House Energy and Commerce Subcommittee on Health Hearing
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Chairman
We have an exciting opportunity today to talk about the future of health care--a future where we can harness electronic data to improve patient care through a better understanding of how medical products impact health outcomes and more rapid cycles of product development. Technological advances allow us to consider evidence development as a continuous cycle that begins before a product is approved and continues as the product is used by patients.
This process begins during the product development and approval phase.
This total life-cycle approach supports the development of the next generation of products while ensuring that sufficient data is collected both before and after approval. New electronic tools have the potential to improve the quality of the data and the efficiency of information collection throughout products' life cycles.
In particular, the expansion of health information technology and increased adoption of electronic health records (EHRs) have the potential to dramatically decrease the costs and time it takes to bring products to market.
Clinical trials are the gold standard of medical evidence. They are also the single largest contributor to the cost and length of product development. The key to facilitating innovation of new drugs and devices is to collect the information faster and cheaper, and ensure patients, providers, regulators and payers have the data they need. Registries, large databases that collect information over time on a group of patients treated for a particular medical condition, are one way to accomplish this.
We should seek to conduct clinical trials of the sort done by researchers in
Similarly, registries are used to identify problems with approved products. Registries can assess the real-world performance and long-term outcomes of medical devices that may not be detected in the clinical trial settings. Hip implants, for example, are expected to last 15-20 years n2 but typically require only two years of clinical data for
Registry barriers must be overcome
Within the next few weeks, Pew will release the findings of a series of meetings that brought together medical device stakeholders to better define the role of device registries in our healthcare system. These meetings--hosted jointly by Pew, the
We concluded that registries should be established to collect evidence for those devices for which we do not have good data on their long-term performance, those where physicians and patients have a variety of choices, and those where the outcome may be dependent on surgical technique.
We also developed recommendations on necessary conditions to ensure that registries deliver timely, actionable information to all stakeholders, including the public. We recommend that registry findings and reports should be publicly released on a regular basis, and that the governance, operations, and financing should be made publicly available.
There are a number of challenges that must be overcome to enhance the use of registries in
First, despite the dramatic uptake of electronic health information sources, these systems cannot easily transmit data among one another. This lack of interoperability, for example, hinders the ability for registries to extract clinical and outcomes data from EHRs. Instead, registries must develop the ability to extract information from the EHR systems at each facility, or require manual entry from providers. We urge the Committee to lend its full support to interoperability efforts by the
Additionally, many registries have sought clarity on when their studies are considered research or quality improvement efforts. n7 This confusion has slowed their use by hospitals and their ability to make a meaningful contribution.
Other tools can provide key data
In addition to registries, several other new data collection tools can provide critical information on the performance of new drugs and medical devices.
One such tool is the Sentinel Initiative, which can be used to evaluate the safety of drugs and biologics used in patient care.
Given Sentinel's successes,
To resolve this problem, claims should include information about the specific devices implanted in patients. A new unique device identifier (UDI) system established by the
Documenting UDI in claims can also bolster other efforts to utilize data to better understand device performance. For example, incorporating UDI in claims will also provide payers--including CMS--with the necessary data unavailable elsewhere to evaluate outcomes for patients with devices. n10 As Medicare and
Adding a UDI field to claims has garnered support across the health system--including from hospitals, health plans, physicians, patients, and consumers. Aetna, Mercy,
New initiatives can leverage these tools
Through the development of these new tools,
The success of expediting access by shifting data relies on the prompt collection of postmarket information. Often, despite current
Additionally,
Should
Conclusion
Expediting patient access to new cures requires a holistic view of the product life cycle. New mechanisms to collect data both prior to and after
Given the proven value of electronic health information and registries,
Thank you again for the opportunity to testify, and I welcome your questions.
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n12 Hearing on the nomination of the Secretary of Health and Human Services-Designate
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n15 J.P. Rising,
Read this original document at: http://docs.house.gov/meetings/IF/IF14/20140722/102524/HHRG-113-IF14-Wstate-RisingJ-20140722.pdf
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House Energy and Commerce Subcommittee on Health Hearing
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