1. CMS/Coverage and Analysis Group
CMS Requirements for Reimbursement for Innovation: Medicare Coverage & Evidence Development
Lori M. Ashby
CMS/Coverage and Analysis Group

2. Disclosure Statement of Financial Interest
Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below.
Affiliation/Financial Relationship
Company
Grant/Research Support
Consulting Fees/Honoraria
Major Stock Shareholder/Equity
Royalty Income
Ownership/Founder
Intellectual Property Rights
Other Financial Benefit
Company Names
All TCT 2018 faculty disclosures are listed online and on the App.

3. Disclaimers
This presentation is a general summary that explains certain aspects of the Medicare Program, but is not a legal document. The official Medicare Program provisions are contained in the relevant laws, regulations, and rulings.
This presentation was prepared as a service to the public and is not intended to grant rights or impose obligations. This fact sheet may contain references or links to statutes, regulations, or other policy materials. The information provided is only intended to be a general summary. It is not intended to take the place of either the written law or regulations. We encourage readers to review the specific statutes, regulations, and other interpretive materials for a full and accurate statement of their contents.
This presentation was current at the time it was published or uploaded to the web. Medicare policy changes frequently so links to the source documents have been provided within the document. The Centers for Medicare & Medicaid Services employees, agents, and staff make no representation, warranty, or guarantee that this compilation of Medicare information is error-free and will bear no responsibility or liability for the results or consequences of the use of this guide.

4. Focus on Patients

5. Medicare Construct
Established by the Social Security Act of 1965, Title XVIII
§1862(a)(1)(A) reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member
(E) in the case of research conducted pursuant to §1142, which is not reasonable and necessary
Defined benefit program
Beneficiaries
Age ≥ 65 years
Disabled individuals
End stage renal disease
(557,000)
Providers
Settings
Aged = 48.1 million in 2016 (up from 46.8 million in 2015).
Disabled = 9.0 million in 2016 (same as 2015).
Million
year

6. Evidence-based Medicare Coverage
National Coverage Determination (NCD):
Sufficient evident to conclude that the item or service improves clinically meaningful health outcomes for the Medicare population
Based on a comprehensive review of the published evidence
Focuses on important patient centered outcomes

8. Medicare Evidence Development & Coverage Advisory Committee (MEDCAC)
The MEDCAC:
provides independent guidance and expert advice to CMS on specific clinical topics
supplements CMS' internal expertise and allows for an unbiased and current deliberation of "state of the art" technology and science
reviews and evaluates evidence and examines benefits, harms, and appropriateness of items and services
judges the strength of the available evidence and makes recommendations to CMS based on that evidence.

9. Health Outcomes in Heart Failure Treatment Technology Studies MEDCAC
CMS convened a MEDCAC panel on March 22, 2017.
The MEDCAC panel examined what health outcomes in studies for heart failure treatment technologies should be of interest to CMS.
The MEDCAC emphasized the need for clinical data needed to demonstrate a reduction in the clinical composite endpoint of death/heart failure hospitalization in order to meet the reasonable and necessary standard for coverage following FDA approval.

10. Coverage with Evidence Development (CED)
Coverage in the context of approved clinical studies or with the collection of additional clinical data
Allows for positive coverage when evidence is insufficient for a more favorable decision.
Evidence gaps may be due to low number of beneficiaries in clinical studies, lack of meaningful health outcomes, limited generalizability, inconsistency of study findings.
May involve randomized controlled trials, observational studies and/or registries
Specific interventions,
benefits and harms,
health outcomes

11. Other Clinical Studies under Medicare
Investigational Device Exemptions (IDE) Studies
Regulation at 42 CFR
New centralized process in 2015
Clinical Trial Policy
Routine costs in clinical trials funded by certain federal agencies
National Coverage Determination (NCD)
Pub 100-3, Section 310.1

12. Medicare Beneficiaries in Clinical Studies
Initial studies on new technologies may not include many older adults ≥ 65 years of age for several reasons including:
Heterogeneity – may have multiple comorbidities and/or be taking multiple medications
Non-adherence - may have difficulty following protocols and/or making all study follow-up visits
Other considerations – measurement issues, cognitive function

13. Study Endpoints and Eligibility Criteria
Important to determine the strength and generalizability of published evidence to the Medicare population
May assist in establishing parameters of coverage with evidence development (CED)

14. Inclusion Criteria in National Coverage Determinations
Patients eligibility criteria in national coverage determinations (NCDs) may reflect inclusion criteria of the studies forming the evidence base for the item or services, for example:
Implantable cardioverter defibrillators
Trial
Covered Indication
Multicenter Automatic Defibrillator Trial (Moss, 1996 and 2006); Sudden Cardiac Death in Heart Failure Trial (Brady, 2005)
Patients who have severe ischemic dilated cardiomyopathy but no personal history of sustained ventricular tachyarrhythmia or cardiac arrest due to ventricular fibrillation, and have NYHA Class II or III heart failure, left ventricular ejection fraction (LVEF) ≤ 35%.
Multicenter Automatic Defibrillator Trial II (Moss, 2002)
Patients with a prior myocardial infarction and a measured left ventricular ejection fraction < .30.
Sudden Cardiac Death in Heart Failure Trial (Brady, 2005); Defibrillator Implantation in Patients with Nonischemic Systolic Failure (Kober, 2016)
Patients who have severe non-ischemic dilated cardiomyopathy but no personal history of sustained ventricular tachyarrhythmia or cardiac arrest due to ventricular fibrillation, NYHA Class II or III heart failure, and measured LVEF < 35%; been on optimal medical therapy for at least 3 months.

15. Study Exclusion Criteria
Older adults may be excluded from initial studies assessing efficacy.
Patients with end stage renal disease (ESRD) are often excluded.

16. FDA-CMS Parallel Review Program

17. Coding CMS uses several code sets:
Diagnosis related group (Medicare Severity MS-DRG)
Current Procedural Terminology - CPT® is registered trademark of the American Medical Association.
International Statistical Classifications of Diseases (ICD) codes are alphanumeric codes on diagnosis, symptoms, signs, diseases.
Healthcare Common Procedure Coding System (HCPCS)
CMS Level I (CPT), Level II

18. Payment Prospective Payment Systems Various Fee Schedules
Inpatient (IPPS), outpatient (OPPS), long term care /SNF
Various Fee Schedules
Ambulance Fee Schedule
Clinical Laboratory Fee Schedule
Durable Medical Equipment, Prosthetics/Orthotics & Supplies Fee Schedule
Physician Fee Schedule
Resource-Based Relative Value Scale
Relative value unit (RVU) physician work, practice expense, malpractice
The geographic practice cost indexes (GPCIs)
The conversion factor

20. Thank you!