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Geriatric SarcopeniaDraft Timeline for Obtaining Medicare Coverage and Reimbursement for Screening, Diagnosis and Treatment March 14, 2012

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Overview

• Current Geriatric Sarcopenia Screening, Diagnosis and Treatment Options

• Medicare Coverage and Reimbursement Objectives Expand Patient Access to Current Geriatric

Sarcopenia Screening, Diagnosis and Treatment Options

Pave the Way for New Therapeutics

• Summary Timeline

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Current Geriatric Sarcopenia Screening, Diagnosis and Treatment Options

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Geriatric Sarcopenia Screening

• Elderly patients with observed declines in physical function, strength, or overall health potentially have geriatric sarcopenia

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• Geriatric sarcopenia should be specifically considered in patients who are: Bedridden Cannot independently rise from a chair Who have an unusually slow gait speed

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Geriatric Sarcopenia Diagnosis

• A diagnosis of sarcopenia is consistent with: a low functional assessment score; and an objectively measured low muscle mass.

• No specific ICD Code ICD-9 728.2 and ICD-10 M62.5, “muscle wasting,

NEC” often does not support payable claims• Functional Assessment: Patients at risk for sarcopenia

should undergo a functional assessment, such as the Short Physical Performance Battery (SPPB) or a gait speed test.

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• Objective Muscle Mass Measurement: Patients who meet the screening criteria should have a body composition assessment using dual energy x-ray absorptiometry (DXA) scan.

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Geriatric Sarcopenia Treatment

Examples of current treatments for geriatric sarcopenia include:

• Vitamins and other supplements

• Nutrition therapy

• Exercise / Training / Physical Therapy

• Lifestyle Education / Counseling

• Muscle stimulation by device

• Drug interventions

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Geriatric Sarcopenia Medicare Coverage and Reimbursement Objectives

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Access Expansion: Current Geriatric Sarcopenia Screening, Diagnosis & Treatment

• Work to Expand Geriatric Sarcopenia Screening and Diagnosis Expand Access to Geriatric Sarcopenia Screening

under Medicare Create a Geriatric Sarcopenia Diagnosis Code Establish generally accepted functional

assessment

• Support the Establishment of Clinical Guidelines for the Diagnosis and Treatment of Geriatric Sarcopenia

• Eliminate Barriers to Non-Pharmaceutical Treatments

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Pave the Way for New Therapeutics• Create a Reimbursement Pathway for New

Pharmaceutical Treatments For small molecule and self-administered

biopharmaceuticals Establish USP categories and classes suitable for

geriatric sarcopenia treatment Ensure any therapeutic and generic substitution

rules are appropriate Non-self-administered drugs and biopharmaceuticals

Ensure no restrictions on coverage at national and local levels

Support award of unique billing codes Support CMS approval of HOPD pass-through

status

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Summary Timeline: Medicare Coverage and Reimbursement Objectives

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Geriatric Sarcopenia Medicare Reimbursement Timeline

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2012 2013 2014 2015 2016 2017 2018

DraftLegislation

Introduction and Congressional Consideration

Enactment CMS Implementation

Development/Approval of Clinical Guidelines

Modify CDC Health Risk Assessment Guidance

Modify USP Categories and Classes

Petition WHO for ICD-10 Update

Work to Obtain Positive USPSTF Recommendation

Development/Endorsement of Quality Metrics

Drug Pipeline Analysis Medicare Input to Phase III Coverage/Reimbursement Issues Based on Testosterone

Support Patient Access and Coverage, Coding & Payment

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Transforming Intention into Action

(202) 558-5272 | jscott@appliedpolicy.com