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Teaching Hospital Update - April 5-9, 2010


Email Alert

By Leah Voigt*

April 9, 2010

Reform Inspires Anger, Fear, Praise Amid Projections of Impact on States

The federal healthcare reform package (H.R. 3590, Pub. L. No. 111-148) signed by President Barack Obama on March 23, 2010, has generated a flurry of news releases from Republican governors claiming a financial armageddon for their states.

In Virginia, Governor Bob McDonnell (R) warned that the measure would require the state to add more than 400,000 people to its Medicaid rolls at a cost of $1.1 billion by 2022. "This will have a significant and unavoidable impact on the bottom line of our state budget, and the general fiscal welfare of Virginia," McDonnell said on March 22, 2010. "We simply cannot afford this expansion." Texas Governor Rick Perry (R) vowed to challenge the constitutionality of the bill, which he said would "infringe on the fundamental rights of individuals and the state." And Arizona Governor Jan Brewer (R) called the bill "financially devastating" and predicted that it would cost Arizona "at least $1 billion in 2012 and more than $1 billion in 2013."

But in Ohio, Michigan, and New York--each with Democratic governors--officials were far more upbeat about what healthcare reform would mean to state coffers: They predicted billions in savings from direct federal subsidies of expanded Medicaid enrollments and as an indirect result of cost savings associated with reducing the number of uninsured. In Michigan, for example, the state expects no major new costs associated with Medicaid expansion until 2017.

Wildly varying state projections of how healthcare reform will affect them are a reflection in part of the political divisions surrounding the issue. H.R. 3590 passed the House on a 219-212 vote, with not a single Republican voting "yes." Since the bill's passage, a dozen state attorneys general have filed or threatened lawsuits challenging a fundamental provision of the bill--the individual mandate, which requires that everyone either acquire insurance or pay a penalty (in the form of a tax). The National Conference of State Legislatures reports that legislation aimed at blocking or opposing certain aspects of federal healthcare reform is pending in twenty-six states.

The reform bill--along with the related reconciliation measure (H.R. 4872, Pub. L. No. 111-152) signed March 30, 2010--will create a historic overhaul of the U.S. healthcare system, bringing an estimated thirty-two million more Americans onto insurance rolls through a combination of private incentives, such as tax credits for small businesses to offset the cost of buying insurance, and expanded Medicaid enrollments. The bill also includes tax increases on high earners, a series of revenue raisers, and other provisions--such as insurance exchanges--aimed at lowering costs.

States are set to receive a massive infusion of federal dollars to subsidize the Medicaid expansion and participation in private plans. Yet each jurisdiction must ultimately shoulder its share of the expanded system as well--and how much that expansion ultimately will cost the states is, at the moment, difficult to quantify.

Steven Roll and Dolores W. Gregory, Reform Inspires Anger, Fear, Praise Amid Projections of Impact on States, BNA's Health Care Daily Report (Apr. 6, 2010) (note: registration is required to view this content).

The Joint Commission Gives Final OK to Medical Staff Standard

The Joint Commission (TJC) has formally approved changes to a long-controversial standard governing relations between hospital administrators and organized medical staffs. When it was first adopted in 2004, many physician organizations said that the standard threatened medical staff self-governance. When the standard was revised in 2007 to address those concerns, some hospital officials said that it required too many issues to be covered in medical staff bylaws and would make it too difficult for hospitals to change policies.

The new standard, approved in March, attempts to strike a balance for medical staff autonomy and maintain productive working relationships between physicians and hospital executives. The standard "really supports patient safety and quality of care," said Jay A. Gregory, MD, chair of the governing council of the American Medical Association Organized Medical Staff Section. "It defines clearly that the organized medical staff is accountable to the [hospital] governing body to oversee the quality of care, treatment and services provided by the physicians."

Gregory served on a TJC-convened task force with participants from organizations representing hospitals, physicians, and dentists that met a dozen times from January 2008-March 2009.

The new standard states that the organized medical staff has the primary job of assuring quality and patient safety in the hospital while laying out a mechanism for physicians, the hospital governing body, and chief executives to resolve differences regarding rules, policies, and procedures. By spelling out these respective roles and responsibilities, the standard aims to foster collaborative working relationships to improve the quality of care.

Medical staffs around the country will have to revise their bylaws in the next year to comply with the standard, but Gregory said the changes should give doctors more control over processes such as peer review. "The general practicing physician won't have anything more to do than vote on the bylaws at medical staff meetings," he said. "But now [physicians] can rest assured once and for all that there will be peer review and by their peers. I hope we can get away from the sham peer review that's sometimes brought on by administrators and so forth. Now this is the responsibility of the organized medical staff, and they will have to live up to that responsibility."

As of late March, both the standard and a frequently asked questions document about it were publicly available.

Kevin B. O'Reilly, The Joint Commission Gives Final OK to Medical Staff Standard, Am. Med. News (Apr. 6, 2010).

FDA Warns of Risk in Antibacterial Additive

The U.S. Food and Drug Administration (FDA) has notified consumers that the antibacterial agent triclosan's safety data is being reviewed because of concerns raised in lab tests on animals. Research from the U.S. Environmental Protection Agency's (EPA's) Office of Research and Development found triclosan had thyroid and estrogen effects in animals.

The agent is a common ingredient in antibacterial soaps and washes, toothpastes, and cosmetics, all of which are regulated by the FDA. The ingredient's profile was raised in January when Representative Edward Markey (D-MA), chairman of the House Energy and Commerce Subcommittee on Energy and Environment, wrote FDA to ask about a review of triclosan's use in consumer products. Additional investigation was deemed necessary after animal studies showed potential negative effects of the ingredient, FDA said in a prepared statement. Though studies are ongoing, FDA does not currently have enough evidence to suggest a change to any consumer products with triclosan.

FDA noted that although triclosan provided a clear benefit in some consumer products, the extra health benefit it offered in others was not as apparent. The EPA advised consumers that the ingredient poses no apparent danger to humans, but that soaps and body washes with triclosan may not provide additional health benefits over soaps without the additive; consumers concerned about its potential health hazards should switch to regular soaps without triclosan.

FDA announced that it will work with other federal agencies, including the EPA, to study the effects of triclosan on humans, animals, and the environment. The EPA said that it planned to publish its findings in Spring 2011.

Cole Petrochko, FDA Warns of Risk in Antibacterial Additive, MedPage Today (Apr. 8, 2010).

DOJ Announces Entry of Guilty Plea by Guidant in Criminal Case Involving ICDs

Device maker Guidant LLC, part of Boston Scientific Corp., entered a guilty plea and will pay $296 million to resolve charges of violating the Federal Food, Drug, and Cosmetic Act (FD&C Act) related to problems with implantable cardioverter defibrillators (ICDs), the U.S. Department of Justice (DOJ) said on April 5, 2010 (United States v. Guidant LLC, D. Minn., No. 10-67, guilty plea entered 4/5/10).

The resolution of criminal charges filed by the United States against Guidant LLC represents the largest criminal penalty ever imposed on a device manufacturer for violating the FD&C Act, U.S. Food and Drug Administration (FDA) Commissioner Margaret Hamburg said in the DOJ statement. Guidant entered its guilty plea on April 5, 2010, in federal district court in Minnesota. Under the terms of the plea agreement, Guidant will pay the government a criminal fine of $253.9 million. The company also agreed to a criminal forfeiture of $42 million, based on its pecuniary gain from the offenses.

The government formally charged Guidant in February with violating two provisions of the FD&C Act in connection with the company's handling of short-circuiting problems with three models of its ICDs, the Ventek Prizm 2DR (Model 1861) and the Contak Renewal (Models H135 and H155), according to the DOJ release. The $296 million payment to the federal government was disclosed in February.

In the plea agreement filed March 11, 2010, in the U.S. District Court for the District of Minnesota, the company admitted that it withheld information from FDA regarding catastrophic failures in some of its devices. More specifically, DOJ said that Guidant admitted that it made materially false statements to FDA regarding the Ventek Prizm device and that it failed to notify FDA of a correction to the Contak Renewal devices that it made to reduced health risks caused by the devices, in violation of the FD&C Act. The plea agreement has not yet been approved by the court.

Mary Anne Pazanowski, DOJ Announces Entry of Guilty Plea by Guidant in Criminal Case Involving ICDs, BNA's Health Care Daily Report (Apr. 7, 2010) (note: registration is required to view this content).

Study: Back Pain Too Often Treated With Expensive Surgery

Too many complex back surgeries are being done and people are suffering as a result, according to a study in the current issue of the Journal of the American Medical Association (JAMA). The general tendency noted in the study--that many patients and doctors think more medical care is always better--has implications for the new health overhaul law.

Back pain associated with aging can be treated in one of numerous ways: (1) rest and physical therapy; (2) surgery to remove the bony growths that can push on nerves; (3) fusing two vertebrae together; or (4) fusing many vertebrae together. In the past few years, several studies have failed to show a big advantage for surgery--especially for complex surgery. Researchers from Oregon Health and Science University and several other places looked at Medicare billing records to see whether the rates or type of back surgeries went down as a result.

They found that the number of surgeries has gone down very slightly. But when they looked specifically at complex surgeries, they found a big difference. "The most complex type of back surgery has increased dramatically between 2002 and 2007, with a 15-fold increase," says the study's co-author. In 2002, the rate of complex surgery was 1.4 per 100,000 people in Medicare. It jumped to 19.9 per 100,000 just five years later.

The researchers also checked the rate of complications. "This more complex form of surgery is associated with a higher risk of life threatening complications," he says. Among people who just had the bony growths removed (a surgery called decompression), 2.3% had problems associated with their treatment, such as a heart attack, stroke, or pneumonia. The complication rate was 5.6% among people who had multiple vertebrae fused together.

The researchers say that there's no reason to think people suddenly started developing the spinal deformities that justify the complex surgeries. They offer several possibilities for the upswing. "Many surgeons genuinely believe that the more invasive procedures offer some benefits," one co-author says. "But certainly there are important financial incentives at play as well." Surgical fees for simple decompressions are about $600 to $1,000. The complex surgeries earn surgeons as much as ten times more. Another possible factor is the tendency for both doctors and patients to go for a new, more expensive approach just because it sounds better.

Joanne Silberner, Study: Back Pain Too Often Treated With Expensive Surgery, Kaiser Health News (Apr. 7, 2010).

Doctors and Patients, Lost in Paperwork

In "The Hostile Hospital," from the Lemony Snicket "Series of Unfortunate Events" books, the three young orphans at the center of the story visit the fictitious Heimlich Hospital, where Babs, the head of human resources, asks them if they know what the most important work done in a hospital is. "Healing sick people?" one of the children asks innocently. "You're wrong," Babs growls, silencing the children. "The most important thing we do at the hospital," she continues without flinching, "is paperwork."

It's a satirical stab that comes uncomfortably close to the truth.

Paperwork, or documentation, takes up as much as a third of a physician's workday; and for many practicing doctors, these administrative tasks have become increasingly intolerable, a source of deteriorating professional morale. Having become physicians in order to work with patients, doctors instead find themselves facing piles of charts and encounter billing forms, as well as the innumerable bureaucratic permutations of dozens of health insurance companies.

But despite the paperwork burden, there are few studies on the amount of time current doctors devote to charting, ordering, filling out forms, and dictating. That is, except among one subset of doctors--doctors-in-training, or residents. According to a study published earlier this year, residents now spend up to twice as much time on documentation as their counterparts did two decades earlier. Analyzing the results of a national survey of more than 15,000 trainees in internal medicine, researchers at the Mayo Clinic in Rochester, MN, found that a majority of residents reported spending as many as six hours a day documenting, while only a small fraction of residents spent as much time with patients. In other words, young people who are learning to become doctors spend as much time writing, typing, or dictating about their patients as they do seeing them.

Even though fatigue-related errors might be decreasing as a result of duty-hours reform, new types of errors are now on the rise. Residents must make clinical decisions with less time to investigate the complexities of a patient's symptoms and relatively little information culled from a one-on-one interview. While the introduction of electronic medical records has increased overall efficiency by allowing access to all of a patient's previous documents, they have also spawned a whole host of electronic ways of bypassing actual patient contact when doctors are pressed for time.

Residents may rely on notes written by other doctors instead of talking to the patients themselves. These other notes may have also been pieced together from previous notes rather than from actual interactions with the patient. As a list, a paragraph or whole sections get pasted into progressively more documents; important information, like a reaction to a certain treatment, can be lost in the transfer. Clinicians who rely mostly on computer notes for their information are at risk of inadvertently choosing the wrong therapeutic course of action for a patient. A doctor's note turns into a cut-and-paste collage instead of an accurate and personalized narrative of illness; and documentation becomes an electronic and potentially dangerous version of the game "Telephone."

In the years ahead, achieving some kind of balance between documentation and patient interaction for physicians-in-training will be an ongoing challenge for doctors and medical educators. But the fundamental question driving these changes will be even more difficult to answer. Doctors and, even more significantly, patients must ask themselves what is the most important thing that young doctors must do with their limited hours of training.

Pauline W. Chen, Doctors and Patients, Lost in Paperwork, N.Y. TIMES (Apr. 8, 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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