HCFA's new rules on the use of patient restraints and seclusion have some hospital officials in such an uproar that they may have to be placed in restraints themselves.
The regulations severely restrict the use of restraints and seclusion. If restraints are used, they say, a physician or "licensed independent practitioner" must evaluate the patient in person within one hour.
Complaints have been pouring in to state hospital associations, the American Hospital Association and the Joint Commission on Accreditation of Healthcare Organizations.
"I've talked to about 150 hospitals so far," said Patricia Ryan, a behavioral health policy expert at the California Healthcare Association. "What they're telling me is they are going to have great difficulty complying with the new rule, and they don't think it's clinically necessary. And they barely had time to even hear about the regulations before they were implemented."
HCFA published the restraints and seclusion provision as part of a larger set of rules on July 2. The provisions went into effect Aug. 2.
Richard Wade, senior communications adviser for the AHA, said he has received more member calls on this issue in the last 10 days than on anything in recent memory.
The AHA and the National Association of Psychiatric Health Systems sued to halt the restraints provision on July 29, but the courts declined to issue a temporary restraining order (Aug. 2, p. 4).
Many healthcare operators say they didn't hear about the provision until it was in effect. The usual comment period is lengthy, with ample notification before regulations go into effect.
In a peculiar twist, HCFA's comment period for the rules extends until Aug. 31-29 days after they took effect. It's unclear what good commenting would do.
Now the AHA is pushing a letter-writing campaign to HCFA Administrator Nancy-Ann Min DeParle, requesting that the restraints provision be altered.
The AHA says the new regulation "inappropriately dictates medical practice" and may force physicians to forgo treating less-stable patients.
The Texas Hospital Association is worried about the effect on small, rural hospitals unable to get a doctor on-site quickly. Matt Wall, the THA's associate general counsel, said the rules present a lot of gray areas, such as what is meant by "licensed independent practitioner." State policies allow a registered nurse to make judgments on restraints use.
"Everybody is out of compliance, probably," Wade said. "We're hoping we can have some influence on the rules. If the rules are done right, that will help resolve the problem."
HCFA moved so fast because the matter was perceived as an urgent public health issue. The media had documented many deaths under restraints (Aug. 16, p. 22). Congress was preparing legislation, and the vice president's wife was lobbying HCFA to do something.
"In too many incidents, people are subjected to inappropriate and harmful physical and chemical restraints," said Tipper Gore at a June 25 Capitol news conference, which announced the rules. "These regulations will save lives."
Laura Young, a spokeswoman for the National Alliance for the Mentally Ill, said the regulations are necessary "because people are dying in restraint. That's exactly why." The government solicited advice from advocacy groups, providers and other organizations, she said. She believes the complaints are exaggerated. "The regs ask for humane treatment of people in a vulnerable situation. If this becomes a costly intervention, then more energy will be put into other interventions at the front end of the problem."
U.S. Rep. Fortney "Pete" Stark (D-Calif.), who has co-sponsored a bill to regulate restraints, is happy with the new regulations, said an aide. Stark is especially concerned about this issue because a close personal friend's son died while being restrained in a healthcare facility, the aide said.
The new rules differ markedly from Joint Commission standards. Margaret Van Amringe, JCAHO vice president of external relations, said the regulations present two problems. JCAHO standards say a physician must evaluate a patient in restraints "as soon as possible," whether in 15 minutes or three hours.
The regulations also require hospitals to immediately report deaths in restraints to HCFA. The Joint Commission considers such deaths to be sentinel events, and requires providers to complete a root cause analysis and send a report to its database. It does not publish the name of the institution.
The JCAHO also allows hospital medical staff to write general guidelines for using restraints on surgical patients when patients may fall through bedrails or pull out intravenous tubing.
"The literal wording of the HCFA reg would not permit that," Van Amringe said. "It requires a physician to write an order every time a restraint is used." She said the disparity could be resolved in rules yet to be written.