[Federal Register Volume 59, Number 79 (Monday, April 25, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-9950]


[[Page Unknown]]

[Federal Register: April 25, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Health Care Policy and Research

 

Process for Determining Need for Updates of Clinical Practice 
Guidelines

    The Agency for Health Care Policy and Research (AHCPR) announces a 
process for determining when updates are needed of AHCPR-supported 
clinical practice guidelines. The process consists of obtaining 
information about new scientific evidence or new technologies, 
soliciting opinions from the public, and convening a public meeting to 
receive relevant information. Comments on the process are invited.

Background

    The Omnibus Budget Reconciliation Act of 1989 (Pub. L. 101-239) 
added a new Title IX to the Public Health Service Act (the Act), which 
established the Agency for Health Care Policy and Research (AHCPR) to 
enhance the quality, appropriateness, and effectiveness of health care 
services, and access to such services. (See 42 U.S.C. 299-299c-6 and 
1320b-12.) The Agency for Health Care Policy and Research 
Reauthorization Act of 1992 (Pub. L. 102-410), enacted on October 13, 
1992, extended the authorization of AHCPR and amended certain 
provisions related to the development of clinical practice guidelines. 
In keeping with its legislative mandates, AHCPR, through the Office of 
the Forum for Quality and Effectiveness in Health Care (Forum), 
arranges for the development, periodic review, and updating of 
clinically relevant guidelines that may be used by physicians, other 
health care practitioners, educators, and consumers to assist in 
determining how diseases, disorders, and other health conditions can 
most effectively and appropriately be prevented, diagnosed, treated, 
and clinically managed. The AHCPR also supports development, periodic 
review, and updating of medical review criteria, standards of quality, 
and performance measures, based on the guidelines.
    Section 912 of the Act (42 U.S.C. 299b-1(b)), as amended by Public 
Law 102-410, requires that the guidelines:
    1. Be based on the best available research and professional 
judgment;
    2. Be presented in formats appropriate for use by physicians, other 
health care practitioners, medical educators, medical review 
organizations, and consumers;
    3. Be presented in treatment-specific or condition specific forms 
appropriate for use in clinical practice, educational programs, and 
reviewing quality and appropriateness of medical care;
    4. Include information on the risks and benefits of alternative 
strategies for prevention, diagnosis, treatment, and management of the 
particular health condition(s); and
    5. Include information on the costs of alternative strategies for 
prevention, diagnosis, treatment, and management of the particular 
health condition(s), where cost information is available and reliable.
    Section 913 of the Act (42 U.S.C. 299b-2) describes two mechanisms 
through which AHCPR may arrange for development of guidelines:
    1. Panels of qualified private sector experts and health care 
consumers may be established; and
    2. Contracts may be awarded to public and private nonprofit 
organizations. Guideline contractors are assisted by panels of private 
sector experts and health care consumers approved by AHCPR.
    Section 914(a) of the Act (42 U.S.C. 299b-3(a)), as amended by 
Public Law 102-410, identifies factors to be considered in establishing 
priorities for guideline topics, including the extent to which the 
guidelines would:
    1. Improve methods for disease prevention;
    2. Improve methods of diagnosis, treatment, and clinical management 
for the benefit of a significant number of individuals;
    3. Reduce clinically significant variations among clinicians in the 
particular services and procedures utilized in making diagnoses and 
providing treatments; and
    4. Reduce clinically significant variations in the outcomes of 
health care services and procedures.
    Also, in accordance with Title IX of the PHS Act and section 1142 
of the Social Security Act, the AHCPR Administrator is to assure that 
the needs and priorities of the Medicare program are reflected 
appropriately in the priorities for development of guidelines.

Clinical Practice Guidelines Released and Under Development

    The following AHCPR-supported guidelines have been released and 
disseminated widely:

 1. Acute Pain Management: Operative or Medical Procedures and Trauma
 2. Urinary Incontinence in Adults
 3. Pressure Ulcers in Adults: Prediction and Prevention
 4. Cataract in Adults: Management of Functional Impairment
 5. Depression in Primary Care: Volume I: Detection and Diagnosis, and 
Volume II: Treatment of Major Depression
 6. Sickle Cell Disease: Screening, Diagnosis, Management, and 
Counseling in Newborns and Infants
 7. Evaluation and Management of Early HIV Infection
 8. Benign Prostatic Hyperplasia: Diagnosis and Treatment
 9. Management of Cancer Pain
10. Unstable Angina: Diagnosis and Management

    The following AHCPR-supported guidelines are under development:

 1. Treatment of Pressure Ulcers in Adults
 2. Acute Low Back Problems in Adults
 3. Quality Determinants of Mammography
 4. Recognition and Initial Assessment of Alzheimer's and Related 
Dementias
 5. Diagnosis and Treatment of Anxiety and Panic Disorders
 6. Smoking Prevention and Cessation
 7. Otitis Media with Effusion in Young Children
 8. Heart Failure: Evaluation and Care of Patients with Left 
Ventricular Systolic Dysfunction
 9. Post Stroke Rehabilitation
10. Cardiac Rehabilitation

    The following guidelines are currently being reviewed and updated 
by private sector panels of experts and consumers.

1. Urinary Incontinence in Adults
2. Acute Pain Management: Operative or Medical Procedures and Trauma

Process for Determining Need for Guideline Updates

    Information regarding the need for a guideline update will be 
obtained from several sources.
    1. Not later than 24 months following the release of an AHCPR-
supported guideline, the Office of the Forum will arrange for a survey 
of subsequently published scientific literature in the topic areas 
addressed by the guideline. The purpose of this survey is to determine 
the volume of new scientific evidence, its quality, and the likelihood 
that such information would cause a change in the guideline's 
recommendations.
    2. The AHCPR is required by section 914(a) (42 U.S.C. 299b-3(a)) to 
publish annually in the Federal Register a list of guideline topics 
under consideration for development. This annual notice will also 
include a listing of those guidelines which have been published by 
AHCPR and for which updates are being contemplated. Comments will be 
solicited from the public regarding the availability of new scientific 
evidence or new technologies that may warrant the updating of a 
clinical practice guideline.
    3. Other information relevant to the updating of guidelines may be 
obtained from evaluation studies conducted to examine the 
implementation or effects of the guidelines; from development and use 
of guideline-derived medical review criteria, performance measures, and 
standards of quality; or from other related activities.
    4. When sufficient data are obtained from the above sources to 
indicate that a guideline update may be needed, a public meeting to 
address the need for and timing of an update will be convened. This 
meeting will provide an opportunity for interested parties to 
contribute relevant information and comments, including new scientific 
evidence not available at the time the guideline was written.
    The Office of the Forum will review all the information and 
scientific evidence obtained in steps 1 through 4 above. When the need 
for a guideline update has been established, the Forum will recommend 
the update and the timing of the update to the AHCPR Administrator. 
Following administrative approval, and as allowed by available 
resources, AHCPR will arrange for the development of the guideline 
update by a panel of private sector experts and consumers or a 
contractor assisted by such a panel.

Request for Comments

    Written comments on the process are invited. The AHCPR will not 
respond to individual comments, but will consider all comments in 
determining future modifications to the guideline update process. 
Comments, in writing, should be submitted by June 24, 1994, to: Linda 
K. Demlo, Ph.D., Director, Office of Program Development, AHCPR, suite 
603, 2101 East Jefferson Street, Rockville, Maryland 20852. All 
comments will be available for public inspection at the Office of 
Program Development, telephone (301) 594-1457, weekdays between 8:30 
a.m. and 5 p.m.

For Additional Information

    Additional information on the guideline development process is 
contained in the AHCPR Program Note, ``Clinical Practice Guideline 
Development,'' dated August 1993. This document describes AHCPR's 
activities with respect to clinical practice guidelines, including the 
process and criteria for selecting panels. This document may be 
obtained from the AHCPR Publications Clearinghouse, P.O. Box 8547, 
Silver Spring, MD 20907; or call Toll-Free: 1-800-358-9295.
    Also, information may be obtained by contacting Carole Hudgings, 
Ph.D., Acting Director, Office of the Forum for Quality and 
Effectiveness in Health Care, Agency for Health Care Policy and 
Research, Willco Building, 6000 Executive Blvd, suite 310, Rockville, 
MD. 20852.

    Dated: April 18, 1994.
J. Jarrett Clinton,
Administrator.
[FR Doc. 94-9950 Filed 4-22-94; 8:45 am]
BILLING CODE 4160-90-P