Study 4
ISSUES ASSOCIATED WITH CAPPED ENROLLMENT AND WAITING LISTS

Jeffrey Levi, Julia Hidalgo, John Palen, E. Blaine Parrish, Kendra Williams, and Anthony S. Lara

Background

Through the CARE Act, HRSA’s HIV/AIDS Bureau (HAB) provides funding to States and U.S. territories to administer the AIDS Drug Assistance Program (ADAP). Over the past several years, ADAPs have experienced insufficient funds to support growing enrollment, increased expenditures, and lengthened enrollment periods. To deal with those difficulties, ADAPs have instituted a variety of cost-containment measures, including capped enrollment and waiting lists.

The purpose of this assessment was to identify ADAP policies and procedures developed by States to guide ADAP staff in implementing and operating capped enrollment programs, waiting lists, or both.

State ADAPs Participating in the Assessment

  • State ADAPs with Waiting Lists or Capped Enrollment
    Alabama, Arkansas, Idaho, Iowa, Kentucky, Montana, North Carolina, Oklahoma, South Dakota, and West Virginia
  • States Anticipating Waiting Lists and/or Capped Enrollment
    Massachusetts, Missouri, and New Mexico
  • States with Capped Enrollment or Waiting Lists Not Participating in the Assessment
    Alaska and Colorado

Methodology

GWU researchers interviewed the ADAP administrators of 14 States. Eleven States reported using capped enrollment: Alabama had set its cap at 1,232; Arkansas, at 460; and Idaho, at 109. Kentucky had a rolling cap, as did Montana and North Carolina. South Dakota had set its cap at 70, and West Virginia at 200. Iowa, which had 210 clients, but needed to limit the program to 135 to 165 clients but had not officially set a cap. Indiana had set a cap of 1,250 but was just approaching the cap. Oklahoma had set a monetary cap of $1,200 per client per month, but was just reaching that amount. Three additional States—Massachusetts, Missouri, and New Mexico—reported that they anticipated capping enrollments or instituting a waiting list in the near future.

Eight States reported having waiting lists. Alabama had 391 people on the waiting list at the time of the study. Idaho had 17; Iowa, 16; Kentucky, 18; Montana, 8; North Carolina, 774; South Dakota, 25; and West Virginia, 35. Arkansas reported having reached its cap of 460 and beginning a waiting list. Three applications had been received; if space was not available for those applicants, they would be the first three on the waiting list.

Alaska and Colorado reported having capped enrollment or a waiting list but did not participate in the interviews.

GWU researchers interviewed key program staff from each ADAP. The interviews ranged from 45 to 80 minutes. Staff were asked a series of 34 open-ended questions about the policies and procedures of their State ADAPs as they related to methods of controlling enrollment of new clients. Staff were given the opportunity to share other information not specifically covered by the questions.

Limitations

Two States with capped enrollments or waiting lists did not participate in the interview. It is unclear to what extent the characteristics of their capped enrollment programs or waiting lists differ from those used by responding ADAPs.

Major Findings and Discussion

ADAPs’ decisions to cap enrollment are based on attempts to forecast demand and costs as well as on close monitoring of ongoing expenditures. ADAPs with capped enrollments or waiting lists, however, then rely on “back-of-the-envelope” forecasting approaches, finding other available tools too cumbersome.

All ADAPs reported that the primary factor causing capped enrollment policies was a combination of increased costs and increased demand for services. Administrative and political factors (at the State level) were not seen as significant contributors to the cap. Common factors resulting in capped enrollment included increased applications for ADAP enrollment; increased rates of utilization of medication on the formulary among ADAP clients; lower rates of people enrolling in the Supplemental Security Income (SSI) Program and Medicaid; longer duration of enrollment among ADAP clients; and rising medication costs. Reduced State funding or State funding that did not keep pace with programmatic expenditures of ADAPs aggravated all those factors.

All but three ADAPs reported that their cap applies to the entire ADAP formulary. Three ADAPs have a separate cap on a specific medication (Fuzeon).

All ADAPs reported estimating expenditures per enrollee as a basis for setting the enrollment cap at the beginning of a fiscal year. They use three variables for this forecast: average expenditures, total number of enrollees and applicants, and total available funds. Two ADAPs also estimate future medication costs. ADAPs reported that current tools provided by HAB to forecast expenditures are difficult to use and not more informative than using the simple formula described.

All ADAPs monitor expenditures and utilization to determine when capped enrollment must be enforced. Eleven ADAPs monitor the data monthly, two monitor the data weekly, and one State monitors the data every other month. All ADAPs reported that the determination of the cap and level of the cap is based exclusively on the amount of funds available at the time the determination is made. ADAPs reported keeping data mostly in the form of Excel spreadsheets that are updated by ADAP staff.

All ADAPs reported similar processes in operationalizing capped enrollment. ADAPs begin by disseminating information about the cap to various constituencies. On the government level, States reported requesting additional State funding for the ADAP as a starting point for making State legislators aware of the situation. Only one ADAP reported receiving additional dollars. Several ADAPs have approached their Title I programs and received funding or other support. ADAPs use several avenues (e.g., statewide planning groups, a governor’s advisory council, regular meetings with State legislators, and health department administrators) to increase public awareness of the ADAP and its needs.

ADAPs reported consultations with various officials and groups regarding development and implementation of capped enrollment. These include community advisory boards; scientific, clinical, and medical advisory groups; community planning boards; health department directors and administrators; and program and financial staff.

ADAPs define capped enrollment differently; most ADAPs have established a “hard” cap—setting a maximum number of enrollees who can be permitted in the program. Others have created a “rolling” cap that adjusts to demand on a monthly basis.

“Capped enrollment” generally meant that an ADAP had determined a set number of enrollees that could participate in the program; several States reported having “rolling” caps, a limit of enrollees in the program that changes throughout the year based on available funding and program costs. For example, one ADAP caps annual enrollment at 200 clients. This number does not change throughout the year. Another ADAP has a rolling cap, currently set at 135, which changes as program staff evaluate program utilization from the past month and add clients as funding allows. For ADAPs with rolling caps, capped enrollment is based on available funding, so no set number is determined.

Eleven of the interviewed ADAPs reported capping the number of clients that are enrolled in the program. The cap ranged from 70 clients to 1,250 clients. Five ADAPs reported hard caps that had been exceeded. Four ADAPs reported rolling caps that were at capacity. One ADAP reported having set a hard cap but not having reached the number, and one ADAP reported its cap as a monetary cap of $1,200 per client per month, which had been exceeded. (This ADAP had no cap on the number of clients.)

Given underlying variability in available resources and, thus, variability in eligibility requirements (Table 4), ADAPs cap enrollment at different levels. Because ADAPs are given flexibility in determining eligibility criteria (including income levels) for the program, an applicant at a certain income level might be wait-listed in one State and not in another.

ADAPs vary in the steps taken to contain costs prior to imposing capped enrollment. All ADAPs have considered a standard set of cost-containment measures (e.g., reduced formulary, change in eligibility rules, use of 340B pricing, use of ADAP Task Force negotiated prices, back-billing third-party payers, and imposition of client co-payments), but no standardized approach to cost-containment yet exists.

All ADAPs reported having used other budget control measures before implementing capped enrollment. Those measures include using a reduced formulary (3 States); changing the eligibility rules (2 States), using 340B pricing (7 States), using ADAP Task Force contracts (11 States), and back-billing Medicaid and other sources (3 States). Several ADAPs specifically mentioned ruling out several of these options, most commonly the reduced formulary, client copays, and lowering the income eligibility as a percentage of Federal Poverty Level (FPL). At least in some cases, the ADAP determined that the cost savings were insufficient to be worth the change in policy. For a full discussion of the policy opportunities in this area, see GWU’s earlier report prepared under this Task Order, The AIDS Drug Assistance Program: Assessing the Use and Distribution of Scarce Resources, submitted to HAB in May 2004.

Table 4. ADAP Eligibility Requirements
State Federal Poverty Level % Income Household, Family, or Individual Income Asset Limits Require No Insurance Medicaid Denial Letter, Application, or None
Alabama 250 Gross H N Y A
Alabama 250 Gross H N Y A
Arkansas 300 Gross H N N DL
Idaho 200 Gross F N Y A
Iowa 200 Gross F Y N A
Kentucky 300 Gross H N N DL
Montana 330 Net F N N DL
North Carolina 125 Net F N N A
South Dakota 300 Gross H N N A
West Virginia 250 Gross F N N DL
Indiana 300 Gross H N N DL
Oklahoma 200 Gross F N N DL
Massachusetts $50,000/yr and $2,900/
dependent		 Gross I N N DL
Missouri 300 Gross I N N A
New Mexico 300 Gross F N N N

Most ADAPs maintain waiting lists. ADAPs, even those not maintaining formal waiting lists, continue to receive and process new applications to determine program eligibility.

In all the ADAPs interviewed, case managers continue to take and forward applications for the program after the cap has been reached. Applications are sent to the ADAP staff where they are either held until a slot becomes available or the person is put on an official waiting list. Case managers trained to provide assistance to clients through other programs, primarily patient assistance programs established by the pharmaceutical companies. Case managers are updated regularly (usually monthly) on the status of clients on waiting lists. Clients are informed by letter regarding their status. All ADAPs provide this letter to clients. A copy of the letter is usually sent to the case manager. Information on the client (e.g., updating of address, current medical status) is maintained by the case managers at the organization level.

All ADAPs that maintain waiting lists determine client eligibility for the ADAP before placing them on the waiting list. The level of review of the applications varies for ADAP enrollment in general. For example, some States do not require proof of Medicaid denial or State residency, only statements to that effect. Variation also occurs in how frequently people on the waiting lists are recertified for eligibility in the program, though this generally follows the program’s criteria for recertification.

Data collected vary from State to State. ADAPs reported using the following data to determine eligibility and add the applicant to the waiting list: FPL (12 States), residency requirement (12 States), Medicaid denial (7 States), no insurance (2 States), and asset limits (1 State). All ADAPs verify eligibility at the ADAP programmatic level after receiving the applications. Providing proof of residency, Medicaid denial, etc., varies. Some ADAPs require documentation, while others do not.

All ADAPs regularly review the status of current clients to determine whether a slot can be opened for someone on the waiting list.

Variability exists in how ADAPs make room for applicants to be moved from the waiting list. All ADAPs use recertification (meeting the criteria set by the ADAP to be eligible for the program) to open slots. Twelve ADAPs reported that they conduct recertification yearly, two ADAPs reported that they recertify every 6 months, and one ADAP reported recertifying every month. Eight ADAPs recertify applicants on the waiting list before they are placed on the program, unless they have been on the list less than 4 months (on average). Several ADAPs move clients off the program if they have not filled prescriptions in 90 days or more (unless documentation of a drug holiday is on file), and a few ADAPs remove applicants from the waiting list who move to a Title I EMA that covers medications.

Coordination between ADAPs and Medicaid programs varies. Some ADAPs have excellent working relationships, including online access to Medicaid eligibility verification systems; other ADAPs have essentially no working relationship with the Medicaid program, even with regard to eligibility determination.

ADAPs reported the following approaches to coordination with State Medicaid programs: access to online eligibility database (five States), access to phone eligibility database (five States), regular meetings with Medicaid staff (three States), and meetings at the case manager level (one State). Four ADAPs reported no coordination or contact. Some ADAPs reported a positive and highly interactive relationship with their Medicaid program, whereas others reported a poor, almost adversarial relationship with their Medicaid counterparts. Personal relationships provide the best hope for strong program coordination, but with strained Medicaid budgets, these relationships were not always helpful in coordinating programs.

No ADAP reported coordination between ADAP staff and the Social Security Administration (SSA) in determining SSI eligibility. Seven ADAPs reported this coordination as taking place at the case management level, although most reported that such coordination depends on personal relationships between case managers and SSA staff.

Clients on waiting lists receive varying levels of support in enrolling in pharmaceutical company patient assistance programs (APAs). Case managers have had a variety of levels of training and experience with this usually complex process, which requires different application forms for each pharmaceutical company.

All ADAPs reported having processes (although not written policies) for assisting clients in finding other sources of medications while on the waiting list. All reported that case managers are trained to assist clients in accessing APAs and are responsible for helping the client fill out the applications. Two ADAPs reported that clinics provide assistance in filling out applications for the programs. All reported that the APA application process is cumbersome because each pharmaceutical company has its own application process and most clients must apply to more than one company to cover their drug regimen.

Most waiting list policies and procedures are not in writing, and the process for their development is not always transparent. Many ADAPs acknowledged that the lack of written policies and procedures for the management of waiting lists, including criteria for transitioning applicants off waiting lists to enrollment, has created challenges in terms of “institutional memory.” Given ADAP staff turnover, the absence of documentation diminishes continuity of programmatic operations. Although all ADAPs consult with outside experts in determining capped enrollment and waiting list protocols, it is unclear that consistent consumer involvement is part of their development.

ADAPs reported enacting caps as early as December 1997 and as late as May 2004. Most States enacted their caps in late FY 2002 and FY 2003. Several ADAPs reported seeing a spike in utilization and enrollment in late FY 2003 but were unable to determine the reason for the spike.

ADAPs were asked how providers, pharmacies, case managers, and clients are informed about the existence of a cap for their ADAP. The strongest link is between providers and ADAP staff: Most ADAPs reported that providers are contacted by telephone. Some ADAPs also use letters and emails or faxes to provide information. All ADAPs inform the providers (i.e., individual providers, agencies, organizations) of the cap. Several ADAPs have a centralized pharmacy, so they provide the information in person or by telephone, email, or fax. ADAPS that have reimbursement programs (through various pharmacies) reported that they provide a letter or, in the case of five ADAPs, that they do not inform the pharmacy that they have a cap on ADAP enrollment.

All ADAPs inform the case managers, primarily by telephone (but also by letter, fax, or email), that a cap is in place. Most ADAPs inform the case managers about the ceiling number of ADAP clients, the status of the cap, and the likelihood that the cap will be exceeded and that clients will have to wait for services. ADAPs indicated that this is the most important relationship of the three—relying on the case managers to provide information directly to clients. Because ADAPs are aware of the names of ADAP clients’ case managers and because the number of case managers is relatively small, information about the status of the ADAP is usually accurate and up-to-date.

All ADAPs rely on case managers to provide information to clients regarding capped enrollment. However, most clients are not informed unless they are placed on a waiting list. Most communities have consumer groups that are informed of issues, including capped enrollment and waiting lists, through regular meetings or other correspondence. But ADAPs reported that this information does not always get disseminated in a way that informs potential applicants. ADAPs reported that the same communication mechanisms that are used to announce the cap are used to inform providers, pharmacies, case managers, and clients when the cap has been lifted.

Two ADAPs reported that they have written policies and procedures on program caps (rationale, design, implementation, operationalizing, and maintenance). Two ADAPs reported written policies and procedures in development. All other ADAPs reported that they have no written policies and procedures, although program staff had developed internal protocols and procedures. Some ADAPs recognized this as problematic because loss of staff could cause loss of institutional knowledge about how the cap was developed and is operationalized.

Four ADAPs reported that they have written guidelines for their waiting list. Six ADAPs reported that they have no written guidelines, and four reported that they are in process of writing guidelines. These guidelines cover the process of managing the list, determining how applicants are placed on the list and removed from it, and providing assistance to applicants while they are on the list.

Eleven ADAPs reported relying on case managers to gather information about applicants being placed on the waiting list (completing the application and maintaining contact information). The case managers fill out the information and keep the client informed about movement of applicants on the list. Six ADAPs reported that ADAP staff also collect information on the applicants. No ADAPs reported that providers are involved in collecting information.

Criteria for moving applicants off waiting lists vary by ADAP. Some ADAPs use a strict “first come, first served” approach; others use a medical need approach (e.g., pregnant women, those with severely compromised immune systems) or a combination of the two. Most ADAPs move applicants from the waiting list to ADAP enrollment as slots become available, although at least one ADAP reported waits for enough slots to open up to move the entire waiting list at one time.

All ADAPs with waiting lists reported that they manage the waiting list at the ADAP programmatic level. Priority for placement on the list was reported as follows: first come, first served (nine States); medical need (six States); pregnant women (two States); those already on medications (two States) and, those that are non-EMA clients (two States). A few ADAPs list first come, first served as their priority, but actually bump clients with medical need to the top then prioritize by first come, first served.

Priority determination was developed in various ways: Program staff developed the guidelines; ADAP staff talked to each other to determine the best priority list; medical advisory boards were convened to determine the priority list; standing clinical care committees or ethics committees were used to determine the priority list; clinical advisory boards were used to set medical eligibility criteria for priority; and other methods were used. Most ADAPs did not include consumers in determining priority lists.

ADAPs reported simple policies and procedures for moving applicants off the waiting list. For example, when a space (or spaces) become available, the person (or group) of persons is moved off the list. However, some ADAPs wait until they have enough slots available to move all applicants off the waiting list at one time. Other ADAPs move applicants off the waiting list one at a time. Both clients and case managers are notified by letter.

Recommendations and Policy Considerations

Establish minimum cost-containment standards for ADAPs.

This study demonstrated that some variation exists in the use of cost-containment measures by State ADAPs. HAB could establish as a condition of award that all State ADAPs demonstrate that they have undertaken a minimum set of cost-containment strategies, including the following:

Ensure that all ADAPs are able to monitor their programs effectively.

In working with HAB and State ADAP staff to conduct this and other recent studies, GWU staff identified the need for ongoing technical assistance (TA) among State ADAP staff in the management and analysis of their budgetary, enrollment, utilization, and claims data. The increasingly complex information requirements of many State ADAPs has presented a challenge to State ADAP staff in managing and analyzing their data.

Ensure that all Title I–funded APAs are coordinated with ADAPs and are maximizing the use of resources.

The study found variation in the level of coordination between APAs and ADAPs. Additionally, APAs did not adopt many of the cost-containment strategies common among ADAPs. HAB might adopt the following conditions for Title I award for funding of APAs:

Adapt criteria for ADAP supplemental funding eligibility to accurately reflect current funding deficits.

The study demonstrated that certain ADAP programmatic elements could be changed to improve access to the program and to ensure that supplemental funds target those State ADAPs that face shortfalls in funding. As discussed in the report, the following are among the policy options that might be considered:

Consider a national “minimum” standard for State ADAPs.

The steps recommended above would accomplish an important goal of maximizing the purchasing power of existing ADAP funds based on their current method of distribution. Without a substantial increase in ADAP funding, however, these steps likely will not be able to address the fundamental issue at hand: the significant geographic disparity in access to HIV-related treatments under the CARE Act.

One option would be to adopt a “needs-based” formula for distribution of ADAP funds. The formula would require consideration of various factors, including the number of HIV-infected people who might be enrolled, the income levels of PLWH, the relative generosity of a State’s Medicaid and other safety-net programs, and the accessibility of private insurance. Reaching consensus on what elements might establish “need” would be challenging. Indeed, the Institute of Medicine in its recent report noted that such formulas are difficult to develop. It is unlikely that sufficient data exist to develop such a formula.1 As noted earlier, the fiscal and programmatic climate surrounding ADAPs is constantly shifting. Thus, it is unclear whether formulas could be sufficiently flexible to reflect these changes. Finally, if such an approach resulted in significant shifts in funding, to avoid disruption in services to current clients, hold-harmless provisions may be required. As a result, few, if any, changes in distribution of funds will address the issues, absent a major increase in Federal budget allocations to ADAP.

GWU believes that the problem of geographic inequity cannot be addressed without totally overhauling the health care financing system of which the CARE Act is just one small part. Indeed, the structure of the national health care financing system is geared toward leaving to the States the determination of how generous their publicly funded safety net will be, as reflected in State-by-State variation in Medicaid.

As is also reflected in the Medicaid program, however, a precedent exists for establishing a minimum level of eligibility and services to be provided to poor people in need of health care. Applying that concept to ADAP, and to the CARE Act more generally, is possible by establishing a minimum level of eligibility for a core set of services for persons with HIV. Although the data probably are not sufficient to determine whether such a minimum standard could be achieved nationally based on current funding allocation formulas, this minimum standard could be defined by HAB. A consensus process could be undertaken involving HAB, grantees, consumers, ethicists, and other key experts to establish a minimum core set of services. Grantees could be required to achieve this goal to the degree resources permit.

In the very specific context of ADAP, HAB could establish a minimum formulary to be provided to all persons with HIV without other third-party payers who are at or below 200 percent of FPL or another agreed-upon level. A sliding scale of eligibility above 200 percent of FPL could also be established if deemed fiscally possible. If the ADAP can meet this standard, it would be free to expand its formulary or income eligibility levels with its current resources. Such resources might include non-Federal ADAP funds, such as State or local funds or transfers from other parts of the CARE Act. ADAP supplemental funds could be awarded to those State ADAPs that maintain their prior funding efforts and cannot meet the minimum standard with their formula award.

This approach to ADAP funding could be incorporated into a larger effort to establish a “core” set of services under Titles I and II of the CARE Act. Presumably, HIV-related medications would be part of any core set of services. In this instance, States and Title I entities might be required to coordinate and ensure that all core services are met for individuals below a certain FPL and without other third-party coverage for medications and other services. Title I and Title II grantees might then be required to transfer some of their grant funds to ADAPs to help reach this minimum level of service. In this scenario, the “supplemental” portion of Title I grants and ADAP supplemental awards might be used to assist jurisdictions unable to meet the national minimum of eligibility for core services.

GWU recognizes that this approach would be a fundamental shift in the philosophy of allocation of resources and flexibility given to grantees. As resources become more constrained at the Federal, State, and local levels, however, establishment of a Federal floor for HIV funding would be consistent with the management of other poverty-based health care financing programs.

Based on currently available data, it is not possible to determine the impact of a change to this approach. GWU believes this might be a useful avenue for research to determine both its practical applicability and its impact on access to HIV-related pharmaceuticals by HIV-positive clients.

Consider establishing consistent policies across State ADAPs.

The approaches taken by ADAPs to cap enrollment and institute and manage waiting lists vary significantly. These differences reflect the larger variations in ADAP approaches noted in GWU’s early studies for HAB. Although current fiscal challenges do not permit the elimination of this geographic variation, the creation of ADAP waiting lists is an overt form of rationing access to potentially life-saving medications. Thus, HAB is obligated to ensure that all effective mechanisms are adopted to avoid waiting lists and that applicants placed on waiting lists are treated similarly across the country. To that end, HAB could assist ADAPs in the following ways:

1 Institute of Medicine. Measuring What Matters: Allocation, Planning, and Quality Assessment for the Ryan White CARE Act. Washington, DC: National Academy of Sciences; 2003.

Health Resources and Services Administration
HIV/AIDS Bureau
5600 Fishers Lane, Suite 7-05
Rockville, MD 20857
Telephone 301.443.1993
www.hab.hrsa.gov

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