[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
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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