- From the ‘Journal of Health Affairs’ research (2009), extrapolated facts and statistics related to the Medicare Part-D Program, and Patient Assistance Program are presented below:
- One-third of Americans of all ages, and two-thirds of elderly report difficulty paying for medications. Nearly, more than one-fourth patients do not fill prescriptions, or reduce the prescription doses, because of high out-of-pocket expenditure.
- Employer-based or Governmental programs such as Medicaid, do not provide drug coverage for a sizable number of adult Americans. Even individuals on the ‘Medicare Part D’ program deal with tiered co-payments, or coverage gaps, and out-of-pocket expenses for prescription medicines; which in turn reduces the use of prescribed medications.
- The cost of healthcare that is potentially preventable by compliance to medications, is in jeopardy, because of limited compliance or non-compliance to prescription medicines. Hence, there is a need for Patient Assistance Programs (PAP) to fill the gap.
- Patient Assistance Programs (PAP) are (i) largely sponsored by the pharmaceutical companies, (ii) some are sponsored by the non-profit organizations, and (iii) some are state-run programs.
- PAP offered by pharmaceutical manufacturers provides eligible patients with access to brand-name medications at little or no cost. Also, known as ‘safety-net for Americans’ who are either uninsured or under-insured.
- Upon enrollment in a pharmaceutical-based Patient Assistance Program, there are certain limits to how many medications an individual can receive, and the duration of the program is specified.
- The eligible population for PAP includes individuals who are (a) uninsured, or (b) under-insured, or (c) individuals under certain poverty cap and cannot afford the cost of medications. Though, in order to enroll, the following requirements need to be met (i) permanent or a legal citizen of the USA, (ii) prove that individual is uninsured, or under-insured, (iii) meet certain annual income requirements., (iv) requires a health care provider to fill out a form.
(I) PHARMACEUTICAL SPONSORED PROGRAMS
Partnership for Prescription Assistance (PPA)
- In 2005, the ‘Pharmaceutical Research and Manufacturers of America (PhRMA)‘ formed a ‘Partnership for Prescription Assistance (PPA) Program,’ which formed a consortium of public and private programs, to connect uninsured and underinsured individuals to prescription assistance programs – which offer medicines for free, or with minimal co-pay.
- The PhRMA created the Medicine Assistance Tool (MAT) – a search engine that assesses an individual’s eligibility and presents individuals with a list of financial assistance resources through the various biopharmaceutical industry programs available for patients.
- MAT is a free, and confidential service that provides information about more than 475 public and private assistance programs, which is inclusive of nearly 200 programs offered by biopharmaceutical companies.
- MAT is designed to address the following needs to the safety net Americans:
- PhRMA also advocates for the ‘340B Program,’ which was chartered by Congress in 1992, that helps the uninsured/underinsured population with access to prescription medicines at safety-net facilities. The pharmaceutical manufacturers provide mandatory discounts on a certain lot of medicines to clinics and hospitals, as per the condition that the drug is covered by Medicaid. The beneficiaries of this program are uninsured/underinsured patients seeking care at clinics/hospitals and receiving prescription medicines at no cost, or markedly reduced cost.
- Since 2005, the PPA has connected more than 10 million people to Patient Assistance Programs (PAPs) – which serve as a critical safety net for uninsured/underinsured Americans.
- The PPA has a potential market of 46.6 million uninsured Americans in 2005, which reduced to 28.9 million in 2018.
- The PPA receives an average of 75,000 visitors on a monthly basis
- The PPA’s database also helps navigate Americans to 10,000 free or low-cost health care clinics across the country.
- A list of “Pharmaceutical-sponsored Patient Assistant Programs” include: Gilead Advancing Access Program , GSK Patient Assistance Program , Lilly Cares Foundation Patient Assistance Program , Novartis Patient Assistance Foundation , Novo Patient Assistance Program, and Pfizer Patient Assistance Program.
- A customized excel spreadsheet has been made to illustrate a few examples of pharmaceutical-sponsored Patient Assistant Programs, the link to the spreadsheet is available here.
(II) NON-PROFIT SPONSORED PROGRAMS
- The Partnership for Prescription Assistance Program brings together non-profit organizations, such as the Kaiser Family Foundation and various other organizations have pitched in to fill the gap, by providing safety net Americans to access to prescription medicines. The PPA program is co-run by doctors, patient advocacy organizations, and civic groups.
- According to the data from the Kaiser Family Foundation, since 2006, deductibles have shown an increase of 300%, with an increase of 89% in co-pay insurance.
- Another non-profit organization, the Healthwell Foundation, “provides financial assistance to adults and children to cover the cost of prescription drug coinsurance, co-payments, deductibles, health insurance premiums, and other selected out-of-pocket health care costs.”
- The Pan Foundation also assist underinsured patients with out-of-pocket expenses for the treatment and medications of life-threatening, chronic, and rare diseases.
- The PhRMA’s mission states, “As the program has done for 13 years, it will continue to commit to the promise made to the American people when it first began: when the system fails you, PPA is here to help you get the medicines you need.”
- Other non-profit platforms such as NeedyMeds, RxAssist, RxHope, and RxOutreach have also provided assistance to underinsured or uninsured Americans.
- RxOutreach: a mail-order pharmacy for uninsured or underinsured individuals.
- NeedyMeds: a credible group that provides information about Patient Assistant Programs, drug discount programs, state assistance, and free or low-cost medical care.
- RxAssist: provides access to a large database of drug company programs that provide free drugs, or co-pay assistance.
- Center for Benefits: the program provides information about assistance programs specifically for low-income senior citizens, and young people with disabilities.
- RxHope: a search engine that provides information about medication-specific assistance programs. The platform also helps with the application process.
(III) STATE SPONSORED PROGRAMS
- The State-sponsored Patient Assistant Subsidy Programs are also known as SPAPs. This program utilizes state funds to pay for a portion of the cost that meets enrollment criteria.
- A number of states utilize discounts or bulk purchasing approaches that do not entail the expenditure of state funds, which is known as ‘Discount Programs.’ A list of discount programs can be found here.
- Nearly 20 states administer an option subsidy program that either wraps around or adds to the federal benefit.
Process for seeking Patient Assistant Programs (PAP’s)
- The majority (88%) of Patient Assistant Programs provide medications (with/without co-pay) directly to uninsured or underinsured patients. Around 2% of Patient Assistant Programs provide both medications and patient assistance with co-payments. Nearly 8% offer pharmacy discount cards. One-percent offer rebates. One-percent offer only co-payment assistance.
- 29% of the Patient Assistant Programs serve beneficiaries of Medicare Part D. While, 17% only require Medicare Part D beneficiaries who have reached their coverage gap known as the “doughnut hole,” where drug expenses are not covered after the beneficiary spends a specified amount.
- The majority (71%) of the Patient Assistant Programs require proof-of-income documents (i.e., tax returns).
- Most (92%) of the programs require a prescription as part of the application process.
- Nearly 12% also require additional details such as the International Classification of Diseases (ICD) code, or physician license number for insurance verification, or confirmation from a physician that the medications are being used for approved indications (5%).
Federal Poverty Levels (FPL) – Guidelines and LIS qualifications
- The FPL guidelines determine the annual income requirements for individuals applying for the Medicare Part-D’s (i) Low-Income Subsidy (LIS) or (ii) Extra Help program.
- The FPL determines the eligibility for the Medicare Savings Programs (for example, the QMB or SLMB or QI programs).
- The Medicare Part D extra help or LIS program helps Medicare beneficiaries pay less for their medicare prescription drug plan premiums, co-payments, and deductibles.
- Individuals under 135% of FPL, are eligible for Low-Income Subsidy (LIS).
- Individuals at or below 150% of FPL, are eligible for partial LIS benefits.
- Federal Poverty Level Guidelines – LIS Qualifications:
- The Low-Income Subsidy (LIS) is based on 135% of the Federal Poverty Level (FPL). The LIS is offered to individuals in a household with the following annual income and the corresponding number of family members.
- As per our research, the Federal Poverty levels (FPL) are not defined by underlying medical conditions, instead, it is based on annual household income and the number of family members in the house (as shown above). Please refer to the Federal Poverty Level Guidelines on Sheet 7 compiled in the excel spreadsheet.
- The following Federal Poverty Levels (FPL) are used to determine the eligibility and the co-payment for reduced-cost health coverage.
- Income between 100% and 400% FPL: All states qualify individuals for premium tax credits (for any marketplace health insurance plan).
- Income less than 138% FPL: If the state has expanded Medicaid coverage, the individual is eligible for Medicaid.
- Income less than 100% FPL: Not eligible for Marketplace health insurance plan, or for income-based Medicaid.
- Link to the excel spreadsheet: https://docs.google.com/spreadsheets/d/1p6YZ1z75CtnHvYG70QmcQTNmXg4GgYdaHkER0PWK1og/edit?usp=sharing
‘Medicare Part D’ Prescription Drug Plan for 2020
- Initial Deductible: will be increased by $20 to $435 (in 2020).
- Initial Coverage Limit (ICL): will increase from $3,820 in 2019 to $4,020 in 2020.
- Out-of-Pocket Threshold (or TrOOP): will increase from $5,100 in 2019 to $6,350 in 2020.
- Coverage Gap (Donut Hole): begins once an individual reaches their Medicare Part D plan’s initial coverage limit (i.e., $4,020 in 2020), and ends upon a total out-of-pocket expenditure of $6,350 (in 2020).
- The Donut Hole Discount: Medicare Part D enrollees are eligible to receive a 75% discount on the total cost of brand-name drugs. Of the 75% discount offered, 70% is covered by brand-name drug manufacturer (based on Patient Assistance Programs), while 5% is covered by Medicare Part D plan. While the Medicare Part D beneficiaries still have to co-pay 25% of the generic drug cost.
- An excel spreadsheet tables illustrating statistics for benefits, required co-payments, low-income subsidies (LIS), and plans covering LIS for individuals enrolled in ‘Medicare Plan D.’ Access the google link to the spreadsheet here.
Disease-Specific Federal Poverty Levels
According to research published in the American Journal of Public Health (2014), disease-specific (Diabetes) disparities in demographic factors such as race and poverty levels were examined. The research utilized the 1999–2004 NHANES, and the 2000 US Census datasets. The mean odds (95% confidence intervals or 95% CI) and p-values (for significance) of diabetes prevalence, which was stratified based on Federal Poverty Levels, are shown below:
- Household poverty levels greater than equal to 400% FPL (Reference): mean odds of diabetes=0.053; 95% CI = 0.036, 0.071.
- Household poverty levels betwen 300%–399% FPL: mean odds of diabetes= 0.087; 95% CI = 0.059, 0.116; p-value=0.014
- Household poverty levels betwen 3200%–299% FPL: mean odds of diabetes= 0.107; 95% CI = 0.077, 0.137; p-value=0.017
- Household poverty levels betwen 3100%–199% FPL: mean odds of diabetes= 0.127; 95% CI = 0.097, 0.157; p-value=<0.001
- Household poverty levels betwen below FPL: mean odds of diabetes= 0.121; 95% CI = 0.0.87, 0.156; p-value=0.004
The findings reveal a direct, and dose-response relationship between an increase in FPL levels and the higher odds of diabetes prevalence.
Disease-Specific Drug Assistance Programs
- Specific states offer disease-specific assistance programs based on FPL’s, known as ‘State Pharmaceutical Assistance Programs,’ such as the state of Pennsylvania. Examples of programs are illustrated below:
- Chronic Renal Disease Program (CRDP): End-Stage Renal Disease patients currently on dialysis, or received a renal transplant, and falling within the bounds of Federal Poverty levels between 0% to 300% are eligible for this program.
- SPBP HIV/AIDS: A patient with a diagnosis of HIV/AIDS, having a gross annual income less than or equal to 337% of FPL are eligible.
- SPBP Mental Health: Patients having a medical need with a DSM diagnosis of schizophrenia, and having the ICD-9-CM diagnosis code number, with a gross annual income of less than $35,000 are eligible for this program.
- Similarly, the state of Texas offers disease-specific programs such as the ‘Kidney Health Care Program (KHC),’ and the ‘HIV SPAP.’
- The state of Illinois provides drug coverage for patients falling between the bounds of FPL 200% to 225%, and suffering from 11 medical conditions including Diabetes, Cardiovascular disease, Lung and smoking-related diseases, Cancer, Alzheimer’s, Parkinson’s or multiple sclerosis, Arthritis, Osteoporosis, and Glaucoma.
- Further state-based programs that offer disease-specific drug assistance can be found in the tables on the following website.
Our extensive research indicated that there is ample information available on the subject of Patient Assistance Programs (PAP) which are offered by pharmaceutical companies, non-profit organizations, and some are also backed by federal and state governments. In our attempt, we covered a holistic view of the process of seeking Patient Assistance Programs, related statistics, and the eligibility criteria based on Federal Poverty Levels (FPL) guidelines. We identified some State-led Pharmaceutical Assistance Programs (SPAPs), that were specific for disease conditions, and tailored according to FPL poverty categories. Though, we could not identify the FPL range of values for Pharmaceutical-sponsored Patient Assistance Programs tailored for specific therapeutic areas (or different disease conditions). Our research instead indicated that FPL values are determined by annual household income and the number of household members. Instead, the FPL values are commonly used to define the eligibility criteria for a specific population, with certain medical conditions. In addition, we presented scientific research conducted through NHANES and Medicare databases, which outlined an overview of disease-specific demographic factors that are representative of Federal Poverty Guidelines; none of which indicated that poverty guidelines are based on disease conditions.We also customized excel spreadsheets to illustrate some important facts and relevant information.1. https://docs.google.com/spreadsheets/d/1p6YZ1z75CtnHvYG70QmcQTNmXg4GgYdaHkER0PWK1og/edit?usp=sharing 2. https://docs.google.com/spreadsheets/d/1smS032QoidxR4bzJ-0vnMWAkqzwECzjb3fdqgUW30T8/edit?usp=sharing