Tag Archives: government accountability office

GAO report on medical loss ratio finds insurers spend little on quality improvement

The U.S. Government Accountability Office generated some minor headlines last week when it reported on how much health insurers paid in rebates to policyholders in the first two years under the Affordable Care Act’s medical loss ratio (MLR) rules.

A close read of the report, “Private Health Insurance: Early Effects of Medical Loss Ratio Requirements and Rebates on Insurers and Enrollees,” reveals important details about how insurers spent the premium income they collected from consumers and businesses. The report shows insurers spend very little on quality improvement, that they report modest profit numbers and that MLR rules have not had caused them undue harm.

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GAO evaluates FDA’s overseas inspectors

A couple of new GAO reports are seeking to shed some light on the FDA’s overseas regulatory efforts. The first is part overview, part progress report (52-page PDF). It’ll answer your basic questions.

September 18, 2007: An FDA chemist is shown conducting a rapid screening using an automated immunoassay instrument to detect cell surface antigens of Salmonella on food products. Photo by Black Star/Michael Falco for FDA

An FDA chemist tests food for antigens of Salmonella. (Photo: Black Star/Michael Falco for FDA)

In 2008 and 2009, the FDA sent 42 staffers overseas to establish foreign offices. The staff are on two-year overseas rotations, though it’s been difficult to find qualified workers for certain locations, especially since some of them had to take a pay cut. There’s a map of all 11 offices on the 12th page of the PDF.

According to the GAO, what do FDA overseas offices do?

  • Build relationships with foreign regulators and stakeholders, and with other U.S. agencies that are overseas
  • Gather information about regulated products
  • Inspect overseas facilities which are exporting to the U.S. (China and India only)
  • Train foreign stakeholders to better understand FDA regulations and systems

The second report is focused specifically upon inspections of overseas drug manufacturers producing for the U.S. market. The FDA has prioritized a list of such facilities that it would like its inspectors to visit, and the overseas agents managed to check off 11 percent of that list last year. At that rate, it will take about nine years for them to cover everything. For domestic facilities, that turnover rate is about 2.5 years.

GAO sting spotlights sketchy herbal meds

Undercover sting operation reports may not be the meatiest documents released by the Government Accountability Office, but they’re almost always the most entertaining.

This time, the target was herbal supplements marketed to elderly patients. In addition to reviewing marketing materials and chemical compositions, investigators posing as elderly customers called supplement companies and received all sorts of bad advice. Check the highlights page for a nifty table of the most common and egregious errors, all of which involved garlic, gingko biloba or ginseng. You can also hear recordings of sellers peddling these treatments here.

All claims were deceptive, but two were also potentially dangerous. They are reproduced, along with GAO commentary, below.

Claim: Ginseng cures diseases, including cancer.

Comment: NIH specifically recommends that breast and uterine cancer patients avoid this product, as it may have an adverse interaction with some cancer drugs.

Claim: Ginkgo biloba can be taken with a daily aspirin prescription.

Comment: Taking this product with aspirin may increase the risk of bleeding.

And, of course, there’s also the matter of toxic substances lurking in the supplements.

GAO also found trace amounts of at least one potentially hazardous contaminant in 37 of the 40 herbal dietary supplement products tested, though none in amounts considered to pose an acute toxicity hazard. All 37 supplements tested positive for trace amounts of lead; of those, 32 also contained mercury, 28 cadmium, 21 arsenic, and 18 residues from at least one pesticide. The levels of heavy metals found do not exceed any FDA or Environmental Protection Agency (EPA) regulations governing dietary supplements or their raw ingredients.

GAO: FDA designation doesn’t ensure safety

Ammonium Hydroxide and Phosphoric Acid, both GRAS. Photo by Benny BNut via Flickr.

On his blog Cold Truth (and on AOL News), Andrew Schneider brought our attention to the GAO’s recent investigation into the well-known FDA loophole created by the “generally regarded as safe” or GRAS designation.

The GRAS designation is meant to spare manufacturers lengthy and expensive testing that might otherwise slow the flow of new products to market. It’s conferred, Schneider writes, as long as a “scientific panel selected by the manufacturer can rule that no harm will result from the intended use of an additive.”

Schneider’s version of the highlights of the GAO report:

  • The FDA generally doesn’t know about most of these determinations of “generally regarded as safe,” or GRAS, because companies are not required to inform the agency.
  • The FDA has not taken steps that could help ensure the safety of additives listed as GRAS.
  • Food products may contain numerous ingredients, including GRAS substances, making it difficult, if not impossible, for public health authorities to attribute a food safety problem to a specific GRAS additive.
  • The FDA does not systematically reconsider the safety of GRAS substances as new information or new methods for evaluating safety become available.

The GAO said nanomaterials and imported additives were of particular concern.

(Hat tip to OMB Watch in general and Matthew Madia in particular)

GAO looks into why nursing home evals are flawed

The Government Accountability Office has followed up its May 2008 report that found a high level of inconsistency in nursing home evaluations (PDF) with a blockbuster sequel: Addressing the Factors Underlying Understatement of Serious Care Problems Requires Sustained CMS and State Commitment (PDF).

In this report, the GAO seeks to figure out exactly what’s causing state inspectors to miss serious violations on at least 15 percent of their surveys. The answers? Bad survey methodology, workforce shortages, inexperienced surveyors, bad survey documentation, odd state practices and, most interestingly, outside pressure from stakeholders like those in the nursing home industry.

The entire report deserves a close review, but for now we’ll settle for a few cherry-picked highlights. Keep in mind that while the federal government sets and enforces standards, much of the process, including hiring, training and review of surveyors, is left up to the discretion of the states. For the report, the GAO surveyed 98 percent of state agency directors (Pennsylvania’s Deputy Secretary for Quality Assurance asked that state’s surveyors not respond) and 61 percent of eligible nursing home surveyors.

Practices vary, as do the reasons behind them

“Forty percent of surveyors in five states and four directors reported that their state had at least one practice not to cite certain deficiencies.”

“… over 40 percent of surveyors in four states reported that their states’ informal dispute resolution processes favored concerns of nursing home operators over resident welfare.”

“… directors from seven states reported that pressure from the industry or legislators may have compromised the nursing home survey process, and two directors reported that CMS’s support is needed to deal with such pressure.”

“If surveyors perceive that certain deficiencies may not be consistently upheld or enforced, they may choose not to cite them.”

“Fifty-four percent of surveyors nationwide reported on our questionnaire that supervisors at least sometimes removed the deficiency that was cited, and 53 percent of surveyors noted that supervisors at least sometimes changed the scope and severity level of cited deficiencies. Of the surveyors, who reported that supervisors sometimes removed deficiencies, 13 percent reported that supervisors always or frequently removed deficiencies — including 12 states with 20 percent or more of their surveyors reporting that deficiencies were removed.”

The survey – the length and complexity of which was cited as a contributor to incorrect deficiency reporting – includes 200 standards grouped into 15 categories, which are then rated based on a scope and severity grid.

Scale is always an issue

About 1.5 million Americans live in nursing homes. That’s more than live in Maine, Hawaii, South Dakota or any one of eight other states. Combine this with state budget issues, and you can see how scale would be a serious obstacle to consistency.

“More than two-thirds of state agency directors reported on our questionnaire that staffing posed a problem for completing complaint surveys, and more than half reported that staffing posed a problem for completing standard or revisit surveys. In addition, 46 percent of state agency directors reported that time pressures always, frequently, or sometimes contributed to understatement in their states.”

Does CMS new survey system fix anything?

When the GAO sent out its questionnaires, eight states had begun adopting QIS, which is CMS’ new, and theoretically improved, nursing home survey method (PDF). While the sample size is small, early returns aren’t promising:

There was no consensus among the eight state agency directors who had started implementing the QIS as of November 2008 about how the new survey methodology would affect understatement.44 Three directors reported that the QIS was likely to reduce understatement; three directors reported that it was not likely to reduce understatement; and two directors were unsure or had no opinion… Similarly, there was no evidence that the QIS resulted in higher-quality documentation or improved surveyor efficiency.

Covering the Health of Local Nursing HomesSlim guide:
Covering the Health of Local Nursing Homes

Check out AHCJ’s latest volume in its ongoing Slim Guide series. This reporting guide gives a head start to journalists who want to pursue stories about one of the most vulnerable populations – nursing home residents. It offers advice about Web sites, datasets, research and other resources. After reading this book, journalists can have more confidence in deciphering nursing home inspection reports, interviewing advocacy groups on all sides of an issue, locating key data, and more. The book includes story examples and ideas.

AHCJ publishes these reporting guides, with the support of the Robert Wood Johnson Foundation, to help journalists understand and accurately report on specific subjects.

Other resources

AHCJ resources

  • Aging Nation: Troublesome Health Care Issues
  • Headlines an advocate for seniors would like to see
  • The impact of aging upon health care
  • Covering nursing homes and other issues of aging
  • How will retiring boomers affect the national health agenda?
  • You Can Run, but You Can’t Hide: Policy and Problems in Long-Term Care
  • Biology of Aging: Sources and Resources