Preventable Patient Safety Errors Still a Problem for Medicare

A report from the Health and Human Services (HHS) Office of the Inspector General (OIG) found that preventable patient safety errors still dog Medicare. Using a random sample of Medicare beneficiaries discharged from hospitals during a 1-month period, the OIG report found that 13.5% experienced adverse events and that for nearly 2% of beneficiaries, these adverse events contributed to their deaths. An additional 13.5% of beneficiaries in the sample experienced temporary harm as a result of their medical care, bringing the total percentage of beneficiaries experiencing instances of care-related harm to 27%. Physician reviewers determined that 44% of the cases in the sample were preventable.

The report is part of the OIG Compendium of Unimplemented Recommendations. The overall recommendation is that the Centers for Medicare and Medicaid Services (CMS) broaden patient safety efforts to include all types of adverse events. OIG first made this recommendation in November 2010. The report notes, however, that CMS has made “considerable strides” since that time.

AACC Calls for Transition Period in Blood Glucose Monitor Rules for Hospitals

The Centers for Medicare and Medicaid Services (CMS) must give hospitals time to implement new protocols—and the Food and Drug Administration (FDA) to approve new devices—before forcing hospitals to abide by tough rules for off-label use of blood glucose monitors (BGM), according to AACC comments to CMS. The association supports the essential CLIA rules that require stringent personnel and quality control for high complexity testing—one category of which is off-label use. But in the unique case of BGMs used for critically ill patients, strict enforcement would unnecessarily disrupt and jeopardize patient care.

CMS released draft guidance on March 13 emphasizing BGM regulations that, on paper, were always required under CLIA but never implemented. Under these regulations, laboratories should not use BGMs for critically ill patients without proving that the device is accurate and effective in this population, and even then only a small number of hospital personnel would qualify to perform testing.

“A sudden shift of all or most BGM testing from the bedside to the core laboratory for those patients most in need of this testing could significantly impact the ability of healthcare practitioners to diagnose and treat hyperglycemia and recognize hypoglycemia in a timely manner,” noted AACC in the comment letter. “The clinical protocols in place require active monitoring of the patient and the interpretation of the glucose results in the context of clinical symptoms.”

AACC pressed CMS to take a “pragmatic and educational approach” as FDA reviews new claims for BGMs in critical care populations, and hospitals examine their protocols.

CMS Proposal Would Cover Joint Pap and HPV Testing

Under a proposed coverage decision, the Centers for Medicare and Medicaid Services (CMS) stated that evidence is sufficient to add human papillomavirus (HPV) testing once every 5 years as an additional preventive service benefit for asymptomatic beneficiaries age 30–65, in conjunction with a Pap smear. CMS would cover screening using Food and Drug Administration-approved or cleared tests.

Medicare currently covers the Pap test every 24 months for average-risk beneficiaries and every 12 months for high-risk beneficiaries. For cytology, the current recommendations from medical societies are that for women who have a cervix, regardless of sexual history, a Pap smear alone every 3 years is a reasonable balance between benefits and harms, the agency noted. The U.S. Preventive Services Task Force recommends screening for cervical cancer in women age 21–65 years with cytology every 3 years or, for women ages 30–65 who want to lengthen the screening interval, screening every 5 years with a combination of cytology and human HPV testing.