[Federal Register Volume 67, Number 64 (Wednesday, April 3, 2002)]
[Notices]
[Pages 15812-15814]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-8067]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Agency for Healthcare Research and Quality, HHS.

ACTION: Notice.

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SUMMARY: This notice announces the intention of the Agency for 
Healthcare Research and Quality (AHRQ) to request the Office of 
Management and Budget (OMB) to allow the proposed information 
collection project: ``Enrollee Survey of Relationship Between Out-of-
Pocket Costs and Use of Prescribed Medications''. In accordance with 
the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 
3506(c)(2)(A)), AHRQ invites the public to comment on this proposed 
information collection.

DATES: Comments on this notice must be received by June 3, 2002.

ADDRESSES: Written comments should be submitted to: Cynthia D. 
McMichael, Reports Clearance Officer, AHRQ, 2101 East Jefferson Street, 
Suite 500, Rockville, MD 20852-4908.
    Copies of the proposed collection plans, data collection 
instruments, and specific details on the estimated burden can be 
obtained from the AHRQ Reports Clearance Officer.

FOR FURTHER INFORMATION CONTACT: Cynthia D. McMichael, AHRQ Reports 
Clearance Officer, (301) 594-3132.

SUPPLEMENTARY INFORMATION:

Proposed Project

``Enrollee Survey of Relationship Between Out-of-Pocket Costs and Use 
of Prescribed Medications''

    The project is being conducted in response to an AHRQ task order 
entitled ``Patient Safety and the Quality of Care: An Examination of 
Economic and Structural Characteristics, Working Conditions, and 
Technological Advances'' (issued under Contract 290-00-0012: 
Accelerating the Cycle of Research through a Network of Integrated 
Delivery Systems with the Center for Health Care Policy and Evaluation, 
UnitedHealth Group, Minnetonka, MN).
    Past research suggests that increases in out-of-pocket costs are 
associated with decreased medication use in the elderly who have a drug 
benefit. Furthermore, reductions in medication use have been associated 
with increases in visits to physicians' offices and emergency 
departments and admissions to hospitals and long-term care facilities.
    When Medicare beneficiaries alter their use of prescription 
medications in

[[Page 15813]]

response to their out-of-pocket costs, patient safety and quality of 
care may be compromised.
    As suggested by OMB, we have been in communication with the Center 
for Medicare & Medicaid Services (CMS) (contact: Frank Eppic, Deputy 
Director, Information and Methods Group, ORDI, tel: 410-786-7950 or 
[email protected]) regarding the availability of data on this topic, 
particularly CMS's Medicare Current Beneficiary Survey (MCBS). 
Examination of raw response frequencies on the 1999 MCBS survey 
indicate that fewer than 2% (319/16670 total respondents) cite costs or 
lack of coverage as primary reasons for not getting a prescription 
filled. This small percentage seems to be inconsistent with other 
reports on the inadequacy of drug benefits for the elderly. However, 
the MCBS does not inquire whether Medicare beneficiaries get 
prescriptions filled, but take less medication than prescribed because 
of out-of-pocket costs or caps on drug benefits. In addition, the 
amount of drug coverage is not ascertained. Since data to determine the 
prevalence of cost-related reductions in medication use under different 
drug benefits and subsequent worsening health or increased use of 
health care services are sparse, additional research on this important 
issue is warranted.
    The proposed study will utilize the Center for Health Care Policy 
and Evaluation's administrative database that includes several 
Medicare+Choice health plans that have provided a limited drug benefit 
in 2002. Data collected by survey will determine how often out-of-
pocket costs or caps incurred under the available drug benefit caused 
Medicare beneficiaries to alter their use of prescription medicines 
including not getting a prescription filled or refilled or taking 
reduced doses. These are the dependent variables for the study.
    Survey data will be used to identify medications that have not been 
taken or reduced and alternatives that have been used to make judgments 
about the potential clinical consequences of any changes in medication-
taking behavior. In addition, respondents' perceptions of the effects 
of any changes in medication use on their health status and utilization 
of other services (physician visits, emergency department visits and 
hospital admissions) will be ascertained. Several potential correlates 
will be assessed as well, most of which are based on previous studies 
of medication use in the elderly population. Other key variables will 
be extracted from administrative (enrollment and claims) data including 
age, gender, identity of the health plan, duration of enrollment, 
number of prescription claims, types of medications, prescription 
copayments, number of physician visits and hospital admissions during 
the period prior to the survey.

Data Confidentiality Provisions

    Assurances of confidentiality will be given to participants within 
the informed consent form that each person will sign prior to 
participation (See Appendix 1). These assurances explain the 
applicability of AHRQ's confidentiality statute, 42 U.S.C. 299c-3(c). 
(See Appendix 2). The consent form will be reviewed, modified if 
requested and approved by an Institutional Review Board and sent to 
survey recipients along with the survey (see Appendix 3). the Center 
for Health Care Policy and Evaluation has an extensive security program 
in place to safeguard the privacy and confidentiality of data. This 
multi-tiered program, comprised of both policies and specific 
procedures, promotes compliance with all legal and regulatory 
requirements for privacy protection of individually identifiable health 
information. Building and office access cards and computer 
identification codes and passwords are in operation.
    Encryption and authentication are utilized where control over 
sensitive information is required including file transfers (e.g., (FTP) 
and data processing applications. Automated monitoring (network and 
platform intrusion detection) and system firewalls are established for 
all major network interface points.
    Additional confidentiality procedures include: (1) Written 
agreements with a subcontractor hired to administer the questionnaire; 
(2) use of key-code processes and encryption to protect individual 
identity of data records in the Center for Health Care Policy and 
Evaluation's administrative database; (3) use of study-specific keys 
for data transmission and linkage of sample information and survey 
data; (4 efforts to ensure that the least sensitive level of data 
possible is used or transmitted in the conduct of research; (5) 
destruction of data files after completion of the research project, 
approximately one year after the final report is filed under the task 
order or one year after the final report is filed under the tasks order 
or one year after a journal article is published based upon the final 
report, whichever is later (to allow access to assist other scientists 
seeking to validate or replicate results); and (6) written policies and 
procedures and training of employees in regards to protection of human 
subjects and data confidentiality.

Data Products

    Data will be produced in the following forms:
    1. A file will be developed comprising the sample from the Center 
for Health Care Policy and Evaluation's database of enrollment and 
claims to be used to collect the survey data. The sample file will 
contain an investigator-assigned, study specific case identity code 
that will allow the survey results file to be linked back to the 
administrative data.
    2. A second file will include information on the final disposition 
of all cases and survey responses along with variables derived from 
administrative data. This file will be analyzed to generate research 
reports. The proportion (probability) that an individual in the study 
population altered his/her prescription mediation-taking behavior 
because of out-of-pocket costs or limits on drug benefits will be 
estimated with 95% confidence intervals. The probabilities of altered 
medication use secondary to out-of-pocket costs or caps on drug 
benefits will be analyzed separately. Since the sampling design 
provides equal probabilities of selection without cluster techniques, 
design effects do not need to be taken into consideration during 
estimation of the probabilities and confidence intervals (variance). 
The finite population correction factor should also be negligible. 
Missing data on partially completed surveys will be imputed. Estimates 
and tests of potential explanatory variables will be generated by two-
step regression models in an effort to control non-response bias.
    The data are intended to be used for purposes such as:
    1. Providing information about the extent and correlates of reduced 
prescription drug use to help define the circumstances when out-of-
pocket costs might become a quality/safety issue.
    2. Helping to inform policymakers about how current drug benefits 
being provided by Medicare+Choice plans affect patients' quality of 
care.
    3. Informing the design of drug benefits for Medicare beneficiaries 
that foster quality care by considering financial barriers to effective 
use of pharmaceuticals.

Method of Collection

    The population to be studied consists of individuals enrolled in 
the Center for Health Care Policy and Evaluation's UnitedHealthcare 
Medicare+Choice health plans that provide a drug benefit in 2002, from 
which a sample will be drawn and surveyed. The Center for

[[Page 15814]]

Health Care Policy & Evaluation maintains a database comprised of 
enrollment and claims data generated by these health plans. Actual 2002 
enrollment will be used for sampling. None of drug benefits being 
studied require a deductible and all will use the same formulary or 
preferred drug list.
    Investigators will use the enrollment and claims database to define 
the sampling frame for the study. Pharmacy claims will not be used for 
sample selection because they would be missing if enrollees do not get 
prescriptions filled, and selecting people because they had a pharmacy 
claim could bias estimates of cost-altered medication use. Since 
medication use and out-of-pocket prescription costs are related to the 
presence of chronic conditions, selection of enrollees will be based on 
diagnoses listed in the administrative data. The focus will be on 
medical conditions that are common in the elderly population for which 
medications are often prescribed including hypertension, hyperlipidemia 
(high cholesterol), coronary artery disease, congestive heart failure, 
diabetes, arthritis, glaucoma and gastrointestinal ulcers. The presence 
of one or more of these diagnoses on claims from physician visits or 
hospital admissions that occur in the first quarter of 2002 will be 
used to create a sampling frame. This will help assure that sampled 
enrollees have recently seen a physician who has acknowledged the 
presence of the condition and a high likelihood of having been 
prescribed medication.
    Eligible health plan members must also be enrolled during the 
entire first quarter of 2002 to facilitate collection of administrative 
variables for the analysis.
    The sample of eligible enrollees will be stratified by health plan 
and a simple random sample will be selected from each health plan using 
a proportionate (uniform) sampling fraction. Missing sampling frame 
elements are not expected to be a problem, and anyone excluded from the 
sampling frame because of missing diagnoses due to claims lags will be 
considered missing at random because physician and hospital claim lags 
should be totally independent of cost-related changes in medication-
taking behavior.
    The sample file will contain an investigator-assigned, study 
specific case identity code that will allow the survey results file to 
be linked back to the administrative data. Checks for changes in 
address will be made and survey packets prepared. A cover letter from 
the investigators will invite Medicare beneficiaries enrolled in 
UnitedHealthcare Medicare+Choice health plans to participate in the 
study, and a written consent form approved by a duly constituted 
Institutional Review Board will be sent along with the survey 
questionnaire. Two mailings with a postcare reminder sent in the 
interim period and follow-up calls to non-responders after the second 
survey mailing are planned to obtain a response rate similar to the 
Medicare Consumers Assessment of Health Plans Survey response rate of 
75% to 82%. Respondents will not receive any gifts or payments as 
incentives to respond.

Estimated Annual Respondent Burden

    This is a one-time survey with 24 multiple choice questions, plus 
one question that asks respondents to name any medication(s) they did 
not use as prescribed because of cost, plus one question that asks 
respondents to name the medication(s), if any, that they used as 
alternative(s) to the medication(s) that cost too much. The survey will 
be conducted in 2002.

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                                                           Estimated time
             Survey year                  Number of      per respondent in   Estimated total   Estimated cost to
                                         respondents           hours           burden hours     the  government
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2002................................              1,125                .25                281            $35,000
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Request for Comments

    In accordance with the above cited legislation, comments on the 
AHRQ information collection proposal are requested with regard to any 
of the following: (a) Whether the proposed collection of information is 
necessary for the proper performance of functions of the Agency, 
including whether the information will have practical utility; (b) the 
accuracy of the Agency's estimate of the burden (including hours and 
costs) of the proposed collection of information; (c) ways to enhance 
the quality, utility, and clarity of the information to be collected; 
and (d) ways to minimize the burden of the collection of information on 
respondents, including the use of automated collection techniques or 
other forms of information technology.
    Comments submitted in response to this notice will be summarized 
and included in the request for OMB approval of the proposed 
information collection. All comments will become a matter of public 
record.

    Dated: March 26, 2002.
Carolyn M. Clancy,
Acting Director.
[FR Doc. 02-8067 Filed 4-2-02; 8:45 am]
BILLING CODE 4160-90-M