Impatience grows as Sunshine Act not yet finalized
In a joint letter to hasten the implementation of the much-postponed Physician Payments Sunshine Act (PPSA), the National Physicians Alliance (NPA) and the American Medical Student Association (AMSA) has urged the White House Chief of Staff, Jack Lew, to release a final version of the regulation no later than January of this year.
"[We] are deeply discouraged that [Health and Human Services Department (HHS)] has not yet released final regulations, even though the statute called for regulations to be issued by October 1, 2011," wrote NPA executive director, Jean Silver-Isenstadt, and AMSA's PharmFree Fellow, Reshma Ramachandran. "We are now 15 months past the statutory deadline," they added, concluding that "there is no call for further delay."
The Affordable Care Act (ACA) - signed into law in 2010 - includes the PPSA, which requires pharmaceutical, medical devices, biological and medical supply manufacturers to report to the HHS any "payment or other transfer of value" to physicians and teaching hospitals. Benefits ranging from consulting fees to grants, drug samples to catered lunches, will be posted on publicly accessible websites to allow for potential conflicts of interest to be openly considered.
After numerous delays, the Center for Medicare and Medicaid Services (CMS) sent its final rule last November to the Office of Management and Budget (OMB), which has 30 days to review it. Once the OMB provides feedback to the CMS, the latter is allowed up to 90 additional days to issue the final rule. Some companies are currently still required to produce a list of financial ties on March 31 for the 2012 calendar year.
"As physicians and medical students," the letter stated, "we understand that payments from industry can set the stage for significant conflicts of interest that can lead to the prescription of costly treatment, even when equally effective, safe, and less expensive treatments are readily available."
"Such conflicts," they continued, "pose a grave threat to the intent of the Affordable Care Act, which is to deliver quality and affordable care to all Americans. Transparency about industry payments is an important step toward restoring trust and integrity in medicine."
Medical industry and public interest groups have also expressed concern about the delay in finalizing the provision as they need to invest resources and prepare to comply with the PPSA. Medtronic and Pew Charitable Trusts issued a letter to the CMS last November requesting that regulations be finalized no later than December so that procedures can be established to report payments and gifts and "restore trust in our healthcare system."
By Peter Sergo, medwireNews Reporter