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House Subcommittee Explores Obstacles to Treatment Evidence Development and Communication

July 25, 2014— The House Energy and Commerce Subcommittee on Health July 22 held a hearing focused on the obstacles to developing evidence and communicating information regarding treatments.  The hearing was the sixth as part of the subcommittee’s 21st Century Cures initiative.

Health Subcommittee Chair Joseph Pitts (R-Pa.) opened the hearing by noting, “Discovery of the risks and benefits of a drug or treatment does not end with FDA approval or clearance…. Treatment in the real world also brings out additional information on safety and efficacy, and ensuring that this knowledge is shared widely among providers, patients, and researchers is critical.”

Chairman Pitts went on to say, “Unfortunately, many of the witnesses and participants we have had before us since the Cures initiative began have raised concerns regarding barriers to communication and evidence development…. [E]fforts to limit off-label use among the provider community, limitations on communication found under HIPAA, and the Physician Sunshine Act are just a few of the barriers to 21st Century Cures that have been raised with us over the past few months.”

Josh Rising, M.D., M.P.H., director, Medical Devices, The Pew Charitable Trusts, told the subcommittee that new approaches such as registries to harness data from electronic health records are needed to decrease the length and cost of clinical trials.  He added that we must have the tools necessary to identify problems with approved drugs and medical devices quickly and efficiently and to assess their performance in real world settings. He urged Congress to work with the administration to maximize the potential of new mechanisms to collect data prior to and after FDA approval.

Michael A. Mussallem, chairman and CEO, Edwards Lifesciences, testified that he is worried that innovation in the U.S. is “suffering from [an] increasingly costly and cumbersome and risk-averse culture in our regulatory and payment systems.”  He said there are several opportunities to remove barriers to device approval and reimbursement, including improving evidence development mechanisms to reduce cost and delay, aligning reimbursement incentives with promoting innovation, and accelerating FDA’s vision to improve the regulatory process.

Mussallem also noted, “[W]hen registries are done right, they can yield extremely useful information about patient outcome and device benefits.” He cautioned, however, that the clinical and scientific benefits of registries must be balanced with their potentially significant cost, complexity, and potential misuse of that data.”

Gregory Schimizzi, M.D., cofounder, Carolina Arthritis Associates, who testified on behalf of the Alliance for Specialty Medicine, told the subcommittee “there are still considerable problems with the current implementation” of the Physician Payments Sunshine Act, “including the lack of guidance and clarity regarding the physician registration process as well as the review of dispute process lacking necessary protection for physicians.”  He urged the Centers for Medicare and Medicaid Services (CMS) to “provide additional provider-specific guidance for the registration process and adopt policies that allow for flexibility of enrollment requirements, so that physicians struggling to enroll remain able to participate in a meaningful manner.” 

Dr. Schimizzi also said CMS should “ensure an impartial process for disputing the accuracy of financial information intended for public disclosure, take steps to enhance the fairness and accuracy of the program by ensuring that healthcare providers have access to meaningful mechanisms for limiting the distribution of disputed information,” and reconsider a proposal to eliminate the continuing medical education exemption.

Healthcare Leadership Council President Mary Grealy, echoed concerns about the potential impact of the Physician Payment Sunshine Act, saying, “We're concerned that physicians may feel stigmatized by the federal reporting of their interactions with manufacturers in a way that does not communicate the patient benefits of such collaborations.” She testified that some “member companies are already witnessing physicians withdrawing from collaborative activities, which can have a devastating impact not only on innovation but also on product efficacy and safety.”

Grealy also testified that while the Health Insurance Portability and Accountability Act (HIPAA) privacy law is generally serving patients well, “there are certain aspects of HIPAA that warrant continuing review and discussion. We need to keep in mind that HIPAA was created at a time in which policymakers weren't thinking about the knowledge that could be gained by accessing data residing in large databases, and the technological ability to process that data very rapidly.”  She added, “It may be necessary to adjust the authorization components of HIPAA to ensure that the data can be used effectively for research. Also, in order to transmit data and collaborate in its use, we need to review the utility of having 50 separate sets of state privacy laws and regulations instead of a single national standard.”

Louis Jacques, M.D., senior vice president and chief clinical officer, ADVI, and former director of CMS’s coverage and analysis group, testified that while external stakeholders have requested more opportunities for CMS Coverage with Evidence Development (CED), the agency’s ability to furnish CED is limited by its statutory authority, which resides with the Agency of Healthcare Research, and Quality (AHRQ), and inadequate staffing, which is approximately half of 2007 levels.

Dr. Jacques said that due largely to staffing cuts, the annual number of National Coverage Determinations (NCDs) has dropped from approximately 12 to 13 in fiscal years 2007 and 2008 to only five in 2012 and six in 2013.


Dave Moore
Senior Director, Government Relations
Telephone: 202-828-0559


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