Plan to Increase Data Availability Raises Patient-Privacy Concerns

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 care.”

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.

Aid in 'Value-Based Purchasing'

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 physician's practice.”

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.

Rule Threatens Patient Privacy

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 patients.

“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.

The proposed rule is posted at<www.access.gpo.gov/su_docs/fedreg/a061018c.html>. APA's comments are posted at<www.psych.org/members/download.cfm?file=1438>.▪