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June 26, 2013

Physician Payment Sunshine Act: AMA House of Delegates Voice Concern over Accuracy and Potential Inclusion of CME Meals

Last week, we reported that the American Medical Association (AMA) would be discussing at its annual meeting in Chicago a number of important topics including the Physician Payments Sunshine Act

Modern Healthcare (subscription required) noted that officials from the Center for Medicare & Medicaid Services (CMS) attempted to reassure physicians at the meeting that "the burdens of reporting their connections to drug and devicemakers under the Physician Payment Sunshine Act would fall almost entirely on industry.

Bloomberg BNA quoted Anita Griner, CMS's deputy director for the Data Sharing & Partnership Group, who spoke to physicians at the meeting. She stated that "Data accuracy is the number one goal of our program." "We want the data put on the public website to be complete and accurate. We do not want it to be disputed. We do not want it to be inaccurate. We do not want to perpetuate any false information about a physician or teaching hospital. So data accuracy is key. And that will come from you tracking your own transfers and checking the website before it goes public.''

However, doctors at the AMA meeting expressed concern about "protecting their reputations after details of their business relationships get publicized."

"The media can really sensationalize this," said Dr. Lynda Young, a pediatrician from Worcester, Mass., and the former president of the Massachusetts Medical Society. Massachusetts is already posting information on physician relationships with pharmaceutical and medical-device manufacturers. When the information becomes public, "the media jumps on it," Young said during the Chicago meeting. 

Outgoing AMA president Dr. Jeremy A. Lazarus, said that AMA supports efforts that provide the public with additional transparency over financial relationships between the medical profession and players in the health industry. At the same time, Lazarus said data accuracy is paramount. "We want the law implemented appropriately and physician rights to challenge false or misleading reports protected,'' Lazarus said in his June 15 address before the House of Delegates. He also pointed to the AMA Sunshine Act resource page we previously covered.

Dr. Nancy Nielsen, former president of the AMA, asked whether the law would be triggered when industry sources pay for coffee and pastries at accredited continuing medical education (CME) events.

 "We're trying to be pragmatic," replied Dr. Shantanu Agrawal, director of the CMS data-sharing and partnership group, explaining that the agency would not get too preoccupied with "who picked up what" at a large buffet. Whether this is CMS' official position about meals at CME events, however, is uncertain. CMS still has left questions about CME related issues unanswered on its FAQ webpage as we come up to a little over 5 weeks before Sunshine tracking begins.
"We hope that you keep track of your own transfers of value," said Anita Griner, deputy director of the CMS data-sharing and partnership group. Griner said physicians' records would help resolve disputes. The CMS, though, will not mediate them, she said. If industry and doctors cannot agree on the figure, the CMS will post the industry-supplied number and mark it as under dispute.  "The CMS will audit some of the reports supplied by manufactures and GPOs, and disputes could trigger an audit," the article noted.

While Agrawal acknowledged that relationships between physicians and manufacturers contribute to important innovations, he emphasized the concerns raised by conflicts of interest. Those conflicts, he said, become "far more magnified" because 60% of physicians reporting an industry relationship are involved in medical education and 40% are involved in creating clinical practice guidelines. It's unclear where Argawal got such numbers from. Irrespective, physicians who participate in accredited CME must comply with all disclosure and conflict of interest standards set by the ACCME Standards for Commercial Support.

Griner reviewed with the audience how the business relationships of physicians, teaching hospitals, podiatrists and chiropractors would be subject to reporting. When she asked if physician assistants and nurse practitioners would be subject to sunshine reports, the audience replied in unison: "No, but they should be."

In related Sunshine Act news, the Financial Times reported that manufacturers are "scrambling to create data collection systems by 1 August that comply with a template the federal government revised as recently as last month," citing comments from Michaeline Daboul, CEO and president, MMIS.

According to the article, "Some physicians are not familiar with the details of the new rules, added a Senate aide involved in crafting the sunshine law. A significant minority of physicians are also not aware of the fact that a company might be reporting their income in a publicly listed manner, the aide said."


In addition, the Financial Times quoted an official from HHS-OIG, who noted that either DOJ or OIG could flag certain payments that raise concerns about possible kickbacks or other fraud violations. "Either agency can take the lead in pursuing suspected violations of the antikickback statute, agreed the OIG spokesperson." "As far as whether payments will be viewed as kickbacks, that is evidently a possibility," he said.


Information posted to the CMS site "would not be sufficient in and of itself to bring any kind of legal case," the OIG spokesperson told the Financial Times, but the data could be cause for further investigation. It is "certainly fair to assume that DoJ and the OIG will be taking a look" at the information, noted Andrew Van Haute, associate counsel, Advanced Medical Technology Association (AdvaMed), a medical technology trade group. However, he added, the sheer act of disclosure does not mean investigations are warranted.


Interestingly, former Chief Counsel to HHS-OIG Lew Morris was also quoted in the article. Manufacturers and healthcare providers could face multiple sources of scrutiny, countered Lewis Morris, former OIG chief counsel. The published data will likely be of interest to "whistleblowers and investigative reporters and law enforcement," among other groups, he said.


This attention could be unjustified for those "outliers that really aren't outliers and are just a matter of information being put into the wrong category," pointed out Morris, who is now an attorney at Adelman, Sheff & Smith.

Additionally, Morris told Financial Times that "there is broad understanding that Sunshine implementation will involve some complications." Based on his conversations with the DoJ and the OIG, he said it is unlikely that enforcers "are going to be handing out traffic tickets the first day that the rule goes into effect." Morris also cautioned government officials, industry attorneys and other interested parties against making snap judgments immediately after the CMS posts the data. "There are some extremely well-reimbursed physicians and experts who earn every penny of it," Morris said.


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