[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
