It’s estimated that hundreds of thousands of patients die annually from preventable harm suffered while undergoing medical care. The infections, injuries and errors could rank as a leading cause of death in the United States.

Last year’s sweeping health-care reform law — the Patient Protection and Affordable Care Act — promised to improve the problem by allowing outside groups to use Medicare billing records to analyze and publicly report on the quality of care. But proposed rules that would guide the release of the data are being criticized by consumer groups that say the rules would make independent accountability impossible.

Agencies typically adopt rules to administer laws like the health-care act. The rules being developed by the Centers for Medicare & Medicaid Services (CMS) propose restricting the release of Medicare billing data to “qualified entities.” To qualify, a group would have to:

• Pay up to $200,000 for the data.
• Have its methods pre-approved before obtaining the data.
• Already possess billing information from other sources to combine with the Medicare data — an advantage to insurance companies.
• Limit public reporting to quality measures approved by the health-care industry.
• Present its reports and findings to every doctor and facility being measured before they are released to the public — a requirement that would make large-scale reports difficult.

Medicare officials declined to discuss the proposed rules because they are being finalized after a public comment period ended Aug. 8. But interviews and a review of comments show that the rules have sharply divided consumer-oriented groups and health-care providers.

Lisa McGiffert, director of the Safe Patient Project run by Consumers Union, the nonprofit publisher of Consumer Reports magazine, said the new law was seen as “a real opportunity” because, for the first time, Medicare data could be used to tell the public about the performance of doctors. But the proposed rules would make it impossible for Consumers Union to use the data, she said.

“The best-kept secret in America is what doctors are doing,” McGiffert said. “People should be able to find out information about outcomes of care, whether their docs are using appropriate practices and whether they’re providing too much of something that people don’t need.”

Bruce Boissonnault, president and CEO of the Niagara Health Quality Coalition, a nonprofit that’s been independently measuring the quality of health care since 1995, said the rules are needlessly complex and designed to suppress freedom of information. He said the rules would make it impossible for all but industry insiders to access the new data, giving them control over what’s released.

“We will only see the scraps of information that the industry wants us to discuss,” Boissonnault said. “It’s advertising wrapped in a lab coat.”

Boissonnault and Consumers Union submitted public comments, urging Medicare to reconsider the restrictions.

The American Medical Association submitted comments mostly supporting the access limitations and in some cases urging more restrictive rules. For instance, the proposed rules say doctors would need 30 days to review any analysis before it’s publicly reported, but the AMA wants that review period increased to 90 days.

The AMA also wants Medicare to consider complaints by physicians against an organization before allowing the organization access to the data.

The Federation of American Hospitals, which represents investor-owned health-care facilities, said in its comment that it is “very troubled” by the proposed rules, despite the increased restrictions, because billing data have a limited ability to measure quality. The federation wants a limit on the number of qualified entities that have access to the data.