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CMS pushes for more in informed consent process
An interpretive guideline that calls for a more thorough informed consent process, whether the patient wants to hear the details or not, is causing consternation for physicians and risk managers across the country. The conflict is most pronounced in Oregon, where the instruction seems to contradict a state statute.
The issue is that the Centers for Medicare & Medicaid Services (CMS) has issued an interpretive guideline regarding a physician's requirement to gain an informed consent prior to any procedure, says Paul Frisch, JD, general counsel and director of medical legal affairs with the Oregon Medical Association (OMA) in Portland. The new guideline states that a comprehensive procedure, alternatives, and risks (PAR) conference with pre-procedure patients must be given even if the patient waives the right to or resists hearing all the risks and/or alternatives to the procedures the physician prescribes.
Legacy Emanuel Hospital & Health Center in Portland was sanctioned by CMS for failure to comply, he says. The hospital's policies said if a patient waived the right or resisted hearing the PAR details, the physician could note that in the chart, and it would be acceptable as a PAR conference in obtaining the informed consent. That wasn't sufficient for CMS, and the hospital changed its policies to comply with CMS interpretive guidelines. The hospital threatened to suspend privileges for physicians who failed to comply with the CMS guidelines.
Oregon leaves it to physician
The OMA is fighting CMS because the state has a statute that says a physician should judge the level of PAR given to a patient by the patient's response. The CMS guideline violates the Oregon statute and disregards patients' rights, Frisch says. OMA filed a lawsuit against CMS on Jan. 12, 2007. "If we're right and they're wrong, we'll have a judge at a district court level ruling that their interpretive guideline was improperly drawn," he explains. "Our objection is based on the fact that in 1977, the Oregon legislature passed an informed consent statute that was unique in that it said the physician and the patient have a conversation including the procedure, alternatives, and risks. The physician must ask if the patient wants to hear more, and if the patient says no, under Oregon law there is no further discussion."
Consent may scare elderly?
The Oregon law is premised on the idea that many patients, particularly the elderly, don't want to be unduly scared about possible risks, Frisch says. Forcing physicians to tell more after a patient says no may discourage some from seeking needed medical care, he says. "One of the plaintiffs in our lawsuit is an obstetrician who has women who need C-sections after laboring for several hours. If we follow the CMS guideline, he would have to go in there and detail all the risks and alternatives, even if she says she doesn't want to hear it," Frisch says. "That is really, really cruel and counterproductive to the clinical process.
Oregon is unusual in that it has a state law that contradicts the CMS guideline, and Frisch says most providers would be hard pressed to oppose CMS on this issue. A victory in Oregon could prompt CMS to change the guideline nationwide, but until then, he advises providers in Oregon and elsewhere to comply. "We're not going to back down, but until this is resolved, providers don't have much choice but to do what CMS says," Frisch explains. "Comply with the interpretive guideline. It is absolutely essential that you not put your hospital at risk by failing to comply."
For more information on the Medicare guideline, contact: