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Medicare
News
Information
for HRSA Grantees on Medicare and Pharmacy Services
May
2006
CMS
Pharmacy Resources
Additional Medicare Resources
State
Wraparound Benefits
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CMS
Proposed Regulation Would Affect Pharmacists' Ability
to Supply DME
On May 1 st
, the Centers for Medicare & Medicaid Services
(CMS) issued a proposed regulation that would create
a competitive bidding program for durable medical
equipment, prosthetics, orthotics, and supplies (DMEPOS).
This regulation could affect DMEPOS items commonly
provided by and billed through a pharmacy such as
diabetic supplies (blood glucose strips and lancets),
nebulizers (but not inhalation drugs), enteral nutrition,
walkers, and wheelchairs. Under the competitive bidding
program, which was mandated by the Medicare Modernization
Act of 2003, 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.
Only suppliers
who submitted a bid and contracted with CMS would
be able to bill Medicare for DMEPOS supplied to Medicare
beneficiaries. Pharmacy practices currently providing
DMEPOS who do not submit a bid, or who submit a bid
that is above the pivotal bid, would no longer
be able to supply DMEPOS to Medicare beneficiaries
.
The competitive
bidding program is scheduled to begin in 10 of the
largest metropolitan areas (temporarily excluding
Chicago , Los Angeles , and New York ) in 2007. The
program will be expanded to include 80 areas by 2009
and may be further expanded in 2010 and beyond.
CMS is seeking feedback on a number of issues including
the type of DMEPOS to include in the program such
as testing strips and lancets; whether to establish
a national or regional mail order competitive bidding
program to furnish diabetic supplies; how to determine
the pivotal bid; how many suppliers to contract with;
etc. An APhA summary of the regulation and a link
to the actual regulation text are located on the APhA
website. Comments must be submitted to CMS by June
30, 2006.
Congressional
Proposals Address Medicare Part D Challenges
The return
of Congress from its spring break has brought success
to pharmacists. Several new pieces of legislation
have been introduced to address the challenges that
remain in the new Medicare prescription drug benefit,
Medicare Part D. The proposals would address several
pharmacist-specific concerns. Elements of the various
proposals include: strengthening the standards for
patient access to their preferred pharmacist; paying
pharmacies a fair and adequate dispensing fee on a
timely basis; ensuring that safety-net providers are
able to continue to provide services to the nation's
low-income and uninsured population; minimizing the
benefit's ‘red tape' by requiring additional standardization;
requiring prompt payment of clean claims; prohibiting
co-branding on beneficiary identification cards; standardizing
medication therapy management programs and establishing
a two-year community-based medication therapy management
demonstration program; limiting the number of plan
choices to six defined plan offerings; prohibiting
plans from making mid-year formulary changes; and
holding pharmacies ‘harmless' for certain costs incurred
during the program's implementation.
Senators Cochran
(R-MS), Enzi (R-WY) and Talent (R-MO) introduced the
Pharmacists Access and Recognition in Medicare (PhARM)
Act (S. 2563). Senator Baucus (D-MT) introduced the
Pharmacy Access Improvement Act (PhAIm) of 2006 (S.2664)
and the Medicare Drug Benefit Simplification Act of
2006 (S. 2665). Senators Menendez (D-NJ) and Lautenberg
(D-NJ) introduced the Prompt Payment of Health Benefits
Claims Act of 2006 (S. 2551). Representatives Jones
(R-NC) and Berry (D-AR) introduced the Fair and Speedy
Treatment (FAST) of Medicare Prescription Drug Claims
Act of 2006 (H.R. 5182). And Representative Wilson
(R-NM) introduced HR. 5193.
House
Ways & Means Health Subcommittee Holds Part D
Hearing
On May 3 and
4, 2006, the House Ways & Means Health Subcommittee
held a hearing to review implementation of the new
Medicare prescription drug benefit. Witnesses
included CMS Administrator McClellan, an independent
pharmacy owner, and a representative from RiteAid.
While pharmacist and beneficiary representatives spoke
of the continuing challenges with the new program,
Dr. McClellan provided a much more positive perspective,
referring to pharmacists as the “linchpin” of the
benefit. Dr. McClellan also referenced the establishment
of the newly-established Pharmacy Quality Alliance
- PQA (an alliance on improving health care quality
and patient safety in pharmacy practice and stimulating
the development of new payment models) and how it
reflects the value of pharmacists on the health care
team, and the potential for a medication therapy management
(MTM) demonstration project. More information
on the PQA and APhA's service as a Steering Committee
member is located at www.PQAAlliance.org
.
Congress
Continues to Monitor Part D Implementation
Congress continues
its pursuit of Medicare Part D implementation data.
On February 8 th the Senate Finance Committee and
on March 1 st the House Energy & Commerce Committee's
Subcommittee on Health held hearings to review implementation
of the new Medicare prescription drug benefit during.
At these hearings, Members of Congress and Centers
for Medicare and Medicaid Services (CMS) Administrator
McClellan lauded the efforts of pharmacists and agreed
that the program needs to be fixed. However, the degree
to which the program needs fixing varied widely, with
most Republicans describing the fixes as ‘tweaks'
and Democrats suggesting major changes to the program
such as allowing the government to directly negotiate
with drug manufacturers.
CMS provided
insight into the steps the Agency plans to take to
make the benefit work better for patients and health
care providers, including: creating a system to allow
better ‘apples-to-apples and oranges-to-oranges' comparisons
of plans; improving data transfers between CMS and
prescription drug plans; decreasing help line call
wait times; and, monitoring the formulary management
processes to make sure they are neither burdensome
nor inappropriately delaying or denying care. One
of CMS's short-term goals is to reduce the number
of beneficiaries' enrolling or switching plans late
in the month, a cause of much confusion in the program.
OIG
and CMS Disagree on Part B ASP Methodology
On March 2,
the OIG issued a report that leveled significant criticism
at how CMS calculates the Average Sales Price (ASP)
for Part B drugs and offered an alternative. The report,
entitled “Calculation of Volume – Weighted Average
Sales Price for Medicare Part B Prescription Drugs”
(OEI-03-05-00310), focused on how CMS calculates the
ASP for reimbursing for drugs under Medicare Part
B. The OIG report accuses CMS of using a flawed methodology
to calculate ASP and asserts that if continued, the
OIG will not be able to assess whether reimbursement
adjustments are needed in the future. CMS rejected
OIG's assessment and call for an alternative system.
Instead, they will consider the report's findings
as part of their ongoing efforts to enhance their
implementation of the new ASP calculation.
Since January
2005, CMS has used ASP as the basis for reimbursing
for drugs delivered incident to a physician's care
under Medicare Part B. Many of these drugs are injectible
products used in oncology treatments. During the debate
over Medicaid reform in 2005, some Members of Congress
considered using ASP as basis for calculating reimbursement
for prescription drugs under Medicaid. Ultimately,
Congress decided to use the Average Manufacturers
Price (AMP) instead.
Congress
Monitors Part D Implementation
Congress continues
its oversight of Medicare Part D implementation. On
February 8 th the Senate Finance Committee and on
March 1 st the House Energy & Commerce Committee's
Subcommittee on Health held hearings on implementation
of the new Medicare prescription drug benefit.
At the hearings,
Members of Congress and Dr. Mark McClellan, Administrator
for the Centers for Medicare and Medicaid Services
(CMS) lauded the efforts of pharmacists. There was
general agreement that the program needs to be fixed,
however the degree to which it needs fixing varied
widely. Most Republicans described the fixes as ‘tweaks'
and Democrats suggested the program needed to be scrapped
and totally redesigned to include government negotiations
with drug manufacturers on drug prices.
CMS did provide
insight into some of the steps that they plan to take
next to make the benefit work better for patients
and health care providers including: creating a system
to allow better ‘apples-to-apples and oranges-to-oranges'
comparisons of plans; working to make data transfers
better; working to make help line call waits shorter;
monitoring the formulary management processes to make
sure they are not burdensome or inappropriately denying
and delaying care. One of CMS's short-term goals is
to reduce the number of cases of late enrollment or
plan witches, a cause of much confusion in the program.
APhA's statements
for these hearings include concrete recommendations
to make the program better for pharmacists and the
patients they serve. Those recommendations address
the following problems: The current data lag between
enrollment and availability of eligibility information;
payment for medications and pharmacist services; formulary
management; the lack of standardization amongst the
plans; questionably practices by some plans regarding
the pharmacy access standards; the confusion around
Part B and Part D billing; co-branding and NCPDP issues
with patient identification cards; and general operational
issues. They alsoacknowledged the unique challenges
facing safety net providers including some of the
challenges to participate in the program. Additionally,
APhA has begun pushing CMS and Congress to start working
to ensure that the medication therapy management (MTM)
programs designed by the plans are robust and meet
CMS's goal of MTM being a ‘cornerstone' of the Part
D benefit.
CMS
Considers Revising Requirements for Medicare Part
D Plans in 2007
At the end
of February, the Centers for Medicare & Medicaid
Services (CMS) released several draft documents that
outline requirements for plans that want to offer
a Part D drug benefit in 2007. Two of the documents,
a “Call Letter” for prescription drug plans (PDPs)
and a “Call Letter” for Medicare Advantage Prescription
Drug Plans (MA-PDs), address general requirements
a plan must meet in order to renew their Part D contract
for the 2007 plan year. According to the draft Call
Letters, CMS is considering limiting the number of
plans per region, establishing two new special enrollment
periods for beneficiaries auto-enrolled into a Part
D plan by a State Pharmaceutical Assistance Program
and those who are eligible for the low-income subsidy,
and expanding customer service requirements. The Agency
has also proposed to revise the co-branding requirements
which currently allow plans to include a pharmacy
logo(s) on the beneficiary's identification card.
Under the draft proposal, plans that include a pharmacy
logo(s) on the ID card would also be required to include
the following statement: “ Other
Pharmacies are available in Our Network”.
In a separate
document, CMS released draft formulary guidelines
for Part D plans. The guidelines address a number
of topics from formulary exceptions and prior authorization,
step therapy, and quantity limitations to submitting
accurate formulary information to CMS and minimizing
post-submission changes. A draft document outlining
general requirements for a plan's transition process
was also published. Under the draft requirements,
plans would have to provide beneficiaries with a minimum
30-day transition supply in community pharmacies and
a minimum 90-day transition supply in long-term care
facilities. Plans would also be equired to inform
beneficiaries when they receive a transition supply
– and the temporary nature of that supply – within
72 hours, and inform pharmacists at the point-of-sale
when the medication is being supplied as a transition
supply instead of a formulary drug.
CMS
Announces Medicare Part D Plans
On
Friday, September 23 rd , the Centers for Medicare
& Medicaid Services (CMS) announced the plans
approved to offer a prescription drug benefit under
Medicare Part D. Medicare beneficiaries will be able
to choose from a range of stand-alone Prescription
Drug Plans (PDPs) and in all but two states – Alaska
and Vermont – a number of managed care Medicare Advantage
Prescription Drug Plans (MA-PDs). According to the
CMS announcement, there will be between 11 to 20 stand-alone
PDPs offering drug coverage in each region (including
10 plans that will offer drug coverage nationwide).
A number of Medicare Advantage plans have also been
approved to provide Medicare prescription drug coverage,
but the number of MA-PDs varies significantly by state.
The costs to enroll in a plan and
the benefits each plan provides will vary, but in
every state except for Alaska , there will be at least
one PDP with a premium of less than $20 per month.
And in the majority of states, Medicare beneficiaries
can select a MA plan that provides drug coverage for
no additional cost.
Information on the approved plans
is available on the CMS website at http://www.medicare.gov/medicarereform/map.asp
. The website provides specific information
on the number and type of plans approved in each state.
Starting October
1 st , plan sponsors began marketing their plans to
beneficiaries.
Drug coverage under Medicare Part
D will begin on January 1, 2006 , for those beneficiaries
who sign up for the program. Dual eligible beneficiaries
(those eligible for both Medicare and Medicaid) will
be automatically enrolled into a PDP with a premium
at or below the low-income premium subsidy amount
if they do not enroll in a plan on their own by December
31, 2005 .
New
CMS, APhA Medicare Part D Resources Available
The
Centers for Medicare and Medicaid Services (CMS) recently
released several new Medicare Part D resources. The
resources, which include a number of interactive online
tools, are designed for Medicare beneficiaries who
want to learn more about the new Medicare prescription
drug benefit. The tools, which are available at http://www.Medicare.gov
may also be used by pharmacists and other health
care providers who want to help their patients navigate
the drug benefit.
Medicare beneficiaries
can use the “ Medicare
Prescription Drug Plan Finder ” to look up the
Medicare prescription drug plans available in their
area. The Plan Finder provides general information
on the available Prescription Drug Plans (PDPs) and
Medicare Advantage Prescription Drug Plans (MA-PDs),
including basic cost information such as plan deductible,
monthly premium, cost-sharing or co-payment structure,
and whether or not there is a gap in coverage before
catastrophic coverage begins. Before beneficiary enrollment
begins on November 15 th , the tool will be expanded
to include information on each plan's drug formulary
and pharmacy network, as well as specific drug costs.
The “ Formulary
Finder ” is a more targeted tool that solely provides
information on plan formularies. APhA recommends that
pharmacists use this tool to identify plans in their
area that cover the prescription drugs most commonly
used by their Medicare patients. After entering a
list of medications into the search tool, the site
will provide a list of plans that cover all of those
medications. Printing and keeping a copy of this list
in your pharmacy may help when pharmacists receive
questions from beneficiaries asking which Part D plan
covers the medications they currently take.
Medicare
Prescription Drug, Improvement and Modernization Act
(MMA)
In
August 2004, the Centers for Medicare & Medicaid
Services (CMS) released a proposed regulation outlining
how the Agency intended to implement the new prescription
drug benefit component of the Medicare Prescription
Drug, Improvement, and Modernization Act of 2003 (MMA).
CMS opened a 60-day comment period to solicit public
input on the proposal. During this time, CMS eceived
a total of 7,696 comments from interested stakeholders.
After
reviewing comments and revising the regulation, the
CMS released the final regulations to implement the
new Medicare prescription drug benefit on January
21, 2005. The MMA made several dramatic changes to
the Medicare program; however, the final regulation
implements only the section of the MMA that creates
a prescription drug benefit of Medicare beneficiaries.
Regulations to implement other sections of the Medicare
law are being released separately.
The regulations took effect March
22, 2005 and the Medicare prescription drug benefits
will begin in January 2006. A copy of the final regulation,
as well as several summary and background documents,
are available on the CMS web site at http://www.cms.hhs.gov/medicarereform/pdbma/general.asp.
(Source:
APhA Medicare Prescription Drug Benefit Summary, Feb.
2005)
**Resource**The
Centers for Medicare and Medicaid Services (CMS) and
HRSA are making information available regarding
the Medicare Modernization Act (MMA) of 2003 and the
new Medicare Prescription Drug Coverage for HRSA grantees
and safety-net providers.
If you provide
prescription drugs or contract with a provider of
prescription drugs , you will need to decide about
participating in one or more of the Medicare Prescription
Drug Plans. Beginning January 1, 2006, you will be
able to receive Medicare reimbursement only for those
clients with Medicare (and for those clients with
both Medicare and Medicaid) enrolled in Medicare Prescription
Drug Plans with which your organization has contracts.
Please view the following links for more information.
**Resource**Regional
CMS Offices Pharmacist Contact List
This
PDF document contains a listing of pharmacists in
the
Centers for Medicare & Medicaid Services
Regional Offices who can answer questions about the
Medicare Prescription Drug Program.
State
Legislative Activity Relating to Implementation of
Medicare Part D
This
PDF document contains examples of the types of legislation
that states are considering, or passing, relating
to Medicare Part D. The “progress” of each of the
bills reported is accurate as of May 2005. For updated
information on the status of the bills, please contact
the relevant state legislature directly.
Center
for Medicaid and Medicare Services Pharmacy MMA Information
web site
The Pharmacy
MMA Information web site was created for pharmacists
by pharmacists, provides useful and timely information
about the new Medicare Prescription Drug Coverage.
You will find resources to help learn and prepare
for the new Medicare Prescription Drug Coverage, including
answers to frequently asked questions, links to regulations
and guidance, and information for special-practice
pharmacies.
Prescription
Drug Plans (PDP)
The
Centers for Medicare and Medicaid Services (CMS) created
this web page for those interested in information
regarding Part D of the new Medicare law. The page
contains links to PDP implementation documents, frequently-asked-questions,
and additional resources. The page also contains a
form for interested pharmacies can sign up to make
their interest known about the PDPs. Click on "interested
third party information," then click on the form.
CMS
Medicare Modernization Act Updates
The Centers for Medicare and Medicaid
Services has created this update to provide the public
and other interested parties with up-to-date information
on CMS' efforts to implement the new legislation.
This update will be published monthly. It will contain
information on what CMS accomplished in the past
month as well as major activities scheduled for the
coming month, such as key implementation dates and
regulations being published.
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