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Medicare Drug Program News
Medicare Proposes Making Part D Data Available to
Seek Better Care
Drug claims would join other Medicare data in use
by researchers
October 17, 2006 There is no greater volume of
medical information than the records of treatment for senior citizens
participating in Medicare. The Centers for Medicare & Medicaid Services
has made much of it available for researchers and quality initiatives to
pinpoint opportunities to improve health care for seniors and persons
with disabilities. Now, CMS has proposed adding Medicare Part D (drug
program) claims data to the records available.
CMS, as required, is seeking public input.
Medicare drug claims would be linked to other
Medicare information on patient care such as hospitalizations and
physician visits, and made available to researchers and Federal agencies
for studies only with appropriate privacy protections and safeguards, as
required by the Privacy Act and HIPAA regulations, the agency says.
We have seen great improvements in the quality of
health care based on identifying opportunities for better care based on
Medicare information, CMS Administrator Mark B. McClellan, M.D., Ph.D.,
said on Friday. Through the appropriate use of the new prescription
drug claims data, we have an unprecedented resource to help us learn
more about prescription drug usage by seniors and how we can help
seniors get the most benefit from prescription drugs.
Last Friday, which was McClellan's last day as
administrator, CMS issued a proposed regulation that will allow the
Department of Health and Human Services and CMS to use Part D claims
data to:
● Report on and evaluate the impact of drug use
in the Medicare prescription drug program, including the interaction
between prescription drug coverage and the services and utilization
under traditional Medicare (Parts A & B) and the Medicare Advantage
Program (Part C); and
● Conduct demonstration projects to evaluate the
impact of drug coverage and make recommendations for improving the
economy, efficiency, or effectiveness of the Medicare program.
The proposed regulation continues the approach of
using Medicare data through data use agreements with individual
institutions to assess health care for beneficiaries. Medicare data has
been used in prior studies to evaluate rates of Medicare spending and
spending growth, to assess the impact of drugs and procedures on health
outcomes, and to identify the extent to which practice parallels
evidence based standards.
Under the proposed rule, other federal agencies and
researchers would be able to use the prescription drug data under the
same safeguards that exist today for other Medicare data. These include
obtaining only the minimum data needed to complete the study, not
releasing beneficiary and provider identifiers unless absolutely
necessary for the study, and where identifiers are disclosed, ensuring
strict privacy protections are in place.
The public is invited to comment on the most
effective use of the data, including whether CMS should consider
additional regulatory limitations for external researchers in order to
further guard against the potential misuse of data for non-research
commercial purposes, to assure that priority questions are addressed as
quickly and effectively as possible, or to ensure that proprietary plan
data or confidential beneficiary data are not released.
The proposed rule would provide for the use the
claims information that is now being collected for Part D payment
purposes for other research, analysis, reporting, and public health
functions, including, for example:
● Obtaining more accurate, complete, and timely
information on potentially serious side effects associated with the use
of prescription drugs in certain clinical circumstances, such as where
Food and Drug Administration (FDA) or other experts have identified a
potential safety concern;
● Determining the potential for cost savings in
chronic disease management as a result of more effective adherence to
recommended prescription drug therapies;
● Identifying groups of beneficiaries who are not
receiving evidence-based recommended drug therapies, and ascertaining
effective strategies to increase adherence to recommended treatments, to
assist in reducing health disparities and improving care for all
beneficiaries.
Under the proposed rule, the FDA, the National
Institutes of Health, the Agency for Healthcare Research and Quality,
and academic researchers would have access to the data to address these
and other important public health-related questions.
The proposed rule will appear in the Oct. 17, 2006
Federal Register. Comments will be accepted on the proposed rule until
December 18th, 2006.
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