Senators back push for stepped up tracking of medical devices

Two U.S. senators are urging the agency that controls Medicare to support putting the full serial numbers for medical devices into insurance-claims forms to better track how poorly performing devices affect federal spending and patient health.

"It is essential that the Medicare system support the post-market surveillance of risky medical devices, both to improve patient care and to support program integrity," Sen. Chuck Grassley, R-Iowa, and Sen. Elizabeth Warren, D-Mass., wrote in a Nov. 8 letter to Seema Verma, the administrator of the Centers for Medicare and Medicaid Services, who took office in March.

Currently insurance claims don't track full serial numbers for devices. Many experts in the medical-device industry have opposed including the full serial numbers in insurance claims, saying such a move would not improve device surveillance and would add another layer of costly administrative burden in a field that is already highly regulated.

Such serial numbers should be included in patient medical records but not in insurance claims, critics said.

But when Medicare auditors tried to calculate how much the federal government and its beneficiaries spent on seven recalled heart devices made by manufacturers with major Minnesota operations between 2005 and 2014, they found the task could not be done without a labor-intensive analysis of individual medical records, which took years and required subpoena power.

In the end, the inspector general for the Health and Human Services Department estimated that roughly $1.5 billion was spent on medical services related to replacing and monitoring the seven recalled heart devices, while Medicare beneficiaries spent another $140 million out of pocket.

Published in September, the audit concluded that the lack of serial numbers in claims forms made it more difficult to locate patients affected by defective devices and tally up the spending involved in their care.

Grassley and Warren's letter came after Verma testified before Congress on Oct. 31 that the current administration was still reviewing the former administration's position in favor of including the full serial number for medical devices in Medicare claims forms. Verma said it was customary for new administrations to review the policies of former administrations.

"Similar to other policies under review by the new Administration, this policy is also under consideration," Verma said in a written response to the Medicare auditors. "CMS will carefully evaluate the potential that this policy would impose burden on physicians unnecessarily."

Ben Moscovitch, manager of health information technology at the Pew Charitable Trusts, said many organizations including large hospital systems and influential medical societies support including the serial numbers of claims.

"There's a reason this policy has bipartisan support in Congress: adding device identifiers to claims is a common sense policy that can improve patient safety and reduce costs for taxpayers and patients," Moscovitch said via e-mail.

Joe Carlson • 612-673-4779