# Presentation: 906795

##  An Introduction to Medicare CoverageMATES29 July 2005

**Ross J Brechner, MD, MS (Stat.), MPH**
**Coverage and Analysis Group**
**Centers for Medicare and Medicaid Services**

## Overview

_**Medicare coverage in context**_
**Policy development**
**The coverage (NCD) process**

## Steps to Medicare Reimbursement

**FDA approval (if applicable)**
**Benefit category determination**
_**Coverage**_
**Coding**
**Payment**
**Implementation**

## FDA Review – CMS Coverage

**FDA is a regulator**
**ensures products safe **
**do what they claim**
**assumes marketplace determines clinical value**
**CMS is a purchaser**
**does technology improve health outcomes**
**FDA efficacy standard varies by risk**
**510k vs. PMA devices**
**CMS can cover off-label indications**

## Benefit Category Determination

**The Social Security Act (Title XVIII)**
**gives the Secretary authority to determine Medicare coverage**
**lists benefit categories**

## Authority to Make Coverage Decisions

**Section 1862(a)(1)(A) **
**Payment can only be made for items and services found to be **_***reasonable and necessary***_** for the **_***diagnosis***_*** *****or**_** **__***treatment***_** of illness or injury**

## Frequency

- Appropriate Use

**Frequency**

**Time**

- Experimental
- Stage

**Evidence-based diffusion**

**Spontaneous  diffusion**

-       **TWO PATHS FOR DIFFUSION OF A NEW TECHNOLOGY**

## Medical Technology Diffusion

**For certain technologies more than others (e.g., Dx imaging: PET for AD, surgical Rx: LVRS)**
**Rapid diffusion in spite of limited evaluative data **
**Unanswered questions/gaps in knowledge: **
**patient selection/demo, change in clinical management, effect on mortality,  QOL (invasive procedures actually avoided)**
**Poor quality of evidence leads to lingering debates over conclusions from data, need for RCTs**
**Possibility of CED**

## How Do We Interpret and Apply R&N Today?

**Technology must produce clinical benefit **
**Dx accuracy data necessary but not sufficient**
**Improvement in health outcome**
**Supported by strong research evidence**
**Assessment question**
**Is there adequate evidence to conclude that the service improves net health outcomes of Medicare beneficiaries?**

## EBM approach

**Standard evidence-based medicine principles**
**Study design (minimize bias)**
**Study execution**
**Appropriateness of outcomes studied****	**
**Appropriate analysis**
**Generalizability (beneficiaries, setting)**

## Quality of evidence: general

**Prospective vs. retrospective studies**
**Randomized vs. observational**
**Concurrent vs. hx comparisons**
**Large vs. small studies**
**Blinded vs. unblinded observers**
**Functional vs. technical outcomes**

## Overview

_**The coverage process (NCD)**_

## Local vs. National Coverage

**Most coverage decisions are local **
** ****Local coverage determinations (LCDs)**
**LCDs allow **
**Gradual diffusion**
**Regional variation in policy**
**Responsiveness to local care community input**

## What prompts NCDs?

**External request**
**Current national non-coverage policy**
**Substantial LCD variation questioned**
**Internally generated**
**New technology  with potential major clinical or economic impact on program**
**Concerns about inappropriate use**

## Medicare NCDs

**An open NCD process **
**April 1999 Federal Register notice **
**Revised in September 2003**
**Medicare Prescription Drug, Improvement, and Modernization Act of 2003 **
**amended portions of the NCD development process (effective date: January 1, 2004) **

## MEDICARE NATIONAL COVERAGE PROCESS

**Staff Review**

**Draft **
**Decision**
** ****Memorandum**
** ****Posted**

*** *****National Coverage Request**

**Medicare Coverage Advisory Committee**

**External Technology Assessment **

***6 months***

**Reconsideration**

**Staff Review**

**Public Comments**

**Final Decision**
**Memorandum**
**and**
**Implementation Instructions**

***30 days***

***60 days***

***9 months***

**Preliminary Discussions**

**Benefit Category**

**Department  Appeals Board**

## Review Process
Explain benefit category determination
Explain national coverage determination
Discuss evidence requirements

**Explain benefit category determination**
**Explain national coverage determination**
**Discuss evidence requirements**

- PRELIMINARY MEETING

## Online Access to CAG 						www.cms.gov/coverage

## Important steps

**Preliminary visits to CAG/CMS**
**Invite to FDA meetings and process if desired**
**NCD Guidance documents**
**Coverage process**
**Review of evidence**
**Key to Positive NCD**
**Be able to articulate with good quality evidence how Medicare approval of this technology will improve health status of Medicare beneficiaries**
**Fed Register 2003 for guidance re: NCDs**