On Friday, CMS released a long-awaited final rule on the Physician Payments Sunshine Act, outlining a timeline for its implementation, Modern Healthcare reports (Lee, Modern Healthcare, 2/1).
In December 2011, CMS released a proposed rule detailing procedures for drugmakers and medical device makers to report payments to physicians and teaching hospitals, as required by the Sunshine Act. Last year, CMS said it planned to issue a final rule by the end of 2012.
The Sunshine Act -- established under the Affordable Care Act -- requires medical industry companies to disclose all consulting fees, travel reimbursements, research grants and other gifts with values over $10 that they give to physicians and teaching hospitals.
The delay prompted several advocacy and physician groups and a GOP senator to send letters to the White House urging the administration to finalize the rule.
In a statement announcing the final rule, Peter Budetti -- deputy administrator for Program Integrity at CMS -- said the "[d]isclosure of these relationships allows patients to have more informed discussions with their doctors" (Viebeck, "Healthwatch," The Hill, 2/1).
Details of Final Rule
Under the final rule, manufacturers of pharmaceutical and biological drugs, medical devices and medical supplies -- covered by Medicare, Medicaid and CHIP -- starting Aug. 1 will be expected to report all transfers of monetary value over $10 to physicians and teaching hospitals (Bunis, CQ HealthBeat, 2/1).
The types of transfers that must be reported include charitable contributions, consulting fees, honoraria, and food, entertainment and travel reimbursements, The Hill's "Healthwatch" reports ("Healthwatch," The Hill, 2/1). In addition, the manufacturers and group purchasing organizations will be responsible for reporting physician ownership and investment interests.
CMS set the Aug. 1 start-date for data collection to give the affected entities time to prepare, officials said. All data collected from August through December must be reported to CMS by March 31, 2014, according to the rule (CQ HealthBeat, 2/1). The agency will publish the data on a public website by Sept. 30, 2014, one year later than the date originally set in the ACA (Modern Healthcare, 2/1). CMS is creating an electronic system to help facilitate the reporting process, according to CQ HealthBeat (CQ HealthBeat, 2/1).
Physicians will be given a 45-day "review and correction" period to ensure the accuracy of any disclosures to CMS, according to the final rule. The rule also notes that the Sunshine Act overrides similar state laws, creating the possibility of "cost-savings, since a single reporting system for reporting this information is less burdensome than multiple programs" ("Healthwatch," The Hill, 2/1).
The final rule is scheduled for publication in the Federal Register on Feb. 8 (Frieden, MedPage Today, 2/1).
Sen. Grassley, AMA React to Final Rule
In a statement released Friday, Sen. Chuck Grassley (R-Iowa) -- who authored the Sunshine Act with former Sen. Herb Kohl (D-Wis.) and pressed the administration to finalize the rule -- said the final rule brings "about accountability, and accountability will strengthen the credibility of medical research, the marketing of ideas and, ultimately, the practice of medicine" ("Healthwatch," The Hill, 2/1).
Jeremy Lazarus, president of the American Medical Association, in a statement said the AMA will "carefully review" the rule, adding, "As the rule is implemented, we will work to make sure physicians have up-to-date information about the new reporting process" (MedPage Today, 2/1).