AdvaMed, PhRMA, BIO protest Sunshine law

Medicare’s Sunshine Act database is slated to go public later this month with a year’s worth of data on industry relationships with physicians, but an alliance of life sciences groups is calling for some sunshine of its own.

With just one week to go until the Centers for Medicare & Medicaid’s CMS Open Payments website goes live, lobbying giants representing medical devices, biotech and pharmaceuticals have banded together to demand that Medicare officials open up about the context they plan to provide in a public database of physician payment data.

In an open letter to CMS Administrator Marilyn Tavenner leaders from medtech lobby AdvaMed, biotech lobby BIO and drug lobby PhRMA urged regulators to explain what type of background information will accompany reported physician payments on the site. The groups warned that a lack of context might make all physician-industry relationships appear "suspect."

Healthcare companies have since August 2013 been required to collect and report their relationships with physicians for an online database that will allow the public to examine financial exchanges between physicians and the industry. AdvaMed, PhRMA, BIO lauded the effort, but warned that insufficient context could undermine the transparency effort.

"For implementation of the Sunshine Act to be successful and for the data to be meaningful to patients and the public, the CMS Open Payments program public website must provide clear background information and context regarding such industry relationships," AdvaMed CEO Stephen Ubl, BIO president & CEO James Greenwood and PhRMA president & CEO John Castellani wrote. "Providing context for reported payments and other transfers of value is critical to ensuring patients do not form mistaken impressions that all payments to physicians are suspect."

Medicare officials are under a Congressional mandate to ensure the public database includes appropriate context, but the agency has been mum on what that will look like in practice.

The CMS Open Payments website has the been the subject of much controversy and hand-wringing, especially among physicians who worry that that data errors or lack of context will tarnish their reputations. Physicians’ groups have been pushing for delays and for access to view early versions of the website so that they can ensure their profiles are accurate and complete.

Already the website has been marred with reports of errors and Medicare regulators have reportedly rejected one-third of the records provided by manufacturers, saying that data won’t appear on the website until it’s revised. It’ll be about a year before those records are published in the database and CMS is threatening manufacturers with fines if they can’t get their ducks in a row.

AdvaMed, PhRMA, BIO challenged CMS on the withheld data, asking for more information on what exactly was missing from the records.

"Based on preliminary reviews that many of our member companies have conducted of the removed data, it appears that those companies reported data to CMS in a manner that was consistent with the reporting guidelines and parameters established by CMS," the lobbying leaders wrote. "Accordingly, it is not clear why this volume of data is being withheld. We are hopeful that this issue can be resolved expeditiously so that the data that is made available to the public is accurate, useful and complete."