Print“An absence of established procedures could harm both the companies who are trying to comply with the law and the public who stands to benefit from increased transparency of these relationships.”
Drug and medical device companies awaiting the release of federal rules on reporting gifts and payments to doctors are still waiting, more than a month after the rules were due for release.
Companies responsible for complying with the Physician Payment Sunshine Act expected details about how to disclose gifts to healthcare providers from the Centers for Medicare and Medicaid Services by October 1, but that deadline passed with no rules in sight.
The Act requires public disclosure of cash payments, gifts, and other items valued at more than $10 to doctors and teaching hospitals. It is slated to take effect January 1, 2012.
In preparation, some companies, such as Pfizer and GlaxoSmithKline, have already released data. But, without formal guidance, there’s little uniformity in the way such disclosures are made.
Furthermore, without the rules, a coalition of drug and device industry representatives said in a letter to U.S. Department of Health and Human Services Secretary Kathleen Sebelius “An absence of established procedures could harm both the companies who are trying to comply with the law and the public who stands to benefit from increased transparency of these relationships.”
U.S. Senators Chuck Grassley, R-Iowa, and Herb Kohl, D-Wisconsin, who co-developed the Act, have also criticized CMS for the delay’s potential to “create confusion among both manufacturers and consumers, potentially placing taxpayer dollars at risk.”
Top CMS administrator Donald Berwick says his agency is working on the rules, but it is also seeking to comply with the Obama administration’s directive to reduce regulatory burdens.
“In that vein, CMS is carefully reviewing this statutory requirement and working hard to ensure we meet these goals,” Berwick wrote in a letter to the Senators.
Sen. Grassley called the response “inadequate,” while Sen. Kohl expressed disdain for it coming a month after his original complaint about the delay.
November 04, 2011
http://www.burrillreport.com/article-payment_disclosure_rules_still_unclear.html
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