Federal District Judge Affirms HCFA's One-Hour Restraint Rule
Hospitals Can Submit Economic Impact to HCFA
Court Rules That The One Hour Rule Will Save Lives and Reduce Injuries
The Court ruled that the "Plaintiff's (the hospitals) perspective for evaluating the rule is too narrow. Both the need and justification for it are to be found in the extensive commentary regarding the need for rapid assessment and constant monitoring of the patient's condition...The Secretary (of the Department of Health and Human Services) considered all relevant factors in reaching her decision, and her decision requiring maximum patient protection is a reasonable one."
The Court further ruled: "It is clear that the Secretary's goals were to ensure that restraints and seclusion not be overused or improperly used, that patients be frequently monitored while in restraints and seclusion, and that patients be removed from them as soon as possible...The one-hour requirement imposed in the final rule is a logical outgrowth of the proposed rule, as it specifically addressed those goals..." The Court found "that the final rule was in fact the logical outgrowth of the proposed rule. The Defendant (the Secretary of HHS and its agency HCFA) put the commenters on notice that her overriding concern was for patient's health and safety...and she noted that restraints and seclusion have the potential to produce serious psychological and physical harm to the patient."
The Court refused to issue an injunction stopping the rule, as litigated by the hospitals. The Court determined that the HCFA rule is in "the public interest. The Rule was promulgated to protect patients against the unnecessary and excessive use of restraints or seclusion. Delaying enforcement would create the likelihood that injuries or death could result if the restraints or seclusion continued to be used inappropriately...The public interest lies in continued enforcement of the Rule...Plaintiffs (the hospitals) have failed to show what, if any, irreparable harm would befall them...Plaintiffs offer no concrete, reliable evidence to support their contentions of irreparable harm."
District court decisions are available from www.dcd.uscourts.gov/district-court.html
HCFA Must Conduct an Economic Analysis
The Federal Regulatory Flexibility Act (FRFA) requires agencies to assess the negative impact of their rules on small businesses. The act requires that federal rules not have a significant economic impact on a substantial number of small businesses. The Court found that HCFA "did not obtain data or analyze available data on the impact of the final rule on small entities." The Court ordered HCFA to conduct a FRFA analysis.
Hospitals will now be providing HCFA with supposed data arguing that having a licensed independent mental health practitioner on site for emergency safety situations will have harsh economic impact. NAMI, and other members of the Advocates Coalition for the Appropriate Use of Restraints, have already endorsed waivers for hospitals located in rural or medically underserved areas (as determined by HHS) when such economic hardships can be documented.
NAMI wants to see which hospitals will publicly declare that it is an economic burden to have a licensed independent mental health practitioner on site to respond to limited emergency safety situations. Hospital lobbyists argue that it is a burden to have psychiatrists on site to respond to emergency safety situations. But the rule requires a physician or a licensed independent practitioner (LIP). Many within NAMI advocate that such a role be played by a physician competent in psychiatry, but the rule is a physician or LIP.
NAMI Members Are Encouraged To Identify Hospital Best-Better Practice Sites
Given that HCFA must conduct an economic impact analysis and given that hospitals will be arguing that it is unreasonable to have physicians on site to respond to emergency safety situations, NAMI members should share with NAMI best-better practice hospital sites where restraints and seclusion (R/S) have been significantly reduced. A description of the practices used to reduce R/S and any data on historic utilization would be most helpful.
Currently NAMI uses the state psychiatric hospitals experiences in New York and Pennsylvania as the current best-better practice sites. A handful of private hospitals were identified by NAMI members in late 1998 and early 1999, resulting in a NAMI published summary. The list needs to be substantially updated.
NAMI members are asked to help NAMI identify best-better practice sites and send this information to the attention of Kim Encarnation (firstname.lastname@example.org).
OIG Concludes that State Policies for Private Hospitals Fall Short of the HCFA Standards
In August 2000, the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) issued a report, "Restraints and Seclusion: State Policies for Psychiatric Hospitals." The report, OIE-04-99-00150 is available from the OIG web site, www.dhhs.gov/progor/oei, or by calling 404-562-7723.
The OIG surveyed state mental health departments, state licensing and certification agencies, and state protection and advocacy agencies, between July and September 1999. The HCFA interim rule was not effective until August 1999. 43 state mental health agencies (84% response rate), 36 state licensing and certification agencies (71% response rate), and 44 P&As (86% response rate) responded.
State practices prior to the adoption of the HCFA one hour rule included:
10 state psychiatric hospitals and 4 state policies for private hospitals required an immediate physician order for the use of R/S; 19 state psychiatric hospitals and 11 state policies for private hospitals required a physician order between 15 minutes and 60 minutes of initiating R/S;
15 state psychiatric hospitals and 2 state policies for private hospitals required between a one and four time hour time limit for the duration of R/S;
4 state psychiatric hospitals and 1 state policy for private hospitals required continuous monitoring of persons while in R/S; 30 state psychiatric hospitals and 12 state policies for private hospitals required monitoring of persons while in R/S every 15 minutes.
The OIG concluded with the recommendation that "HCFA work aggressively with States and accreditation organizations to quickly raise psychiatric hospital compliance with the new Patients' Rights Condition of Participation where necessary. Particular attention should be given to policies for private psychiatric hospitals."