From the Department of Health and Human Services www.hhs.gov
Agency: Assistant Secretary for Planning and Evaluation, Department of Health and Human Services
Action: Request for Information
This Request for Information (RFI) solicits ideas and information relating to ways in which the U.S. Department of Health and Human Services (HHS) could continue to improve its use of resources and authorities to encourage the development and use of new medical technologies, consistent with the goals of (a) maintaining and improving the quality of health care, (b) controlling overall healthcare costs, and (c) using timely and practical administrative procedures.
Innovation is often defined as the development and application of something new (for example, a process, procedure or application of new equipment). A definition more consistent with transforming our healthcare system to one that is both sustainable and produces high quality care might be “the development and application of something new which meaningfully improves the value of the system in which it is applied.” We are issuing this RFI to solicit information that will help us improve how various HHS agencies such as the National Institutes of Health, the Food and Drug Administration, the Centers for Medicare & Medicaid Services, and the Agency for Healthcare Research and Quality can participate in a dynamic system for innovation and diffusion of medical technologies that will significantly increase the value of care provided throughout the healthcare system.
We are interested in new potential roles for HHS or improvements in current procedures. In either case, we are soliciting information on challenges in the current marketplace for medical technology development and application, potential options to reduce or eliminate those challenges, and the likely costs and benefits of those options. Costs and benefits cover a wide range of factors, including incentives to create and bring new medical technologies to market, incentives to control medical costs both currently and in the future, effects on quality of healthcare and healthcare outcomes, effects on healthcare providers, and ease of administration of the Medicare and Medicaid programs and private insurance programs. Considering the escalating costs of health care and the rapid increase in the share of the gross domestic product devoted to health care, we are interested in ideas or proposals that would encourage the development and adoption of cost-reducing as well as cost-effective technologies.
In this RFI, we use the term “new medical technology” to mean: 1) drugs, biological products, devices, procedures and processes that differ meaningfully from those in current practice; or 2) new uses (e.g., new indications, target populations) for existing medical technologies.
We are particularly interested in receiving comments regarding actions that are consistent with the existing statutory framework and that build on HHS’s efforts to date. Therefore, we are not asking for comments regarding changes to the basic criteria of safety and effectiveness FDA uses to evaluate drugs, biological products, or devices. Nor are we asking for comments on the underlying methods used in current Medicare payment systems, such as the hospital inpatient prospective payment system and the Diagnosis-Related Group system on which it rests. Rather, we solicit information on ways to improve the application of those methods as new medical technologies emerge.
An innovation “system” might be thought of as including: funding entities; basic, translational and applied research; regulation of market entry; complete assessment of clinical and economic impacts of medical technologies; decisions concerning coverage and payment for medical technologies; and decisions by healthcare providers and patients to use these medical technologies. HHS agencies play a substantial role in the full spectrum of these activities. We are especially interested in receiving comments regarding how to further improve coordination and consistency among HHS agencies in the medical technology innovation and diffusion processes. We also welcome comments on new methods used in the private sector to develop, cover and pay for, and adopt new medical technologies. We request that comments take into account the need for the federal government to follow various standards of due process, transparency, and notice.
Dates: Responses should be submitted to the U.S. Department of Health and Human Services on or before 5:00 pm, EDT, April 16, 2009.
Instructions for Submitting Comments: Electronic responses are preferred and should be addressed to email@example.com. Written responses should be addressed to the US Department of Health and Human Services, Room 434E, 200 Independence Ave, SW, Washington, DC 20201. Attention: Medical Technology Innovation RFI. A copy of this RFI will also be available on the website of the Assistant Secretary for Planning and Evaluation at http://aspe.hhs.gov/sp/medtechinnovation/rfi.
The submission of written materials in response to the RFI should not exceed 25 pages, not including appendices and supplemental documents. Responders may submit other forms of electronic materials to demonstrate or exhibit concepts of their written responses. Any information you submit will be made public. Consequently, do not send proprietary, commercial, financial, business confidential, trade secret, or personal information that you do not wish to be made public.
Public Access: Responses to this RFI will be available to the public in the Policy Information Center Reading Room, 200 Independence Avenue, SW, Washington, DC, 20201. Please call (202) 690-6445 between 9:00 am and 5:00 pm to arrange access.
For further information contact: Medical Technology Innovation Desk, Office of the Assistant Secretary for Planning and Evaluation, (202) 690-7858.
HHS’ mission includes the roles of:
- considering innovation and benefits to society when investing medical research funds;
- promoting and protecting the public health through the regulation of drugs, biological products, medical devices and foods;
- implementing policies that assure beneficiaries access to effective, appropriate and high quality services while being prudent purchasers of health care; and
- improving the quality, safety, efficiency, and effectiveness of health care for all Americans.
New diagnostics and therapies offer the healthcare system the tools to extend life and improve its quality. HHS recognizes that medical technology-related policies that are predictable and responsive help to foster an investment climate conducive to medical technology development and innovation. Biomedical research funding in 2003 was estimated to be $94 billion. Approximately 35 percent of the funding came from federal sources (largely through funding by the National Institutes of Health); 57 percent from private investment sources, such as from pharmaceutical, biotechnology and device companies; 5 percent from state and local sources; and 3 percent from foundations and other sources of private philanthropy. The processes used to make coverage and payment decisions, their timeliness and predictability, and the types of evidence required can directly affect the level and composition of future biomedical investment. Similarly, Medicare’s decisions can directly affect the treatment decisions made by physicians and patients. Thus, in exercising its statutory authorities HHS must ensure that its policies are rigorously evidence-based, transparent to the public, timely, and reevaluated as necessary in light of changing circumstances.
We recognize that new medical technologies are a significant causal factor for the rapid growth in health care costs. To maximize value from new and existing medical technologies, there must be well-informed decisions made by all stakeholders with the appropriate financial incentives. We are particularly interested in the roles HHS can play through its agencies in balancing the costs and impacts of new medical technologies by providing scientific information about its value, encouraging the use of such information, and in making coverage and payment decisions that provide complementary financial incentives.
Towards this end, in the fall of 2008, HHS hosted a series of conferences around the country on HHS’s dynamic role in fostering medical technology innovation. At these conferences, senior officials from the National Institutes of Health (NIH), the Food and Drug Administration (FDA), the Centers for Medicare & Medicaid Services (CMS), and the Agency for Healthcare Research and Quality (AHRQ) highlighted the work taking place in and among their respective agencies to facilitate the development of innovative medical technologies.
Some of the topics that were covered included:
- The role of basic and clinical research conducted and supported by the NIH in the development of new products;
- FDA’s efforts to use state-of-the-art science in review of medical product development, as well as to promote consistency and efficiency in medical product review;
- CMS's perspective on the challenges innovators face in current payment and coverage processes and how innovators can better navigate the system; and
- AHRQ's role in promoting quality research and tools for research, as well as how these benefit innovators.
These conferences highlighted important HHS initiatives such as the NIH Roadmap [see http://nihroadmap.nih.gov/] which supports transformative, cross-cutting research that is beyond the scope of any single NIH Institute or Center; NIH’s Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs, which provide funding and technical assistance for domestic small business concerns that have the potential for commercialization [see http://grants.nih.gov/grants/funding/sbir.htm]; FDA’s Critical Path Initiative, which is an effort to improve the safety and predictability of the review process and to facilitate and stimulate a national effort to modernize the sciences through which FDA-regulated products are developed, evaluated, and manufactured [see http://www.fda.gov/oc/initiatives/criticalpath/]; CMS’s recent publication of the Innovators’ Guide to Navigating CMS, which is designed as a practical user’s guide to help innovators navigate Medicare’s coding, coverage, and payment processes [see http://www.cms.hhs.gov/CouncilonTechInnov/Downloads/InnovatorsGuide8_25_08.pdf] and various initiatives of the AHRQ, including the HealthCare Innovator’s Exchange Website [see http://www.innovations.ahrq.gov/] and the Effective Health Care Program [see http://effectivehealthcare.ahrq.gov/], which are designed to improve the quality, safety, efficiency, and effectiveness of healthcare.
These conferences allowed HHS to highlight the extensive efforts it has undertaken to develop programs and initiatives that will help to streamline the medical technology innovation process. The conferences also provided healthcare providers, researchers, and innovators the opportunity to exchange ideas with HHS officials and other conference participants. By focusing on innovation, collaboration, and transparency, this initiative has advanced HHS’s efforts to empower those with the knowledge to develop and bring to market the tools, preventive measures and life-saving treatments of the 21st century. Additional information regarding these conferences, including a report summarizing comments from attendees and HHS agency accomplishments, is available at http://www.hhs.gov/deputysecretary/innovationconference/index.html.
This Request for Information builds on these and other efforts to improve the innovation process and the dialogue at the conferences by initiating a public process to address the critical issues associated with medical technology innovation. The intent is to add and update, rather than replicate, the substantial existing body of work generated from previous HHS efforts along these lines as described above, as well as similar efforts led by other entities.
In addition to the general solicitation of comments above, we are also asking the following questions for the public to consider in the context of the preceding discussion within this document:
- How can HHS continue to improve its use of resources and authorities to encourage the development and use of new medical technologies that enhance health system value?
- How can federal medical technology research funds be better coordinated with state and private sector research to maximize value to society?
- How do the terms and conditions of NIH research awards affect the development of innovation and what specific changes would encourage innovation?
- Given our current policies for the management of intellectual property (e.g., the Bayh-Dole Act), what policy options or considerations need to be addressed to ensure that the United States remains competitive and can reward innovation while at the same time maximize the public health benefits of scientific knowledge and medical technology?
- How can FDA’s practices and procedures be enhanced to further encourage innovation while ensuring safety and effectiveness?
- How can FDA further facilitate its review of innovators’ development of new tools (e.g., biomarkers, assays) and medical technologies (e.g., information technologies) as part of FDA’s oversight of such products?
- Are there specific CMS coverage or payment policies that should be considered to help assure timely, affordable access to effective new technologies for beneficiaries?
- Are there specific refinements within CMS’control or that would require rulemaking to the criteria or methods used to determine eligibility for Medicare inpatient add-on payments, outpatient new medical technology Ambulatory Payment Classification payments, or pass through payments that may potentially be modified to potentially improve access to new medical technologies and provide greater value for the program and its beneficiaries (specifically, for providing care that achieves good health outcomes at the lowest possible cost)?
- Is there research on medical technology, tools, or funding that is not currently being conducted that potentially could be conducted and/or funded by AHRQ?
- What role should HHS play in making information regarding the cost and quality of new medical technologies available and encourage its use by healthcare providers and patients to make informed healthcare decisions?
- How can HHS better inform the public about the risks and benefits of new medical technologies and their use to maximize value to patients?
- To what extent should HHS participate in and fund comparative effectiveness research? What should HHS’ role be and how should the results be used?
Date: January 15, 2009
Mary M. McGeein
Principal Deputy Assistant Secretary
Office of the Assistant Secretary for Planning and Evaluation
US Department of Health and Human Services