Healthcare Leadership Council & NPC Submit Comments to CMS on Access to Part D Data

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March 7, 2014

The Honorable Marilyn Tavenner, Administrator
Centers for Medicare & Medicaid Services
U.S. Department of Health and Human Services
Attention: CMS-4159-P, P.O. Box 8013,
Baltimore, MD 21244-8013

Dear Administrator Tavenner:

We write in response to the Proposed Rule of January 10, 2014 (CMS-4159-P) – specifically in regard to the request for comment on the proposal to expand access to Part D Data.  We applaud CMS for soliciting comments on this important topic.  Expanding access to health data is a necessary component of CMS’s mission of “strengthening and modernizing the nation’s health care system to provide access to high quality care and improved health at lower cost.”[1]

The Healthcare Leadership Council (HLC), a coalition of chief executives from all disciplines within American healthcare, is the exclusive forum for the nation’s healthcare leaders to jointly develop policies, plans, and programs to achieve their vision of a 21st century system that makes affordable, high-quality care accessible to all Americans.  HLC members advocate measures to increase the cost-effectiveness of American healthcare by emphasizing wellness and prevention, care coordination, and the use of evidence-based medicine, while utilizing consumer choice and competition to elevate value.  HLC works to provide access to health coverage for the uninsured, accelerate the growth of health information technology, reform healthcare payment systems, promote quality improvement, advance patient safety, address workforce challenges, reform medical liability, and improve care through patient information sharing while also protecting patient confidentiality.

The National Pharmaceutical Council (NPC) is a health policy research organization dedicated to the advancement of good evidence and science, and to fostering an environment in the United States that supports medical innovation.  Founded in 1953 and supported by the nation’s major research-based biopharmaceutical companies, NPC focuses on research development, information dissemination, education and communication of the critical issues of evidence, innovation and the value of medicines for patients.  Our research helps inform critical healthcare policy debates and supports the achievement of the best patient outcomes in the most efficient way possible.

CMS invites comments on whether its current ban on access to Part D Drug Event data for commercial purposes should be revised to allow access for research with a commercial purpose.  Currently, access to Research Identifiable Files (RIFs), which include the Medicare Part D data, is not allowed under a variety of situations—either because the research could have commercial implications, or the researcher is associated with a commercial enterprise. 

We support continued examination of data access policies by CMS and believe it is appropriate to continue restriction of commercially and financially sensitive data.  With that understanding, we would like to expand the discussion of appropriate access to Prescription Drug Event (PDE) data by entities with commercial interests to the broader, long-standing HHS policy that denies access by commercial entities to federal Medicare A, B, D, Medicaid, and possibly other program datasets.  For reasons discussed below, we believe it is time to re-consider this overarching policy that affects access to federal program RIFs in Medicare, including Part D, and in other federal health programs.

In Our Changing Healthcare System, When Should Data Access Be Prohibited?

CMS has been at the forefront of moving the US healthcare system to the next level—to a system that values and rewards quality, good health outcomes, effectiveness, and efficiency.  We strongly support those goals.

In order to achieve our shared goal of a high performing, value- and evidence-based healthcare system, greater alignment of stakeholder incentives is required.  Alignment means that all stakeholders are rewarded for new and different behaviors focused on quality not quantity.  CMS is keenly aware of this pivotal requirement for success.  Indeed, the challenge of quantifying greater efficiency and evidence of improvement as part of overall health reform requires more access to federal data.   

Consider these scenarios involving data access, health system improvement for patients, and commercial interest: 

  • A multi-specialty provider group that uses Medicare Protected Health Information (PHI) beyond their patient base to determine more effective ways to case manage high-risk patients resulting in better patient outcomes as well as savings to the Medicare program, beneficiaries, and providers under a bundled payment or Accountable Care Organization-type arrangement.
  • A hospital that uses data to identify high-risk patients and discern the key factors that reduce re-admission rates and thus reduce their financial penalties while improving quality of patient care. 
  • A pharmaceutical company that uses data to look for factors that improve medication treatment adherence to improve health.
  • A diagnostic company that uses predictors of patient response to existing treatments and therefore identifies a diagnostic test to better stratify patient populations who are likely to respond.
  • A device company that uses data to identify types of patients who are not optimally managed with medical care and develops a patient decision-aid to help patients and their providers determine which treatment (including a device) is needed.
  • A consumer group that uses data to determine which wellness programs work best for whom so that individuals or groups of individuals can maximize their financial rewards under various wellness programs.

In addition to producing better patient outcomes, each of these scenarios also could produce clear benefit to the particular stakeholder.  Each of these scenarios, if successful, will benefit the healthcare system overall as the results are published and as best practice diffuses through a competitive system.  There are commercial interests as well as positive developments for patients and potentially the Medicare Trust Funds.  In an aligned, high functioning healthcare system, everyone should be able to benefit financially from effective use of data to improve quality and efficiency in the healthcare system.  We know that CMS shares these goals, and has sought to encourage data access specifically for research that will benefit CMS in its effort to monitor, manage, and improve the Medicare and Medicaid programs or the services provided to beneficiaries.  We believe that broadening this interpretation will create further benefit to both CMS programs and patients by dramatically increasing the bandwidth for research leading to increased care quality, system efficiency, and consumer satisfaction.

Financial benefit and profit status of the organization should not overlay the criteria by which a research proposal is evaluated.  The standard should be: Is the research proposed high quality and does the research have the potential to improve program administration or the health of the covered population?

CMS Interpretation of “Commercial Interest”

There is standing Department policy that prohibits the sharing of certain federal program data with entities that have a commercial interest.  Entities with commercial interest can access public use files and limited dataset files.  However, direct access to Research Identifiable Files (which includes the Part D Prescription Drug Event data) is generally prohibited for these entities.  Entities that are presumed or determined to have a commercial interest are denied access to RIFs that contain person-level, protected health information (PHI).  This policy is referenced in different department documents, including the proposed rule. 

We applaud CMS for reopening discussion of this important distinction in the proposed rule.  In our rapidly evolving healthcare sector, the way in which data are being used has changed dramatically.  Patient level information is needed to achieve the very care transformation CMS seeks.  The lines are blurred with respect to which types of entities have commercial interest – commercial purposes could encompass much more than just a product or tool.  Because the quality and efficiency of all physician groups, health plans, hospital systems and suppliers can be enhanced using data, any notion that commercial interest is limited and discrete is outdated. 

Within organizations currently excluded, there is deep scientific and analytic expertise which enables a broader understanding and knowledge of public health issues across the entire healthcare ecosystem.  Ultimately, any standard that essentially bars access to important data is detrimental to the larger goals of our healthcare system and our common goals for the evolution of that system. 

Does the CMS Ban Affect New Data Infrastructure and Multi-Payor Datasets?

The current CMS policy gives rise to another important issue or question.  When CMS data is included in the Food and Drug Administration Sentinel system, the Patient-Centered Outcomes Research Institute Clinical Data Research Networks, and other multi-payor, multi-source data networks, does the CMS prohibition persist?  Will entities that CMS deems to have a commercial interest be prohibited from accessing these large, innovative sources that seek to improve infrastructure and patient health?  If a commercial entity is contributing data to one of these databases, would that entity not be permitted to access these multi-source data files?

CMS Access Criteria Should Apply to All Research Requests, Without Regard to Profit Status or Commercial Interest.

All researchers should be subject to the same rules of data access for PHI Medicare data.  The criteria[2] for access are currently: 

  • Strong research design
  • Research question must assist CMS in managing programs/improving services[3]
  • Researcher must have expertise and experience
  • Researcher must sign a Data Use Agreement generally concerning handling and use of the data
  • Researcher will not disclose research findings if such findings can be linked with other data where an individual’s identity can be deduced
  • Researcher will adhere to CMS cell size policy

There are a host of important public policy considerations that should lead to a revision in how CMS and HHS view access to RIF by a broad range of researcher requestors.  The goal is a high-functioning, efficient, quality healthcare system.  It will take all stakeholders in that system to reach that very important goal within the foreseeable future.

Conclusion

We applaud CMS for requesting public comments on this important topic, however, we urge you to expand your examination of data access beyond just the Medicare Part D program.  Patient-level data held by federal agencies is key in allowing stakeholders to improve quality and create efficiencies needed to meet ambitious health goals in the coming years.  CMS facilitation of greater data access would be a positive development that aligns with federal policy goals.  The question of access and commercial interest is larger, more important, and more urgent than CMS has considered thus far.

We would be pleased to meet to discuss these issues.  Please contact Tina Olson Grande, Senior Vice President for Policy at the Healthcare Leadership Council ([email protected]), or Robert Dubois, MD, PhD, Chief Science Officer at the National Pharmaceutical Council ([email protected]), for further information.

Sincerely,                                               

Tina Olson Grande
Senior Vice President for Policy
Healthcare Leadership Council                                

Robert W. Dubois, MD, PhD
Chief Science Officer
National Pharmaceutical Council

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[1] CMS Strategy: The Road Forward 2013-2017.  Accessed  2/27/14 from cms.gov

[2] For the complete list of criteria, see CMS information for researchers.  Accessed 2/7/2014.  http://www.cms.gov/Research-Statistics-Data-and-Systems/Computer-Data-and-Systems/Privacy/Researchers.html

[3] In other places on the CMS website, it states that research proposals are evaluated on the potential of the research to improve the quality of life of Medicare beneficiaries in addition to improving services or program administration.