October 4, 2004
Mark B. McClellan, M.D., Ph.D.
Administrator
Centers for Medicare and Medicaid Services
Department of Health
and Human Services
Attention: CMS-4068-P
P.O. Box 8014
Baltimore , MD 21244-8014
Dear Dr. McClellan:
The National Association of Social Workers (NASW) welcomes
the opportunity to provide comments on the proposed rule "Medicare
Program; Medicare Prescription Drug Benefit," 69 FR 46632. NASW
is the largest professional social work organization with more
than 153,000 members nationwide. NASW promotes, develops, and
protects the practice of social work and social workers, while
enhancing the well being of individuals, families, and communities
through its work, service, and advocacy. We are concerned that
the proposed rule does not provide sufficient protections for
the 13 million Medicare beneficiaries with disabilities and
chronic health conditions. The following are critical recommendations:
Coverage of Dual Eligibles (§ 423.34)
Of grave concern is the impact of the new Medicare drug benefit
on those beneficiaries who currently have drug coverage through
their state Medicaid programs, i.e. the dual eligibles . CMS
must ensure that these very vulnerable beneficiaries receive
coverage for the medications they need under the new drug benefit
and are not harmed or made worse off when their drug coverage
is switched from Medicaid to Medicare.
Based on social workers experience with this group of beneficiaries,
we are gravely concerned that the proposed regulations would
cause harmful disruption in care and inadequate drug coverage
for dual eligibles . In particular, the proposed regulations
do not address how access to needed medications by dual eligibles
will be maintained when their drug coverage is switched from
Medicaid to Medicare.
We urge CMS to take account of the unique circumstances and
needs of this population, and delay transfer of drug coverage
from Medicaid to Medicare for the dual eligibles for at least
six months to allow adequate time to educate and enroll these
vulnerable and often hard-to-reach individuals and to ensure
they receive the drug coverage to which they are entitled.
CMS must also address the real threat of adverse health outcomes
facing dual eligibles . Under the proposed rule, dual eligibles
would effectively be forced to enroll in the lowest cost plans
in their areas because the low-income subsidy they will receive
will only cover the premium for these plans (and automatic
enrollment would require placement in a low-cost plan). While
it is critical that the transfer from Medicaid to Medicare
drug coverage maintain continuity of care, the proposed regulations
provide no such protection. To the contrary, the formularies
for these low-cost drug plans will not be as comprehensive
as the drug coverage these individuals currently have through
Medicaid. Without access to the coverage they need, dual eligibles
would have no real choice but to switch medications. Yet changing
medications for those with complex conditions is both very
difficult and potentially dangerous. For example, abrupt changes
in psychiatric medications bring the risk of serious adverse
drug reactions and interactions and the potential for a severe
loss of functioning.
With respect to beneficiaries with mental illness, these regulations
must give meaningful effect to the concern Congress itself
voiced, stating in the conference report on the Act that: “[
i ]f a plan chooses not to offer or restrict access to a particular
medication to treat the mentally ill, the disabled will have
the freedom to choose a plan that has appropriate access to
the medicine needed. The Conferees believe this is critical
as the severely mentally ill are a unique population with unique
prescription drug needs as individual responses to mental health
medications are different.” [Report No. 108-391, pp. 769-770]
Unfortunately, the proposed rule does not adequately provide
the protection for people with mental illness that Congress
called for. We urge that the regulations be revised to provide
for “grandfathering” coverage of psychiatric medications for
dual eligibles into the new Part D benefit, as a number of
states have done in implementing preferred drug lists for their
Medicaid programs.
Lastly, for the dual eligibles in particular, CMS must f und
collaborative partnerships with organizations representing
people with disabilities and other vulnerable populations.
Such partnerships will be critical to an effective outreach
and enrollment process. Targeted and hands-on outreach to vulnerable
Medicare beneficiaries, especially those with low-incomes,
is vitally important in the enrollment process. We strongly
urge CMS to develop a specific plan for facilitating enrollment
of beneficiaries with disabilities and complex medical conditions
in each region that incorporates collaborative partnerships
with the state and local agencies and the advocacy organizations
that serve them.
Alternative, Flexible Formularies for Beneficiaries for Vulnerable
Populations (§ 423.120(b))
For people with serious and complex medical conditions, access
to the right medications can make the difference between living
in the community, being employed and leading a healthy and
productive life on the one hand, and facing deteriorating health,
unnecessary hospitalizations and even death, on the other.
Often, people with disabilities and complex medical conditions
need access to the newest medications, because they have fewer
side effects and may represent a better treatment option than
older less expensive drugs. Many individuals have multiple
disabilities and health conditions making drug interactions
a common problem. Frequently, extended release versions of
medications are needed to effectively manage these conditions.
In other cases, specific drugs are needed to support adherence
to a treatment regimen. Individuals with cognitive impairments
may be less able to articulate problems with side effects making
it more important for the doctor to be able to prescribe the
best medication for the individual. Often that pharmacological
process takes time since many people with significant disabilities
must try multiple medications and only after much experimentation
find the medication that is most effective for their circumstance.
The consequences of denying the appropriate medication for
an individual with a disability or chronic health condition
are serious and can include injury or debilitating side effects,
even hospitalization or other types of costly medical interventions.
We strongly support the suggestion in the proposed rule that
certain populations require special treatment due to their
unique medical needs, and the enormous potential for serious
harm (including death) if they are subjected to formulary restrictions
and cost management strategies envisioned for the Part D program.
We believe that to ensure that these special populations have
adequate, timely, and appropriate access to medically necessary
medications, they must be exempt from all formulary restrictions
and they must have access to all medically necessary prescription
drugs at a plan's preferred level of cost-sharing. We recommend
that this treatment apply to the following overlapping special
populations who:
- are dually eligible for Medicare and Medicaid;
- live in nursing homes, ICF-MRs and other residential
facilities;
- have life threatening conditions; or
- have pharmacologically complex condition such
as mental illness, Alzheimer's disease, multiple sclerosis,
HIV/AIDS, and epilepsy.
Furthermore, new limits on cost management tools must be imposed
for these vulnerable populations. We urge CMS to make significant
improvements to the consumer protection provisions in the regulations
in order to ensure that individuals can access the medications
they require. For example we strongly oppose allowing any prescription
drug plan to impose a 100% cost sharing for any drug. We urge
CMS to prohibit or place limits on the use of certain cost
containment policies, such as unlimited tiered cost sharing,
dispensing limits, therapeutic substitution, mandatory generic
substitution for narrow therapeutic index drugs, or prior authorization.
We are also concerned that regulations will create barriers
to having the doctor prescribe the best medication for the
individual including off-label uses of medications that are
common for many conditions. We strongly recommend that the
final rule prohibit plans from placing limits on the amount,
duration and scope of coverage for covered Part D drugs.
Involuntary Disenrollment for Disruptive Behavior
(§ 423.44)
The proposed regulation raises grave concerns in allowing
Medicare drug plans to involuntarily disenroll beneficiaries
for behavior that is “disruptive, unruly, abusive, uncooperative,
or threatening” (§ 423.44(d)(2)). These provisions create
enormous opportunities for discrimination against individuals
with mental illness and cognitive impairments. Those who are
disenrolled will suffer severe hardship as they would not be
allowed to enroll in another drug plan until the next annual
enrollment period and as a result they could also be subject
to a late enrollment penalty increasing their premiums for
the rest of their lives. Plans must be required to develop
mechanisms for accommodating the special needs of these individuals,
and CMS must provide safeguards to ensure that they do not
lose access to drug coverage.
As a matter of principle, for a critical safety net program
such as Medicare prescription drugs for dual eligibles, NASW
cannot support automatic disenrollment of this population under
any circumstances. We are therefore alarmed that CMS has proposed
an expedited disenrollment process that would undermine the
minimal standards and protections included in the proposed
rule. This expedited process proposal must not be included
in the final rule. In addition, CMS must provide a special
enrollment period for beneficiaries who are involuntarily disenrolled
for disruptive behavior and must waive the late enrollment
penalty for these individuals as well. The final rule must
include the following protections:
- drug plans must be prohibited from disenrolling
a beneficiary because he/she exercises the option to make
treatment decisions with which the plan disagrees, including
the option of no treatment and/or no diagnostic testing;
- drug plans may not disenroll a beneficiary
because he/she chooses not to comply with any treatment
regimen developed by the plan or any health care professionals
associated with the plan;
- documentation provided to CMS arguing for
approval of a plan's proposal to involuntarily disenroll
an individual must include:
- documentation of the plan's effort
to provide reasonable accommodations for individuals
with disabilities in accordance with the Americans with
Disabilities Act; and
- documentation that the plan provided
the beneficiary with appropriate written notice of
the consequences of continued disruptive behavior or
written notice of its intent to request involuntary disenrollment
; and
- drug plans must provide beneficiaries subject
to involuntary disenrollment with the following notices:
- advance notice to inform the individual that
the consequences of continued disruptive behavior
will be disenrollment ;
- notice of intent to request CMS' permission
to disenroll the individual; and
- A planned action notice advising that CMS
has approved the plan's request for approval of
involuntary disenrollment
Appeals Procedures (§§ 423.562-423.604) The appeals processes outlined in the proposed regulations
are overly complex, drawn-out, and inaccessible to beneficiaries.
Under these proposed rules, there are too many levels of internal
appeal that a beneficiary must request from the drug plan before
receiving a truly independent review by an administrative law
judge (ALJ) and the timeframes for plan decisions are unreasonably
long. In order to qualify for a hearing by an ALJ, beneficiaries
must first request a coverage determination or exception from
a tiered cost-sharing scheme or formulary which can take between
14 and 30 days, unless a plan honors a beneficiary's request
that the determination or exception be expedited in which case
it could still take up to 14 days. To appeal adverse determinations
or exception decisions, beneficiaries must request plans to
review their decision again and make a redetermination within
30 days unless the beneficiary paid out-of-pocket for the medication
at issue, in which case the plan has 60 days to decide. Even
if a plan honors a request to expedite a redetermination ,
the deadline for plans to make a decision could be as long
as 14 days. Following a redetermination , beneficiaries may
appeal to a so-called independent review entity for a reconsideration
of their case, but these entities will not be authorized to
review or question the criteria plans use to evaluate exceptions
requests. The proposed rules do not even set deadlines for
reconsideration decisions. After receiving a reconsideration
decision, beneficiaries are only allowed to appeal to an administrative
law judge if the amount in controversy meets a threshold level
of $100 and it is unclear how CMS will calculate whether a
beneficiary has met this threshold.
In addition to imposing unreasonable delays and burdens on
beneficiaries, these appeal processes are far from transparent.
Drug plans would be authorized to establish their own criteria
for reviewing determination, exceptions, and redetermination
requests and these criteria will vary from plan to plan. Plans
would also be authorized to establish varying degrees of paperwork
requirements for beneficiaries and their prescribing physicians
who wish to request exceptions from tiered cost-sharing schemes
or formularies. Far from ensuring that beneficiaries ' rights
are protected, which should be their primary function, these
procedures would actually impede the right of beneficiaries
to a fair hearing.
Beneficiaries with disabilities and complex health needs often
have an extremely limited capacity to navigate grievance and
appeals procedures. To accommodate the special needs of these
beneficiaries and others who are vulnerable or with low income,
CMS must establish a simpler process that puts a priority on
ensuring ease of access and rapid results for beneficiaries
and their doctors and includes a truly expedited exceptions
process for individuals with immediate needs, including individuals
facing health care crises, which should be modeled after the
federal Medicaid requirement that states respond to prior authorization
requests within 24 hours.
We also urge CMS to require plans to dispense a temporary
supply of drugs in emergencies. The proposed system does not
ensure that beneficiaries' rights are protected and does not
guarantee beneficiaries have access to needed medications.
For many individuals with disabilities such as epilepsy, mental
illness or HIV, treatment interruptions can lead to serious
short-term and long-term consequences. For this reasons the
final rule must provide for dispensing an emergency supply
of drugs pending the resolution of an exception request or
pending resolution of an appeal.
Outreach and Enrollment (§ 423.34)
The proposed regulations do not adequately address the need
for collaboration with state and local agencies and community-based
organizations on outreach and enrollment of beneficiaries with
disabilities and complex health conditions. In the conference
report for the Medicare Modernization Act, Congress directed
that “the Administrator of the Center for Medicare Choices
[sic] shall take the appropriate steps before the first open
enrollment period to ensure that Medicare beneficiaries have
clinically appropriated [sic] access to pharmaceutical treatments
for mental illness” (Report No. 108-391, pp. 769-770).
To respond to Congress's concern with ensuring enrollment
and comprehensive coverage for beneficiaries, CMS must partner
with community-based organizations focused on addressing the
needs of vulnerable beneficiaries and the state and local agencies
that coordinate benefits for them. Beneficiaries with special
needs will most likely turn to organizations that they know
and trust with questions and concerns regarding the new Part
D drug benefit. Making information and educational materials
available at these sites will help inform beneficiaries about
the new benefit, but providing community-based organizations
with pamphlets and brochures alone is not adequate. To answer
the many difficult, detailed, and time-consuming questions
that beneficiaries will have about the new program, extensive
face-to-face counseling services will be needed. Social workers
and community-based organizations can provide the kind of detailed
help needed, but they will need additional resources.
CMS must develop a specific plan for facilitating enrollment
of beneficiaries with special needs, in each region that incorporates
collaborative partnerships with and additional funding for
state and local public and nonprofit agencies and organizations
focused on these needs. In addition, in their bids, drug plans
should include specific plans for encouraging enrollment of
often hard-to-reach populations.
NASW strongly urges that the concerns discussed above be addressed
in order to ensure access to medications under the Part D drug
benefit for the many Medicare beneficiaries who need them.
Thank you for your consideration of our comments.
Sincerely,
Toby Weismiller, ASCW
Director, Professional Development and
Advocacy
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