The Centers for Medicare & Medicaid Services released its 2017 guidance on the FFM and this PowerPoint highlights the most critical takeaway points for pharma and biotech manufacturers.

1. By Amy DemskeBy Amy Demske
2017 Federally Facilitated Marketplaces:
Implications for Pharmaceutical and
Biotech Companies
Presentation by Amy Demske

2. By Amy Demske
Overview of Federally Facilitated Marketplaces (FFM)
• 2017 Draft FFM Guidance Largely Mirrors 2016 Parameters
• Expands Clinical Appropriateness Review to 9 High Cost,
Chronic Conditions
• Requires Issuers to Accept Premium and Cost-Sharing from
Federal, State and Local Government Programs,By Amy DemskeFederal, State and Local Government Programs,
Subgrantees and Downstream Entities (e.g. PBMs)
• Proposes Reviews of:
Outlier Thresholds
Drug Coverage
Cost-Sharing
Formulary and Adverse Tiering

3. CMS Proposes 9 Chronic, High Cost Conditions for Review
• Bipolar Disorder
• Breast Cancer
• Diabetes
• Hepatitis C
• HIV
Drug Regimens
Tier Placement/
Adverse Tiering• HIV
• Multiple Sclerosis
• Prostate Cancer
• Rheumatoid Arthritis
• Schizophrenia Formulary Outliers
Adverse Tiering
Cost-Sharing

4. CMS to Review QHP Drug Formularies
Outlier Analysis
Drug Coverage
• Review of State and National Outlier Threshold Values
• Requires a QHP to Meet/Exceed Both Standards
• Review of QHP Coverage of Drugs for Bipolar Disorder,
Diabetes, HIV, Rheumatoid Arthritis and Schizophrenia
• Coverage of Standard Treatment Protocols (First, Second
Line Therapies) and Step Therapy
• Review QHPs with Unusually Large Numbers of Drugs
Formulary/
Adverse Tiering
Cost-Sharing
• CMS will Identify Plans Looking for Unusually High
Estimated Out-of-Pocket Costs As Compared to Similar
Plans at State and National Level.
• Review QHPs with Unusually Large Numbers of Drugs
Subject to Prior Authorization
• Evaluate Whether QHP Drug Coverage for Chronic, High-
Cost Conditions is Consistently Assigned to High-Cost
Tiers

5. Additional Considerations:
● CMS Proposes an Optional Lower-Cost Drug Tier for QHPs – Beyond 4
Standard Tiers
Clinicians Should Consider Whether Therapies are Evidence-Based, and
not Simply Cost-Based
● QHP’s are Required to Publish its Formulary Drug List on Healthcare.gov
Drug Lists and Tiering must be Fully Transparent to Enrollees
● Non Discrimination Requirements of Essential Health Benefits are Largely the
Responsibility of State Regulators
The Decision-making Process must Ensure the Appropriate Therapy at the
Right Time