Article

The Exclusion of Benzodiazepine Coverage in Medicare: Simple Steps for Avoiding a Public Health Crisis

Harvard University, Cambridge, Massachusetts, United States
Psychiatric Services (Impact Factor: 2.41). 10/2005; 56(9):1143-6. DOI: 10.1176/appi.ps.56.9.1143
Source: PubMed

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Available from: Stephen Soumerai, Jan 05, 2016
PSYCHIATRIC SERVICES http://ps.psychiatryonline.org September 2005 Vol. 56 No. 9
11114433
W
hen the Medicare drug benefit,
the Prescription Drug, Im-
provement, and Modernization Act of
2003 (MMA), goes into effect on Jan-
uary 1, 2006, several categories of
medications will be explicitly exclud-
ed from coverage, including benzodi-
azepines. Approximately 24 percent
of the elderly and disabled “dually el-
igible” Medicaid and Medicare bene-
ficiaries who receive benzodiazepines
(1), or 1.7 million people, will sud-
denly lose coverage for these medica-
tions when they make the transition
from Medicaid to Medicare prescrip-
tion drug coverage under the MMA.
Given that benzodiazepines are an
effective and frequently used class of
medications in the United States
(2,3), why were they left off the list of
covered medications? This Open Fo-
rum discusses the history of the ex-
clusion of benzodiazepines from pre-
scription drug coverage and the im-
pact that the exclusion will have on
Medicare beneficiaries and recom-
mends ways to prevent or ameliorate
the potential catastrophic outcomes
expected from this flawed policy. [See
Economic Grand Rounds, p. 1056.]
History of
benzodiazepine coverage
The exclusion of benzodiazepines in
the MMA dates back to the Omnibus
Budget Reconciliation Act of 1990
(OBRA 1990). Congress allowed
states to exclude or restrict coverage
of benzodiazepines from Medicaid
coverage as part of the Medicaid
Drug Rebate Program, created by
OBRA 1990 in section 1927(d)(2)
(4,5). OBRA 1990 was designed to re-
form the relationship between the
pharmaceutical industry and the fed-
eral government by altering Medicaid
pharmaceutical reimbursement pro-
grams. In response to pressure from
state Medicaid agencies, OBRA 1990
allowed ten categories of medications
to be excluded from prescription
drug coverage (personal communica-
tion, David Schulke, February 10,
2005). They included agents used for
weight loss, fertility, hair growth,
coughs and colds, and smoking cessa-
tion, as well as barbiturates and ben-
zodiazepines. It is noteworthy that al-
though OBRA 1990 allowed states to
exclude benzodiazepines from cover-
age, all state Medicaid programs cur-
rently cover benzodiazepines; howev-
er, about one-third of the states either
impose limits on the number of pre-
scriptions or require prior authoriza-
tion before a patient can fill a benzo-
diazepine prescription (4,6).
When the MMA was passed in
2003, creating the Medicare Part D
prescription drug benefit, it kept the
original wording from section
1927(d)(2) of OBRA 1990 with two
important differences. First, the
MMA states that “drugs that must be
excluded from Medicare coverage
are, with limited exception, drugs that
may also be excluded from Medicaid
coverage under section 1927(d) (2) of
the Act [OBRA 1990].” As Rosack
noted in Psychiatric News, “Medic-
aid’s may became Medicare’s must”
(7). Second, because the MMA
makes an exception for smoking ces-
sation agents among the ten drugs in
section 1927(d)(2), it is clear that
Congress was prepared to modify the
exclusions but chose not to do so for
benzodiazepines. Although benzodi-
azepines were excluded from
Medicare reimbursement, the Cen-
ters for Medicare and Medicaid Ser-
vices (CMS) suggested that private
drug plans and states could provide
them as supplemental benefits; how-
ever, the feasibility of this approach is
uncertain.
On August 3, 2004, CMS released
the proposed regulations for the pre-
scription drug benefit and requested
public comment by October 4, 2004.
They received more than 7,000 re-
sponses addressing all aspects of the
proposed benefit (8). The final rule
was released on January 28, 2005. Al-
though several respondents argued
against the exclusion of benzodi-
azepines from the proposed benefit
(3,9–13), the exclusion remained un-
changed in the final rule. During this
time, the United States Pharma-
copeia released final guidelines on
the Part D benefit (14) in which ben-
zodiazepine derivatives were re-
moved from the category of suggest-
ed covered anticonvulsants, and bus-
pirone and meprobamate were added
as examples of covered anxiolytics.
Given that meprobamate is an older
The Exclusion of Benzodiazepine
Coverage in Medicare: Simple Steps
for Avoiding a Public Health Crisis
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The authors are affiliated with the depart-
ment of ambulatory care and prevention at
Harvard Medical School and Harvard Pil-
grim Health Care. Send correspondence to
Dr. Soumerai at 133 Brookline Avenue, 6th
Floor, Boston, Massachusetts 02215 (e-
mail, ssoumerai@hms.harvard.edu).
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sab.qxd 8/22/2005 9:50 AM Page 1143
Page 1
antianxiety medication with substan-
tial toxicity, known for its overdose
potential and its highly addictive and
sedative properties (15), its use as an
example is perplexing.
In response to concerns about
medications such as benzodiazepines
that were excluded from the MMA,
CMS issued a letter to state Medicaid
directors on June 3, 2005 (16). The
letter acknowledged the large gaps in
MMA coverage and asked the Med-
icaid directors to help fix the prob-
lem by using state funds to cover
medications that the MMA excludes.
The letter specified, however, that if
the state Medicaid program covers
an excluded medication for Medicaid
enrollees, it must cover the medica-
tion for dually eligible enrollees as
well. Given that states will already be
making “clawback” payments
(monthly payments to the federal
government for MMA coverage), it is
unlikely that they will want to take fi-
nancial responsibility for fixing the
gaps in the MMA (17).
On June 30, 2005, Representative
Benjamin Cardin (D-Md.) intro-
duced a bill (HR 3151)(18) cospon-
sored by Representative Jim Ramstad
(R-Minn.) entitled “To Amend Part D
of Title XVIII of the Social Security
Act to Remove the Exclusion of Ben-
zodiazepines From Required Cover-
age Under the Medicare Prescription
Drug Program,” which was subse-
quently referred to the House Sub-
committee on Health. Strong encour-
agement for this legislation came
from the Medicare Rights Center, the
Maine Benzodiazepine Study Group,
and the Drug Policy Research Group
at Harvard Medical School, and the
national press covered the issue (19).
The bill would remove the benzodi-
azepine exclusion in the MMA and
provide for the review of prescrip-
tion-filling policies for benzodi-
azepines by the Secretary of Health
and Human Services to ensure appro-
priate use, prevent abuse, and devel-
op quality improvement and educa-
tional guidelines for benzodiazepine
prescribing. The passage of this bill
would ensure that the negative out-
comes of the benzodiazepine exclu-
sion from the MMA would be pre-
vented. According to Nicholas Mey-
ers, director of the American Psychi-
atric Association’s (APAs) division of
government relations, APA is very
concerned about the negative impact
that the exclusion could have on pa-
tients with mental illness; therefore
APA is trying to find a regulatory or
legislative solution to this problem
(7), and this bill could be the solution
that APA is looking for. The bill was
also strongly supported by the Amer-
ican Medical Association (20) in re-
sponse to prompts from the Maine
Medical Association as well as from
psychiatrists.
Use of benzodiazepines
and the impact of the MMA
Benzodiazepines are not only widely
prescribed (21) but also are highly ef-
fective, safer than many other seda-
tive and hypnotic treatments (22,23),
and inexpensive treatments for anxi-
ety, panic disorder, insomnia (23), and
neurologic and rheumatologic disor-
ders (such as muscle spasms and
epileptic seizures) (24,25); there is
some evidence that they are effective
for treatment of the manic phase of
bipolar disorder (26). They are, in
fact, mainstays of pharmacotherapy
for many disorders (27) and have vir-
tually no lethal potential when taken
alone (28). In addition, benzodi-
azepines are included as “essential
medications” on the World Health
Organization’s essential medication
list (29) and are often used when no
suitable alternative medications are
available (30). Concerns that patients
who use benzodiazepine medications
on a long-term basis will increase
their dosage or engage in problemat-
ic use are unfounded for the vast ma-
jority of patients (more than 95 per-
cent) (31). Research indicates that
even patients for whom benzodi-
azepines are prescribed on an as-
needed basis use lower than pre-
scribed dosages (32). On the other
hand, potential negative side effects
such as tolerance and dependency
can occur in subgroups of vulnerable
patients, such as elderly persons, and
benzodiazepines are sometimes pre-
scribed when they are less likely to be
effective, such as in the treatment of
depressed patients (1,33). These
risks, although real, call for informed
prescribing, not a blanket exclusion.
Failure to reimburse for entire cat-
egories of effective medications, such
as benzodiazepines, can adversely af-
fect both clinical and health outcomes
(1,34–38). For example, we recently
found that a New York state triplicate
prescription policy designed to limit
(but not entirely exclude) benzodi-
azepine use led to a sudden and sus-
tained drop in benzodiazepine treat-
ment among black patients, who had
the lowest rates of use before the pol-
icy (unpublished manuscript, Pearson
SA, Soumerai S, Mah C, et al 2005).
Although this policy decreased inap-
propriate use, it had an even greater
effect on appropriate use of benzodi-
azepines (1). Poorly treated psycho-
logical disorders can exacerbate
chronic physical illness and increase
use of expensive acute services, and
poor treatment may offset any poten-
tial savings achieved by limiting cov-
erage of benzodiazepines (36). Fur-
thermore, more expensive, newer,
and less appropriate medications may
be substituted for benzodiazepines
(39), such as selective serotonin reup-
take inhibitors (40).
Poor and chronically ill patients will
suffer the most when Medicaid en-
rollees who receive benzodiazepines
are cut off from coverage by
Medicare. Patients who are poor and
over age 65 or disabled and those who
are dually eligible for Medicare and
Medicaid coverage will have to make
a transition from Medicaid prescrip-
tion drug coverage to Medicare Part
D prescription drug coverage on Jan-
uary 1, 2006. As noted above, about
1.7 million of these dually eligible
beneficiaries receive benzodi-
azepines (7). Many are long-term
users and will lose prescription drug
coverage for benzodiazepines. Many
will not be aware that coverage of
benzodiazepine therapy will be
abruptly terminated in the new sys-
tem and will not be able to afford
even the relatively inexpensive ben-
zodiazepine medications that are
available in generic form. Substantial
literature exists demonstrating that
lower or discontinued drug benefits
lead poor patients to reduce or dis-
continue prescribed treatment (41),
particularly those with mental illness
(42). In addition, many additional
near-poor Medicare beneficiaries
who are not eligible for Medicaid will
PSYCHIATRIC SERVICES http://ps.psychiatryonline.org September 2005 Vol. 56 No. 9
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also lack access to benzodiazepine
therapy.
If benzodiazepine medications are
abruptly terminated, negative effects
are likely to occur, such as withdrawal
reactions, seizures, emergency de-
partment visits, and hospital admis-
sions (36). Physicians may seek to de-
crease the dosage and duration of use
of benzodiazepines in order to reduce
negative health outcomes for their
patients (43), but they may have no
control over the negative outcomes
that will occur when dually eligible
patients suddenly stop refilling or tak-
ing their medications after the MMA
goes into effect.
Recommendations
We have three recommendations for
policy changes that need to take
place before January 2006 to prevent
gaps in benzodiazepine drug cover-
age and associated adverse clinical
outcomes for millions of Medicare
beneficiaries.
First, Congress should pass the bill
proposed by Cardin and Ramstad that
would modify the language of the
MMA so that in addition to smoking
cessation medications benzodi-
azepines will also be removed from
the excluded list, ensuring that they
are covered medications under the
Medicare Part D drug benefit.
Second, Congress should revisit
and modify the Medicaid restriction
that is part of OBRA 1990. In the
paragraph following section
1927(d)(2), section 1927(d)(3) states
that the Secretary of Health and Hu-
man Services can “periodically up-
date the list of excluded drugs” (4). In
the 15 years since OBRA 1990 was
passed, the Secretary has never up-
dated or modified the list of excluded
drugs (4). It is time that OBRAs list of
potentially excluded drugs be modi-
fied to reflect current clinical practice
and findings from research on bene-
fits and risks of excluded medications.
Removal of benzodiazepines from the
list of drugs that can be excluded by
Medicaid could lead to the removal of
benzodiazepines from the list of med-
ications the MMA must exclude as
well.
Third, in the absence of any policy
change leading to benzodiazepine
coverage, CMS has a duty to explicit-
ly notify providers who may be pre-
scribing benzodiazepines that their
patients will lose coverage for benzo-
diazepines in January 2006 and that
they should immediately start devel-
oping alternative treatment strategies
or weaning their patients off benzodi-
azepines to avoid serious withdrawal
effects that occur because of abrupt
termination of use.
Conclusions
Millions of poor and vulnerable elder-
ly and disabled patients face abrupt
and potentially dangerous termination
of benzodiazepines when Medicare
Part D goes into effect in January
2006, and many other near-poor
Medicare-only beneficiaries will also
lose access to these potentially useful
medications. The negative impact on
the health and quality of life of these
patients could be catastrophic unless
corrective policies are enacted. The
time to act is running out.
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    Full-text · Article · Jan 2006 · New England Journal of Medicine
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    [Show abstract] [Hide abstract] ABSTRACT: The Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003 represents the most significant expansion of Medicare benefits since the program's inception and has important implications for mental health. Medicare will become a major payer for psychotropic medications through the new prescription drug benefit. The structure of the drug benefit's delivery system creates incentives for plans to underprovide medications, like psychotropic drugs, that are used persistently and are associated with high expected costs. Regulators have put policies in place to counteract these incentives. This paper examines these strategies' likely success and suggests additional approaches to be considered.
    Preview · Article · May 2006 · Health Affairs
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    [Show abstract] [Hide abstract] ABSTRACT: Medicare Part D excludes benzodiazepines from coverage, and numerous state government policies limit use of benzodiazepines. No data indicate that such policies have decreased the incidence of hip fracture. To assess whether a statewide policy that decreased the use of benzodiazepines among elderly persons by more than 50% has decreased the incidence of hip fracture. A quasi-experiment comparing changes in outcomes before and after a policy change in a study U.S. state (New York) and a control state (New Jersey). Two U.S. state Medicaid programs, 1988-1990. Medicaid enrollees in New York (n = 51 529) and New Jersey (n = 42 029) who received or did not receive a benzodiazepine. Benzodiazepine prescribing and hazard ratios for hip fracture, adjusted for age and eligibility category. A statewide policy, implemented in New York in 1989, that required triplicate forms for benzodiazepine prescribing to allow surveillance by health authorities. The triplicate prescription policy immediately resulted in a 60.3% (95% CI, -66.3% to -54.2%) reduction in benzodiazepine use among women and 58.5% (-64.3% to -52.8%) among men. Benzodiazepine use in New Jersey remained stable. Hazard ratios for hip fracture that were adjusted for age and eligibility category did not change in New York or New Jersey when the periods before and after use of the triplicate prescription policy were compared (change from 1.2 to 1.1 among female benzodiazepine recipients [P = 0.70], 1.3 to 1.1 [P = 0.08] among female nonrecipients, 0.8 to 1.1 [P = 0.56] among male recipients, and 1.1 to 1.3 [P = 0.46] among male nonrecipients). Information was lacking on race, benzodiazepine dose, and other potential determinants of continued benzodiazepine prescribing. Policies that lead to substantial reductions in the use of benzodiazepines among elderly persons do not necessarily lead to decreased incidence of hip fracture. Limitations on coverage of benzodiazepines under Medicare Part D may not achieve this widely assumed clinical benefit.
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