Appendix C- Evidence Preview Template 07-25-22.docx

This document does not represent a formal Medicare National Coverage Determination (NCD). All NCDs must follow the statutory process (see https://www.cms.gov/Medicare/Coverage/DeterminationProcess/Downloads/FR09262003.pdf).

Evidence Preview

Contents

I. Preamble CMS is committed to ensuring Medicare beneficiaries have access to new cures and technologies that improve health outcomes. To improve the timeliness and predictability of national coverage for emerging technologies, we are piloting an expedited pathway that aims to decrease uncertainty, allows CMS to prioritize high value devices, and protects the quality and safety of service delivery.

Per the Medicare statute, the Secretary has authority to determine whether a particular medical item or service is “reasonable and necessary” under section 1862(a)(1)(A) of the Social Security Act.[footnoteRef:2] When making coverage determinations, CMS policies have long considered whether the item or service is not just safe and effective, but also whether the item or service is not experimental or investigational, and is appropriate for Medicare beneficiaries.[footnoteRef:3] These factors are found in Chapter 13 of the Medicare Program Integrity Manual (PIM) at section 13.5.4—Reasonable and Necessary Provisions in LCDs as instructions for Medicare contractors.[footnoteRef:4] [2: See Heckler v. Ringer, 466 U.S. 602, 617 (1984).] [3: For more information see the January 30, 1989 notice of proposed rulemaking (54 FR 4307). ] [4: 86 FR 26850 and 26851, May 18, 2021.]

Evidencebased coverage policy is essential to CMS’ objective of improving health outcomes while delivering greater value. A device may only be beneficial in a subset of the Medicare population or when used only by clinicians within a certain specialty. Without clinical evidence on the device's clinical utility for the Medicare population or evidence on appropriate providers, it is challenging to determine Medicare coverage conditions for newly market-authorized devices.[footnoteRef:5] Furthermore, a device’s FDA approved or cleared indications for use may not include information that is important for Medicare patients and clinicians when making treatment decisions. [5: CMS, Guidance for the Public, Industry, and CMS Staff: Coverage with Evidence Development, available at https://www.cms.gov/medicare-coverage-database/view/medicare-coverage-document.aspx?MCDId=27]

As a first step in a new expedited coverage pathway, this document is a preview of our analysis of the currently available evidence for a specific device. For simplicity, we refer to this document as an “Evidence Preview.” An Evidence Preview may be initiated either before or after FDA market authorization of a device, but it will be most useful once studies are complete and the FDA labelling is reasonably clear. Using the National Coverage Determination (NCD) process, in some instances, CMS may determine that the available evidence is already sufficient to meet the reasonable and necessary standard for coverage. In other instances, CMS may determine that important evidence gaps persist, and these will be enumerated in the Summary of Evidence Deficiencies section of the report. Where devices have significant evidence deficiencies at the time of FDA market authorization, CMS may propose transitional coverage through the Coverage with Evidence Development (CED) pathway because additional evidence is needed to determine the best treatments for Medicare patients and to ensure that the benefits of treatments outweigh the potential harms.

The Evidence Preview may be used in one of three ways: (1) to aid CMS in prioritizing topics for CMS review at the national level; (2) to accelerate completion of a national coverage analysis or NCD; or (3) to identify potential evidence gaps. Using the NCD process, if material evidence gaps are identified, devices may not be covered but may instead be eligible for Medicare coverage through the CED pathway.[footnoteRef:6] CMS invites stakeholders to discuss their evidence development plans at any time. [6: CMS, Guidance for the Public, Industry, and CMS Staff: Coverage with Evidence Development, available at https://www.cms.gov/medicare-coverage-database/view/medicare-coverage-document.aspx?MCDId=27]

CMS approval of an Evidence Preview and/or evidence development plan does not constitute a commitment to Medicare coverage after CED is completed. The CED pathway is available when FDA market authorized devices have considerable promise but have not yet met the reasonable and necessary threshold completely when furnished to the Medicare population. Evidence developed through the CED pathway may or may not generate results that satisfy the reasonable and necessary standard.

II. FDA Review

a. General information Device Generic Name: XXX Device Trade Name: XXX Device Procode: XXX Applicant’s Name and Address:

[Company; Address; Telephone]

Date(s) of Panel Recommendation: Month Day, Year Premarket Approval Application (PMA) Number: XXX Date of FDA Notice of Original Approval: Month Day, Year Date of FDA Notice of Subsequent Approval(s): Month Day, Year; Month Day, Year Priority Review: XXX Breakthrough Device:

Granted breakthrough device status on Month Day, Year because the device treats a life-threatening disease (XXX) and addresses an unmet medical need.

b. Description of Item/Service General description Components description

Theory of Operation Paragraph description

c. Market history As of Month Day, Year, the XXX is commercially available in [name countries]. [The device has not been withdrawn from marketing for any reason related to its safety or effectiveness.]

d. Panel meeting recommendation Paragraph description Url link

e. FDA post panel action

Paragraph description

f. Labelling

A. Indications Original label (Month Day, Year) FDA indication

Updated label (Month Day, Year) Revised FDA indication, if applicable

B. Contraindications FDA contraindications (Month Day, Year)

Revised FDA contraindication (Month Day, Year), if applicable

C. Potential adverse events, with frequency Below is a list of the potential adverse effects (e.g., complications) associated with the use of the device:

· List from SSED The incidence of adverse events was [qualitative or quantitative description as appropriate]. The SSED may be found here: url (Accessed Month Day, Year).

III. Systematic Literature Review

a. CMS benefit category For an item or service to be covered by the Medicare program, it must fall within one of the statutorily defined benefit categories outlined in the Social Security Act [§1812 (Scope of Part A); §1832 (Scope of Part B); §1861(s) (Definition of Medical and Other Health Services)].

[Name of device] may qualify as:

· [Benefit category].

· [Benefit category].

Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.

b. CMS coverage history [There is currently no applicable national or local coverage decision. Or provide coverage history].

c. Reasonable and Necessary Criteria Medicare payment may be made under part A or part B for any expenses incurred for items or services that are “reasonable and necessary” for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. Thus, with limited exceptions, section 1862(a)(1)(A) of the Act requires that an item or service be “reasonable and necessary” to be covered by Medicare. A second statutory provision, Section 1862(a)(1)(E) of the Act, may permit Medicare payment for items and services related to research in connection with the Agency for Health Care Research and Quality (AHRQ).

When making national coverage determinations, CMS generally evaluates relevant clinical evidence to determine whether or not the evidence is of sufficient quality to support a finding that an item or service falling within a benefit category is reasonable and necessary consistent with section 1862(a)(1)(A) of the Act. The critical appraisal of the evidence enables us to determine to what degree we are confident the intervention will improve health outcomes for beneficiaries.

CMS coverage policies at the local MAC level use the PIM to define reasonable and necessary such that an item or service is considered reasonable and necessary when it is:

(1) Safe and effective;

(2) Not experimental or investigational; and

(3) Appropriate for Medicare patients, including the duration and frequency that is considered appropriate for the item or service, in terms of whether it meets all of the following criteria:

· Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient's condition or to improve the function of a malformed body member;

· Furnished in a setting appropriate to the patient's medical needs and condition;

· Ordered and furnished by qualified personnel;

· One that meets, but does not exceed, the patient's medical need; and

· At least as beneficial as an existing and available medically appropriate alternative.

d. General Methodologic Principles CMS evaluates relevant clinical evidence to determine whether or not an item or service falls within a coverable benefit category, and the evidence is of sufficient quality to find that it is reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. The critical appraisal of the evidence enables us to determine to what degree we are confident that: 1) the CMS assessment questions can be answered conclusively; and 2) the intervention will improve health outcomes for beneficiaries. A detailed account of the methodological principles of study design that the Agency utilizes to assess the relevant literature on a therapeutic or diagnostic item or service for specific conditions can be found in Appendix A.[footnoteRef:7] [7: https://www.cms.gov/Medicare/Coverage/DeterminationProcess/downloads/id166b.pdf]

e. Background [Paragraph 1: Treated condition; Incidence, prevalence; impact on patients] [Paragraph 2: Therapeutic options; unmet need] [Paragraph 3: Description of device; intended application]

f. Summary of unpublished clinical evidence [Paragraph description]

g. Summary of published clinical evidence [Description of studies submitted by the manufacturer] [Description of studies identified through a supplemental literature search] [Description of what was considered in the Evidence Preview vs. excluded] [Summary of overall body of evidence reviewed in Evidence Preview: number of studies, number of patients, duration of study] [Discussion of individual studies, multiple paragraphs] [Discussion risk of bias; note strategies that mitigate risk of bias] [Conclusion paragraph]

h. References Reviewed [List reviewed references]

i. References Excluded [List excluded studies, reason for exclusion]

IV. Considerations for Clinical Studies CMS maintains an interest in monitoring important health outcomes to better inform our understanding of the risk/benefit profile, particularly for subpopulations, as the [Name of device] is used in the Medicare population.

To better serve Medicare beneficiaries, additional evidence should address:

· Sufficient patient enrollment to have confidence that expected outcomes will be reliably achieved in real world use;

· Sufficient representation of Medicare beneficiaries and minority populations in clinical studies of the [device] to demonstrate generalizability to those populations;

· Clinical studies with of sufficient duration to demonstrate that observed outcomes are durable to an extent appropriate to the item/service;

· Clinical studies including the site of service, clinical staffing, and experience profiles expected for real world use of the [device].

A Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) examined what health outcomes in studies for [topic] treatment technologies should be of interest to CMS.[footnoteRef:8] Based on MEDCAC input, CMS believes that evidence published in the peer-reviewed literature should critically evaluate one or more of the following outcomes through a minimum of 1 year: [8: https://www.cms.gov/medicare-coverage-database/view/medcac-meeting.aspx?MEDCACId=73]

· Outcome 1;

· Outcome 2;

· Outcome 3.

CMS believes that evidence published in the peer-reviewed literature should critically evaluate one or more of the following outcomes through a minimum of 2 years:

· Outcome 1;

· Outcome 2;

· Outcome 3.

V. Quality Measurement The Medicare Access and CHIP Reauthorization Act of 2015 established the Quality Payment Program to shift the way in which clinicians are paid by Medicare and to reward high value care. If a local or national coverage analysis is opened in the future, proposed quality measures may be published with the proposed coverage determination to provide an opportunity for public feedback. [Company] is therefore encouraged, but not required, to consider measures that would inform beneficiaries, clinicians, and payers about quality and outcomes achieved through provision of the [Device]. Specifically, [company] should assess: (1) whether quality measures are appropriate for the [device]; (2) if any existing measures are appropriately aligned with the [device]; and (3) if a new measure (or measures) is needed. In recent years, CMS has focused extensively on reducing administrative burden on clinicians and facilities, and manufacturers are encouraged to carefully consider the least burdensome option when proposing aligned quality measures. A current list of measures approved within the Quality Payment Program is available at: https://qpp.cms.gov/mips/explore-measures.

VI. Summary of Evidence Deficiencies [Executive summary of reviewed evidence, generally less than 3 paragraphs]

After reviewing these results, the following is noted:

· Deficiency 1;

· Deficiency 2;

· Deficiency 3;

· Deficiency 4;

· Deficiency 5.

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