Healthcare Reform & Women in Surgery: Opportunities & Challenges

1. Healthcare Reform & Women in Surgery:Opportunities & Challenges Barry M. Straube, M.D. Immediate Past (Retired) Chief Medical Officer, Centers for Medicare & Medicaid Services October 23, 2011 Association of Women Surgeons

3. Shifting of the Poles

4. The Healthcare Quality/Value Challenges • In the U.S. we spend more per capita on healthcare than any other country in the world • In spite of those expenditures, U.S. Healthcare quality is often inferior to that of other nations and often doesn’t meet expected evidence-based guidelines • There are significant variations in quality and costs across the nation with increasing evidence that there may be an inverse relationship between the two • Healthcare expenditures account for a larger section of the U.S. economy over the years and funding those expenditures is increasingly more difficult

5. The HealthcareQuality/Value Challenges • There continues to be considerable waste in the delivery of healthcare, as well as fraud & abuse • CMS/HHS, and the executive branch is responsible for the healthcare of a growing number of persons in the public sector, and influences healthcare quality in the private sector • CMS/HHS, in partnership/collaboration with other healthcare leaders, must address these issues • Academic Medical Centers & Surgeons could provide great value • Health Information Technology is indispensable in this • The Affordable Care Act of 2010 is a major step forward to address the healthcare quality/value challenges

6. The “Triple Aim” Better Health for the Population Better Care for Individuals Lower Cost Through Improvement

7. IOM Aims for Quality Improvement • Safety • Effectiveness • Patient-centeredness • Timeliness • Efficiency • Equity

8. Department of Health & Human Services Veterans Affairs Department of Defense Department of Labor Department of Housing & Urban Development United States Coast Guard Office Personnel Management Federal Bureau of Prisons Federal Trade Commission Office of Management & Budget Department of Commerce National Highway Transportation & Safety Administration Federal Stakeholders in the U.S. Healthcare System

9. Secretary of HHS Administration for Children and Families Administration on Aging Agency for Healthcare Research & Quality Agency for Toxic Substances & Disease Registry Centers for Disease Control Centers for Medicare & Medicaid Services (CMS) Food & Drug Administration Health Resources & Services Administration Indian Health Service National Institute of Health Program Support Center Substance Abuse & Mental Health Services Administration Multiple other Assistant Secretaries Department of Health & Human Services:Agencies

10. Centers for Medicare & Medicaid Services (CMS) • Will provide health benefits for over 114 million Americans in FY 2011 PP Budget • Medicare – 48.1 million beneficiaries • Medicaid – 56.1 million beneficiaries • CHIP– 10 million beneficiaries • Will spend $784 billion in FY 2011 PP Budget • Medicare - $476 billion • Medicaid - $297 billion • CHIP - $11 billion • Effective January, 2011 incorporated the Office of Consumer Information and Insurance Oversight (OCIIO) as part of CMS

11. Ongoing CMS Core Medicare Work • Provider payment-focused activities • Efficient, timely, accurate payment of claims • Ongoing demonstrations and pilots of alternative payment methodologies and systems • Addressing fraud & abuse • Beneficiary focused activities • Benefit education • Health promotion and disease management education • Beneficiary protection and advocacy • Multiple tools to improve quality, efficiency and value • Data collection & availability 11

12. Partners/Targets For Advocacy • Federal Government • Congress • House: Ways & Means, Energy & Commerce • Senate: Finance, HELP • A variety of caucuses • White House • Many senior advisors • Office of Management & Budget

13. Partners/Targets For Advocacy • Executive Branch Agencies • U.S. Department of Health & Human Services (HHS) • Office of the Secretary, Office of the Assistant Secretary of Health • Centers for Medicare & Medicaid Services (CMS) • Agency for Health Research & Quality (AHRQ) • Centers for Disease Control (CDC) • Food & Drug Administration (FDA) • Health Resources and Service Administration (HRSA) • National Institutes of Health (NIH) • Office of the National Coordinator (ONC) for HIT • Many other HHS and other federal agencies have influence over surgical topics and issues

14. Partners/Targets For Advocacy • Centers for Medicare & Medicaid Services • Office of the Administrator • Key Surgery Areas • Office of Clinical Standards & Quality (OCSQ) • Conditions of Participation, Conditions for Coverage • Quality Improvement and Measurement • Quality Improvement Organizations (QIOs) and ESRD Networks • Information Services: Clinical Data systems • Coverage decision making • Center for Medicare • Payment • Center for Medicaid • State Survey Agencies and regulatory oversight processes • Regional Offices (10) • Innovation Center

15. Partners/Targets For Advocacy • State Governments • Dialysis Providers/Organizations • Professional Associations • Renal Physicians Association • American Society of Nephrology • American Nephrology Nurses Association • National Renal Administrators Association • American Medical Association • Kidney Care Partners • Kidney Care Quality Alliance • Private health plans • Patient Advocacy Organizations: Should probably be #1 stop

16. Some Personal Notions & Experience • Know the framework of the regulatory system that affects you, the people who run it, and work with them • Congress passes laws (statutes) that direct federal agencies what to do and defines their authorities • The President can sign or veto any law passed • Agencies implement laws, following Congressional directives and “intent”, but if unclear have discretion to interpret the law as the agency (and executive branch leadership sees fit • Regulations, through public rulemaking • Administrative rulings, sometimes, with or without public comment • Guidance and directives through manuals, letters, and other mechanisms • There are multiple points at which advocates can effectively influence the above

17. Some Personal Notions & Experience • Advocates can and do have major influence on the federal framework • With regards to federal rulemaking • Notice of Proposed Rule Making (NPRM) • 30-90 days of public comment • Agency reviews comments, responds to all comments, and revises the proposed rule as indicated • Final Rule is issued, published and implemented • Cycles of rulemaking at CMS • If final rules are unacceptable • Influence subsequent laws and regulations • Judicial challenges • Elect new leaders

18. Ensuring Quality & Value:CMS Tools/Drivers/Enablers • “Contemporary Quality Improvement” • Transparency: Public Reporting & Data Sharing • Incentives: Financial through payment reform • Regulatory vehicles • National & Local Coverage Decisions • Demonstrations, pilots, research, innovation

19. “Contemporary” Quality Improvement • Need to set priorities, goals and objectives, strategic framework first • Evidence-Based goals, metrics, interventions, evaluations • Includes conformance with evidence-based guidelines, balanced with patient-centered considerations • Cost-effectiveness, let alone comparative effectiveness, has not yet been addressed adequately • Rapid-cycle development, implementation and change methodology • Leveraging of resources and efforts: Current and future models-collaboration, alignment, synergy, priorities • Many examples: Hospital Quality Initiative, Organ Donation Campaign, QIOs, ESRD Networks, IHI, Bridges to Excellence, NCQA, Nursing & Home Health Campaigns, many health plan collaboratives, local collaboratives, etc.

20. “Contemporary Quality Improvement”: Collaboratives & Communities • Quality Improvement Organization (QIO) 9th SOW • Care Transitions Theme • “Every Diabetic Counts” • Mississippi Health First (expanding to Texas) • Links to: • ACA Section 3025: Hospital Readmissions Reduction Program • ACA Section 3026: Community-Based Care Transitions Program

21. Transparency:Public Reporting & Data Availability • CMS Compare Websites • Hospital Compare • Nursing Home Compare • Home Health Compare • Dialysis Facility Compare • MA Health Plan and Medi-Gap Compare • Prescription Drug Plan Compare • New under ACA • Physician Compare • VBP Programs: Above plus ASCs, LTCHs, IRHs, Hospices, others • MyMedicare.gov • HHS/CMS Data Dissemination Efforts: www.data.gov, www.healthcare.gov • Potential explosion of federal government data availability for private sector to drive data use innovation in previously unimaginable ways

22. Surgical Care Improvement Project Process of Care

23. Heart Attack-Chest Pain Process of Care

24. Heart Failure Process of Care

25. Pneumonia Process of Care

26. Outcomes Measures: Mortality

28. Outcome Measures: Readmission Rates

30. Medicare Payment & Volume Data

31. Medicare Payment & Volume Data

32. Incentives • Current: Pay for Reporting and Adoption Programs • P4R: Hospital Inpatient/Outpatient , PQRI, e-Prescribing • ARRA /HITECH: EHR adoption and “meaningful use” • Value-based Purchasing (VBP) • Hospital VBP Report to Congress (Nov 2007) • Physician VBP RTC (2010) • ESRD Quality Incentive Program (QIP) January 1, 2012 • Hospital VBP (ACA Section 3001) by October 1, 2012 • ACA mandates VBP in many additional settings • Competitive bidding, gain sharing, shared savings, bundled payment, ACOs, medical homes, salaries, integrated delivery, etc.

33. Incentives:CMS Hospital Quality Initiative National Voluntary Hospital Reporting Initiative (NVHRI) public-private initiative Federation of American Hospitals AHA AAMC CMS , JCAHO, others Hospital Quality Alliance Medicare Modernization Act of 2003: Section 501b – Financial incentive of 0.4%

34. Other Pay for Reporting Programs • Hospital Inpatient Quality Reporting Program • Hospital Outpatient Quality Reporting Program • Physician Quality Reporting System (PQRS) • E-prescribing Program • HITECH Meaningful Use Programs • Home Health Reporting Program

35. PQRS 2011 Overview Toward Value-Based Purchasing VBP • 2007 • TRHCA • 74 measures • Claims-based only • 2008 • MMSEA • 119 measures • Claims • 4 Measures Groups • Registry • 2009 • MIPPA • 153 measures • Claims • 7 Measures Groups • Registry • EHR-testing • eRx • 2010 • MIPPA • 175 individual measures • Claims • 13 Measures Groups • Registry • EHRs • eRx • Large Groups • 2011 • ARRA and ACA • 190 individual measures • Claims • 14 Measures Groups • Registry • EHRs • eRx • Large Groups • Small Groups • Maintenance of Certification • Physician Compare Web Site

36. Goals for Value Based Purchasing • Incentivize the best care and improve transparency for Beneficiaries • Transform CMS from a passive payer to an active purchaser of care • Link payment to quality outcomes and stimulate efficiencies in care • Recognize and address potential unintended consequences for Beneficiaries

37. Hospital Value Based Purchasing : Background • Hospital Value Based Purchasing Report to Congress 2007 • Premier Demonstration and other Demos • Experience with other reporting programs • Hospital Inpatient and Outpatient Quality Reporting Programs • Physician Quality Reporting System • ESRD Quality Incentive Program beginning January 1, 2012

38. Hospital Value Based Purchasing Program (HVBP) • Affordable Care Act (ACA), Section 3001 • Effective date: FY2013 payment for discharges on or after October 1, 2012 • Criteria: • Must be a Hospital Inpatient Quality Reporting Program participant • Meets quality metrics by demonstrating improvement or high levels of achievement

39. Hospital Value Based Purchasing • FY2013 Medicare payment based on quality measure performance • 5 Clinical topics • Acute Myocardial Infarction • Heart Failure • Pneumonia • Surgeries and Hospital Acquired Infections (HAIs) • HCAHPS patient survey

40. Hospital Value Based Purchasing • Replace current 2% with HVBP in a 5-year phased in approach between FY 2013 and FY 2017. *Annual Payment Update **Reduction from the Base DRG payment for all hospitals

41. Regulation • Conditions of Participation or Conditions for Coverage • COPs are minimum health and safety standards set by CMS for facilities that may receive Medicare payments • 17 separate provider/supplier settings have COPs • Survey & Certification • U.S. healthcare facilities certified must be in compliance with current Medicare regulations & applicable state laws • S&C process uses interpretive guidelines to assess compliance with regulations • In combination, a powerful tool for quality/value

42. Other Tools • National Coverage Decisions, Payment Policy, Benefit Design • Deciding whether a device, service or therapy is paid for (or not) can influence quality of care • E.g., Non-payment for Hospital Acquired Conditions (HACs) • E.g., Non-coverage of “Never Events” for both hospitals or physicians • E.g., limitation of services to “qualified” facilities or providers, such as ICD implantation, etc. • CED and use of registries collects further quality information • Patient incentives: Waiver of co-pays • Demonstrations, pilots, research • Numerous CMS Demonstrations in past and going forward with the ACA

43. Conclusions • CMS Statutory Authority provides powerful tools to focus on improving quality, value & patient safety • QI by providers, payers, collaboratives, others • Transparency: Public Reporting and Data Dissemination • Incentives • Regulatory compliance • Coverage, benefit, and utilization purposes • Research and Demonstrations • Health Information Technology essential to above • Opportunities for input & alignment abound

44. Conclusions • CMS Statutory Authority provides powerful tools to focus on improving quality, value & patient safety • QI by providers, payers, collaboratives, others • Transparency: Public Reporting and Data Dissemination • Incentives • Regulatory compliance • Coverage, benefit, and utilization purposes • Research and Demonstrations • Health Information Technology essential to above • Opportunities for input & alignment abound • Academic Medical Centers have a potential major leadership role

45. Affordable Care Act (ACA) of 2010 • Patient Protection & Affordable Care Act (PPACA) • Health Care & Reconciliation Act of 2010 (HCERA) • Affordable Care Act of 2010 (ACA)

46. Affordable Care Act (ACA) of 2010 • Title I: Quality, Affordable Health Care for all Americans • Title II: Role of Public Programs • Title III: Improving the Quality & Efficiency of Health Care • Title IV: Prevention of Chronic Disease & Improving Public Health • Title V: Health Care Work Force

47. Affordable Care Act (ACA) of 2010 • Title VI: Transparency and Public Reporting • Title VII: Improving Access to Innovative Medical Therapies • Title VIII: Community Living Assistance Services & Support (CLASS) Act • Title IX: Revenue Provisions • Title X: Strengthening Quality, Affordable Health Care for All Americans (Amendments)

48. ACA & Women • Search term “women” • 145 instances • Mostly relate to “women’s health” and “women as patients” • Frequent linkage to “pregnant” or “young” modifiers • Search term “surgeon” • 41 instances, most “Surgeon General” • 2 instances: American College of Surgeons-trauma center accreditation and guidelines • 5 Instances: General surgeons-rural, committees

49. ACA & Surgeons • Search term “surgery” • 10 total instances • 4 instances: Cosmetic surgery-5% tax • 3 instances: “General Surgery” services • Search term “surgical” • Ambulatory Surgical Centers (8): VBP plan mandated to Congress by 1/1/2011 • “Surgical specialties”

50. High Profile ACA Topics • Greater Access to healthcare coverage • National Priorities & Strategic Plan • HHS Interagency Quality Work Group • Quality Measurement comment by NQF • Data collection and national work plan • Focus on outcomes, efficiency • Patient Centeredness • High-cost Chronic Disease Management • Care coordination & care transitions