Ryan White HIV/AIDS Program Part B Virtual AdministraAve Reverse Site Visit. February 3, The AIDS Drug Assistance Program Overview

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1 The AIDS Drug Assistance Program Overview Ryan White HIV/AIDS Program Part B Virtual AdministraAve Reverse Site Visit February 3, 2016 Glenn Clark, MSW ADAP Advisor Division of State HIV/AIDS Programs (DSHAP)

2 Agenda Background InformaAon on Ryan White HIV/AIDS Program (RWHAP) and the AIDS Drug Assistance Program (ADAP) ADAP AdministraAve Structure and ResponsibiliAes ADAP OperaAons ADAP MedicaAon Assistance ADAP Health Insurance Assistance Technical Assistance Resources 2

3 Agenda Background InformaAon on RWHAP and ADAP 3

4 AIDS Drug Assistance Program DefiniAon ADAP is a State/Territory- administered program authorized under Part B of the RWHAP that provides Food Drug AdministraFon (FDA)- approved medicafons to low- income individuals with HIV disease who have limited or no coverage from private insurance, Medicaid, or Medicare. Program funds may also be used to purchase health insurance for eligible clients and for services that enhance access to, adherence to, and monitoring of drug treatments. 4

5 RWHAP LegislaAon ADAP Milestones Ryan White LegislaFon was signed into law on August 18, : Zidovudine (AZT) DemonstraFon project incorporated into Title II of the Ryan White CARE Act. 1996: First reauthorizafon created the Federal ADAP earmark. 2000: Second reauthorizafon allowed insurance purchasing and flexibility for access, adherence and monitoring and created ADAP supplemental grants. 2006: Third reauthorizafon of the Ryan White Program created a new formula incorporafng living HIV/AIDS cases in the state award, minimum formulary, ADAP supplemental set aside & eligibility. 2009: Currently reauthorized for four years as the Ryan White HIV/AIDS Treatment Extension Act (Ryan White HIV/AIDS Program 5

6 ADAPs NaAonal Overview All 59 States and Territories are provided funding for ADAP. There is a wide variafon in program characterisfcs due to individual State administrafon of each ADAP and HIV/AIDS prevalence in each State. Differences most pronounced in areas of funding, eligibility criteria, formulary size, and cost- saving strategies. 6

7 ADAP s Impact (as per 2014 ADR)! 1 in 4 People Living With HIV (PLWH) receiving anfretroviral (ARV) in USA use ADAP services.! 268,636 PLWH served through ADAPs in CY 2014*. 142,760 received full- cost medicafon assistance only 46,533 received insurance assistance (premiums and/ or copays) only 23,971 received both medicafon and insurance assistance *UFlizaFon data missing on 55,372 clients 7

8 FY 2015 RWHAP AppropriaAons Total $2.319 Billion 8

9 RWHAP AppropriaAons History FY FY 2015 $1,000 $900 Millions $800 $700 $600 $500 $400 $300 $200 $100 $ Part A Part B Base Part B ADAP Part C Part D Part F Dental Part F AETC SPNS 9

10 Affordable Care Act and ADAPs Key impacts of the ACA on ADAPs have included: CreaFon of Pre- ExisFng CondiFons Insurance Plans (PCIPs) ADAP expenditures counfng towards Medicare Part D True Out of Pocket (TrOOP) Costs Medicaid Expansions Access to insurance for those with pre- exisfng condifons 10

11 ADAP- Specific Funding (FY15) Part B (X07) ADAP Base: $784,180,379 ADAP Supplemental: $41,313,113 ADAP Emergency Relief Funding (X09) $75,000,000 (from ADAP Base) Other sources of ADAP Funding: State match, drug rebates, state general revenue funds, Part A/B contribufons 11

12 ADAP Funding DistribuAon 95% of the ADAP Base is distributed by formula, based on the number of living HIV/AIDS cases in the state in the most recent calendar year. 5% of the ADAP Base is set- aside for the ADAP Supplemental grant, which is distributed based on need: ReducFon in eligibility standards, (Federal Poverty Level) ReducFon in formulary IniFaFon of waifng list UnanFcipated increase in eligible PLWH There are 15 ADAP Supplemental grantees in FY15. 12

13 ADAP Overview ADAP is a drug assistance program. All ADAP funding must be related to drug assistance. ADAP provides access to medicafons by either: 1. purchasing medicafons; or 2. providing assistance with health insurance premiums, medicafon co- pays and deducfbles (HAB Policy 07-05). 13

14 ADAP Flexibility The RWHAP legislafon* allows States to redirect up to 5% of their ADAP earmark under the Flexibility policy (10% in extraordinary circumstances) for expenditures that: improve access to medicafons, increase adherence to medicafon regimens, and help clients monitor their progress in taking HIV- related medicafons ADAP must ensure that clients receive medicafon therapies consistent with current HHS HIV/AIDS treatment guidelines. *SecFon [300ff 26] (c)(6); also see HAB Policy

15 RWHAP Part B Minority AIDS IniAaAve The parameters for the use of RWHAP Part B Minority AIDS (MAI) outlined in the legislafon are narrow it can only be used for educafon and outreach services for the specific purpose of increasing minority enrollment in ADAP, and only for the racial and ethnic minorifes indicated in the legislafon. RWHAP Part B MAI funding may not be used to purchase medicafons or health insurance. 15

16 Local Pharmacy Assistance Programs (LPAPs) A Local PharmaceuFcal Assistance Program (LPAP) allows a RWHAP Part A or Part B recipient to provide on- going assistance to HIV/AIDS medicafons to eligible clients outside of ADAP. It may not be used to provide short- term or emergency medicafon assistance. ImplementaFon of an LPAP involves the development of a drug distribufon system that includes, but is not limited to: a client enrollment and 6 month eligibility determinafon process; an LPAP advisory board; uniform benefits for all enrolled clients; compliance with RWHAP requirement of payer of last resort; and a drug formulary approved by the LPAP advisory board. 16

17 Agenda Background InformaAon on RWHAP and ADAP QuesAons? 17

18 Agenda ADAP AdministraAve Structure and ResponsibiliAes 18

19 Key AdministraAve Requirements ADAP Staffing HRSA requires that recipients have sufficient staffing, whether employees or contractual, to provide ADAP services in compliance with legislafve and programmafc requirements. ADAP Policies and Procedures HRSA requires that recipients have appropriate guidelines and controls in place to ensure compliance with legislafve and programmafc requirements. Financial Oversight and Monitoring HRSA requires that recipients have appropriate financial systems and controls in place to ensure the appropriate use and reporfng of Federal awards. 19

20 Sub- award ResponsibiliAes RWHAP Part B recipients may choose to sub- award some, or in some cases all, of their ADAP operafons. The RWHAP Part B recipient is responsible for ensuring that all legislafve, programmafc, administrafve, and fiscal requirements are met and that there is appropriate oversight and monitoring of RWHAP funds. The liability for improperly used RWHAP funds or delivered services is a responsibility of the RWHAP Part B recipient. 20

21 ADAP Planning Requirements RWHAP Part B programs are responsible for conducfng planning in order to guide decisions about use of RWHAP Part B funds, including funds being used within the AIDS Drug Assistance Program (ADAP). HRSA HAB strongly encourages RWHAP Part B programs to have advisory bodies to provide recommendafons to the RWHAP Part B recipient on the use of RWHAP funds on at least an annual basis. The RWHAP legislafon does not mandate an ADAP- specific Advisory Commioee; however, most States convene one as a best pracfce. 21

22 ADAP Planning Components HRSA HAB requires ADAPs to engage in planning for key aspects of ADAP structure and operafons, including: ADAP eligibility criteria, the scope of ADAP services, ADAP budgefng, ADAP client capacity, ADAP formulary, cost effecfveness of health insurance assistance, and Clinical Quality Management. 22

23 Clinical Quality Management Requirements for ADAP The RWHAP legislafon requires that all RWHAP recipients have a clinical quality management (CQM) program. ADAPs, as part of the overall Ryan White Part B program, must be included in the CQM program either as an integrated component or a separate program. The expectafons of a RWHAP Part B recipient s CQM program are outlined in Policy ClarificaFon NoFce

24 CQM Requirements for ADAP, cont. At a minimum, RWHAP Part B recipient quality management program must have: Appropriate and sufficient infrastructure to make the CQM program successful and sustainable. Performance measurement to appropriately assess outcomes. Quality improvement acfvifes aimed at improving pafent care, health outcomes and pafent safsfacfon. 24

25 ADAP Performance Measures HAB s recommended performance measures for ADAPs include: Percent of ADAP applicafons approved or denied for new ADAP enrollment within 14 days (two weeks) of ADAP receiving a complete applicafon in the measurement year. Percentage of ADAP enrollees who are reviewed for confnued ADAP eligibility two or more Fmes in the measurement year. 25

26 ADAP Performance Measures Percentage of new ARV classes that are included in the ADAP formulary within 90 days of the date of inclusion of new anf- retroviral classes in the Public Health System Guidelines for the Use of AnFretroviral Agents in HIV- 1- infected Adults and Adolescents1 during the measurement year. Percent of idenffied inappropriate ARV regimen components prescripfons that are resolved by ADAP during the measurement year. 26

27 ADAP Performance Measures Viral Load Suppression is the ulfmate goal of all RWHAP services. ADAPs are strongly encouraged to use viral load suppression as an outcome measure for their program. 27

28 ReporAng on ADAP ADAP- related allocafons and expenditures are reported to HAB through a variety of reports, including: ADAP Data Report (ADR) Regular RWHAP Part B reports Emergency Relief Funds (ERF)- specific reports 28

29 ADAP Data Report (ADR) The ADAP Data Report (ADR) is a client level data report due annually in June. Recipients report on clients enrolled, services provided, and expenditures. The ADR is comprised of two components: the Grantee Report and the Client Report (i.e. client- level data). The ADR must be submioed in a specific file format (.xml) to HAB. The ADR enables HRSA HAB to evaluate the impact of the ADAP on a nafonal level, inclusive of client demographics, what ADAP- funded services are being uflized, and the associated costs of these services. 29

30 Agenda ADAP OperaAons 30

31 ADAP- Related LegislaAon: Eligibility [300ff 26](b) (b) ELIGIBLE INDIVIDUAL. To be eligible to receive assistance from a State under this secaon an individual shall (1) have a medical diagnosis of HIV/AIDS; and (2) be a low- income individual, as defined by the State. Payer of Last Resort requirement is in SecAon 2617(b)(7)(F) 31

32 ADAP Eligibility Criteria Eligibility Criteria is determined by each State or Territory, and includes: Financial eligibility: Income limit (as percentage of Federal Poverty Level) Medical eligibility: Diagnosis of HIV infecfon Residency: Proof of current State residency Uninsured or Underinsured: Proof of no other insurance coverage or that the client s insurance coverage does not cover all their medicafon costs. 32

33 ADAP Income Eligibility by Federal Poverty Level (FPL) Income Cap (as reported on the FY14 ADR) 200% FPL ADAPs 250% FPL ADAPs 300% FPL ADAPs 357% FPL ADAP 400% FPL ADAPs 420% FPL ADAP 430% FPL ADAP 435% FPL ADAP 450% FPL ADAP 500% FPL ADAPs 33

34 ADAP CerAficaAon/RecerAficaAon At the Fme of inifal enrollment, and on an annual basis thereauer, ADAP must provide a complete assessment of an individual s eligibility for the AIDS Drug Assistance Program. ADAPs are required to recerffy client eligibility every 6 months, and must meet HRSA s minimum requirements for recerfficafon. Self- aoestafon is allowable for 6 month recerfficafon ADAP enrollment, cerfficafon and recerfficafon processes must be designed to allow clients access to medicafons in a Fmely manner. 34

35 ADAP CerAficaAon/RecerAficaAon ProhibiAon of PresumpAve Eligibility It is unallowable for ADAP to provide services before a client has been determined to meet the ADAP s eligibility criteria (i.e. presumpfve eligibility ) ProhibiAon of Grace Periods It is unallowable for a client to receive ADAP services auer their 6 month eligibility period has expired and before they recerffy their eligibility. 35

36 ADAP- Related LegislaAon: Formulary SecFon [300ff 26](e) (e) List of Classes of Core AnFretroviral TherapeuFcs For purposes of subsecfon (c)(1), the Secretary shall develop and maintain a list of classes of core anfretroviral therapeufcs, which list shall be based on the therapeufcs included in the guidelines of the Secretary known as the Clinical PracFce Guidelines for Use of HIV/AIDS Drugs, relafng to drugs needed to manage symptoms associated with HIV. Public Health Service ARV Drug Classes FDA- approved anfretroviral drug classes currently available include: Entry and Fusion Inhibitor, Non- nucleoside Reverse Transcriptase Inhibitor, Nucleoside Reverse Transcriptase Inhibitor, and Protease Inhibitor. 36

37 ADAP Formulary An ADAP formulary must include at least one drug from each class of HIV anfretroviral medicafons. RWHAP funds may only be used to purchase medicafons approved by the FDA and the devices needed to administer them. An ADAP formulary must be consistent with the most recent Adolescent and Adult HIV/AIDS Treatment Guidelines published by the Department of Health and Human Services. All therapeufc treatment and ancillary devices included on the ADAP formulary and all ADAP- funded services must be equally and consistently available to all eligible enrolled individuals throughout the State/Territory. 37

38 Cost Containment AIDS Drug Assistance Programs have devised and implemented a variety of cost- containment strategies to manage scarce resources in the most efficient and effecfve manner possible, including cost- cuxng and cost- saving strategies. Cost- cuxng Measures: Any measures taken that restrict or reduce enrollment or benefits. HRSA defines a waifng list as a register of individuals who have applied for and been deemed eligible for a State s ADAP, but who the State cannot immediately serve due to insufficient resources. Cost- saving Measures: Any measures taken to improve the cost- effecfveness of ADAP operafons. 38

39 Payer of Last Resort Requirement RWHAP funds are intended to fill gaps in care and serve as the payer of last resort. RWHAP resources can only be used to pay for allowable costs when there is no other public or private payer or when the costs are not covered by other public and private payers. ADAPs must ensure eligible individuals are expedifously enrolled in other programs for which they are eligible and that the ADAPs coordinate with other payers. 39

40 Payer of Last Resort Requirement Vigorously Pursue Health Care Coverage Recipients and their contractors are expected to vigorously pursue enrollment into health care coverage for which their clients may be eligible CoordinaAon with Other Payers ADAPs are expected to work with other payers and programs to provide clients with access to HIV medicafons and a confnuum of care. 40

41 Agenda ADAP AdministraAve Structure and ResponsibiliAes and ADAP OperaAons QuesAons? 41

42 Agenda ADAP MedicaAon Assistance 42

43 ADAP- Related LegislaAon SecFon [300ff 26] Provision of Treatments (a) IN GENERAL. A State shall use a porfon of the amounts provided under a grant awarded under secfon 2611 to establish a program under secfon 2612(b)(3)(B) to provide therapeufcs to treat HIV/AIDS or prevent the serious deteriorafon of health arising from HIV/AIDS in eligible individuals, including measures for the prevenfon and treatment of opportunisfc infecfons. 43

44 ADAP MedicaAon Assistance MedicaFon Assistance is when ADAP pays for the full cost of a medicafon for a client. MedicaFon co- pays, deducfbles and co- insurance are considered Health Insurance Assistance, not MedicaFon Assistance. In CY2014, ADAPs spent $1,421,460,581 purchasing medicafons for enrolled clients. 44

45 ADAP Drug Purchasing AIDS Drug Assistance Programs (ADAPs) can either purchase medicafons directly from a wholesaler ( Direct Purchase ) or reimburse retail pharmacies for dispensing medicafons to ADAP clients ( Pharmacy Network/Rebate Model ) or both ( Hybrid/Dual ). 45

46 340B Program ADAPs have access to discounted drug prices through the 340B program, which requires drug manufacturers to provide outpafent drugs to eligible health care organizafons/covered enffes at significantly reduced prices (average savings of 25-50%). 340B discounts are required by the Veterans Health Care Act of 1992 (SecFon 602). There were an esfmated $6 billion in 340B drug purchases last year. 46

47 340B Prime Vendor Program (PVP) HRSA s Prime Vendor provides a number of services, including: Drug price negofafon services MulFple wholesale distributor agreements Favorable discounts on other pharmacy related products/ service 340B University educafonal opportunity There is no cost to parfcipate. For more informafon, go to hops:// or ApexusAnswers@340bpvp.com 47

48 340B Eligible EnAAes All RWHAP grantees are eligible enffes under the 340B Program. RWHAP sub- grantees are eligible enffes under 340B on the confirmafon of the receipt of RWHAP funding by the RWHAP recipient. RWHAP grantees (and sub- grantees) can contract with pharmacies to provide 340B services to eligible clients. Contract pharmacies need to register with the Office of Pharmacy Affairs (OPA). 48

49 340B Program Requirements ProhibiFon on Duplicate Discounts Duplicate Discount = Accessing the 340B Discount and Medicaid Rebate on same drug Only one 340B covered enfty can access 340B pricing for a pharmacy claim (no double dipping ). ProhibiFon on Drug Diversion 340B pricing can only be used for 340B eligible clients at 340B covered enffes. Maintenance of Auditable Records Audits 49

50 340B Proposed Mega- Guidance On August 31, 2015, HRSA posted in the Federal Register proposed 340B Drug Pricing Program Omnibus Guidelines for public comment. The proposed omnibus guidelines provide revised guidance on a number of issues relevant to ADAP, including the generafon of ADAP rebates. The public comment period ended on October 27, As of now, the Office of Pharmacy Affairs is in the process of reviewing the 1,273 public comments received. 50

51 ADAPs and 340B ADAP access the 340B pricing in the following ways: For Direct Purchase, ADAP purchases the medicafons from a drug wholesaler at the 340B price For Pharmacy Network/Rebate Model, ADAP purchases medicafons through a retail pharmacy network at a price higher than the 340B price then submits claims to drug manufacturers for rebates on full pay medicafons or medicafon copayments, coinsurance, or deducfbles to achieve cost savings comparable to those received by ADAPs that directly purchase medicafons at the 340B price. For Hybrid/Dual, ADAPs do a combinafon of the above. 51

52 ADAP Drug Purchasing In addifon to the 340B price reducfon, ADAPs have negofated deeper discounts on ARV therapies through the ADAP Crisis Task Force (ACTF). ACTF discounts received as rebates may be referred to as supplemental rebates or voluntary rebates. 52

53 ADAP- Related LegislaAon: Rebates [300ff 26](g) (g) DRUG REBATE PROGRAM. A State shall ensure that any drug rebates received on drugs purchased from funds provided pursuant to this secfon are applied to acfvifes supported under this subpart, with priority given to acfvifes described under this secfon Timeframe for ObligaFon and Expenditure of Grant Funds (d) Treatment of Drug Rebates 53

54 Rebates HRSA defines a rebate as a return of a part of a payment. ADAPs who purchase medicafons through a retail pharmacy network at a price higher than the 340B price can submit claims to drug manufacturers for rebates on full pay medicafons or medicafon copayments, coinsurance, or deducfbles to achieve cost savings comparable to those received by ADAPs that directly purchase medicafons at the 340B price. HRSA provides guidance on rebates in Policy ClarificaFon NoFce 15-04, UFlizaFon and ReporFng of PharmaceuFcal Rebates. 54

55 Rebates: Allowable Expenditures As per the RWHAP legislafon, any rebates received on drugs purchased with ADAP funds must be used for RWHAP Part B allowable acfvifes, with priority given to ADAP. Rebates are not part of the recipient s RWHAP Part B award, and are not subject to the 10% administrafve cost cap or the requirement to spend 75% on core medical services. The statute exempts Part B recipients from Unobligated Balance (UOB) penalfes resulfng from the expenditure of rebate dollars before grant funds. 55

56 Rebates: Timing of Expenditure Federal regulafons require that rebate funds are spent prior to drawing down grant funds from the Payment Management System (PMS) (45 CR (f)(2)). HRSA has determined that recipients can spend rebate funds in the grant year in which they are received and prior to drawing down grant funds. If rebates are received at the end of a grant year, PCN states that recipients can spend those rebates in the subsequent grant year, prior to the expenditure of new RWHAP funds. 56

57 ReporAng of Rebates Rebates should not be included in any X07, X08 or X09 program reports since they are not federal funds. Rebates are reported in two places on the Federal Financial Report (FFR): the Ryan White Rebate Funding secfon and the comments secfon. In the Comments secfon, recipients provide informafon on rebates received during the grant period, rebates expended during the grant period, and any remaining balance. If a recipient has an unobligated balance greater than 5% directly due to the receipt and expenditure of rebate funds, they must inform HRSA of this in order to not be penalized. 57

58 Drug Supply Chain Safety Act (DSCSA) The Drug Quality and Security Act, signed into law in November 2013, contains provisions in Title II, known as the Drug Supply Chain Security Act (DSCSA), that are intended to enhance the safety of pharmaceufcals as they make their way from the manufacturer to the pafent. Chief among those provisions are: 1) a new system to track and trace drugs as they move across the supply chain, and 2) new licensure and oversight requirements for wholesalers. The Act and related guidance can be found on FDA s website at the following link: hop:// DrugIntegrityandSupplyChainSecurity/ DrugSupplyChainSecurityAct/default.htm 58

59 Drug Supply Chain Safety Act (DSCSA) Track and Trace The track and trace component of the DSCSA requires manufacturers and repackagers to put a unique product idenffier on certain prescripfon drug packages, and for manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) in the drug supply chain to provide informafon about a drug and its handlers, each Fme it is sold in the U.S. market. ADAPs that meet the Act s definifon of one of these components of the drug supply chain will need to comply with the track and trace requirements of the Act. 59

60 Agenda ADAP Health Insurance Assistance 60

61 ADAP- Related LegislaAon: Health Insurance Assistance [300ff 26] (f)(1) (f) USE OF HEALTH INSURANCE AND PLANS. IN GENERAL. In carrying out subsecfon (a), a State may expend a grant under secfon 2611 to provide the therapeufcs described in such subsecfon by paying on behalf of individuals with HIV/AIDS the costs of purchasing or maintaining health insurance or plans whose coverage includes a full range of such therapeufcs and appropriate primary care services. 61

62 ADAP- Related LegislaAon: Health Insurance Assistance, cont [300ff 26] (f)(2) (2) LIMITATION. The authority established in paragraph (1) applies only to the extent that, for the fiscal year involved, the costs of the health insurance or plans to be purchased or maintained under such paragraph do not exceed the costs of otherwise providing therapeufcs described in subsecfon (a). Also see HAB Policy

63 ADAP Health Insurance Assistance Health Insurance Assistance includes payment of qualified premiums, medicafon co- pays, deducfbles and co- insurance. In CY2014, ADAPs spent $337,939,020 on health insurance assistance for enrolled clients. 63

64 ADAP Health Insurance Assistance Policy ClarificaFon NoFce (PCN) states, If resources are available, RWHAP grantees and subgrantees are strongly encouraged to use RWHAP funds for premium and cost- sharing assistance for these individuals when it is cost- effecfve, as appropriate. RWHAP recipients can provide health insurance assistance outside of ADAP through the Health Insurance Premium and Cost- Sharing Assistance service category 64

65 ADAP Health Insurance Assistance Requirements Premium Assistance: Minimum Coverage Standard The RWHAP legislafon sfpulates that an ADAP can only pay for health insurance whose coverage includes both primary care services and HIV treatments. HRSA clarifies in PCN that the health coverage purchased must include at least one drug in each class of core anfretroviral therapeufcs from the HHS Clinical Guidelines for the Treatment of HIV/AIDS (i.e. the minimum formulary requirement for ADAPs). 65

66 ADAP Health Insurance Assistance Requirements Premium Assistance: Minimum Coverage Standard, cont. ADAPs cannot pay for health insurance premium that does not include a pharmacy benefit. For example, an ADAP cannot pay for a stand- alone dental or vision insurance policy. HRSA allows ADAPs to pay for Medicare Part D premiums, since they provide the medica=on assistance component of the Medicare program. 66

67 ADAP Health Insurance Assistance Requirements MedicaAon Cost- Sharing ADAPs can choose to use their resources to pay for medicafon cost- sharing (deducfbles, co- payments and/or co- insurance costs) for clients who have another payer. ADAPs can only provide cost- sharing for drugs that are on the ADAP formulary. ADAP funds cannot be used for non- medicafon- related cost- sharing (e.g. medical visit deducfbles, co- payments and/or co- insurance). Reported as an ADAP Health Insurance Assistance service, not as an ADAP MedicaFon service. 67

68 ADAP Health Insurance Assistance: Cost- EffecAveness Requirement Cost- EffecAveness Assessment The RWHAP legislafon states that ADAP can purchase insurance if, for the fiscal year involved, the costs of the health insurance or plans to be purchased or maintained do not exceed the costs of otherwise providing therapeufcs. PCN clarifies that ADAP must assess and compare the aggregate cost of paying for the health insurance opfon versus paying for the full cost for medicafons. The required cost comparison is in the aggregate. 68

69 Program Income PCN defines program income as gross income earned by the non- Federal enfty that is directly generated by a supported acfvity or earned as a result of the Federal award during the period of performance (or grant year) except as provided in 45 CFR (f). In the context of the ADAP, program income is most commonly generated billing third party insurance for medicafons purchased at 340B pricing. Program income in this case would be the difference between the insurance reimbursement for 340B drugs and the cost of this medicafon. 69

70 Program Income: Expenditure Rules Must be used for the purposes for which the award was made, and may only be used for allowable costs under the award. Should be spent in the grant year in which they are received, not generated; and should be spent prior to drawing down grant funds. Program income received at the end of the grant year can be spent in the subsequent grant year, but must be spent prior to the expenditure of new RWHAP funds. The statutory exempfon from UOB penalfes for Part B recipients that expend rebate dollars before requesfng addifonal grant RWHAP funds does not extend to UOBs accrued as a result of expending program income. 70

71 Agenda ADAP MedicaAon Assistance and ADAP Health Insurance Assistance QuesAons? 71

72 Agenda Technical Assistance Resources 72

73 Resources ADAP Manual hops://careacoarget.org/content/adap- manual HAB and TARGET Center Websites hop://hab.hrsa.gov/index.html hops://careacoarget.org/ NASTAD hop:// ADR- related Technical Assistance Project Officer and ADAP Advisor 73

74 Contact InformaAon Glenn Clark, MSW ADAP Advisor Telephone: