working with regulators: a focus on cms | june 24, 2014 | all slides

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

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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

• 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

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.

Delivery system and payment transformation

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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

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

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Source: P.H. Conway and Clancy C. Transformation of Health Care at the Front Line. JAMA 2009 Feb 18; 301(7): 763-5

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?

CMS Authorized Programs & Activities

CMS

HHS Survey & 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

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

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*

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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.

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

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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

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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

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FY 2015 Finalized Domains and Measures/Dimensions

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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

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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

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

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

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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

• 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

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http://www.qualityforum.org/Field_Guide/Feedback.aspx

http://www.qualityforum.org/Field_Guide/Feedback.aspx

• 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_Development_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_Standards.aspx

http://www.qualityforum.org/Measuring_Performance/Consensus_Development_Process%e2%80%99s_Principle/Public_and_Member_Comment.aspx



http://www.qualityforum.org/Measuring_Performance/Submitting_Standards.aspx



Affordable Care Act Statutory Requirements

25 MAP 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;

http://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=71953



Measure Selection Process Measure Implementation Cycle


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




• 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





Balancing Measurement Goals

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• 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

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

http://www.regulations.gov/

http://www.reginfo.gov/public/jsp/Utilities/faq.jsp

http://www.archives.gov/federal-register/tutorial/online-html.html





• 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

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http://cms.hhs.gov/Outreach-and-Education/Outreach-and-Education.html











http://innovation.cms.gov/Share-Your-Ideas/index.html






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

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?

Contact Information

Shari M. Ling, MD CMS Deputy Medical Officer

410-786-6841 [email protected]

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Conditions of Participation

Clinical Standards Group -----

Center for Clinical Standards & Quality

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.

36 INFORMATION 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.

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.

37 INFORMATION 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.

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


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


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


Examples of Current Priority Issues in CoPs

• Reduce Healthcare Acquired Conditions

• Reduce avoidable hospital readmissions

• Reduce burden on providers

• Antibiotic Stewardship



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Medicare’s National Coverage Determination

Process

http://www.cms.gov/medicare-coverage-database/






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

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:

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

PATIENT

Usual Workup

Usual Therapy

Usual Outcome

Workup + New Test

Different Therapy

Better Outcome

Worse Outcome

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

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.

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

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

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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

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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)

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

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Evidence Deficits

• No evidence

• Standard measures missing

• Short term follow-up to studies

• Lack of comparative effectiveness

• Generalizability for Medicare beneficiaries

National Coverage Determinations

• National Coverage

• National Non-Coverage

• National Coverage with Limitations

• Contractor Discretion

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.


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The Medicare Coverage Process 101:

Optimizing Your Voice

June 2014

Avalere Health LLC

Jenny Gaffney, Director

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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.

Presentation Objectives

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● 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

Statutorily, Medicare Has Broad National Coverage Authority

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“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

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

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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

The Vast Majority of Medicare Coverage Decisions Occur at the

Local Level

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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

http://www.cms.hhs.gov/manuals/downloads/pim83c13.pdf

At the National and Local Levels, Medicare Coverage Reviews

Are Typically Initiated by One or More Triggers

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● 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

http://www.cms.gov/Medicare/Coverage/DeterminationProcess/Downloads/FR08072013.pdf

Local Coverage Determination Process

LCDs are Under the Jurisdiction of Different MACs And Can Be

Issued in the Absence of an NCD

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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

http://www.cms.gov/Medicare/Medicare-Contracting/Medicare-Administrative-Contractors/Spotlight.html







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

https://www.cms.gov/manuals/downloads/pim83c13.pdf

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

National Coverage Determination Process

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)

https://www.cms.gov/About-CMS/Agency-Information/CMSLeadership/Office_CCSQ.html





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






http://cms.hhs.gov/Medicare/Coverage/CouncilonTechInnov/Downloads/InnovatorsGuide5_10_10.pdf

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

Memorandum

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

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

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

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

3

0

2

4

6

8

10

12

14

16

2006 2007 2008 2009 2010 2011 2012 2013 2014

Nu

mb

er

of N

CD

s

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

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

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

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

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

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

Opportunities for Engagement in the NCD

Process

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

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

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

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

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

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

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.

● 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

http://www.google.com/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&docid=iSceb-XS-1eIzM&tbnid=N1yzIgS_iEAJgM:&ved=0CAUQjRw&url=http://www.123rf.com/stock-photo/mouse_click.html&ei=H2GGU9awLbfMsQTNlYLABg&bvm=bv.67720277,d.b2k&psig=AFQjCNEO0OGYpN0axLpoK_29p9DVzED_Wg&ust=1401401981512428

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

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

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

Question and Answer


96

waljoe\home\My Documents\Political Engagment\2013-2014\Presentations\Boston.pptx

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%


Congressional Approval and the Generic Ballot Congressional Job Approval Rating: 13.0%

Democrats and Republicans are tied in the Generic Congressional Ballot


73.8%

19.8%

75.0%

18.0%

79.2%

13.0%


44.0%

39.0%

47.3%

42.0% 42.0%

47.5%


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


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%


Composition of Democratic and Republican Districts

D+12 PVI

R+10 PVI

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

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

SD AR WV 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


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)


104

working with regulators: a focus on cms | june 24, 2014 | all slides

Healthcare

health care coverage

transformation of health

preventing health care

community measures

clinical care settings

domains measures

best measures

readmission measures