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HCFA’s new regs led to lawsuit but are still being enforced
You may be out of compliance with the Health Care Financing Adminis tration’s (HCFA) newly released restraint regulations that went into effect of as Aug. 2 and not even realize it, warn experts contacted by ED Management.
The regulations apply to physical restraints, chemical restraints, and seclusion. "There are several standards which are very difficult for EDs to comply with," says Karen Milgate, senior associate director for policy development at the Washington, DC-based American Hospital Association, which filed a lawsuit in response to the HCFA regulations.
HCFA changed its regulations in response to public reaction to news accounts of restraint-related deaths. "The primary issue was a series of newspaper articles in The Hartford Courant, which cited 142 deaths from seclusion or restraints over 10 years in facilities," says Milgate. "There was a huge outcry to do something. So HCFA thought they would go ahead and address this issue by putting out detailed regulations." (See story on the differences between Joint Com mission of Accreditation of Healthcare Organizations and HCFA standards, p. 112, and update on Joint Commission’s upcoming revisions, p. 113.) The intentions were good, but the process was seriously flawed, suggests Milgate.
"They made it impossible to get effective public comment," she says. The standards were issued on July 2, 1999, and became effective 30 days later. "That’s not enough time to even get the word out to the health care field, let alone enough time for hospitals to put in appropriate policies and procedures," says Milgate. (For details on how to access the standards, see box, p. 111, top right column.)
Toni Mitchell, MD, FACEP, a member of the Dallas-based American College for Emergency Physicians (ACEP) board of directors and chief consultant for acute care at the Veterans Health Administration in Washington, DC, says, "These came out with so little fanfare and so little notice. Generally, as a federal agency, HCFA gives us more notice about changes in regulations, and a chance to provide comment. But there was not an adequate comment period in this case."
As a result, some of the standards are very problematic to comply with, Milgate says. "There is less flexibility and the regulations are more specific, which is causing problems for EDs." The regulations also weren’t field tested, which would have resulted in necessary changes being made, she says.
The controversial regulations have taken EDs by surprise. More than a dozen ED managers contacted by ED Management were unaware of the new regulations. Nonetheless, "Our surveyors are currently enforcing them," reports a spokesperson for HCFA, who under agency policy can’t be identified.
Here are the key changes that will affect your ED:
1. Behavioral health standards will apply in some cases instead of medical/surgical standards.
Previously, only the less-stringent medical/surgical standards was used in the ED for restraint. The new standards make it difficult to decide which standard should be used — the behavioral health or medical/surgical. "There is some discussion in the preamble to the standards to help you figure it out, but there is still a lot of gray area," says Milgate.
Which standard applies is now based on the reason the restraints were applied, instead of the setting the patient is treated in. "So the behavioral health standards will apply if the patient is restrained because of their behavior," says Milgate.
You will have to decide which standard to use based on whether a patient is being restrained for behavioral management or a medical/surgical purpose, she explains. "This may cause problems for your ED, because the behavior health standards are very difficult to meet."
The behavior health standards were designed with psychiatric facilities in mind, not EDs, Milgate notes. "These standards are more stringent; for example, they require a face-to-face evaluation within one hour by a physician," she says.
Most patients meet restraint standards
However, the vast majority of restraints in the ED could be construed as medically necessary, Mitchell says. "The most common reasons for restraints are drug and alcohol abuse, but you must always presume there is something medically wrong with the patient," she stresses. "We have to rule out significant things like diabetic conditions and brain bleeds. So most patients would fall under the med/surg standards."
Occasionally, patients may have a long psychiatric history and have stopped taking their medications. "Under the new regulations, those patients would fall under the behavioral health standards, but that scenario is very uncommon in the ED," says Mitchell.
Still, the fact that HCFA would apply the behavioral health standard in the ED setting is surprising, says Mitchell. "The application of psychiatric standards in a general medical hospital is not appropriate, because the nature of what we do is rapid assessment and determination," she says. "Then the patient would be admitted to the psychiatric unit, where the behavioral health standards would apply."
It’s rare to have a patient’s complete psychiatric history in the ED, Mitchell stresses. "And even if you do, that might not be the explanation why they need to be restrained," she says. "So you would still have to evaluate for an underlying medical condition. Because if we miss something, it can be a catastrophe for the patient."
2. A face-to-face evaluation by a physician is required within one hour if behavioral health standards are used.
The behavior health standards require a physician to perform a face-to-face evaluation within an hour when a patient is restrained. "That may be difficult to comply with if your ED is very busy and you don’t have the necessary staff," Milgate notes.
The face-to-face evaluation by a physician is considered unnecessary by experts, she says. "The clinical field is united in suggesting it’s unnecessary in all cases." Also, nurses feel it’s an insult to suggest they don’t have the ability to do the face-to-face evaluation and then discuss it with the physician afterward, she explains. "That’s what has been done traditionally."
Previously, nurses could initiate the restraint, then get in touch with a physician as soon as possible to obtain a written order. "The face-to-face evaluation by the physician wasn’t required, although it probably occurred when the nurse and physician were talking about writing the order," says Milgate. "Also, before, there was no specific time frame for the evaluation to take place."
Many restraints aren’t used for a full hour, Milgate notes. "Particularly with seclusions, there may be just simply time out for a few minutes," she says. "This new standard makes it more onerous to apply restraints and seclusions, so one concern is that this will discourage appropriate use of restraints."
The regulations also don’t specify what the physician needs to evaluate within the one-hour time frame, notes Margaret Van Amringe, Joint Commission vice president of external affairs. "It’s not clear what are they evaluating: Is it the need for restraint in first place, the continued need for that restraint, or whether the patient is having any distress while in that restraint?" she asks. "Clarification from HCFA is needed on this point."
3. Because psychiatric departments don’t always have physicians available, they may have to rely on ED physicians.
"For hospitals that are intent on doing that, they may be asking ED physicians to leave less stable patients to come and do this evaluation," says Milgate. "So that’s another challenge ED physicians may have which could increase their workload." (See story about the regulation’s impact on nursing, p. 112.)
If staff at a psychiatric hospital cannot find a physician at the point of restraint to do a face-to-face evaluation, they may wind up transferring that patient to the ED. "They will have two choices: Either they are out of compliance with Medicare rules or will send the patient somewhere else, which would be the ED," says Milgate. "So your ED may have more patients to deal with."
However, EDs should find it easier to comply with regulations involving psychiatric patients and restraint due to the Emergency Medical Treatment and Active Labor Act (EMTALA) regulations.
"We’ve been on the leading edge of making changes in restraint ever since 1991 when EMTALA came out," notes Mitchell. "It became clear that psychiatric patients were covered under EMTALA, so we’ve already had to make a number of changes to comply with that."
EMTALA requires a medical screening exam to determine if a patient has a medical emergency, she says.
"Early on, we had to recognize psychiatric patients as emergencies and evaluate them upon arrival. Part of that evaluation means providing the appropriate environment for them, whether that meant physical or chemical restraints, or seclusion," Mitchell explains.