Medicare/Medicaid Condition of Participation Regarding Patients' Rights

On Friday, July 2, 1999, the Health Care Financing Administration ("HCFA") published a rule introducing a new Patients' Rights Condition of Participation ("COP") that hospitals must meet to be approved for, or to continue participation in, the Medicare and Medicaid programs. As you may recall, HCFA published a proposed rule in December, 1997 that introduced proposed comprehensive revisions to the hospital COPs. As HCFA believes there is a pressing need to codify and enforce the Patients' Rights COP, the patients' rights requirements are being finalized separately in an accelerated time frame. The effective date of the new Patients' Rights COP was August 2, 1999.

The commentary accompanying the rule indicates that HCFA intends to issue interpretive guidelines to further flesh out the patients' rights requirements. It does not indicate when the guidelines will be issued.

The Patients' Rights COP applies to all Medicare and Medicaid participating hospitals, including short-term, psychiatric, rehabilitation, long-term, children's and alcohol-drug treatment hospitals. The new COP addresses a patient's right to: (1) notification of his or her rights; (2) the exercise of his or her rights in regard to his or her care; (3) privacy and safety; (4) confidentiality; (5) freedom from the use of restraints for hospital care unless clinically necessary; and (6) freedom from seclusion and restraints used in behavior management unless clinically necessary. Each of the six standards is discussed below.

1. Notice of Rights.

A hospital must inform each patient, or when appropriate, the patient's representative (as allowed under state law) of the patient's rights, in advance of furnishing or discontinuing care whenever possible. The notice of patients' rights must inform the patient of his or her right to (1) file a grievance; (2) participate in the development of his or her plan of care; (3) make decisions concerning his or her care; (4) be informed of his or her health status, be involved in care planning, and have the right to refuse treatment; (5) formulate advance directives; (6) personal privacy; (7) receive care in safe setting, free from verbal or physical abuse or harassment; (8) confidentiality of the patient's medical records and access to the information in the records; and (9) be free from restraints and seclusion in any form used as a means of coercion, discipline, convenience or retaliation by staff.

The COP does not specify how or where the notice of patients' rights should be displayed or delivered. The commentary accompanying the COP suggests that hospitals should provide the patient with the written notice of patients' rights at the time of admission, and that the notice might also be posted along with other notices (such as those regarding nondiscrimination) which the hospital is required by law to disseminate.

This standard also mandates a written grievance process, and requires the hospital to identify the person or persons who the patient can contact to express a grievance. The hospital's governing body must approve and be responsible for the effective operation of the grievance process, including the review and resolution of grievances, unless the oversight of grievances is delegated in writing to a grievance committee. At a minimum, the hospital must (1) establish a clearly explained procedure for the submission of written or verbal grievances; (2) establish timeframes for review and response by the hospital; and (3) provide the patient with written notice of its decision along with the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process and the date of completion. The grievance procedure must also inform the patient of his or her right to lodge a complaint with the state survey agency (regardless of whether the patient has first used the hospital's internal grievance policy), and must provide the patient with the name, address and telephone number of the state survey agency.

2. Exercise of Rights.

The patient has the right to participate in the development or implementation of his or her plan of care, to make informed decisions regarding his or her care, to be informed of his or her health status, to be involved in care planning and to request or refuse treatment. Furthermore, the patient has the right to formulate advance directives for end of life situations, and to have hospital staff and practitioners comply with these directives. In accordance with existing law, the advance directive requirements apply only in the inpatient hospital setting.

A new requirement added by the COP states that the patient has the right to have a family member or representative and his or her physician notified promptly of admission to the hospital.

3. Privacy and Safety.

The patient has the right to personal privacy, to receive care in a safe setting, and to be free from any sort of abuse or harassment including verbal, physical, psychological, sexual or emotional abuse. The commentary accompanying the rule makes it clear that the right to "privacy" does not mean that each patient is entitled to a private room. However, even if the patient has a semi-private room, the hospital should provide the patient with privacy by steps such as pulling curtains closed for exams and requesting visitors to leave the room when treatment issues are being discussed.

4. Confidentiality and Access to Patient Records.

The patient has the right to the confidentiality of his or her medical record and the right to access information contained therein within a reasonable timeframe. The hospital must not frustrate the legitimate efforts of individuals to gain access to their own medical records and must actively seek to meet these requests as quickly as its record keeping system permits. The commentary accompanying the rule recognizes that there may be circumstances where the hospital can legitimately limit the release of the patient's records (such as where inspection could be reasonably likely to endanger the life of the patient or anyone else) but HCFA believes the patient should be given access to his or her own record "in all but the most extreme cases."

5. Restraint for Acute Medical and Surgical Care.

The most controversial of the patient rights standards are those which spell out the patient's right to be free from inappropriate restraint and seclusion. Separate standards are provided for in the use of restraints in the acute care setting and for situations where restraint or seclusion is used to manage behavior, although the elements of the two standards are in many respects the same.

The COP states that a patient has the right to be free from restraints which are not medically necessary or are used as a means of coercion, discipline, convenience, or retaliation by staff. In the view of HCFA, the use of a restraint should be the exception to the rule, and not a standard practice. Accordingly, the COP mandates that restraints must be used in accordance with a written modification to the patient's plan of care, may be used only when other less restrictive measures have been found to be ineffective, and must be removed or ended at the earliest possible time.

The definition of "restraint" includes not only physical restraints, but also drugs used as a restraint. Physical restraints include any "manual method or physical or mechanical device, material or equipment attached or adjacent to the patient's body that he or she cannot easily remove that restricts freedom of movement or normal access to one's body." A drug used as a restraint is a medication used to control behavior or restrict the patient's freedom of movement which is not a standard treatment for the patient's condition.

The requirements concerning restraint in the acute care setting are very specific. Licensed independent practitioners (in addition to physicians) may write restraint orders if authorized by state law and hospital policy. However, the patient's treating physician must be contacted as soon as possible if the physician did not write the order. Restraint must never be written as a standing order or on an as-needed basis. Furthermore, the restrained patient must be continually assessed, monitored and reevaluated, with the restraint ended at the earliest possible time. Lastly, all direct care staff are required to have ongoing education and training regarding restraint use.

The COP regarding use of restraints is based in large part upon 1999 JCAHO Hospital Accreditation Standards. HCFA believes, therefore, that compliance, at least by accredited hospitals, should not be difficult.

6. Seclusion and Restraint for Behavior Management.

The requirements for use of restraint and seclusion for behavior management are in many respects similar to the requirements for use of restraints for acute medical and surgical care, but additional, more specific requirements are included. The behavior management standard is also based on the current JCAHO Standards.

Seclusion is defined as the involuntary confinement of a person in a room or other area where the person is physically prevented from leaving. The definitions of the terms "restraint" and "drug used as a restraint" are the same as those contained in the standard for acute care restraint.

Seclusion or restraint use for behavior management must be in accordance with the order of a physician or other authorized licensed professional, and the treating physician must be consulted as soon as possible if he or she did not write the order. A physician or independent practitioner must see and assess the patient within one hour of the initiation of restraint or seclusion, and seclusion or restraints may never be ordered on a standing or as-needed basis.

A durational limit is set for each order, based upon the patient's age. The limits are as follows: Adults - 4 hours; Ages 9 to 17 - 2 hours; under Age 9 - 1 hour. The original order may be renewed for up to a total of not more than twenty four (24) hours. Then, the patient must be seen and reassessed before issuing a new order.

Any restraint or seclusion use must be in accordance with a written modification to the patient's plan of care, must be implemented in the least restrictive manner possible, must utilize appropriate restraining techniques, and may be selected only when less restrictive measures have been found to be ineffective to protect the patient or others from harm. Restraint and seclusion may not be used simultaneously unless the patient is continually visually monitored in person or by audio and video equipment in close proximity to the patient. The condition of the behavior management patient must continually be assessed, monitored and reevaluated and the restraint or seclusion must be ended at the earliest possible time. Additionally, staff must have training in use of seclusion and restraints and alternative methods of handling behaviors traditionally treated with seclusion and restraint. Finally, HCFA must be notified of any patient death during, or as a result of, restraint or seclusion for behavior management.

The rule specifically states that the standard for restraint or seclusion use for behavior management will be superseded by existing state laws that are more restrictive.


HCFA believes that most hospitals are already fulfilling many of the patients' rights requirements through compliance with existing state laws and JCAHO standards. Therefore, HCFA is not prescribing the exact process that must be followed to meet the new regulatory requirements. The interpretive guidelines that HCFA intends to issue will provide much more detail regarding HCFA's expectations. However, since the patients' rights COP became effective on August 2, 1999, hospitals will have to take action now. At a minimum, hospitals will need to establish compliance policies and procedures, prepare a written statement of patients' rights, develop and secure governing board approval of a grievance process, and ensure that staff receive ongoing education and training in order to comply with the requirements concerning restraint and seclusion.

If you have any questions, or if we may be of assistance in developing your compliance strategies, please contact any of the members of Buchanan Ingersoll's Healthcare Group.