Archived
Information
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. 
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:
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) -
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.
Call
for Comment: Children's Hospitals
The Health Resources and Services
Administration (HRSA) published a notice
in the July 9, 2007 Federal Register
soliciting public comment relating to
proposed guidelines addressing the addition
of certain children's hospitals to the
list of entities eligible to participate
in the 340B Drug Pricing Program. All
interested individuals and organizations
are encouraged to review the proposed
guidelines and submit comments to HRSA
by September 7, 2007.
Open
letter to OPA from Bayer HealthCare Pharmaceuticals
(PDF
- 117 KB) regarding temporary limited
distribution of Yasmin (05/31/2007)
340B
Drug Pricing Program - Results of a Survey
of Participating Hospitals (Acrobat/pdf)
- A joint publication of
the NORC Walsh Center for Rural Health
Analysis and the North Carolina Rural
Health Research & Policy Analysis
Center , May 2007. This report presents
the results of a 2006 survey of pharmacy
directors at rural hospitals currently
buying discounted outpatient drugs through
the 340B program. The purpose of this
study was to understand the perspectives
of pharmacy directors at participating
hospitals on the 340B program in general,
the financial impact of the program, and
which specific program features presented
barriers to its broader implementation.
Fed Biz Ops Announcement – Prime
Vendor Agreement -
“In accordance with HRSA 340B Prime
Vendor Agreement, Section VIII, Terms
effective September 10, 2004, the Agreement
will be extended, through the exercise
of Option Year Two, by one year (September
10, 2007 through September 9, 2008). HRSA's
340B Prime Vendor (PV), Apexus Inc. (formerly
HPPI), has brought significant value to
participating 340B safety-net hospitals
and clinics during the first three years
of the five year agreement with HRSA by
performing tasks under the agreement,
such as, negotiating for over 2600 brand
and generic drug prices at 1 to 90 percent
below the statutory 340B ceiling price,
with an average of 17 percent below ceiling;
negotiating drug wholesale distributor
agreements with 12 national and regional
distributors, including specialty wholesalers
to address the special needs of smaller
clinics for an average 7 percent reduction
in distribution costs; and negotiating
“other value added products and
services” that include such items
as vaccines, diabetic meters and strips
and rapid HIV Test kits. THIS ANNOUNCEMENT
IS NOT A NOTICE OF SOLICITATION.”
Call for Comment on Proposed Clarifications to 340B Drug Pricing Program Regarding Contract Pharmacy Arrangements, Patient Definition
Two January 12, 2007 Federal Register Notices solicit public comment relating to proposed guidelines under the 340B Drug Pricing Program. All interested individuals and organizations are encouraged to review the proposed guidelines and submit comments to HRSA by March 13, 2007.
No
Medicare Part D Late Enrollment Penalty
for Low-Income Enrollees, CMS Says
- CMS Acting Administrator Leslie V. Norwalk
announced the elimination of the 2007
late enrollment penalty for any beneficiary
eligible for the low income subsidy for
a Part D plan even if they failed to sign
up by the program's initial deadline.
Review
of 340B Prices (OEI-05-02-00073; 07/06)
(Acrobat/pdf)
- This report reviews 340B prices charged
to a subset of covered entites and compares
them to the 340B ceiling prices.
Oversight
and Administration of the 340B Drug Discount
Program: Improving Efficiency
and Transparency. The Committee on Energy
and Commerce, Subcommittee on Oversight
and Investigations December 15, 2005
New
Information for Manufacturers
(PDF - 620 KB) - Letter requesting voluntary
submission of manufacturer 340B ceiling
price data.
GlaxoSmithKline
Posts Discount Prices on 340B Prime Vendor
Web Site -
The
340B Prime Vendor Program, which is managed
by Apexus Inc. (formerly HPPI) (Irving,
TX), announced that GlaxoSmithKline (Research
Triangle Park, NC) is the first pharmaceutical
manufacturer to post its PHS/340B discount
program prices on the 340B Prime Vendor
Program's secure Web site at www.340bpvp.com.
Posting pricing on the Web site is an
effective way to make the discounted PHS
Ceiling Price information accessible to
participating organizations. GlaxoSmithKline
became a contracted supplier with the
Prime Vendor Program on March 15, 2005.
The 340B Prime Vendor Program provides
deep discounts on outpatient drug purchases
to public hospitals, community health
centers, clinics, state-operated AIDS
drug assistance programs and other safety-net
health care providers serving low-income
and uninsured patients.
New
Manual for 340B Hemophilia Treatment Centers
(PDF - 334
KB)
– the Maternal and Child Health Bureau
has posted a “Hemophilia Treatment Center
Manual for Participating in the Drug Pricing
Program Established by Section 340B of
the Public Health Service Act”. This manual
provides guidance and reference material
for Hemophilia Treatment Centers (HTCs)
eligible to participate in the Drug Pricing
Program authorized by section 340B of
the Public Health Service Act (PHS Act).
It provides information on the authorizing
legislation, the program’s method of operation,
and specifics on how HTCs can become approved
covered entities and make effective use
of 340B discounts while complying with
its statutory requirements.
Rural
Assistance Center Guide to Pharmacy and
Prescription Drugs
The Rural Assistance Center (RAC) is a
collaborative effort of the University
of North Dakota Center for Rural Health,
and the Rural Policy Research Institute
(RUPRI); and is funded by a grant through
HRSA's Office of Rural Health Policy.
RAC has developed a new information guide
entitled "Pharmacy and Prescription Drugs."
Evaluation
of HRSA's Clinical Pharmacy Demonstration
Projects – Volume 1: Synthesis Report
(PDF
- 698 KB) Final evaluation report of the
Clinical Pharmacy Demonstration Projects
(CPDP) managed by OPA. The purpose of
these projects was to examine the effects
of expanded access to clinical pharmacists
and comprehensive pharmacy services on
the health outcomes of medically underserved
populations. This report is an evaluation
of expanded access and improved outcomes
due to the Clinical Pharmacy Demonstration
Projects.
Volume
II: Case Studies (PDF - 268
KB) Presents five case studies of Clinical
Pharmacy Demonstration Project networks
whose experience may prove beneficial
to other Community Health Centers and
providers exploring the potential for
clinical pharmacy service.
The
PHS 340B Drug Pricing Program: Results
of a survey of Eligible Entities
(PDF - 388 KB) Is a report of a survey
conducted between October 2003 - March
2004 by Mathematica Policy Research, Inc.
on behalf of the Pharmacy Affairs Branch
(now OPA). The report describes results
of a survey of 340B Covered Entities eligible
to purchase prescription drugs under the
340B Drug Pricing Program. This report
is part of OPA's effort to improve outreach,
communication, and services to all entities
eligible to participate in the 340B program.
The report contains recommendations for
improving the program.
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