[Federal Register Volume 67, Number 110 (Friday, June 7, 2002)]
[Notices]
[Pages 39400-39402]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-14382]


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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.
    The proposed information collection was previously published in the 
Federal Register on April 3, 2002 and allowed 60 Days for public 
comment. No public comments were received. The purpose of this notice 
is to allow an additional 30 Days for public comment.

DATES: Comments on this notice must be received by July 8, 2002.

ADDRESSES: Written comments should be submitted to: OMB Desk Officer at 
the following address: Allison Eydt, Human Resources and Housing 
Branch, Office of Information and Regulatory Affairs, OMB: New 
Executive Office Building, Room 10235; Washington, DC 20503.
    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 be a matter of public record.

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 by the elderly patients 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 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

[[Page 39401]]

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 judgements 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 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 co-
payments, 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 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 medication-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 variable 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 
prescriptions 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 sample will be drawn and surveyed.
    The Center for 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

[[Page 39402]]

random sample will be selected from each health plan using a 
proportionate (uniform) sampling fraction.
    Mission 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 postcard 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                    Estimated cost
                 Survey year                     Number of      per respondent  Estiamted total       to the
                                                respondents        in hours       burden hours      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: May 15, 2002.
Carolyn M. Clancy,
Acting Director.
[FR Doc. 02-14382 Filed 6-6-02; 8:45 am]
BILLING CODE 4160-90-M