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Highlights from ExLPharma’s 2nd Annual Patient Assistance Programs,[object Object],January 25-26, 2010,[object Object],Washington, D.C.,[object Object]
Health Care Reform and Compliance Considerations:  Assessing the Current Regulatory Landscape and Impact of Proposed Legislative Changes on Industry PAPs and Co-Pay Assistance Foundations,[object Object],September 27, 2010,[object Object]
Manufacturer Patient Support Programs:  Common Features,[object Object]
Health Care Reform,[object Object],?,[object Object]
Health Care Reform: Common Themes,[object Object],“Expand PHS 340B Pricing”,[object Object],“Fill the Donut Hole”,[object Object],“Universal Coverage”,[object Object],“Public Option”,[object Object]
340B Expansion Implications,[object Object],Proposed bills would expand categories of safety net providers eligible for 340B pricing, and would likely lower PHS prices due to Medicaid rebate formula changes,[object Object],Manufacturers might review IPAPs for covered entities and overall PAP budgets,[object Object]
Donut Hole Closure Implications,[object Object],Proposed bills would establish minimum Part D rebates to “narrow” the donut hole,[object Object],Assistance could be deferred under expenditure-based eligibility criteria of “outside-the-benefit” programs,[object Object],Manufacturers may review overall PAP budgets,[object Object],Potential shift to independent foundations?,[object Object]
Expanded Coverage Implications,[object Object],Proposed bills would expand insurance coverage,[object Object],Existence of coverage as disqualifier for existing PAPs?,[object Object],Subsidies as federal health care program trigger?,[object Object]
“Public Option” Implications,[object Object],House bill contained “public option” for insurance to compete with private plans,[object Object],“Government option” plan as federal health care program?,[object Object]
Assisting with a Growing Uninsured Population,[object Object]
Top Changes to Manufacturer-Sponsored Patient Assistance Programs,[object Object],Multi-pronged approach to address the needs of the underinsured ,[object Object],Addition of New Criteria for Assistance,[object Object],Increased need for support services to help patients navigate new coverage options and address barriers to access,[object Object]
Manufacturer sponsored “copay” assistance programs,[object Object],Modify existing patient assistance programs,[object Object],Donations to “copay” assistance charities,[object Object],Multi-pronged approach to address the needs of the underinsured ,[object Object]
Limited to non-federally funded, some state exclusions apply,[object Object],Product(s) specific offering,[object Object],Provides financial assistance to patients with copay or deductible obligations,[object Object],Allows for multiple options for assistance,[object Object],Implement manufacturer sponsored “copay” assistance programs,[object Object],Manufacturer Sponsored Copay Assistance Programs,[object Object],Fastest growing segment in assistance programs,[object Object]
How do manufacturers determine if their current assistance offerings are meeting existing needs,[object Object],Conduct payer, geographic and product-specific analyses,[object Object],Update program processes to better track and monitor data,[object Object],Number or percent of underinsured patients requestingassistance,[object Object],[object Object]
Financial hardship or affordability profiles (Affordability ~ income as it relates to insurance status and/or medical spend)Number or percent of underinsured patients qualifying for assistance,[object Object],[object Object]
Insurance profilesNumber of denied patients requesting exceptions, reasons for request, outcomes ,[object Object],There will be an ongoing need to monitor patient “need and utilization” as the number of underinsured patients continues to rise ,[object Object]
Evaluate donations to “copay” assistance charities,[object Object],Financial assistance with patient obligations such as copays, deductibles, or premiums (very limited),[object Object],Assistance can be made available from a variety of charities,[object Object],Charity funding is based on disease-specific funds,[object Object],Available to both federally funded and privately funded insured patients,[object Object],Manufacturers can control the amount of funding they contribute,[object Object]
Addition of New Criteria for Assistance,[object Object],Informed by routine and ongoing surveillance, benchmarking, and analysis of key market influences,[object Object],Guided by development of overall strategic PAP plan and governance approach,[object Object],PAP criteria adjusted to reflect market changes and ensure appropriate assistance continues,[object Object]
New Criteria for Assistance,[object Object],Financial Criteria,[object Object],Insurance Criteria,[object Object],Residency Criteria,[object Object],[object Object]
Other adjustment factors
FPL adjustments
Medicare Part D
Other federally-funded
Privately Insured
Uninsured
Citizenship
Documentation requirements,[object Object]
Strategies for Industry PAPs to Provide Medications to an Escalating Number of Patients in Need,[object Object]
Financing Options,[object Object],20,[object Object],Screen for existing benefits,[object Object],Gain coverage under existing benefits,[object Object],Petition for coverage via alternative benefit, if cost sharing is prohibitive,[object Object],Work with employers to gain exceptions,[object Object],Gain exceptions as needed,[object Object],Counsel patients on alternatives,[object Object]
What Access Programs Do,[object Object],Open doors for vulnerable patients,[object Object],Investigate patient benefits,[object Object],Facilitate prior authorization,[object Object],Assist with proactive re-certification ,[object Object],Appeal claims and prior authorizations,[object Object],Identify alternative funding sources for patients,[object Object],Counsel patients about benefits,[object Object],Coverage limits,[object Object],Costs,[object Object],Access solutions,[object Object],21,[object Object]
Number of Uninsured People,[object Object],22,[object Object],Source: Congressional Budget Office Letter to Majority Leader Reid. page 22.  12/19/09 http://www.cbo.gov/ftpdocs/108xx/doc10868/12-19-Reid_Letter_Managers_Correction_Noted.pdf,[object Object]
Patient Assistance as Part of a Company’s Access Strategy ,[object Object],Offer assistance for patients with no insurance,[object Object],Must meet eligibility requirements,[object Object],Application by phone, fax, US mail, overnight delivery  ,[object Object],Drug is either,[object Object],shipped to physician to dispense to patient,[object Object],accessed at pharmacy with a pharmacy card,[object Object],mailed to patient,[object Object],23,[object Object]
The Underinsured: A Growing Segment,[object Object],24,[object Object],Uninsured,[object Object],during year,[object Object],45.5,[object Object],(26%),[object Object],Insured, not,[object Object],underinsured,[object Object],102.3,[object Object],(58%),[object Object],Uninsured,[object Object],during year,[object Object],49.5,[object Object],(28%),[object Object],Insured, not,[object Object],underinsured,[object Object],110.9,[object Object],(65%),[object Object],Underinsured,[object Object],15.6,[object Object],(9%),[object Object],Underinsured,[object Object],25.2,[object Object],(14%),[object Object],2007,[object Object],Adults 19–64,[object Object],(177.0 million),[object Object],2003,[object Object],Adults 19–64,[object Object],(172.0 million),[object Object],Source: C. Schoen, S. Collins, J. Kriss, M. Doty, How Many are Underinsured? Trends Among U.S. Adults, 2003 and 2007, Health Affairs Web Exclusive, June 10, 2008. Data: 2003 and 2007 Commonwealth Fund Biennial Health Insurance Surveys.,[object Object]

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