340B Survival Kit
The Survival Kit is a comprehensive resource on the 340B program that contains vital information to help 340B hospitals ensure compliance with 340B laws while maximizing discounts.
Below are links to the available chapters and appendices. In an effort to reduce paper waste, this site is set up so that you can download just the sections you need or simply read the Survival Kit online. If you choose to print the entire Survival Kit, as sections are updated in the future, you will be able to replace just the sections that have been updated rather than the entire document.
Please contact Mike Hess at mike.hess@safetynetrx.org or 202-552-5869 if you have any questions or problems.
Disclaimer: Some of these chapters were written several years ago and contain information that may be outdated.
| REPORT COVER |
| TABLE OF CONTENTS |
| 1. OVERVIEW OF THE 340B DRUG DISCOUNT PROGRAM (Rev. June 2008) |
| |
| 1.1 |
Background |
| 1.2 |
Program Eligibility |
| 1.3 |
How Does the 340B Program Operate? |
| 1.4 |
Program Restrictions |
| 1.5 |
Savings |
| 1.6 |
Information Resources |
|
| 2. HOSPITAL ELIGIBILITY (Rev. June 2008) |
| |
| 2.1 |
Criterion One: Government Function |
| 2.2 |
Criterion Two: Medicare DSH Adjustment Percentage Above 11.75 |
| 2.3 |
Criterion Three: Purchase No Covered Outpatient Drugs Through GPOs |
| 2.4 |
DSH Hospital Enrollment Process |
| 2.5 |
Children's Hospitals |
|
| [The following chapters are available to SNHPA members only. Members click here to view additional chapters.] |
| 3. DEFINING THE SCOPE OF AN ELIGIBLE DSH HOSPITAL (Members Only) |
| |
| 3.1 |
Medicare Cost Report Test |
| 3.2 |
Medicare Provider-Based Test |
| 3.3 |
Home Health Agencies, Long-Term Care Facilities, Etc. |
| 3.4 |
Enrollment Process For New Outpatient Sites |
|
| 4. WHAT DRUGS ARE ELIGIBLE AND AT WHAT PRICE? (Members Only) |
| |
| 4.1 |
Medicaid Definition of Covered Outpatient Drugs |
| 4.2 |
Application to 340B Program |
| 4.3 |
340B Price Calculations |
| |
| 4.3.1 |
Formula and Its Components |
| |
| 4.3.1.1 |
AMP |
| 4.3.1.2 |
Unit Rebate Amount |
| 4.3.1.3 |
“Best Price” |
|
| 4.3.2 |
Calculation Process and Timing |
|
| 4.4 |
New Drugs |
| 4.5 |
Confidentiality of 340B Prices |
| |
| 4.5.1 |
AMP and “Best Price” |
| 4.5.2 |
340B Ceiling Prices |
| 4.5.3 |
340B Actual Prices |
|
|
| 5. WHO MAY RECEIVE THE DISCOUNTED DRUGS? (Members Only) |
| 6. MEDICAID BILLING REQUIREMENTS (Members Only) |
| 7. MEDICARE PRESCRIPTION DRUG BENEFIT AND 340B (Members Only) |
| |
| 7.1 |
Part D Basics |
| |
| 7.1.1 |
Program Administration and Access |
| 7.1.2 |
Standard Benefit |
| 7.1.3 |
Part D Drug Coverage |
| |
| 7.1.3.1 |
Medicare Part D v. Medicare Part B |
| 7.1.3.2 |
Plan Formularies |
|
| 7.1.4 |
Eligibility and Enrollment |
| |
| 7.1.4.1 |
Auto-Enrollment of Low-Income Beneficiaries |
| 7.1.4.2 |
Long Term Care Residents |
| 7.1.4.3 |
Medicare Advantage Enrollees |
|
| 7.1.5 |
Provider Marketing Guidelines |
| |
| 7.1.5.1 |
What Activities Are Permissible |
| 7.1.5.2 |
Prohibited Activities |
|
| 7.1.6 |
Medication Therapy Management |
|
| 7.2 |
The Low-Income Subsidy |
| |
| 7.2.1 |
Dual Eligibles |
| 7.2.2 |
Point of Sale Facilitated Enrollment |
|
| 7.3 |
Formulary Safeguards |
| |
| 7.3.1 |
Restrictions on Formulary Changes |
| 7.3.2 |
Transitioning to the Part D Plan Formulary |
|
| 7.4 |
New Drugs |
| |
| 7.4.1 |
What Qualifies As TrOOP? |
| 7.4.2 |
Pharmacy Waiver/Reduction of Cost-Sharing and Applicability Toward TrOOP- General Overview |
| 7.4.3 |
Cost-Sharing Subsidies by DSH Hospitals |
| 7.4.4 |
Anti-Kickback Concerns |
| 7.4.5 |
Manufacturer Patient Assistance Programs |
| 7.4.6 |
State Pharmacy Assistance Programs |
|
| 7.5 |
Contracting with a Medicare Part D Plan |
| |
| 7.5.1 |
AMP and “Best Price” |
| 7.5.2 |
340B Ceiling Prices |
| 7.5.3 |
340B Actual Prices |
| 7.5.4 |
Key Contracting Issues |
| |
| 7.5.4.1 |
Discounts to Uninsured/Underinsured |
| 7.5.4.2 |
Reimbursement Rates |
| 7.5.4.3 |
Medicare and Duplicate Discounts |
| 7.5.4.4 |
Unique 340B Contracts |
| 7.5.4.5 |
Preferred Pharmacy Status |
|
|
| 7.6 |
SNHPA’s Advocacy Efforts on Medicare Part D |
| |
| 7.6.1 |
Pharmacy Networks and 340B Pharmacies |
| 7.6.2 |
Payment Rates |
| 7.6.3 |
Medication Therapy Management Plans |
| 7.6.4 |
Co-Branded Drug Cards |
| 7.6.5 |
TrOOP |
|
|
| 8. INVENTORY MANAGEMENT (Members Only) |
| |
| 8.1 |
Relevant 340B Standards |
| 8.2 |
Stock Replacement |
| |
| 8.2.1 |
NDC-by-NDC Substitution |
| 8.2.2 |
Reverse Substitution |
|
| 8.3 |
Meeting the Challenge of NDC-by-NDC Substitution |
| |
| 8.3.1 |
Inadequate Tracking Systems |
| 8.3.2 |
Unavailability of Replacement Product |
| 8.3.3 |
Generic Substitution |
|
| 8.4 |
Emergency Room Drugs |
| 8.5 |
Cherry Picking |
| 8.6 |
Future Considerations |
|
| 9. CONTRACT PHARMACIES (Members Only) |
| APPENDIX |
|
Washington, DC 20005 
