| Chapter IV | Table of Contents | Chapter VI |
Although newer antidepressant and antipsychotic medications were much more readily available to health care consumers in 1999 than they were when first introduced, health care payers have been less aggressive at promoting appropriate use than they had been at discouraging inappropriate use. Primary research indicated few cases where payers have implemented processes and procedures to insure appropriate prescribing and dosing, detection of mental illness, reimbursement, or patient compliance with care. These programs appear to be in their infancy, with many respondents indicating that their programs were relatively new. In this section, we report on the status of utilization as assessed in our research.
In summary, this study found:
Health care payers have not been active in designing treatment algorithms or comparing the effectiveness of competing agents head to head.
Clinical development and marketing decisions affect the utilization of any pharmaceutical agent. However the impact of marketing strategies on utilization has not been assessed in any systematic way.
Most payers use some form of utilization review mechanism to track the utilization of psychotherapeutics.
Payers are more likely to monitor providers for compliance with formularies or protocols than they are to monitor consumers for compliance with therapy.
Guidelines for the treatment of schizophrenia, depression and other mental disorders have been produced by various sources. By and large, however, these have been the products of individual health plans, health service programs, or professional associations. Two sets of guidelines have come from national sources: The Agency for Health Care Policy and Research (AHCPR) has published guidelines for the treatment of depression in primary care30 as well as the findings of the Patient Outcomes Research Team (PORT) study on the treatment of Schizophrenia.31 The American Psychiatric Association produces clinical practice guidelines for a variety of mental illnesses including Major Depressive Disorder32 and Schizophrenia.33 In general, all guidelines list effectiveness, safety, patient history, and cost as important factors to consider in making treatment decisions.
The AHCPR depression guidelines, published in 1993, describe a range of issues to be considered in the selection of a pharmacological therapy for depression. These guidelines specify that one of the SSRIs available at the time of publication (fluoxetine, sertraline, and paroxetine), bupropion, trazadone, or a secondary amine TCA (e.g., notriptyline, desipramine) are appropriate first-line choices for the treatment of depression. The guidelines also make specific recommendations regarding dosing of each type of agent, recognizing that TCAs are frequently underdosed. These guidelines recognize that the case for superior efficacy of any one single agent is not clear and that patient preference and physician experience should factor into the decision.
Similarly, the recommendations of the PORT focus on dosing and management of care.31 The guidelines recommend that an antipsychotic other than clozapine be used first line and that the dosing level be in the range of 300 -- 1,000 chlorpromazine equivalents per day for at least six weeks. Specifically the guidelines state
Since studies have found no superior efficacy of any antipsychotic medication over another in the treatment of positive symptoms, except for clozapine in the treatment-refractory patients, choice of the antipsychotic medication should be made on the basis of patient acceptability, prior individual drug response, individual side-effect profile, and long-term treatment planning.
Guidelines from The American Psychiatric Association for the treatment of both depression32 and schizophrenia33 are similar to guidelines discussed above. They provide general guidance to the physician on approach to treatment, but fall short of endorsing any one particular agent or class thereof. The APA depression guideline recommends that any non-MAO antidepressant is an appropriate first-line therapy for a patient with depression unless the patient presents with atypical depression or has had a prior good response to a MAO inhibitor. For patients with atypical depression either an SSRI or a MAO inhibitor is an appropriate first choice. The schizophrenia guideline recommends conventional antipsychotics and risperidone are reasonable first-line medications for patients in acute phases of schizophrenia. Although not completely reviewed at the time of publication, these guidelines recognize that olanzapine and quetiapine may fall into this category as well. The APA schizophrenia guidelines reserve clozapine for treatment-refractory schizophrenia.
Neither the NMHA nor NAMI endorse any particular treatment algorithm. The consumer associations generally believe that all drugs should be available on formulary and defer to the medical community for the choice of individual drugs for an individual patient.
The Health Care Financing Administration(now known as Centers for Medicare and Medicaid Services(CMS)) does not in general instruct States on the choice of individual pharmaceutical agents for inclusion in formulary or treatment guidelines. However, HCFA(now known as CMS) has sent a letter to State Medicaid Directors urging the coverage of atypical antipsychotics as first line agents for the treatment of schizophrenia.25
In general, State Medicaid and State Mental Health programs have not adopted treatment guidelines for depression or schizophrenia. This situation has begun to change somewhat with the advent of Medicaid Managed Care. The outstanding example of treatment guidelines in development and implementation are those developed by the Texas Medication Algorithm Project (TMAP), which is being conducted in four phases.34 In Phase I, algorithms for schizophrenia, depression, and bipolar disorder were developed.
The algorithm for the treatment of nonpsychotic depression makes treatment recommendations for six stages of therapy. In Stage I, the algorithm recommends monotherapy with an SSRI, bupropion, nefazadone, venlafaxine or mirtazapine. In Stage II (after partial or nonresponse), the algorithm recommends trying either a different medication from the Stage I list or a TCA. Alternatively, augmentation is recommended after partial response at each stage. In Stage III, the algorithm recommends use of an antidepressant in a class other than one used in Stage I or II. The algorithm also states that the use of a MAOI may be appropriate in Stage III. Stages IV-VII recommend (in this order) lithium augmentation, combination therapy, electroconvulsive therapy (ECT), or any other antidepressant not listed in Stages I-III.35
The TMAP schizophrenia algorithm recommends use in any order of olanzapine, quetiapine or risperidone whether or not the patient has a history of failure on a typical antipsychotic. After non-response to the two remaining atypical agents or to a typical agent (in patients with no history of failure on a typical agent), clozapine is recommended. In the case of non-compliance with the second atypical antipsychotic, haloperidol decanoate or fluphenazine decanoate is recommended. With partial response to clozapine, an augmenting agent is recommended. With non-response or refusal on clozapine, the algorithm recommends either the use of combinations of atypical and/or typical antipsychotics or the combination of an antipsychotic with ECT.35
In Phase II of TMAP, a feasibility trial determined the suitability of the recommendations, as well as strategies and resources necessary for implementation into the public sector. Phase III, a clinical impact study, compares treatment as usual (TAU) to the algorithms. This study will determine whether the algorithms and associated efforts (e.g., patient/family education and increase in clinical staff to implement the algorithms) produce better clinical outcomes and whether they affect service utilization (and therefore cost). Phases II and III provided clinical staff and physicians with continuing education to ensure understanding and use of the algorithms and medications. Preliminary results indicate that the physicians largely followed the algorithms, requested ongoing continuing medical education/information for the new algorithms, and plan to continue use of the algorithms after completion of the study.35 Respondents within the VA and the DoD reported that treatment guidelines have been found useful in the management of patients with mental illness within organizations.
The VA's Medical Advisory Panel (MAP) for Pharmacy Benefits Management recently developed guidelines for the pharmacologic management of major depression as part of a greater effort to standardize and reduce treatment costs for common diseases within the VA. Currently there are no guidelines for the management of schizophrenia at the national level within the VA or the DoD.36
These guidelines for the treatment of depression rely primarily on APA, AHCPR and other evidence-based published guidelines. Guidelines are reviewed and updated routinely. The guidelines are intended to "assist practitioners in clinical decision-making, to standardize and improve the quality of patient care, and to promote cost-effective drug prescribing."
The guidelines focus on pharmacotherapy from a primary care perspective, encouraging monitoring, appropriate dosage, and maintenance therapy, or referral to a psychiatrist if necessary. The guidelines also state that a psychiatrist should immediately evaluate patients who present with depression and suicidal thoughts and/or symptoms of psychosis. Though no one therapy for depression is recognized as clearly superior, SSRIs are recommended as first-line antidepressants due to the lower risk for suicide in overdose. In developing the guidelines, the MAP did not find sufficient evidence to recommend one SSRI over another.
Several health care payers and health maintenance organizations have produced more explicit guidelines for the choice of antidepressant and antipsychotic medications. These range in scope from designations of preferred medications to more comprehensive sets of guidelines for the management of these illnesses.
Among the payers interviewed in this study, there was no consensus on the choice of recommended first line agents. In general, however, payers are more concerned about managing antidepressant utilization than they are about managing the utilization of antipsychotics. This is largely because the antidepressants (in particular the SSRIs) have a far greater potential for misuse, including their use in the promotion of weight loss, performance enhancement (the "better than well" effect), and the treatment of melancholy that does not constitute depression.
In designing treatment guidelines/disease management, most MCOs try to integrate pharmaceuticals with non-pharmacotherapies. Plans may recommend choice of agents by brand, drug class, dose, duration of therapy, side effects, and required follow-up care. Although distribution of guidelines is not common, one of the five plans interviewed reported distributing these materials to the patient as well as making them available for sale to other health plans. The focus of the program at one large, group-model HMO was more one of physician monitoring and education. This MCO has implemented guidelines to insure better management of depressed patients.
Another large, group-model HMO recommends that either a TCA or an SSRI is an appropriate first-line choice for an antidepressant, leaving the option to the physician. Another group-model HMO admitted to recommending the least expensive agent available, whether it was an SSRI or a TCA.
First-line choices for antipsychotics likewise vary by payer, although few actively promote the use of atypical over typical antipsychotics. One HMO reported promoting the use of typical antipsychotics first-line even though prior authorization requests for atypicals are never denied.
Several PBMs are in the process of developing diagnosis and treatment guidelines (e.g., disease management, preferred drug list). Several reported using the AHCPR guidelines for depression, while others reported following those of their MCO clients. One large PBM has organized an outcomes research division to inform its development of guidelines for the diagnosis and treatment of depression. On the other hand, another large PBM feels that its role in the treatment selection should be minimal and that guidelines should be as general as possible. PBMs reported marketing the guidelines and programs they develop to providers, consumers, and employer and MCO clients.
Often, treatment guidelines published by PBMs have embraced the most up-to-date pharmacotherapies. For example, treatment guidelines published by the pharmaceutical benefits manager PCS state that SSRIs are the drugs of first choice for the treatment of depression, citing less risk of overdose, decreased side effects, increased patient compliance, and demonstrated cost effectiveness. At the time of publication, the national formulary of PCS included all five SSRIs currently available in the US. These guidelines also recommend atypical antipsychotics as first-line therapy for "patients experiencing psychotic episodes in which both positive and negative symptoms are apparent."37 PCS has also implemented formal disease management programs for both depression and schizophrenia.
Pharmaceutical manufacturers play a role in developing treatment guidelines, although these generally cannot focus on their product or pharmacotherapy alone. Rather, they aim for broad coverage of a class of drugs and integration of pharmaceuticals into overall treatment of the disease. One manufacturer stated that most schizophrenia guidelines have atypicals as first-line. Manufacturers may also assist academic institutions with the development of treatment guidelines. This was particularly true for schizophrenia guidelines, such as TMAP.
Employers do not generally concern themselves with the selection of preferred or covered pharmaceutical agents. Likewise, they do not develop or adopt treatment guidelines or disease algorithms for depression, bipolar disorder or obsessive-compulsive disorder. However, health benefits consultants report that they generally encourage employers to cover the most up-to-date pharmacotherapies for mental illness. Only one employer interviewed reported implementing a disease management program for depression, although others expressed interest. This program was a PBM-sponsored program monitored through the PBM contract.
Surprisingly, most BHMCOs are not involved in the writing of clinical practice guidelines for the treatment of mental illnesses. Magellan, the largest BMHCO, recently announced a program to produce general guidelines on the use of antidepressant medications as a component of comprehensive mental health care. However, these guidelines will focus on prescribing practices and appropriate use. They will not endorse specific pharmaceutical agents. The guidelines are being developed within a 3-year program designed to identify prescribing patterns for antidepressants. These guidelines will develop an independent Expert Consensus Panel Guidelines that specify a standard of care. The program will also analyze prescribing data to identify the appropriateness of prescribing in current practice. Finally, the program will develop an educational program to instruct physicians on appropriate prescribing protocols. These guidelines are being developed in collaboration with Eli Lilly.38
The New York State department of Corrections currently administers treatment algorithms and guidelines for the treatment of mental illness. The primary goals of these programs are to provide the highest level of care combined with some level choice to individuals with mental illness.
The Navaho region of the IHS reports no formal guidelines for the treatment of depression or schizophrenia. The principal goal of the treatment strategy within the IHS is symptomatic relief. The Service believes that its primary obstacle to providing effective treatment of mental illnesses within Native American populations is a resistance to "Anglo" medicine a priori. Therefore, the IHS often partners with traditional Medicine Men or seeks to portray itself as an alternative to these.
The clinical trials submitted for review to the FDA by the manufacturer determine the indications for which a drug may be marketed. Although trials used to obtain approval may be sufficient to convince regulatory authorities that a new drug is safe and effective, their design may or may not be adequate to convince health care payers that a new drug represents a therapeutic advance over existing therapies. Therefore, trial design from first toxicology testing to pivotal trials and post-marketing studies is of paramount importance in affecting future drug utilization.
Numerous factors influence which drugs manufacturers choose to develop, and for which particular indications:
In general, manufacturers express no bias against developing a new drug for mental health indications in comparison with physical health indications. One manufacturer did mention that because most behavioral health users have public health insurance, patient recruitment and retention could be a greater challenge for behavioral health than for physical health drugs. This could be especially true in non-institutionalized schizophrenia patients, for example. Similarly, if a product demonstrates potential for both mental health and physical health indications, a lack of clinical expertise in mental health may lead the manufacturer to pursue the physical health indication. In general, manufacturers do not design trials for specific racial/ethnic groups or special populations (e.g., children) unless requested to do so by the FDA.
The MCOs and PBMs interviewed reported that traditional clinical trials are of relatively short duration and measure outcomes using instruments not readily translatable into regular clinical practice, such as standardized psychiatric rating scales. As a result, many manufacturers conduct outcomes studies that measure clinical, quality of life and/or economic endpoints. The respondents interviewed in this study indicated that in order to speed formulary acceptance, manufacturers should:
Some health care payers are beginning to standardize their operating procedures for the review of new agents. For example, Regence BlueShield (Seattle, WA)39 and Blue Cross/Blue Shield of Colorado and Nevada40 have published guidelines for the submission of clinical and economic data supporting formulary consideration.
Manufacturers are responding to the request for such studies. We are aware of numerous outcomes studies of this type for both antidepressants and antipsychotics. Eli Lilly has conducted two direct comparisons of olanzapine and risperidone.41 Janssen is conducting a comparison of outcomes in patients treated with risperidone to those achieved in patients treated with one of 13 different conventional antipsychotics (this trial is named the ROSE trial). Often, payers are conducting this work themselves. For example, Group Health of Puget Sound conducted a comparison of the efficacy and cost-effectiveness of SSRIs to TCAs in a naturalistic, primary care setting.42
Manufacturers devote considerable effort to marketing psychotherapeutics to physicians, although tactics vary. For example, both Janssen and Eli Lilly maintain a specialized detail force for mental health, whereas SmithKline Beecham promotes paroxetine largely through a non-specialty force. AstraZeneca promotes quetiapine through a generalized sales force dedicated to central nervous system products.14
The experience of a company in marketing through certain channels may affect the success of a particular drug. Eli Lilly and Janssen are recognized as experts in mental health marketing. The synergy of fluoxetine and olanzapine doubtless provide Lilly with a certain advantage in promotion. On the other hand, the relative inexperience of AstraZeneca in the mental health market may account in part for the slow diffusion of quetiapine in the treatment of schizophrenia.
It is generally assumed that manufacturer contracts and rebates may affect drug utilization. However, no data exists to support this idea, largely because such data are considered trade secrets. Indeed, none of the manufacturers or health care payers interviewed would discuss any such arrangements. For example, Medi-Cal requires manufacturers to enter into supplemental rebate arrangements with the State prior to including a drug on the formulary, although the exclusion of a drug from the formulary does not necessarily represent the failure of the manufacturer to offer Medi-Cal an acceptable rebate. However, Medi-Cal would not disclose the terms of any such arrangements. Our research does not support the assertion that rebate arrangements are more or less common for physical health medications than they are for psychotherapeutics. Although several MCOs and PBMs participate in volume-based or market share-based rebates or contracts for psychotherapeutics, the significant price differential between the branded and generic therapies prevents contracts or rebates from demonstrating considerable cost-effectiveness to providers.
To increase consumer demand and awareness for particular drugs, manufacturers often use direct-to-consumer advertising. There is a strong belief among consumer and provider associations that direct-to-consumer (DTC) marketing affects drug utilization. However, there are currently no data to support this. This issue may represent another area where follow up research may be useful.
The NMHA believes that direct-to-consumer advertising disseminates valuable information to patients that they may not otherwise receive. However, other respondents feel that marketing efforts may be merely a form of physician or consumer "brainwashing." That is to say, physicians are convinced to prescribe drugs manufactured by the company whose representative visits most frequently, even as consumers grow to demand the drugs with the most appealing promotional materials. The APA reported that DTC marketing probably increases drug utilization, but has not collected data to support this.
Several manufacturers maintain websites that describe their drugs or the diseases they are intended to treat. Sites generally have areas for consumers and for providers. Manufacturers believe these methods of promotion to be effective, but did not provide data on their direct effect on product sales. Sites are often named for the drug on which they provide information. Examples include citalopram (www.Celexa.com), fluoxetine (www.Prozac.com), paroxetine (www.Paxil.com), olanzapine (www.Zyprexa.com), and quetiapine (www.Seroquel.com). Solvay maintains a comprehensive site of information on the treatment of obsessive compulsive disorder (www.ocdresource.com). The paroxetine site now focuses heavily on the use of paroxetine in the treatment of social anxiety disorder, the newest indication for paroxetine. The launch of paroxetine for social anxiety disorder also represents one of the most visible uses of DTC in the mental health area.
Providers express some frustration at the potential for misinformation and the increase in consumer demand for particular products that may or may not be the best therapy for a patient who demands it.
Health care payers have turned to utilization review (DUR) as a primary means of quality assurance and cost-containment. All of the payers interviewed maintain some form of utilization review program. DUR monitors providers, identifies outliers (i.e., over/under-prescribers), and screens patients (e.g., high cost cases eligible for disease management). The majority of providers use DUR as an educational tool to encourage good prescribing practices. Several providers use DUR as a monitoring tool to enforce compliance with formulary, PA and treatment guidelines.
HCFA(now known as CMS) performs drug utilization analysis on an ad hoc basis for the mental health therapeutic classes. The findings of HCFA(now known as CMS)'s reviews are not for public distribution. All Medicaid and State Mental Health Agencies perform some type of drug utilization review, in accordance with the requirements OBRA '90. A survey of Medicaid programs found that 14 States perform DUR in-house, 31 contract the process out, and 4 do a combination of the two.19 A large majority of States (42) perform Prospective DUR (PRODUR) in addition to retrospective DUR.
The DoD performs DUR through a contract staff. For mental health prescriptions, the goal is to minimize duplicated medications and overdosing. The VA has a national in-house DUR database that is reviewed on a regular basis.
Most PBMs track and monitor drug utilization. The majority of DUR programs run through PBMs are retrospective only (although two PBMs run concurrent DUR). They are either managed in-house or through the main health plan. Quality assurance is the most important goal of DUR, followed by formulary compliance (and reduction of drug costs). DUR is often used to identify physicians who are over- or under-prescribers of medications. This identification helps to target physician education initiatives. Criteria for DUR include assuring appropriate dosage, preventing drug interactions, and formulary compliance. One PBM tracks individual physician utilization patterns rather than tracking utilization at the request level. Another PBM has a quality initiative based upon SSRI compliance.
MCOs either perform DUR in-house or contract out to PBMs. Clinical pharmacists run the DUR program at one MCO (in-house, prospective, retrospective and concurrent). The goals of DUR are quality assurance (i.e., appropriate use of drugs in a cost-effective manner) and cost minimization. Monitoring of psychotropic medications occurs no differently than for other classes of pharmaceuticals and tracks duplication, overuse, under-use and possible drug interactions. One MCO interviewed has set standards of compliance for both acute and maintenance phase antidepressant treatment. Utilization review found that the majority (65%) of patients receiving antidepressant medication met their standards for acute phase treatment by remaining on the antidepressant during the entire phase, and almost 50% met the six-month long continuation phase standards by remaining on the drug during that time period.
Employers generally contract out to a PBM or other source for DUR. For these payers, DUR primarily serves as a screening device to identify patients in need of disease management.
BMHCOs are involved in utilization management for both their public and their private sector clients. However, these organizations focus on the entire scope of care and seek to insure that patients are cared for in the least intensive locus of care that meets their mental health needs.
Although the use of psychotherapeutics is part of the continuum of care, the BMHCOs are not generally involved in either the choice of particular agents or the administration of pharmaceutical benefits. The single BMHCO interviewed who is involved in managing pharmaceutical benefits performs utilization review and case management for its MCO, employer, or State customers. This company often serves as an administrative organization for their customers by the handling cost and utilization data necessary to project risk and justify rates. The BHMCO emphasized that available data are not adequate for analysis and stressed the need for better data collection.
The New York State Corrections system did not report engaging in any formal DUR activities. The IHS performs DUR in-house, designed to assure quality, safety, formulary compliance, and cost minimization. Criteria included in regular reviews of drug classes include overuse, underuse, and avoidance of drug-drug interactions. These criteria do not differ from those used in other drug classes.
Programs that monitor patients for compliance with therapy, or providers for compliance with treatment guidelines, are in their infancy. Provider compliance programs usually take the form of monitoring for adherence to a formulary, although programs that monitor for compliance with treatment guidelines are growing in popularity. It should be remembered, however, that treatment guidelines usually take the form of recommendations on overall pathways of care (usually including the use of pharmaceuticals), rather than rigid guidelines on drug choice and dosing recommendations. Therefore, monitoring physicians for the appropriate use of psychotherapeutics is yet to be widely used.
Payers have been slow to implement patient compliance programs, largely because requirements for maintaining patient confidentiality make tracking mental health patients difficult at best. Nevertheless, some employers and managed care plans have begun to implement such programs in the form of call centers or educational programs (e.g., pamphlets). Disease management programs are intended to foster patient compliance; however, pharmaceutical compliance is only one aspect of these programs. PBMs take the most active role in encouraging patient compliance with pharmacotherapy by using various forms of reminders to patients to refill prescriptions.
Provider compliance is a greater priority within the private sector than the public sector. This trend is consistent with the trend toward greater use of restrictive formularies and treatment guidelines in the private sector. Provider compliance programs are likely to grow in the future as the private sector insurers become increasingly concerned with cost-effectiveness.
The APA tracks prescribing practices of a sample of psychiatrists through the Practice Research Network (PRN). This program monitors issues such as the use of different classes of medications. The APA also attempts to monitor dosing practices, although these data have not been published. The primary goal of the PRN is to follow current practices in the treatment of mental illnesses and provide a platform for education to improve the quality of treatment provided by clinicians.
Local chapters of NAMI have engaged in educating provider groups and associations about clinical practice guidelines, such as those published by the APA. As in the case of the PRN, a primary goal of these initiatives is provider education in an attempt to improve care quality.
Provider compliance programs generally do not operate in traditional Medicaid programs. Most drugs are available on formulary and few treatment guidelines are employed. Any willing provider (AWP) legislation generally excludes the possibility of provider credentialling. Medicaid Managed Care programs may monitor physicians for compliance, but this was not within the scope of our research.
State Mental Health programs do not monitor their providers for compliance with treatment or prescribing guidelines on a statewide basis. These programs often are implemented at the level of the individual hospital or community mental health center. As may be expected, such programs vary in scope between individual sites. The outstanding example is the TMAP (Texas Medicaid Algorithm Project). In Phase II of this program, a feasibility trial, physicians self-reported their use of the algorithms and preliminary results indicated the majority complied with the guidelines and would continue to use them after completion of the trial.34,35 Physician manuals are available at the Texas Department of Mental Health and Mental Retardation. The program does not plan to monitor providers for compliance with algorithms. However, some pharmaceutical prescribing patterns are monitored (e.g., different dosages accepted for different indications). Data collected in monitoring physicians is reviewed and physicians are contacted to confirm unique circumstances (via letters, etc.).
The DoD and the VA are more aggressive in monitoring provider practice patterns. Both routinely review provider records to monitor for compliance with formularies, evaluate dosing patterns, and monitor inappropriate use of medications. These evaluations are generally carried out at the local (i.e., treatment facility) level. The VA also carries out an external peer review of physician treatment practices.
Within the private sector, strategies to monitor and encourage compliance with formularies and treatment guidelines include DUR, physician profiling, self-reported surveys and peer review. Physician profiling is perhaps the most aggressive of these methods, as individual physicians are provided with counts of their prescribing of individual drugs on a regular basis. Although most payers interviewed use formularies, treatment guidelines, and profiling primarily as educational tools, several do enforce compliance. Physicians who are found to prescribe off formulary frequently may be targeted by the payer for either education or encouragement to comply with the formulary. Both incentives (e.g., rebates) and disincentives (e.g., withholding of physician bonuses) are used to encourage provider compliance, although these practices appear to be less common than many may fear.
Manufacturers track provider treatment patterns in two ways. First, manufacturers monitor physicians who are high prescribers either of a particular medication or a general class of medications. Prescription data are available for purchase from several sources including IMS Health and Scott-Levin. These data form the basis for a manufacturer's detailing strategy by identifying physicians who are likely to prescribe a particular product or who may be candidates to target for switching. Furthermore, manufacturers target the broader payer population, offering rebates or contracts to health plans to encourage use of a particular product. Second, manufacturers may encourage physician compliance on the individual level by offering physician education programs or materials. One manufacturer also reported offering incentives to physicians who increase patient compliance and reintegration rates.
Most MCOs do not monitor providers for compliance with treatment guidelines or algorithms. However, many plans are beginning to implement comprehensive disease management programs that include a provider component.
One HMO interviewed reported instituting an early detection pilot study for depression within one of its medical groups. This program was developed internally and its organization and outcomes have not been published. This HMO reported that the goal of this pilot program was to develop a screening tool that included depression assessment and treatment guidelines for use by primary care physicians. The goal of this program was to screen patients for undetected or undiagnosed depression. The study team developed a simple, easy-to-use screening form and worked closely with the medical director and providers to improve it over the course of the study. The study team also offered training to providers on use of the assessment tool and treatment strategies. The HMO believes that the program has been successful in a variety of ways. First, this program achieved detection rates that approach what the Agency for Health Care Policy and Research reports as the actual prevalence of depression. Further, most of these patients are willing to pursue treatment. Lastly, physicians are complying with the study, even though the bonuses paid to physicians for performing the detection screen have run out.
Similarly, another integrated MCO is operating a pilot project to systematize the treatment of depression within primary care. The program specifically aims to demonstrate that primary care clinics can develop systems that consistently manage and follow-up depressed patients and to describe and evaluate the change process used to do this, the new care process and its effects. The project has found that regular low-end management (such as 4-5 minute telephone calls with patients) can have as much of an impact as medication on patients with depression.
Finally, another large group model HMO has developed a more comprehensive disease management program for depression. The program consists of disease management guidelines for use in both primary care and specialty behavioral health settings. The guidelines give recommendations for appropriate dosing of medications, and specify that either TCAs or SSRIs are acceptable first-line choices of medication for depression. The choice of a particular agent is left to the physician who is expected to consider cost in making a choice of agent. The program collects data on patients enrolled in the program, including measures of illness severity, medication regimen, costs and treatment outcomes. Within the first year of operation, this program successfully enrolled 50% of new depression patients.
PBMs generally do not enforce physician compliance with treatment guidelines or disease management programs, but encourage compliance through education and notification. One PBM asks physicians to complete a volunteer survey. Another runs a quality initiative based upon SSRI compliance. Maintaining patient confidentiality often precludes adequate data collection and monitoring on a case specific basis.
Employers monitor providers for compliance with guidelines via concurrent or retrospective DUR. This process is usually contracted out to a PBM or other outside source. Furthermore, employers may partner with their PBMs or HMOs to conduct provider education. Employers who take a more activist role in the management of their health benefits report that they are attempting to implement programs to monitor providers for quality assurance purposes.
In the correctional system, providers are internally monitored for compliance with treatment algorithms and guidelines through the health information management department. The management department generates pharmacy profiles of physicians and patients which provides a vehicle for "auditing" provider compliance.
The Indian Health Service does not monitor providers for adherence to treatment guidelines on a regional or national level. Individual treatment facilities develop their own protocols and clinicians are monitored for compliance at that facility.
Patient compliance and disease management programs appear to be more common in the private sector than the public sector. This observation likely reflects several trends currently operating in the mental health services sector. These trends include:
Health care payers are not necessarily convinced of the economic value of compliance and disease management programs. While patient confidentiality remains a barrier to data collection, adequate data is not available to discern the cost-effectiveness of these programs. Despite this uncertainty, some payers continue to offer patient compliance and disease management programs as an added value to patients. Several payers interviewed (mostly private sector) are currently developing or have implemented patient registries or quality of life initiatives for depression. As is the case with treatment guidelines, compliance/disease management programs are less common for schizophrenia than for depression.
Although the national consumer and provider associations do not run patient compliance programs, both NAMI and NMHA maintain outreach programs to underserved populations and are beginning to increase those efforts.
The outstanding public sector example of disease management and compliance is TMAP. TMAP worked with 20-30 patients, consumers and NAMI to design a 6-step patient and family education program. This program includes an array of educational materials ranging from pamphlets to videotapes. These materials cover issues such as how to monitor medications, and speak with physicians about mental illness. Twelve States have requested copies of these pamphlets, which are available from the Texas Department of Mental Health and Mental Retardation.35
In the DoD health care programs, the goal of military service is to maintain worldwide deployability of its active duty officers. Therefore, if a mental illness is documented, medical retirement might be mandated, regardless of disease severity. These policies vary among the service branches. For instance, the Navy and Marine Corps are more likely to allow individuals with a mild mental illness, such as depression, to continue service than the Army and Air Force. An individual might be asked to retire if a particular mental illness affects his/her "fitness to do duty." Dependents and retirees are not affected by this rule unless they would be stationed overseas with an active duty officer. One DoD health care product has the motto: "We are the HMO that goes to war." Therefore, ensuring that an individual who could go to war and handle weapons is of sound mental health lies at the heart of the military's mission of worldwide deployability.
Although it is widely assumed that patient compliance with therapy should ultimately reduce overall medical costs, it is clear that private payers are only beginning to investigate whether this is actually the case.
Manufacturers focus on physician compliance rather than patient compliance due to concerns for patient confidentiality and greater ease of tracking physicians. Furthermore, patient compliance and disease management programs have not necessarily proven financially beneficial to manufacturers. One manufacturer noted that their depression guidelines have not been widely adopted and, in general, there is no accurate measurement of effectiveness for these programs.
Despite these limitations, several manufacturers have begun to develop or implement programs that attempt to assist patients in complying with antidepressant or antipsychotic treatment regimens. Strategies include automated refill systems, 800 hotlines, patient education programs, and the sending of reminders to providers. Manufacturers distribute programs/guidelines to consumers, families, providers and sometimes health plans.
PBMs, MCOs and employers are beginning to implement case management programs for depression and to a lesser degree, schizophrenia, even though case management is often delegated to behavioral health carve-outs. Programs that focus on screening and diagnosis are more common than programs that actually focus on case management.
One integrated HMO interviewed has implemented a confidential health risk assessment program for members that is administered via telephone. Confidential feedback is provided to the health plan member, with recommendations for individual lifestyle and health improvements. Results of the employee's risk data are also sent to their health care provider. This payer is also testing new approaches to chronic care delivery. One recent initiative involves the use of telephone follow-up. Nurses and care managers make a total of six telephone calls during the first six months following a mental health episode -- initially at two-week intervals and phasing into one call every two months. Staff are evaluating the success of this approach and believe that it contributes more to health outcomes than more traditional chronic care (e.g., medications, self-care, other types of follow-up).
This HMO has also implemented programs to monitor and insure follow-up after hospitalizations for mental illness and proper management of antidepressant medications. For example, the HMO tracks the percentage of hospitalized mental health patients age six years and older who were continuously enrolled for 30 days after discharge and who received some form of outpatient treatment (ambulatory care or day/night treatment). Sixty-eight percent of the patients who met these criteria sought outpatient care within seven days of discharge; 86% sought such treatment within 30 days of discharge. Similarly, this HMO monitors three performance indicators that assess multiple facets of appropriate treatment. Each measures the percentage of patients with new episodes of depression who were treated with antidepressant medication and who meet specified treatment criteria.
Employer-sponsored programs designed to assist patients in recognition and treatment of mental illness are not as common as physician-targeted programs. Employers expressed reluctance to implement these programs due to patient confidentiality, the difficulty of data acquisition and the difficulty of demonstrating value of these programs. When in place, they are usually designed and run through the MCO or PBM. Employee assistance programs (EAPs) often serve as a triage mechanism for minor episodes of mental illness or as screening and referral services. When presented with more serious cases, EAPs serve as a referral mechanism to get patients experiencing mental illness into the proper treatment system. At one employer, patients are targeted for a depression screening/education/awareness program through DUR. Pharmacotherapy is an essential part of this employers depression program.
Once employees are undergoing treatment for mental illness, BHO carve-outs may provide generic case management. However, few formal programs are in place, again, due to the difficulty of data acquisition and patient confidentiality.
In general, PBMs are reluctant to operate patient compliance programs due to confidentiality concerns. However, one PBM offers compliance assistance for antidepressants and will survey physicians for effectiveness. Others are planning programs to improve patient compliance (e.g., packaging medications in a box that can be placed on a kitchen counter or dresser).
In designing disease management programs, the manufacturers interviewed did not report explicitly considering physiological differences based on ethnicity (although one manufacturer considers gender). Neither do manufacturers consider sociological perceptions of psychotherapeutics among different cultural groups, although one manufacturer acknowledges that the condition and treatment of schizophrenia is highly dependent on the social/cultural environment (e.g., stigma).
Our respondents reported that patients in correctional facilities of New York State are not forced or coerced to take their medications, but are encouraged through education.
One respondent from within the Indian Health Service indicated that difficulties in patient compliance with "Anglo" medicine is no greater in patients with mental illness than in those with any other disease. This respondent indicated that if the consumer accepted "Anglo" medicine, then compliance with therapy was generally pretty good. In attempting outreach among Native American populations who are suspicious of "Anglo" medicine, the IHS may attempt to work with traditional medicine men and women to increase their credibility among these patients.
The management of patients who become severely mentally ill (SMI) is not uniform across service sectors. Most patients in public programs already meet the criteria of SMI or SED (for severely emotionally disabled children). However, the experience of patients in other insurance programs may be somewhat different.
Pharmaceutical companies have developed no major programs for high cost episodes of care or lifetimes of care (e.g., one that might offer discounts/incentives to increase access/compliance/utilization in high cost cases). One manufacturer believes the greatest costs (in high-cost cases) are generated by hospital days, not drug utilization, and should be accounted for through the medical benefit, not the pharmacy benefit. Another manufacturer is planning a program for combination therapies and additional drugs for treatment resistant patients.
One mixed-model HMO has organized a team of case managers to attempt to reduce inpatient admissions among its high utilizing mental-health population. The case managers are bachelors' level social workers who conduct outreach, help patients with medication, keep appointments, and increase compliance. The team approaches the appropriate clinician about each high-utilization patient and tries to help the provider treat the patient. This HMO believes this program has been very helpful in reducing the number of admissions among the high utilization population and is popular among patients.
The benefits consultant interviewed suggested that employers are rarely familiar or experienced with cases that become eligible for public assistance under SMI/SED guidelines. This is because employees who become this ill generally leave the workforce and are cared for under SSI disability provisions. One employer interviewed provides 60% of pay until age 65 for those out on disability and provides health coverage for two years (i.e., until Medicare eligibility under SSDI has been established). Furthermore, employers may not be aware that a patient has exceeded his or her maximum lifetime benefit until that patient has done so. In these cases administrative override is at least possible. The focus continues to be on maintaining the patient within least intensive locus of care. Strategies to promote least intensive locus of care include providing a flexible benefit design (e.g., exchange inpatient days for other types of treatment; no limit on benefits up to 1 million dollars for a lifetime). For example, in some behavioral health carve-outs, high cost/lifetime of treatment cases are managed separately.
Currently the PBMs interviewed do not have case management programs for patients on psychotropics or for high cost cases. Nor are there special programs for underserved populations.
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Last updated August 20, 2000