DEC 3, 2012 12:13pm ET

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Final Rule on Transparency of Manufacturer/Physician Relationship Could be Soon

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Manufacturers of drugs, devices, biological products and medical supplies would be required to annually report payments and other transfers of value to physicians and teaching hospitals under a final rule sent to the Office of Management and Budget for review.

OMB review is one of the final steps before publication of a rule. This final rule from the Centers for Medicare and Medicaid Services, mandated under the health reform law, also would require manufacturers and group purchasing organizations to annually report physician ownership stakes or investment interests.

Under the final rule, which follows a proposed rule issued in December 2011, the Department of Health and Human Services would publish payment and ownership information on a public Web site. “The data must be downloadable, searchable and easily aggregated,” CMS states in the proposed rule. “In addition, we must submit annual reports to the Congress and each state summarizing the data reported.”

CMS in the proposed rule acknowledged that disclosure alone is not sufficient to differentiate beneficial and legitimate financial relationships from those that can create conflicts of interests or other improper incidents, nor do financial ties indicate inappropriate relationships. “However, transparency can shed light on the nature and extent of relationships, and may dissuade inappropriate conflicts of interest from developing,” the agency contended. The proposed rule from last December is available here.

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As the feds ramp up enforcement of privacy and security rules, providers look to fill protection gaps.

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