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Contact: John Lewis
ACRO Implores CMS To Limit
Research Definition For Sunshine Reporting
February 17, 2012 - WASHINGTON, D.C. – Expressing concerns that many physicians will be discouraged from conducting medical research because of cumbersome reporting requirements and potential mischaracterizations of their income, the Association of Clinical Research Organizations (ACRO) is urging the Centers for Medicare & Medicaid Services to adopt a limited definition of research for purposes of reporting under the Physician Payment Sunshine Act.
“While ACRO has maintained, and will continue to argue, that bona fide research activities should be exempt from so-called sunshine reporting, we believe, at a minimum, that CMS should define ‘research’ to exclude any research payments related to drugs that have not yet been approved for sale by the FDA,” said ACRO Executive, Doug Peddicord, Ph.D. “As proposed, the reporting requirements for ‘research’ would be so burdensome, and yield such confusing information, that the costs incurred would far exceed any public benefit that we can see.”
The reporting requirements were included as Section 6002 of the Patient Protection and Affordable Care ACT (PPACA). A 2010 survey of physicians who conduct clinical trials, referred to as investigators, found that 24 percent would be less likely to conduct research or would not participate in research at all if their income were disclosed. ACRO is very concerned that placing one-quarter of the investigator population at risk threatens medical innovation and research related jobs in the United States.
“We understand and support the need for transparency, but this proposed rule, as it applies to research payments, would be difficult if not impossible to implement as it presumes a level of visibility into the allocation of research dollars within medical practices and hospitals that simply does not exist today,” said Peddicord. “Make no mistake, while the ultimate responsibility for reporting these payments falls to pharmaceutical, biotech and medical device companies, there will be substantial compliance costs and burden imposed on physicians and hospitals, diverting valuable resources from patient care.”
ACRO believes that the CMS estimate of $224 million in first-year implementation costs grossly underestimates the actual costs that will be incurred by not only manufacturers and group purchasing organizations but also by CROs, hospitals and medical practices. ACRO has requested that CMS “go back to the drawing board” and provide another iteration of a proposed rule for comment. In any case, ACRO has requested sufficient time to implement any final regulation, up to 15 months, as is consistent with the intent of the law.
ACRO’s full comment can be downloaded here.
The Association of Clinical Research Organizations (ACRO) represents companies that provide a variety of specialized services that support the development of new pharmaceuticals, biologics and medical devices. The association provides an active voice for the CRO industry globally. Through its member companies, ACRO helps improve the quality, efficiency and safety of biomedical research. ACRO member companies employ approximately 75,000 professionals worldwide and annually conduct more than 11,000 clinical trials involving nearly two million participants in 115 countries. For more information, please visit www.acrohealth.org. Twitter @acrohealth.
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