Organized medicine seeks more latitude to challenge industry gift reports

Washington -- Proposed rules requiring transparency reports on what physicians receive from drugmakers and medical device manufacturers would impose costly burdens on practices and could lead to the publication of misleading information to the public, according to physicians and health industry organizations.

The American Medical Association and more than 90 specialty and state medical societies urged the Centers for Medicare & Medicaid Services to make several changes to its proposed rule implementing the Sunshine Act, a provision included in the 2010 health system reform law. In a Feb. 17 letter to CMS, the organizations stated that they supported the underlying goal of enhancing transparency but said the rule needs numerous revisions.

The Sunshine Act requires drug and device manufacturers to track gifts and payments to physicians and teaching hospitals starting in 2012. Any transfers of value of more than $10 -- as well as any smaller individual payments to doctors whose total transfers exceed $100 -- would be made available on a searchable website beginning in 2013.

The reform law gives physicians the right to challenge reports after their publication. However, organized medicine said Congress did not intend for those disputes to be resolved only during a 45-day period once a year, as proposed by CMS.

"We oppose limiting a physician's ability to challenge the accuracy of reports to the 'current' and prior reporting year within a compressed 45-day window each year," the letter states. "There is no statutory support for this provision, and it is inconsistent with the Congress' intent to ensure such reports are accurate."

CMS instead should allow physicians and manufacturers to make any needed corrections on an ongoing basis, the physician organizations said.

Trade groups agreed that 45 days would not be enough time for the corrections process. Pharmaceutical Research and Manufacturers of America said in its comments on the proposed rule that drug companies have no way of knowing how many doctors and others would dispute data during the first year. PhRMA recommended an initial review period of 45 days and another 45-day period to adjudicate disputes.

CMS also included indirect transfers to physicians as reportable events in the proposed rule. However, the organized medicine groups said the inclusion of such transfers was not authorized by Congress and exceeds the limits of the statute.

The physicians argued, for example, that payments by a certified continuing medical education provider to a physician should not be reportable under the law. Grants from manufacturers for CME programs already are regulated, and companies are prohibited from having influence over how funds are used, such as through the selection of faculty.

Medtronic, the medical device manufacturer, called for other changes that it said would make data reporting more accurate and meaningful for patients. Medtronic already has experience disclosing such information. In 2010, it began posting financial relationships with physicians that meet a minimum threshold of $5,000.

CMS should provide more context to help the public understand the information, the manufacturer said. For instance, the Food and Drug Administration requires clinical trials before the agency will permit a new device to enter the marketplace. Such trials can last years, involve many entities and end up being very costly.

"Simply posting the total dollars paid for consulting and research arrangements, for example, does not tell the whole story and, therefore, provides little value to the public," said Thomas J. Schumacher, Medtronic chief ethics and compliance officer, in a Feb. 17 letter. "In some ways, it is very misleading."

The drug manufacturer Merck & Co. took issue with several aspects of the proposed regulation that it said needed at least further clarification. The methodology for calculating the allocation of meals during group settings, for instance, would lead to inaccurate data, Merck said. The manufacturer would be required to report the cost per covered recipient regardless of whether noncovered individuals, such as office staff, had meals or if a physician attended a session but declined to eat.

The drugmaker suggested that manufacturers be required to report only on a physician who partakes in a meal and then to attribute a value for what he or she ate.