Final Rule on Patient's Rights in Hospital Conditions of Participation is Effective January 8, 2007

08 January 2007 Publication

Legal News Alert: Health Care

The CMS Final Rule finalizing the “Patient's Rights” Condition of Participation for Hospitals is effective January 8, 2007. It was released last month in response to over 4200 comments CMS received after it released the Interim Rule on July 2, 1999.

The Final Rule, which is organized into seven standards, maintains without change most of the minimum protections and rights outlined in the Interim Rule. The Final Rule does make significant changes to the restraint standards with which Medicare-certified hospitals must comply:

  • CMS has combined the Interim Rule’s “Restraint For Acute Medical And Surgical Care” and the “Seclusion And Restraint For Behavior Management” standards into a single, “Restraint Or Seclusion” standard. In this new standard, CMS redefines “restraint” and places new limitations on the ordering of restraints and seclusion.
  • CMS has added a “Staff Training Requirements” standard. CMS recognizes that a patient has a right to the safe implementation of restraint or seclusion by a trained staff. Therefore, hospitals now must train staff in the application of restraints; implementation of seclusion; and the monitoring, assessment, and providing care for patients in restraints or seclusion before staff can performing any of these actions. This training must be part of orientation and must occur subsequently on a periodic basis consistent with hospital policy.
  • CMS has created a “Death Reporting Requirements” standard, which expands upon the Interim Rule requirement that hospitals report to CMS any death that occurs while a patient is restrained or in seclusion, or where it is reasonable to assume that a patient's death is a result of restraint or seclusion. As of January 8, 2007, hospitals must report deaths that occur (a) while a patient is restrained or in seclusion, (b) within 24 hours after the patient has been removed from restraints or seclusion, or (c) within one week after restraint or seclusion where it is reasonable to assume that the use of restraints or seclusion contributed to the patient's death. CMS requires hospitals to make the report by telephone no later than the close of business the next business day following knowledge of the patient's death, and hospitals must note that it notified CMS in the patient’s medical record.

The standards left unchanged in the Final Rule are as follows:

  • Notice of Rights. This standard requires the patient or the patient's representative to be informed of the patient’s rights prior to furnishing or discontinuing care whenever possible. It also requires that the hospital have, and inform the patient about, a grievance process that includes specific elements enumerated in the standard.
  • Exercise of Rights. This standard gives patients the right to participate in the development and implementation of his or her plan or care, and to request and refuse treatment.
  • Privacy and Safety. The third standard provides patients the right to personal privacy, safety, and freedom from abuse or harassment.
  • Confidentiality of Patient Records. This standard provides patients with the right to confidentiality of his or her records.

Because of the significant changes to the restraint and seclusion standards, Foley & Lardner LLP will be issuing a Law Watch shortly to describe in detail those changes and what hospitals must do to comply.

If you have any questions about this or would like additional information, please contact any of the attorneys listed below or the attorney in the firm who generally handles your legal matters:

Janice A. Anderson at 312.832.4530 or

Sarah G. Benator at 310.975.7795 or

Maureen F. Kwiecinski at 414.319.7325 or

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