CMS Business Development Strategy

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Transcript CMS Business Development Strategy

Geriatric Sarcopenia
Draft Timeline for Obtaining Medicare Coverage
and Reimbursement for Screening, Diagnosis and
Treatment
March 14, 2012
© Copyright 2010 Applied Policy, L.L.C., All Rights Reserved.
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
• 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.
• 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
2012
Draft
Legislation
2013
2014
Introduction and Congressional
Consideration
Development/Approval of Clinical Guidelines
2015
Enactment
2016
2017
2018
CMS
Implementation
Development/Endorsement of Quality Metrics
Modify CDC Health Risk Assessment Guidance
Modify USP Categories and Classes
Petition WHO for ICD-10 Update
Work to Obtain Positive USPSTF Recommendation
Drug Pipeline Analysis
Medicare Input to Phase III Coverage/Reimbursement
Issues Based on Testosterone
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Support Patient Access and
Coverage, Coding & Payment
11
Transforming
Intention into Action
(202) 558-5272 | [email protected]
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