On February 22, the Wall Street Journal published an article about the tissue graft manufacturer MiMedx Goup, Inc. and its failure to report payments to physicians under CMS’s Open Payments Program established by the Centers for Medicare & Medicaid Services under the Patient Protection and Affordable Care Act (P.L. 111-148, Sec. 6002, amending Social Security Act Sec. 1128G), also known as the Physician Payments Sunshine Act (PPSA).  MiMedx executives claim that such reporting is unnecessary because the company’s products are tissues, which are not explicitly included in the regulatory definition of “covered drug, device, biological, or medical supply” to which the Open Payments Program apply (42 C.F.R. 403.902). As a result of falling outside this definition, MiMedx argues that it is not an “applicable manufacturer” required to disclose payments to physicians and teaching hospitals.  MiMedx’s product-specific reasoning aside, the company’s argument brings up an interesting point about the evolution of FDA-regulated products and the enforcement of the Open Payments Program requirements: Does the PPSA, and its corresponding regulations, require manufacturers of tissue-based therapies to disclose payment information? Continue Reading Are HCT/Ps a Dark Spot in the Sunshine Act Requirements?

Last week, HHS, along with the Department of Labor and the Treasury, provided long overdue guidance regarding the third category of supplemental “excepted benefits” as defined by Section 2791 of the Public Health Services Act, Section 733 of ERISA and Section 9832 of the Internal Revenue Service Code.  Coverage that meets the definition of supplemental excepted benefits is not required to comply with a variety of requirements, including certain requirements established under the Affordable Care Act.

The first two categories of supplemental excepted benefits were relatively well-defined as coverage meeting the definition of Medicare supplemental health insurance and Tricare supplemental programs, but the third category of “similar” supplemental coverage had left policy issuers scratching their heads.

The agencies last provided substantive guidance on what qualifies as supplemental excepted benefits in 2008.  In their announcement last week, the agencies repeated their previous guidance and addressed whether supplemental coverage that provided additional categories of benefits, rather than just reducing coinsurance and deductibles under the insured’s primary coverage, could qualify as “excepted.”  The agencies responded with the age old legal answer of “it depends.”

Continue Reading Supplemental Excepted Benefits? “It depends.”