Working with Regulators: A Focus on CMS | June 24, 2014 | All Slides

1. www.CancerSupportCommunity.org Uniting The Wellness Community and Gilda’s Club Worldwide 1

2. In Pursuit of Person-centered Cancer Care Engaging Patients & Families Shari M. Ling, MD CMS Deputy Chief Medical Officer Center for Clinical Standards and Quality Cancer Policy Institute at the Cancer Support Community June, 2014

3. • Patient-centered measures of cancer care are critical to incentivize improvement in the care for patients with cancer • Most measures for Oncologists, radiation oncologists and Cancer hospitals have been measures of the technical approaches/processes that should lead to improved outcomes • CMS would very much welcome input from the Cancer Support Community on the quality issues that most affect patients and caregivers that could inform our measure development efforts • CMS is also working with external stakeholders, including private payers, to align on the best measures for use across settings. This alignment will reduce reporting burden for clinicians, and will ensure a consistent focus on the quality issues that matter most to patients. Framing

4. Size and Scope of CMS Responsibilities • CMS is the largest purchaser of health care in the world. • Combined, Medicare and Medicaid pay approximately one-third of national health expenditures (approx $800B) • CMS programs currently provide health care coverage to roughly 105 million beneficiaries in Medicare, Medicaid and CHIP; or roughly 1 in every 3 Americans. • The Medicare program alone pays out over $1.5 billion in benefit payments per day. • Through various contractors, CMS processes over 1.2 billion fee-for- service claims and answers about 75 million inquiries annually. • Millions of consumers will receive health care coverage through new health insurance exchanges authorized in the Affordable Care Act.

5. Delivery system and payment transformation 5 PUBLIC SECTOR Future State – People-Centered Outcomes Driven Sustainable Coordinated Care New Payment Systems (and many more)  Value-based purchasing  ACOs, Shared Savings  Episode-based payments  Medical Homes and care mgmt  Data Transparency Current State – Producer-Centered Volume Driven Unsustainable Fragmented Care FFS Payment Systems PRIVATE SECTOR

6. Transformation of Health Care at the Front Line • At least six components – Quality measurement – Aligned payment incentives – Comparative effectiveness and evidence available – Health information technology – Quality improvement collaboratives and learning networks – Training of clinicians and multi-disciplinary teams 6 Source: P.H. Conway and Clancy C. Transformation of Health Care at the Front Line. JAMA 2009 Feb 18; 301(7): 763-5

7. Questions to Run on… • What are the outcomes that matter? – For patients, families, providers, systems • How do we best align around those outcomes? – Within and across clinical care settings – Across research and health care • What are the obstacles we need to overcome?

8. CMS Authorized Programs & Activities CMS HHSSurvey & Cert. Payment Value-based Purchasing Quality Improvement Clinical Standards Quality & Public Reporting Coverage Program Integrity CMMI & Medicaid Reducing & Preventing Health Care Associated Infections Reducing & Preventing Adverse Drug Events Community Living Council Multiple Chronic Conditions National Alzheimer’s Project Act Partnership for Patients Million Hearts Data.gov Coverage of services Physician Feedback report Quality Resource Utilization Report Hospital Readmissions Reduction Program Health Care Associated Conditions Program ESRD QIP Hospital VBP Physician value modifier Plans for Skilled Nursing Facility and Home Health Agencies, Ambulatory Surgical Centers QIOs ESRD Networks Hospital Inpatient Quality Hospital Outpatient In-patient psychiatric hospitals Cancer hospitals Nursing homes Home Health Agencies Long-term Care Acute Hospitals In-patient rehabilitation facilities Hospices Accountable Care Organizations Community Based Transitions Care Program Dual eligible coordination Care model demonstrations & projects 1115 Waivers Hospitals, Home Health Agencies, Hospices, ESRD facilities National & Local decisions Mechanisms to support innovation (CED, parallel review, other) Target surveys Quality Assurance Performance Improvement Fraud & Abuse Enforcement

9. CMS framework for measurement maps to the six national priorities Greatest commonality of measure concepts across domains – Measures should be patient- centered and outcome- oriented whenever possible – Measure concepts in each of the six domains that are common across providers and settings can form a core set of measures Person- and Caregiver- centered experience and engagment •CAHPS or equivalent measures for each settings •Shared decision-making Efficiency and cost reduction •Spend per beneficiary measures •Episode cost measures •Quality to cost measures Care coordination •Transition of care measures •Admission and readmission measures •Other measures of care coordination Clinical quality of care •HHS primary care and CV quality measures •Prevention measures •Setting-specific measures •Specialty-specific measures Population/ community health •Measures that assess health of the community •Measures that reduce health disparities •Access to care and equitability measures Safety •Healthcare Acquired Infections •Healthcare acquired conditions • Harm

10. Hospital Quality Reporting • Medicare and Medicaid EHR Incentive Program • PPS-Exempt Cancer Hospitals • Inpatient Psychiatric Facilities • Inpatient Quality Reporting • Outpatient Quality Reporting • Ambulatory Surgical Centers Physician Quality Reporting • Medicare and Medicaid EHR Incentive Program • PQRS • eRx quality reporting PAC and Other Setting Quality Reporting • Inpatient Rehabilitation Facility • Nursing Home Compare Measures • LTCH Quality Reporting • ESRD QIP • Hospice Quality Reporting • Home Health Quality Reporting Payment Model Reporting • Medicare Shared Savings Program • Hospital Value- based Purchasing • Physician Feedback/Value- based Modifier* “Population” Quality Reporting • Medicaid Adult Quality Reporting* • CHIPRA Quality Reporting* • Health Insurance Exchange Quality Reporting* • Medicare Part C* • Medicare Part D* 10 CMS Quality Programs * Denotes that the program did not meet the statutory inclusion criteria for pre-rulemaking, but was included to foster alignment of program measures.

11. PCHQR – Background • PCHQR Statutory Authority and Initial Implementation Date – Section 3005 of the Patient Protection and Affordable Care Act (ACA) – Implemented October 1, 2012 • Statutory Authority for Medicare Fee-for-Service Payment – Section 1886 (d)(1)(B)(v) of the Social Security Act excludes 11 cancer hospitals as designated by Congress from payment under the Inpatient Prospective Payment System (IPPS) • List of PCHs: http://www.cms.gov/Medicare/Medicare-Fee-for-Service- Payment/AcuteInpatientPPS/PPS_Exc_Cancer_Hospasp.html 11

12. Existing PCHQR Measures SCIP (6) • Surgery Patients who Received Appropriate VTE Prophylaxis within 24 Hrs Prior to Surgery to 24 Hrs After Surgery End Time • Urinary Catheter Removed on Post- Operative Day 1 or Post-Operative Day 2 with Day of Surgery Being Day Zero • Prophylactic Antibiotic Received Within 1 Hr Prior to Surgical Incision • Prophylactic Antibiotic Selection for Surgical Patients • Prophylactic Antibiotics Discontinued Within 24 Hrs After Surgery End Time • Surgery Patients on Beta Blocker Therapy Prior to Admission who Received a Beta Blocker During the Perioperative Period Clinical Process / Oncology Care (5) • Oncology-Radiation Dose Limits to Normal Tissues • Oncology: Plan of Care for Pain • Oncology: Pain Intensity Quantified • Prostate Cancer-Adjuvant Hormonal Therapy for High-Risk Patients • Prostate Cancer-Avoidance of Overuse Measure-Bone Scan for Staging Low-Risk Patients Clinical Process / Cancer-specific Treatments (3) • Adjuvant Chemotherapy is Considered/Administered Within 4 Months of Diagnosis to Patients Under the Age of 80 with AJCC III (lymph node positive) Colon Cancer • Combination Chemotherapy is Considered/Administered Within 4 Months of Diagnosis for Women Under 70 with AJCC T1c, or Stage II or III Hormone Receptor Negative Breast Cancer • Adjuvant Hormonal Therapy Safety and Healthcare Associated Infection – HAI (3)  NHSN Central Line-Associated Bloodstream Infection (CLABSI) Outcome Measure  NHSN Catheter-Associated Urinary Tract Infection (CAUTI) Outcome Measure  Harmonized Procedure Specific Surgical Site Infection (SSI) Outcome Measure Patient Engagement / Experience of Care (1)  HCAHPS 12

13. Value-Based Purchasing • Goal is to reward providers and health systems that deliver better outcomes in health and health care at lower cost to the beneficiaries and communities they serve. • Hospital value-based purchasing program shifts approximately $1 billion based on performance • Five Principles - Define the end goal, not the process for achieving it - All providers’ incentives must be aligned - Right measure must be developed and implemented in rapid cycle - CMS must actively support quality improvement - Clinical community and patients must be actively engaged VanLare JM, Conway PH. Value-Based Purchasing – National Programs to Move from Volume to Value. NEJM July 26, 2012 13

14. FY 2015 Finalized Domains and Measures/Dimensions 14

15. Patient Experience of Care Measures • HCAHPs used for Hospital VBP – weighted at 30% of total score starting in FY 2015 • CG-CAHPS used in the PQRS, ACO and Physician VM programs for groups of 25 or more – CMS is exploring expansion of this measure for all clinicians • CAHPS measures are in use or in development for every setting of care – Post Acute Care (LTCH, IRF, Home Health) – In-Center Dialysis • First caregiver experience measure implemented in the Hospice quality reporting program 15

16. Value-Based Purchasing Program Objectives over Time Towards Attainment of the Three-part Aim Initial programs FY2012-2013 Near-term programs FY2014-2016 Longer-term FY2017+ •Limited to hospitals (HVBP) and dialysis facilities (QIP) •Existing measures providers recognize and understand •Focus on provider awareness, participation, and engagement •SNF and HH VBP Plans •Expand to include physicians •New measures to address HHS priorities •Increasing emphasis on patient experience, cost, and clinical outcomes •Increasing provider engagement to drive quality improvements, e.g., learning and action networks •VBP measures and incentives aligned across multiple settings of care and at various levels of aggregation (individual physician, facility, health system) •Measures are patient-centered and outcome oriented •Measure set addresses all 6 national priorities well •Rapid cycle measure development and implementation •Continued support of QI and engagement of clinical community and patients •Greater share of payment linked to quality Vision for VBP

17. 18

18. 19

19. NQF: Multiple Chronic Conditions (MCC) Measurement Framework High-Leverage MCC Measure Concepts National Quality Strategy Priorities Corresponding High Priority Illustrative Measures Optimizing function, maintaining function, or preventing further decline in function Enable healthy living; optimize function • Long-stay nursing home residents with moderate-severe pain • Long-stay nursing home residents with depressive symptoms • Change in basic mobility or function for post-acute care Seamless transitions between multiple providers and sites of care Effective communication and coordination of care • Care Transition Measure—CTM-3 • Transition record with specified elements received by discharged patients Patient important outcomes (includes patient-reported outcomes and relevant disease-specific outcomes) Prevention and treatment of leading causes of mortality • Health outcomes—mortality and morbidity Avoiding inappropriate, non-beneficial care, including at the end of life Make care safer • Hospice patients who didn’t receive care consistent with end-of-life wishes • CARE mortality follow back survey of bereaved family members • Inappropriate non-palliative services at end of life Access to a usual source of care Effective communication and coordination of care • People unable to get or delayed getting needed medical care, dental care or prescription medications • Access problems due to cost Transparency of cost (total cost) Making quality care more affordable • Average annual expenditures per consumer unit for healthcare • Consumer price indexes of medical care prices • Personal health care expenditures, by source of funds Shared accountability across patients, families, and providers Effective communication and coordination of care • Children with effective care coordination and with a medical home Shared decision-making Person- and family-centered care • Persons whose healthcare providers always involve them in decisions about their healthcare as much as they wanted

20. CMS Activities on Patient Reported Outcome Measures • In 2012, CMS funded the NQF to develop guidance on development of PROMs • CMS currently uses a number of PROMs in our clinician reporting programs (e.g. depression, functional status) • CMS and HHS working to identify existing PROMs that can be rapidly incorporated into our quality reporting programs, including the ACO program and CMMI models. • CMS and ONC are currently developing PROMs for the hospital and outpatient setting – Disease-specific functional status – General functional status • CMS now includes patients in all measure development work, in order to understand the outcomes that are most important to patients and families 21

21. The Future of Quality Measurement for Improvement and Accountability • Meaningful quality measures increasingly need to transition away from setting-specific, narrow snapshots • Reorient and align measures around patient-centered outcomes that span across settings • Measures based on patient-centered episodes of care • Capture measurement at 3 main levels (i.e., individual clinician, group/facility, population/community) • Why do we measure? – Improvement Source: Conway PH, Mostashari F, Clancy C. The Future of Quality Measurement for Improvement and Accountability. JAMA 2013 June 5; Vol 309, No. 21 2215 - 2216

22. • Becoming a Member: Interested orgs can apply for membership- directed to healthcare stakeholders, consumer orgs, public and private purchasers, doctors, etc. NQF members can participate on committees and panels. http://www.qualityforum.org/Membership/Join_NQF.aspx • Providing Feedback on NQF Measures: NQF has a tool, the Quality Position System (QPS), that allows feedback on NQF-endorse measures by measure implementers and users. Users can request an ad-hoc review, submit measure use info, and general feedback. http://www.qualityforum.org/Field_Guide/Feedback.aspx 23

23. • Public and Member Comments on Draft Reports: Both NQF members and the general public can review and comment on a steering committee’s draft report. This is process is only open for 30 days. http://www.qualityforum.org/Measuring_Performance/Consensus_Develop ment_Process%e2%80%99s_Principle/Public_and_Member_Comment.aspx • Submitting Candidate Standards for Consideration: Interested stewards and/or developers of performance may submit standards for consideration by the NQF. Again, this process is not directed towards patients or their families. http://www.qualityforum.org/Measuring_Performance/Submitting_Stand ards.aspx

24. Affordable Care Act Statutory Requirements 25MAP Strategic Plan:2012-2015 Report • Convening multi-stakeholder groups to provide input on the selection of quality and efficiency measures under consideration by HHS; • Transmission of that input to HHS no later than February 1st of each year; • Consideration of that input by HHS; • Publishing rationale for the selection of any quality and efficiency measures not endorsed by the National Quality Forum (NQF); and • Assessing the impact of the use of endorsed quality and efficiency measures at least every three years (The first report was released to the public in March of 2012. The next impact assessment report is scheduled for release in March of 2015.). Making publicly available by December 1st annually a list of measures under consideration by HHS for qualifying programs;

25. Measure Selection Process Measure Implementation Cycle 26MAP Strategic Plan:2012-2015 Report Pre- rulemaking measure list published by December 1st, annually Pre- rulemaking MAP input due to HHS no later than February 1st, annually NPRM for each applicable program Public comment on Measures HHS implements Measures Measure Performance Review and Maintenance Pre- rulemaking Assessment of Impact of Measures Program Staff and Stakeholders Suggest Measures

26. • To obtain expert multi-stakeholder input on quality and efficiency measures considered for implementation in programs by the Secretary for the 2014 Federal rulemaking process – Which measures should we propose in programs? – What are the high priority measures? – What are the gaps and how will we fill those gaps in the future? Our Goals for this Process 27MAP Strategic Plan:2012-2015 Report

27. Balancing Measurement Goals 28 • Enable improvement and assess the performance of all providers and to empower patients with this information. Achieve high participation rates by providers • Address and measure high priority conditions and domains in order to provide a comprehensive assessment of the quality of health care delivered. Align reporting requirements with National Quality Strategy priorities • Drive quality improvement of the healthcare delivery system Increase the reporting of quality data by providers and more rapid feedback loops • Improve quality of care through the meaningful use of EHRs and use of registry- based measures. Increase EHR and registry reporting for quality reporting programs • Ensure measurement focus is on patients , includes information derived from patients, and is useful to patients Increase patient-centered outcome measures, including patient reported measures • Empower providers and the public with information to make informed decisions and drive quality improvement (e.g., Compare sites) Increase the transparency, availability, and usefulness of quality data

28. Cancer Hospital Quality Reporting • Late April proposed rule publication of CMS's policy on cancer services and treatment • Public comment and feedback 60 days after NPRM published – Submitted to http://www.regulations.gov/#!home. Public has 60 days to provide their feedback and comments. • CMS will answer the public comments in the final rule- usually sometime in early August. • Additional resources: http://www.reginfo.gov/public/jsp/Utilities/faq.jsp; http://www.archives.gov/federal- register/tutorial/online-html.html

29. • General Outreach & Education: CMS has a list of their outreach and training programs. Most are directed towards stakeholders who work with CMS. http://cms.hhs.gov/Outreach-and-Education/Outreach-and-Education.html • Sharing an Idea with CMMI: On CMMI’s site, anyone is able to share an idea that would provide better care, lower costs, improve the system, etc. http://innovation.cms.gov/Share-Your-Ideas/index.html 30

30. Opportunities and Challenges of a Lifelong Health System • Goal of system to optimize health outcomes and lower costs over much longer time horizons • Payers, including Medicare and Medicaid, increasingly responsible for care for longer periods of time • Health trajectories modifiable and compounded over time • Importance of early years of life Source: Halfon N, Conway PH. The Opportunities and Challenges of a Lifelong Health System. NEJM 2013 Apr 25; 368, 17: 1569-1571

31. Discussion • What are the outcomes that matter? – For patients, families, providers, systems • How do we best align around those outcomes? – Within and across clinical care settings – Across research and health care • What are the obstacles we need to overcome?

32. Contact Information Shari M. Ling, MD CMS Deputy Medical Officer 410-786-6841 shari.ling@cms.hhs.gov 33

34. Conditions of Participation Clinical Standards Group ----- Center for Clinical Standards & Quality

35. What are Conditions of Participation? Conditions of Participation (CoPs) and Conditions for Coverage (CfCs) are health and safety regulations which must be met by Medicare and Medicaid-participating providers and suppliers. They serve to protect all individuals receiving services from those organizations. 36INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law.

36. What are Conditions of Participation? The CoPs help CMS ensure that all providers and suppliers participating in the Medicare and Medicaid programs provide high quality care, and work towards continued quality improvement. 37INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law.

37. Health Care Organizations & Provider Types CMS has CoPs or CfCs for the following health care organizations and provider types: • Ambulatory Surgical Centers • Community Mental Health Centers • Comprehensive Outpatient Rehabilitation Facilities • Critical Access Hospitals • End-Stage Renal Disease Facilities • Federally Qualified Health Centers • Home Health Agencies • Hospices • Hospitals 38INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law.

38. Health Care Organizations & Provider Types • Hospital Swing Beds • Intermediate Care Facilities for the Intellectually Disabled • Long Term Care Facilities • Organ Procurement Organizations • Portable X-Ray Suppliers • Providers of Outpatient Services (physical and occupational therapists in independent practice, outpatient physical therapy, occupational therapy, and speech pathology services) • Religious Nonmedical Health Care Institutions • Rural Health Clinics • Transplant Centers 39INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law.

39. Revisions to the CoPs Revisions are made to the CoPs in response to: • Statutory Changes • Administration Policies and Priorities • National Issues and Events • Changes in Medical Practice 40INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law.

40. Examples of Current Priority Issues in CoPs • Reduce Healthcare Acquired Conditions • Reduce avoidable hospital readmissions • Reduce burden on providers • Antibiotic Stewardship 41INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law.

42. Medicare’s National Coverage Determination Process http://www.cms.gov/medicare-coverage-database/

43. NCD Definitions in SSA 1862(l)(6) National and local coverage determination defined.—For purposes of this subsection— (A) National coverage determination.—The term “national coverage determination” means a determination by the Secretary with respect to whether or not a particular item or service is covered nationally under this title

44. What is a Covered Service? • which, if subject to FDA review, has been approved or cleared for at least one indication; • which falls within a Medicare Benefit Category (generally found in §1861 of the Act); • which is not statutorily excluded based on §1862(a)(2)-(15) of the Act; • which is reasonable and necessary based on §1862(a)(1) Generally, an item or service:

45. Reasonable & Necessary • Sufficient level of confidence that the evidence is adequate to conclude that the item or service: – Improves health outcomes – Is generalizable to the Medicare population – Is generalizable to general provider community

46. PATIENT Usual Workup Usual Therapy Usual Outcome Workup + New Test Different Therapy Better Outcome Worse Outcome

47. The Preferred Road to Diagnostic and Therapeutic Coverage Diagnostic  Provide adequate evidence that  The incremental information obtained by new diagnostic technology compared to alternatives  Changes physician recommendations  Resulting in changes in therapy  That improve clinically meaningful health outcomes  In Medicare beneficiaries Therapeutic  Provide adequate evidence that  The new therapeutic intervention compared to alternatives  Results in improve clinically meaningful health outcomes • In Medicare beneficiaries

48. Health Outcomes of Interest • Longer life and improved function/participation • Longer life with arrested decline • Significant symptom improvement allowing better function/participation • Reduced need for burdensome tests and treatments • Longer life with declining function/participation • Improved disease-specific survival without improved overall survival • Surrogate test result better • Image looks better • Doctor feels confident More Impressive Less Impressive Medicare has stated publicly that as a matter of policy that it does not generally consider cost in making national coverage determinations.

49. What prompts NCDs? • External request (statutory) – Current national non-coverage policy – Substantial LCD variation • Internally generated – Extensive literature or important new study – Technological advance with potential major clinical or economic impact – Major concerns about inappropriate use

50. NCD Process • Formal Request (30 day comment period) • Benefit Category Determination • Review of evidence by CMS • Technology Assessment/MEDCAC • Proposed Determination (30 day comment period) • Final Determination posted on CMS Web site 60 days later 51

51. MEDICARE NATIONAL COVERAGE PROCESS Staff Review Proposed Decision Memorandum Posted National Coverage Request MEDCAC External Technology Assessment 6 months Reconsideration Staff Review Public Comment Final Decision Memorandum and Implementation Instructions 30 days 60 days 9 months Preliminary Discussions Benefit Category Departmental Appeals Board

52. 53 Evidence for NCDs • Medical Literature Peer Reviewed Journal Medical texts • Technology Assessments thru AHRQ Evidence Based Practice Centers • Medicare Evidence Development and Coverage Advisory Committee (MEDCAC)

53. MEDCAC Medicare Evidence Development Coverage Advisory Committee • Meets on controversial issues • Votes only on the quality of the evidence and not on a coverage determination • Not necessarily on NCDs – Usual Care of Chronic Wounds 2006

54. 55 Evidence Deficits • No evidence • Standard measures missing • Short term follow-up to studies • Lack of comparative effectiveness • Generalizability for Medicare beneficiaries

55. National Coverage Determinations • National Coverage • National Non-Coverage • National Coverage with Limitations • Contractor Discretion

56. Reconsideration of NCD • An NCD Reconsideration may be requested when: An NCD currently exists, any individual or entity may request that we reconsider any provision of that NCD by filing an acceptable request for an NCD reconsideration. 1) Additional material medical and/or scientific information that was not considered during the initial review, that is, results from new clinical trials, new scientific or medical publications, or studies supporting the request 1) Arguments that our conclusion materially misinterpreted the existing evidence at the time the NCD was made.

58. The Medicare Coverage Process 101: Optimizing Your Voice June 2014 Avalere Health LLC

59. Jenny Gaffney, Director 60 Jenny Gaffney advises clients on how to optimize public and private coverage for physician-administered drugs, medical devices, and diagnostics. Jenny has specific expertise in assisting clients engage in Medicare’s national and local coverage determination processes. Over the past seven years, she has helped multiple clients optimize Medicare coverage for their items and services. Additionally, Jenny regularly advises clients on how to design their clinical trials and frame their body of evidence to directly respond to Medicare’s and commercial payers’ evidentiary standards. Jenny has an AB in Government from Harvard University with minors in Health Policy and Economics.

60. Presentation Objectives 61 ● Increase understanding of Medicare’s coverage determination process for Parts A and B items and services o National coverage determination process (focus) o Local coverage determination process ● Answer the following questions: o What are the engagement opportunities in the national Medicare coverage process? o Where do I monitor Medicare coverage activity? o How do I optimize my engagement? ● Increase understanding of when and why it is advantageous to proactively engage Medicare at the local and national levels, including the benefits and risks of engaging

61. Statutorily, Medicare Has Broad National Coverage Authority 62 “No payment may be made under [Medicare] for any expenses incurred for items or services [that] are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member” - Section 1862(a)(1)(A) of the SSA ● To meet the reasonable and necessary qualification, products or services must: o Improve health outcomes o Be safe and effective o Not be deemed experimental or investigational ● In addition, a product or service must: o Be approved by the Food and Drug Administration (FDA) (with a few exceptions) o Fall into a statutorily-defined benefit category ● Cost or cost-effectiveness is not an explicit factor in determining coverage o May be considered in payment policies and decision to initiate formal coverage reviews This presentation focuses on the coverage process for Medicare Parts A and B items and services

62. Both CMS National and Local Contractors Make Coverage Determinations at the Class-Level, Not the Product-Level NATIONAL COVERAGE DETERMINATION (NCD) ● Less than 5% of coverage decisions ● Developed by CMS Central Office/Coverage and Analysis Group (CAG) ● Typically controversial, high-volume, and/or expensive procedures ● Follows set timelines; lengthy public process ● Sets one national policy; binding on all contractors 63 LOCAL COVERAGE DETERMINATION (LCD) ●In the absence of an NCD, Medicare Administrative Contractors (MACs) may develop an LCD ●Historically, more transparent than the NCD process ●Follows set timelines; typically swifter review than NCD process ●Allows for local variation in coverage In the absence of a formal Medicare coverage policy, claims are generally processed and paid, however documentation of medical necessity is vital in the case of a manual review

63. The Vast Majority of Medicare Coverage Decisions Occur at the Local Level 64 Source: ttp://www.cms.hhs.gov/manuals/downloads/pim83c13.pdf * Avalere analysis CMS’ NCD Download Database, last accessed July 3rd, 2013 ** Avalere analysis of CMS’ LCD Download Database, last accessed July 3rd, 2013 *** Avalere analysis CMS’ Article Download Database, last accessed July 3rd, 2013 CMD: Contractor Medical Director Number of Active Coverage Policies/Articles in 2013 N = 5,895 NCD* 4% • NCD: Coverage policies issued by the Coverage and Analysis Group within CMS National that are binding for all local Medicare contractors LCD** 25% • LCD: Coverage policies issued by local Medicare Contractors that govern a specific part of the country Local Article*** 71% • Articles: Policy updates, coding, and claims processing guidance issued by local Medicare Contractors

64. At the National and Local Levels, Medicare Coverage Reviews Are Typically Initiated by One or More Triggers 65 ● Stakeholder groups (e.g., MACs, competitors, providers, beneficiaries, and professional societies) can act on one or more of these triggers to request and NCD or LCD o CMS does not act on all formal NCD requests and “prioritizes these requests based on the magnitude of the potential impact on the Medicare program and its beneficiaries and staffing resources” ● Additionally, CMS National and individual MACs can internally generate coverage reviews based on one or more of these triggers Utilization Spikes / High Patient Volumes Challenges to Standard of Care Effectiveness Safety or Post-Market Concerns Off-Label or Expanded Use Key Medicare Coverage Review Triggers Cost Concerns CMS: Center for Medicare & Medicaid Services NCD: National Coverage Determination LCD: Local Coverage Determination MACs: Medicare Administrative Contractors Source: CMS. Revised NCD Process. http://www.cms.gov/Medicare/Coverage/DeterminationProcess/Downloads/FR08072013.pdf

65. Local Coverage Determination Process

66. LCDs are Under the Jurisdiction of Different MACs And Can Be Issued in the Absence of an NCD 67 MAC Jurisdictions, Each Responsible for Issuing LCDs E E F H 5 6a 8 9b 10b 11 La Ka 15 Cahaba Government Benefits Administrator (GBA), LLC Noridian Administrative Services, LLC (NAS) First Coast Service Options, Inc. (FCSO) Palmetto GBA, LLC Novitas Solutions, Inc. (Novitas) Wisconsin Physicians Service (WPS) National Government Services (NGS) CIGNA Government Services (CGS) F 9C MMA: Medicare Prescription Drug, Improvement, and Modernization Act of 2003 Source: http://www.cms.gov/Medicare/Medicare-Contracting/Medicare-Administrative-Contractors/Spotlight.html Note: This map represents the MAC contracts as of 7/11/2013. NGS received the contract award for JK (formally J13 and J14) on 2/22/2013, however National Heritage Insurance Corporation (NHIC) will continue to be a legacy contractor for JK until the transition is complete. NGS will be subcontracting several significant functions to NHIC under the new JK MAC contract. Additionally, NGS received the contract award for J6 on 1/16/2013, but WPS and Noridian will continue to be a legacy contractors for J6 until the transition is complete. a. Implementation in progress b. Recompete in progress

67. Triggers for Initiation of Local Coverage Policies are Identical to Those at the National Level 68 Presents issue to Contractor Advisory Committee (CAC)* Contractor reviews issue; schedules public meeting Holds public meeting Issue identification Posts draft LCD for public comment Posts comments and responses to draft LCD Develops draft LCD based on medical literature and local practice Posts final LCD Within 90-120 days 45 days 45 days Process Starts Here Spurred by triggers similar to NCD process (e.g., utilization spikes) Process Takes an Average of Six Months (though delays can lengthen this timeframe) *CACs are transitioning to be called jurisdiction advisory committees (JACs) in the future Source: Medicare Program Integrity Manual, Chapter 13 – Local Coverage Determinations, 2008, https://www.cms.gov/manuals/downloads/pim83c13.pdf

68. MACs Use the Following Evidence in Developing Coverage Determinations 69 While the FDA approved label and peer-reviewed, published literature are the gold standard for coverage decision-making, contractors frequently utilize other information sources: ● Local/Regional Contractor Advisory Committees (CACs) o CACs are composed of physicians representing a range of medical and surgical specialties who advise Contractor Medical Directors (CMDs) about coverage policies o CAC members hold certain sway over many Medicare reimbursement decisions made at the local level ● Opinions of community physicians who are key opinion leaders (KOLs) and early adopters o Other local contractors and their policies o State and national professional societies and position statements o Evidence-based treatment guidelines o Unpublished literature (e.g., posters from society meetings, clinical abstracts, articles submitted for publication) when published literature is not available o Advocacy groups o Expert opinions While the FDA label and peer-reviewed articles are essential in developing both NCDs and LCDs, the LCD process allows for more expert and KOL input than the NCD process. Expert and KOL support will be essential for a successful local coverage strategy

69. National Coverage Determination Process

70. The Coverage and Analysis Group is Housed Under the Center for Clinical Standards and Quality 71 Senior Leadership Administrator Principal Deputy Administrator Chief Operating Office Deputy Chief Operating Officer Deputy Administrator for Innovation and Quality CMS Chief Medical Officer External Engagement Office of Communications Office of Legislation Office of Minority Health Federal Coordinated Health Care Office Office of Actuary Office of Strategic Operations and Regulatory Affairs Office of Equal Opportunity and Civil Rights Operations Chief Operating Officer Office of Acquisitions and Grant Management Office of Information Services Office of Operations Management Offices of Hearings and Inquiries Center for Clinical Standards and Quality Coverage and Analysis Group Center for Medicare and Medicaid Innovation Center for Medicare Center for Medicaid and CHIP Services Center for Program Integrity CCIIO Source: https://www.cms.gov/About-CMS/Agency-Information/CMSLeadership/Office_CCSQ.html (Page last updated 6/2/2014)

71. Center for Clinical Standards and Quality (CCSQ) Patrick Conway, M.D., Director Wesley Perich, Deputy Director Shari Ling, M.D., Deputy Chief Medical Officer Clinical Standards Group Coverage and Analysis Group (CAG) Tamara Syrek Jensen, Acting Director Information System Group Quality Improvement Group Quality Measurement & Health Assessment Group Items and Devices James Rollins, Director Medical and Surgical Services Lori Ashby, Acting Director Operations and Information Management Janet Brock, Director CCSQ Oversees National Quality Initiatives and Includes the Coverage and Analysis Group 72 Sources: https://www.cms.gov/About-CMS/Agency-Information/CMSLeadership/Office_CCSQ.html (Page last updated 6/2/2014) and http://cms.hhs.gov/Medicare/Coverage/CouncilonTechInnov/Downloads/InnovatorsGuide5_10_10.pdf (Document last update Spring 2010) CCSQ: Centers for Clinical Standards and Quality • Responsible for national Medicare coverage decisions about physician- administered drugs, non-implantable devices, and laboratory/diagnostic tests • Responsible for national Medicare coverage decisions about surgical procedures and implantable devices • Scans industry developments to keep CAG staff abreast of new and developing items and services that may result in national coverage issues and responsible for oversight of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) and public notice and comment

72. Medicare’s NCD Process Involves Multiple Steps and Opportunities for Comment 73 Denotes public comment opportunity AHRQ: Agency for Healthcare Research and Quality MEDCAC: Medicare Evidence Development & Coverage Advisory Committee (formerly the Medicare Coverage Advisory Committee, or MCAC) TA: Technology Assessment Draft Decision Memorandu m Posted National Coverage Request MEDCAC AHRQ TA Maximum Six Months (Without TA or MedCAC) Reconsideration Staff Review Public Comments Due 30 days Maximum 60 days Additional Three Months Preliminary Meeting Department Appeals Board 30 days Public Comments Due Staff Review Maximum Nine Months (With TA or MEDCAC) Benefit Category Final Decision Memorandum and Implementation Instructions National Coverage Analysis (NCA): Process that results in an NCD Medicare requests MEDCAC meetings and/or AHRQ TAs for a subset of NCDs when they feel an additional review of the evidence by other experts would be helpful

73. CMS Leverages Several Types of Evidence to Inform its Coverage Analyses 74 Health Technology Assessments Systematic reviews of available data on the safety, efficacy, and cost-effectiveness of a drug or device Clinical Trials All pre- and post- market data generated through manufacturer sponsored or other pivotal trials Real-World Evidence Data on the safety/efficacy of a drug or device generated in a non- controlled environment (e.g., registry, EHR data) Clinical Guidelines Consensus recommendations issued by professional societies regarding the routine clinical use of a drug/device MEDCAC Recommendations Insights from an independent panel of experts regarding the value of a product for Medicare beneficiaries

74. An NCA Can Result in a Variety of Outcomes, Ranging From Benign to Detrimental for Patient Access 75 THE MAJORITY OF NCAS END IN COVERAGE WITH RESTRICTIONS OR CED National Decision National Coverage National Coverage with Restrictions Coverage with Evidence Development (CED) National Non-Coverage • Consistent with FDA-approved label • Specific indications • Patient sub- populations • Provider requirements • Approved clinical sites • Post-market data collection requirements • Clinical trial participation • Registry participation • Access to item or service is restricted No National Decision Coverage left to local contractor discretion

75. High-Level Overview of Components of an NCD for an Innovative Technology 76 Benefit Category • Delivery site for class of products or service being evaluated (e.g., Inpatient Hospital Services for MT) Item Description • Description of the class of products and the specific condition the item or service is intended to treat Indications and Limitations of Coverage • States CMS’ ruling regarding whether item is covered nationally, locally, with restrictions, or not covered at all • If covered, CMS typically restricts coverage to the FDA label and additional coverage restrictions • Potential coverage restrictions: o Patient selection criteria o Facility and operator certification requirements o CED: item must be used in a CMS-approved clinical trial or registry to be covered NCDs for highly technical procedures typically include patient selection criteria and operator requirements that are narrower than the FDA label

76. 3 0 2 4 6 8 10 12 14 16 2006 2007 2008 2009 2010 2011 2012 2013 2014 NumberofNCDs Non-CED CED CMS is Increasingly Deploying CED in its Medicare Coverage Determinations 77 Open NCDs • Transcatheter Mitral Valves • Lung Cancer Screening • Microvolt T-wave Alternans Of the 3 CED NCDs, CMS removed the existing CED requirements in 2 NCDs and issued a new CED requirement for 1 NCD Source: Avalere Analysis using the Tufts Medicare NCD Database and Medicare Coverage Database. Analysis conducted May 28, 2014. UNDER CED, MEDICARE MAKES COVERAGE CONTINGENT ON ADDITIONAL EVIDENCE COLLECTION THROUGH A REGISTRY OR PROSPECTIVE TRIAL

77. While CED is Better Than Non-Coverage, There Are Several Concerns with the Policy 78 CED can be financially burdensome for participating providers and manufacturers, which can lead to geographic inequalities in patient access Medicare only reimburses for the item or service(s) explicitly dealt with in the NCD. Medicare does not cover the cost of evidence collection or evaluation; these activities are typically funded by participating providers or affected manufacturers. For example, hospitals pay an initial fee of $25,000 and an annual renewal fee of $10,000 to participate in the transcatheter aortic valve replacement (TAVR) CED registry. CMS does not typically set timelines to reevaluate Medicare's coverage for an item or service studied under CED Of all of the CED decisions, there has been only a few cases in which CMS expanded coverage based on data generated from CED. CMS has yet to change its coverage parameters on prior CED decisions, even for decisions implemented over 5 years ago. The NCD timeframe does not allow sufficient time or enough stakeholder input to develop well-considered methods for CED implementation Stakeholders have argued that the six to nine month NCD timeframe does not allow sufficient time to appropriately design and implement CED

78. Medicare Typically Looks to Professional Societies for Advice on How to Structure Its Coverage Decisions 79 Generating Evidence to Fill Evidence Gaps Initiating NCDs and Reconsiderations Informing Content of Decisions • At 2012 MEDCAC on DME, AAO called the panel’s attention to a new NIH-sponsored CER study comparing the effectiveness of the anti-VEGF agents under question as a means to fill key evidence gap • In 2011, CMS accepted a request from the ACC and STS to initiate a NCD on TAVR • In 2012, CMS accepted a request from MITA to reconsider its existing PET NCD • In 2012, CMS modeled TAVR CED policy after the registry that ACC and STS established • CMS largely adopted the facility and operator requirements outlined by the professional societies in the TAVR NCD ACC: American College of Cardiology STS: Society of Thoracic Surgeons MITA: Medical Imaging & Technology Alliance PET: Positron Emission Tomography AAO: American Academy of Ophthalmology DME: Diabetic Macular Edema VEGF: Vascular Endothelial Growth Factor NIH: National Institutes of Health TAVR: Transcatheter aortic valve replacement It is critical to ensure alignment across professional societies and understand what registry vehicles and/or appropriateness criteria may be put forward to Medicare for a topic undergoing NCD review

79. Key Questions Medicare Asks When Developing an NCD 80 • Are there distinct patient populations for which the therapy is clinically effective? o Medicare typically establishes different coverage restrictions for distinct patient populations (e.g., with different risk profiles) • How does the therapy in question compare to the standard of care in improving health outcomes? o Medicare weighs evidence on health outcomes (e.g., mortality, stroke rate) more heavily than evidence on surrogate endpoints (e.g., recanalization rate) o Medicare wants evidence on the durability of health outcomes (≥1 year) • Is the evidence generalizable to the Medicare population? o Medicare wants evidence on the clinical effectiveness of the therapy for the >65 population • Is the evidence generalizable to real-world settings? o For high-risk or highly technical procedures in particular, Medicare will want assurances that the therapy will work as good as it does in a controlled clinical study o To mitigate its concerns, Medicare could restrict coverage to accredited facilities and/or require registry participation to track outcomes and ensure compliance with facility and operator requirements

80. Key Evidence Medicare Uses to Answer These Key Questions 81 FDA Approval • Medicare often ties coverage of a therapy specifically to its FDA-approved indication so that it does not have to reopen the NCD with every label expansion Published Clinical Trial Evidence with a Preference for U.S. Based Studies • Medicare does not give much weight to unpublished evidence or studies that are exclusively performed outside of the U.S. U.S. and ex-U.S. Health Technology Assessments • Medicare strongly considers both U.S. and ex-U.S. systematic reviews of the clinical evidence Professional Society Consensus Statements and Guidelines • Medicare relies heavily on the input of proactive professional societies particularly when determining patient selection, facility and operator criteria o It is critical for the HPAB to identify whether there is existing criteria that the group support that could be leveraged to inform a coverage policy Mandated Evidence Collection Through CED • When Medicare identifies key evidence gaps, it will consider whether to issue CED o If it does, Medicare will mandate coverage through an approved clinical registry or clinical trial

81. Medicare Coverage Decision-Making Often Directly Informs Private Payer Policies 82 ● CMS is a leader in defining evidence necessary for coverage and payment o CMS’ process for evaluating an item or service often sets the standard for many payers o Medicare payment systems, rates, and quality measures are frequently benchmarks for private payers and Medicaid ● Since CMS’ processes are publicly accountable and transparent, private payers can easily reference NCDs and the evidence evaluated to get to get to the determination ● In turn, private payers can influence Medicare decision-making on an issue by directly commenting on national coverage analyses or by publicly posting their coverage policies on the topic of interest It is important to recognize that Medicare NCDs and LCDs for drugs typically have a ripple effect throughout the private payer community especially when the majority of the affected patient population is 65 and older

82. Opportunities for Engagement in the NCD Process

83. There Are Three Key Engagement Opportunities 84 1 Request an NCD be Opened or Reconsidered 2 Get Early Input on a Trial Design of a Therapy Likely to Be Reviewed by Medicare National Prior to Launch 3 Respond to an Open NCD to Inform Coverage Parameters

84. There Are Only Select Circumstances Where It Might Be Advantageous to Request an NCD 85 Existing national coverage decision or legislative language denies or restricts coverage for beneficiaries OR Existing national coverage decision is outdated, not representative of the current data and needs to be retired OR Coverage policies at the local level are negative or significant variation in extent of coverage at the local level AND Medicare is a big payer for the technology and there is a robust evidence base Given the high stakes associated with pursuing an NCD which is time and cost intensive with its multi-faceted strategy, the life sciences industry has historically supported local coverage practices 1

85. Director: James Rollins, M.D., Director Director: Jyme Schafer, M.D., Director Director: Janet Brock, Director Who Do You Direct Communications to at CMS to Schedule a Meeting or Send a Written Request? 86 1 Office of Clinical Standards and Quality Patrick Conway, M.D., Director and Chief Medical Officer Division of Items and Devices Division of Medical and Surgical Services Division of Operations and Information Management “We encourage, but do not require, potential requesters to communicate, via conference call or meeting, with our staff in the Coverage and Analysis Group (CAG)…before submission of a formal [NCD] request.” -CMS, Revised Process for Issuing NCDs, Aug. 2013 Clinical Standards Group Coverage and Analysis Group (CAG) Acting Director Tamara Syrek Jensen, JD* Information System Group Quality Improvement Group Quality Measurement & Health Assessment Group *Note: Tamara Syrek Jensen is the acting CAG Director until a formal replacement is selected. More information about the specific components of a request letter to CAG is available here: http://go.cms.gov/1itrGEj

86. Meeting with CMS Prior to Launch is a Strategic Decision for Product Sponsors and Other Stakeholders 87 2 Key opportunities to meet with CMS prior to launch may include: • Identify the strength of the current evidence base to gain an understanding for what gaps exist and may influence coverage • Gain insight into how CMS perceives the specific “ therapeutic need” for beneficiaries based on the existing epidemiology and demographics Evidence Base • Obtain guidance on trial design to elucidate any concerns that may currently exist in a specific protocol • Gain informal agreement that the existing or proposed design meets the evidentiary needs Trial Design • Enhance understanding of the current policy on a specific class of products and why coverage has been difficult or denied • Seek to understand what quality of life parameters may also influence coverage for this therapeutic area Policy Clarification

87. A Successful Meeting with CMS Prior to Launch May Yield Valuable Insight 88 2 Create awareness • Provides a lens into how receptive Medicare is to evaluating or re-evaluating coverage for a specific product or class of products • Gauges Medicare’s initial reactions to the strength of the evidence supporting the use of the product or class of products Gain Insight • Reveals what level of impact quality of life measures have on the evidence base though these measures may be more subjective • Identifies expectations of collaborative support (if appropriate) by other industry members or stakeholders Inform actions • Elucidates potential areas of concern for CMS including additional types of evidence that may be needed to influence coverage • Guides preparation of a potential coverage request that will resonate best with CMS Building a relationship of mutual collaboration will only enhance communication and trust for when an explicit request is made

88. However, It Is Important to Consider the Following Before Engaging CMS 89 2 Risks of Pre-Launch Engagement • If CMS makes recommendations prior to a formal coverage request on such things like trial design or beneficiary type, CMS will hold the requestor accountable for factors previously discussed • A meeting also puts the therapy on CMS’ radar for future coverage activity (that could be restrictive) particularly if there are concerns expressed about the quality of evidence being collected Risks of Post-Launch Engagement Via a Formal NCD Request • Not all services and products need a national coverage determination o If results are unfavorable, the coverage decision is binding and may affect private payers as well since they frequently reference NCDs o The decision also pertains to the entire country • Once a formal request is received, all correspondence and data become public record » Manufacturers, professional societies, and other public stakeholders will be able to inform CMS’ decision-making

89. Preemptive Due Diligence is Necessary as Engagement With CMS is Not Always Advisable or Required 90 2 Factors to Help Determine Whether to Engage CMS Example Areas of Due Diligence Assess existing local and national Medicare coverage Are there existing policies that dictate coverage for your item and service? Is it more restrictive than desired? Who is the decision-maker you would need to engage with (e.g., CAG vs. local MAC)? Determine coding and payment Does your item or service have an adequate code and payment rate in place? Evaluate the competitive landscape How will other players affect the coverage situation (physician societies, manufacturers, hospitals)? Understand the evidence base Does your evidence base and that in the public domain align with Medicare's evidence requirements? Are there any potential gaps? Explore professional societies How do professional societies align or do not align with your position given their influence with the Agency? Assess risk/benefit of engaging at national or local level What are the pros and cons of engaging at the national level and the local level? Are you prepared for either outcome, positive or negative? If so, what are the next steps? Formulate a clear ask if it is determined CMS must be engaged Why are you asking for CMS’ time? What do you aim to accomplish? Stakeholders benefit most from the coverage process when a targeted approach is applied. It is not advantageous to engage CMS for a broad therapeutic area or list of therapies.

90. ● Sign up for the CMS Coverage listserv to receive notification regarding updates to the CMS Coverage pages on the bottom right of any page on CMS.gov ● All open NCDs can be viewed here: http://go.cms.gov/1mADpF5 o Click on each NCD and then click on the tracking sheet to see the dates for public comment o All public comments can be accessed through each NCD’s tracking sheet ● There is no list of future NCDs to help anticipate upcoming NCDs o There is a “Potential NCD List,” but it has not been updated since November 2012 and thus not a good indication of future NCDs ● AHRQ technology assessments that are in-progress are also a signal that CMS may be interested in opening an NCD on the topic but it does not guarantee NCD activity: http://1.usa.gov/1kMexdy Where Can you Monitor NCD Activity? 91 3

91. How Can the Public Engage Once an NCD is Opened? 92 ● By submitting evidence-based public comment letters (1) when the NCD is initially opened and/or (2) when the proposed NCD is posted ● If an AHRQ TA is conducted or a MEDCAC is convened, patients can provide written comments for the former and both written and public testimony at the latter o AHRQ TAs commissioned by Medicare are available here: http:// 1.usa.gov/Rz6l58 o Upcoming MEDCAC meetings are available here: http://go.cms.gov/1lPKb6M ● If a MEDCAC is convened, there is at least one patient advocate that sits on the panel. The roster for a MEDCAC is announced in advance of each meeting o The pool of MEDCAC members that can be called on for a MEDCAC meeting (15 are called) is available here: http://go.cms.gov/1ri5hTD o There are also opportunities for scheduled 5-10 minute presentations and ad hoc public comments at each MEDCAC meeting 3

92. Evidence-Based Comment Letters Carry More Weight in Medicare Coverage Decisions 93 “Public comments providing information on unpublished evidence, such as the results obtained by individual practitioners or patients, are less rigorous and therefore less useful for making a coverage determination.” -CMS, Revised Process for Issuing NCDs, Aug. 2013 ● CMS prefers evidence-based comment letters that cite published clinical evidence regarding the clinical benefit of a medical intervention ● Form comment letters that do not cite any new published evidence and/or is purely anecdotal are less useful to CMS ● A robust comment letter addresses three key points with supporting published evidence where appropriate: 1. Medical Need for Coverage: Addresses the need for expanded coverage in the Medicare population 2. Clinical Benefit for the Over 65 Population: Cites relevant clinical evidence on meaningful endpoints (quality of life and clinical health outcomes) 3. Desired Coverage Outcome: Clearly states the desired coverage outcome

93. Key Takeaways About Medicare’s Coverage Process 94 1 Both CMS National and local Medicare Contractors issue coverage decisions for Part A and B services 2 Most coverage decisions are made at the local level 3 The absence of a coverage decision does not equate to non-coverage 4 Coverage decisions are made at the class, not product level 5 The national and local coverage processes are lengthy and public pathways that can be initiated by Medicare or any stakeholder 6 Medicare relies on the FDA label, published evidence, health technology assessments, and clinical guidelines to inform its coverage decisions 7 Medicare’s coverage decisions for surgical procedures for high-risk patients often condition coverage on specific patient selection and facility and operator criteria

94. Question and Answer

96. Presidential Approval and Direction of Country President Obama’s Job Approval Rating: 41.0% 29.1% of Americans believe the country is headed in the right direction Historical Comparison: 1,951 Days in Office W. Bush Reagan Clinton 36% 61% 41%Obama 60% Source: Gallup 45.0% 52.0% 46.0% 53.0% 41.0% 49.0% Source: Real Clear Politics 63.6% 31.4% 53.0% 42.0% 29.1% 63.6%

97. Congressional Approval and the Generic Ballot Congressional Job Approval Rating: 13.0% Democrats and Republicans are tied in the Generic Congressional Ballot Source: Real Clear Politics 73.8% 19.8% 75.0% 18.0% 79.2% 13.0% Source: Real Clear Politics 44.0% 39.0% 47.3% 42.0% 42.0% 47.5%

98. Republican Party Party Branding Democratic Party 37% 37% 40% 42% 36% Source: NBC / WSJ, April 21-23, 2014 37% 31% 44% 36% 43% 25% 44% Source: NBC / WSJ, April 21-23, 2014

99. Q. What are your feelings towards President Obama? Q. What do you think is the most important problem facing the country today? Issues That Will Drive the Election 4% 8% 12% 16% 20% 6% 8% 11% 17% 19% 20%UNEMPLOYMENT / JOBS DISSATISFACTION WITH GOVERNMENT HEALTHCARE FEDERAL BUDGET DEFICIT/DEBT Source: Gallup, May 8-11 2014 ECONOMY IN GENERAL MORAL / ETHICAL / RELIGIOUS DECLINE Q. Do you generally approve or disapprove of the Affordable Care Act? 15.0% 41.0% 44.0% Source: NBC / WSJ, Apr. 23-27, 2014 66.0% 14.0% 17.0% Source: Gallup, Feb 28-May 25, 2014 6.0% 51.0% 43.0%

100. Composition of Democratic and Republican Districts D+12PVI R+10PVI Contrast Between Democratic Popular Vote and Percentage of Seats Won WHITE HISPANIC WHITE HISPANIC US House Landscape Source: Cook Political Report 46.2% 50.6% 44.4% 46.6% 2.2% 4.4% Source: Cook Political Report # OF COMPETITIVE SEATS # OF COMPETITIVE SEATS

101. ME Democrats are defending seats in seven states that Romney won, including six he carried by between 13.5% to 26.8% Republicans are defending one state that Obama won +15.1 US Senate Landscape +26.8 SDARWV LA AK MT NC +14.0 +13.5 +18.0+23.6 +2.2 +17.2 Source: CNN Exit Polls Legend Open Democratic Seat Democratic Held Seat Republican Held Seat

102. 2014 Election: US Senate (Democrats +6) The fight for control of the Senate is a toss up Breakdown of Competitive Races (17 seats) DEMOCRATIC SEATS (14) REPUBLICAN SEATS (3) NH (D-Shaheen) VA (D-Warner) KY (R-McConnell) GA (R-Chambliss Open) AR (D-Pryor) NC (D-Hagan) AK (D-Begich) MI (D-Levin Open) LA (D-Landrieu) CO (D-Udall) IA (D-Harkin Open) MN (D-Franken) OR (D-Merkley) MT (D-Baucus Open) SD (D-Johnson Open) WV (D-Rockefeller Open) LIKELY DEMOCRAT LEAN DEMOCRAT LEAN REPUBLICAN LIKELY REPUBLICAN TOSS-UP 2 2 9 1 3 MS (R-Cochran)

Working with Regulators: A Focus on CMS | June 24, 2014 | All Slides

Esté a ler uma amostra.

Confira estes a seguir

Working with Regulators: A Focus on CMS | June 24, 2014 | All Slides

Mais Conteúdo rRelacionado

Diapositivos para si (20)

Semelhante a Working with Regulators: A Focus on CMS | June 24, 2014 | All Slides (20)

Mais recentes (20)