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Physicians Brace for Drug, Device 'Transparency'

 |  By jcantlupe@healthleadersmedia.com  
   August 02, 2013

Doctors groups are alerting members to be prepared to respond to public disclosures as pharmaceutical and medical device manufacturers begin tracking and reporting their financial interactions with physicians.



Ardis Dee Hoven, MD

The American Medical Association and other physician groups have scrambled to alert doctors to prepare to respond to what may be some embarrassing disclosures.

Under the Physician Payment Sunshine Act, which went into effect Thursday, drug and medical device manufacturers are required to begin tracking and reporting financial interactions with physicians. The law requires public reporting of payments to physicians and teaching hospitals.

This means that honoraria, gifts, and other "transfers of value" physicians receive from pharmaceutical and medical device manufacturers will be reported. Manufacturers are required to collect and report this data to the Centers for Medicare & Medicaid Services, which will publish it in an online database by Sept. 30, 2014.

Physician groups acknowledge that many doctors aren't up to date on the requirement, which is designed to perpetuate "transparency" in a field sometimes clouded by complicated relationships and payments involving physicians and pharmaceutical companies and device manufacturers.

"We strongly urge physicians to make sure all of their financial and conflict of interest disclosures, as well as their information in the national provider identifier (NPI) database, are current and regularly updated," AMA president Ardis Dee Hoven said in a statement.

Over the years, several investigations that have focused on doctors being paid by drug companies whose medicines they prescribe, or for having alleged conflicts with medical device manufacturers who make implants the doctors use.

Last fall, a Senate Finance Committee investigationrevealed what it termed "questionable fees between the Medtronic medical device company and the physician consultants tasked with testing and reviewing Medtronic products. In 2011, a Pro Publica investigation showed that the same drug companies whose medicine they prescribe are paying many doctors.

"(Thursday) is an important day, but not the most important day," says Jonathon Kellerman, principal in PwC's Pharmaceuticals and Life Sciences Industry Group. "It marks when manufacturers must start collecting data. It is an internal challenge. The clock really starts ticking when the first reporting period begins."

Pharmaceutical and device manufacturers are slated to turn over their first reports to CMS on March 31, 2014. Physicians will have a minimum of 45 days to challenge any information before it is public and they may dispute inaccurate reports and seek corrections during a two-year period.

Physicians may also ask manufacturers and their representatives to provide information they intend to report. Doctors may register with CMS, beginning in January 2014, to receive a consolidated report on activities each June for the prior reporting year.

The Sunshine Act covers gifts or payments valued at $10 or more. The only physicians exempt are medical residents because many do not have a National Provider Identifier or a state professional license.

Ray Quintero, director of government relations department at the American Osteopathic Association in Washington D.C., acknowledges that the information the government receives is "reliant on the pharmacy or device manufacturer. What we are trying to do is prepare our physicians, and ensure that the information is reviewed for accuracy. If something is inaccurate, it should be disputed."

"This is the first time a federal standard has been created around data reporting, and payment," related to pharmaceutical companies and device manufacturers, says PwC's Kellerman. While many companies have prepared for the disclosures, there are significant challenges ahead, he adds.

One hurdle may involve third-party vendors, and the lack of standardization of data "across multiple systems," according to Kellerman. "It's incumbent upon healthcare professionals to keep their eyes and ears open about registration and guidelines and to review the data so they can take ownership of the information that is being published," he says.

According to a 2007 study the New England Journal of Medicine, 94% of physicians had a relationship with the industry; 83% received gifts, and 28% received payments for professional services, such as consulting or research participation.

Prior efforts to increase disclosure of industry-physicians financial relationship include a 2009 Institute of Medicine report, that developed recommendations "to identify, limit and manage without affecting constructive collaborations with industry and called for broad public transparency," according to the NEJE report.

The Physician Payment Sunshine Act was created by Congress to ensure transparency in physicians' interactions with the pharmaceutical, biologic and medical device industries as well as group purchasing organizations.

The law covers meals, honoraria, travel expenses, and grants from manufacturers, and ownership and investment interests by physicians or members of their immediate family. Eventually, physicians who have received payments or hold ownership will be posted on a website, under the National Physician Payment Transparency Program of the CMS.

The AMA is offering doctors a Physician Sunshine Act Tool Kit to help navigate the changes.

Joe Cantlupe is a senior editor with HealthLeaders Media Online.
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