States of the
Medicare Drug
Benefit
Information for
State Administrators
Prepared by
Linda Schofield, BSN, MPH
President, Schofield Consulting
April 2005
Summary
The MMA has established an important new benefit for senior and disabled Medicare beneficiaries, thereby assuring their
access to a full array of medical services. States have numerous policy decisions to make in implementing the Part D drug
benefit, including several options to enhance the Part D program. These decisions must be made quickly in order to be ready
for the January 1st, 2006 implementation date. As the safety net provider for many vulnerable individuals, the state’s choices
on these matters are important to the future well-being of the elderly and disabled.
Medicaid
• Cover non-Part D drugs, non-formulary drugs and/or copayments for dual eligibles.
• Incentivize or mandate pharmacies to waive copayments for dual eligibles that cannot pay.
• Establish a dedicated unit for education and assistance for dual eligibles related to plan selection, benefit use, and appeals.
• Re-evaluate existing and planned cost containment policies.
• Re-evaluate current DUR program structure and objectives.
• Re-evaluate disease and case management program structure and vendor contracts.
• Review current managed care program structure and benefit design.
• Review current and proposed LTC programs and alternative structures.
Other
• Fund training and education for other affected agencies.
• Fund contingency drug supplies for high risk patients.
• Fund a program evaluation to inform future policy decisions.
• Decide how to structure retiree drug benefits to produce savings.
Medicaid
The Centers for Medicare and Medicaid Services (CMS) has
also indicated that pharmacies may waive copayments for dual
The MMA makes its most sweeping impact on the Medicaid eligibles at their own expense. Under federal Medicaid rules, in
program, carving out the coverage of drugs for dual eligibles states that have Medicaid drug copayments, the pharmacists
and transferring this responsibility to the Medicare program. may not refuse to supply a prescription to a beneficiary who
Federal matching funds will no longer be available for Medicaid cannot afford the copayment. States may want to work with
drug benefits provided to dual eligibles, except for drugs that their state pharmacies to incentivize them to extend this same
are not included in the list of Part D drugs. However, the protection to dual eligibles enrolled in Part D plans.
transfer of program responsibility is not a complete hand-off. Alternatively, states may want to determine if they can extend
The states are still largely financially responsible for the cost of their current mandates for pharmacists to serve those dual
drugs for dual eligibles, in the form of the “clawback.” eligibles who cannot pay, even though the duals are covered
“Clawback” is the popular term for the mandatory payment by Part D plans.
1 April 2005
Education and Assistance: Although CMS will be Cost Containment Initiatives: States have implemented
responsible for enrolling duals (voluntarily or randomly) into many cost containment initiatives such as preferred drug lists
PDPs, there are likely to be many individuals who do not (PDLs), monthly prescription limits, and copayments for drugs.
understand their benefits, who are enrolled in a plan not best It is important for states to realize that each of these cost
suited to their needs, or who in some way need further containment initiatives must be re-evaluated for policy modifi-
assistance once they are initially enrolled. The final regulations cations in light of the MMA Part D shift of prescription
enable dual eligibles to switch plans as often as they like, but coverage for dual eligibles out of the Medicaid program.
many individuals may not recognize that they have this right, or
that they may be able to gain access to a drug that is not 1. Preferred Drug Lists: Preferred Drug Lists (PDLs) are lists
covered by the PDP in which they initially enrolled. of specific drugs that can be prescribed without prior
Furthermore, they may not have the technical ability to authorization based on the decision of a manufacturer to
evaluate plan options against their personal needs in order to offer state supplemental rebates for those products. The
determine best fit. Similarly, the federal regulations provide for savings from a PDL are dependent on:
an exception and appeal process that enables enrollees to
pursue coverage of a denied drug. But the process will be a. The total volume of prescriptions (particularly in chronic
unfamiliar and the duals may need assistance to navigate their use drug classes) that are subject to therapeutic substi-
way through it. If the state does not establish a dedicated tution with higher supplemental rebate products, and
resource unit for providing such assistance, the duals will
inevitably contact their case workers, case managers, and b. The state’s current federal medical assistance percentage
other state resource people in the Medicaid agency and (FMAP) or “federal match.”
elsewhere. Therefore, states may want to fund an education
and assistance unit, especially during the early phase of tran- The shift of dual eligibles out of the Medicaid pharmacy
sition to the new program in order to assure that beneficiary program significantly reduces the total volume of
needs are met to the best degree possible. They may also prescriptions by at least 50 percent for most states and
want to coordinate their efforts with Area Agencies on Aging, more in states with a high percentage of dual prescription
State Health Insurance assistance Programs (SHIPs), and users. The reduction of prescription volume reduces the PDL
other non-profit organizations that provide outreach and infor- savings by reducing the volume of prescriptions subject to
mation services to older and disabled populations. the supplemental rebate. The MMA shift also affects the
utilization mix of different drug classes, since the dual
In addition to educating and assisting members, the Medicaid eligibles tend to use more chronic use medications, which
agency and/or health department might also consider sending contribute the greatest savings from a PDL. States with a
information to or holding seminars for other providers who will higher federal match rate must return that percentage of
be affected by the Part D program. Nursing homes, savings to CMS, further reducing the state savings from PDL
Intermediate Care Facilities for Persons with Mental supplemental rebates.
Retardation (ICFs-MR), and other residential treatment facilities
will be affected by provisions pertaining to long-term care For these reasons, states will need to consider, post-MMA,
pharmacies and copayment exemptions for institutionalized whether different drug classes should be included or
dual eligibles. These facilities can and should play a role in excluded from their PDLs and also how the shift in volume
assisting their clients to apply for subsidies, select PDPs, and and utilization mix will affect the PDL structure and policies.
effectively use the Part D benefits to which they are entitled. States will also need to consider the return on investment of
continuing a PDL, based on the extensive administrative
costs and resources required to administer it. For states that
have not already implemented a PDL, it may not be cost
effective or generate enough savings to justify pursuing the
program.
2 April 2005
which includes claims for both the Medicaid-only and the Managed Care Benefit Structure: In response to the transition
dual population. The dual population is more likely to need of dual eligibles to Medicare Part D, many states are considering
multiple drugs and specifically those drugs used to treat changes to their managed care Medicaid program benefit
chronic diseases. Once the dual eligibles transition to structures. States that originally allowed the managed care
Medicare, states will need to conduct a cost/benefit analysis organizations (MCOs) to include prescription drugs in their capi-
of limiting the number of prescriptions. The administrative tation rates are concerned that the significant reduction in claim
costs that result from manual reviews and prior authori- volume for their fee-for-service (FFS) drug program will reduce
zations for overrides above the limit may not be justified by their base CMS rebates, as well as any PDL supplemental
the savings from the monthly limit policy on the Medicaid- rebates and savings. They are considering carving out the drug
only population. benefit from the MCOs and moving it back into the FFS drug
program in order to increase total prescription volume. This will
3. Prescription Copayments: In recent years, states have serve to increase the state’s base CMS rebates because the
implemented or increased copayments for prescriptions to states obtain better rebates than the MCOs, and to increase PDL
generate savings to the drug program. The post-MMA supplemental rebates and savings because of the volume
significant reduction in the volume of prescriptions will increase which they believe offers better leverage when nego-
reduce the effects of this cost containment strategy. In tiating manufacturer rebates. Other states have viewed the MMA
addition, the population under federal law that is exempt dual shift differently and propose expansion of managed care by
from copayments, i.e., pregnant women and children, will transferring all remaining non-dual eligibles into MCOs, eliminating
represent a large proportion of the remaining Medicaid the FFS drug program completely. They believe this will reduce
population. the administrative costs of the Medicaid drug program and
simplify the delivery of services through the MCOs. To reduce
Drug Utilization Review Programs: States are required total program costs, several states propose allowing MCOs to
under federal Medicaid law to conduct both prospective and offer various levels of benefit packages that better fit the health
retrospective drug utilization review (DUR) programs to identify care needs of a younger, healthier post-MMA population.
the potential inappropriate use of medications. The transition of
all dual eligibles out of the Medicaid drug program will dramat- Long-Term Care Costs and Benefit Structures: Medicaid
ically reduce the volume of prescriptions identified by DUR programs fund almost 50 percent of all long-term care (LTC)
edits and subject to intervention. This volume reduction may costs nationally. This tremendous resource burden consumes
necessitate changes to the way resources are allocated and to about 35 percent of most state Medicaid budgets and is
the primary objectives of DUR programs. States may find it increasing each year. In recent years, states have sought to
more cost efficient to conduct more detailed retrospective case restructure their long-term care programs by obtaining CMS
reviews, which integrate medical and pharmacy claims data in waivers for demonstration projects that allow patients to
order to identify statistical outliers. The detailed medical case remain in less costly home and community-based envi-
reviews could shift to a smaller, more targeted intervention ronments, assisted living facilities (ALFs), and all inclusive care
group of patients with chronic disease rather than conducting programs such as PACE (Program of All-Inclusive Care for the
large numbers of superficial drug claim reviews and sending Elderly). The provisions of MMA Part D provide prescription
providers DUR generated form letters. It should be noted that cost-sharing exemptions for institutionalized dual eligibles,
the dual eligibles are required to undergo traditional DUR, but such as those residing in skilled nursing facilities and inter-
that function will be provided by the PDPs, not Medicaid. The mediate care facilities. However, under MMA Part D, dual
MMA calls for implementation of a new program for PDP eligibles that reside in home-based environments will be
plans, defined as Medication Therapy Management Programs subject to increased prescription cost-sharing above their
(MTMPs). This program will require more intensive, targeted currently low or non-existent Medicaid cost-sharing
medication therapy management of individual patients that requirements. There is some concern among states that these
meet CMS’s defined criteria for high total drug costs and the provisions will deincentivize patients from remaining in their
presence of multiple chronic diseases. States may want to use existing, alternative LTC environments and promote their
a similar model for their modified DUR/medical case review movement into traditional, more costly institutional care
programs with the Medicaid-only population. facilities in order to obtain free medications. This could serve to
further increase the Medicaid budget.
3 April 2005
Disease and Case Management Programs: Disease and In exchange for meeting these requirements, SPAP payments
case management programs have been implemented and of Part D deductibles and copayments are granted special
expanded in many states during the past several years. There treatment: they count towards “true out-of-pocket costs”
are a few ways that the MMA will affect how states structure (TrOOP). Note: SPAP payments for drugs not covered by the
these programs in the immediate future. States that have dual PDP’s formulary or for drugs not covered by Part D of
eligibles enrolled in disease and case management programs Medicare do not count towards TrOOP and therefore do not
will need to reassess their participation in these programs and assist beneficiaries in reaching their catastrophic benefit level.
whether changes should be made to existing vendor contracts. Likewise, payments made by most other third party payors do
States and their vendors currently have access to all drug claim not count towards TrOOP, however payments made by
information enabling them to perform the detailed drug relatives and bona fide charities, including patient assistance
utilization and medical care reviews vital to the success of programs supported by pharmaceutical manufacturers, will
disease and case management activities. However, once the count towards TrOOP.
dual eligibles shift to PDPs, there are no requirements that the
PDPs share drug utilization data with the states. This will create Several states are considering whether the special treatment of
a significant challenge for states and vendors performing their payments is sufficient incentive to give up their desire to
Medicaid disease and case management. Since many of the auto-enroll all of their members into a preferred PDP, since
physicians serving these patients with chronic disease are CMS has indicated that such action would constitute “discrimi-
Medicare enrolled providers (not affiliated with the Medicaid nation” and cause them to lose their bona fide SPAP status.
program), there will be no opportunity for Medicaid to share the Thus, the first option a state has is whether to continue its
dual eligibles’ drug utilization data with the multiple prescribing SPAP program as a recognized or unofficial SPAP under CMS
physicians for those patients as part of the disease and case rules. It should be noted that the decision to continue the
management coordination efforts. States and vendors will have SPAP as such could have a negative impact on the SPAP’s
to decide if this will severely impede their efforts and whether potential savings from the Part D program if the SPAP includes
they should exclude dual eligibles for those programs. enrollees who are above the low-income subsidy levels. The
State Pharmacy
loss of special status for SPAP payments as counting toward
Assistance Programs
TrOOP will result in the delay of a member reaching the out-of-
pocket threshold for catastrophic benefits. This delay in
reaching federal catastrophic benefits will leave the SPAP’s
State Pharmacy Assistance Programs (SPAPs) enjoy special responsible for continued higher copayments in an extended
treatment in the MMA and will reap savings as Medicare takes “donut hole.” Furthermore, CMS has indicated that it will not
on primary payor status for many members. SPAPs have approve certain aspects of some of the specific proposals that
several options to consider in how they will coordinate with the states have considered as non-qualified SPAPs.
Part D program in the future:
4 April 2005
possible for the needs of each individual. Therefore, SPAPs may Program Design: Each state can decide how it wants to
want to consider developing a tool for matching individuals to design its program in relation to the Part D program. They
PDPs on the basis of their formularies and copayments, rather have a variety of options, which all comport with federal
than simply randomly assigning people to plans. requirements and enable SPAP payments to count towards
TrOOP. Their options most simply are:
Note that, regardless of how the SPAP decides to assist
enrollees in signing up for a PDP, the state may want to pass a. To continue as a full benefit plan and simply act as a
legislation changing the eligibility rules for the SPAP to require secondary payor. This means they need not change their
SPAP enrollees who are eligible for Part D to enroll in Part D benefits and everyone enrolled in their program receives the
plans and apply for low-income subsidies as a condition of same or better benefits in total than they received before
their SPAP enrollment. This will help to assure that the SPAP is Part D implementation. The SPAP simply deducts what the
reaping all of the possible savings from the Part D program. PDP paid from what the SPAP would otherwise pay. If the
SPAP has an open formulary, it would pay when the PDP
Eligibility Applications for Low-income Subsidies: It is in denies coverage of a drug that is not on the PDP formulary.
the SPAP’s financial interest to get its enrollees promptly The SPAP would also pay for “covered” drugs during the
signed up for Part D low-income subsidies. Although SPAPs donut hole and deductible periods, and might pay part of
cannot make eligibility determinations, they can submit appli- the copayments due under the Part D plans, depending on
cations on behalf of their enrollees using the information they the relative copayment structures of each plan.
already obtained during the eligibility process. The Part D
application also requires information about assets, so SPAPs b. To provide only “supplemental” or “wraparound” coverage,
will need to gather that information from their enrollees. To like a Medigap plan. This means they would pay only the
facilitate the application process, SPAPs will want to develop copayments and deductibles for PDP-covered drugs, and
an information technology solution to map their eligibility infor- would pay nothing for drugs denied by the PDPs.
*Income up to $12,560 and assets < $6,000 for individual; income up to $16,862 and assets < $9,000 for couple (2004)
**Income between $12,569 and $13,965 and assets < $10,000 for individuals; income between $16,862 and $18,735 and assets < $20,000 for
couples (2004)
©2005 Southeastern Consultants, Inc.
5 April 2005
d. To subsidize any beneficiary premium due for those benefi- need to decide whether to change their SPAP rules to allow their
ciaries who do not qualify for full federal Part D low-income beneficiaries to obtain SPAP secondary coverage for out-of-
premium subsidies. This would assist all SPAP beneficiaries to state/out-of-network pharmacies and home infusion pharmacies.
6 April 2005
Under the final rule, Pharmacy Plus program costs, including leverage in effectuating any necessary future policy
the state share of the program, cannot be counted towards adjustments. States are in a unique position to collect data as
TrOOP because these programs do not qualify as SPAPs. a collective consumer in a manner that any individual bene-
ficiary could not do. For example, SPAPs will receive the same
Due to the limitations listed above, it is recommended that notices as CMS regarding formulary changes. Medicaid and
states restructure their waiver programs into SPAPs so they the SPAPs will have information about which PDPs their
can realize the maximum amount of savings available under clients enroll in and disenroll from. If either agency elects to
Part D. States that convert their waivers to SPAPs will be able pay for non-formulary drugs or copayments, they will have
to enjoy all the benefits offered under MMA to SPAPs, such as information about denials and cost sharing levels. If either
the ability to have payments count toward TrOOP for enrollees agency decides to assist beneficiaries to appeal or to appeal
so they reach catastrophic thresholds sooner. on their behalf, they will have information about the turn-
State Retirees
available for outpatient use or the hospital should complete the
exception request process before the patient is discharged.
Program Evaluation
Like all employers, the states will be able to pursue federal
subsidies for drug benefit costs for Part D eligible retirees who
Many states and advocacy groups will closely observe the are covered by the retiree plan in lieu of a Part D plan. In order
ability of PDPs, most of whom have never traditionally served to collect these subsidies, states (or their health plan adminis-
low-income populations, to ascertain their ability to sensitively trators) will need to certify that their plans are at least
serve the needs of low-income individuals. However, without actuarially equivalent to Part D benefits and will need to report
documentation of patterns and trends, states may have little their benefit costs. The subsidy is equal to 28 percent of costs
7 April 2005
Definitions
per retiree between $250 and $5,000. In other words, states
can collect a per retiree subsidy of up to $1,330.
Employers, including states, may also pursue an alternative Part D Drug – Any prescription drug not categorically
approach to maintaining their retiree benefits but collecting excluded in 1927(k) of the MMA (i.e., benzodiazepines, barbi-
federal revenue: they may seek a waiver to become a PDP. As turates, drugs used for anorexia, etc.) or any prescription drug
a waivered PDP, they would provide their usual retiree benefits that is not covered under Part B.
low-income subsidies like any other PDP. The waiver would excluded in 1927(k) of the MMA (i.e., benzodiazepines, barbi-
exempt them from certain other PDP requirements, such as turates, drugs used for anorexia, etc.) or drugs covered under
Of course, a state may also decide to drop its retiree benefits definition of a Part D drug and is also covered under a plan. A
entirely. Or states may require their retirees to enroll in Part D covered Part D drug is covered because: it is on the plan’s
plans, including Medicare Advantage plans, and provide them formulary or the beneficiary receives an exception or
only supplemental benefits, such as coverage during the donut successfully appeals non-coverage; the drug is determined to
hole. It is important to note, however, that such supplemental be medically necessary by the plan; and the drug is not
coverage will not count toward TrOOP and therefore will not otherwise excluded by the plan for some reason listed in
assist the retiree in reaching the catastrophic benefit threshold. section 1862(a) of the Act (i.e., drugs used for cosmetic
purposes, foot care, etc.).
accordingly. of a Part D drug but for some reason the plan does not cover
it, perhaps because it is off-formulary, because the plan finds
the drug not reasonable and necessary, or because the plan
believes the drug is excluded under 1862(a).
8 April 2005
The National Pharmaceutical Council
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