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Pharmacy Affairs & 340B Drug Pricing Program

 

Current Issues

Emergency Prescription Assistance Program (EPAP) – Ike Activation (PDF - 29.57KB) (September 12, 2008)

HHS Provides Prescription Drug and Durable Medical Equipment Assistance for Uninsured Texas Victims of Hurricane Ike (September 12, 2008)

Emergency Prescription Assistance Program (EPAP) - Gustav Activation (PDF - 55KB) (Revised 9/10/2008)

HHS Press Release - HHS Provides Prescription Drug and Durable Medical Equipment Assistance for Uninsured Louisiana Victims of Hurricane Gustav (September 6, 2008)

Warner-Chilcott Letter - 340B Pricing Errors (September 5, 2008)

IMPORTANT NOTIFICATION (September 1, 2008) - Due to the public health emergency created by recent hurricane activity, the Office of Pharmacy Affairs has implemented the published 340B Drug Pricing Program Flexibilities During Disasters policies and is temporarily accelerating the start dates for new sites so that they may immediately begin participation in the 340B Program.

340B Drug Pricing Program Flexibilities During Disasters (June 26, 2008) - During disasters, HRSA can help by making it easier for entities already covered by the 340B Drug Pricing Program to dispense pharmaceuticals to displaced patients and by making it easier for new entities to register for the 340B Program in counties with federal major disaster declarations, federal emergency declarations, and federal public health emergency declarations.

Schering-Plough Letter - Refunds to 340B Covered Entities (May 15, 2008)

Schering-Plough Letter – Limitations on Contraceptives (May 15, 2008)

HRSA issues Medicaid Exclusion Tutorial and Medicaid Exclusion File Basics for the 340B Covered Entities billing Medicaid for the 340B Drugs - March 2008

Patient Safety & Clinical Pharmacy Services Collaborative - HRSA will adopt best practices in patient safety and clinical pharmacy services to improve health outcomes and reduce adverse events.

BARR Labs letter to 340B Covered Entity (Acrobat/pdf) - Refund checks are mailed to covered entities for overcharges.

“My Medicine List” Helps Health Care Professionals and Patients Keep Track of Medications
The American Society of Health System Pharmacists (ASHP) Foundation and ASHP have developed a tool that health care professionals can use with their patients to help keep track of their medications. For more information visit the ASHP Foundation web site.
(not a U.S. Government Web site)

New health literacy tools for pharmacies
Individuals with limited health literacy are much more likely to be unable to tell the difference between their medications or understand basic medication instructions and warning labels. Health literacy is a particular problem for people who are elderly, minorities, immigrants and/or poor. The Agency for Healthcare Quality and Research documents the problem in its 2006 National Healthcare Disparities Report and provides two new tools:

New - STD and TB Entities Registration Now Available Online
The new feature in the Office of Pharmacy Affairs Database now allows the new STD and TB Entities to register online as an alternative to the 340B Registration Form.

Barrier Therapeutics enters into agreement with 340B Prime Vendor (Acrobat/pdf) - Inpatient Hold Harmless Letter

Pharmacist’s Guide to Pandemic Preparedness (Acrobat/pdf) - (not a U.S. Government Web site)
The document provides pharmacists with key elements to consider in preparing for pandemic influenza. It was developed collectively by the American Pharmacist Association (APhA), American Society of Health System Pharmacists (ASHP), and National Association of Chain Drug Stores (NACDS) Foundation.

CMS Releases Tamper-Resistant Prescription Pad Information(Acrobat/pdf)
The law requires that all written, non-electronic prescriptions for Medicaid outpatient drugs must be executed on tamper-resistant pads in order for them to be reimbursable by the federal government. In the letter to the State Medicaid Directors dated August 17, 2007 (Acrobat/pdf), CMS clarifies a prescription pad must contain at least one of three characteristics to be considered tamper resistant on October 1, 2007.

Dear Manufacturer Letters

VA Will Exempt Inpatient Generic and OTC 340B Sales from FSS Reporting
The Office of Pharmacy Affairs has been notified that the Department of Veterans Affairs (VA) will allow pharmaceutical manufacturers to exclude the sale of 340B inpatient generic and over-the-counter (OTC) drugs from their Federal Supply Schedule (FSS) reporting requirements. As a result, manufacturers may now offer 340B discounts on inpatient generic and OTC drugs without affecting the prices that they are required to provide to FSS.
VA letter to Manufacturers dated July 8, 2004 (Acrobat/pdf) 07/08/2004 and a
Sample request for a "hold harmless" letter (Text File)
As of this date, the OPA has received hold harmless letters from:
Pharmion Corp., Boulder, CO (Labeler code 67211)
Bedford Laboratories, Bedford, OH (Labeler code 55390)
Bausch & Lomb, Tampa, FL (Labeler code 24208)
Eisai, Inc., Woodcliff, NJ (Labeler code 58063)
Élan Pharmaceuticals, Inc., South San Francisco, CA (Labeler code 51479)
This list will be updated as additional hold harmless letters are received.

non-Federal Average Manufacturer Price Calculation

Archived Information