Sunshine Act Final Rule Requires CL Manufacturers to Report Payments to ODs but Does Not Apply to Eyeglasses, Sunglasses or OTC Readers
|February 11, 2013 12:30 AM
WASHINGTON, D.C.—Contact Lens manufacturers will now be required to document and report all payments (any transfers of value) they make to physicians (including optometrists), according to the recently released final Sunshine Act ruling. Manufacturers of eyeglasses, sunglasses and over-the-counter readers are exempt under the ruling. Eyeglasses, sunglasses and over-the-counter readers are designated as Class I medical devices and are exempt from the new law. Contact lenses are not Class I medical devices and are not exempt.
Centers for Medicare & Medicaid Services (CMS) announced on Feb. 1, 2013, its
final rule on the “National Physician Payment Transparency Program: Open Payments,” also known as the “Physician Payment Sunshine Act.” One of the many steps in the Patient Protection and Affordable Care Act designed to create greater transparency in the health care market, the Sunshine Act was created to prevent fraud, abuse and waste in the health care system by making the public aware of payments made to health care providers by manufacturers of health care devices.
This rule finalizes the provisions that require manufacturers of drugs, devices, biologicals, and medical supplies covered by Medicare, Medicaid, or the Children’s Health Insurance Program (CHIP) to report payments or other transfers of value they make to physicians and teaching hospitals to CMS. CMS will post that data to a public website. A teaching hospital is defined as any hospital that receives direct or indirect graduate medical education payments from CMS, which will annually publish a list of these hospitals. The final rule also requires manufacturers and group purchasing organizations (GPOs) to disclose to CMS physician ownership or investment interests.
The final rule only applies to medical device products requiring a premarket approval by or premarket notification to the Food and Drug Administration and does not include most Class I medical devices, which are exempt from premarket notification requirements.
In order to give applicable manufacturers and applicable GPOs sufficient time to prepare, data collection will begin on Aug. 1, 2013. Applicable manufacturers and applicable GPOs will report the data for August through December of 2013 to CMS by March 31, 2014, and CMS will release the data on a public website by Sept. 30, 2014. CMS is developing an electronic system to facilitate the reporting process.
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