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FDA
Releases Guidance on Patient-Focused Consumer Medication
Information Leaflets
Earlier
this month, the Food and Drug Administration (FDA)
released a final guidance document on Consumer Medication
Information (CMI) leaflets. The document provides
guidance to pharmacists and CMI developers on how
to create CMI that will be considered “useful” to
patients.
Pharmacists
are strongly encouraged to provide CMI, which is often
generated by the pharmacy's computer system, to patients
with each new prescription. The 1996 law which created
the CMI requirement gave pharmacists time to phase
in its implementation; to avoid a Federal mandate
to distribute FDA-approved information, the private
sector was asked to distribute useful written CMI
with 75% of new prescriptions by the year 2000 and
with 95% of new prescriptions by 2006. While pharmacists
exceeded the 2000 goal for distribution – a study
found that 89% of patients received CMI – the quality
of the information distributed varied and did not
meet the criteria for measuring “usefulness”. The
new guidance document released by the FDA is designed
to help pharmacists and CMI developers examine and
evaluate the usefulness of their CMI and make improvements
necessary to meet the 2006 goal.
The
guidance document recommends that CMI contain:
Drug name
Indications for use
Contraindications
Directions on how to use and store the medication
Information about overdose
Other drugs and food to avoid because of possible
interactions
Patient activities and behaviors to avoid
Risks to specific patient populations such as pregnant
females
Common side effects
Information on how to monitor for effectiveness
Information
in CMI should also be scientifically accurate, unbiased
in tone and content, and up-to-date. The guidance
document also provides formatting recommendations
including the use of 10-point or larger font, short
paragraphs or bullets, and dark text on white or pale
yellow paper. A copy of the guidance document is available
on the FDA
website .
CMS
Proposes to Create a DME Competitive Bidding Program
The
Centers for Medicare &
Medicaid Services (CMS) proposed a competitive bidding
program for durable medical equipment, prosthetics,
orthotics, and supplies (DMEPOS). Under the competitive
bidding program, DMEPOS suppliers would be required
to submit bids for each type of DMEPOS they supply
to Medicare beneficiaries. Based on the bids received,
CMS would select a “pivotal bid” or reimbursement
ceiling for each item of DMEPOS. CMS would only select
and contract with suppliers whose bids meet or fall
under the pivotal bid.
APhA
submitted comments to CMS at the end of June urging
the Agency to make significant revisions to the competitive
bidding program. The comments addressed the Agency's
failure to protect existing relationships between
Medicare beneficiaries and their providers, the fact
that t he program does
not provide small DME suppliers with sufficient opportunity
to participate as required by law, the development
of a program that appears to consider cost savings
more than quality care, and the negative impact the
program will have on patient access to DMEPOS if implemented
as proposed .
CMS
is currently reviewing all of the comments it received
and developing a final regulation on the competitive
bidding program. We will provide additional information
on the competitive bidding program and the related
DME supplier accreditation program as soon as it becomes
available. Background information on the competitive
bidding and supplier accreditation programs is available
on the APhA
Resources: Medicare website.
OIG
releases July 2006 report: Review of 340B prices
For full
text of the report,
click here.
For OPA's
response, click
here.
New
Federal Register Notice
On July 19,
2006, HRSA published a notice in the
Federal Register (71 FR 41028) asking for comment
on a proposed data collection. The notice focused
on the guidelines to permit a manufacturer to audit
a 340B covered entity as part of the OPA dispute Resolution
process, and included an estimated reporting burden
for parties. HRSA asked for comment on the necessity
of collecting the information, the accuracy of their
estimated compliance burdens, ways to enhance the
quality of the information, and ways to minimize the
burden of collecting the information.
FDA
to Require Drug Pedigrees to Protect Against Counterfeit
Drugs
On
June 9, 2006, the Food and Drug Administration (FDA)
announced new steps to strengthen exsting protections
against the growing problem of counterfeit drugs.
The measures, which were released as part of a report
by the Agency's Counterfeit Drug Task Force, emphasize
certain regulatory actions and the use of new technologies
to safeguard the integrity of the drug supply. One
of the most significant new measures includes the
implementation of a drug pedigree requirement for
prescription drugs. (A pedigree is a s tatement of
origin that identifies each prior sale, purchase,
or trade of a drug, including the date of those transactions
and the names and addresses of all parties to them.)
Under the drug pedigree requirement, wholesale distributors
must provide a pedigree to the purchaser (i.e., a
secondary distributor or pharmacy).
The FDA will begin implementing the pedigree requirement
at the end of this year. The Agency's enforcement
of the pedigree regulations will initially focus on
products most susceptible to counterfeiting and diversion
such as those with high market value and those that
have been counterfeited in the past. A draft compliance
policy guide that provides guidance on the type of
drugs that are currently of greatest concern to the
FDA, as well as information on the Agency's enforcement
approach, is available on the FDA
website . APhA will work with the FDA to evaluate
the pedigree requirement's impact on pharmacists.
It is important to note that safety net pharmacies
will also need to comply with the new requirements.
A
copy of the Counterfeit Drug Task Force's full report,
which includes a number of other recommendations such
as spurring the development and adoption of electronic
track and trace technology include radio-frequency
identification (RFID), is also available on the FDA
website .
United
States Supreme Court Refuses to Hear ‘Clawback' Challenge
On June 19,
2006, the United States Supreme Court declined to
hear an action that was filed by five states to challenge
the ‘clawback' provision of the Medicare Modernization
Act (MMA). Five states ( Texas , Kentucky , Maine
, Missouri and New Jersey ) filed the suit, claiming
that the law was an unconstitutional tax. Although
the Supreme Court did not assert original jurisdiction
(or hear the original claim) on the matter, it is
very likely that they will have the case placed before
them again, in the future. As individual states challenge
the provision throughout the country, if the various
courts reach different conclusions on the matter,
it may come back to the Supreme Court for a final
decision.
House
Ways & Means Committee Holds Part D Hearing
On June 14
th , the House Ways & Means Committee held a hearing
to discuss the status of Medicare Part D since the
May 15 th enrollment deadline. Witnesses included
HHS Secretary Leavitt and CMS Administrator Mark McClellan.
Both Sec. Leavitt and Administrator McClellan described
the benefit as a great success. A highlight of the
hearing was when Cong. Lloyd Doggett (D-TX) expressed
concern about pharmacists not being able cover their
costs because of low reimbursement levels and slow
payments. In response, Administrator McClellan assured
the Congressman that CMS would step in if plans were
not meeting their contractual obligations. However,
he clarified that the reimbursement rate and payment
frequency are both contractual issues — something
in which CMS will not get involved. Additional information
on the hearing, including copies of Leavitt's and
McClellan's statements can be found on the Committee's
website . PSSC staff worked with APhA to develop
a statement for the hearing. APhA's statement for
the hearing is posted on the APhA
Federal Government Affairs website .
APhA
Testifies at AMA House of Delegates
Once again,
the American Medical Association (AMA) addressed several
issues of interest to pharmacists at their recent
House of Delegates. As in years past, APhA provided
our profession's perspective on several of the proposed
resolutions. This year, APhA Member Margaret
Tomecki testified on three proposals: 1) a resolution
calling on pharmacists to alert prescribing physicians
of situations that involved patient referral to an
alternative pharmacy; 2) a resolution asking the Centers
for Medicare and Medicaid Services to reconsider reimbursement
for non-FDA-approved compounded medications; and 3)
six r esolutions
that address various aspects of immunization administration
and distribution. Copies of the resolutions
are posted on the AMA
website . APhA's impact was positive.
The AMA House referred for further discussion the
above mentioned compounding resolution and the resolution
to require notification of when a pharmacist refers
a patient to an alternative pharmacy. Regarding
the immunization resolutions, the AMA House of Delegates
adopted policy stating that all health care providers
should have access to all vaccines, that all vaccines
should be administered by a physician or other qualified
health care provider under the supervision of a physician
and that the AMA would work with the CDC and others
to establish a comprehensive distribution system for
vaccines in the U.S.
HHS
National Advisory Committee Issues Report on Rural
Pharmacy
The National
Advisory Committee on Rural Health and Human Services
recently released its 2006 Report to the Secretary
of Health and Human Services. Each year, the
Committee chooses three topics to study and makes
recommendations directly to the Secretary based on
their research and findings. For 2005, one of their
topics was “Access to Pharmaceuticals and Pharmacy
Services in Rural Areas.” Given the broad range of
possible topics, it is significant that this group
chose to focus on access to pharmaceuticals AND pharmacy
services. In addition to access to prescription medications
in rural areas, the Committee's report looked at the
challenges facing rural pharmacists, and the impact
on rural communities that lose their only pharmacy.
The chapter also looked at how the Medicare Part D
drug benefit (and increasing percentage of rural patients
receiving drug coverage from the government instead
of private third party payors) may affect rural patients
and their pharmacists.
During 2005,
PSSC and APhA worked with the Committee on this topic.
Additionally, PSSC and APhA submitted formal comments
to the Committee. Finally, PSSC 's previous Senior
Director Diane Goyette and PSSC Consultant Todd Sorenson
attended the Committee's field hearings throughout
the year. The full report, including the Committee's
recommendations, can be found at http://ruralcommittee.hrsa.gov/
.
OIG
Issues Report on Deficit Reduction Act Changes to
AMP
On May 30,
the HHS Office of the Inspector General (OIG) issued
a report on the changes made to Average Manufacturers
Price (AMP). The Deficit Reduction Act of 2005 (DRA)
amended section 1927 of the Social Security Act, dealing
with the Medicaid program. One provision of the DRA
required the OIG to issue a report to review the calculation
of AMP for Medicaid and to make recommendations for
implementing the new AMP provisions. As CMS prepares
to implement using AMP to calculate the federal upper
limit (FUL) for pharmacy reimbursement for certain
drugs under Medicaid, they specifically looked at
the 340B program and its use of AMP to calculate the
340B ceiling price. In this review, they found two
primary issues. The first is the timely submission
of AMP data by manufacturers, and the second is the
accuracy of the reported AMP data. The OIG acknowledged
that such problems with AMP to calculate the 340B
price could also affect pharmacy reimbursement for
generic drugs under Medicaid.
The OIG
acknowledged in the report that manufacturers used
a variety of methods to calculate AMP, and specifically
recommended that CMS develop more specific policies
for calculating AMP. The report also recommended a
clarification in the definition of retail class of
trade and the treatment of PBM rebates and other price
concessions. APhA met with the OIG and submitted comments
on behalf of pharmacy. Additionally, PSSC and OPA
have worked on many of the DRA implementation issues,
especially as they relate to the 340B drug pricing
program.
GAO
Report Suggests Oversight on ADAP Prices
In April,
the Government Accountability Office (GAO) issued
a report examining the prices that AIDS Drug Assistance
Programs (ADAPs) pay for medications. ADAPs are eligible
to participate in the 340B drug pricing program to
purchase their medications. Congress is preparing
for the reauthorization of the Ryan White CARE Act
that funds AIDS programs, including ADAPs. The Act
also specifically identifies 340B as an economical
source for AIDS drugs. Consequently, Members of the
Senate and the House of Representatives submitted
a request for the GAO to study whether participating
ADAPs were receiving the 340B ceiling price for their
drugs. The GAO noted that OPA does not systematically
check whether ADAPs comply with the grant requirements
to use 340B, nor whether they actually receive the
340B price. The report noted that prices paid by the
ADAPs were sometimes more than prices paid by the
prime vendor program (PVP), and by other federal agencies.
However, this statement does not, on its own, demonstrate
need for greater oversight. In fact, the PVP regularly
negotiates sub-ceiling prices for its participants
and other agencies typically have prices that fall
below the 340B ceiling.
The GAO
made recommendations to HRSA to require all ADAPs
to report the final prices paid for their drugs (including
any other discounts or rebates) and for HRSA to routinely
ensure that the ADAPs paid no more than the 340B ceiling
price.
OPA
Funding in President's 2007 Budget
For the first
time, the Office of Pharmacy Affairs has a specific
line item in the 2007 budget that the President submitted
to Congress. Congress then uses the President's proposal
to shape their own budget measures. The House Appropriations
Subcommittee
on Labor, HHS, Education and Related Agencies
on Wednesday June 7, voted 9-7 along party lines to
approve the fiscal year 2007
Labor-HHS-Education appropriations bill , which
does still contain the OPA line item. The House and
Senate versions of the budget typically are different
and must go to a conference committee for reconciliation
before the final budget is voted upon. We will continue
to watch and track the OPA line item as Congress continues
its work on the budget.
House
Energy & Commerce Subcommittee Holds Pharmacy
Hearing
On May 23,
the House Energy and Commerce Health Subcommittee
held a hearing to examine the Federal Government's
Partnership with America 's Pharmacists. Witnesses
included CMS Deputy Administrator Leslie Norwalk,
and representatives from pharmacy associations, PBMs,
health plans, drug manufacturers, retailers and wholesalers.
Many of the Members of the Committee praised pharmacists'
efforts during the Part D drug implementation, and
focused on ways to improve the program. CMS was pressed
about delays for pharmacy payments under Part D, and
was specifically asked about medication therapy management
(MTM) provisions of the program. Norwalk 's response
was that the plans were given wide discretion for
MTM for 2006, because the entire program was new.
CMS wanted to give them flexibility and to see how
each plan developed their own MTM program. Rep. Allen
(D-ME) specifically asked about individuals that are
eligible for the low-income subsidies, and the need
to continue outreach to bring them into the program.
CMS agreed with the need for more outreach, and specifically
mentioned working with community health centers. Concerns
were also raised about the plight of small, rural
pharmacies, and their unequal bargaining power with
plan sponsors.
Pharmacy
Groups Meet with OIG on Medicaid Changes
In mid-March,
APhA met with representatives from the HHS Office
of Inspector General (OIG) to discuss changes made
to Medicaid reimbursement and other matters in the
Deficit Reduction Act of 2005. (P.L. 109-171). APhA
staff in the meeting included Susan Winckler, Vice
President of Policy and Communications. The OIG wanted
to meet with APhA and other pharmacy groups to talk
about the changes to how AMP is calculated and how
it will be used to calculate pharmacy reimbursement
for dispensing generic drugs under Medicaid after
January 1, 2007. The meeting will assist the OIG in
preparing a report by June, as required by the DRA.
Although PSSC staff did not take part in the meeting,
we have worked closely with APhA staff throughout
the Medicaid reform debate, and have drawn attention
to the specific concerns of safety net providers as
the new law is implemented.
Congress
Adopts New Federal Standard to Curb Meth Production
After working
throughout 2005, the House and Senate passed the ‘
Combat Methamphetamine Epidemic Act of 2005' as part
of the legislation to reauthorize the U.S. Patriot
Act (Public Law 109-177). Unlike earlier versions
of the proposal, the enacted version does not make
ephedrine, pseudoephedrine (PSE), or phenylpropanolamine
Schedule V products under the Controlled Substances
Act (CSA). Instead, it places these chemicals in a
new CSA category of ‘ scheduled listed chemical products'
. Drug products whose ingredients include chemicals
on this list and that may be marketed as a nonprescription
drug are subject to sales restrictions, storage requirements
and record keeping requirements.
Specifically,
the ‘ Combat Methamphetamine Epidemic Act of 2005'
- limits daily retail sales to 3.6 grams per person;
- limits 30-day retail purchases to 9 grams per
person;
- requires non-liquid forms to be sold in blister
packs (with some exceptions);
- requires sellers to place the product behind-the-counter;
- requires sellers to maintain a written or electronic
list ‘logbook' of sales that identifies
- the product name,
- quantity sold,
- names and addresses of purchasers, and
- dates and times of sales;
- and requires purchasers to present a photo ID
and sign the logbook.
Mobile sellers
(such as kiosks in airports) must place the product
in a locked cabinet and are subject to a 7.5 gram
sales limit per customer during a 30-day period. Similarly,
mail-order sellers must, prior to shipping the product,
confirm the identity of the purchaser and may not
sell more than 7.5 grams of products per customer
during a 30-day period.
The U.S.
Attorney General is directed to establish criteria
for the logbook and training programs that all sellers
must take and to promulgate regulations to address
the privacy issues that could arise with the logbook.
The legislation was signed into law by the President
on March 9 th ; the sales limits and blister pack
requirements will go into effect 30-days after this
date; the ‘behind-the-counter' and other requirements
go into effect by September 30, 2006.
The new
standards do not pre-empt state laws; they will be
considered a minimum standard. Tougher state laws,
such as the Oregon law that requires a prescription
to obtain pseudoephedrine-containing products, will
continue to remain in force. The federal law also
establishes tougher penalties for individuals who
make methamphetamine illegally and commits additional
federal resources to finding and shutting down so-called
“super labs” in Mexico , which supply most of the
methamphetamine for U.S. users.
Budget
Update –President Signs 2005 Budget Bill and Presents
2007 Budget Proposal
On February
8 th President Bush signed the Deficit Reduction Act
(S. 1932) into law. The large budget bill includes
provisions that will cut pharmacy reimbursement under
Medicaid, and add Children's Hospitals to the list
of entities eligible to purchase discount drugs under
340B. However, in an unprecedented legislative
error, the version of the bill that the President
signed is different than the version approved by the
House and the Senate. While a public law number (P.L.
109-171) was assigned and most are proceeding as if
the language was properly enacted, a lawsuit challenging
the Constitutionality of the provision has been filed.
To recap,
the legislation set a new Federal upper limit of 250%
of Average Manufacturer's Price (AMP) for multiple
source drugs that would go into effect January 1,
2007. The proposal also will permit some Children's
Hospitals to purchase discount prescription drugs
through the 340B program.
Unfortunately,
the Administration has not finished targeting pharmacy
to find budget savings. The President's proposed 2007
budget includes more cuts to pharmacy by reducing
the recently enacted reimbursement formula for multi-source
drugs in the Medicaid program [250% of Average Manufacturer
Price (AMP)] to 150% of AMP. Fortunately, reports
indicate that neither chamber of Congress is expected
to pursue another savings package; it is a very difficult
process, and one that many Members facing an election
this fall would like to avoid.
Internet
Pharmacy Legislation Introduced
On February 16 th , Congressmen Norwood
(R-GA) and Strickland (D-OH) introduced legislation
(H.R. 4769) to address aspects of Internet access
to prescription drugs. The ‘ Prescription Drug Abuse
Elimination Act of 2006' seeks to have online pharmacies
meet the same requirements as traditional pharmacies
before shipping controlled drugs. The legislation
would require an Internet pharmacy to provide the
following information on its website: contact information
for the pharmacy and its supervising pharmacist; all
States in which the pharmacy is licensed or otherwise
authorized to dispense prescription drugs; contact
information for the practitioners to whom the pharmacy
refers and the State in which such practitioners are
licensed to prescribe; and a statement that the pharmacy
will dispense drugs only upon showing of a prescription.
Sellers
of Schedule II, III, or IV drugs would be required
to limit their sales to those in accordance with a
prescription of the patient's treating provider. The
seller would have to verify that the prescription
is legitimate through direct communication with the
provider and keep a record of that communication for
at least two years. Persons selling prescription drugs
through an Internet site would also be required to
inform the appropriate State licensing authorities
that they are selling the drugs and their contact
information.
Each of
the above requirements would be deemed to have been
met if the Internet site or pharmacy is certified
by the National Association of Boards of Pharmacy's
Verified Internet Pharmacy Practice Sites (VIPPS)
program.
In addition
to creating requirements for online pharmacies and
health care providers, the legislation creates new
jurisdiction for the courts over websites and creates
new chain-of-custody requirements for manufacturers,
importers, distributors, and retailers for these Schedule
II, III, and IV drugs. Finally, the bill would direct
the Secretary of Health and Human Services to conduct
studies on pharmaceutical counterfeiting to determine
the best methods to ensure that unused controlled
substances are not diverted for unlawful use, and
on issues related to prescription drug abuse. There
is some sense that because the bill is focused on
controlled substances, it will have greater support
than other, more broadly applicable proposals.
APhA
Update on Medicaid Payment Reform (Dec 21, 2005)
States
consider importation programs as alternative access
to lower-cost drugs
Prescription
drug importation programs, although prohibited by
federal law, have long been considered by some
as
a means to help people (especially seniors and people
with limited incomes) access costly medications. Despite
passage of the Medicare Part D prescription drug benefit
in 2003 (which will go into effect on January 1, 2006
) the desire for imported drugs has not abated. In
2005, many states continue to consider legislation
that would institute, expand, or refine Canadian and
internet drug programs. Now, at least 12 states have
websites that direct citizens to Canadian prescription
drugs.
In
June, Nevada enacted legislation that would allow
state residents to buy prescription drugs through
Canadian pharmacies over the internet. The law provides
that the Nevada Board of Pharmacy will send representatives
to Canada to license pharmacies that meet the state's
licensure standards.
Additionally,
Rhode Island has long been working on regulations
implementing legislation passed in 2004 that would
allow residents to buy drugs imported from Canada
, as it moves to license Canadian pharmacies. The
U.S. Food and Drug Administration (FDA) has already
warned the state that such a move would violate federal
law.
However, not all
states (and not all patients) agree that importation
is the best solution. According to the National Conference
of State Legislatures, nationwide introductions of
importation legislation are down this year, compared
to last year. For example, last year, California Governor
Schwarzenegger (R) vetoed one piece of Canadian importation
legislation that was passed by the legislature, which
was one of several introduced. This year, only one
legislative proposal was introduced that included
importation, and the issue will not be a part of the
November ballot initiatives on health care.
Some patients are exercising caution
as well. The I-SaveRx program, that was created by Illinois
and has expanded to Kansas , Missouri , Vermont and
Wisconsin , has processed far fewer prescriptions than
were anticipated when the program began last October.
Instead, many patients are looking to manufacturers'
pharmaceutical assistance programs, and other programs
such as 340B (where applicable) to meet their needs.
Multi-state
importation program expanding global reach
The
I-SaveRx program, created by Illinois to facilitate
citizens importing prescription drugs from Canada
, Britain , and Ireland , has announced that it is
expanding to add Australia and New Zealand to the
list of suppliers for the program. The I-SaveRx program,
which is less than a year old, was created in Illinois
, and has expanded to include Wisconsin , Kansas ,
Missouri and Vermont . The move to include Australia
and New Zealand is not surprising, since Canada recently
announced its own plans to introduce legislation that
may limit bulk prescription drug exports to the United
States . Illinois has consistently stated that the
nations included in the I-SaveRx Program have comparable
safety standards to those of the United States Food
and Drug Administration's (FDA), and that the program
will only work with foreign pharmacies that comply
with Illinois pharmacy standards. The state also argues
that the drugs dispensed must originate in the countries
that are parties to the agreement, so that the participating
nations will not be able to pass-through prescription
drugs from other non-contracting nations.
Although
the program is growing, it still has not met expectations
for the volume of prescriptions that it could deliver.
About 10,000 orders have been placed so far through
the nine-month old program, but observers have commented
that it has had a slow start. According to Illinois
, the I-SaveRx program has secured an average savings
of 25 to 50 percent on prescription drugs for citizens
who use the service. Illinois officials have blamed
pressures by the FDA and pharmaceutical manufacturers
for the less than robust numbers, claiming that seniors
and others have been unduly scared away from using
the service. However, both FDA officials and manufacturers
continue to oppose importation plans that sidestep
current law and FDA provisions on importing prescription
drugs.
Texas
Governor Leads Efforts on “Clawback”
Texas
Governor Rick Perry (R) has called for the nation's
governors to join his efforts on changing the “clawback”
formula. In the new Medicare Part D prescription drug
benefit, individuals who are fully eligible for coverage
under both Medicare and Medicaid, will be transitioned
from Medicaid to Medicare Part D on January 1, 2006
. Consequently, states will be required to make monthly
payments to the Federal Government for the costs of
coverage for these patients.
In
its 2006-2007 budget provisions, the Texas legislature
approved funding of $440 million to cover the state's
“clawback” payments to the Centers for Medicare and
Medicaid Services (CMS). However, Governor Perry vetoed
the funding, and sent a letter to all governors explaining
his objections and asking for their support in seeking
changes to the funding mechanism. So far, the governors
of around 20 states have responded positively to his
message. However, it is unclear what changes to the
funding mechanism can be secured at this time.
In
the message accompanying his veto, Perry protested
that the current formula is unfair and does not recognize
states' efforts to reduce prescription drug costs
for Medicaid patients, such as use of prior authorization,
supplemental rebates, and preferred drug lists. The
current formula is based on the estimated amount states
would have paid in drug expenses in 2006. Additionally,
the formula does not take into account the costs states
will incur to establish systems to deal with the new
administrative burdens that come with making determinations
about which patients are eligible for the Medicare
benefit.
Despite
his position on the “clawback” and his veto of the
funding provision, Perry has vowed to continue to
work with President Bush, Department of Health and
Human Services Secretary Michael Leavitt (both former
governors) and current governors on other reform proposals.
Office
of Pharmacy Affairs Studies and Reports
Evaluation
of HRSA's Clinical Pharmacy Demonstration Projects
- Volume 1: Synthesis Report
is the final
evaluation report of the Clinical Pharmacy Demonstration
Projects (CPDP) managed by HRSA's Office of Pharmacy
Affairs, formerly the Pharmacy Affairs Branch.
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:, 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: This report describes
the results of a survey conducted on 340B Covered
Entities eligible to purchase prescription drugs under
the 340B Drug Pricing Program and contains recommendations
for improving the Program. The survey was conducted
between October 2003 and March 2004 by Mathematica
Policy Research, Inc. on behalf of the Pharmacy Affairs
Branch (now the Office of Pharmacy Affairs (OPA) in
HRSA's Healthcare Systems Bureau). This report
is part of OPA's effort to improve outreach, communication
and services to all entities eligible to participate
in the 340B Program.
Other
Studies and Reports
Quality
Through Collaboration: The Future of Rural Health
Care (2005)
offers a strategy to address the challenges in rural
communities by assessing the quality of health care
and providing a framework and recommendations to deliver
services to those rural communities. Read It Online
Free.
Medicaid:
A Critical Source of Support for Family Planning in
the United States: This reports provides
updated information on Medicaid and family planning
across the nation done by the Kaiser Family Foundation
and Alan Guttmacher Institute.
IOM
Report: Quality Through Collaboration: The Future
of Rural Health: This report assesses
the quality of health care in rural areas and offers
a strategy to address quality challenges in theses
areas.
Uninsured
and Underserved: The Health Care Experiences of Latinos
in the Nation's Capital: A summary of
Latino experiences and opinions regarding access to
health care in the District of Columbia, this brief
also contrasts the experiences of Latinos in the District
of Columbia with those of Latinos nationally.
Doughnut
Holes and Price Controls: This Health
Affairs report by Gerard Anderson, a professor
at Johns Hopkins University's Bloomberg School of
Public Health, Dennis Shea, a professor at Pennsylvania
State University , and colleagues examines how government
price controls could affect the gap in Medicare prescription
drug coverage. The report says that, if Medicare could
negotiate drug prices similar to those in Canada and
other nations, where they often are 34% to 59% cheaper,
"Congress could eliminate the doughnut hole in
the Medicare drug benefit.”
Closing
the Doughnut Hole: No Easy Answers: There
are no simple ways for Congress to reduce drug prices,
and legalizing prescription drug reimportation "will
appear to be the easiest, least regulatory 'fix,'"
according to a Health Affairs report by
Patricia Danzon, a professor at the University of
Pennsylvania's Wharton School. The report notes that
reimportation "would be ineffective" at
lowering drug costs and could lead to "serious
health risks to U.S. consumers," a reduction
in drug research and development and less access to
drugs for foreigners in their home countries.
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