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Teaching Hospital Update - August 31-September 4

 
 

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By Reesa N. Handelsman*

September 4, 2009

Expanding Medicaid Could Cover 17 Million

Expanding Medicaid to those with incomes of up to 133% of the federal poverty line would cover at least 17 million uninsured individuals, according to a report released by the Robert Wood Johnson Foundation and the Kaiser Commission on Medicaid and the Uninsured. The report, "How Will the Uninsured Be Affected by Health Reform?," calculated how many nonelderly, uninsured people would gain coverage under this type of expansion to Medicaid, a scenario that was modeled for this analysis and draws on proposals being discussed on Capitol Hill.

Under this scenario, 17 million uninsured would be eligible to receive benefits under the program, and more than 16 million would be eligible to receive subsidies to purchase private health insurance coverage. Another 4.3 million uninsured would not be eligible for subsidies, however, because their income would be too high to qualify, though they would be required to purchase coverage under an individual mandate, another proposal that is being considered as part of healthcare reform.

The researchers reported that nearly 70% of the uninsured under the current system are either uninsurable or face premiums of up 10% or more of their incomes in today's market. "Consequently, access to affordable coverage under reform will depend on the benefit package offered, cost-sharing projections, and the amount and structure of subsidies," the report concluded.

Jennifer Lubell, Expanding Medicaid Could Cover 17 Million: Report, Modern Healthcare's Daily Dose (Aug. 28, 2009) (note: registration is required to view this content).

Retail Clinics Give Good Low-Cost Care for Minor Ills

According to a recent study, sore throats and common infections were treated effectively and at relatively low cost in retail medical clinics, compared with more traditional venues. Average costs paid for treatment of pharyngitis, otitis media, and urinary tract infections at physicians' offices, urgent-care centers, and emergency rooms were 42% to 420% higher than at clinics in large retail stores such as Wal-Mart, according to Ateev Mehrotra, MD, of the University of Pittsburgh, and colleagues.

Quality-of-care scores, receipt of preventive care, and prescription drug costs at these locations were virtually identical, except at emergency departments, where drugs costs were higher and care was relatively inferior, the researchers said in the September 1, 2009, edition of Annals of Internal Medicine. "Retail clinics provide less costly treatment than physician offices or urgent-care centers for three common illnesses, with no apparent adverse effect on quality of care or delivery of preventive care," Mehrotra and colleagues concluded.

The study used claims data for members of a large health plan in Minnesota called HealthPartners, covering a total of 15,000 cases involving the three common medical conditions. Of these, 2,100 were treated at in-store retail clinics; about 6,000 each in physician offices and urgent-care centers, and close to 1,000 in emergency rooms. Cases were matched according to patient age, sex, income (on the basis of averages for census tract of residence), and comorbidity score. Illness episodes seen at multiple locations over time—for example, patients who initially went to a retail clinic and then to a physician office the next day—were categorized according to the first location visited. Average total costs for the four locations were: (a) Retail clinics: $110;
(b) Physician offices: $166; (c) Urgent-care centers: $156; and
(d) Emergency rooms: $570.

Care quality was scored according to the RAND Corporation's Quality Assurance Tools and adherence to guidelines for otitis media and streptococcal pharyngitis treatment established by major physician specialty societies. Scores were created by dividing all visits in which patients received recommended care by the number of times patients could receive such care at each type of location. The researchers found that mean quality scores were in the range of 61% to 64% at retail clinics, physician offices, and urgent-care centers (differences not significant). Episodes first seen at emergency departments had a mean quality score of 55%. The researchers said nurse practitioners generally provide the care in retail clinics. Mehrotra and colleagues said most patients seen at retail clinics for an acute condition who later received preventive care did so at physician offices. This finding indicates that retail clinics "are not disrupting opportunities for preventive services," they said. Mean prescription drug costs were $21 to $22 at retail clinics, physician offices, and urgent-care centers; they averaged $26 for cases first seen in emergency rooms.

The researchers noted several limitations to the analysis: (i) all patients in the sample had insurance by definition; (ii) all the retail clinics in the study were operated by a single chain; and (iii) retail clinic patients in the sample and their illnesses may have differed from those seen in the other settings, despite the efforts to match them. In fact, the researchers said this was likely.

John Gever, Retail Clinics Give Good Low-Cost Care for Minor Ills, MedPage Today (Aug. 31, 2009).

AHIMA Foundation Receives $1.2 Million HIE Grant

The American Health Information Management Association (AHIMA) Foundation states that it has received a $1.2 million grant from the Department of Health and Human Services (HHS) to continue the foundation's state-level health information exchange consensus project, which it began in 2006. Sponsored by HHS' Office of the National Coordinator for Health Information Technology, the consensus project is led by a thirteen-member steering committee of state-level health information exchange (HIE) leaders. It supports a leadership forum, open to all states, that encourages both public- and private-sector leaders to participate, learn, and receive technical support to help them implement practical and effective HIE.

Preparing to respond to the American Recovery and Reinvestment Act of 2009's Health Information Technology for Economic and Clinical Health Act, "states are being challenged to achieve and demonstrate value and impact from HIE to improve health and healthcare delivery," said Mary Madison, executive director of the AHIMA Foundation, in a news release about the grant. "The consensus project will continue to provide practical and field-based resources to support this work."

The consensus project's priorities include expanding the knowledge bases regarding effective HIE and state-level HIE governance; providing targeted, one-on-one technical support and assistance to state-level HIE leaders; and providing a HIE information service to enhance networking, shared learning, and promising practices, according to the foundation, which was established in 1962 as AHIMA's philanthropic and charitable arm.

Jessica Zigmond, AHIMA Foundation Receives $1.2 Million HIE Grant, Modern Healthcare's Daily Dose (Sept. 1, 2009) (note: registration is required to view this content).

Ninth Circuit Holds Whistleblower Did Not Show Evidence of False Claims to Medicare

On August 27, 2009, a federal appeals court held that a whistleblower did not present sufficient evidence that his former employer, a hospital in Hawaii, knowingly submitted false claims to Medicare (United States ex rel. Lockyer v. Hawaii Pacific Health, 9th Cir., No. 07-17174, 8/27/09). In an unpublished opinion, the U.S. Court of Appeals for the Ninth Circuit upheld the lower court's dismissal of the claims by James Lockyer, a physician formerly with Kauai Medical Clinic, a subsidiary of Hawaii Pacific Health, after finding that Lockyer failed to establish a genuine issue of material fact as to whether Hawaii Pacific Health had the required knowledge to support liability under the False Claims Act (FCA).

The appeals court found that Lockyer presented evidence that raised genuine issues of fact as to whether Hawaii Pacific violated the Medicare "incident to" rules, which permit a physician to bill for the services of non-physicians as if the physician performed those services himself. However, the appeals court found that the FCA requires more than just a false statement—it requires that a defendant knew the claim was false.

The U.S. District Court for the District of Hawaii dismissed Lockyer's allegations that Kauai submitted claims to Medicare, using his provider number, for chemotherapy services he neither ordered nor oversaw. The district court also dismissed Lockyer's allegation that he was unlawfully terminated after he requested an audit of Kauai's billing practices. The hospital's procedures did not run afoul of Medicare rules requiring a supervising physician be on site and available to provide assistance during the administration of chemotherapy services, the district court found. Further, the district court concluded that the hospital lacked sufficient knowledge that Lockyer was engaging in any protected action.

The Ninth Circuit determined that the evidence produced by Lockyer, viewed in the light most favorable to him, suggested only that any noncompliance with the Medicare regulations was because of a good faith interpretation of the regulations or, at worst, to negligence in Kauai's compliance. The appeals court also found that Lockyer failed to raise a genuine issue of material fact as to whether he engaged in protected conduct or that Kauai knew that his conduct was protected. The appeals court concluded that even if Lockyer were acting in the belief that Kauai had committed fraud against the government, there was no evidence that the clinic was aware he engaged in protected conduct. Although Lockyer's FCA qui tam complaint also alleged violations of the Hawaii law, the appeals court found no state law issues raised in the briefs. Therefore, the appeals court determined that its analysis of the federal claims was sufficient for the disposition of the appeal and affirmed the district court's decision.

Ninth Circuit Holds Whistleblower Did Not Show Evidence of False Claims to Medicare, BNA'S HEALTH L. REP. (Sept. 3, 2009) (note: registration is required to view this content).

Pfizer Settles Fraud Charges for $2.3 Billion

Pfizer will pay the government $2.3 billion to settle criminal and civil charges that it promoted off-label uses for the disgraced painkiller valdecoxib (Bextra) and three other drugs. The Department of Justice said it was the largest healthcare fraud settlement in history.

More than half the settlement—$1.3 billion—involves Pfizer's efforts to promote valdecoxib, a COX-2 inhibitor withdrawn from the market in 2005 because of cardiovascular and other risks. Pfizer's sales staff had urged doctors to prescribe the drug for surgical pain and to prevent deep vein thrombosis, according to court records from a criminal trial of a Pfizer manager earlier this year.

The other $1 billion covered charges that Pfizer improperly promoted the antipsychotic drug ziprasidone (Geodon), the antibiotic linezolid (Zyvox), and pregabalin (Lyrica), approved for epilepsy, fibromyalgia, and neuropathic pain. The settlement will be shared between the federal government, state Medicaid programs, and whistleblowers. The latter include a Pennsylvania psychiatrist and at least one former Pfizer employee whose allegations helped launch the investigation. Their complaints, which had been sealed until the settlement was reached, provided details on Pfizer's alleged transgressions. For example, according to one complaint, Pfizer pushed linezolid for several types of infections not named on its FDA-approved labeling, and also claimed it was superior to vancomycin without FDA approval. Similarly, Pfizer was said to have promoted ziprasidone—approved only for schizophrenia or acute manic or mixed episodes associated with bipolar disorder—for depression, obsessive-compulsive disorder, autism, and a host of other conditions.

In addition to promoting the off-label uses, Pfizer was also accused of paying kickbacks to doctors who prescribed the drugs. In the settlement deal, Pfizer's Pharmacia & Upjohn subsidiary agreed to plead guilty to a felony criminal charge relating to promotion of off-label use of valdecoxib. Pfizer said it expressly denies all the civil allegations involving the four drugs, except for acknowledging "certain improper actions related to the promotion of Zyvox."

John Gever, Pfizer Settles Fraud Charges for $2.3 Billion, MedPage Today (Sept. 2, 2009).

What a Pilot Eats Could Affect Flight Performance

Diet may affect the way a pilot performs on the job, a randomized, crossover trial showed. When commercial pilots ate a diet high in carbohydrates or fats, they did significantly better in simulated flight performance than when they ate a high protein diet, according to Glenda Lindseth, PhD, RN, of the University of North Dakota in Grand Forks. Sleep and cognitive function were also significantly better for diets high in carbohydrates and fats, she reported at the Military Health Research Forum in Kansas City, MO.

"I think that this does have an impact for the military, especially the pilots who are flying, but also for anybody who needs to be alert and have high cognitive performance," she said. The results will be explored further in a larger study that will be started next year, Lindseth said. Results should be available in about three years.

Previous studies have shown that up to 90% of flight accidents are the result of human error, according to Lindseth. To evaluate the contribution of diet to professional and cognitive performance, Lindseth and colleagues enrolled forty-five pilots from a university-based commercial aviation program in a study that lasted about fourteen weeks. The diet plan was divided into four segments—a control diet, a diet high in carbohydrates, one high in fats, and one high in protein. Each pilot ate each of the diets for four days in random order with a washout period between each diet.

At the end of a session with each diet, the pilots underwent cognitive testing with the Sternberg Item Recognition Test—for short-term memory—and with the Vandenberg Mental Rotation Test—for spatial orientation. The pilots performed significantly better on the short-term memory test after eating the diets high in fats and carbohydrates. Diet had no effect on performance on the spatial orientation test. The participants also completed a twenty-minute flight test in a full-motion flight simulator and were judged based on the number of errors they committed. Further studies, Lindseth said, would be needed to determine whether dietary factors contribute to aviation safety.

Todd Neale, What a Pilot Eats Could Affect Flight Performance, MedPage Today (Sept. 2, 2009).

*AHLA would like to thank Reesa N. Handelsman, Esquire (Hall Render Killian Heath & Lyman PC, Troy, MI), for providing this week's update.

AHLA Teaching Hospital Updates are intended to provide quick summaries of cutting-edge issues of interest to teaching hospitals and their counsel. Additional information and more in-depth coverage on these topics may be available from AHLA Health Lawyers Weekly and appropriate AHLA Practice Groups.

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