The AIDS Drug Assistance Program ADAP LPAP

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The AIDS Drug Assistance Program ADAP LPAP Powered By Docstoc
					The AIDS Drug Assistance Program
     Administrative Overview Training
                Ryan White Part A
                   June 14, 2011

                   Kerry Hill, MSW
         Northeastern/Central Services Branch

           Jose Au Lay, MD, MMS, MSHA
       Director, AIDS Drug Assistance Program

      Department of Health and Human Services
     Health Resources and Services Administration
                  HIV/AIDS Bureau
    Ryan White HIV/AIDS Program - Intent
 Signed into law 1990, last reauthorization 2009
 Increase access to care for people living with HIV disease
 Only disease-specific discretionary grant program for care
  and treatment of PLWH
 Payer of last resort – safety net for uninsured and low-
  income individuals living with HIV/AIDS
 Funding for:
    Primary health care including medications and support
    Provider training, Technical Assistance, Demonstration
             Basic Tenets of Ryan White
 Local and State planning and prioritization of funding based on
  needs assessment
 Involvement of people living with HIV/AIDS and representatives
  of the continuum of service providers in the planning process
 Funding of both primary care and support services to improve
  access to care
    Support of a multidisciplinary team
    Building of a medical home

 Quality of care
                Core Medical Services

 Ambulatory/outpatient health    Health insurance premium
  services                         and cost sharing assistance
 AIDS Drug assistance             for low-income persons.
  Program treatments (Section     Home health care
  2616).                          Medical nutrition therapy
 AIDS pharmaceutical             Hospice services
  assistance                      Home and community based
 Oral health care                 health services
                                  Mental health
 Early intervention services
                                  Medical case management
 Substance abuse outpatient       and treatment adherence
  care                             services
Ryan White HIV/AIDS Program Primary Care
            Services Funded
 Outpatient Medical Care (includes clinical evaluation,
  laboratory testing and specialty care)
 Oral Health Care
 Mental Health
 Substance Abuse Treatment
 Medications
 Medical Nutrition Therapy
 Medical Case management, including treatment
       Ryan White HIV/AIDS Program
         Support Services Funded
 Outreach
 Medical Transportation
 Child care
 Respite care
 Psychosocial Services
 Rehabilitation Services
 Food Bank/Home Delivered Meals
 Housing Services (emergency/short-term)
 Legal services
Ryan White HIV/AIDS Program - Clients Served

 Over 529,000 uninsured and underinsured persons affected by
  HIV/AIDS annually
 Approximately 205,446 people received medications through
  ADAP in 2009
     1 in 4 receiving ARVs in USA use ADAP services
 ADAP served 228,708 clients in CY 2010. This represents a 10%
  increase over 2009.
 Reach those most in need, with an estimated 72 percent racial
  minorities, 33 percent women, and 79 percent
  uninsured/underinsured or receiving public health benefits (2007)
     CDC reported 64% minority, 23% women
        Ryan White HIV/AIDS Program

 Heavily Impacted Cities (Part A)
 States and Territories (Part B)
    AIDS Drug Assistance Program (ADAP)
 Community Based Organizations
    HIV Primary Care (Part C)
    Women, Infants, Children and Youth (Part D)
 Other programs
    Dental, Training (AETC), Planning, Capacity Development,
     Demonstrations (SPNS)
   FY 2010 Ryan White HIV/AIDS
Program Appropriation: $2.29 Billion

     Note: Includes $25 million for SPNS funding from Evaluation Set-Aside
                       Source: HAB/HRSA Budget Office
 Ryan White HIV/AIDS Program
Appropriations History 1991-2010



                                                                                                                                                               Part A
            $600                                                                                                                                               Part B Base
                                                                                                                                                               Part C

            $400                                                                                                                                               Part D
                                                                                                                                                               Dental Reimb.
            $300                                                                                                                                               AETCs



                   Ryan White – Part B

 Provides grants to all 50 States, the District Columbia, Puerto
  Rico, Guam, U.S. Virgin Islands, Palau, American Samoa,
  Commonwealth of the Northern Mariana Islands, Marshall
  Islands and Federated States of Micronesia to pay for care for
  people living with HIV/AIDS

 The AIDS Drug Assistance Program (ADAP) component pays
     Medications to treat HIV disease
     Insurance continuation for eligible clients
     Services that enhance access, adherence, and monitoring of drug
FY 2009 Ryan White HIV/AIDS Program Spending
               N=2.15 billion
                                                                    Women, Infants, Health Insurance
                                                                   Children, and Youth    Continuation
                                                                         (Part D) 3           1%       Quality Management
                                                                            3%                                  2%
                                     Administration /
                                     Program Support                      Capacity Building                Dental Programs        4

                                           7%                                    <1%                              <1%
                                                        Planning and
                                                                                                                        Medical Care     1
                                                            2%                                                              25%
                                              Training and
                                          Technical Assistance
                                                   2%                                                                       Medications -
                                                          Case Management                                                   Discretionary
                                                                 9%                                                              2%

                                                                   Support Services
                                                                         7%                       Medications (ADAP)    2


                                               *Spending data reflected in this chart are based in part on planned spending reported by grantees.
1   Medical Care includes Part A and B outpatient/ambulatory health services; oral health care; home health care; home and community-based health services; hospice services; mental
                             health services; medical nutrition therapy; outpatient substance abuse services; and Part A, B and C early intervention services
                                     2   Approximately 10% of spending under Medications (ADAP) was for health insurance and adherence support.
                                           3   Part D program reflects only a portion of spending for Women, Infants, Children, Youth and Families.
                                                               4   Dental Program reflects only a portion of spending for oral health.
            ADAPs: National Overview

 56 ADAPs, including the District of Columbia, Puerto Rico,
   Virgin Islands, Guam, Marshall Islands, Northern Mariana
   Islands, and the American Samoa Islands.
 Wide variation in program characteristics due to individual
   State administration 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.
          ADAP Program Requirements

 Formulary must contain at least one medication from each
    Many ADAPs have advisory boards
 ADAPs must set eligibility requirements and certify patients
  are eligible
    HIV infection or AIDS
    Low income:
        Federal Poverty Level (FPL) 200-500%
        In some cases meet the asset test
                       ADAP Eligibility Criteria
 Determined by the State or Territory through an advisory committee
 Eligibility criteria include both financial and medical eligibility.
 Financial eligibility: is usually determined as a percentage of Federal
  Poverty Level (FPL), such as 200% FPL.
     Financial: proof of income < established __% of the Federal Poverty Level (FPL)
      based on household size and is updated annually. Financial eligibility is calculated on
      the gross income available to the household, excluding Medicare and Social Security
      withholding and the cost of health care coverage paid by the applicant. The eligibility
      criteria also include the determination of an assets test.
 Medical: Diagnosis of HIV-infection (symptomatic or asymptomatic)
     Some ADAPs may require applicants to bring in a CD4 and Viral Load laboratory
      results within the past six months and a prescription for an antiretroviral medicine in
      the ADAP formulary.
 Residency: proof of current State residency
 Lack of Insurance: proof of no other insurance coverage
   ADAPs are required to recertify the clients’ financial eligibility every six
    months. In some States, clients are required to go through a face-to-face
    ADAP eligibility determination every 6 months, based on FPL and household
    size which is updated annually.
   During the ADAP requirement determination, clients are screened for
    eligibility for Medicaid, Medicare, and other third party payer sources to
    ensure that the Ryan White program is the payer of last resort.
      Some ADAPs may require documentation of Medicaid denial or Department of
       Labor income screens, etc.
      Clients who are deemed underinsured for prescription medications may also be
       determined eligible for ADAP at this time. This can include inadequate insurance
       coverage under Medicare Part D, Medicaid Share-of Cost, No Brand Name
       Coverage, No Prescription Coverage, Open Enrollment (pending), Pharmaceutical
       Benefits Cap, Pre-existing Clause, Reimbursement and Discount Plans, and
       Unaffordable Co-payments.
           ADAP Services

 HIV/AIDS Medications
 Insurance
 Other services
   Adherence support
   Monitoring of drug treatment
   Enhanced access to services
                    ADAP Funding

 FY 2010 federal funding
    $835,000,000 originally appropriated
    Added $25 million to assist states with waiting lists and cost
     containment measures
 Other sources
    State match, drug rebates, state general revenue funds,
     Part A/B contributions
 Overall, Federal ADAP line item is ~50% of the
  state’s total ADAP funding
              ADAP Funding Distribution

 95% of funds distributed by formula, based on the number
  of living HIV/AIDS cases in the state in the most recent
  calendar year
 5% set-aside for the ADAP Supplemental grant
    Distribution based on need, factors include:
       Reduction in eligibility standards, (FPL)
       Reduction in formulary
       Initiation of waiting list
       Unanticipated increase in eligible PLWH/A
                  ADAP Supplemental
 In FY 2010, 27 Part B jurisdictions received ADAP
  Supplemental awards I
 In FY 2011, 42 Part B jurisdictions are eligible:
    35 States
    District of Columbia, US Virgin Islands, Puerto Rico
    Pacific jurisdictions: American Samoa, Federated States of
     Micronesia, Guam and Northern Mariana Islands
 The ADAP Supplemental requires additional match of
  $1 for each $4 of federal funds
    Waived for states that meet match requirement for larger Part
     B grant
                       ADAP Costs

 Approximately $11,500/year per client
    Vary significantly by state depending on formulary
     and program costs
 ADAPs have access to 340B pricing
    340B discounts are required by the Veterans Health
     Care Act of 1992 (Section 602).
    States may either directly buy drugs (Direct Purchase)
     or collect rebates from drug companies (Rebate option)
     or distribute medications through a established pharmacy
                ADAP Waiting Lists

 State managed
   Policies differ by state

 8,072 PLWH in 13 states as of 6/6/11
 Must make sure wait-listed patients have
  access to medications via manufacturers’
  Patient Assistance Programs (PAPs)
      Increased Demand for ADAP

 18% growth from 2008 to 2009
 Factors:
     Economic downturn
     Increased HIV testing
     Push for earlier HIV treatment
     More effective medications
     Longer survival rates
   Increased HIV prevalence
    Cost Containment Measures

   Lower the FPL eligibility criteria
   Add an asset test
   Reduce formularies
   Initiate/increase co-pays
   Negotiate lower drug costs
 Aggressively pursue 3rd party payers
    (e.g. screening for Medicaid and Medicare Part D
    eligibility at least every 6 months)
  Local Pharmacy Assistance Program

 Overview of LPAP
   A local pharmacy assistance program is implemented by
    Ryan White grantees (Parts A or B) to provide HIV/AIDS
    medications to eligible clients who would otherwise not have
    access to them.
   A policy will be issued to address the requirement for
    accountability and coordination across all Ryan White
    HIV/AIDS Programs in developing, implementing,
    monitoring, and the administration of Ryan White funded

                     LPAP Criterion

 Consistent with the most current HIV/AIDS
  Treatment Guidelines.

 Compliance with legislative and program
   Ryan White is the payer of last resort.
          LPAP Criterion (continued)

 Coordinated with the State’s Part B AIDS Drug
  Assistance Program
    Achieve administrative and cost efficiencies
    Avoid duplication of services
    Ensure that clients are not receiving medications from
     LPAP that are available from other sources.
    Implemented in accordance with 340B Drug Pricing
     Program, Prime Vendor Program, and/or Alternative
     Methods Project.
                 LPAP Criterion (continued)

 Coordinated with the State’s Part B AIDS Drug Assistance
  Program (continued)
    Structured to assure effective grantee administrative, fiscal,
     programmatic oversight.
    Consistent procedures/systems to account for tracking/ reporting of
     expenditures, income, drug pricing, utilization, client eligibility,
     clinical quality management, medication therapy management.
    Consistent administration throughout EMA/TGA.
    Uniform benefits should be available to all eligible individuals.
                LPAP Design

The purpose of a LPAP in accordance with the
Ryan White HIV/AIDS Program is to provide
therapeutics to treat HIV/AIDS and prevent the
deterioration of health arising from HIV infection.
This includes measures for the prevention and
treatment of opportunistic infections.
                The Purpose of LPAPs
 As a Bridge service to the Part B ADAP, Medicaid, Medicare Part
  D, and other local or State prescription drug programs for clients
  who are undergoing eligibility determination for one or more of
  these programs.
 As a Wrap-around service to those who are underinsured and/or
  the Part B ADAP in one or more of the following ways:
    Provide access to HIV medications not included on the
      covered formulary,
    Expand coverage to individuals whose incomes exceed the
      ADAP financial eligibility criteria,
    Provide time-limited emergency coverage of HIV prescriptions
      for low-income clients who cannot otherwise pay for their HIV
                     LPAPs “Musts”

 Establish a local advisory committee/board as defined in
  the LPAP Guidelines.
 Ensure that clients applying for LPAP undergo both
  ADAP and LPAP eligibility screening.
 Recertify the eligibility of clients every 6 months if the
  LPAP serves as an on-going wrap-around to the State
  run ADAP.
 Participate in the HRSA Office of Pharmacy Affairs 340B
  program. (
             Affordable Care Act
         Provisions that Impact ADAP

 Pre-Existing Conditions Insurance Plans (PCIPs)
 ADAP now counts toward Medicare Part D True
  Out of Pocket (TrOOP) Costs
   For ADAP-eligible patients who also are Medicare
    eligible, ADAP may cover their Part D co-pays and
    premium, and/or provide their HIV/AIDS medications
    when they are in the Part D “donut hole.”
             LPAPs “Musts” (continued)

 Require sub-grantees who do not dispense medications
  to set up pharmacy contracts with pharmacies. This will
  enable sub-grantees to purchase medications at 340B
  prices for LPAP clients thru contract pharmacy services.
 Ensure that a LPAP is not used to pay for non-
  prescription medications.
 Establish and implement processes and procedures for
  back billing Medicaid and other third-party payers for
             What is Medicare Part D?

Since January 1, 2006, Medicare prescription drug coverage
 has been available to everyone with Medicare. Known as
 Part D, this benefit provides outpatient prescription drug

Private companies provide the drug coverage. Beneficiaries
 choose the drug plan and pay a monthly premium. Like other
 insurance, if a beneficiary decides not to enroll in a drug plan
 when they are first eligible, they may pay a penalty if they
 choose to join later.
       Coverage Gap: The Donut Hole

All plans have a coverage gap, also known as the
“donut hole.” Once a beneficiary reaches the gap,
he/she must pay for 100% of the drug costs until
reaching catastrophic coverage. After reaching
catastrophic coverage, the beneficiary would be
responsible for approximately 5% of the drug cost.
       What is the DONUT HOLE?

                            Coverage gap

         Initial Coverage             Catastrophic Coverage
                      What is TrOOP?
   TrOOP (True Out-of-Pocket) Costs
      Drugs provided by AIDS Drug Assistance Programs (ADAP) or
       the Indian Health Service count as TrOOP
      Effective January 1, 2011
   TrOOP (true out-of-pocket costs – “incurred costs”) is the amount a
    beneficiary must spend on covered Part D drugs to reach
    catastrophic coverage. Based on the 2008 standard benefit design:
        $275.00 (deductible)
      + $558.75 (beneficiary coinsurance during initial coverage)
      + $3,216.25 (beneficiary coinsurance during coverage gap)
      = $4,050 (total TrOOP spending before catastrophic coverage)
   Part D premium is not part of TrOOP
                   Medicare Part D
 Closes the coverage gap over time
    Provides a $250 rebate to those who enter the gap (or
     “doughnut hole”) in 2010
       CMS automatically sends a rebate check when a
        beneficiary’s Part D spending reaches the coverage gap
          Checks are issued each month through mid-2011
          Checks are issued within 75 days of the quarter in
           which the beneficiary enters (or hits) the gap
       Two groups do NOT receive the $250 rebate
          LIS enrollees
          Enrollees in a qualified retiree drug plan
        What Counts Toward TrOOP?

 Payments count toward TrOOP if:
    They are made for covered Part D drugs through a coverage
     determination or appeal) at a network pharmacy

    They are made by:

       The beneficiary
       Another “person” (including charities) on behalf of a
       CMS as part of the low-income subsidies
       A State Pharmaceutical Assistance Program (SPAP)
      What Doesn’t Count Toward TrOOP?

 Payments DO NOT count toward TrOOP if they
  are made by:
      A group health plan
      Insurance
      A government–funded health program
      Another third-party payment arrangement
   Data Sharing Agreements (DSA)

 A Data Sharing Agreement (DSA) permits CMS to
 share Medicare entitlement information with another
 entity – the DSA Partner. Partners are:

 Pharmaceutical Manufacturer Patient Assistance
  Programs – PAPS.

 State Pharmaceutical Assistance Programs (SPAPs
  or ADAPs), and Pharmaceutical Benefit
  Management companies (PBMs).

 Employers, or insurers acting for employers.
                Why Have A DSA?
A DSA permits the exchange of health care coverage data
between the Medicare program and another health benefit

The DSA partner can learn who among those it covers are
also Medicare beneficiaries.
Medicare can learn if a group of beneficiaries has other
benefit coverage.
Both Medicare and the DSA partner can then adjust their
coverage activities, making sure all benefits provided are
correct and appropriate.
Claims Adjudication Process With TrOOP COB
  1. Beneficiary presents prescription and health plan card(s) to pharmacist.
  2. Pharmacist queries Medicare plan’s (primary payer) computer to
     communicate prescription and verify eligibility, coverage and cost-
     sharing terms.
  3. Medicare Plan performs drug utilization review (e.g. safety checks) and
     verifies eligibility, coverage, and applicable co-pay.
  4. Plan alerts pharmacy to presence of secondary payer.
  5. Pharmacist queries secondary payer’s computer (e.g. employer or
  6. Secondary payer identifies share of remaining beneficiary cost it will
     pay. Record of contribution goes to Medicare plan for TrOOP
     calculation and to CMS for audit purposes.
  7. Pharmacist dispenses drug and collects any co-pay that remains after
     all payers have paid.
Ryan White HIV/AIDS Program Challenges

 Increased demand for services in an environment of few
  new/declining resources,
    Rising costs and
    Growing HIV/AIDS prevalence
    Increasing financial pressure on medical systems
    Focus on early initiation of treatment
 Chronicity of HIV disease/aging
    More co-morbidities, increased need for primary care
 Identifying HIV infection earlier
    Expanding HIV testing
    Improving linkage to and retention in care
 Supporting the HIV workforce
    Need for both primary care and specialty services
Ryan White HIV/AIDS Program Accomplishments

  Provide care, treatment and support services to
   approximately half of the PLWH in the US.
     Of the estimated 1.0 – 1.2 million PLWH/A in USA, Ryan
      White programs served over 529,000 uninsured and
  Built networks and systems of care with and
   between public and private providers for a
   comprehensive response to the epidemic.
  Extended our knowledge base and expertise to
   improve the quality of HIV/AIDS care and treatment
   across the health care system.