[Federal Register Volume 60, Number 97 (Friday, May 19, 1995)]
[Notices]
[Pages 26886-26887]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-12397]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Health Care Policy and Research


Nominations of Clinical Practice Guideline Topics

    The Agency for Health Care Policy and Research (AHCPR) is inviting 
recommendations of health topics, with supporting rationale, for 
consideration by AHCPR in selecting topics for development of clinical 
practice guidelines. The process AHCPR employs in establishing 
priorities and selecting topics for guidelines, based on statutory 
criteria, is described below.

Background

    The Agency for Health Care Policy and Research (AHCPR) is charged, 
under Title IX of the Public Health Service Act (PHS Act), with 
enhancing the quality, appropriateness, and effectiveness of health 
care services, and access to such services. The AHCPR accomplishes its 
goals through the establishment of a broad base of scientific research 
and through the promotion of improvements in clinical practice and in 
the organization, financing, and delivery of health care services. (42 
U.S.C. 299-299c-6 and 1320b-12.)
    As part of its charge, under section 912 of the PHS Act, the 
Administrator of AHCPR arranges for the development, periodic review, 
and updating of clinically relevant guidelines that may be used by 
physicians, other health care practitioners, providers, educators, and 
health care consumers to assist in determining how diseases, disorders, 
and other health conditions can most effectively and appropriately be 
prevented, diagnosed, treated, and clinically managed. (See 42 U.S.C. 
299b-1(a).)
    The guidelines are required to:
    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, providers, 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 
review of 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 914(a) of the PHS Act (42 U.S.C. 299b-3(a)) identifies 
factors to be considered in establishing priorities for guidelines, 
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.
    Section 914 also provides that the methodology may include the 
considerations under section 904 of the PHS Act, relevant to 
establishing priorities for technology assessments, and other 
considerations determined by the Administrator to be appropriate.
    The criteria for determining priorities for technology assessments 
include: The prevalence of a particular health condition; variations in 
current practice; the economic burden posed by the prevention, 
diagnosis, treatment, and clinical management of a health condition, 
including the impact on publicly funded programs; aggregate cost of the 
use of the technology(ies) involved; the morbidity and mortality 
associated with the health condition; and the potential to improve 
health outcomes or affect costs associated with the prevention, 
diagnosis, or treatment of the condition.
    Consistent with several Title IX provisions, such as sections 
912(e) and 914(a)(2)(B) of the PHS Act, and with section 1142 of the 
Social Security Act, the Administrator assures that the needs and 
priorities of the Medicare program are reflected appropriately in the 
agenda and priorities for development of guidelines. In the future, the 
Administrator will also give special consideration to topics which are 
not likely to be addressed by the private sector, and to those which 
are likely to be implemented by organized systems of care.
    In response to section 914(a)(2)(C), which requires the 
Administrator to publish a methodology for establishing priorities for 
guideline topics and a Federal Register notice of topics under 
consideration annually, a notice was published on September 1993, 
entitled ``Criteria for Selection of Clinical [[Page 26887]] Practice 
Guidelines and Topics under Consideration for Development of Clinical 
Practice Guidelines'' (58 FR 49308). This solicitation of topics is a 
further step in determining priorities for future guideline 
development.

Process for Selection of Guideline Topics

    The AHCPR's method for setting priorities and selecting guideline 
topics consists of the process outlined below:
    1. Inviting suggestions for guideline topics with supporting 
information through published notice in the Federal Register and from 
HCFA, PHS agencies, professional organizations, managed care 
organizations, and professional review and other health care 
organizations;
    2. Determining what consensus statements, practice parameters, and 
evidence-based guidelines have been recently developed or are under 
development by other organizations in order to avoid unnecessary 
duplication of effort;
    3. Studying the topics proposed and the supporting documentation to 
determine compliance with AHCPR criteria and legislative requirements;
    4. Determining compliance with the legislation by assessing, among 
other factors, the adequacy of the available scientific evidence; the 
prevalence and cost of the particular topic/condition, with particular 
concern for the Medicare and Medicaid populations; the potential for 
improvement in health outcomes; the potential for reducing clinically 
significant and unexplained variations in the prevention, diagnosis, 
treatment, management, and outcomes of health services; and the 
potential for improvement of methods of prevention;
    5. Seeking advice of public and private sector experts on setting 
priorities for proposed topics;
    6. Determining resource availability from AHCPR and other sources 
to develop the priority guidelines for the current and upcoming fiscal 
years; and
    7. Considering recommendations from the National Advisory Council 
on Health Care Policy, Research, and Evaluation.

Clinical Practice Guidelines Completed and Under Development

    The following guidelines have been released and disseminated:

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
11. Heart Failure: Evaluation and Care of Patients with Left 
Ventricular Systolic Dysfunction
12. Otitis Media With Effusion in Young Children
13. Treatment of Pressure Ulcers in Adults
14. Acute Low Back Problems in Adults
15. Quality Determinants of Mammography

    The following guidelines and one guideline update are under 
development:

1. Post Stroke Rehabilitation
2. Cardiac Rehabilitation
3. Recognition and Initial Assessment of Alzheimer's and Related 
Dementias
4. Smoking Prevention and Cessation
5. Screening for Colorectal Cancer
6. Chronic Pain: Headache
7. Urinary Incontinence in Adults (Update)

    Nominations of new guideline topics with supporting rationale, 
including specific evidence and other data, must be received by July 
18, 1995 at the following address: Douglas B. Kamerow, M.D., M.P.H., 
Director, Office of the Forum for Quality and Effectiveness in Health 
Care, Agency for Health Care Policy and Research, 6000 Executive 
Boulevard, Suite 310, Rockville, Maryland 20852.

    Dated: May 15, 1995.
Clifton R. Gaus,
Administrator.
[FR Doc. 95-12397 Filed 5-18-95; 8:45 am]
BILLING CODE 4160-90-M