A Medical Device Daily

The Department of Health and Human Services has proposed to establish a series of patient safety organizations (PSOs, in response to the need to reduce medical errors and save lives).

The proposed regulation conforms to the requirements of the Patient Safety and Quality Improvement Act (Patient Safety Act) of 2005, which was, in turn, prompted to some extent by the well-known report on patient safety published in 1999 by the Institute of Medicine (IOM; Washington), “To Err is Human.” The IOM report estimated that from 44,000 to 98,000 patients die in hospitals each year due to medical errors.

PSOs, the Feb. 15 HHS announcement said, would be separate from any existing entities that address healthcare quality. One of the advantages of PSOs is that they provide a shield of confidentiality with regard to such reports and hence allow providers to sidestep legal liability. This protection was encoded in the Patient Safety Act by according such reports the status of privileged legal communication. IOM recommended this protection, as well as the establishment of PSOs, in its 1999 report.

AHRQ director Carolyn Clancy, MD, said in the statement that government is aware that providers are interested in and want to “participate in efforts to improve patient care, but they often are inhibited by fears of liability and sanctions.” She said that the liability provisions will “make the right thing to do the easy thing to do.”

Those provisions, however, are not ironclad, and one exception would allow a breach of confidentiality for legal proceedings that might not be able to obtain the information in question by other means.

HHS Secretary Mike Leavitt said in the statement that PSOs “will help make healthcare safer for all Americans,” and that “[b]y making it easier for patient safety events to be reported and the lessons learned from them to be shared more broadly, patients will ultimately receive safer healthcare.”

According to the HHS statement, AHRQ will be tasked with administering the rules for accrediting PSOs, and the HHS Office for Civil Rights will enforce the confidentiality provisions.

The proposed regulation provides specifics on how providers will report information to PSOs as well as on how entities can become PSOs. The legislation mandates that a PSO must be primarily engaged in patient safety data activities, which should suppress conflicts of interest by keeping hospitals from participating directly in the PSO business.

The comment period ends April 14, and HHS will hold an audio conference on the subject Feb. 29.

GAO: Too many ‘challenges’ for care pilot

The Physician Group Practice (PG) demonstration was one in the family of pilot projects that offered optimism about the potential for healthcare reform. Unfortunately, the PGP effort has apparently demonstrated little more than that CMS needs to rethink the structure of the program, according the Government Accountability Office.

A recent report by the GAO states that 10 physician practices accepted the invitation to participate in the pilot, but that this group was not typical of physician practices.

The design for the pilot “was generally a reasonable approach,” but “created challenges,” including that “neither bonuses nor performance feedback for pilot year one were given to participants until after the third year had begun.” While CMS provided practices with forms for quarterly reports, GAO said that “most participants report[ed] that they do not have the resources to analyze these data sets and generate” the required reports.

GAO recommended that CMS “provide participating physician groups with interim summary reports that estimate participants’ progress in achieving cost savings and quality of care.”

“The large size of the 10 participating physician groups (all had 200 or more physicians) compared with most U.S. physician practices (less than 1% had more than 150 physicians) gave the participants certain size advantages” not enjoyed by most group practices, the GAO said.

One of the advantages afforded to these larger groups was “institutional affiliations that allowed greater access to financial capital, access to and experience with electronic health records systems, and prior experience with pay-for-performance programs.”

Of this initial cohort of 10 practices, two earned bonuses of roughly $7.4 million total, according to the GAO report, but while the other eight practices met “most of the quality targets, they did not achieve the required level of cost savings to earn a bonus.”

In some instances, practices did not have all their care coordination programs in place during the first year of the project, 2005.

To qualify for the bonuses, participating physician groups “had to generate savings greater than 2% of their target expenditure amounts relative to a comparison group of [Medicare] beneficiaries,” the GAO report said.

The care coordination was for a cluster of diseases including cancer, diabetes mellitus and heart failure.