When the Medicare drug benefit, the Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), goes into effect on January 1, 2006, several categories of medications will be explicitly excluded from coverage, including benzodiazepines. Approximately 24 percent of the elderly and disabled "dually eligible" Medicaid and Medicare beneficiaries who receive benzodiazepines (1), or 1.7 million people, will suddenly lose coverage for these medications when they make the transition from Medicaid to Medicare prescription 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 Forum discusses the history of the exclusion of benzodiazepines from prescription drug coverage and the impact that the exclusion will have on Medicare beneficiaries and recommends ways to prevent or ameliorate the potential catastrophic outcomes expected from this flawed policy. [See Economic Grand Rounds, p. 1056.]
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 reform the relationship between the pharmaceutical industry and the federal government by altering Medicaid pharmaceutical reimbursement programs. In response to pressure from state Medicaid agencies, OBRA 1990 allowed ten categories of medications to be excluded from prescription drug coverage (personal communication, David Schulke, February 10, 2005). They included agents used for weight loss, fertility, hair growth, coughs and colds, and smoking cessation, as well as barbiturates and benzodiazepines. It is noteworthy that although OBRA 1990 allowed states to exclude benzodiazepines from coverage, all state Medicaid programs currently cover benzodiazepines; however, about one-third of the states either impose limits on the number of prescriptions or require prior authorization before a patient can fill a benzodiazepine 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, "Medicaid's may became Medicare's must" (7). Second, because the MMA makes an exception for smoking cessation 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 benzodiazepines were excluded from Medicare reimbursement, the Centers for Medicare and Medicaid Services (CMS) suggested that private drug plans and states could provide them as supplemental benefits; however, the feasibility of this approach is uncertain.
On August 3, 2004, CMS released the proposed regulations for the prescription drug benefit and requested public comment by October 4, 2004. They received more than 7,000 responses addressing all aspects of the proposed benefit (8). The final rule was released on January 28, 2005. Although several respondents argued against the exclusion of benzodiazepines from the proposed benefit (3,9,10,11,12,13), the exclusion remained unchanged in the final rule. During this time, the United States Pharmacopeia released final guidelines on the Part D benefit (14) in which benzodiazepine derivatives were removed from the category of suggested covered anticonvulsants, and buspirone and meprobamate were added as examples of covered anxiolytics. Given that meprobamate is an older antianxiety medication with substantial 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 Medicaid directors to help fix the problem 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 medication 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 financial responsibility for fixing the gaps in the MMA (17).
On June 30, 2005, Representative Benjamin Cardin (D-Md.) introduced a bill (HR 3151)(18) cosponsored by Representative Jim Ramstad (R-Minn.) entitled "To Amend Part D of Title XVIII of the Social Security Act to Remove the Exclusion of Benzodiazepines From Required Coverage Under the Medicare Prescription Drug Program," which was subsequently referred to the House Subcommittee on Health. Strong encouragement 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 benzodiazepine exclusion in the MMA and provide for the review of prescription-filling policies for benzodiazepines by the Secretary of Health and Human Services to ensure appropriate use, prevent abuse, and develop quality improvement and educational guidelines for benzodiazepine prescribing. The passage of this bill would ensure that the negative outcomes of the benzodiazepine exclusion from the MMA would be prevented. According to Nicholas Meyers, director of the American Psychiatric Association's (APA's) division of government relations, APA is very concerned about the negative impact that the exclusion could have on patients 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 American Medical Association (20) in response to prompts from the Maine Medical Association as well as from psychiatrists.
Benzodiazepines are not only widely prescribed (21) but also are highly effective, safer than many other sedative and hypnotic treatments (22,23), and inexpensive treatments for anxiety, panic disorder, insomnia (23), and neurologic and rheumatologic disorders (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 virtually no lethal potential when taken alone (28). In addition, benzodiazepines 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 problematic use are unfounded for the vast majority of patients (more than 95 percent) (31). Research indicates that even patients for whom benzodiazepines are prescribed on an as-needed basis use lower than prescribed 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 prescribed 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 categories of effective medications, such as benzodiazepines, can adversely affect both clinical and health outcomes (1,34,35,36,37,38). For example, we recently found that a New York state triplicate prescription policy designed to limit (but not entirely exclude) benzodiazepine use led to a sudden and sustained drop in benzodiazepine treatment among black patients, who had the lowest rates of use before the policy (unpublished manuscript, Pearson SA, Soumerai S, Mah C, et al 2005). Although this policy decreased inappropriate use, it had an even greater effect on appropriate use of benzodiazepines (1). Poorly treated psychological disorders can exacerbate chronic physical illness and increase use of expensive acute services, and poor treatment may offset any potential savings achieved by limiting coverage of benzodiazepines (36). Furthermore, more expensive, newer, and less appropriate medications may be substituted for benzodiazepines (39), such as selective serotonin reuptake inhibitors (40).
Poor and chronically ill patients will suffer the most when Medicaid enrollees 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 prescription drug coverage to Medicare Part D prescription drug coverage on January 1, 2006. As noted above, about 1.7 million of these dually eligible beneficiaries receive benzodiazepines (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 system and will not be able to afford even the relatively inexpensive benzodiazepine medications that are available in generic form. Substantial literature exists demonstrating that lower or discontinued drug benefits lead poor patients to reduce or discontinue prescribed treatment (41), particularly those with mental illness (42). In addition, many additional near-poor Medicare beneficiaries who are not eligible for Medicaid will also lack access to benzodiazepine therapy.
If benzodiazepine medications are abruptly terminated, negative effects are likely to occur, such as withdrawal reactions, seizures, emergency department visits, and hospital admissions (36). Physicians may seek to decrease 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 taking their medications after the MMA goes into effect.
We have three recommendations for policy changes that need to take place before January 2006 to prevent gaps in benzodiazepine drug coverage 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 benzodiazepines 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 Human Services can "periodically update the list of excluded drugs" (4). In the 15 years since OBRA 1990 was passed, the Secretary has never updated or modified the list of excluded drugs (4). It is time that OBRA's list of potentially excluded drugs be modified to reflect current clinical practice and findings from research on benefits 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 medications the MMA must exclude as well.
Third, in the absence of any policy change leading to benzodiazepine coverage, CMS has a duty to explicitly notify providers who may be prescribing benzodiazepines that their patients will lose coverage for benzodiazepines in January 2006 and that they should immediately start developing alternative treatment strategies or weaning their patients off benzodiazepines to avoid serious withdrawal effects that occur because of abrupt termination of use.
Millions of poor and vulnerable elderly 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.
The authors are affiliated with the department of ambulatory care and prevention at Harvard Medical School and Harvard Pilgrim Health Care. Send correspondence to Dr. Soumerai at 133 Brookline Avenue, 6th Floor, Boston, Massachusetts 02215 (e-mail, firstname.lastname@example.org).