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Teaching Hospital Update - April 12-16, 2010


Email Alert

By Leah Voigt*

April 16, 2010

Health Reform's Next Challenge: Who Will Care for the Newly Insured?

The health system reforms signed into law in March will cover an estimated thirty-two million uninsured patients by 2019. But there may not be enough physicians to care for them. The nation likely will see a shortage of about 160,000 physicians by 2025—leaving too few to keep up with the flood of newly insured patients seeking care for long-neglected health problems.

"It's sort of a race against time," said Edward Salsberg, director of the Association of American Medical Colleges' Center for Workforce Studies, whose 2025 physician supply estimate includes a shortage of 46,000 primary care physicians and 41,000 general surgeons, even after accounting for the supply of international medical graduates. Several reform provisions are aimed at addressing the projected work force crisis, especially in primary care.

From 2011 through 2015, for example, primary care physicians and general surgeons who work in health professional shortage areas will get a 10% Medicare pay bump for certain services. In 2013 and 2014, Medicaid will increase pay to Medicare levels for primary care services delivered by primary care physicians. Unused residency slots will be shifted to programs that promise to train more primary care doctors and general surgeons. And a national work force commission will analyze the shortage problem and issue guidance for a competitive state grant program. The American Medical Association (AMA) lauded the healthcare reform provisions but said that further changes are needed to strengthen the physician work force, noting that at least twenty-one states and seventeen medical specialty societies already are reporting doctor shortages.

Work force experts and some physician leaders also say that healthcare reform provisions and other efforts may not avert a crisis, given the crush of the newly insured.

Kevin B. O'Reilly, Health reform's next challenge: Who will care for the newly insured?, Am. Med. News (Apr. 12, 2010).

Hospital-Acquired Infection Problem Persists

The nagging and largely solvable problem of hospital-acquired infections remains as resistant to cure as the germs that contribute to an estimated 100,000 deaths a year, according to an annual government study issued Tuesday. Despite a renewed focus on prevention and threats of governmental sanctions, hospitals continue to see increased rates of post-operative bloodstream infections and catheter-associated urinary tract infections, the Agency for Healthcare Research and Quality (AHRQ) reported. The rates increased by 8% for bloodstream infections and 4% for urinary tract infections over the year before.

There was no change in the incidence of bloodstream infections caused by the placement of catheters in central veins. The only positive news came from a 12% reduction in the rate of post-operative pneumonia. The report concluded that hospital-acquired infections merited "urgent attention."

Dr. Carolyn M. Clancy, the agency's director, pointed out that projects across the country had shown remarkable success in reducing infection rates by adhering to basic standards for hand hygiene, disinfection of patients, sterile handling of equipment, and proper use of antibiotics, but at many hospitals those successes have yet to overcome an entrenched medical culture. "Despite promising improvements in a few areas of health care," Dr. Clancy said, "we are not achieving the more substantial strides that are needed to address persistent gaps in quality and access."

Kathleen Sebelius, the Secretary of Health and Human Services (HHS), called the trend troubling but said the new healthcare law would "help turn these numbers around." Under the law, hospitals with high rates of infections will be penalized by the government starting in the 2015 fiscal year. The agency has been releasing its Congressionally mandated reports on healthcare quality and disparities since 2003. Overall, this year's report found that the quality of care, based on thirty-three separate measures, was improving but at a slow pace.

The study found deep disparities in access to healthcare between those with insurance and those without it. For instance, 74% of women ages forty to sixty-four who had insurance had received a mammogram in the previous two years, compared with 38% of those without insurance. Children were twice as likely to have had a dental exam in the past year if they were insured.

Kevin Sack, Hospital Infection Problem Persists, N.Y. TIMES (Apr. 13, 2010).

HHS Proposal to Tighten Regulation of Business Associates Imminent, Panel Told

HHS has finished drafting a proposed rule that would tighten the privacy and security regulations that apply to businesses that have relationships with healthcare entities covered by the Health Insurance Portability and Accountability Act (HIPAA), a HHS Office for Civil Rights (OCR) senior policy specialist on health information technology said on April 14.

OCR sent the text of the proposed rule to the Office of Management and Budget (OMB) for review on April 12, according to OMB's list of its current rulemaking activities. The proposed regulation is among HIPAA modifications required by the Health Information Technology for Economic and Clinical Health (HITECH) Act, part of the American Recovery and Reinvestment Act.

OCR's Adam Green said the proposed rule would "add more specificity to the obligation and compliance requirements of business associates." He noted that the proposal would be subject to public comment and possible modification before it could become a final regulation. Green's comment came during a conference call held by the Nationwide Health Information Network (NHIN) workgroup, a panel drafting recommendations for the HIT Policy Committee, one the federal advisory committees for the Office of the National Coordinator for Health IT.

The NHIN panel discussed, but did not finalize, a draft proposal for a national "trust framework" meant to undergird multi-provider health information exchanges (HIEs). The framework would identify "essential elements" for HIEs meant to foster providers' trust in the systems and ensure the security of shared patient information. As drafted, those so-called essential elements would include: agreed-upon operational, policy, and legal expectations and requirements; clear accountability and enforcement for privacy and security violations; and minimum technical requirements. Doctors who knew each other well could exchange information without further proof of provider identity, under the draft.

The NHIN panel finalized a separate draft recommendation for policies and procedures that would govern the direct sharing of electronic medical records between two providers via the Internet. Members agreed that numerous solo providers and small group practices would have little interest in implementing the technical procedures needed for secure messaging. Entities providing that technical service should be business associates governed by HIPAA, the panel agreed.

Jeff Day, HHS Proposal to Tighten Regulation of Business Associates Imminent, Panel Told, BNA's Health Care Daily Report (Apr. 15, 2010) (note: registration is required to view this content).

Gene Patents Rejected by Federal Judge

In a recent groundbreaking decision that could have far-reaching implications for healthcare and biomedical research, a federal judge invalidated patents on a pair of genes linked to breast and ovarian cancer. The U.S. District Court for the Southern District of New York found that the patents violated long-standing precedents barring the patentability of natural phenomena, saying the DNA over which Myriad Genetics Inc. claimed a monopoly represented "the physical embodiment of laws of nature." The court also rejected Myriad's patent claims on a testing method in which it compared gene mutations to determine a patient's predisposition for breast or ovarian cancer. Myriad plans to appeal to the U.S. Court of Appeals for the Federal Circuit, which oversees patent cases. The U.S. Patent and Trademark Office was dismissed from the case.

The March 29 ruling—which casts doubt on existing patents covering 20% of the human genome—is believed to be the first of its kind and has fueled debate about whether such monopolies help or hinder medical innovation. Organized medicine declared the decision a victory that will pave the way for broader research and more accessible treatments for patients. On the other side of the debate, patent lawyers and biotechnology firms contend that the decision could hinder such developments if the patent system isn't available to help attract the investment needed for new research.

Physicians agree that patents can be useful in spurring medical inventions, such as new drugs. But overly broad patents, like those held by Myriad, created a monopoly "that hampered scientific discovery and medical care," said AMA President J. James Rohack, MD. The Litigation Center of the AMA and State Medical Societies joined a group of other medical organizations in filing a court brief contesting the gene patents.

According to the lawsuit, because Myriad had exclusive rights to the use of the BRCA1 and BRCA2 genes and related diagnostic testing, some women were unable to confirm their cancer test results elsewhere, while others could not afford the $3,000 test. In addition, several researchers already engaged in similar testing were forced to stop their work once Myriad began enforcing its patent.

Amy Lynn Sorrel, Gene patents rejected by federal judge, Am. Med. News (Apr. 12, 2010).

Industry Comments Tell FDA to Improve Transparency of Guidance, Product Reviews

In letters to the Food and Drug Administration (FDA), pharmaceutical and medical device industry members applauded recent agency efforts at increasing transparency with manufacturers of medical products, and commented on ways FDA could improve those efforts. FDA in a March 12 Federal Register notice (75 Fed. Reg. 11893) solicited comments about how the agency could improve transparency to regulated industries. Comments were due April 12.

The call for comments was the third phase of FDA's Transparency Initiative. The first phase was the January launch of the FDA Basics website, which provides basic information about the agency and how it does its work. FDA said the second phase of the transparency work was aimed at improving FDA's disclosure of information to the public. The third phase is intended to improve transparency to regulated industry.

In an April 9 letter, the Pharmaceutical Research and Manufacturers of America (PhRMA) told FDA that it strongly supports the agency's efforts to improve openness and communication, specifically with regard to the review of medical products. PhRMA said that it will be critical for the agency to ensure that increased transparency does not undermine the incentives for innovative biomedical research. PhRMA also suggested that FDA could improve transparency by changing the content and frequency of its communications during its review of applications. According to the group, FDA should provide sponsors with the opportunity to participate in a mid-cycle review meeting that would highlight issues that surface during the review process, thereby allowing a sponsor to address those issues during the first cycle. PhRMA also suggested that FDA implement good review management principles and practices across all review divisions and in both the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).

In a separate April 9 letter, manufacturer Bausch & Lomb recommended that FDA should enhance transparency in the guidance development process. The company suggested FDA follow the same path it does with its medical device division, and publish the CDER and CBER guidance agenda in the Federal Register. The company also noted that FDA sometimes issues companion question and answer documents in support of particular guidance documents. According to the letter, "these Q&A's are based on questions posed by applicants and provide a useful tool for additional clarity on topics covered, specific examples, etc."

The Medical Imaging and Technology Alliance (MITA), a group representing medical imaging equipment manufacturers, innovators, and product developers, also commented on the agency's need to improve the guidance process. MITA recommended that public meetings be convened to obtain input from all interested parties when new guidance documents are planned or if existing guidances are to be revised. The group wrote that FDA should provide adequate public notice of the meetings so that all stakeholders are able to participate.

Nathaniel Weixel, Industry Comments Tell FDA to Improve Transparency of Guidance, Product Reviews, BNA's Health Care Daily Report (Apr. 13, 2010) (note: registration is required to view this content).

Mortality Higher on Weekends for Kidney Injuries

Patients with an acute kidney injury were more likely to die if they were admitted to the hospital on a weekend, Canadian researchers found.

After adjustment for age, sex, race, Charlson comorbidity index, and the requirement for mechanical ventilation, weekend admission with acute kidney injury was associated with a 22% increased odds of death by day three of admission (OR 1.22, 95% CI 1.15 to 1.30), according to researchers at the University of Calgary in Calgary, Alberta. Weekend admission was also associated with a 7% increase for the duration of the hospital stay (OR 1.07, 95% CI 1.02 to 1.12), they reported online in the Journal of the American Society of Nephrology.

The researchers had noted that previous studies found that patients with a primary diagnosis of renal failure had a 34% higher risk of adjusted in-hospital mortality when admitted on a weekend compared with a weekday. But those studies did not distinguish between admissions for acute kidney injury and those for chronic kidney disease, so there was some speculation "that this association was in fact driven by admissions of patients with end-stage renal disease ("ESRD")," the researchers wrote.

To determine if patients with acute kidney injury were at a higher mortality risk if they were admitted on a weekend—presumably delaying access to diagnostic or therapeutic procedures—the researchers looked at data from the Nationwide Inpatient Sample, a large U.S. database of admissions to acute care hospitals. They found 963,730 admissions to U.S. hospitals from 2003 through 2006 that included acute kidney injury as a diagnosis. It was the primary diagnosis for 214,962 of those admissions, and 45,203 patients in that group were admitted on a weekend. There were few demographic differences between the weekday and weekend patient groups, and the seven-day median length of stay was similar for both groups.

Increases in mortality associated with weekend admissions were most pronounced in smaller hospitals, where a 35% increase in the adjusted odds of death was observed by day three and a 17% increase in the adjusted risk of death remained for the total hospital admission. For medium-sized and larger hospitals, mortality associated with weekend admission was increased to a lesser degree.

The authors suggested several possible reasons for the higher mortality rate on the weekend. "On the basis of recorded diagnoses and procedures, patients admitted on a weekend appeared to be more severely ill than those admitted on a weekday," they wrote. "However, higher mortality with weekend admission persisted in analyses adjusted for demographic characteristics, recorded comorbidities, and provision of mechanical ventilation and across most of the acute medical conditions that coexisted with [acute kidney injury]." In addition, they speculated that if nephrology consultation and the provision (and timing) of renal replacement therapy affect survival, improved weekend access to specialist care or dialysis could reduce mortality for patients admitted over the weekend. But, they wrote, further research would be needed to test that hypothesis.

Primary source: M.T. James et al., Weekend Hospital Admission, Acute Kidney Injury, and Mortality, DOI:10.1681/ASN.2009070682, J. AM. SOCIETY OF NEPHROLOGY (2010).

Joyce Frieden, Mortality Higher on Weekends for Kidney Injuries, MedPage Today (Apr. 15, 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 Leah Voigt, Esquire (Squire Sanders & Dempsey LLP, Washington, DC), for providing this week's update.

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