The Federal Government's Key Role In Healthcare Innovation


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Federal government standards, regulations, funding, and policy are critical to driving innovation to reduce healthcare costs, expand access to quality healthcare, develop new cures, and improve health outcomes.

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  • The Agency for Healthcare Research and Quality (AHRQ) provides a website called Health Care Innovations Exchange which publishes biweekly issues aimed at spreading knowledge within the health care industry. In addition to the issues, the site hosts a library with more than 700 innovation profiles and 1500 online tools that health care providers can search by topic, state, etc. to help improve patient satisfaction, increase efficiency and reduce costs.
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The Federal Government's Key Role In Healthcare Innovation

  1. 1. The Federal Government’s Key Role inHealthcare InnovationbyLucy StribleyStribley_lucy@bah.comLisa Egbuonu-Davis, MDEgbuonu-davis_lisa@bah.comPatrick
  2. 2. The Federal Government’s Key Role inHealthcare InnovationThe need for innovation in healthcare has never been population and public health.4 The federal governmentgreater. Healthcare spending in the United States participates in and funds medical product researchis projected to grow 5.8 percent annually through and development through the National Institutes of2020, placing increasingly larger burdens on American Health, which has an annual budget of over $30.7households and the economy with each passing year. billion.5 Federal funding also supports health andBy 2020, total healthcare spending will encompass product development research within the Department19.8 percent of the US gross domestic product (GDP), of Defense; the Biomedical Advanced Research andup from just 17.6 percent in 2012 and 16 percent in Development Authority (BARDA) within the Department2005.1 Innovative models of care and payment, new of Health and Human Services targets responses totechnologies, new products, and new approaches to pandemic infections and countermeasures to chemical,prevention and patient engagement can help reduce biologic and radiologic threats; and the Food and Drugcosts and, equally important, improve overall patient Administration (FDA) regulates clinical research andhealth and outcomes. However, the current economic medical product approval, marketing and distribution.climate has dampened funding for healthcare research Booz Allen Hamilton recently sponsored a panelinstitutions, and many healthcare leaders now worry discussion on “The Federal Governments Role inthat cuts in federal and private funding of medical Medical Innovation.” The panel focused on federalresearch will slow discoveries of new therapies programs, regulations and policies that can reduceand diagnostic tools.2 In addition, without new and barriers and foster innovation in healthcare deliveryinnovative models of care delivery and financing to and medical product development in the Unitedsupport wider access to care, dissemination of new States. Participating on the panel and in the audiencetreatments and therapies to patients in need will be discussion were leading experts from payer, provider,delayed. The healthcare community must find ways to and life science companies in the biotechnologysupport continued innovation and advances in health and pharmaceutical sectors, as well as key policyservices and products. makers and staff from government agencies. WhileConcerns about spurring innovation are not limited to participants acknowledged the challenges, they agreehealthcare; the federal government has been engaged that government should play a continuing role—and,in a number of initiatives to promote innovation in in some instances, a strengthened role—in promotingenergy, education, science, and other sectors. However, innovation in several key areas:the government is uniquely positioned to address • Providing targeted funding to support developmenthealthcare innovation because of its dominant role of product and service innovation at junctures wherein healthcare funding and regulation. The Centers for private funding is inadequateMedicare and Medicaid Services (CMS) serves asthe nation’s largest healthcare purchaser through its • Facilitating collaboration by setting standards forfinancing of Medicare and Medicaid programs, which information exchange and leading selected cross-together accounted for 35 percent of total national sector initiativeshealth expenditures in 2009.3 Through its budget • Developing regulations and policies that incentivizeof $6.1 billion, the Centers for Disease Control and innovation and promote the dissemination andPrevention (CDC) funds both research and services for widespread use of models, technology, and products 1
  3. 3. that demonstrate measureable gains in healthcare quality, efficiency and outcomes. Examining Government’s Role in Finding agreement on the precise standards, Promoting Innovation regulations, funding levels, and other issues will The Booz Allen Hamilton sponsored panel require ongoing discussion and negotiation among all discussion, “The Federal Governments Role in members of the healthcare community. Nevertheless, Medical Innovation,” brought together leaders federal organizations are playing an essential role from across industry and government to dis- in fostering innovation, and their activities provide cuss research investment, product pipelines, many opportunities for payers, providers, life science development timelines, health system change companies, researchers, and other stakeholders to and requirements for evidence of value. Select leverage government programs and resources while participants at the event included: partnering to spur much-needed innovation. • Chris Austin, MD, Scientific Director, NIH Federal funding can jump-start innovation in Center on Translational Therapeutics healthcare products and services at critical junctures where private funding is inadequate. Health • ShaAvhree Buckman, MD, PhD, Director of information technology can cut costs and improve care the Office of Translational Sciences, FDA delivery in countless ways, from reducing complications Center for Drug Evaluation and Research in patient care and enhancing coordination across • Bob DuBois, MD, PhD, Chief Scientific care settings to streamlining administrative processes Officer, National Pharmaceutical Council and providing information on healthcare quality and outcomes. Federal funding and incentives are already • James Meyer, MD, Family Physician, being used in a variety of programs to support the Mountaintop Family Health adoption of electronic medical records and quality • Timothy Andrews, Vice President, reporting among providers. The Health Information Booz Allen Hamilton Technology for Economic and Clinical Health (HITECH) Act is designed to speed up investment by practitioners The panelists spurred a dynamic conversation in electronic medical records and processes, which about the role and impact of government can improve care coordination and tracking of health policy and regulations, public-private partner- outcomes. Signed by President Obama in 2009, ships, health service delivery, and payment HITECH authorized $19.2 billion for enhanced Medicare reforms on medical innovation and patient and Medicaid payments to providers who adopt access. The resulting dialogue generated new “meaningful use” of health information technology into insights into how the government and broader their practices between 2011 and 2015. Meaningful healthcare community can work together to use was defined to include standards for electronic foster innovation. health records and their use in tracking medication, lab tests, prescribing and provider communication.6 The Congressional Budget Office predicted that these The CMS Innovation Center is funding an array of incentives would lead to the adoption of electronic initiatives to test care delivery and payment models health records by 90 percent of physicians and 70 to address critical needs in the current healthcare percent of hospitals by 2019.7 system, such as strengthening primary care delivery and medical homes, increasing coordination between2
  4. 4. health and social services, and improving care and various combinations of antigens and adjuvants tooutcomes for the most vulnerable populations, obtain a more robust immune response. BARDA alsoincluding those who are chronically ill, poor and/or helps facilitate cooperation among companies in theelderly. In November 2011, CMS announced the Health early, pre-competitive stages of research, thus fosteringCare Innovation Challenge, a $1 billion nationwide greater innovation and sharing of expertise.8funding initiative to test creative ways for delivering The federal government can facilitate innovation byhigh quality medical care and reducing costs in a setting standards and rules for information sharingvariety of populations and settings. The initiative is among stakeholders and by leading cross-sectoralso seeking innovations in workforce development collaborative initiatives. In order to speed innovationand deployment. Providers, payers, local government, and reduce the cost, organizations must share insightspublic-private partnerships, and multi-year collaborative learned during health system reform, health careprojects have been encouraged to apply for funding. It delivery, and medical product research. As a marketis hoped that after successful models are created, they regulator, the federal government is in a uniquecan be replicated and sustained through the healthcare position to develop information sharing standards andfinancing system. guidelines that will facilitate appropriate data sharingFederal agencies also play an important role in and collaboration while protecting intellectual propertysupporting the development of new products, and individual rights to privacy. For example, the Healthparticularly in addressing industry’s need for pre- Insurance Portability and Affordability Act (HIPAA)competitive information about basic mechanisms of protects patients’ information and sets standardsdisease and biomarkers and surrogate endpoints that for secure and consistent data exchange. HITECHcan predict treatment response and outcomes. The Act provisions strengthen data security and privacyNational Institutes of Health (NIH) has traditionally protections and specify penalties for data breaches.9been a major source of funding for basic science Additionally, in 2013, the government will require theresearch, which does not provide economic returns collection and submission of quality indicators bysufficient to attract private investment, but which providers, which will facilitate quality measurementprovides critical foundational knowledge for developing and improvement.innovative products. One example of a federal program Federal-sponsored collaboration and informationsupporting medical product development is the exchange can also play a critical role in supportingFoundation for NIH’s Biomarkers Consortium, which medical product development and management offunds multiple projects across a variety of disease medical product risk and benefit. In some instances,areas including Alzheimer’s, diabetes, cancer in order the federal government has spearheaded public andto discover and qualify biomarkers to support drug private-sector data sharing to facilitate clinical researchdevelopment. Another federal organization, BARDA, in areas on unmet medical needs. The FDA’s Criticalprovides direct funding to address public health Path Initiative (C-Path) brought together more thanemergencies. It manages Project BioShield, which 54 public and private-sector organizations to improveincludes the procurement and advanced development the efficiency and quality of clinical trials. C-Pathof medical countermeasures for chemical, biological, led the development of an information database ofradiological, and nuclear agents, as well as pandemic approximately 4,000 Alzheimers subjects from eleveninfluenza and other emerging infectious diseases. An industry-sponsored clinical trials; the database isexample of innovation from the Pandemic Influenza accessible to researchers for the design of futureprogram is BARDAs Mix and Match study assessing 3
  5. 5. clinical trials and the identification of potential are especially important to investors, because therapies that have a positive effect on disease clear standards regarding the evidence needed for progression. Similarly, the FDA sponsored Mini-Sentinel product approval, reimbursement, and comparative project supports data exchange among 17 clinical effectiveness will enhance the efficiency of research and payer partner organizations. This collaborative and reduce investment uncertainty. In October 2011, facilitates the analysis of data from more than 100 Commissioner Dr. Margaret Hamburg launched a million patients to assess the safety risks of medical program for “Driving Biomedical Innovation: Initiatives products. This system enhances the FDA’s ability to for Improving Products for Patients,” which includes conduct proactive surveillance of safety events and creating a rapid drug development pathway for targeted supports the acceleration of product approval with therapies.12 The FDA will host a series of scientific limited safety data. It also provides an opportunity to meetings to recommend steps for accelerating identify patient populations for which the product risk regulatory processes when an investigational drug to benefit ratio may not be appropriate. Identifying being studied for a serious disease shows exceptional the higher risk populations and limiting product use in promise during early stages of development. New these groups can help keep products on the market for regulatory guidance will specify enrichment strategies other patient populations.10 for patient selection to support targeted drug development and expedited approval. Federal policies and regulations can support processes and provide incentives that promote Financial incentives for innovation investment can also the widespread adoption of proven interventions. be provided via tax policy, such as the Therapeutic Policies and regulations can support the development Discovery Project Tax Credit included in the Affordable of innovative health service delivery and financing Care Act. Extended exclusivity for therapeutics and models, reduce the time-to-market for biologics, drugs medical devices may also spur innovation and increase and devices, and incentivize sustainable private investment in research. Exclusivity has already been investment in efficient, high quality delivery models and proven to work for companies developing “orphan in medical product innovation. CMS has established drugs,” and such policies could be expanded to focus an innovative program to develop Accountable on other areas where new treatments and products will Care Organizations—new models of care in which improve health outcomes. physicians, hospitals, and health plans collaborate to provide integrated services to Medicare patients who Next Steps: Strengthening the Public-Private were previously utilizing fee-for-service care. These Innovation Partnership new organizations can participate in shared-savings Leading experts in government, industry, and Congress or shared-risk arrangements: If CMS quality standards have offered a number of recommendations for for care are achieved, they are eligible for financial ensuring the government’s continued role in promoting benefits from cost savings. To facilitate these changes innovation and for strengthening some aspects of its in care delivery, regulations that had prohibited certain activities and responsibilities in each of the three main “anticompetitive” negotiations between hospitals, areas. Among their recommendations: physicians, and health plans were modified to allow • Provide continued funding for key federal research collaborative care, and financial incentives promoting initiatives that complement and support private- efficiency while maintaining quality were established.11 sector research. Budget constraints could hinder In the medical product sector, the FDA has established the ability of both the NIH and CMS under the a number of initiatives to speed product development president’s proposed FY 2013 budget. Although the and approval through enhancements of regulatory NIH budget contains targeted funding for programs science. Regulatory transparency and predictability such as the National Center for the Translational4
  6. 6. Sciences and fighting Alzheimer’s disease, some Ed Towns (NY). The FAST act would enable sponsors experts contend that many medical researchers will to request fast track designation for drugs that struggle under NIH’s flattened budget.13 Similarly, demonstrate potential to address unmet medical budget constraints may slow CMS’s push for needs for treatment of serious or life-threatening innovations in health IT. At the FDA, funding for conditions. Fast track designation would enable the biosimilars approval pathway and enhancing the FDA to provide for accelerated approval of such FDA’s generic drug review capacities could crowd products based on either a surrogate endpoint out spending in other areas.14 The healthcare likely to predict clinical benefit or a clinical endpoint community should work to ensure that funding for likely to predict an effect on irreversible morbidity critical research initiatives is maintained. or mortality.18 These proposals, along with many of the changes proposed in the reauthorization of the• Extend the uses of successful innovative programs. Prescription Drug User Fee Act (PDUFAV)—including Among the programs that have applications beyond enhanced efficiency and communication during the their initial use, the FDA’s new Sentinel drug review process for new products, increased staff to safety surveillance system is being considered for review biomarkers and pharmacogenetic markers, a number of valuable “secondary” uses, including and enhanced outreach and inclusion of patient gathering evidence for comparative research advocacy groups in the review of benefit and risk and post-marketing activities for pharmaceutical assessments—could help foster continued medical manufacturers.15 The Accountable Care product innovation.19 Organizations (ACOs) created by the Affordable Care Act also offer opportunities for building on their initial value. 16 The extension of successful models Conclusion The federal government plays a crucial role in to other organizations and to other payers beyond promoting innovation across a wide spectrum of Medicare would provide for broader impact on healthcare activities. Stakeholders in both the public quality and savings. In addition, the extensive cost and private sectors can work together to address and outcome data generated by the ACOs’ increased the challenges of sustaining innovation and seek use of electronic health records could yield valuable opportunities to accelerate innovation. Federal funding data for comparative research. for healthcare information technology infrastructure,• Continue regulatory reform. Sen. Kay Hagan (NC) basic science and translational research and recently introduced the Transforming the Regulatory other “public goods” helps fuel innovation, as do Environment to Accelerate Access to Treatments clear standards for exchange of information about (TREAT) Act proposing changes at the FDA.17 Among scientific advances, patient needs, and health its provisions, the TREAT Act would accelerate outcomes. Transparent regulations can support rapid the review and approval process for treatments development, approval and adoption of strong delivery of serious life threatening diseases with unmet systems, high quality care, and medical product needs; establish an Office of the Chief Innovation advances. Federal healthcare policy can incentivize Officer at FDA to identify innovative approaches sustained private investment in the healthcare sector. to ensure rapid development, testing, and review The success of these efforts is critical to driving of drugs and devices, including the development innovation to reduce healthcare costs, expand access of pilot programs; and enhance FDAs access to to quality healthcare, develop new cures, and improve external scientific and medical expertise. Similar health outcomes. legislation—the Faster Access to Specialized Treatments (FAST) Act—has been introduced in the House by Reps. Cliff Stearns (FL) and 5
  7. 7. Methodology For nearly a century Booz Allen has been at the caBIG®program. Booz Allen provided expertise forefront of management consulting for businesses and assistance in multiple areas, including and governments. Our approach to management bio-banking and pathology, data sharing and technology consulting combines deep domain standards, infrastructure, and the deployment expertise with strong capabilities in strategy and of software tools nationwide. Booz Allen guided organization, analytics, technology, and operations. the efforts of 57 National Cancer Institute By leveraging domain expertise and capabilities, (NCI)-designated cancer centers as they Booz Allen anticipates, identifies, and addresses participated in the program, and assisted our clients’ specific needs while looking for smart outreach and recruitment efforts to solicit applications of our management and technology cancer center participation in the program. consulting solutions in the future. • Partnering extensively with CMS, contributing Booz Allen’s health practice integrates and expertise and stakeholder analyses to help the applies industry expertise in supply chain, agency shape the policy, design, and roll out clinical, scientific, emerging global standards, and the Medicare prescription drug benefit (Part D) innovative health technologies, and includes more in 2007; and continuing to assist Part D quality than 500 professionals with PhDs or master-level assurance, monitoring of provider marketing degrees in health-related disciplines. For over practices and payment audits. Booz Allen is also 20 years, Booz Allen has partnered with federal supporting the development and implementation healthcare organizations on key strategic programs, of health insurance exchanges as mandated in including: the Affordable Care Act. • Working with the FDA since 2004 to evaluate • Booz Allen also has long-stranding portfolios of and improve regulatory processes including assignments with the Department of Veterans New Drug Applications/Biologic License Affairs, Military Health Services, Center for Application (NDA/BLA) review, post-marketing Disease Control and Prevention, and Agency for commitments, and Risk Evaluation and Healthcare Research and Quality. Mitigation Strategies (REMS).20 Booz Allen is committed to helping clients solve • Partnering with the NCI Center for Biomedical their toughest problems, working with them side Informatics and Information Technology (CBIIT) by side to help them achieve their missions and to design the pilot and structure for the entire delivering results that endure.6
  8. 8. Notes1 "National Health Expenditure Projections 2010-2020," p. 1 and Table 1, "National Health Expenditures and Selected Economic Indicators, Levels, and Annual Percentage Change: Calendar Years 2005-2020," Centers for Medicare and Medicaid Services.2 See, for example, "Gone Tomorrow: A Call to Promote Medical Innovation, Create Jobs, and Find Cures in America," The Council for American Medical Innovation, June 10, 2010.3 NHE Fact Sheet, CMS4 Summary: Fiscal 2012 Final Consolidated Appropriations Bill, House Appropriations Committee, December 15, 2011, p. 9.5 Ibid.6 "CMS EHR Meaningful Use Overview" ( Tom Spoth, “Agencies advance use of health IT,” Federal Times, August 13, 2010.8 See "BARDA Strategic Plan 2011-2016."9 Harry Rhodes and Dan Rode, "HIPAA, Too: Many ARRA Privacy Provisions Amend HIPAA, Not Create New Regulation," Journal of AHIMA 81, no. 1 (January 2010): 38-39.10 Richard Platt, Professor and Chair of the Department of Population Medicine at Harvard Medical School and the Harvard Pilgrim Health Care, "Overview of FDA’s Mini-Sentinel Pilot," September 15, 2011.11 "Statement of Antitrust Enforcement Policy Regarding Accountable Care Organizations Participating in the Medicare Shared Savings Program," Federal Trade Commission, Department of Justice Antitrust Division, Federal Register , Vol. 76, No. 209 , Friday, October 28, 2011, Notices.12 "Driving Biomedical Innovation: Initiatives to Improve Products for Patients," FDA, October 2011.13 Research!America’s Statement in Response to President Obama’s FY 2013 Budget, February 13, 2012.14 Cathy Dombrowski, "Biosimilars, Generic Programs Leave Little Room For Other New FDA Drug Initiatives in FY’13." The Pink Sheet, February 20, 2012.15 Michael McCaughan, "Secondary Uses of Sentinel," The RPM Report, February 2012.16 Scott Steinke, "Looking Ahead To 2012: ACOs Get In Gear, Accelerating The Need to Prove Biopharma Products Overall Value In Health Care." The Pink Sheet, January 2. 2012.17 S.2113, introduced February 15, 2012.18 H.R., 4132, introduced March 5, 2012.19 "Reauthorization of PDUFA: What it Means for Jobs, Innovation, and Patients," Statement of Margaret Hamburg before the House Energy and Commerce Subcommittee on Health, February 1, 2012.20 Booz Allen Hamilton, Evaluations and Studies of New Drug Review Programs Under PDUFA IV for the FDA Contract No. HHSF223201010017B Task No. 2, “Assessment of the Impact of the Electronic Submission and Review Environment on the Efficiency and Effectiveness of the Review of Human Drugs,” Final Report, September 9, 2011; Booz Allen Hamilton, Assessment of GRMPs Implementation Evaluations and Studies of New Drug Review Programs Under PDUFA IV for the Food and Drug Administration, Task Order 1, Order Number: HHSF223201010017B, Final Report, April 29, 2011; and Booz Allen Hamilton, Drug User Fee Act III – Evaluations & Initiatives Contract No. 223-04-8100 Task No. 4, “Postmarketing Commitments Study,” Final Report, January 2008. 7
  9. 9. About the Authors Lucy Stribley is a leader in Booz Allen Hamilton’s Life Services at a Top 5 global pharmaceutical company, Sciences practices, with over 19 years of consulting supporting product development and commercialization, experience and 15 years focused on healthcare. As a management of organizational transformation and Principal, she focuses strategy, process analysis and mergers, and participation in development of health evaluation, and information technology for federal and policy. She has been a member of the National commercial health clients. She has over 13 years’ Advisory Council of the Agency of Healthcare Research experience working with the U.S. Food and Drug and Quality. Her focus is on strategic business Administration (FDA), supporting all of the centers responses to health care policy and regulation, and offices. Stribley has also supported U.S. Army particularly in medical affairs and market access. Medical Research and Materiel Command (USMRMC), Patrick Fritz has more than 10 years of government Centers for Medicare and Medicaid Services, National relations, commercial, and nonprofit management Institutes of Health, commercial pharmaceutical and experience with a focus on developing strategic biotechnology manufacturers, and not-for-profit clients. partnerships. Fritz has served in advocacy and public Lisa Egbuonu-Davis, MD is a leader in Booz Allen policy positions for the American Cancer Society and Hamilton’s Life Science practices, with over 18 the ALS Association. He has extensive experience years of pharmaceutical experience. She served as in organization effectiveness practices change Vice President of U.S. Medical Operations and Vice management, strategic communications, and strategic President of Global Outcomes Research and Medical and business planning. Contact Information: Lucy Stribley Lisa Egbuonu-Davis, MD Patrick Fritz 240-314-5632 301-251-7261 202-346-95328
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