APA is protesting a proposed rule by the Centers for Medicare and Medicaid
Services (CMS) that would allow the government to use claims information now
being collected for payment purposes in the Medicare prescription drug program
for other research, analysis, reporting, and public health functions.
In comments submitted to CMS last month, APA said the broadly expanded use
of Part D claims data is prohibited by existing provisions in the Social
Security Act (under which the Medicare program was enacted). And APA maintains
that such expanded use could violate patient privacy and pressure physicians
to change their prescribing patterns.
The proposed rule, published in the Federal Register on October
18, 2006, outlines several purposes for which claims data might be used.
Broadly, these include evaluating the effectiveness of the prescription-drug
benefit and its impact on health outcomes, performing congressionally mandated
or other demonstration projects and studies, reporting to Congress and the
public regarding expenditures and other statistics involving the Part D drug
benefit, studying and reporting on the Medicare program as a whole, and
creating a research database for the evaluation of utilization and outcomes
associated with the use of prescription drugs.
In the rule, CMS states that it intends to develop a "chronic-care
warehouse" (CCW) of information to be made available to researchers who
want to study chronic illnesses in the Medicare population—an initiative
CMS says is in keeping with a congressional mandate under the Medicare
Modernization Act to develop recommendations for improving the quality of care
for chronically ill Medicare beneficiaries.
"The absence of drug data is a significant gap in data available to
study chronically ill Medicare beneficiaries," according to CMS."
Integrating Part D enrollment information and drug claims data into the
CCW will address this data need and greatly enhance the analytic power and
utility of the [warehouse]."
The proposed rule also states that CMS would share the claims information
with other government agencies—including the National Institutes of
Health, Food and Drug Administration, and Agency for Healthcare Research and
Quality— for public-health studies. "These studies will assess
outcomes and investigate clinical effectiveness [and] appropriateness of
health care items and services (including prescription drugs), and develop
strategies for improving the efficiency and effectiveness of clinical
In addition, oversight agencies such as the Office of the Inspector
General, General Accountability Office, and Congressional Budget Office"
require access to data in order to evaluate the cost-effectiveness of
various policies under the Part D program, to evaluate spending for various
classes of drugs under such program, to analyze brand-name versus generic
prescribing trends, and to conduct other oversight activities that are not
specifically related to payment," according to the proposed rule.
Finally, CMS says claims data will be important in developing"
value-based purchasing" programs, such as the Bush
administration's controversial "pay-for-performance" project.
"As Medicare moves toward value-based purchasing, it will be critical
to design a payment system that provides incentives for physicians to
appropriately prescribe proven pharmacologic therapies," according to
CMS. "This will require individual Part D claims linkable to a
But APA is objecting to the proposed rule, saying that it seeks to create
authority under one provision of the Social Security Act—a provision
governing collection of data from prescription drug plans for the purposes of
paying claims—that is prohibited by other provisions.
"APA does not find a supportable legal base for cms to create
regulations under the authority of one statutory provision that are designed
expressly to circumvent another statutory provision," wrote APA Medical
Director James H. Scully Jr., M.D., in a letter sent last month to Acting CMS
Administrator Leslie Norwalk. "The goal of the proposed rule is to
broadly expand the access and use of Part D prescription data. If implemented
this rule would launch Part D data into spheres that have been intentionally
precluded from such access and use through federal statute. This sweeping
approach is contrary to sound public policy.
Scully continued, "The negative ramifications for expanding data
availability include increased risk of patient-privacy violations and use of
the data to pressure physicians to alter prescribing patterns and to request
or pressure patients to accept certain drugs."
Irvin "Sam" Muszynski, J.D., director of APA's Office of
Healthcare Systems and Financing, told Psychiatric News that there
are legitimate public health benefits to be derived from judicious sharing of
Part D data with other agencies and carefully chosen entities. But he said the
Bush administration needs to reconsider whether the proposal is the best
method for achieving the desired goals while also protecting doctors and
"The important questions are whether this proposed rule provides
sufficient protection of patient confidentiality, whether it guards against
the data being used to punish doctors, and whether claims data are really
capable of answering the comparative effectiveness questions these agencies
are charged with evaluating," Muszynski said.