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Teaching Hospital Update: November 17-21, 2008


Email Alert

By Leah Voigt Romano*

November 21, 2008

Federal Lawmakers Praise Daschle Appointment as HHS Secretary

Lawmakers from both sides of the aisle on Capitol Hill lauded former Senate Majority Leader Tom Daschle's decision to accept President-Elect Barack Obama's offer to be Secretary of Health & Human Services (HHS). News of Daschle's appointment to HHS was reported by various sources, including The Associated Press.

"I'm elated," said Senator Max Baucus (D-MT), chairman of the Senate Finance Committee, a panel that will be pivotal in any plan to reform the healthcare system. "Senator Daschle clearly knows Congress (and) he specifically knows the Senate. He knows the rhythms of this outfit."

Senator Orrin Hatch (R-UT), a member of the Finance and Health, Education, Labor & Pensions committees, similarly praised the Daschle choice. "He understands both sides of the Hill," said Hatch, adding that HHS is "one of the most difficult agencies" in government and that the former senator "is a very, very good choice."

Daschle, an adviser to the law firm of Alston & Bird in Washington, has also been appointed to lead a healthcare policy working group by the Obama-Biden presidential transition team. This decision "speaks volumes about the importance the Obama administration places on working with Congress to enact comprehensive health reform, and on managing our current health programs," said Representative Pete Stark (D-CA), chairman of the House Ways and Means Health Subcommittee.

Daschle's appointment to HHS also drew praise from advocacy group Families USA. It confirms that the incoming administration has made healthcare reform "a top and early priority for action in 2009," said Ron Pollack, the group's executive director, in a statement.

Matthew DoBias and Jennifer Lubell, Lawmakers Praise Daschle Appointment, Modern Healthcare's Daily Dose (Nov. 19, 2008) (note: registration is required to view this content).

Physicians Reluctant to Follow CDC Call for Routine HIV Testing

According to researchers, the 2006 recommendation from the Centers for Disease Control and Prevention (CDC) that HIV testing should be essentially universal in healthcare, even for low-risk patients, has been largely unheeded, in part because many clinicians have declined to go along.

The reasons vary, with payment and reimbursements issues, staff time constraints, and concerns about informed consent and availability of counseling all contributing to low compliance with the recommendations, according to several studies presented at the Forum for Collaborative HIV Research's national summit. The summit focused on the extent of HIV testing in the United States and how it could be improved.

Although much of the summit was devoted to testing and follow-up among people at high risk for HIV infection, those issues would largely vanish if the CDC's 2006 recommendations were widely followed. The CDC called for virtually all patients younger than sixty-five admitted to hospitals or seen in primary care and emergency departments to be routinely tested for HIV on an opt-out basis. It said patients should automatically be tested unless they specifically refuse, an approach called opting out. Of course, patients who request HIV testing should continue to receive it as well.

Out of 5,000 emergency departments in the U.S., about 50 to 100—mostly concentrated in a few areas—are routinely testing all patients for HIV, according to a physician-researcher at Johns Hopkins. A survey of staffers at a big emergency department in Cleveland also shed some light on the reluctance to follow the CDC recommendations in emergency departments. Among thirty-four staff members who responded—including nineteen nurses, five attending physicians, and ten other clinical professionals—only nine believed the emergency department should offer HIV testing.

John Gever, Physicians Reluctant to Follow CDC Call for Routine HIV Testing, MedPage Today, Nov. 20, 2008.

FDA Scientists Allege Coercion in Medical Device Approval Process

On Monday, November 17, the House Energy and Commerce Committee launched an investigation into allegations by at least eight scientists from the Food & Drug Administration (FDA) that agency managers coerced those in the medical device division into approving products despite serious safety and effectiveness concerns. Committee Chair John Dingell (D-MI) and Oversight and Investigations Subcommittee Chair Bart Stupak (D-MI) said that the investigation was prompted by an October 14 letter "written on behalf of a large group of Center for Devices and Radiological Health scientists and physicians who state that CDRH managers have 'corrupted and interfered with the scientific review of medical devices.'" The letter to the committee, released publicly on Monday, did not include the names of the FDA scientists or information on which device approvals the scientists questioned.

The scientists claim that they were threatened with removal or negative performance reviews if they did not modify their scientific data to obscure unscientific clinical and technical data submitted by device companies and legal violations, including a lack of informed consent from study participants. "This misconduct reaches the highest levels of CDRH management including the Center Director and Director of the Office of Device Evaluation," the scientists wrote.

The scientists first expressed these concerns in a letter sent to FDA Commissioner Andrew von Eschenbach in May. Von Eschenbach instructed William McConagha, the agency's assistant commissioner for integrity and accountability, to investigate the matter further. McConagha found the evidence provided by the scientists "'sufficient' to justify curative and disciplinary actions," according to the October letter. The scientists wrote, "The director of CDRH then conducted his own investigation and concluded that we, FDA physicians and scientists, need to 'move forward,' thus allowing managers to avoid and evade any accountability."

Stupak said that the committee "intends to learn what action FDA plans to take to ensure the integrity of the medical device approval process and prevent retaliation against the scientists who blew the whistle on these activities." Dingell and Stupak, in a letter sent to von Eschenbach on Monday, wrote that "our preliminary witness interviews and document review confirm that sweeping measures may be necessary to address the distortion of science alleged by so many CDRH scientists."

Kaiser Daily Health Policy Report, FDA Scientists Allege Coercion in Medical Device Approval Process, House Panel Investigates, Henry J. Kaiser Fam. Fdn. (Nov. 18, 2008).

Employee Fired, Others Suspended for Snooping

Officials at University of Iowa Hospitals and Clinics are stepping up employee training and enforcement on patient privacy in the wake of a discovery that at least eight employees inappropriately accessed the records of a patient in the past month.

One person at the 653-bed hospital in Iowa City was terminated as a result of the discovery and seven others were given five days unpaid leave. According to a hospital spokesman, the security breach was discovered as part of a routine review of confidential patient records accessed by hospital staff.

The hospital plans to increase staff training, in addition to the requirement that all employees and volunteers are already required to sign an annual statement saying they understand the hospital's patient-privacy policy.

Joe Carlson, Employee Fired, Others Suspended for Snooping, Modern Healthcare's Daily Dose (Nov. 18, 2008) (note: registration is required to view this content).

First Circuit Holds Residents' Research Time Must Be Excluded from Hospitals FTE Count

On November 17, a Federal Appeals Court held that the Secretary of HHS was not acting in an arbitrary or capricious manner in determining that time residents spend in research activities unrelated to patient care must be excluded from a hospital's full-time equivalent (FTE) resident count (Rhode Island Hospital v. Leavitt, 1st Cir., No. 07-2673, 11/17/08).

Rhode Island Hospital, an acute care hospital in Providence, RI, argued that because residents assigned to a research rotation were not assigned to a reasonable cost billing unit, their work must count toward a hospital's total number of FTEs. However, the U.S. Court of Appeals for the First Circuit, in reversing the Secretary's decision, determined that the purpose of the FTE regulation was to exclude residents from a hospital's FTE count who did not contribute to the added costs, which the indirect medical education (IME) adjustment was intended to reimburse.

The IME adjustment's legislative and administrative history adequately support the Secretary's conclusion that the provision was intended to compensate teaching hospitals for added costs of patient care unremunerated by the prospective payment system.

The Secretary, acting through the administrator for CMS, reversed the decision by the Provider Reimbursement Review Board (PRRB) after determining the time a resident spent exclusively in research activities must be excluded from the full-time equivalent resident count used to calculate the indirect medical education adjustments. The Secretary disagreed with the PRRB's finding that the regulation did not exclude research time from the IME resident count computation.

First Circuit Holds Residents' Research Time Must Be Excluded From Hospital's FTE Count, BNA'S HEALTH L. REP. (Nov. 20, 2008) (note: registration is required to view this content).

Medicare Proposes Coverage of Bariatric Surgery for Morbidly Obese Diabetics

Medicare is planning to cover bariatric surgery for morbidly obese patients with type 2 diabetes. The agency's proposal, which is subject to a thirty-day comment period, would apply to beneficiaries with diabetes who have a body mass index (BMI) of thirty-five or higher.

Medicare has paid for bariatric surgery since 2006 for morbidly obese beneficiaries with at least one serious comorbidity such as hypertension, coronary artery disease, and osteoarthritis. The new proposal would add type 2 diabetes to the list of eligible comorbidities. Medicare currently covers gastric bypass, open and laparoscopic Roux-en-Y gastric bypass, laparoscopic adjustable gastric banding, and open and laporoscopic biliopancreatic diversion with duodenal switch. The four approved procedures are only covered when performed in high-volume centers from surgeons that are deemed "high quality" by the American College of Surgeons or the American Society for Bariatric Surgery.

Medicare said it ruled out beneficiaries with type 2 diabetes with a BMI of less than thirty-five because it was not persuaded that the surgery would help them. For those with a BMI under thirty-five, the current evidence suggests the risks outweigh the benefits.

While recent medical reports claimed that bariatric surgery may be helpful for these patients, Medicare did not find convincing medical evidence that bariatric surgery improved health outcomes for non-morbidly obese individuals.

Emily Walker, Medicare Proposes Coverage of Bariatric Surgery for Morbidly Obese Diabetics, MedPage Today (Nov. 20, 2008).

*We would like to thank Leah Voigt Romano, Esquire (Hall Render Killian Heath & Lyman PLLC, Troy, MI) for providing this week's Teaching Hospital Update.

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