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The patients' rights regulations will strengthen existing protections for patient health and safety and will help assure that high quality care is provided to all patients in hospitals participating in the Medicare and Medicaid program. The six basic patient rights specified in the regulations include the right to confidentiality of patient records and communications, and the freedom from the inappropriate use of restraints and seclusion.

The patients' rights protections are part of Medicare's revised Conditions of Participation requirements that hospitals must meet to participate in the Medicare and Medicaid programs. The interim final regulations, which will be effective in 60 days, were published in today's Federal Register.

HCFA carved out the patients' rights section from the larger proposed revision of the hospital Conditions of Participation regulation, published as a Notice of Proposed Rulemaking on December 17, 1997, so that the patient protections could be expanded as soon as possible.

"By carving out this section, HCFA will be able to move more quickly to hold all hospitals that participate in Medicare and Medicaid accountable for protecting patients' rights, and for the inappropriate use of restraints and seclusion. These protections underscore the Administration's determination to ensure basic protections for patient health and safety in hospitals, as well as our commitment to patients' rights," said HCFA Administrator Nancy-Ann DeParle.

The new patients' rights protections build on HCFA's improved enforcement of quality of care in hospitals, DeParle said. The proposed patients' rights protections will apply to all participating hospitals, including acute, psychiatric, rehabilitation, long-term, children's, and alcohol-drug hospitals.

The new regulations require that a hospital provide a patient or family member with a formal notice of their rights at the time of admission. These rights include the right to be free from restraints and seclusion in any form when used as a means of coercion, discipline, convenience or retaliation. Other rights include the right to privacy and confidentiality and the right to make decisions about the patient's care.

If patients and their families have any concerns about the quality of care provided at a hospital, they may contact the state survey agency or HCFA regional office to find out whether the hospital has been cited for a violation of the patient safety requirements.

The new patient protections also make consistent standards used by HCFA and the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) to ensure only appropriate use of restraints and seclusion. HCFA adopted the same approach and time frames for monitoring the use of restraints and seclusion developed and enforced by the Joint Commission when it accredits hospitals and behavioral health facilities.

HCFA's regulations also contain new requirements on staff training so that health care workers who have direct patient contact will learn the appropriate and safe use of seclusion and restraints.

In addition to the regulations published today, HCFA already has regulations restricting the use of restraints in other settings, including intermediate care facilities for the mentally retarded and nursing home facilities. The Clinton Administration has made improving the quality of nursing homes and oversight a top priority. Last July, the President announced a broad initiative to strengthen the enforcement of the strict nursing home regulations that were published in 1995.

In addition to HCFA's efforts, a number of HHS agencies are increasing attention to the use of inappropriate seclusion and restraint practices. Most notably, the Substance Abuse and Mental Health Services Administration provides funds to state mental health protection and advocacy systems. These systems, present in each state, have a strong record of addressing and resolving consumer complaints related to the misuse of seclusion and restraint. Moreover, HCFA staff is actively participating with SAMSHA in the development and implementation of an action plan that will continue to address problems with the misuse of seclusion and restraints in health care facilities.

HCFA is also working with the HHS Office of the Inspector General (OIG) to obtain more information about existing patient abuse reporting systems and oversight of psychiatric hospitals. The OIG is currently conducting three studies to provide policy makers with up-to-date information about these issues.

"Children and other vulnerable patients must be able to count on quality care that is safe and free of improper seclusion and restraints. This regulation is one of many steps that we are taking to protect the health and welfare of Americans receiving psychiatric services. Working with Congress and health care providers, we will ensure that these patients get those protections," DeParle said.

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