AMA urges more clarity in gift-reporting rules

Disclosure requirements should not imply that federal officials are regulating ethical conduct, the Association tells CMS.

By Charles Fiegl — Posted Oct. 22, 2012

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The agency overseeing the implementation of regulations requiring financial disclosures of industry-physician financial relationships must make changes to ensure the accuracy of reporting information and avoid the appearance that the final rules will enforce ethical guidelines, the American Medical Association stated in an Oct. 10 letter.

The proposed rule implementing the Sunshine Act would lead to burdensome paperwork requirements for physicians and misleading information on doctors’ relationships with device and drug industries, said the letter addressed to acting Centers for Medicare & Medicaid Services Administrator Marilyn Tavenner. The letter followed a Sept. 12 Senate roundtable discussion on the December 2011 proposed regulation and future implementation of the law, enacted as a provision of the 2010 health system reform law.

“It is critically important that the final rule and resulting mode of implementation do not create the impression that the transparency reporting requirements establish ethical standards or reflect program integrity or fraud and abuse laws,” wrote AMA Executive Vice President and CEO James L. Madara, MD.

The disclosure requirements do not set ethical standards, and the agency implementing the law should make that clear, the AMA said. The act also does not replace the profession’s role in regulating physician conduct or create laws that counter fraud and abuse. The Association said finalized rules should not convey such appearances.

The profession is in a better position to maintain ethical standards, the letter said. Organized medicine has taken steps to reduce conflicts of interest so the delivery of health care is based on science and maintains trust in the physician-patient relationship. Responsibility to patients is paramount, and doctors must not place financial interest above the welfare of their patients, it said.

The AMA is worried that the proposed rules could cause a perception of unethical or illegal behavior and further discourage collaboration between doctors and researchers, which would cause a significant barrier to advancements in medicine. There have been many benefits from physician partnerships with industry members, such as research on the human genome and advancements in molecular pathology diagnostics.

“Physician decisions are heavily dependent on the quality of the scientific information available, provided to them, in part, by industry and federal regulators,” the letter said. “There remains a need for interactions between physicians and industry to ensure the free flow of valid scientific information. When the information is accurate and complete, physicians have the necessary tools to make the right treatment decisions.”

CMS has chosen its Center for Program Integrity to carry out final implementation of the Sunshine Act, raising concerns about possible confusion regarding the purpose of disclosure reports. The center’s main task is to prevent and ferret out fraud in federal health programs. Instead, the AMA recommended bifurcation of the responsibilities of the Sunshine Act. One agency should collect data and manage reporting and appeals, while the program integrity division could oversee compliance matters, including enforcement of reporting requirements and fining companies that fail to comply with them.

The Association also strongly urged CMS to restructure how industry firms provide physicians with access to financial relationship information that would be disclosed to the public. The proposed process would deny physicians due process to review, dispute and correct inaccurate reporting, the AMA said. For instance, the proposed rule lacked a requirement that pharmaceutical or device companies allow physicians database access to their own information on an ongoing basis. The ability to challenge reports is confined to a 45-day window, according to the proposed rule.

“The proposed rule opens the door to the real possibility that a large number of physicians could become the victims of false, inaccurate or misleading reporting and suffer significant damages, including investigation by government and private entities, potential disciplinary actions, public censure, ridicule, and destruction of professional reputation and livelihood,” the AMA said.

The Association advocated for CMS to provide adequate opportunity to comment on transfer disclosures and create a neutral arbiter to resolve disputes over reports.

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