Final Regulations Allow PAs to Order

Patient Restraint or Seclusion

The Centers for Medicare and Medicaid Services (CMS) has issued final regulations clarifying that under Medicare's Conditions of Participation for Hospitals physician assistants may order patient restraint or seclusion as a delegated responsibility, when such delegation is allowed by state law and hospital policy.

 

The rule was issued December 8, 2006, and takes effect on January 8, 2007. It amends and finalizes provisions issued as an interim final rule on July 2, 1999. The rule sets forth the Patients' Rights Conditions of Participation requirements, which address the notice of rights to patients, the exercise of rights, privacy and safety, confidentiality of patient records, and seclusion and/or restraint of patients. Only the section on restraint and seclusion was open for public comment from July 2-August 31, 1999.

 

Under the July 1999 interim final rules, the authority of a physician to delegate the ordering of restraint or seclusion was unclear. That rule stated, "The use of restraint must be (ii) in accordance with the order of a physician or other licensed independent practitioner permitted by the State to order a restraint." The language of the December 8, 2006, final rule states, "The use of restraint or seclusion must be in accordance with the order of a physician or other licensed independent practitioner who is responsible for the care of the patient as specified under Section 482.12(c) and authorized to order restraint or seclusion by hospital policy in accordance with State law."

 

The key to delegation is the reference to Section 482.12(c), a separate section of the Hospital Conditions of Participation, in place since 1986. Section 482.12(c), states, "Every Medicare patient is under the care of: (i) A doctor of medicine or osteopathy (This provision is not to be construed to limit the authority of a doctor of medicine or osteopathy to delegate tasks to other qualified health care personnel to the extent recognized under State law or a State's regulatory mechanism.) ."

 

Preamble Clarifies Delegation Decision

In the preamble to the December 8, 2006, final rule, where CMS staff discuss a range of public comments and explain some of their decision making, they state, "For the purposes of this rule, a LIP is any individual permitted by State law and hospital policy to order restraints and seclusion for patients independently, within the scope of the individual's license and consistent with the individually granted clinical privileges. This provision is not to be construed to limit the authority of a physician to delegate tasks to other qualified healthcare personnel, that is, physician assistants and advanced practice nurses, to the extent recognized under State law or a State's regulatory mechanism, and hospital policy. It is not our intent to interfere with State laws governing the role of physician assistants, advanced practice registered nurses, or other groups that in some States have been authorized to order restraint and seclusion or, more broadly, medical interventions or treatments."

 

Their comment continues, "Each State faces the issue of how to best provide its citizens with access to needed health care services. The issue is complex, as some States have special considerations such as geographic barriers to care delivery, medically underserved areas, and special population needs, all of which would affect how a State resolves this issue. To disregard a State's decision about who is qualified to order medical treatments and interventions and render patient care would be unproductive and arbitrary."

 

In response to public comments opposing any providers besides physicians ordering restraint or seclusion, CMS responded, "Physicians are individually accountable for the care of their patients. The physician has the discretion to delegate, or to withhold the delegation of, tasks or responsibilities, as he or she deems appropriate. We believe that the physician is more than capable of making the determination regarding whether his or her direct oversight is necessary, or whether in some situations, as permitted by hospital policy, these functions can be performed by another practitioner. The continued physician accountability for actions taken under his or her license provides a direct incentive for taking the decision to delegate very seriously."

 

"To ensure physician oversight of restraint and seclusion, we have retained the requirement that the attending physician must be consulted as soon as possible if the attending physician did not order the restraint or seclusion," the preamble noted. "Our intent is to ensure that the physician who has overall responsibility and authority for the management and care of the patient is aware of an involved in the intervention."

 

Changes in Patient Assessment Requirements

The final regulations also make changes to the requirements for face-to-face assessment of a retrained or secluded patient within an hour of initiation of restraint or seclusion. The new language is clear that this responsibility can be delegated to physician assistants. Previously, the regulation stated, "A physician or other licensed independent practitioner must see and evaluate the need for restraint or seclusion within 1 hour after the initiation of this intervention," which CMS staff interpreted as something a physician could delegate to a PA. That interpretation appeared in guidelines for surveyors, but not in the regulation itself.


The final regulations clarify that physicians, LIPs, PAs, and RNs can perform the face-to-face assessment that must be done within one hour. They state, "When restraint or seclusion is used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others, the patient must be seen face-to-face within 1 hour after the initiation of the intervention (i) By a (A) Physician or other licensed independent practitioner; or (B) Registered nurse or physician assistant who has been trained in accordance with the requirements specified in paragraph (f) of this section." The regulations also require that if an RN or PA performs the assessment that they contact the attending physician with the results as soon as possible.

 

Most Medical/Surgical Restraints Exempt

In response to public comments, CMS combined what had been separate regulations for restraint of medical/surgical patients and restraint or seclusion of behavioral patients. The new consolidated section states, "(1) Definitions. (i) A restraint is- (A) Any manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely; or (B) A drug or medication when it is used as a restriction to manage the patient's behavior or restrict the patient's freedom of movement and is not a standard treatment or dosage for the patient's condition."

 

Instead of separating medical/surgical patients from behavioral patients, the final rule includes a category of devices "typically used in medical/surgical care" that are not subject to this rule: "(C) A restraint does not include devices, such as orthopedically prescribed devices, surgical dressings or bandages, protective helmets, or other methods that involve the physical holding of a patient for the purpose of conducting routine physical examinations or tests, or to protect the patient from falling out of bed, or to permit the patient to participate in activities without the risk of physical harm (this does not include a physical escort)."

 

Stronger Training Requirements Detailed

In response to public comment, CMS revised the regulatory language to provide more detail about requirements for staff training that focus on demonstrated competencies and building a skill set for working with patients. They created a separate standard (f) that lists the training requirements.

 

Patient and Staff Protection - The Heart of the Matter

In issuing this final rule, the CMS faced the challenge of sifting through more than 4,000 public comments and weighing the "fundamental disagreement among commenters" on the role of restraint and seclusion for behavior management. Comments from patient advocates reflected a belief that use of restraint or seclusion should be eliminated or restricted to physician orders and physician oversight only. Comments from the provider community reflected a broader spectrum of beliefs about how and when restraint and seclusion should be used, from extreme emergencies to more routine applications.

 

"While we believe that restraint and seclusion are not desirable interventions, we recognize the diversity of patients and situations that clinicians must address. In some of these situations, the patient poses a real safety risk to self or others, and alternative, less restrictive interventions are not sufficient to assure the safety of the patient or others," CMS states. The interim final rules published July 2, 1999, specified that "Seclusion or a restraint can only be used in emergency situations if needed to ensure the patient's physical safety and less restrictive interventions have been determined to be ineffective." Numerous public comments questioned limiting the use of restraint or seclusion to emergencies. CMS responded, "We recognize that there may be circumstances in which the use of restraint or seclusion may be necessary to prevent a situation from escalating into an emergency situation in which a patient is in immediate danger of harming himself, staff, or others. . Based on public comment we have clarified this provision by replacing the reference to emergency situations with more descriptive language." The new regulation states, "Restraint or seclusion may only be imposed to ensure the immediate physical safety of the patient, a staff member, or others and must be discontinued at the earliest possible time."

 

AAPA Pleased with Outcome

The AAPA has communicated with CMS on behalf of the PA profession countless times since the publication of the interim final rule with comment period on July 2, 1999. As a result of requests from the AAPA, from 2000-2004, the state surveyors manual clarified that both ordering of restraint and seclusion and face-to-face assessment could be delegated by physicians to PAs. A new surveyors' manual, published in May 2004, dropped the delegation clarification from the standard on ordering restraint or seclusion, but kept it in the section on assessing the patient within one hour.

 

That omission launched another flurry of communication from AAPA to CMS, resulting in the final rule, published December 8, 2006, clearly allow physician delegation to the extent allowed by state law and hospital policy.

 

A copy of the final regulation (49 pages of explanation and 3 pages of actual standards) is available on-line.

 

 

 

Last Revised: 2/22/08