APA has commended the Centers for Medicare and Medicaid Services (CMS) for"
recognizing the medication needs of the particularly vulnerable
population our members serve." The Association continues to be
concerned, however, over some drug utilization management techniques and the
potentially discriminatory restrictions those techniques may impose on
patients' access to medications in the Medicare Part D prescription drug
The praise and concern were part of written comments submitted to CMS on
March 6 in response to a draft guidance outlining how the agency plans to
review drug formularies submitted by prescription drug plans (PDPs) that
intend to participate in the program in 2007.
In that draft guidance, issued February 23, CMS proposed to continue the
2006 requirement that all PDPs include in their Part D formularies "all
or substantially all" medications in six specific classes, including
antidepressants, antipsychotics, and anticonvulsants.
In response, APA "strongly endorsed" the continued protection
for the six classes of medications, which also include the immunosuppressants,
antiretrovirals, and antineoplastics.
"Denial of the medications in these classes would not only harm
enrollees," APA told CMS, "but in the long run would be
detrimental to the entire Medicare program because of [potential] expenses
incurred in increased hospitalizations and other acute care
Moreover, APA strongly recommended that the agency add several protective
steps to its review process for formularies, in addition to the core
requirements outlined in the United States Pharmacopeia (USP) Model
The USP's Model Guidelines were developed in 2004 as an outline of the drug
categories, classes, and key drug types that should be included in formularies
of all PDPs participating in Part D (Psychiatric News, October 1,
2004). Under the Medicare Modernization Act, which created the Part D benefit,
all PDPs participating in Part D must cover at least two medications"
within each therapeutic category and class of covered Part D drugs,
although not necessarily all drugs within such classes."
In the comments that APA submitted to CMS, APA stated that the final
guidance should refer to treatment guidelines that outline best practices to
guide PDPs in developing their 2007 formularies. PDPs could, for example,
review the practice guidelines developed by APA, the Texas Medication
Algorithm Project, and the Schizophrenia Patient Outcomes Research Team. These
expert guidelines, APA noted, could be valuable in alleviating problems
experienced with some PDPs' denial of certain medications or particular dosing
regimens for specific illnesses.
In addition, APA continued, "it is our view that many widely used
pharmacy management practices are wholly inappropriate if applied to medically
vulnerable populations.... Best practices for the Part D patient population
served by APA members have been developed and should be CMS's reference
APA is particularly concerned with the current guidelines' use of"
so-called safety edits by PDPs to establish quantity limits." The
Association commends the use of such edits when they serve as Drug Utilization
Review alerts, that is, requiring verification from the physician of, for
example, a dose of medication prescribed that is outside usual parameters. APA
is concerned, however, that "[u]nder Part D thus far in 2006, safety
edits are being used to restrict access to necessary doses of medications,
even when the physician assures the PDP that the patient has been stabilized
on the dose prescribed."
APA also expressed concern over language in the draft guidance that would,
for example, appear to allow step therapy or "fail-first"
utilization management techniques, as well as language that appears to allow
formularies to exclude extended-release formulations when immediate-release
versions of the same medication are covered.
Finally, APA told CMS, it is working "with other expert groups"
to develop a detailed analysis of issues "inherent in the use of
conventional utilization techniques for patients with mental illness."
APA welcomes "the opportunity to dialog with CMS about this activity and
hope[s] that [APA and CMS] can develop specific guidelines that will aid CMS
in its review of PDP utilization management practices."
APA's latest round of comments came two months after the Association had
submitted written comments to the USP regarding a proposed revision of its
Model Guidelines for 2007 for drug categories and classes covered in Part D
formularies. In those comments, signed by APA President Steven Sharfstein,
M.D., APA said that without the addition of specific protections, the proposed
revision would likely lead to decreased access to psychiatric medications for
Medicare beneficiaries with mental illness and result in substandard clinical
"The proposed guidelines," Sharfstein wrote, "do not
provide an appropriate drug classification system for beneficiaries with
mental illnesses and substance use disorders. The specific therapeutic
categories involved are antidementia agents, antidepressants, antipsychotics,
and bipolar agents. Moreover, the complete absence of a therapeutic category
for addiction treatment agents is inexplicable" (see story below).
Not only are the proposed model guidelines inconsistent with current
standards of care, the proposed categories and classes (see table at right)
compress the available medications in a manner that is "inconsistent
with appropriate organizing principles for these drugs and inconsistent with
accepted practice in the field."
Sharfstein told USP that the "potential chilling effect of the
current guidelines on beneficiary access and physician treatment
options" had been partially ameliorated [during 2006] by CMS's adoption
of the "all or substantially all" formulary guidance. However, he
cautioned, "subregulatory guidance should not and cannot be a substitute
for an appropriate classification system."
Sharfstein noted that APA's review of the original model guidelines"
found them insufficient to support necessary access to
"APA believes that the proposed revisions to the USP Model
Guidelines... have deficiencies that could harm beneficiaries' access to
needed drugs," he wrote.
Last year CMS issued a subregulatory guidance aimed at clarifying how the
agency would determine whether formularies submitted by PDPs included all the
drugs required by the USP Model Guidelines. (A guidance is an interpretative
document that can be changed by a federal agency without going through the
formal regulatory process.)
The USP Model Guidelines for 2006 listed 146 drug categories, classes, and
key drug types; however, psychotropic medications were distilled into
categories and classes that APA believed would promote PDPs' coverage of only
two of the least-expensive antidepressants or antipsychotics. In addition,
coverage of medications for substance abuse appeared to be absent.
Partly in response to input from APA and allied organizations, CMS adopted
the "all or substantially all" requirement to ensure access to
specific medications. The February 23 CMS draft guidance proposes to continue
the 2006 policy and updates how the agency will use the revised USP Model
Guidelines to ensure adequate drug coverage in formularies in 2007.
More information on USP's revision of the Part D Model Guidelines is
CMS draft guidance on formulary review is posted at<http://new.cms.hhs.gov/PrescriptionDrugCovContra/03_RxContracting_FormularyGuidance.asp>.▪