Health IT and Public Policy Issues Dr. Rich Hodge


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Connecting Michigan for Health 2013

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Health IT and Public Policy Issues Dr. Rich Hodge

  1. 1. Current Health IT Public Policy Issues Richard M. Hodge, MBA, MPA Senior Director, Congressional Affairs 703-562-8847; June 6, 2013 1
  2. 2. Vice President Government Relations Tom Leary Executive Director Institute for E-health Policy Neal Neuberger Executive in Residence Simeon Niles National Health IT Week Congressional Luncheon Seminar Series Internships/Student Experiences Senior Director Congressional Affairs Rich Hodge Director Government Services Stephanie Jamison Senior Director Federal Affairs Vacant Manager Federal Affairs Katie Boyer Coordinator Government Relations Evan Yeckley Manager Public Policy Kathie Westpheling Senior Manager Public Policy Communications Elinore Boeke Manager Public Policy Initiatives Arnol Simmons 2 HIMSS Government Relations Team Coordinator Government Relations Leslie Irvine
  3. 3. HIMSS does not Lobby  Advocacy is the organization of information into arguments used to persuade an audience towards some attitude and predisposition to action.  Lobbying is the practice of influencing decisions made by government including attempts to influence legislators and officials, whether by other legislators, constituents or organized groups.  A lobbyist is a person who tries to influence legislation or regulation on behalf of a special interest. 3
  4. 4. The Policy Conundrum – Multiple Players • U.S. Congress • The Administration • Federal Courts • State Courts • Governors • State Legislatures  Involves Policy, Resources, and Conflicting Priorities  The intersection of Commerce, Governme nt, and the Public Interest 4
  5. 5. • Senate Appropriations - Labor, HHS, Education and Related Agencies Subcommittee • Senate Finance Committee - Health Care Subcmte • Senate Health, Education, Labor, and Pensions Committee • House Appropriations - Labor, HHS, Education and Related Agencies Subcmte • House Energy and Commerce Committee - Health Subcmte • House Ways and Means Committee - Health Subcmte • House Science, Space, and Technology – Technology and Innovation Subcmte • Caucuses and Special Interests (Doctors, Nurses, Internet, Tech and Health Congressional Committees of Jurisdiction - Health Info Technology
  6. 6. 113th U.S. Congress - By the Numbers New Congressional Profile - Results of the 2012 Election House Senate Democrats 201 51 Republicans 233 45 Independents 0 2** Vacancies 1 2* Totals 435 100 *The two Senate vacancies are those of former Senators John Kerry (D-MA) who has become the Secretary of State and Frank Lautenberg (D-NJ) who died June 3, 2013. House vacancy is that of Joanne Emerson who resigned January 22, 2013. **The two Independent members of the Senate are Angus King (I-ME), who was elected to Olympia Snowe’s seat when she retired, and Bernie Sanders (I-VT); both of who caucus with the Democrats. 6
  7. 7. 7 HIMSS Public Policy Team HIMSS Board of Directors (sets policy) Public Policy Committee Government Relations Staff Government Relations Roundtable (HGRR) HIMSS Diversity Business Roundtable Legal Task Force HIMSS Non Profit Partners Chapter Advocacy Roundtable (CAR) State Government Relations Staff
  8. 8. HIMSS Public Policy Process  HIMSS Board of Directors - sets policy  Public Policy Principles – approved by Board; provides continuing guidance (Advocacy and Public Policy webpage)  Call to Action - Top 10 Policy Positions – expresses priorities  Public Policy Committee – makes recommendations  Other committees, WG, and TFs (Legal, etc.)  Public Policy Statements and Fact Sheets – expresses Board established policy related to specific issues  HIMSS Government Relations Team – implements the Board’s decisions and HIMSS’ GR activities HIMSS 2011 - 2012 Public Policy Principles December 10, 2010 2011 – 2012 Public Policy Principles December 10, 2010 SUMMARY HIMSS is a cause-based, not-for-profit organization exclusively focused on providing global leadership so that lives can be saved, outcomes of care improved, and costs reduced by transforming the delivery of healthcare through the appropriate use of information technology (IT) and management systems. Founded 50 years ago, HIMSS and its related organizations have offices in Chicago, Washington, DC, Brussels, Singapore, Leipzig, and other locations across the United States. HIMSS represents more than 30,000 individual members, of which two thirds work in healthcare provider, governmental and not-for-profit organizations. HIMSS also includes over 470 corporate members and more than 85 not-for-profit organizations that share our mission of transforming healthcare through the effective use of information technology and management systems. HIMSS frames and leads healthcare practices and public policy through its content expertise, professional development, and research initiatives designed to promote information and management systems’ contributions to improving the quality, safety, access, and cost-effectiveness of patient care. Each year, HIMSS creates policy principles for all stakeholders to consider for inclusion as provisions in legislation proposed by the U.S. Congress or state legislatures, or for inclusion in federal and state regulations, to foster enhanced healthcare using IT. For 2011 - 2012, HIMSS addresses its policy principles in eleven separate categories: 1. Funding and Incentives 2. Quality and Outcomes 3. Organizational Structure 4. Safety, Standards, Infrastructure, and Innovation 5. Privacy and Security 6. Legal 7. Patient Empowerment 8. Equity and Access 9. Population Health 10. Workforce Development 11. Administrative Simplification The American Recovery and Reinvestment Act of 2009 (ARRA) includes billions of dollars in Medicare and Medicaid incentive payments for the "Meaningful Use" of certified Electronic Health Record (EHR) technology and will help to close the health IT adoption gap in the United States. We agree with Dr. David Blumenthal, of the Office of Page 1 of 18 8
  9. 9. Top Items for 2013 – Fiscal Stability, C&BI, Value of Health IT to Secure MU – Interoperability – Addressing Scrutiny from Congress – Meaningful Use – Delivering on MU2; Preparing for MU3 – Affordable Care Act Requirements –Eligibility, EFT/ERA, Insurance Exchanges, Results of Payment Reform Initiatives – Fraud/Abuse/Compliance – Code of Conduct – Patient Safety/ Device Regulation/Patient Data Matching – ICD-10 Implementation – Relevance to HCT – Workforce Development – New Careers, Hiring Vets – Consumer Engagement & Mobile Health – Privacy and Security 9
  10. 10. Top 3 Congressional Affairs Priorities for 2013 • Preserve HITECH EHR Incentive Program Funding In Austere Times • Advance the Patient Data Matching Strategy • Educate the 113th Congress on Health IT Potential and Issues – Dispel with Facts the Fraud and Abuse Concerns – Impress upon Congress the Successes of the Health IT/MU Program – Advance Congressional Understanding of Interoperability – Advance Congressional Understanding of Privacy and Security – Build Congressional Support for Adhering to the ICD-10 Implementation Date – Focus on Key Committee Leadership and staff – Focus on Educating New Members and staff
  11. 11. • The Economy and Jobs • Federal Budget • 12 Congressional Appropriations Bills • The Federal Budget Deficit • Entitlement programs (Social Security, Medicare, and Medicaid) • Sequestration • Healthcare Reform • (Medicare, Medicaid, CHIP) • Congressional Reform • Senate Rules on 60 votes to end debate (filibuster) and rule allowing a single member hold on legislation, earmarks, and the appropriations process Congressional Priorities for 2013 11
  12. 12. Sequestration • Legal procedure to enact automatic across-the-board spending cuts to non-exempt mandatory programs – Programs exempted from sequestration were Social Security, Medicaid, military pay and veterans’ benefits • Reductions take effect January 2, 2013 • Time for Congress to pass new law prior to effective date • President Obama has said he would veto any legislation to modify this program • Sequestration requires a minimum of $1.2 trillion in deficit reduction over ten years 12
  13. 13. Potential Implications for Health IT • Medicare Reimbursement under Sequestration limited to 2% cut – Excluding Medicare Sustainable Growth Rate (SGR) fix • Any reduction in Medicare reimbursement not good for EHR Adoption • Uncertainty around implications for Health IT and HITECH EHR Incentive Program • Congressional intent is expressed in the HITECH Act • Both Bush and Obama Administrations have supported EHR/HIE Adoption • Congressional leaders still express bipartisan support for EHR/HIE Adoption 13
  14. 14. Congressional Interest in Health IT Reboot: Re-examining the Strategies Needed to Successfully Adopt Health IT April 16, 2013 • Senators John Thune (R-ND) • Lamar Alexander (R-TN) • Pat Roberts (R-KS) • Richard Burr (R-NC) • Tom Coburn (R-OK) • Mike Enzi (R-WY) 14
  15. 15. Senators’ Reboot Whitepaper 1. Lack of Clear Path To Interoperability (HIMSS PPP Sec 4) 2. Misuse of EHRs May Actually Increase Health Care Costs (HIMSS PPP #s 3.15 and 5.5) 3. Insufficient Oversight Has Put Taxpayer Money at Risk (HIMSS PPP Sec 4) 4. Long-Term Questions on Data Security and Patient Safety Remain (HIMSS PPP Sec 5 and 6) 5. Questions Remain About Long-Term Sustainability of the EHR Program (HIMSS PPP #s 4.10 and 14.8) HIMSS 2013 – 2014 Public Policy Principles Approved by the Board of Directors on December 7, 2012 15
  16. 16. Federal Healthcare issues • Costs Control – Medicare and Medicaid • Payment Reform • Medicare Sustainable Growth Rate (SGR or “Doc Fix”) • Quality and Value • Provider Availability and Mix • Access to Care / Rural / Underserved Communities • Demographics • Patient Engagement / Lifestyle • Chronic Disease Management • ICD-10 Adoption
  17. 17. .  There were 7,031 bills and variations of bills introduced in the First Session (2011) of the 112th Congress alone  Includes Senate House and Bills, Joint Resolutions, Concurrent Resolutions, and Simple Resolutions  Does not include the multitude of amendments offered  Does not reflect the multitude of hearings, reports, markups statements, press releases, and floor debates and statements
  18. 18. Health IT Related Legislation at Federal Level 18 • HR 28, Working Families' Access to Health Innovations Act of 2013 • HR 756, Cybersecurity Enhancement Act of 2013 • HR 983, Online Communications and Geo-location Protection Act of 2013 • HR 986, Rural Health Clinic Fairness Act of 2013 • HR 1309, Health Information Technology Reform Act • HR 1326, Health Care Price Transparency Promotion Act of 2013 • HR 1331, Electronic Health Records Improvement Act of 2013 • HR 1379, Puerto Rico Hospital HITECH Amendments Act of 2013 • HR 1701, Cutting Costly Codes Act of 2013 • HR 1790, Health IT Modernization for Underserved Communities Act of 2013
  19. 19. Health IT Related Legislation at Federal Level (continued) • HR 1913, Application Privacy, Protection, and Security Act of 2013 • S 612, Social Security Number Protection Act of 2013 • HR 523 Protect Medical Innovation Act of 2013 • HR 29, Mobile Medical Homeless Health Improvement Act of 2013 • HR 581, First Responder Medical Device Tax Relief Act HR 1295, Medical Device Tax Elimination Act • S 21, Cybersecurity and American Cyber Competitiveness Act of 2013 • S 232, Medical Device Access and Innovation Protection Act • S 467, Wireless Device Independence Act of 2013 • S 490, Mobile Mammography Promotion Act of 2013
  20. 20. Health IT Related Legislation at Federal Level (continued) • Privacy and Security of Personal Health IT • Meaningful Use Incentive Eligibility Expansion • Regulation of Medical Devices and Apps • Cybersecurity Enhancement • Regulation EHRs as Medical Devices • Broadband and Rural Access • Mitigate Meaningful Use Adoption Penalties
  21. 21. TIER 1: ONC DoD* VA CMS* CDC* FDA IHS* HRSA* OMB/EOP HITPC + HITSC TIER 2: AHRQ, NIST, DO C, OMH, OCR, S SA, NCVHS, FCC TIER 3: OPM, DEA, IRS, SAMSHA, FTC, NSF, USDA, DHS, DoC Federal Affairs Team Tiered External Focus *Organizational Affiliate Government Services 21
  22. 22. 22 Regulatory Agency Regulatory Activity NPRM Due Date(s) Anticipated Final Rule Published Centers for Medicare and Medicaid Services (CMS) Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Fiscal Year 2014 Rates; Quality Reporting Requirements for Specific Providers; Hospital Conditions of Participation NPRM Comments Due: June 25, 2013 TBD Centers for Medicare and Medicaid Services (CMS) and Office of Inspector General (OIG) CMS: Medicare Program; Physicians’ Referrals to Health Care Entities With Which They Have Financial Relationships: Exception for Certain Electronic Health Records Arrangements OIG: Medicare and State Health Care Programs: Fraud and Abuse; Electronic Health Records Safe Harbor under the Anti- Kickback Statute Joint NPRMs Due: June 10, 2013 TBD Centers for Medicare and Medicaid Services (CMS) and Office of the National Coordinator for Health IT (ONC) Request for Information on Advancing Interoperability and Healthcare Information Exchange HIMSS Submitted Comments April 18, 2013 RFI Comments Due: April 22, 2013 TBD Federal Health IT Regulatory Activity
  23. 23. 23 Regulatory Agency Regulatory Activity NPRM Due Date(s) Anticipated Final Rule Published Centers for Medicare and Medicaid Services (CMS) Request for Information on Use of Clinical Quality Measures (CQMs) Reported under the Physician Quality Reporting System (PQRS), the Electronic Health Record (EHR) Incentive Program, and Other Reporting Programs HIMSS Submitted Comments April 8, 2013 RFI Comments Due: April 8, 2013 NPRM TBD Office of National Coordinator for Health IT (ONC) Health IT Patient Safety Action & Surveillance Plan for Public Comment – Released December 21, 2012 HIMSS Submitted Comments February 4, 2013 RFC Comments Due: February 4, 2013 Final Plan TBD Centers for Medicare and Medicaid Services (CMS) Request for Information on Hospital and Vendor Readiness for Electronic Health Records Hospital Inpatient Quality Data Reporting HIMSS Submitted Comments February 1, 2013 RFI Comments Due: February 1, 2013; NPRM TBD NPRM TBD Office of Civil Rights (OCR) Final Omnibus Privacy Rule: Breach Notification, HIPAA Modifications, Protected Health Information, GINA and Privacy Protections Multiple NPRMs led to this Omnibus Final Rule Final Rule Published January 17, 2013 Federal Health IT Regulatory Activity
  24. 24. 24 Regulatory Agency Regulatory Activity NPRM Due Date(s) Anticipated Final Rule Published Centers for Medicare and Medicaid Services (CMS) Meaningful Use Stage 3 Request for Comments to the Health IT Policy Committee-- Released November 26 HIMSS Response Letter to Health IT Policy Committee Proposed Meaningful Use Stage 3 Request for Comment HIMSS Response to HITPC on Stage 3 Proposed Objectives and Measures NPRM Anticipated TBD 2014; Stage 3 will not be introduced in 2013 TBD 2014 Centers for Medicare and Medicaid Services (CMS) Administrative Simplification: Adoption of Operating Rules for Electronic Funds Transfer and Electronic Remittance Advice – IFR Released. HIMSS Submitted Comments October 9, 2012. Released: August 10, 2012; Comments Due: October 9, 2012 Now Final: No changes from proposed IFR HHS Office of Civil Rights (OCR) HIPAA Privacy Rule Accounting of Disclosures under the Health Information Technology for Economic and Clinical Health Act NPRM Released 2011 Final Plan Still TBD Federal Health IT Regulatory Activity
  25. 25. 25 Public Policy Tools and Resources HIMSS Members and HIMSS Committees, WGs and TFs Fact Sheets and Position Statements Legislative Action Center HIMSS Public Policy Principles Calls for Action HIMSS Health IT Policy Update (subscribe at HIMSS Advocacy and Public Policy webpage Collaboration with other similar minded organizations
  26. 26. “Obama Care” Patient Protection and Affordable Care Act 2010 (PPACA or ACA) Signed March 23, 2010 (PL 111-148, PL 111-152). • 2010: A new Patient’s Bill of Rights goes into effect, protecting consumers from the worst abuses of the insurance industry. Cost-free preventive services begin for many Americans. 2011: People with Medicare can get key preventive services for free, and also receive a 50% discount on brand-name drugs in the Medicare “donut hole.” 2012: Accountable Care Organizations and other programs help doctors and health care providers work together to deliver better care. 2014: All Americans will have access to affordable health insurance options. The new Health Insurance Marketplace will allow individuals and small businesses to compare health plans on a level playing field. Middle and low-income families will get tax credits that cover a significant portion of the cost of coverage. And the Medicaid program will be expanded to cover more low-income Americans. All together, these reforms mean that millions of people who were previously uninsured will gain coverage, thanks to the Affordable Care Act.
  27. 27. ICD-10 Implementation Date • ICD-10 is the very basic foundation for other healthcare transformation efforts, including Meaningful Use. • ICD-10-CM/PCS will have positive implications for patients. Better clinical intelligence data can describe multiple levels of severity, which should result in improved care algorithms to support accurate, more individualized patient care and lead to or promulgate improved outcomes. • ICD-10-CM/PCS will provide more accurate payment structures for providers over time. • ICD-10 has the potential to reduce costly requests for health information. • Increased research capabilities, quality metrics and public health tracking and reporting made possible due to ICD-10 cannot be overemphasized • The ICD-9 numbering system cannot accommodate today’s current medical technology used for patient procedures • Continued use of ICD-9, with its limited codes, will hinder progress towards clinical best practice and evidence-based medicine.
  28. 28. The Meaningful Use Program Stage 1: 2011-2012 Data capture and sharing Meaningful use criteria focus on: Stage 2: 2014 Advance clinical processes Meaningful use criteria focus on: Stage 3: 2016 Improved outcomes Meaningful use criteria focus on: • Electronically capturing health information in a standardized format • More rigorous health information exchange (HIE) • Improving quality, safety, and efficiency, leading to improved health outcomes • Using that information to track key clinical conditions • Increased requirements for e- prescribing and incorporating lab results • Decision support for national high-priority conditions • Communicating that information for care coordination processes • Electronic transmission of patient care summaries across multiple settings • Patient access to self- management tools • Initiating the reporting of clinical quality measures and public health information • More patient-controlled data • Access to comprehensive patient data through patient- centered HIE • Using information to engage patients and their families in their care • Improving population health
  29. 29. Components of health IT • Capturing Data – Electronic Health Records • Interoperability – Exchanging Data – Coordination of Care • e-Prescribing – Patient Compliance • Quality Reporting and Improvement • Clinical Decision Making Support • Secondary Uses • Public Health and Population Health Management • Research and Clinical Trials • Patient Engagement – Patient Portal / Personal Health Records • Big Data Implications!
  30. 30. Health Information Technology Issues • Historic Bipartisan Approach to Health IT • Consumer/Patient Engagement • Differing Privacy and Security Laws Across Jurisdictions • Fraud/Abuse/Compliance • Health Information Exchanges, Survivability • ICD-10 Implementation • Interoperability, Addressing Scrutiny from Congress • Meaningful Use, Delivering on MU2; Preparing for MU3 • Mobile Health, Security, Regulation, Definition • Nationwide Patient Data Matching Strategies • Patient Safety/ Device Regulation/Patient Data Matching • Privacy and Security • Value of Health IT to Secure MU • Workforce Development, Adequate Workforce, New Careers, Veterans • Managing Expectations
  31. 31. Patient Identity Integrity Solution • Information exchange requires accurate, robust patient matching methods to ensure the right patients are receiving the right treatments at the right time • Unique patient identifier concept surfaced within the healthcare industry to ameliorate mismatching and realize full benefits of HIE to ensure patient safety • 1998 Federal legislation prohibits HHS from studying the feasibility or impact of national patient identifiers • Prohibition has forced numerous marketplace solutions, yet a lack of national standards has led to differing and suboptimal approaches to patient-data matching 31
  32. 32. FDA Regulating EHRs as Medical Devices • Per FDA, health IT has advanced so far that the professional intermediary is no longer required or used • “Under the Federal Food, Drug, and Cosmetic Act, health IT software is a medical device.” • Per voluntary reports from patients, clinicians, and user facilities, the FDA cites data indicating 260 reports of HIT-related adverse events, including 44 reported injuries and 6 reported deaths • FDA issued a final rule in February 2011 classifying “Medical Device Data Systems” as low Class 1 Medical Devices, requiring post-market surveillance - Testimony of Dr. Jeffery Shuren, Director for FDA Center for Devices and Radiological Health to the HIT Policy Committee 2/25/10 32
  33. 33. . 33 17 21 25 34 4042 48 51 57 72 0 10 20 30 40 50 60 70 80 2008 2009 2010 2011 2012 PercentofPhysicians Percent of office-based physicians with EHRs: 2008-2012 SOURCE: ONC analysis of 2009-2012 National Electronic Health Records Surveys. Basic EHR Any EHR
  34. 34. . 34 9.4 12.2* 15.6* 27.6* 44.4* 71.9 85.2* 0 10 20 30 40 50 60 70 80 90 2008 2009 2010 2011 2012 PercentofHospitals Basic EHR System Certified EHR Percent of hospitals with EHRs: 2008-2012 Basic EHR includes clinician notes. A certified EHR has been certified as meeting federal requirements for the hospital objectives of Meaningful Use. *Significantly different from previous year (p < 0.05). SOURCE: ONC/American Hospital Association (AHA), AHA Annual Survey Information Technology Supplement
  35. 35. . 35 Progress of Eligible Providers in the Medicare and Medicaid EHR Incentive Programs as of January 2013 Eligible HospitalsEligible Professionals SOURCE: Medicare and Medicaid EHR Incentive Program Data
  36. 36. 7/23/2013 Office of the National 36
  37. 37. 39 Institute for e-Health Policy Launched in May 2008 under HIMSS Foundation. Complimenting services of HIMSS Government Relations Department. Key Projects: Capitol Hill Steering Committee on Telehealth and Healthcare Informatics Seminars. National HIT Collaborative for the Underserved: Public/Private Partnership for a Healthier America in conjunction with HHS. Executive-in-Residence Program. Government Relations Internship Program. National Health IT Week – September.
  38. 38. 40 HIMSSStrategic Relationships HIMSSContentand TechnicalExpertise Government Relations PublicAffairs,Media,Web Services,andMarketing RegionalandStateAffairs. Chapters,andCARs HIMSSBoard,Committees &Members HIMSS Public Policy Impactfulness Education MeetingServices
  39. 39. 41 What happens in Washington does matter!
  40. 40. Questions? HIMSS Government Relations Team Thomas M. Leary, MPA, CAE, FHIMSS, VP Government Relations, 703-562-8814 Leslie Irvine, Coordinator, Government Relations, 703-562-8815 Richard M. Hodge, MBA, MPA, Senior Director, Congressional Affairs, 703-562-8847 Elinore Boeke, Senior Manager, Public Policy Communications, 703-562-8817 Arnol Simmons, Manager, Public Policy Initiatives, 703-562-8826 Neal Neuberger, Executive Director, Institute for e-Health Policy, 703-508-8182 Kathie Westpheling, MPH, Manager, Public Policy, 703-562-8831 Simeon Niles, Executive in Residence, 571-437-6167 TBD, Senior Director, Federal Affairs, 703-562-8814 Stephanie Jamison, Federal Affairs, 793-562-8844 Katie Boyer, Federal Affairs, 793-562-8872 Evan Yeckley, Coordinator, Federal Affairs, 703-562-8824 HIMSS National Capital Area Office 4300 Wilson Boulevard, Suite 250 Arlington, VA 22203