Access to Care and Treatment in the U.S. Achieving the Goals of the U.S. National HIV/AIDS Strategy: A Community Perspective July 26, International AIDS Conference – Satellite Session

Outline  Treatment in the United States –Medicaid and Ryan White –ADAP  Opportunities and the Future –Affordable Care Act –Ryan White –HarborPath

Goals of the National Strategy Reduce New HIV Infections Increase Access to Care and Improve Health Outcomes –Increase proportion of newly diagnosed patients linked to clinical care within three months of their HIV diagnosis from 65% to 85% –Increase proportion of Ryan White HIV/AIDS Program clients who are in continuous care from 73% to 80% Reduce HIV-Related Health Disparities

HIV Treatment in the U.S.

In the United States:  Nearly 20% of people living with HIV do not they are infected  Nearly one-third of people living with HIV continue to be diagnosed late –One-third of those progress to AIDS within 12 months of diagnosis  Approximately half of people living with HIV are in regular care  Nearly two-thirds of those in regular care have suppressed viral loads (28% of people living with HIV)

Also, in the United States:  HIV disproportionately affects poor people.  Medicaid eligibility currently limited to individuals who are both very poor ($698/month) AND disabled, single parents or over 65, in most states.  Most people with HIV do not qualify for Medicaid until they are sick and disabled.  Even once eligible for Medicaid, significant state variation in what’s covered and in provider participation.  Medicare for disabled individuals.  Therefore, many PLWH rely on Ryan White Program for care and treatment (70% of Ryan White clients under 100% Federal Poverty Level – or about $11,000).

AIDS Drug Assistance Programs (ADAP)  As of July 19, 2012 – 1,805 individuals in nine states on waiting lists. –Most wait-listed clients receive medications from Welvista or manufacturer patient assistance programs (PAPs).  HRSA recently announced $69 million to 25 states (FY12 funding; including the President’s World AIDS Day commitment). –States received all funding they requested. –Expected to address “current” waiting lists. –Continued enrollment and fiscal challenges (FY13).

Opportunities to Increase Treatment Access for PLWHA

Opportunities to Improve  Science!  The Affordable Care Act (ACA)  Increased and improved (more reliable) coverage  New and diverse payers of HIV care  Build on Ryan White system of care and successes (medical home model)  Ryan White in a post-ACA environment  HarborPath and Streamlined Access to Patient Assistance Programs (PAPs)

What’s Ahead  2012 Election –Results will affect ACA implementation and Ryan White reauthorization/extension  ACA Implementation –Uncertainty of full ACA implementation –States may not comply with Medicaid expansion –Access and health care will vary by state –Insufficient medical workforce capacity  Ryan White Program –Program up for reauthorization in September 2013

The Affordable Care Act

Affordable Care Act Implementation What to look for moving forward:  HHS/CMS will likely release information/guidance about how they are interpreting the ACA ruling –Clarify the implications on other pieces of reform –Answer questions from states, including whether there will be flexibility around incremental expansion  Regulations on essential health benefits requirements for newly-eligible beneficiaries still forthcoming  If/when will states have to notify HHS/CMS about whether they will expand

Next Steps (continued) The ACA is the Law of the Land, and Implementation Will Continue

The Ryan White Program

Ryan White Extension of 2009  “Ryan White HIV/AIDS Treatment Extension Act of 2009” –Authorized the program for four years (FY10-FY13) –Removed “sunset” provision allowing program to remain funded at end of authorization period

Ryan White Post-FY13 Options  Full reauthorization –Would open up legislation completely for changes from community and Congress –Big risk potential as some Members of Congress think there’s no need for Ryan White post-health reform  Do nothing –Since current law does not contain sunset provision it is possible to do nothing –Congress can still appropriate funding –Potentially risky in this fiscal environment

Ryan White Post-FY13 Options (continued)  Extension with a few minor agreed upon modifications –Would allow Congress to weigh-in, but hopefully with community input on changes –Would entail much work with community to ensure modifications were well crafted and virtually non- contoversial

Implementation of ACA: Short Term Issues for Ryan White  Far reaching changes of the ACA will not be fully realized and understood for years after full implementation begins in  Changes must be fully analyzed before making significant modifications to the Ryan White Program.  Need to ensure that all critical RW services continue while clients transition to new sources of coverage.  Changes made prematurely could be very harmful to current systems of care for people living with HIV/AIDS.

Implementation of ACA: Long Term Issues for Ryan White  RW will still be needed to address gaps in covered services and populations along with enabling and support services –There is unmet need for current RW services – ACA will help but won’t address all. –Medicaid reforms and private insurance reforms are being left to the states. Scope of coverage will vary. –States that “opt-out” of Medicaid expansion may continue to have very limited programs. People under 100% FPL hurt – no subsidy to buy insurance. –Undocumented individuals will not be eligible for either Medicaid coverage or private insurance through exchanges.

Patient Assistance Programs (PAPs) And HarborPath

The Role of HIV PAPs  PAPs operated by pharmaceutical manufacturers play a small, but very important role in the U.S. health system for delivering medications to people living with HIV/AIDS (PLWHA).  PAPs operate in the context of a patchwork health care system: –A drug coverage safety net for the public safety net programs. –In an environment where ADAPs and other programs restrict access to medications, PAPs are critical.

The Role of HIV PAPs  All 8 companies that manufacture HIV antiretroviral medications in the U.S. operate PAPs. –One additional PAP for a two company/combination drug.  Varying eligibility levels (most 500% FPL), application processes and medication distribution methods.  Each company has worked to simplify their PAP enrollment, eligibility and distribution processes: many successes are noted.

Challenges Accessing PAPs  PLWHA, providers and case managers often report these programs can be difficult for individuals to access: –Multi-drug regimens (from multiple companies) require multiple applications with varying requirements. –Lack of knowledge of PAPs. –Confusing and/or challenging application and income verification requirements that vary by company. –Delays in eligibility processing (vary by company and on a case-by-case basis).

Challenges Accessing PAPs (continued)  PLWHA, providers and case managers often report these programs can be difficult for individuals to access for a number of reasons: –Communication about status of application. –Inconsistent eligibility requirements (eligible for some but not all PAPs). –Differing time frames and locations for receiving medications. –Differing re-certification time frames.

HarborPath: Overview and Purpose To implement a “single portal” for uninsured or under-insured people living with HIV in the United States to simplify access to medications from PAPs. A collaborative undertaking between NASTAD, Clinton Health Access Initiative (CHAI), donors and pharmaceutical companies, government agencies, and advocacy groups. Advisors include NASTAD, CHAI, Congresswoman Barbara Lee, Jeff Crowley and AKA Health.

Actions to Optimize the Safety Net Provided by PAPs Develop a common application form (HHS) All PAP enrollment forms serve the same purpose; BUT there are differences in: type and amount of data requested for the same purpose requirements for supporting paperwork the number and types of signatures required 1 Streamline eligibility determination Simplify and standardize income determination/verification 2 Improve prescription fulfillment Single pharmacy with delivery options, refills and medication assistance that meets patient and care manager needs 3

A Common PAP Form PLUS a Cooperative Entity Current State Single portal model for access to donated drugs Multiple pharma manufacturers Multiple PAP vendors –Multiple phone numbers and websites –Multiple applications –Multiple sets of criteria Approval of some meds, not others Fulfillment of some meds at one time; other meds at another time Fulfillment of various meds to different locations Patient, prescriber and case manager must contact multiple PAPs for status Need to contact each supplier for refills Multiple pharma manufacturers PAP access through web-based portal – One phone number and website – One application – One set of criteria Approval of all meds at one time Fulfillment of all meds at one time; safety checks on multi-drug regimens Fulfillment of all meds to one location Patient, prescriber and case manager are notified of status in one database One contact for all refills

The HarborPath Single Portal  Provides case managers with a single portal and one time data entry for completion of all PAP forms

The HarborPath Single Portal (continued)

 Case managers most important needs are to simplify eligibility documentation and to track status.

HarborPath Pilot Program

The Way Forward

The Way Forward – Turning the Tide People living with HIV in the U.S. need:  Full funding and support for effective implementation of the Affordable Care Act.  A sustained federal commitment to Medicaid and Medicare Programs.  A continuing, robust Ryan White Program to fully address the HIV public health crisis.  Partnerships among all organizations and agencies working to serve their needs.

Murray Penner Deputy Executive Director