January 9, 2007
The Honorable Nancy Pelosi
Speaker
Dear Speaker Pelosi:
On behalf of the 210,000
members and 1,200 affiliates of the National Alliance on Mental Illness (NAMI),
I am writing to express concerns regarding HR 4, the Medicare Prescription Drug
Price Negotiation Act of 2007. As the
nation’s largest organization representing individuals with severe mental
illnesses and their families, NAMI is concerned about the potential impact of
HR 4, and repeal of the so-called “non-interference” provision in the Medicare
drug benefit, on critical access protections for the most vulnerable Medicare
beneficiaries living with severe mental illness.
As you know, the
“non-interference” protection was a part of numerous legislative proposals for
extending a prescription drug benefit in Medicare going back nearly a
decade. Legislative proposals that were
put forward by members of Congress on both sides of the aisle, and by both the Clinton
and Bush Administrations, included this restriction on the Secretary
negotiating a single price and formulary structure given the diverse treatment
needs of the Medicare population. In
NAMI’s view, this restriction is an important part of ensuring that
beneficiaries can work with their doctors to access the treatment that works
best for them. While NAMI strongly
supports the shared goal of making prescription drug coverage affordable for
all Medicare beneficiaries, we also want to ensure that this is properly
balanced against the need to ensure broad access to all covered Part D drugs –
especially for the most vulnerable beneficiaries.
NAMI would like to offer
the following concerns regarding HR 4 and its potential impact on the Medicare
Part D benefit for individuals living with severe mental illness.
1) HR 4 and its Mandated Negotiation Requirement Jeopardize
the CMS Formulary Guidance Allowing for Broad Coverage of Psychiatric
Medications in Medicare
For the 2006 and 2007 plan
years, CMS has put in place guidance to all Part D Prescription Drug Plans
(PDPs) and Medicare Advantage (MA) plans requiring coverage of “all or
substantially all”
of the medications in 6 protected classes: anti-neoplastics, immuno-supressants, anti-retrovirals, anti-convulsants, anti-depressants and anti-psychotics. Of these 6 protected classes, 3 are essential to effective treatments for mental illness: anti-convulsants (commonly prescribed as mood stabilizers for bipolar disorder), anti-depressants (commonly prescribed to treat major depression) and anti-psychotics (prescribed for both schizophrenia and bipolar disorder).
NATIONAL
CMS put this “all or
substantially all” coverage requirement in place on top of the basic statutory
provision in the MMA for 2 drugs per class.
The separation of these 6 drug classes is based on the reality that the
medications in these categories are not clinically interchangeable and that a
limit in formularies of only 2 drugs would pose a dangerous risk to the most
vulnerable and medically fragile Medicare beneficiaries.
It is important to note
that this requirement for “all or substantially all” coverage is NOT delineated
in Section 1860D4(b)(3), the statutory requirements for formularies. As a result, this guidance is not part of the
Part D regulations. Instead, it is
“sub-regulatory” guidance given annually to PDPs and MA plans and must be
renewed each year. As such, its
existence is subject to the discretion of the Secretary and would certainly be
displaced by any mandate imposed by Congress to negotiate directly with manufacturers
on price.
Further, it is almost
certain that the Secretary’s ability to demand “discounts, rebates or price
concessions” as required in HR 4 would be undermined by maintaining this
guidance (i.e., the Secretary would have little or no leverage to demand
discounts or rebates). NAMI is extremely concerned that placing
this new legal mandate on the Secretary would directly result in loss of the
“all or substantially all” guidance in the 6 protected classes, and therefore poses
a significant risk to Medicare beneficiaries with mental illness.
2) The Formulary Protections in HR 4 are Vague and
Could Allow Imposition of a Single Preferred Drug List (PDL) for all Part D
Plans as in Medicaid
Currently under Medicaid,
most states include their pharmacy benefit a requirement for physicians to
prescribe off a limited PDL. This PDL is
typically distinct from a larger formulary that includes a broader list of
available medications. Medications on
this preferred list are typically chosen on the basis of manufacturers who are
willing to pay higher supplemental rebates (deeper discounts) to the state –
NOT on the basis of clinical superiority.
For years, NAMI has been concerned about the proliferation of such
policies in Medicaid and we fought to create and maintain exemptions from these
PDLs for medications to treat mental illness.
NAMI is extremely concerned
that the language in HR 4 that is intended to prevent a single national
formulary in Part D (page 2, lines 19-22) would still allow the Secretary to
establish a national PDL for all Part D plans.
The rule of construction in the bill speaks only to “a particular
formulary,” not a PDL. Further, the
second rule of construction (page 2, line 23) appears to merely restate the
existing formulary standards in Section 1860D4(b)(3). If mandatory price negotiation by the
Secretary were to follow the pattern established in Medicaid, use of a national
PDL is likely a tool that HHS would be forced to employ – and the language in
HR 4 would not prevent it.
3) The Experience of the VA and Medicaid Raise
Concerns About Direct Government Negotiation and its Impact on Access
Advocates for repeal of the
“non-interference” protection cite both the Department of Veterans’ Affairs and
Medicaid as examples of how the government has used negotiation to deliver deep
discounts from manufacturers. At the same
time, both Medicaid and the VA have also placed significant restrictions on
access for individuals with mental illness.
For example, as noted above PDLs are prevalent across state Medicaid
agencies – any of which limit the choice of available anti-psychotics to as few
as 2 medications.
Further, in recent years,
Medicaid programs have been increasingly relying on step therapy and “fail
first” requirements. Likewise, the VA’s
single national formulary completely excludes a number of anti-depressants that
now included in all Part D formularies.
Finally, the VA imposes a policy that permits individual VISN clinical
directors to require a veteran with a mental illness prescribed an
anti-psychotic to first go on one of the older 1st generation
“typical” agents before being able to access a second generation “atypical”
agent. NAMI is certainly troubled by
references to both Medicaid and VA as viable alternative models to the current
Part D program.
Conclusion
NAMI understands that HR 4
is being brought to the full House without the benefit of hearings in the
Energy & Commerce and Ways & Means Committees where the impact of
repeal of the “non-interference” protection on access to medications for the
most vulnerable Medicare beneficiaries could be explored in greater detail. Likewise, repeal of the “non-interference”
clause was never voted on by the House in the 109th Congress. NAMI will certainly press the issues related
to patient access when HR 4 reaches the Senate.
NAMI shares the goal of all
House members to ensure that the Part D program reaches its full potential of
meaningful and comprehensive prescription drug coverage. There are a range of legislative changes to
Part D that are needed to make the program work better for beneficiaries living
with mental illness including codifying the status of the 6 protected
therapeutic classes, allowing coverage of benzodiazepines, exempting certain
non-institutionalized dual eligibles from cost sharing, repealing the asset
test for the Low-Income Subsidy (LIS) and permitting private prescription assistance
programs to provide free medications in the “doughnut hole” coverage gap. NAMI looks forward to working with you and
your colleagues to move these needed reforms forward in 2007.
Sincerely,
Michael J. Fitzpatrick,
M.S.W.
Executive Director