Access and Utilization of New Antidepressant and Antipsychotic Medications. D. Compliance

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

  • 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.

    1. Public Programs

       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.

    2. Private Payers

       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.

    3. Special Populations

       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/Disease Management

  • 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:

    • Public sector programs such as Medicaid and State Mental Health agencies have been aggressively moving their mental health patients into managed care programs. These agencies likely look to the managed care vendor to provide compliance and disease management.
    • Private sector insurers are increasingly cost-conscious and seek to manage costs by insuring quality of care via these programs.

    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.

    1. Public Programs

       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.

    2. Private Payers

       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).

    3. Special Populations

       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.

    4. Severely Mentally Ill Populations

       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.