Alan E. Reider, JD, MPH

KOLOA, Hawaii ― No matter what happens with respect to Trumpcare in the next 2 or 3 years, there will be more and more consolidation in health care, reflecting a "bigger is better" trend, according to Alan E. Reider, JD, MPH, who spoke on the topic at Hawaiian Eye 2017.

Alan E. Reider, JD, MPH, and Allison Shuren, MSN, JD, at Hawaiian Eye 2017.

Kevin Corcoran, COE, CPC, FNAO, SPMA, Donna M. McCune, CCS-P, COE, CPMA, Alan Reider, JD, MPH, Allison Shuren, MSN, JD, and Candace S. Simerson, COE, CMPE, CAHCM, at Hawaiian Eye 2017.

Alan E. Reider, LD, MPH, Allison W. Shuren, MSN, JD, and Candace S. Simerson, COE, CMPE, CAHCH, at Hawaiian Eye 2017.

To ensure compliance with the Sunshine Act, medical device manufacturers have several unique factors to consider due to the nuances and intricacies of medical device development not applicable to manufacturers of drugs, biologicals or suppliers. For example, in many cases, physicians need to test, evaluate and be trained on medical devices before their practice or institution will purchase or use the device, which in some cases is mandated by the U.S. Food and Drug Administration in its device clearance or approval letter. These interactions, which are necessary to ensure the safety and efficacy of the medical device in patients, are all subject to the reporting requirements under the Sunshine Act, eg, education or training; associated educational or training materials; meals, travel and lodging; or honoraria.

As noted in part 1 of this series in the April 25 issue of Ocular Surgery News, the Physician Payments Sunshine Act requires “applicable manufacturers” of drugs, devices, biologicals or medical supplies covered under Medicare, Medicaid or CHIP to report annually to the Centers for Medicare and Medicaid Services, in an electronic format, certain payments or other transfers of value to “covered recipients” — physicians and teaching hospitals. These include, but are not limited to, payments for meals, travel, research, consulting, honoraria, training or education, grants, textbooks, journal reprints and other related items.

Somewhere between the extreme of having your Medicare contractor ask you for records to confirm the medical necessity of services provided and being visited by the FBI and Office of the Inspector General as part of a criminal investigation is a relatively new initiative that is creating headaches for the physician community.

Somewhere between the extreme of having your Medicare contractor ask you for records to confirm the medical necessity of services provided and being visited by the FBI and Office of the Inspector General as part of a criminal investigation is a relatively new initiative that is creating headaches for the physician community.

In the summer of 2009, a prominent Indiana ophthalmologist and his wife were accused in a U.S. District Court of medical fraud and, days later, died in a reported murder-suicide. The couple was accused of making false and fraudulent cataract diagnoses and performing unnecessary cataract surgeries.

Alan E. Reider Allison Weber Shuren I have been writing about health care compliance issues for many years, but never have I written about a managed care case. And before you turn the page to look for something relevant to your practice, I urge you to be patient and read on. Although this article involves a managed care company, it really is about the extraordinary reach of government enforcement and how missteps by health care providers may generate unanticipated liability. It is a lesson that applies to everyone. For years, health care enforcement has been driven by the extraordinary power of the False Claims Act. A violation of the act triggers liability of three times the amount of damages, plus a penalty of $5,500 to $11,000 per claim. Although early False Claims Act cases focused on prosecuting providers for submitting claims that were false, such as upcoding, billing for a non-covered service as if it were a covered service or billing for a service not performed at all, government theories of liability under the statute have expanded dramatically. For example, in the early 1990s, laboratories were pursued under the False Claims Act, not because they submitted false claims, but because they influenced physicians to order tests that were not medically necessary, thereby causing a false claim to be submitted.