1. INTRODUCTION

On July 2, 1999, the Health Care Financing Administration ("HCFA") of the Department of Health and Human Services ("HHS") issued an interim final rule with comment (the "Rule") in which it introduced a new patients’ rights condition of participation ("COP") that hospitals must meet in order to be approved for, or continue participation in, the Medicare and Medicaid programs. 64 Fed. Reg. 36070. Publication of the Rule follows HCFA’s issuance of a December 1997 proposed revision of all hospital COPs, including a new patients’ rights COP. According to HCFA, the patients’ rights COP was finalized separately on an accelerated timeframe as a result of recent media and other reports that have evidenced a pressing need for the codification and enforcement of fundamental patients’ rights, most particularly the right to freedom from restraints and seclusion.

The new patients’ rights COP applies to all Medicare- and Medicaid-participating hospitals, including short-term, psychiatric, rehabilitation, long-term, children’s and alcohol-drug facilities, and is scheduled to become effective on August 2, 1999.

2. BACKGROUND
1. COPs In The Survey And Certification Process

COPs are the requirements that hospitals must meet in order to participate in the Medicare and Medicaid programs. See generally 42 C.F.R. Part 482. Under contract with HCFA, state survey agencies ("SAs") (in many jurisdictions, the state Department of Health) survey hospitals to assess their compliance with the COPs. SAs conduct these surveys using the State Operations Manual (HCFA Publication No. 7) (the "SOM"), which contains interpretive guidelines for the COPs and outlines the facility survey process. SAs evaluate hospitals’ compliance with the COPs and make corresponding recommendations to HCFA regarding the facilities’ certification under the Medicare and Medicaid programs.

Pursuant to Section 1865 of the Social Security Act, hospitals that are accredited by the Joint Commission on Accreditation of Healthcare Organizations ("JCAHO") or the American Osteopathic Association are not subject to routine surveys by the SAs, but rather are deemed to satisfy the requirements in the COPs based on their accreditation. Notwithstanding their deemed compliance status, accredited facilities are still required to comply with applicable COPs. Providers may be subject to so-called "validation surveys," which can be ordered by HCFA in order to assess the ongoing acceptability of accreditation as an alternative to routine survey and certification activities. If a facility fails to comply with the validation survey protocol or the SA finds that the facility is out of compliance with one or more COPs, the provider will no longer be deemed to satisfy the COPs and will be subject to full Medicare survey.

2. Basis For The Patients’ Rights COP

In the preamble to the Rule, HCFA reported that numerous complaints had been voiced to the agency in recent years by state surveyors, patient advocacy groups, the media and the general public about hospitals’ violations of patients’ rights. According to HCFA, these violations "consisted of denying or frustrating a patient’s access to care, denying a patient’s full involvement in his or her treatment, disregarding a patient’s advance directives, denying a patient’s access to his or her medical records or inappropriately using seclusion or restraints." Most particularly, HCFA cited an October 1998 series of articles published by The Hartford Courant, a Connecticut newspaper, in which were described the results of a study that identified 142 deaths from seclusion or restraints use in behavioral health treatment facilities over the past 10 years. HCFA’s desire to address these concerns served as the primary basis for the new COP.

In developing the patients’ rights COP, HCFA also incorporated a number of the consumer protections articulated in the Consumer Bill of Rights and Responsibilities, which was recommended by the Presidential Advisory Commission on Consumer Protection and Quality in the Health Care Industry and was applied to all federal health plans by Presidential Order in February 1998.

3. PATIENTS’ RIGHTS CONDITION OF PARTICIPATION
1. Notice Of Rights

Under the new COP, a hospital is required to inform each patient, or when appropriate the patient’s representative, of the patient’s rights, in advance of furnishing or discontinuing care whenever possible. In the preamble to the Rule, HCFA indicated that it did not prescribe more particular requirements than stated in the general standard for how, where and when patients must receive notice of their rights because it desired to preserve flexibility for hospitals and to promote creativity on how to implement the requirement. Notwithstanding this view, HCFA did suggest that, for some of the educational notices required under the COP, bundling notices with the existing information that is posted publicly to satisfy civil rights requirements may be appropriate.

The notice of rights standard also mandates that hospitals establish a formal grievance process for resolution of patient complaints and inform each patient who to contact to file a grievance. The hospital’s governing body must approve and be responsible for effective operation of the grievance process, unless it delegates that responsibility in writing to a grievance committee. The grievance process must include a mechanism for timely referral of concerns about quality of care or premature discharge to the appropriate Utilization and Quality Control Peer Review Organization.

While HCFA chose, again, not to be highly prescriptive in mandating the form or operation of hospital grievance processes, the COP does state three minimum requirements: (i) that the hospital establish a clearly explained procedure for submission of a patient’s written or verbal grievance; (ii) that the grievance process specify time frames for review of a grievance and provision of a response; and (iii) that, in resolving a grievance, the hospital provide the patient with written notice of the decision that contains 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. Further, HCFA indicated in the preamble to the Rule that, in interpretive guidelines for the new COP that will be published in the SOM, the agency will specify that patient notification of the grievance process must include the fact that the patient can address his concerns to the state survey agency, regardless of whether he has first used the hospital’s grievance process, and must provide the phone number and address for lodging a complaint with the state survey agency.

2. Exercise Of Rights

The new COP establishes four standards concerning patients’ exercise of their rights. First, each patient has the right to participate in the development and implementation of his plan of care. Second, the patient (or his representative, as allowed under state law) has the right to make informed decisions regarding his care. In particular, this right includes the patient’s right to be informed of his health status, to be involved in care planning and treatment, and to be able to request or refuse treatment. The second standard states, however, that the right does not entitle a patient to demand the provision of treatment or services deemed medically unnecessary or inappropriate.

Third, the patient has the right to formulate advance directives and to have hospital staff and practitioners comply with those directives. According to comments made by HCFA in the preamble, this standard is not intended to affect the existing regulations (at 42 C.F.R. §§ 489.100-489.104) concerning provider requirements for acknowledgement and handing of advance directives. Further, in response to comments received by HCFA concerning facilities’ responsiveness to advance directives for psychiatric emergencies, the agency indicated that, in interpretive guidelines, it will further describe the aspects of advance directives that relate to psychiatric emergencies and place a greater emphasis on responsiveness to such situations. Fourth, the new COP provides that each patient is entitled to have a family member or representative of his choice and his own physician notified promptly of his admission to the hospital.

3. Privacy And Safety

This standard states three basic patient rights: (i) the right to personal privacy; (ii) the right to receive care in a safe setting; and (iii) the right to be free from all forms of abuse or harassment. The COP does not provide further detail on how HCFA will interpret these standards; instead, HCFA indicated its intention to expound upon these requirements, including specifically the concepts of a "safe" environment of care and patient "privacy," in the interpretive guidelines that will implement the Rule. Notwithstanding this approach, in the preamble to the Rule, HCFA was willing to state that the concept of privacy does not mean that each patient has a right to a private room.

4. Confidentiality Of Patient Records

The new COP not only states that a patient is entitled to confidentiality of his clinical records, but also that he has the right to access the information contained in those records within a reasonable time frame. In order to provide further guidance on the meaning of the term "reasonable," HCFA included in this standard that hospitals are prohibited from frustrating individuals’ legitimate efforts to gain access to their medical records and must actively seek to meet requests as quickly as their recordkeeping systems permit. Although many commenters requested the establishment of specific time frames within which facilities must respond to patient information requests, HCFA chose not to take this approach in light of the variety of factors (e.g., location of data, urgency and staff workload) which can legitimately affect response time.

HCFA implicitly acknowledged that there might be limited circumstances in which it would be appropriate to limit access by patients to their medical records. In the preamble to the Rule, the agency discussed HHS’ policy position on patient access to medical records as set forth in "Confidentiality of Individually-identifiable Health Information, Recommendations of the Secretary of Health and Human Services, pursuant to section 264 of the Health Insurance Portability and Accountability Act of 1996," in which the Secretary recommended federal legislation to protect patients’ rights with respect to their health information. This policy states that patients should be allowed to inspect and copy their health information held by providers and payors, but that providers and payors, in their discretion, could withhold information from the patient under very narrowly-defined circumstances:

· the information is about another person and disclosure would cause sufficient harm to the other individual to warrant withholding;

· inspection could be reasonably likely to endanger the life or physical safety of the patient or another person;

· the information includes information obtained under a promise of confidentiality (from someone other than a health care provider), and disclosure could reveal the source;

· the information is held by an oversight agency, and disclosure could impede an ongoing oversight or law enforcement activity;

· the information is collected as part of a clinical trial, the trial is in progress, an institutional review board has approved the denial of access and the patient has agreed to the denial when consenting to participate; and

· the information is compiled principally in anticipation of, or for use in, a legal proceeding.

HCFA chose not to incorporate these circumstances into the Rule but, instead, raised them in the preamble as examples of the narrow areas in which providers should exercise discretion in providing patients with access to their clinical information.

In the preamble to the Rule, HCFA stated its refusal to establish a fair market value standard for the price at which records are supplied to patients, but it did indicate that it would regard charging an excessive fee for copies of records as a violation of the patients’ rights COP. Further, in response to comments about the risk management issues inherent in providing access to incomplete medical records, HCFA stated that it would be acceptable for a hospital to provide a staff member to review records with patients as necessary to minimize misunderstandings and respond to concerns.

5. Restraints And Seclusion

The bulk of the provisions in the patients’ rights COP, as well as half of the comments received by HCFA with respect to the new standards, concern the two standards on restraints and seclusion. HCFA has attempted to differentiate between situations where restraints are used to provide acute-level medical and surgical care and those where restraint or seclusion is used to manage patient behavior, an approach similar to that adopted by JCAHO. In the preamble to the Rule, HCFA stressed that the standards for use of restraints are not specific to the treatment setting, but rather pertain to the situation the restraint is being used to address. For example, use of restraints to manage the behavior of patients in the psychiatric wing of a hospital would not be governed by the medical care restraint standard merely because treatment occurs in an acute care facility, but instead would be subject to the restraint and seclusion behavior management standard. One issue that may arise under the new COP, however, is how hospitals should characterize a particular application of restraints as being for medical or surgical purposes or for behavior management purposes.

1. Restraint For Acute Medical And Surgical Care

This standard provides generally that a patient "has the right to be free from restraints of any form that are not medically necessary or are used as a means of coercion, discipline, convenience or retaliation by staff." For purposes of the standard, the term restraint includes either a physical restraint or a drug that is being used as a restraint. A physical restraint is further defined as "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 own body." HCFA stressed that an object is a restraint by functional definition and gave the example that putting up side rails that inhibit the patient’s ability to get out of bed when he desires would constitute a restraint. A drug used as a restraint is "a medication used to control behavior or to restrict the patient’s freedom of movement and is not a standard treatment for the patient’s medical or psychiatric condition."

Restraints for medical or surgical care may only be used if needed to improve the patient’s well-being and less restrictive interventions have been determined to be ineffective. Language in the preamble to the Rule suggests that HCFA will view the "improvement of well-being" standard as being met where the restraints are required in order for the patient "to receive effective treatment." HCFA also stated its expectation that patient medical records would contain information on the less restrictive measures that were considered before the selection of restraint use (or seclusion). Restraints may only be used in accordance with the order of a physician or other licensed independent practitioner who is permitted under applicable state law to order restraints. The order for a restraint may never be written as a standing order or on an as needed basis (i.e., "PRN"), and the order must be followed by consultation with the patient’s treating physician as soon as possible if it was not the treating physician who ordered the restraint.

In the preamble to the Rule, HCFA stated its view that professional staff, such as nurses, should be able to use standard restraint (or seclusion) protocols, in accordance with standards of medical practice and hospital policies and procedures consistent with the new COP. In the agency’s view, if a hospital and medical staff develop and authorize use of a protocol for emergency situations, it would satisfy the requirement that restraints (or seclusion) be used only in accordance with the order of a physician or other licensed independent practitioner. The nurse or other practitioner who initiates the protocol must then contact the appropriate physician at the earliest possible time to obtain a verbal order for the restraint or seclusion intervention.

The standard requires that restraints be implemented in the least restrictive manner possible and that they be applied in accordance with a written modification to the patient’s plan of care. HCFA made reference to a "modified" plan of care to reinforce its expectation that restraints (or seclusion) will not be a standard response to a particular behavior or situation, rather they are only an emergency measure to protect temporarily the safety of the patient and others. Further, restraints must only be applied in accordance with safe and appropriate restraining techniques. The standard requires that the condition of the restrained patient be continually assessed, monitored and reevaluated and that the restraint be ended at the earliest possible time. Finally, all staff who have direct patient contact must have ongoing training in the proper use of restraints.

2. Seclusion And Restraint For Behavior Management

The restraint and seclusion behavior management standard contains many of the same elements as the medical care restraint standard; however, it goes further by adding the concept of seclusion and providing specific requirements for the monitoring of patients who are secluded or restrained for behavior management. The significant new elements in the behavior management standard include the following:

First, the standard adds a definition of "seclusion," which means any "involuntary confinement of a person in a room or an area where the person is physically prevented from leaving." Second, whereas the focus in medical care restraints is the use of restraints in order to improve the patient’s well-being, the focus in behavior management is use only in emergency situations where needed to protect the patient’s physical safety (i.e., in response to unanticipated outbursts of severely aggressive or destructive behavior that poses an imminent danger to the patient and others). Third, in establishing the requirements for behavior management seclusion or restraint orders, HCFA has adopted more prescriptive patient monitoring requirements, consistent with JCAHO’s 1999 Hospital Accreditation Standards. Specifically, the agency has mandated that:

· a physician or other licensed independent practitioner must see and evaluate the need for restraint or seclusion within 1 hour after initiation of the intervention;

· each written order for restraint or seclusion is limited to 4 hours for adults, 2 hours for children and adolescents ages 9 to 17, and 1 hour for patients under 9 years of age; and

· the original order may only be renewed (in accordance with the limits) for up to a total of 24 hours, and, thereafter, a physician or licensed independent practitioner must see and assess the patient before issuing a new order.

Fourth, restraints and seclusion may not be used simultaneously unless the patient is continually monitored (i) face-to-face by an assigned staff member or (ii) by staff using both video and audio equipment, where such monitoring occurs in close proximity to the patient. Fifth, in addition to the requirements described above, training for staff with direct patient contact must also include techniques and alternative methods for handling behavior, symptoms and situations that traditionally have been treated through the use of restraints or seclusion. Sixth, hospitals are required to report to HCFA any death that occurs while a patient is restrained or in seclusion, or where it is reasonable to assume that the death was a result of restraint or seclusion.

4. REQUESTS FOR COMMENTS

Comments on the Rule are due to HCFA no later than August 31, 1999. Throughout the preamble to the Rule, HCFA solicited comments on a number of subjects that still remain under consideration within the agency. These are the following:

· whether HCFA should adopt restraint and seclusion standards for other kinds of health care entities with which it has provider agreements that are similar to or more stringent than those set forth in the Rule;

· the inclusion of additional consumer rights in the COPs, including facility-related information disclosure, protection of whistleblowers and nondiscrimination, that HCFA believes would be needed to achieve compliance with the Consumer Bill of Rights and Responsibilities;

· the pros and cons of requiring the reporting of serious injury or abuse related to the use of restraints or seclusion, as well as the type of injury or abuse that would be reported and the process whereby reports would be made; and

· whether HCFA should adopt more restrictive requirements that would allow only physicians to order restraints or seclusion for behavior management.

5. CONCLUSION

Although hospitals will have to establish policies and procedures in order to comply with the patients’ rights COP (namely, to create a grievance process and to implement the standards on seclusion and restraints), HCFA believes that the benefits of complying with the new COP will outweigh the costs involved. In particular, the agency sees no significant additional burden for the 80% of Medicare-participating hospitals that are accredited by JCAHO, since many of the COP’s requirements are modeled on JCAHO standards for the hospital and behavioral health care accreditation programs. In addition, hospitals should already meet many of the new patients’ rights standards based on requirements of state law and as a result of their own facility-specific policies and procedures. Notwithstanding this fact, hospitals would be well-advised to review their policies and procedures and, if necessary, modify them to comply with the requirements of the new COP.

Please do not hesitate to contact Andrea M. Kahn-Kothmann (215-851-8106) or any other member of the Reed Smith health care group with whom you work if you would like additional information on the Medicare hospital patients’ rights COP or on Medicare or Medicaid certification matters generally.