Issue Date: July 23, 2018 Pharmaceutical manufacturers may sponsor patient assistance programs (PAPs) that provide financial assistance or drug free product (through in-kind product donations) to low income individuals to augment any existing prescription drug coverage.
Full Answer
What are coupons and patient assistance programs (Paps)?
In recent years, coupons and patient assistance programs (PAPs) have become more popular to help make prescription drugs more affordable.
What is guidance for pharmaceutical manufacturers sponsoring patient assistance programs?
Guidance for pharmaceutical manufacturers sponsoring patient assistance programs (PAPs) providing important information on CMS policy with respect to PAPs, and also providing some helpful links to other information contained on the Office of the Inspector General's Web site.
What is an example of a drug assistance program?
For example, the manufacturer GlaxoSmithKline offers an assistance program for its medications Benlysta and Nucala. In their qualification section, they list what your maximum monthly gross income must be under, which is dependent on your household size and where you live. What are some examples of these programs?
How do I sign up for a medication assistance program?
To sign up, you will either call the program or register online. You will need to submit forms like your tax documents and proof of residence to prove your eligibility. Most programs also require your healthcare provider to fill out a form. Once you are enrolled, there may be limits on how much medication you can get or how long the program lasts.
Is patient assistance program legitimate?
Patient assistance programs (PAPs) are usually sponsored by pharmaceutical manufacturers and are promoted as a safety net for Americans who have no health insurance or are underinsured.
What is PAP in pharmacy?
Pharmaceutical manufacturers may sponsor patient assistance programs (PAPs) that provide financial assistance or drug free product (through in-kind product donations) to low income individuals to augment any existing prescription drug coverage.
How does the pan foundation work?
What does PAN cover? Our 12-month grants offer financial assistance for out-of-pocket medication costs, including co-pays, health insurance premiums, and transportation costs associated with medical care. Co-pay funds: assistance with deductibles, co-pays, and coinsurance for medications.
What is Takeda patient Assistance Program?
(the Program) provides assistance for people who have no insurance or who do not have enough insurance and need help getting their Takeda medicines. All applications are reviewed on a case-by-case basis in accordance with program criteria. To be eligible, you should: Be a resident in the United States.
What is Pfizer Assistance Program?
Pfizer Patient Assistance Program Provides free Pfizer medicines to eligible patients through their doctor's office or at home. To qualify, patients must: Have a valid prescription for the Pfizer medicine for which they are seeking assistance.
How do patient support programs work?
A patient assistance or support programs (PAPs or PSPs) exist to get you timely access to medication and to help you stay on track of your therapy. Being diagnosed with a complex disease or condition may come with unexpected financial burden and a need to better understand treatment options and next steps.
Is the PAN Foundation legit?
The PAN Foundation is an independent, national 501 (c)(3) organization dedicated to helping federally and commercially insured people living with life-threatening, chronic and rare diseases with the out-of-pocket costs for their prescribed medications.
How do you qualify for free eliquis?
You may be eligible for the Free 30-Day Trial Offer for ELIQUIS® (apixaban) if:You have not previously filled a prescription for ELIQUIS;You have a valid 30-day prescription for ELIQUIS;You are being treated with ELIQUIS for an FDA-approved indication that an HCP has planned for more than 35 days of treatment;More items...
What does HealthWell foundation cover?
Which services does HealthWell provide? HealthWell provides financial assistance to eligible individuals to cover coinsurance, copayments, health care premiums and deductibles for certain medications and therapies.
How can I get Vyvanse free?
As mentioned earlier, Takeda offers a free Vyvanse program for those who are experiencing financial hardship due to loss of income. The Help At Hand program provides up to six months of free Vyvanse. Eligible patients will need to submit proof of hardship with their application.
What is the dexilant Advantage program?
Dexilant's manufacturer, Takeda, offers a manufacturer coupon to help insured and uninsured patients save. Save up to $55 per month. For insured patients, the card covers out-of-pocket expenses greater than $20, up to a maximum of $55 for a 30-day prescription.
How can I get help paying for Trintellix?
How to Get Trintellix Prescription Assistance. To get the help you need affording your Trintellix, simply enroll with Simplefill by applying online or calling us at 1(877)386-0206.
What is a patient access position?
Patient access representatives serve an essential role at health-care facilities as the first point of contact when a patient calls or walks into the office. They are usually responsible for answering the phone, scheduling appointments, billing, and submitting insurance claims.
What does patient access mean?
At its most basic, “patient access” is defined quite literally. It refers to the availability of healthcare, the ability of consumers to access care and treatment. Patient access is an integral part of the Affordable Care Act (ACA).
Introduction
Patient assistance programs (PAPs) have been around for years, and the government has expressed concern about them for a while, but there has been a recent uptick in enforcement.
OIG Provides AKS Guidance
The Department of Health and Human Services’ Office of Inspector General (OIG) issued a Special Advisory Bulletin in November 2005 on PAPs for Medicare Part D enrollees (Advisory Bulletin).
Department of Justice Activity
The DOJ has been investigating pharmaceutical manufacturers regarding their donations to charitable organizations offering cost sharing subsidies to needy beneficiaries. In September 2017, the U. S. Attorney's Office for the District of Massachusetts (USAO-MA) settled criminal and civil False Claims Act allegations with Aegerion Pharmaceuticals.
Conclusion
PAPs can provide great benefit to patients in financial need, but can run the risk of violating the fraud and abuse laws if not properly structured and administered.
Where do patient assistance programs come from?
PAPs are most often sponsored by pharmaceutical companies. There are also state programs and nonprofit-sponsored programs.
How to sign up for a med program?
To sign up, you will either call the program or sign up online. You will need to submit forms like your taxes and residence status to prove your eligibility. Most programs also require your health provider to fill out a form. Once you apply and enroll, there may be limits on how much medication you can get or how long the program lasts.
Do you have to pay for prescription drugs out of pocket?
And those without health insurance or adequate prescription drug coverage must pay for their medications out of pocket.
Does GlaxoSmithKline offer assistance?
For example, GlaxoSmithKline offers an assistance program for its medications Benlysta and Nucala. Here, under their qualification section, they show what your maximum monthly gross income must be under, depending on your household size and where you live.
Can a patient assistance card help you?
Like manufacturer copay cards, patient assistance programs have received some criticism. But, they can and do help you if you are struggling to afford your medications. Keep reading to find out more about PAPs.
Is there a standard enrollment process for a college?
Unfortunately, there is no standard enrollment process. Each program defines and sets their own qualification standards.
Why do pharmaceutical companies not subsidize the cost of their own drugs?
Because pharmaceutical companies cannot directly subsidize the cost of their own drugs by covering the costs for Medicare beneficiaries, independent patient assistance programs were designed to fill the void. Patient assistance programs cover out-of-pocket costs for expensive treatments.
Why is patient assistance important?
As others have noted, patient assistance programs may provide a critical safeguard for patients against the financial burden that may accompany treatment with high-cost drugs. 2 However, there is concern that patient assistance programs may actually act as intermediaries to facilitate financial incentives from pharmaceutical companies to patients in exchange for patients using their own (expensive) drugs. 3 In fact, funds from the pharmaceutical industry provided to Medicare beneficiaries to assist those patients in acquiring Medicare Part D drugs are exactly what the federal Anti-Kickback Statute is designed to prohibit.
What are the findings of Kang et al 1 and the Department of Justice settlements?
The findings of Kang et al 1 and the Department of Justice settlements highlight the need to address the legality of some current patient assistance program practices. By preferentially covering co-payments for high-cost drugs (in lieu of coverage for generic equivalents), the cost-containment purpose of Medicare cost-sharing obligations is hindered. Although patient assistance programs may provide important financial relief for patients, the current patient assistance program structure largely neglects uninsured individuals.
Can pharmaceutical companies pay for a referral?
The apparent noncompliance raises the question if it is time to revisit the requirements of the Office of Inspector General for patient assistance programs to operate within the confines of Anti-Kickback Statute prohibitions, and whether any contributions from pharmaceutical companies to specific patient assistance programs should be permitted. The Anti-Kickback Statute prohibits pharmaceutical companies from paying any remuneration in exchange for a referral for an item or service that may be paid for by a federal health care program, including Medicare or Medicaid. 5 For this reason, pharmaceutical companies cannot directly cover cost-sharing obligations for patients with Medicare or Medicaid. Covering the cost would constitute “remuneration” in exchange for the Medicare beneficiaries to purchase their drugs, for which Medicare would then make a payment to the pharmaceutical company.
Is patient assistance tax deductible?
The extent to which patient assistance programs violate tax exemption standards that prohibit private benefit that does not further its charitable purpose and is intentionally aimed to benefit the pharmaceutical companies warrants further scrutiny. It is particularly egregious that the payments made from pharmaceutical companies to patient assistance programs may be illegal yet simultaneously tax deductible. In 2017, the Internal Revenue Service initiated inquiries into the compliance of one patient assistance program. 10 However, enforcement activity has focused on anti-kickback violations by the pharmaceutical companies.
Is patient assistance violating federal law?
Coupled with recent enforcement activity by the Department of Justice, the data reported by Kang et al 1 suggest that some patient assistance programs may be violating federal law and warrant continued regulatory scrutiny and enforcement. As was stated in one Department of Justice settlement, “This misconduct is widespread, and enforcement will continue until pharmaceutical companies stop circumventing the anti-kickback laws to artificially bolster high drug prices, all at the expense of American taxpayers.” 4
Is JAMA Network Open accepting submissions?
New! JAMA Network Open is now accepting submissions. Learn more.
Where do patient assistance programs come from?from goodrx.com
PAPs are most often sponsored by pharmaceutical companies. There are also state programs and nonprofit-sponsored programs.
What is drug assistance?from assistrx.com
Drug assistance programs—another term for patient assistance programs—can also be offered by state programs or independent third-party nonprofits/charitable organizations. Whether a patient qualifies for these programs will depend on their insurance and the prescribed therapy. Patients typically qualify for these programs if they do not have ...
What insurance do you need to get medical assistance?from aafa.org
Patient must be insured by Medicare, Medicaid or military benefits, and insurance must cover the medicine for which patient seeks assistance
What is a senior program?from aafa.org
Programs are for seniors and/or people with certain chronic conditions; The programs assist low-income seniors and adults with disabilities in paying for their prescription drugs
What is the purpose of the asthma coupons?from aafa.org
They compile coupons and prescription assistance information to help patients and families find free or reduced-cost asthma medicines.
How to sign up for a med program?from goodrx.com
To sign up, you will either call the program or sign up online. You will need to submit forms like your taxes and residence status to prove your eligibility. Most programs also require your health provider to fill out a form. Once you apply and enroll, there may be limits on how much medication you can get or how long the program lasts.
How to contact Social Security for extra help?from aafa.org
Extra Help (Social Security Administration) 800-772-1213. (TTY 800-325-0778) Check with organization for more details. Yes, for eligible individuals. To qualify you must receive Medicare, have limited resources and income, and live in one of the 50 states or the District of Columbia.
What information should a PAP provider share with patients?
The company should also limit the information it shares about independent PAPs with patients and providers. For example, if the company’s reimbursement hub triages requests for co-pay or other financial assistance, the hub should provide only a general overview of the third-party assistance options to the patient or provider, along with contact information for each independent PAP that has an applicable fund and is currently accepting new applications (i.e., a “cold transfer”). Hub representatives should explicitly inform the patient or the patient’s provider that the referral to the independent PAP is not a guarantee of assistance and that the PAP has full discretion whether to provide assistance based on its own independent eligibility criteria. To this end, company personnel should generally be restricted from (a) filling out applications for patients or seeking information about the status of any individual application for assistance from any PAP, or (b) seeking detailed information regarding why and from which PAP any patients received or were denied assistance. In addition, the company should limit, as much as possible, the information coming from patients who were transferred to PAPs for assistance and who were denied or received assistance; if company personnel receive such information, they should not (1) share it beyond reimbursement support personnel, or (2) record it in the patient’s case notes.
What is a meaningful review and processing of funding requests?
Meaningful Review and Processing of Funding Requests: All requests should follow the company’s customary and generally applicable grant request processes, and these requirements should be incorporated within the PAP policy/procedure described above. The PAP policy/procedure should specify standardized, objective criteria for assessing requests from independent PAPs for both initial and additional or supplemental funding (e.g., funding beyond that which is set forth in the annual budget). Supplemental requests for funding must be reviewed for compliance with applicable Federal health care program requirements, OIG guidance, and company policies and procedures.
What should compliance officers be reexamining?
In light of the recent and, likely, increasing enforcement in the area of patient support programs, including independent PAPs and free drug programs, compliance officers should be reexamining the processes and internal controls surrounding these activities . Although the historical OIG and industry compliance guidance remain instructive in mitigating risk, recent CIAs resulting from allegedly abusive independent PAP activities should also be examined to determine whether enhancements and improvements are necessary. This article contains a framework for this self-assessment, but a drug company’s specific activities will inform the level of compliance risk and the degree of customization necessary to make any mitigation efforts as effective as possible.
What are the restrictions on PAP data sharing?
Implementation of Data Sharing Restrictions: The company should take all necessary steps to ensure it does not receive (directly or indirectly through third parties) any data or information from the PAP that would enable the company to correlate the amount or frequency of its donations with support for its products or any related services. Such prohibited information may include individual patient information, or any information related to the identity, amount or nature of the products or services that are made available by the PAP from donations provided by the company, including any projections for additional funding required to continue a specific type of support. Within the company, the aggregate-level data received from independent PAPs should not be shared with commercial personnel.
What is the DOJ's interest in PAPs?
DOJ interest in drug company relationships with independent PAPs began in earnest in the midst of larger concerns regarding sharply rising drug prices. While investigating pricing schemes and specialty pharmacy relationships in 2015, DOJ began issuing subpoenas to pharmaceutical companies that manufacture expensive and specialty drugs that requested information on the companies’ relationships with independent PAPs. 9 Since then, the DOJ has broadened its inquiry to numerous pharmaceutical companies and independent PAPs.
What is compliance monitoring and auditing?
Conducting Monitoring and Auditing Activities: The compliance monitoring and auditing functions should conduct regular activities to identify and correct any issues of noncompliance with the PAP policy/procedure requirements. Such activities may include: (a) review of interactions with selected independent PAPs, by assessing the relevant documentation relating to the company’s decision to provide funding, the written agreement (s) in place between the company and the independent charity, and any correspondence, communications or other types of documentation reflecting interactions between the company and the independent PAP; and (b) performing appropriate review and follow up based on the results reported.
Why do we need cookies?
These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. They help us to know which pages are the most and least popular and see how visitors move around the site. All information these cookies collect is aggregated and therefore anonymous. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance.
What is a coupon card?
Coupons are sometimes referred to as manufacturer coupons, copay coupons or copay assistance cards. They can easily be found online and are sometimes provided to patients by a doctor. Some basic information may be collected by the manufacturer, and coupons generally are available to all for the drug for which they are offered.
Why are coupons important for actuaries?
While this may be beneficial to an individual consumer at a specific point in time, it may interfere with health plan design—therefore actuaries must be aware of and account for the impact of both coupons and PAPs on the health care system. Actuaries can help align incentives and develop strategies to ensure all patients can receive necessary care while not distorting benefit structures . The resultant improvement in care also should help mitigate growth in total cost of care, thereby addressing the core issues identified in the Society of Actuaries’ (SOA’s) 18|11 Initiative report.
Why are PAPs important?
PAPs help lower-income consumers who may otherwise struggle to afford treatment. Because PAPs typically do not interfere with insurance benefits, there is little controversy regarding these programs.
Why are PAP coupons good?
Improved patient affordability as a result of coupons or PAP programs may improve adherence to prescribed treatment regimens, helping to avoid downstream adverse health events and associated medical claim costs. On the flip side, there are also some cons associated with using PAPs and coupons:
How does couponing affect health insurance?
Coupons may lower the out-of-pocket expense for the consumer, but they could increase expenses for the health plan and therefore increase premiums for all members. For example, a member may have the choice of a $200 brand-name drug with a $30 copay or $20 generic drug with a $5 copay. If the member is using a coupon that will eliminate the $30 copay for the brand-name drug, the best choice for the member, at least in the short term, is to choose the brand-name drug and pay $0 out-of-pocket. However, if the brand-name drug is purchased instead of the generic alternative, the health plan would be liable to pay an additional $155 ( ($200 – $30) – ($20 – $5)).
Why are coupons banned?
Banning coupons on drugs where generic alternatives are available, as has been done in Massachusetts and California, may help reduce some overspending in the health care system by not incentivizing the use of brand-name drugs over generics. Also, coupons would still be available to help consumers afford drugs with no lower-cost alternatives. Some methods that health plans may employ to attempt to steer members away from brands with coupons include formulary exclusions, increased tier differential for nonpreferred drugs and step therapy.
How much higher is branded utilization when a coupon for a brand name drug is available?
A study found that coupons for brand-name drugs significantly slow the adoption of a new generic, and in the years following generic entry to the market, branded utilization was 60 percent higher when a coupon for a brand-name drug was available. 12.
