Advocacy & Practice Updates — Advocacy & Practice

Have You Registered for Open Payments?

September 10 is the deadline to dispute data under the Sunshine Act

The Centers for Medicare & Medicaid Services (CMS) has extended until September 10 the deadline for physicians to register, review, and dispute any data attributed to them under the Open Payments system.

CMS originally set the deadline at August 27 but was forced to extend it after reports of misattribution of data led to a temporary shutdown of the registration site in August. CMS has extended the review and dispute period one day for every day that the site is inaccessible. Last week CMS issued a notification that the next scheduled outage of the site will be September 6.

The Sunshine Act requires manufacturers of drugs, medical devices, and biologicals that participate in US federal health care programs to report certain payments and items of value given to physicians and teaching hospitals. CMS is responsible for implementing the Sunshine Act and has renamed it the Open Payments program.

Once physicians have registered with Open Payments, they have the right to review their reports and challenge information that is inaccurate or misleading. Despite the extension of the review and dispute period, CMS is holding firm on the September 30 public posting of data and information. Any payments or transfers of value still in dispute as of September 30 will be flagged as such on the public site.

Due to concerns with data accuracy, CMS has announced it will withhold from public reporting information on one-third of payments until next June. There are also reports circulating that CMS plans to withhold from reporting research grants made by pharmaceutical companies to physicians through intermediaries, known as contract research organizations. Reportedly, physicians have not been given a chance to verify and dispute payments attributed to them.

Physicians who have completed the registration and review process state that it is cumbersome, time consuming, and confusing, and its not helped much by the 359-page user guide provided by CMS. The American Medical Association has asked for a delay of all data release until March 31, 2015.

Manufacturers also believe that the data release will be confusing to the public, as stated by John Castellani, CEO of the Pharmaceutical Research and Manufacturers of America. Castellani wrote in an op-ed published by the Morning Consult, “One of the primary concerns that PhRMA shares with more than two dozen other patient and industry organizations is that the data needs to include context to explain what the payments represent—collaborations that benefit patient health and innovation.”1

The ASRS is closely following this issue and will provide updates to the process as we have them. CMS will respond to questions via the Open Payments Help Desk at openpayments@cms.hhs.gov or (855) 326-8366.
 

References

  1. Castellani J. Bringing Sunshine into the light. Morning Consult. August 18, 2014. http://themorningconsult.com/2014/08/bringing-sunshine-light/. Accessed September 3, 2014.

Updated September 3, 2014

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