15 April 2013

USA: LEGAL RISK of GUIDELINES

From AMERICAN MEDICAL NEWS

Doctors win first safe harbor against ACA use in liability suits

States and Congress are urged to pass legislation based on an AMA model bill to prevent health reform criteria from exposing doctors to medical liability.

By Alicia Gallegos amednews staff — Posted April 15, 2013
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Physician leaders hope a first-of-its-kind bill approved in Georgia protecting doctors from civil liability for breaching federal health system reform requirements will be replicated in other states.
Medical associations long have been concerned that federal quality-of-care and payment reform measures, such as those authorized by the Affordable Care Act, could be used to fuel negligence accusations against individual physicians. The Georgia law, drafted from American Medical Association model legislation, prevents such health reform metrics from being used as evidence in liability cases. Georgia's law states that payer guidelines and quality criteria under federal law shall not establish a legal basis for negligence or a standard of care for the purposes of determining medical liability.
“We're saying if it's a breach in those federal guidelines based on administrative behavior, let's make sure that evidence is not admissible in court, and more than anything, let's make sure that evidence is not being used as a determinant in the standard of care,” said Marcus Downs, director of government relations for the Medical Assn. of Georgia, which advocated for the enactment of the shield law. “There could be some [administrative] wrongdoing, but it is definitely not malpractice. It's definitely not negligence.”
The passage of the Georgia bill, which at this article's deadline was expected to be signed by Gov. Nathan Deal by the end of April, came as a federal version of the legislation was being reintroduced in Congress. The Standard of Care Protection Act would prohibit health system reform provisions from being construed to establish a standard or duty of care owed by a health professional to a patient in any liability case. A similar version of the bill died in committee at the end of the last Congress.
The Standard of Care Protection Act would ensure that federal laws do not change the way health care professionals practice medicine or treat patients through the threat of liability, said Rep. Phil Gingrey, MD (R, Ga.), the bill's chief sponsor.
“This legislation provides that lawsuits cannot be brought against health care providers based simply on whether [they] followed national guidelines created by the health care law,” Dr. Gingrey stated in an email. “This bill reinforces my belief that medical decisions must be made between patients and their doctors. The practice of medicine is not one-size-fits-all. It must be protected from policies or rules that may threaten a physician's ability to treat patients according to their specific needs.”
The AMA supports the federal legislation and also advocated for the Georgia law. In a statement, AMA Board of Trustees member Patrice A. Harris, MD, praised Georgia's shield law, saying federal reform statutes and regulations are intended to enhance access to high-quality and efficient health care, not to justify windfalls through lawsuits against physicians.
“Georgia is the first state to take decisive action to prevent federal health care reform laws and regulations from fueling the unrestricted excesses of the state's broken medical liability system,” she said. “To hold the line against tort abuse, Georgia relied on AMA model legislation to make it clear that federal health care standards or guidelines cannot be skewed to invent new legal actions against physicians.”
The Georgia Trial Lawyers Assn. also worked with MAG on the state legislation and was pleased with how the final bill turned out, said Bill Clark, GTLA's director of political affairs. The association successfully pushed for including a “goose-gander” provision in the bill that also protects plaintiffs in medical liability suits from having defendants introduce reform standard compliance as evidence.
“The only way we were willing to allow the bill to go forward was to have it go both ways,” Clark said. “If a physician can't be held accountable for malpractice for failing to adhere to a payment guideline, then they also shouldn't be able to use their compliance with a standard as evidence that they complied with the standard of care. If it can't be used against you as a sword, you also can't use it for a shield.”
The director of policy for the American Assn. for Justice, Susan Steinman, declined to comment on the Georgia law. The national association represents trial attorneys.

Potential risks from reform

Without explicit legal protections, observers said doctors who are sued for medical liability face various legal risks from the ACA or other health system reform statutes.
To find negligence, a plaintiff generally has to show — usually through expert testimony — that his or her treatment did not meet the standard of care observed by a reasonable physician, said Hal Dasinger, vice president for government relations for The Doctors Company, a national physician medical liability insurer. The Doctors Company supported the Georgia law and is involved with promoting the federal legislation.
“Our concern has been that plaintiff's counsel might attempt to use federal guidelines developed, for example, to cost-effectively manage chronic patients as evidence of negligence, by claiming that any treatment that differed from the federal guidelines is beneath the standard of care, rather than the result of an individual physician deciding what is in the best interest of the patient,” Dasinger stated in an email.
Another potential legal risk could come from the ACA's hospital value-based purchasing program. Those provisions authorize payment adjustments for certain hospitals based on designated health care performance criteria. Whether a hospital-based physician met such criteria easily could be raised in a medical negligence lawsuit to challenge the doctor's credibility, Downs said.
Physicians' adherence to hospital readmissions limits and prohibitions on payment for treating hospital “never events” also are quality measures that could come up in court. Plaintiffs could attempt to sway juries using such data, said Dan Huff, a medical liability defense attorney based in Georgia.
Plaintiffs alleging an undesired patient outcome could use the information to argue that doctors “have no right to defend themselves or their actions, because statutes and regulations have said these things should never happen, and we're not going to pay them when they happen,” Huff said. “If we have a gallbladder case we're defending about whether the physician has met the standard of care, the plaintiff should not be allowed to introduce evidence about the physician's readmissions rate, complication rate or other issues that deal primarily with reimbursement and payment.”

Federal shield bill redesigned

Despite their failed attempt to enact the federal shield law in 2012, supporters are hopeful a newly redesigned version of the measure will have a different outcome. The new bill has been broadened beyond the provisions of the ACA and also would encompass sections under the Social Security Act that deal with Medicare payments.
Dr. Gingrey said the liability loopholes created by the ACA should be addressed at the federal level. “The bill makes clear that the care standards and guidelines detailed in federal health care laws cannot be used to create new causes of legal action against physicians, nor do they supersede state liability laws,” he said.
The Doctor's Company was not aware of legislation similar to Georgia's that is pending in other state legislatures. However, Dasinger said it is only a matter of time before other states follow the lead.
“With the victory in Georgia, it seems likely that other states will try to enact their own versions,” he said.
State Rep. Edward Lindsey, a Republican who co-sponsored the Georgia law, agreed. “I think it is good, pragmatic legislation, and I certainly would think a lot of other states would look at it, just as we look at other states when they pass pragmatic legislation.”

ADDITIONAL INFORMATION

5 ACA standards that could give plaintiffs an advantage in court

Physicians say a first-of-its-kind bill passed in Georgia will protect doctors from being exposed to increased liability associated with new federal health system reform standards. Supporters argue that without such a safe harbor, more than a dozen provisions of the Affordable Care Act could be used by plaintiffs for establishing civil tort liability in medical cases, including:
  1. Adult health quality measures: The federal government is authorized to develop a core set of health care quality measures to be reported for adult Medicare beneficiaries.
  2. Hospital readmissions reduction program: To decrease Medicare hospital costs, excessive 30-day readmissions of certain patients will mean lower payment rates.
  3. Hospital-acquired conditions initiative: Facilities will be prohibited from receiving additional Medicare payment for treating certain hospital-acquired conditions.
  4. Medicare shared savings program: Hospitals and physicians that coordinate care successfully for patients will share in some of the cost savings to the federal government that result — and might be penalized for failing to restrain costs.
  5. Value-based payment modifier: Medicare payments to certain physician group practices will be modified based on how well they meet certain quality measures.
Source: Medical Assn. of Georgia

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