Citing concerns that physicians will be discouraged from conducting research because of "potential mischaracterizations of their income," the Association of Clinical Research Organizations is calling for the CMS to exclude research on drugs not yet approved for sale by the Food and Drug Administration from new payment-reporting requirements.
Research group calls for reporting-rule changes
The requirements are included in a section of the Patient Protection and Affordable Care Act known as the Physician Payments Sunshine Act, which calls for the CMS to annually publish online payments and "transfers of value" made to physicians and teaching hospitals by GPOs and drug, device, biologic and medical supply manufacturers.
"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," Doug Peddicord, ACRO executive director, said in a news release. "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."
In a letter to HHS Secretary Kathleen Sebelius, Peddicord wrote that the CMS compliance cost estimate of $224 million "represents a serious understatement" and that, based on reports from its members, the ACRO estimates the cost of compliance for a large clinical research organization to be $8 million and $10 million in the first year and then $5 million annually in ongoing costs.
The CMS has estimated that the requirements affect some 334,500 physicians, 1,100 teaching hospitals, 1,150 manufacturers and 420 GPOs. Though it was inserted into the healthcare reform law, whose support was split down party lines, the Sunshine Act had bipartisan roots and was co-sponsored by Sen. Chuck Grassley (R-Iowa) and Sen. Herb Kohl (D-Wis.).
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