[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: 94-9949]


[[Page Unknown]]

[Federal Register: April 25, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
 

Proposed Methodology for Establishing Priorities for Health Care 
Technology Assessments

    The Agency for Health Care Policy and Research (AHCPR) announces a 
proposed methodology to be used for establishing priorities for health 
care technology assessments conducted by AHCPR's Office of Health 
Technology Assessment (OHTA). The methodology consists of weighted 
criteria, which are based on a study by the Institute of Medicine, 
statutory requirements, and the results of a public meeting held by the 
Technology Assessment Task Force of AHCPR's National Advisory Council 
on Health Policy, Research, and Evaluation.

Background

    The AHCPR was established by the Omnibus Budget Reconciliation Act 
of 1989 (Pub. L. 101-239, December 12, 1989) under Title IX of the 
Public Health Service Act (the Act). The AHCPR is to enhance the 
quality, appropriateness, and effectiveness of health care services, 
and access to such services through the establishment of a broad base 
of scientific research, and through the promotion of improvements in 
clinical practice (including the prevention of diseases and other 
health conditions), and improvements in the organization, financing, 
and delivery of health care services. In carrying out these purposes 
AHCPR, among other activities, conducts and supports specific 
assessments of health care technologies.
    Since the establishment of AHCPR, Title IX, including provisions of 
the authority for health technology assessments, has been amended by 
the Agency for Health Care Policy and Research Reauthorization Act of 
1992 (Pub. L. 102-410, October 13, 1992) and the National Institutes of 
Health Revitalization Act of 1993 (Pub. L. 103-43, June 10, 1993).
    Section 904(b)(2) of the PHS Act (42 U.S.C. 299a-2(b)(2)) provides 
that in carrying out health care technology assessments, the 
Administrator, AHCPR shall consider the safety, efficacy and 
effectiveness, and as appropriate, the legal, social, and ethical 
implications and appropriate uses of health care technologies, 
including geographic factors. Public Law 102-410 added as a requirement 
that the Administrator also consider the cost-effectiveness of 
technologies where cost information is available and reliable. Prior to 
the enactment of Public Law 102-410, consideration of the cost-
effectiveness of a technology was optional.
    Section 904(e), as amended by Public Law 102-410, requires that the 
Administrator develop and publish a description of the methodology used 
to establish priorities for health technology assessments and a 
description of the process used to conduct the assessments. The 
``Process for Health Care Technology Assessments and Recommendations 
for Coverage'' was published, with invitation for comments, in the 
Federal Register on December 3, 1993 (58 FR 63988).
    This notice provides the proposed methodology, consisting of 
criteria and numerical weights, that will be used in setting priorities 
for assessments to be conducted by AHCPR. Special consideration in 
setting priorities may be given to requests for assessments from 
federally financed health programs to assist them in making coverage 
decisions.
    Written comments on the proposed methodology are invited. The AHCPR 
will not respond to individual comments, but will consider all comments 
received in determining the final methodology. Once adopted the final 
methodology will be published in the Federal Register. Comments, in 
writing, should be submitted by [Insert 45 days from publication date 
of this notice] to: Linda K. Demlo, Ph.D., Director, Office of Program 
Development, Suite 603; 2101 East Jefferson Street; Rockville, Maryland 
20857. 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.
    The AHCPR, through the Office of Health Technology Assessment 
(OHTA), conducts assessments of health care technologies on behalf of 
the Public Health Service. Technology assessments, at the request of 
federally financed health programs, have been conducted and the results 
published since 1981. However, Title IX of the PHS Act does not limit 
AHCPR's authority for the conduct of technology assessments to only 
those requested by federally financed health programs. In 1990, AHCPR 
contracted with the Institute of Medicine (IOM) to study how topics for 
technology assessments could be prioritized. The IOM published a 
monograph in 1992, which outlines a procedure for establishing such 
priorities entitled ``Setting Priorities for Health Technology 
Assessment: A Model Process.''
    Section 904 of the PHS Act (42 U.S.C. 299a-2(d)(4)), as amended by 
Public Law 102-410 in October 1992, states that the criteria to be used 
in determining priorities shall include:
    1. The prevalence of the health condition which the technology aims 
to prevent, diagnose, treat, and clinically manage;
    2. Variations in current practice;
    3. The economic burden posed by the prevention, diagnosis, 
treatment, and clinical management of the health condition, including 
the impact on publicly-funded programs;
    4. Aggregate cost of the use of the technology;
    5. The morbidity and mortality associated with the health 
condition; and
    6. The potential of an assessment to improve health outcomes or 
affect costs associated with the prevention, diagnosis, or treatment of 
the condition.
    Subsequent to the enactment of Public Law 102-410, OHTA presented 
to AHCPR's Advisory Council a plan for determining priorities, based on 
the IOM report and the statutory criteria, which called for the 
following steps:
    1. Proposal of criteria for setting priorities and assignment of 
weights to each criterion;
    2. Solicitation of potential technologies for assessment or 
reassessment, dependent upon AHCPR resources (This solicitation would 
be published as a separate notice);
    3. Compilation of criterion scores for each technology under 
consideration; that is, quantitative data are gathered for each 
criterion, based on information in the published literature or 
elsewhere in the public record (for example, data compiled by health 
specialties organizations);
    4. Calculation of a priority score for each potential technology, 
by adding the products of each criterion weight and the natural 
logarithm of the associated criterion score; and
    5. Ranking of all technologies based on the priority scores.
    The Council agreed with this plan, and established a Technology 
Assessment Task Force to aid the process. In August, 1993, AHCPR 
announced in the Federal Register that there was to be a public meeting 
for the Task Force to solicit comments and recommendations on criteria 
for setting priorities for technology assessments. The meeting was held 
on September 22, 1993, and was attended by representatives of 
professional societies, private payors and managed care associations, 
medical device and pharmaceutical manufacturers, and other interested 
parties. Oral and written statements were received, representing a 
broad range of views and interests. There was extensive discussion 
about ranking the statutory criteria in order of importance and 
assigning a numerical weight to each criterion. This approach followed 
the ``Model Process'' in the IOM study. The AHCPR was also encouraged 
to provide uniform definitions or explanations for the criteria. 
Additional criteria suggested were: social, ethical, and legal 
considerations and the availability of sufficient data on which to base 
an assessment.
    The Task Force took into consideration the comments and 
recommendations received at the public meeting and presented 
recommendations to the Council, which in turn accepted the numerical 
weights and ranking of the criteria. The AHCPR is, therefore, proposing 
the following rank order and numerical weighting of criteria to be used 
in determining priorities for the conduct of assessments.
    1. ``The potential of an assessment to improve health outcomes or 
affect costs * * *'' is defined as the expected effects of an 
assessment upon the outcomes of a patient with the clinical condition 
in question, or on the cost of that clinical condition. For example, 
the assessment of autologous bone marrow transplantation indicated that 
procedure improved survival in patients with relapsed lymphoma. The 
mean weight proposed for this criterion is 4.8 on a scale of 1.0-5.0, 
where 1.0 is the least important and 5.0 is the most important.
    2. ``The morbidity and mortality associated with the health 
condition * * *'' is defined by equating morbidity to severity of 
illness, and mortality to death. For example, breast cancer would be 
assigned a greater criterion score than would low back pain. The 
proposed mean weight assigned to this criterion is 3.5.
    3. ``Variations in current practice * * *'' is defined as the 
variability in clinicians' use of preventive, diagnostic or therapeutic 
endeavors. For example, rates of carotid endarterectomy have been found 
to vary widely and inexplicably across regions and States. The proposed 
mean assigned weight is 2.8.
    4. ``The economic burden posed by the prevention, diagnosis, 
treatment and clinical management of the health condition * * *'' is 
defined as the total direct and induced cost per case per year of 
management of a clinical condition, such as stage II breast cancer. The 
proposed mean assigned weight is 2.7.
    5. ``Aggregate cost of the use of the technology * * *'' is defined 
as the total direct and induced cost of the technology in question; for 
example, the cost of prostate specific antigen screening in males over 
50 years of age, including cost of the test itself and the required 
followup such as transrectal ultrasound studies and transrectal needle 
biopsies. The proposed mean assigned weight is 2.7.
    6. ``The prevalence of the health condition * * *'' is defined as 
the number of persons with the clinical condition per 1,000 persons in 
the general U.S. population. The proposed mean assigned weight is 2.6.
    7. ``The ability of the assessment to inform ethical, social or 
legal issues'' is defined as the potential that the assessment has for 
influencing such matters. For example, AHCPR's 1990 assessment of liver 
transplantation demonstrated that one year survival rates following 
retransplant were significantly lower than for primary transplant. This 
information could have a bearing upon public concerns about the ethics 
of providing additional liver transplants to some patients, and thereby 
effectively denying first transplants to others on the waiting list. 
The proposed mean weight assigned is 1.8.
    The AHCPR is not including as a criterion the availability of 
sufficient data. The AHCPR agrees with the IOM that data will always be 
inadequate in some sense, and the presence or absence of information 
does not affect whether, but how a technology assessment should be 
done; for example, a full assessment or a more limited technology 
review.
    The AHCPR will use this proposed methodology for establishing 
priorities for conducting assessments pending receipt of comments and 
adoption of a final methodology. For further information on the 
assessment process contact: Thomas V. Holohan, M.D., Director,Office of 
Health Technology Assessment, Agency for Health Care Policy and 
Research, 6000 Executive Boulevard, suite 309, Rockville, MD 20852, 
Phone: (301) 594-4023.

    Dated: April 19, 1994.
J. Jarrett Clinton,
Administrator .
[FR Doc. 94-9949 Filed 4-22-94; 8:45 am]
BILLING CODE 4160-90-P