcement Review and 2018 Outlook: Criminal and Civil Enforcement Trends

As reported in our 2015 Laboratory Industry Year in Review post, the laboratory industry began 2016 amid confusion regarding how to comply with the Protecting Access to Medicare Act of 2014 (PAMA), which made the most significant changes to the Medicare Part B payment structure for laboratories since implementation of the Medicare Clinical Laboratory Fee Schedule (MCLFS) in 1984.  Despite PAMA’s requirement that the Centers for Medicare & Medicaid Services (CMS) publish final regulations no later than June 30, 2015, CMS did not issue a proposed rule until October 1st and has yet to follow up with the final rule.  Given stakeholders’ substantial concerns regarding the proposed rule – and the track record of CMS – the delay is not surprising. Continue Reading Delay in Final Rule Implementing PAMA: Sunshine Act Revisited?

Written by Brian Dunphy and Kate Stewart

Seventy-four state and federal physician organizations, including the American Medical Associationrecently asked the Centers for Medicare & Medicaid Services (“CMS”) to exclude textbooks and peer-reviewed medical journal reprints from the Sunshine Act’s reporting requirements.

As is well known, the Sunshine Act statute and regulations require pharmaceutical and medical device manufacturers (“Manufacturers”) to report payments and transfers of value to physicians and teaching hospitals.  Several types of payments are excluded from reporting, including the provision of educational materials that directly benefit patients or are intended for patient use.  CMS determined in the Sunshine Act regulations that medical textbooks, reprints of peer-reviewed scientific clinical journal articles, and abstracts of these articles do not fit within this reporting exception because they are not directly beneficial to patients or intended for patient use.  Manufacturers must therefore report instances where they provide these materials to physicians.  The physician groups disagree with CMS’s interpretation, which they argue is inconsistent with the Sunshine Act statute, congressional intent in passing the Sunshine Act, and “the reality of clinical practice where patients benefit directly from improved physician medical knowledge.”

Continue Reading Physician Groups Seek Sunshine Act Changes