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CMS action raises questions about accuracy of Sunshine Act data


By Jaimy Lee
Posted: August 8, 2014 - 2:00 pm ET
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The CMS has removed the provider review version of a new database that details financial relationships between healthcare providers and drug and medical-device manufacturers.

It's unclear whether pulling the system offline signals that all its Sunshine Act-mandated information about payments to physicians and teaching hospitals from drug and medical-device makers will be publicly available Sept. 30 as originally scheduled.

“We don't know if that means there will be a delay in the launch of the entire website,” said Dr. Daniel Carlat, director of the Prescription Project at the Pew Charitable Trusts. “This seems just like an appropriate part of the CMS' diligence in making sure the website eventually works smoothly and delivers accurate data once it is launched.”

In an Aug. 7 e-mail, the CMS said the system has been temporarily taken offline to investigate a reported issue. It did not specify the issue. Physicians, teaching hospitals and other authorized parties can continue to access the registration portion of the database but cannot review data at this time.

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The agency also said it would adjust the review and dispute period, which began July 14 and ends Aug. 27, based on each day the system is offline.

The removal of the database was first reported by ProPublica on Aug. 4. The news site reported that the CMS temporarily suspended the verification system for the database after a physician reported that he could also see payments reported to another doctor when logged into the database.

The public database will make available for the first time quarterly data provided by manufacturers about “transfers of value” such as payments, royalty fees, meals and gifts made to physicians and teaching hospitals. Providers have had access to the database since July 14 to review and dispute the data.

“The recent problems resulting in the system being taken offline underscore the need for more time,” said Dr. Robert Wah, president of the American Medical Association, which has called for a six-month delay of the database's publication.

This is not the first time the Open Payments system has faced delays or controversy.

The then-called Physician Payments Sunshine Act, a provision in the Affordable Care Act, originally required data collection to begin in January 2012, but manufacturers began collecting data in August 2013. In addition, the CMS missed its own deadline to issue the final rule on the Sunshine Act rules by several months. The final rule was eventually issued in February 2013.

The delays have frustrated Sens. Chuck Grassley (R-Iowa) and Herb Kohl (D-Wis.), who championed the legislation. In January 2013, Grassley told Modern Healthcare: "It will be two years in March since the Sunshine Act was enacted. Two years is a long time for pretty straightforward regulations. The administration hasn't been forthcoming about the reasons for the delay.”

While Grassley said the most recent delays were disappointing, he agreed that there should be adequate time for providers to review and correct information included in the database.

“I'll take CMS at its word that this is a minor problem and that no delay in launching the program is necessary,” he said in a statement. “Covered entities and providers should continue to work with CMS to make sure the program operates as intended. This is valuable information that should be available to the public.”

Earlier this week, a group of medical associations and societies, including the American Medical Association, sent a letter to the CMS urging a six-month delay in publishing the information, over concerns that disclosing incorrect information about financial relationships might negatively impact physicians.

The organizations said they are not opposed to making financial relationships between doctors and manufacturers more transparent, but question how the Open Payments system is being implemented.

Carlat said it's unlikely that physician groups are opposed to publication of data. Their concern, he expects, is that the data is accurate.

Follow Jaimy Lee on Twitter: @MHjlee


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