2020 National RWHAP Part B and ADAP Monitoring Project Annual Report

NASTAD’s National Ryan White HIV/AIDS Program (RWHAP) Part B and AIDS Drug Assistance Program (ADAP) Monitoring Project, including its Annual Report, documents key trends, challenges, and successes faced by public health programs ensuring access to life-saving treatment and services for people living with HIV (PLWH) nationally. In the 23rd year of its history, this 2020 edition of the Annual Report marks the second featuring comprehensive, longitudinal data spanning several domains of the RWHAP Part B program and ADAP, including budget, expenditures, utilization, and client demographics.

As in the iteration published in 2019, the National RWHAP Part B and ADAP Monitoring Survey and the resulting Annual Report reflect a relatively abbreviated snapshot of calendar year 2018 and fiscal year 2019, highlighting those data points that are most dynamic year-to-year, including budgets and expenditures, as well as client utilization and health outcomes (e.g., viral load suppression). As in previous years, the Annual Report also aims to illustrate the actual or potential impacts of key policies (e.g., federal/state changes to the Affordable Care Act (ACA) and Medicaid coverage) on RWHAP Part B programs’ and ADAPs’ effectiveness in delivering treatment and key support services for HIV and comorbid conditions that disproportionately impact PLWH.

RWHAP Part B programs and ADAPs provide an important safety net for PLWH who are under- or uninsured and are critical players in achieving the goals of the National HIV/AIDS Strategy (NHAS) as well as ending-the-epidemic (ETE) initiatives. Changes to the broader health care and payer landscape could significantly affect RWHAP Part B programs and ADAPs and their contributions to ETE efforts, including the federal Ending the HIV Epidemic: A Plan for America. This year’s iteration of the Annual Report reflects a baseline prior to the allocation of dedicated funding to RWHAP Part B programs and ADAPs enacting this initiative.

In FY2020, the President’s Budget requested $70 million for Ending the HIV Epidemic (EHE) Initiative funding for RWHAP Parts A and Part B. The 2020 National RWHAP Part B and ADAP Monitoring Project Annual Report does not including EHE funding, but future iterations will account for this funding, once it is allocated. This will provide important context for analyzing the impact of EHE funding on RWHAP Part B Programs. Eligible RWHAP Part B Programs that can receive EHE funding are Alabama, Arkansas, Kentucky, Mississippi, Missouri, Ohio, Oklahoma, and South Carolina.

Overview of RWHAP Part B Program

Passed by Congress and signed into law by President George H.W. Bush in 1990, the Ryan White Comprehensive AIDS Resources Emergency (CARE) Act was enacted to create and sustain a responsive care system that spans the continuum of HIV care. This includes: HIV diagnosis; linkage to, and lifelong engagement in, HIV medical care and supportive services; access to safe, effective, and easy-to-use treatment; and durable virologic suppression. Administered by the Health Resources & Services Administration (HRSA) HIV/AIDS Bureau (HAB), the RWHAP was last reauthorized in 2009 and the most recent authorization sunset ended September 30, 2013. In the absence of Congressional action on authorization, the program continues to effectively operate as Congress maintains annual appropriations to it. RWHAP clients demonstrate higher outcomes across the HIV care continuum as compared to all PLWH; in 2018, 87% of clients receiving RWHAP medical services were virally suppressed.

The Part B program is the RWHAP component that ensures state and territorial health departments are funded to provide core medical and support services to eligible clients equitably across urban and rural regions. All 50 states, the District of Columbia, Puerto Rico, the U.S. Virgin Islands, and the six U.S. Pacific Territories/Associated Jurisdictions are eligible to receive Part B program funding. Each jurisdiction’s RWHAP Part B program must customize their administration and service delivery to ensure that they are meeting the needs of the clients they serve as well as the political and structural environment in which they exist. All RWHAP Part B programs aim to guarantee access to treatments and services that bolster clients’ engagement and retention in care so as to ultimately optimize their viral suppression and their overall wellbeing. RWHAP Part B programs are comprised of the following key components: core medical/support service delivery; clinical quality management (i.e., a series of activities that focus on enhancing the quality of HIV care provided and increasing access to services); and program administration (i.e., administrative, planning and evaluation, salaries, overhead, client eligibility and enrollment, and data system management and reporting).

The breadth of core medical and support service categories allowable under RWHAP, including Part B, represent a wholistic approach to serving individuals with a chronic disease who experience complex social and structural barriers and/or comorbid conditions. Core medical services support eligible clients across the HIV-care continuum by bolstering testing, linkage to, and retention in care for HIV and comorbidities. Early Intervention Services (EIS), for example, aims to increase the proportion of PLWH who know their HIV-status and are linked to appropriate HIV care and other necessary core medical/support services. In 2018, 8,444 individuals were served via EIS in 2018 across 19 of 52 (37%) reporting Part B programs, as compared to 7,358 served in 2017 (15% increase) by 20 of 49 (41%) Part B programs. Other service categories such as Mental Health Services and Substance Use Treatment (Outpatient and Residential) are designed to support clients in accessing services to manage comorbid mental and behavioral health conditions that may impede their adherence to and effectiveness of treatment and care. Meanwhile, RWHAP support services (e.g., Housing Services, Medical Transportation Services) undergird these by ensuring adherence to and the effectiveness of clinical care. The array of RWHAP services ensures that public health priorities (e.g., minimizing new infections by optimizing viral load suppression) and individual clients’ overall health and wellness needs are simultaneously addressed.

ADAPs are a component part of the Part B program charged with ensuring access to lifesaving treatments for HIV (e.g., HIV antiretroviral (ARV) medications, “A1” opportunistic infection (OI) medications) and comorbid conditions that disproportionately impact PLWH and/or affect the adherence to or effectiveness of ARV treatment. ADAPs do so through two mechanisms: (1) by paying for the full, negotiated cost of medications for clients; and (2) by paying for a portion or all of a client’s premiums, co-payments, cost-sharing, and/or deductibles for private or public insurance. The Ryan White Comprehensive AIDS Resources Emergency (CARE) Act enables ADAPs to cover a broad array of medications within their formularies for insured and uninsured clients with a limited number of requirements (e.g., all medications and ancillary devices be Food & Drug Administration (FDA)-approved). ADAPs’ expansive medication coverage is critical to their success and consistent with overall goals of the RWHAP to be patient-centered and comprehensive.

With a December 2019 HRSA letter allowing the use of ADAP federal funding to cover the medical costs and insurance cost sharing associated with the administration of long-acting ARVs, ADAPs now have the flexibility to assume the full costs of provider-administered HIV treatments. However, ADAPs cannot always meet the entirety of clients’ medical needs on their own – ADAP federal funding generally may not be used to pay for medical costs. As a result, ADAPs must work in coordination with other RWHAP Part B services (e.g., Outpatient and Ambulatory Health Services and Health Insurance Premium and Cost-Sharing Assistance for Low-Income Individuals) and across all RWHAP Parts to provide the full complement of medical and non-medical services necessary to ADAP clients.

National RWHAP Part B Program Budget

Based on a formula and eligibility-based distribution mechanism, RWHAP Part B programs are eligible to receive the following categories of federal funding: Part B Base, Part B Supplemental (if applicable), Part B ADAP Earmark, Part B ADAP Supplemental (if applicable), and ADAP Emergency Relief Funding (if applicable). In FY2019, RWHAP Part B programs (n=59) were Congressionally appropriated a total of $1.3 billion, with $898 million (69%) awarded by HRSA to ADAP specifically (i.e., via Part B ADAP Earmark (n=59), Part B ADAP Supplemental (n=6), and ADAP Emergency Relief Funding (n=9)). By comparison, RWHAP Part B programs and ADAPs were awarded $1.4 billion and $893 million in FY2018, representing a -5% and 0.5% change for each. RWHAP was last reauthorized in 2009. In the absence of Congressional action on authorization, the program has and will continue to operate as Congress maintains annual appropriations to the program following the end of the most recent authorization sunset on September 30, 2013.

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Chart 1

Total RWHAP Part B Budget, by Source, FY2017-FY2019

¹Rebates are tracked separately from front-end discounts and account for both repayment to ADAP from a manufacturer for a drug expenditure and any additional savings generated.

Note: 54 Part B programs reported data. American Samoa, Federated States of Micronesia, Marshall Islands, Northern Mariana Islands, and Republic of Palau did not respond. Percentages may not total 100% due to rounding.

RWHAP Part B programs may choose to allocate a portion or all their Part B Base and/or Part B Supplemental to ADAP. For FY2019, 30 RWHAP Part B programs reported having allocated at least some portion of their RWHAP Part B Base and/or Part B Supplemental to ADAP, representing 5% of their overall ADAP budgets. As the largest component to the RWHAP Part B program with the greatest number of clients served (86%), ADAPs represented 71% of the overall Part B budget in FY2019. The proportion of the RWHAP Part B budget used for ADAP ranged from 0% in Federated States of Micronesia to 96% in Mississippi. Yet these awards alone do not meet the needs of RWHAP Part B programs or their clients. Instead, jurisdictions must often use other funding streams to sustain their infrastructure and service delivery.

RWHAP Part B programs must use at least 75% of federal RWHAP awards (e.g., Part B Base, Part B Supplemental) to fund core medical services, including ADAP (unless a “75/25 waiver” is approved by HRSA HAB). In 2019, 96% of all RWHAP Part B program expenditures were used for core medical services as compared to 86% in 2018. Part B programs may exceed the 75/25 requirement using non-federal funding including rebates or program income. Additional sources that may be available to RWHAP Part B programs include other federal funding (e.g., carry-over from prior Part B Base or ADAP Earmark awards), state general revenue funding, private donations, program income, and rebates received as part of medication purchasing. RWHAP Part A programs in eligible metropolitan areas may contribute direct-appropriated funds to their Part B counterparts. Such decisions are made locally and reflect an effort between RWHAP Parts A and B programs to avoid duplicating service delivery and to mutually ensure each other’s success in serving the needs of PLWH. Taken together, these additional funding sources make up 55% of the FY2019 RWHAP Part B program and ADAP budgets.

Rebates (41%), Part B ADAP earmark (28%), and Part B base (11%) make up the greatest proportions of the overall Part B budget for FY2019. Rebates, payments received by some ADAPs from pharmaceutical manufacturers after paying for medications for clients, are tracked separately from front-end discounts and account for both repayment to ADAP from a manufacturer for a drug expenditure and any additional savings generated. The total amount of rebates received as well as the proportion of the Part B budget they represented increased significantly between FY2018 and FY2018 FY2019 (i.e., from 32% to 41%). Of note, this is the first increase in the proportion rebates made up of the Part B budget since FY2016, the earliest year in which all portions of the Part B budget were gathered as part of the Annual Report. Between FY2016 and FY2018, the proportion of the Part B budget attributable to rebates decreased an average 2% per year. Further, for FY2019, the first year in which this Annual Report has gathered such data, $18.7 and $72.3 million were the amounts of program income used for 9 Part B programs and 6 ADAPs, respectively, representing 3% of the total Part B budget. Separately from rebates, ADAPs may also generate program income that may be used for allowable RWHAP services and activities, including ADAP. For example, an ADAP may bill third-party insurance for the usual and customary cost for medications sold to ADAP clients where the medications were purchased at 340B pricing.

Between 2016 and 2019, the RWHAP Part B program and ADAP budgets have each increased 11% and 2%, respectively. The Part B budget has increased an average 4% per year over this period whereas the ADAP budget has changed by 0.6% per year. Between 2013 and 2019, ADAPs specifically have reported significant shifts in their total budgets and subsequent expenditures as a result of expansions in ADAP-funded insurance and the migration of ADAP clients to Medicaid. ADAP-funded insurance is defined as when an ADAP client is enrolled in insurance (public or private insurance) and the ADAP pays for part or all the clients’ co-payments/co-insurance, deductibles, and/or premiums. ADAPs began purchasing insurance for clients in 2002 when HRSA HAB specifically clarified this option. In calendar year 2018, 50 ADAPs reported using funds for insurance purchasing/continuation (see Table 14), representing $558 million in estimated expenditures (27% of the total ADAP budget for the year) for 131,047 clients (54%), with an average cost per client of $4,259. By comparison, 44 ADAPs reported using funds for insurance purchasing/continuation in 2013 (i.e., the last year before the Patient Protection and Affordable Care Act (Affordable Care Act, ACA) was fully implemented) for 35% of all clients served by ADAP. From 2013 to 2018, ADAPs have reported an average 19% increase each year in the proportion of clients served by insurance purchasing/continuation programs. The ACA has enabled tens of thousands of PLWH, including those served by ADAP, to transition to expanded Medicaid and private insurance available through Marketplaces. ADAP continues to support more clients than ever to afford private insurance coverage.

Overview of Jurisdictional and Federal EHE Efforts

In February 2019, President Trump announced Ending the HIV Epidemic: A Plan for America (EHE), which is the Administration’s plan to end the HIV epidemic by 2030. The plan’s goals are to reduce new HIV infections by 75% by 2025 and by 90% by 2030. In Phase 1, EHE funding is initially focused on 48 counties with the highest burden, Washington DC, San Juan, Puerto Rico, and 7 states that have substantial rural burden. In the first year, the Administration requested funding for the Centers for Disease Control and Prevention (CDC), HRSA, the Indian Health Service (IHS), and the National Institutes of Health (NIH) in their budget. Congress provided FY2020 funding for EHE programming at CDC, HRSA’s HIV/AIDS Bureau and Primary Care Bureau, and the National Institutes of Health (NIH). EHE implementation will be focused on four pillars: (1) diagnose all PLWH as early as possible; (2) treat PLWH rapidly and effectively to reach sustained viral suppression; (3) prevent new HIV transmissions by using proven interventions, including pre-exposure prophylaxis (PrEP) and syringe services programs (SSPs); and (4) respond quickly to potential HIV outbreaks to get needed prevention and treatment services to the people who need them. In September 2019, EHE jurisdictions began to develop plans to end the HIV epidemic with implementation beginning in 2020.

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Chart 3

Engagement in RWHAP Part B and ADAP, Calendar Year 2018

Client enrollment – the number of clients enrolled by Part B program or ADAP in 2018

Client utilization – the number of clients served by Part B program or ADAP in 2018

Client retention – the number of clients who were successfully recertified twice in a 12-month period of time by Part B program or ADAP

Part B client health outcome – the number of clients served by Part B program or ADAP who reported a suppressed viral load in 2018

Note: 52 Part B programs reported data. American Samoa, Federated States of Micronesia, Guam, Marshall Islands, Northern Mariana Islands, Oklahoma, and Republic of Palau did not respond. 53 ADAPs reported data. American Samoa, Federated States of Micronesia, Guam, Marshall Islands, Northern Mariana Islands, and Republic of Palau did not respond.

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Chart 4

RWHAP Part B Clients Served, by Viral Load, Calendar Year 2018

Note: 52 Part B programs reported data. American Samoa, Federated States of Micronesia, Guam, Marshall Islands, Northern Mariana Islands, Oklahoma, and Republic of Palau did not respond. Data reflect clients enrolled in Part B programs over the past 12 months or the most recent 12 months for which data are available. Data reflect clients enrolled in Part B programs over the past 12 months or the most recent 12 months for which data are available. Percentages may not total 100% due to rounding.

RWHAP Part B programs and ADAPs are critical to jurisdictional and national EtE efforts at all levels, including the Administration’s EHE initiative, by providing broad and tailorable services to meet the needs of all PLWH and key populations. They are also integral to “undetectable = untransmittable (U=U)”, an evidenced-based campaign asserting that PLWH who are on antiretroviral therapy (ART) and durably virally suppressed (i.e., viral load < 200 copies/mL) do not sexually transmit HIV. As compared to the general population, Part B and ADAP clients demonstrate higher outcomes across the HIV care continuum. Part B client enrollment ranges from 164 (U.S. Virgin Islands) to 29,706 (Florida). While forty-percent of PLWH in the U.S. have been estimated to be retained in care (i.e., had two or more medical visits in a calendar year, three months or more apart); 64% of Part B and ADAP clients were reported as retained (i.e., were successfully recertified twice in a 12-month period of time). Seventy-one percent of Part B clients, regardless of whether they are on ARV treatment, were reported as being virally suppressed based on their most recent viral load recorded as of December 31, 2018. This is significantly more than the estimated 51% of all PLWH who are virally suppressed. By comparison, 69% and 61% of clients served in CY2016 and CY2017, respectively, were reported as virally suppressed, demonstrating an upward trajectory overall. RWHAP Part B programs with the highest rates of viral load suppression in CY2018 include Wyoming (96%), Arizona (94%), Rhode Island (94%), New York (92%), Maine (91%), Ohio (90%), South Carolina (90%), and Vermont (90%). These programs vary considerably in geographic region and client enrollment/utilization (Wyoming, 225 and New York, 20,133). Furthermore, seven (Arizona, Maine, New York, Ohio, Rhode Island, South Carolina, Vermont, and Wyoming) have reported having either maintained or increased the proportion of virally suppressed clients since CY2017.

ADAPs, as providers of life-saving treatments necessary to achieving viral load suppression, including ARVs and treatments for comorbid conditions that might affect adherence to or the effectiveness of ARV treatment, demonstrate even higher rates of viral load suppression among their clients served (80%). While ARVs represent 95% of all CY2018 ADAP drug expenditures, 0.4% and 1% were expended on hepatitis B and C treatment, respectively. All other medications comprised 0.2% of drug expenditures. Viral load suppression is highest among those clients served by ADAP-funded insurance alone (94%) and in combination with the full-pay prescription program (83%). Eighteen ADAPs reported viral load suppression rates of 90% or greater; 16 reported rates of 80-90%; ten reported rates of 70-80%; and nine reported rates of less than 70%. The ADAPs with the highest rates of viral load suppression include Arizona (99%), Massachusetts (94%), Oregon (94%), Vermont (94%), Michigan (93%), New York (93%), and Wyoming (93%). Nineteen percent of ADAP clients served in 2014 were reported as virally suppressed, the earliest year in which these data were available. This significant change over time is a testament to the increasing effectiveness of ADAPs in reporting and ensuring optimal health outcomes among their clients served.

Together, RWHAP Part B programs and ADAPs, including those to be funded in the first five years of the EHE, can make meaningful contributions toward widespread viral load suppression.

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Chart 5

ADAP Clients Served by Program, by Viral Load, Calendar Year 2018

Note: 53 ADAPs reported data. American Samoa, Federated States of Micronesia, Guam, Marshall Islands, Northern Mariana Islands, and Republic of Palau did not respond. Data reflect clients enrolled in ADAPs over the past 12 months or the most recent 12 months for which data are available. Percentages may not total 100% due to rounding.

Who are RWHAP Part B Program Clients?

In calendar year 2018 (CY2018), 283,480 clients were served by RWHAP Part B core medical and support services, representing 26% of the 1.1 million people estimated to be living with HIV in the United States. This represents a 16% increase from the 245,245 reported as served in CY2017. Within ADAP, 242,727 clients were reported as served in CY2018, with 54% by ADAP-funded insurance (i.e., the client had either public or private insurance for which the ADAP paid premium(s), deductible payment(s) and/or cost-sharing/co-payments) and 46% by the full-pay prescription program only. As RWHAP Part B programs/ADAPs served over half of all RWHAP clients and one-fourth of all PLWH nationally, they are a critical component to the public health and health care infrastructures necessary to reaching an end to the HIV epidemic.

To fulfill their mission and purpose in achieving optimal health outcomes among the PLWH served by their programs, RWHAP Part B programs and ADAPs must develop and maintain systems that are responsive to the challenges faced by their clients. As stipulated by the Ryan White CARE Act, individuals served by RWHAP Part B programs are low-income and under/uninsured. Among RWHAP Part B clients served during calendar year 2018, 49% had incomes less than 100% of the federal poverty level (FPL) whereas 12% of the general population were living at or below the FPL. By comparison, 53% of RWHAP Part B clients were reported as having incomes below 100% FPL in calendar year 2017. RWHAP Part B clients were also more likely to be people of color (57% vs. 23%), with the majority 82% of clients of color reported as Black/African American. By ethnicity, 21% of RWHAP Part B clients were reported as Hispanic/Latinx (vs. 18% in the general population). The majority of clients served identified as male (72%) whereas 26% were identified as female. Comparatively, 49% and 51% of the U.S. population in 2018 were reported as male and female, respectively. This difference is reflective of the disproportionate prevalence of HIV among men nationally; 76% of all adult PLWH in 2017 were male. One percent of RWHAP Part B clients were reported as transgender in CY2018, 86% of whom identified as trans women, 3% as trans men, and 10% as transgender - other.

There are key differences in the clients served by RWHAP Part B core medical/support services vs. those served by ADAP specifically. RWHAP Part B programs, outside of ADAP, may provide more services to low-income PLWH that are not otherwise covered by Medicaid or other payers. Forty percent of ADAP clients served in CY2018 had incomes below 100% FPL, 13% less than those served by RWHAP Part B (53%). In 2017, 40% of all RWHAP clients were enrolled in Medicaid. Forty-four percent of ADAP clients were reported as people of color – slightly less than the 57% of RWHAP Part B clients. A greater proportion of ADAP clients (89%) were Black/African American, compared to 82% of RWHAP Part B clients. Twenty-seven percent were of Hispanic/Latinx ethnicity (vs. 21% among RWHAP Part B clients). By gender, ADAP clients were more likely to be male than those PLWH served by RWHAP Part B; 77% of ADAP clients were reported as male, 21% as female, and 1% as transgender. Among transgender ADAP clients, 84% were reported as trans women, 3% as trans men, and 13% as transgender – other.

RWHAP Part B programs and ADAPs are well-positioned to address the complex needs of these clients through their expansive and flexible service delivery and the opportunities that an evolving healthcare system has afforded them in bolstering it.