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Teaching Hospital Update October 25-29, 2010

By Adam Mingal and Leah Voigt*

Grassley Letter Asks FDA How Agency Handles Conflicts of Interest in Clinical Trials

Senator Chuck Grassley (R-IA), member of the Senate Finance Committee, has asked the Food and Drug Administration (FDA) how it handles potential financial conflicts of interest from physicians participating in clinical trials for medical devices. In a letter dated October 22, 2010, Grassley asked FDA Commissioner Margaret Hamburg how the agency handles reports of medical device companies' payments to doctors who are participating in clinical studies of the companies' products. Grassley asked FDA to respond to the letter no later than November 12, 2010.

"The FDA should be transparent and describe what it does with information about potential conflicts of interest, including any steps it takes to protect the integrity and reliability of clinical research," Grassley said in a statement. FDA requires manufacturers that submit applications and clinical studies for drug, biologics, and device approvals to file disclosure statements regarding the financial interests of the clinical investigators who are not full-time or part-time employees of the manufacturers but are or were involved in conducting studies submitted to FDA.

According to the letter, while FDA regulations require a manufacturer to disclose to FDA the "significant financial interests" of the manufacturer's clinical investigators, the regulations do not specify how FDA should treat financial interests that may present a conflict. Grassley asked Hamburg to describe how FDA determines whether financial interests reported to the agency "adversely affect the rights and welfare of human subjects" and/or the integrity and reliability of the clinical studies submitted by manufacturers.

"Assuming there are no compelling circumstances, are there financial interests that FDA would consider too significant a conflict to be appropriate for a clinical investigator to be involved in a study?" Grassley asked. He also said he would like to know if FDA advises manufacturers on specific steps that should be taken to minimize potential bias. "Are there actions that FDA expects companies to take to manage potential conflicts of interest?" the letter questioned.

Grassley has long been a proponent of financial disclosures, and is a co-sponsor of the Physician Payments Sunshine Act, which was incorporated as part of the Patient Protection and Affordable Care Act. The sunshine provision requires disclosures by pharmaceutical, medical device, biological, and medical supply companies of payments to physicians. Grassley in the letter noted that in 2001, the Task Force on Financial Conflicts of Interest in Clinical Research established by the Association of American Medical Colleges (AAMC) issued guidelines for the oversight of financial interests in human subjects research. He also said that in February 2008, an advisory committee established by the AAMC and the Association of American Universities issued a report "reiterating the rebuttable presumption that an individual who holds a significant financial interest in research involving human subjects may not conduct such research recommended in 2001 and clarifying the compelling circumstances exception."

Nathaniel Weixel, Grassley Letter Asks FDA How Agency Handles Conflicts of Interest in Clinical Trials, BNA's Health Care Daily Report (Oct. 28, 2010) (note: registration is required to view this content).

Hourly Earnings Lowest in Primary Care

Primary care physicians earn, on average, the lowest income of doctors in any medical specialty: just two-thirds what general surgeons make on an hourly basis, according to a recent study. Evidence of disparities among the specialties is nothing new, the researchers acknowledged, but, they said, their study is among the first to look at earnings per hour rather than annual income.

The consistent finding of a gap might be in part because of an inequitable fee-for-service scheme, suggested one researcher in an accompanying editorial. "This undoubtedly contributes to the shortage of primary care physicians, which likely has deleterious effects on the system as a whole," he wrote.

The researchers agreed, pointing to a looming "critical shortfall" of generalists despite the more cost-effective care they provide. The researchers compared income and work hours reported by 6,381 practicing physicians who participated in the 2004-2005 Community Tracking Study. Overall, physicians' annual income averaged $187,857, working 53.1 hours on average per week for 47.3 weeks each year.

The researchers divided physicians into four broad categories: primary care, surgery, subspecialties of internal medicine and pediatrics, and "other." In primary care, they included pediatrics, geriatrics, family practice, general internal medicine, general practice, and the internal medicine/pediatrics combination dubbed med/ped. OB/GYN was put in the surgery category. Primary care physicians averaged 51.2 hours a week compared with the 59 put in by surgeons, 57.9 by subspecialists, and 47.4 by "other" physicians. As they do in surveys that look at annual income, surgeons came out on top, making $92.10 an hour compared with $60.48 an hour for primary care physicians.

Crystal Phend, Acute Hourly Earnings Lowest in Primary Care, MedPage Today (Oct. 28, 2010).

Little-Known AMA Group Has Big Influence on Medicare Payments

Early this month, a group of twenty-nine doctors gathered in a modern conference room at the Hyatt Regency Chicago, a few blocks from Lake Shore Drive. Over the course of four days, the little-known group of mostly specialists made a series of decisions crucial to the massive government entitlement program known as Medicare—issuing recommendations for precisely how Medicare should value more than 200 different medical procedures.

As the members of the organization waded through technical discussions ranking procedures by how much time, skill, and mental effort they required, more than 100 invitation-only consultants, lawyers, and medical society representatives hunched over their laptops taking notes.

If history is any indication, the Chicago group's decisions will weigh heavily on how much Medicare pays doctors. But the members of this powerful panel are not employed by the federal government. Instead, the group is comprised almost exclusively of physicians themselves, the very people who have the most to win or lose based on how Medicare values the work they perform.

Known as the American Medical Association (AMA)/Specialty Society Relative Value Scale Update Committee, or RUC, the group is unknown to much of the medical profession. Yet for almost two decades, the committee has had a powerful influence on Medicare payment rates. Since 1991, the RUC has submitted more than 7,000 recommendations to the Centers for Medicare and Medicaid Services (CMS) on the value of physician work. CMS has overwhelmingly rubber-stamped RUC recommendations, accepting more than 94%, according to AMA numbers.

That record, critics say, means CMS is handing over some of its payment policy decisions to a physician organization with a massive and obvious conflict of interest. The arrangement has been criticized by bodies like the Government Accountability Office and MedPAC, the independent agency that advises Congress on Medicare issues. But no group has cried out louder than family doctors, who say CMS reliance on the secretive group has undervalued face-to-face consultation between doctors and patients while overvaluing expensive high-tech medical procedures and imaging.

Joe Eaton, Little-Known AMA Group Has Big Influence On Medicare Payments Kaiser Health News (Oct. 27, 2010).

Petition Seeks High Court Review of Ruling That HIPAA Does Not Bar Ex Parte Interviews

The U.S. Supreme Court should review a Michigan Supreme Court ruling that found the Health Insurance Portability and Accountability Act (HIPAA) does not prohibit ex parte interviews by defense counsel with treating physicians, according to a petition filed earlier this month (Holman v. Rasak, U.S., No. 10-518, petition filed 10/11/10). According to the petition, the state court's ruling should be reviewed because it erroneously interpreted HIPAA to allow ex parte interviews under a qualified protective order despite language in implementing regulations that requires either patient authorization or full disclosure by the physician of what information is shared.

The petition claims ex parte oral communications—those made without attorneys representing both parties present—are prohibited under the act because full disclosure of informal communications cannot be achieved and because oral communications cannot be "returned or destroyed at the conclusion of litigation" as is normally required under protective orders covering medical records and other types of health information, the petition said.

The petition relies on the importance of the underlying federal issue—HIPAA privacy—and the argument that the Michigan Supreme court's ruling misinterprets federal law as a basis for high court review. The petition also cites decisions by other courts, including the Missouri Supreme Court's August decision in Missouri ex rel. Proctor v. Messina, that create a conflict in federal law interpretation that the petitioner contends should be reviewed and resolved.

The petition specifically challenges the Michigan Supreme court's July ruling that said Michigan law permits ex parte interviews and that nothing in HIPAA specifically precludes them. Because defense counsel can ensure that any disclosure of protected health information complies with HIPAA regulations by making reasonable efforts to obtain a qualified protective order, HIPAA does not preempt Michigan law, the court added.

Petition Seeks High Court Review of Ruling That HIPAA Does Not Bar Ex Parte Interviews, BNA's Health Care Daily Report (Oct. 26, 2010) (note: registration is required to view this content).

More Kidney Transplants for Older Patients

While the number of older patients with end-stage renal disease who have a kidney transplant remains small, it has increased notably in recent years, analysis of a large database showed. Between 1995 and 2006, the likelihood of patients ages sixty and older receiving a transplant from any source doubled, according to researchers at Charité University in Berlin. Additionally, during that time the risk of an older person dying while awaiting a kidney decreased, the researchers reported online in the Clinical Journal of the American Society of Nephrology.

Almost half of patients with end-stage renal disease in the U.S. are sixty or older, and studies have shown that even for that age group, transplantation confers a survival benefit compared with dialysis. But few older patients are ever placed on waiting lists. And because the availability of deceased and living donors hasn't kept up with the rising demand, older patients who develop end-stage renal disease have been just as likely to die while waiting as they are eventually to receive a transplant.

To explore the current patterns of transplantation among these patients so that appropriate access can be encouraged, the researchers analyzed all incident patients enrolled in the U.S. Renal Data System between January 1995 and December 2006. They identified 397,362 patients with end-stage renal disease ages sixty and older. About half were women, and two-thirds were white. Slightly more than half had diabetes, and more than one-third had congestive heart failure. About 40% were insured by Medicare alone.

During 1995, about 500 transplants were done in patients sixty and older. The number rose to approximately 1,600 in 2006, according to the researchers. Each year of the study, the adjusted likelihood of older patients being placed on a waiting list increased. The likelihood of receiving a kidney from a deceased donor fell during the course of the study, while the chance of obtaining a transplant from a living donor increased.

Despite the small numbers of older transplant recipients, the increased opportunity for transplantation in a wide variety of patients "should be considered a relative success of the transplant system in the U.S.," the researchers wrote. Contributing to the improved outlook for older patients was the implementation of the expanded-criteria donor program in 2002, they pointed out. In that program, donors previously considered unsuitable because of age (older than sixty), a history of high blood pressure, creatinine higher than 1.5 mg/dL, or death from stroke, became eligible for matching with certain recipients.

Patients considered appropriate for these less-than-ideal kidneys include the elderly, those with diabetes, and those from centers where waiting lists are particularly long. And although transplants from living donors also increased, this plateaued after 2000, the researchers observed. Most of the living donors themselves were elderly, and were likely to have medical problems and impaired kidney function. "Additional studies to inform the risk of donation explicitly from elderly donors are important to expand living donation in the elderly," the researchers wrote.

Nancy Walsh, More Kidney Transplants for Older Patients, MedPage Today (Oct. 29, 2010).

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.

*We would like to thank Adam Mingal, JD (Washington, DC), and Leah Voigt, Esquire (Squire Sanders & Dempsey LLP, Washington, DC), for providing this week's update.

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