LAAM in the Treatment of Opiate Addiction
Treatment Improvement Protocol (TIP) Series 22

Hours of Operation

Flexibility is essential in setting hours of operation of clinics dispensing LAAM. Hours of operation must accommodate patient needs. Programs that are open 6 days a week may wish to consider adopting a 7-day-per-week schedule when they add LAAM therapy to the treatment regimen. If this schedule is impossible, they might consider scheduling the 72-hour break in the patient's dosing schedule in the middle of the week, rather than over the weekend. In this way, the program would be open for phone calls or visits by LAAM patients who need extra support. However, as discussed in previous chapters, once patients are stabilized on LAAM, most prefer not having to visit the clinic on weekends.

Extending hours of daily operation, perhaps by putting staff on flex-time schedules, merits consideration, since it would allow employed patients or those with personal responsibilities to visit the clinic before or after work.

Staff Attitudes and Training

Health professionals from many disciplines will be involved in the safe and effective use of LAAM. Training programs are needed for physician assistants and nurse practitioners, who often have key roles in opioid substitution therapy programs. Staff attitudes and knowledge have a direct effect on the acceptance of LAAM treatment by patients. The decision to introduce LAAM treatment should not be made without proper staff education and training. Program managers or other decisionmakers should think through the implications of the decision to offer LAAM treatment to their patients, and staff members should be involved in this process whenever possible. Because LAAM has unique pharmacologic properties, clinics must develop new procedures and protocols before offering the medication to patients.

Anecdotal evidence from the National Institute on Drug Abuse (NIDA) and Food and Drug Administration (FDA) Labelling Assessment Study (LAS), described in Chapter 2, indicates that staff attitudes toward LAAM therapy may be the single most important factor in positive treatment outcomes (Payte, 1992). Staff attitudes provide the context within which LAAM treatment is delivered. Apositive context can mean the difference between treatment success and failure. Although the counselor may have the most contact with patients, every member of the staff must demonstrate support for patients receiving LAAM. Programs should also monitor whether the use of LAAM affects staff attitudes toward methadone patients who do not switch to LAAM.

Before they can effectively care for and counsel patients and families, staff must be thoroughly versed in the advantages and disadvantages of LAAM treatment. This process entails the exploration of a broad range of historical, attitudinal, and economic factors that surround the use of LAAM. Some staff may be resistant to change--even positive change. One challenge to program managers may be to overcome resistance to change. Frequent opportunities for staff discussion of the planned change should be provided. Given the absence of evidence that LAAM treatment produces universally better patient outcomes, some staff may question the need for offering it as a therapeutic option.

LAAM is an anomaly: it is a "new" drug that underwent initial testing two decades ago. Because of this history, LAAM is surrounded by misperceptions, some of which present obstacles to its acceptance as a treatment option. Staff of new programs receiving licensing for the first time should have a minimum number of required training hours in the pharmacology of LAAM. Staff of ongoing programs should be able to show that they have had a sufficient number of hours of training in the use of LAAM and provide evidence of their knowledge and under-standing of its treatment potential.

Staff must be attuned to Federal regulations that differ from those for methadone. Monthly pregnancy tests are required for women of childbearing potential. The regulatory definition of this term has not been spelled out. For example, some clinics may interpret this term to include women who have undergone tubal ligation or who receive contraceptive implants or injections, since none of these methods is 100 percent effective. Staff may need special training to counsel patients on reproductive issues.

Other factors relate to the changing climate of health care and economics. LAAM therapy may be more expensive than methadone treatment, which is related to the cost of required monthly pregnancy testing and the cost of the medication itself. Because the dosing schedule reduces by half the number of weekly visits, many staff are concerned that managed care providers will enact policies that require them to transfer as many patients as possible to LAAM and then to greatly expand staff caseloads. These concerns, although real, are in many cases unfounded. Education of staff, reinforced by regular interdisciplinary staff meetings, can allay misperceptions and make staff more comfortable in recommending and using LAAM, as well as improve patient-treatment matching.

As LAAM therapy is used in additional treatment settings and as existing programs adopt new protocols to accommodate its pharmacology and the needs of patients receiving it, staff roles may change. Counselors will learn to function in an expanded treatment environment. Some may wish to specialize; for example, programs may have counselors who deal only with patients receiving LAAM. However, to optimize staff flexibility, programs should consider assigning mixed caseloads (that is, both methadone and LAAM patients) to staff during the LAAM introduction period. Programs should consider current methadone caseloads, staff skills, and resources when assigning initial LAAM cases. Another way to integrate LAAM cases might initially be to choose the most skilled and effective counselors for LAAM cases. It should be kept in mind that therapy with LAAM does not necessarily mean a reduced number of patient visits, especially in the early weeks of treatment. Patients may receive medication 3 days a week, but their treatment plans might require them to come to the clinic daily to be monitored and to receive other services.

Training must prepare staff to use imagination in their vision of future settings for the delivery of LAAM therapy. The approval of LAAM may help managed care providers to make available opioid substitution therapy services. This trend may benefit patients, provided that attention is paid to quality assurance measures. For example, inclusion of substitution therapy in managed care settings might lead to a better geographic distribution of clinics; such services would no longer be centered in the inner city. Smaller clinics, run by groups of physicians, could treat small groups of patients.

A more equitable geographic distribution of treatment settings might provide treatment access to larger numbers of patients. It might make treatment more attractive to persons in rural areas as well as to an emerging cohort of heroin users, many of whom are middle-class persons living in the suburbs. As new treatment settings are considered, the single greatest risk may be the tendency to separate administration of LAAM from the health and psychosocial services needed to ensure its effective use. Staff must be prepared to ensure that access to health and human services is a part of any narcotic treatment program.

FDA approval of a program's request for a license to dispense LAAM is contingent on all clinic staff's receiving training during the first 2 years after the program's approval. The manufacturer of LAAM, Roxane Laboratories, Inc., can arrange such training for substance abuse counselors and other health professionals. These training resources are described in more detail in Appendix B.

Programs also may wish to adapt existing training documents, such as the Counselor's Manual for Methadone Treatment, published by the Center for Substance Abuse Treatment as part of its Technical Assistance Publication (TAP) series. Some of this information may need to be tailored for use with LAAM patients.

As the use of LAAM grows, hospital staff and medical students will need information on LAAM. Such information is especially important for emergency room staff, who must be forewarned about the pharmacokinetic profile of LAAM and the possibility of overdose (see Chapter 2). Clinics that dispense LAAM should make sure that local hospitals know of their presence in the community.

Patient-to-Counselor Ratio

Minimum counselor staffing ratios governing methadone treatment programs are defined by the States and vary widely. In several States, maximum patient-to-counselor ratios of 50:1 are set by regulation. Introduction of LAAM treatment into some programs may simply change the dosing frequency of medication, rather than the structure or goals of the overall treatment program. In such cases, the patient-counselor ratio may not change. If, however, the use of LAAM changes the overall treatment program, the ratio may change.

Programs should attempt to exceed the minimum requirements. Another TIP in this series, Matching Treatment to Patient Needs in Opioid Substitution Therapy, recommends a maximum counselor caseload of 35 patients. When counselors' caseloads are smaller and staff are better supervised, patients' progress in treatment generally improves.

The degree of patient need should be a factor in determining counselor-to-patient ratios; for example, a counselor providing care for a large number of patients in the early weeks of LAAM treatment should have a smaller caseload. When a substantial number of counseling services are provided offsite, programs should build this factor into the staffing formula. Needs-based ratios permit staff to spend more time with patients who need and want counseling, which helps make staff more productive.

Recordkeeping and Storage of LAAM

Patient records must clearly indicate which medication the patient is receiving. Product storage recommendations are set forth in the manufacturer's insert that accompanies the medication. No additional precautions are needed.

Cost of LAAM per Dose

The cost of a daily 65-mg dose of methadone ranges from 34 cents to 51 cents. Thus, the weekly cost for methadone medication ranges from $2.40 to $3. 56. The cost of a week's supply of LAAM (three 78-mg doses) ranges from $7. 92 per week ($2.64 per dose) to $9.89 ($3.30 per dose). These are costs only for the actual medication, which represent a small percentage of total program costs. Programs must take into account a host of other cost elements, such as cost for salaries, facilities, and support services.

Unit of Pricing

Some programs calculate costs based on a flat or aggregate rate, while others disaggregate costs for different types of services. Setting flat rates--that is, agreeing to provide services based on an average rate of cost per patient per week--sometimes poses undue burdens on programs that offer a wide range of services. Pricing by unit of service rendered may be more equitable.

Attempts to compare costs of LAAM and methadone treatment and estimate cost differences are under way. However, such studies must be carried out with care so that results are not misleading. In many cases, cost differences are ultimately a matter of tradeoffs. For example, decreased time in preparing take-home doses may free staff to complete additional paperwork during working hours. Because LAAM patients receive fewer doses of medication per week, less nursing or pharmacist time is needed for medication preparation. This reduction may make it possible to assign these employees to other important duties. Additionally, patient visits may decrease if LAAM is widely used, but clinics using LAAM may attract new clients who have had difficulty with methadone. Until further data are available, the net effect of LAAM treatment on program operating costs cannot be sufficiently addressed.

Pregnancy Testing

Pregnancy testing is a predictable cost associated with the use of LAAM in female patients of childbearing potential. The cost of pregnancy testing is estimated at $10 per month. Between one fourth and one third of all patients in opiate addiction treatment are women of childbearing potential.

Health Care Funding Reform and Cost Considerations

Although cost is a key factor in patient-care decisions in all health care delivery systems, cost should not be the single driving factor. The principles of managed care, which is the model for many funding reform efforts, are in many ways the antithesis of those of narcotic dependency treatment. Managed care functions as a gatekeeper; for persons in opiate dependency treatment, treatment success depends on continuous services, including medication and case management.

In setting costs, programs should focus on patients' needs for services, not on the specific medication selected. Programs will have to be able to explain to reimbursers that a reduction in the number of visits for medication may not reduce overall costs. If a program has analyzed its costs, it can present the data necessary to make an effective case to reimbursers.

Programs will have to examine LAAM costs in the continuum, making sure they are delivering the most cost-effective treatment possible. Making treatment "cost-effective" does not necessarily mean increasing the number of patients per week, but rather allocating as efficiently as possible administrative costs related to delivery of services, such as administrative activities, salary, equipment, and medication.

With reform, several different reimbursement strategies will come into play. A common strategy is capitation, which provides a set fee for each patient, including patients who "do well" and those who are "chronic relapsers," and which is based on the assumption that not every enrollee uses a high level of services. The ability to control costs and to correctly predict the program's patient mix will make capitation easier and will enable programs to compete in a managed care environment. Programs must find ways to determine their costs and their patient mix. Programs have many types of costs to consider, including salaries, facility and utility costs, supplies and equipment, insurance, laboratory services, and administrative costs (utilization review, standing committees such as pharmacy boards, etc.). Conducting such complex cost analyses may not be realistic for smaller programs. The implementation of managed care may spur smaller programs to merge with other programs in order to survive.

In fact, the most important result of health care reform for treatment programs may be the integration of different treatment modalities. Programs may form associations to standardize procedures and costs. Different treatment modalities may form alliances to offer a full range of care. Despite the fears, mistrust, and resentment that may accompany such change, the benefits of association will become readily apparent with the first successful bid for a contract from an integrated program.

Perspectives on cost change with the players and their concerns. The consumer, or patient, is concerned with coverage or cash outlay and whether the same services can be had for less elsewhere. The provider is concerned with the source of funding and how funds are distributed. Society is concerned with the consumption of huge amounts of public dollars, although the cost of treatment for substance abuse is minimal in comparison with the costs incurred by untreated patients in the criminal justice system, in HIV treatment, and in medical care and other health systems. In this regard, it is important to bear in mind that the costs of treatment should be compared with the costs of not having a service available.

LAAM Cost Offsets

Programs that are providing information to policymakers and funders should be especially aware of the cost offsets that result from alcohol and other drug (AOD) abuse treatment. Such cost offsets have been strongly documented by recently published results of the long-term study of AOD treatment in California, which found that for every dollar spent on substance abuse treatment, more than $7 in future costs were saved (California Department of Alcohol and Drug Programs, 1994). These savings were largely in relation to reductions in criminal activity and in the number of hospitalizations for health problems.

The study examined the costs to society (net productivity loss) and to the taxpayer (theft, expenditures for welfare and disability, and so forth). Specifically for ongoing methadone maintenance treatment, the study found that an untreated opiate-addicted person cost society $92 per day in the year before treatment and $62 per day during treatment. Respective taxpayer costs were $53 and $23. The daily cost of treating an individual in a methadone maintenance program in California at the time of the study was $6.37. Thus, from the view of society and the taxpaying citizen, treatment paid for itself on the day it was delivered.

In addition, a nationwide survey on the effectiveness of treatment conducted by the National Association of State Alcohol and Drug Abuse Directors (NASADAD) also clearly documented significant cost offsets related to decreases in hospitalization and crime and an increase in employment (Young, 1994).

In addition to these types of cost offsets, initial investments in incorporating LAAM into treatment programs will be paid off if the new medication prompts an educational process that helps upgrade and diversify staff capabilities or gives rise to different approaches to outcomes evaluations and funding mechanisms. Incorporating LAAM therapy as a treatment alternative can stimulate the pace of the process of quality improvement. The availability of LAAM treatment may expand the number or type of patients who will enter treatment.

Reimbursement

Reimbursement issues may arise in systems that integrate methadone and LAAM treatment into a service delivery system so that the same provider delivers both drug-free treatment and opioid substitution therapy. Drug-free modalities tend to be reimbursed on a fee-for-service basis, whereas substitution therapy programs usually receive a comprehensive fee. Both kinds of reimbursement (fee-for-service and comprehensive fee) will be needed. Programs may need to establish a minimum number of clinic visits patients will need to qualify for comprehensive fee reimbursement. In fact, a definition of what constitutes a "patient visit" may need to be developed.

There is a trend in some States toward disaggregating methadone treatment rates, so that there are separate rates for dispensing visits, urine test visits, and counseling visits, as opposed to a single comprehensive daily or weekly rate. In response, funding sources might disaggregate reimbursements, which might lower reimbursements. Different types of reimbursement mechanisms should be used. It is not appropriate, however, to set caps on reimbursement for opioid substitution therapy or any kind of chemical dependency treatment, any more than it is appropriate to cap reimbursement for treatment of other chronic diseases.

It is possible that a managed care organization might view LAAM treatment as more cost effective than methadone treatment, specifically when reimbursement is based on the number of visits to the clinic, and the organization might therefore decide to reimburse only for LAAM treatment. Although this is a possible scenario, it is more likely that programs may seek to dispense only LAAM, which is not a viable treatment approach.

As LAAM therapy is incorporated into an increasing number of treatment programs, funding for its use will become a major issue, as will accountability and accessibility. The availability of Federal block grant money could be affected by requirements to introduce LAAM therapy into State treatment systems. Many publicly funded programs receive funding from several sources rather than a single source. Programs have been forced to seek other sources because funding, especially at the State level, has significantly decreased in recent years and patients' needs, particularly their medical needs, have increased. Some scenarios of future funding predict a decrease in block grant funds, with those dollars going to pay for substance abuse benefits under a national health care reform program.

Regardless of specific reforms in health care funding that will be made in various States, programs must become increasingly creative in providing comprehensive services and developing mechanisms for reimbursement. Private, for-profit programs will not be able to rely solely on cash payment for comprehensive services, and all programs will have to be keenly aware of what the various components of treatment actually cost.

More data and further research are needed on the actual long-term costs of treatment for the chronically relapsing population. Patients in narcotic treatment programs tend to use care frequently and intensively, particularly in the first few years, because they have neglected their health and welfare.

Quality Assurance

LAAM treatment offers an opportunity for program staff to review and reevaluate current quality assurance procedures and develop new systems to ensure the appropriate administration of medications and provision of other services. Factors that such systems should monitor include the number of dosage changes, the number of adverse reactions, and the number of pregnancy and tuberculin skin tests performed. Compliance with recordkeeping requirements should also be monitored.

Some programs ensure quality by hiring an internal auditor who performs the same functions as inspectors from FDA, the State, or the Joint Commission on Accreditation of Health care Organizations (JCAHO). Internal auditors generally review program information monthly. Other programs form internal quality assurance teams that assume responsibility for developing monitoring instruments, ensuring that these instruments are properly used, and reporting to the administration concerning problems identified and actions taken. Staff turnover and patient retention are important indicators that should be evaluated by an internal quality assurance team. When a subcontractor performs a service, the program should be certain that the subcontractor maintains adequate quality assurance procedures.

In some settings, quality assurance is integrated into an institutional total quality management (TQM) system. Under the TQM approach, interdisciplinary teams discuss a particular issue, identify problems, and make recommendations concerning their resolution. A program considering the introduction of LAAM might wish to form a team specifically for the purpose of developing appropriate quality assurance systems to govern the administration of this new medication. The team might investigate such matters as provision of informed consent, pregnancy testing, urinalysis, and response to counseling.

States have the opportunity to exercise leadership in the development of quality assurance measures. Program administrators and staff should be prepared to offer guidance to States wishing to develop such measures.

Staff Quality Assurance Measures

The quality of care provided by a treatment program depends to a great extent on the quality of counseling services provided by its staff. For veteran counselors, LAAM treatment offers new incentives and challenges. In opioid substitution therapy, counseling can have a major impact on patient retention and, ultimately, on treatment outcomes (Ball and Ross, 1991). For these reasons, it is important for programs to support their counseling teams and to evaluate the performance of individual counselors.

Counseling approaches vary broadly, both among programs and among counselors at a single program. More uniformity in counseling approaches is needed. Programs should consider developing counseling protocols and minimum requirements for counselors. Staff should be trained to implement counseling protocols.

The effectiveness of counseling may be increased by greater attention to counselor-patient matching. Frequent reinforcement and feedback are beneficial, as are ongoing training and opportunities to participate in case conferences and to offer input into management decisions. Programs should develop ways of evaluating counselor effectiveness.

Outcomes Monitoring

The introduction of LAAM treatment provides an opportunity to develop and refine procedures needed to measure patient outcomes. Careful studies can greatly increase support for opioid substitution therapy. Outcomes monitoring is a relatively new area for the field of chemical dependency treatment. Another TIP in this series, Developing State Outcomes Monitoring Systems for Alcohol and Other Drug Abuse Treatment, addresses the importance of monitoring treatment outcomes in the current health care environment and offers useful guidelines for evaluating treatment outcomes. Chapter 5 of the TIP Matching Treatment to Patient Needs in Opioid Substitution Therapy is a step-by-step guide to designing and conducting program-level monitoring of patient outcomes.

Patient outcomes may be monitored in a variety of ways:

• A standard assessment instrument can be used at periodic intervals to monitor progress in treatment. One example is the Addiction Severity Index (ASI) (McLellan et al., 1980), which measures patients' progress in seven diagnostic domains (drug abuse, alcohol abuse, medical needs, psychiatric needs, family and social support systems, legal needs, and vocational needs). A variety of other instruments are described in the NIDA publication Diagnostic Source Book on Drug Abuse Research and Treatment (Rounsaville et al., 1993). The effective use of any assessment instrument requires staff training, the cost of which is offset in the long run by improvements in the delivery of services and thus a stronger competitive presence in a managed care environment.
• Results of urine testing for drugs of abuse are useful measures of treatment progress.
• A program's rate of treatment retention is an important measure. Both staff and those who pay for treatment are aware that retention in treatment is a positive indicator. It is a clear sign of patient satisfaction. Retaining a patient in treatment increases the chance of a successful outcome.
• The number of patients leaving against medical advice should be monitored, since their leaving may indicate problems in the operation of the program.

Outcomes measures of LAAM treatment must be carefully defined and must be based on an acknowledgment that drug abuse is a chronic, relapsing disease. Some outcomes measures that may have initial appeal are not, in fact, valid indicators of progress or lack of progress in treatment. A transfer from LAAM to methadone, for example, is no more a negative outcome than is a transfer to an alternative antibiotic agent for a patient with a refractory infection. In each case, the change simply indicates the need to explore other options. Likewise, the number of patients who complete medically supervised withdrawal from LAAM or methadone is not an outcome measure in the same sense as a negative urine test for illicit drugs. The significance of completed detoxification depends on its importance in a given patient's overall treatment plan.