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future of patient assistance programs

by Mckayla Nitzsche Published 2 years ago Updated 1 year ago
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What is a patient assistance program (PAP)?

Patient assistance programs (PAPs) help people with no health insurance and those who are underinsured afford medications. These programs are managed by pharmaceutical companies, nonprofits, and government agencies. PAPs may cover the full cost of medications or provide a discount.

What is a patient support program?

Patient support programs (PSPs) were originally created to support patient access to complex medications and to assist patients with navigating through the complex healthcare system.

What do patients want the most from patient services?

When it comes to patient services, the thing that patients desire the most is individualized support. This requires a thoughtful approach to program design and vendor partner selection.

How do you design a patient support program?

When designing patient support programs, too often the focus is based upon the services that can be provided to the patient, rather than how the patient wishes to receive those services and what channels are most effective. Adding digital channels is key, but understanding the patient must come first:

What is drug assistance?

Who sponsors drug assistance programs?

Why are patients more likely to abandon their prescriptions at the pharmacy counter?

Can't afford medication?

Can patients receive medication for little or no cost?

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Why are patient assistance programs important?

By providing financial assistance for hundreds of medications, PAPs provide a valuable resource to patients, helping them comply with recommended drug regimens and, in turn, obtain better health outcomes. Millions of Americans use PAPs to get the medicines they need but can't afford.

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 pharma?

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.

What is patient Assistance Program Canada?

PAPs offer trained staff members who help patients investigate their available coverage options. With access to a private infusion clinic, private drug plans may cover the drug but may require the patient to pay co-insurance.

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.

Why do pharmaceutical companies offer patient assistance programs?

They increase demand, allow companies to charge higher prices, and provide public-relations benefits. Assistance programs are an especially attractive proposition for firms that sell particularly costly drugs. Faced with high out-of-pocket costs, some patients may decide against taking an expensive medication.

What is GSK patient assistance program?

The GSK Patient Assistance Program provides certain GSK medicines at no cost to eligible applicants. Eligibility is based on household income and insurance status. Residents of the United States and District of Columbia may be eligible for both Vaccine and Non-Vaccine Medicines.

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 RxPathways® patients in need get access to their Pfizer medicines. Today, Pfizer RxPathways® connects eligible U.S. patients to a range of Pfizer assistance programs that provide insurance support, co-pay help, and medicines for free or at a savings.

How does a patient support program 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.

What is covered in innoviCares?

The innoviCares card provides financial assistance on more than 100 drugs across all stages of the product lifecycle, from newly launched molecules, specialty and off-patent drugs. Funded by pharmaceutical manufacturers, individual programs may change or end at the independent manufacturer's discretion.

Does Viatris have a patient assistance program?

The Viatris Patient Assistance Program provides certain medicines for free to patients with demonstrated financial need. Viatris is committed to helping patients get the treatments they need, when and where they need them.

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...

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.

What are the income limits for GSK patient assistance program?

You must also meet certain household income eligibility requirements as outlined below:48 States and DCHousehold SizeMaximum Monthly Gross Income1$2,831.252$3,814.583$4,797.924 more rows

What is Pfizer Assistance Program?

Pfizer RxPathways® patients in need get access to their Pfizer medicines. Today, Pfizer RxPathways® connects eligible U.S. patients to a range of Pfizer assistance programs that provide insurance support, co-pay help, and medicines for free or at a savings.

Patient Assistance Programs - Frequently Asked Questions

What steps do you need to take? Yes. Although eligibility differs from program to program, they all have three specific criteria in common. Income: To qualify for any patient assistance program, your total household income must be less than 200% of the Federal Poverty Level. Prescription Coverage: Prescription assistance programs require that you do not currently subscribe to private or public ...

Patient Assistance Programs - Prescription Drugs for the Uninsured

Trisha Torrey is Every Patient's Advocate. She is a newspaper columnist, radio talk show host, national speaker, and the guide to patient empowerment at About.com.

Patient Assistance Programs & Prescription Assistance Programs

Discussion. There are several types of PAPs. There are ones that are designed for patients that do not have insurance, others for individuals whose insurance co-payment amounts are prohibitively expensive, and still other programs to assist with specific types of insurance, such as Medicare Part D.

Patient Assistance Programs: How To Get Help Paying For Medications

A patient’s out-of-pocket costs for medications could be another factor to determine your eligibility for patient assistance. Even with health coverage, some prescriptions are still difficult to afford, especially Tier 3 and 4 drugs. Editor’s note: There are 4 tiers of prescription drugs. Tier 1 is the least expensive and 4 is the most expensive and used to cover very serious medical ...

Patient Assistance Program (PAP) Solutions | McKesson

Proven support for patient assistance programs—whatever the setting. PAPs help patients to receive prescription medication for free either from a hospital pharmacy or directly from the manufacturer.But it’s not just about free medications. Equally important in today’s PAPs is that patients receive support that’s personalized for them.An effective PAP addresses patients’ individual ...

What is drug assistance?

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 ...

Who sponsors drug assistance programs?

Drug assistance programs are usually sponsored by life sciences organizations (manufacturer- sponsored), non-profit or charitable foundation-sponsored, or a combination of the two. Usually, they also fall into these categories:

Why are patients more likely to abandon their prescriptions at the pharmacy counter?

As out-of-pocket costs increase, patients are more likely to abandon their prescriptions at the pharmacy counter. To avoid this outcome and improve patient adherence, pharmaceutical manufacturers are more likely to sponsor patient assistance programs.

Can't afford medication?

According to a 2019 Keiser Family Foundation poll, one in four Americans can’t afford their medications, and 29% reported not taking their medications as prescribed due to cost. There are several types of drug assistance programs that can ensure the patients who need treatment gain timely access to therapy and continuity of care.

Can patients receive medication for little or no cost?

Patients who qualify for patient assistance programs can receive medication for little or no cost, helping the most in-need patients gain access to therapy if they cannot afford the typical drug pricing.

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.

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.

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.

What is the 2020 NBPP?

The 2020 Notice of Benefit Payment and Parameters (NBPP) Rule stated that health plans would have the option to exclude the value of coupons from the satisfaction of cost-sharing limits if there is a generic equivalent for the prescribed drug. However, it was later realized there are potential conflicts with other agency guidance, and this rule is being put on hold pending further clarification. 8

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 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 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)).

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.

What is the 2020 Notice of Benefit Payment and Parameters?

The 2020 Notice of Benefit Payment and Parameters (NBPP) Rule stated that health plans would have the option to exclude the value of coupons from the satisfaction of cost-sharing limits if there is a generic equivalent for the prescribed drug.

Speakers

Rachel has over 20 years’ experience in the life science, biotech, and pharmaceutical industries. She currently manages the strategy and operations of the Otsuka Patient Assistance Foundation, Inc. on behalf of Otsuka America Pharmaceuticals, Inc. She’s an expert in field reimbursement, patient access programs, as well as free goods programs.

What You Will Learn

Panelists will discuss how best-in-class PAPs incorporate multiple elements including:

Xtalks Partner

Covance is a business segment of LabCorp, a leading global life sciences company, which provides contract research services to the drug, medical device and diagnostics, crop protection and chemical industries. Employing over 21,000 people worldwide, we are the world’s most comprehensive CRO, dedicated to improving health and improving lives.

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What is the focus of PAPs?

Ultimately, data sharing and communication between charity PAPs and donors appears to be the key area of focus for OIG, DOJ, and IRS enforcement. If such communication and data sharing is prohibited, whether by state statute or federal regulatory enforcement, it is remains to be seen whether PAPs will continue to operate as they are currently structured. In any event, it is incumbent upon interested parties to stay abreast of changes in the law and developing enforcement trends, and to continually monitor and update their compliance programs accordingly. For example, given the amount of scrutiny applied to coordination between the business and charitable giving arms of medical product manufacturers, compliance programs should be actively examining all intra-firm transactions to assure that no improper influence is being exerted over communications with and donations to charity PAPs.

What is the purpose of PAPs?

Department of Health and Human Services (“HHS”) Office of the Inspector General (“OIG”) has continually acknowledged that properly structured PAPs can provide important “safety net assistance” to patients with limited financial means who cannot afford necessary drugs. This Client Alert provides a comprehensive review ...

What is the OIG opinion on CVC?

In December 2015, the OIG published a Modified Advisory Opinion 06-04, following the OIG’s request that CVC certify compliance with the additional factors outlined in the 2014 Special Advisory Bulletin. The Modified Advisory Opinion stated that CVC had certified compliance to each additional factor, and further that CVC had proposed additional modifications to its current operations. [13] The OIG concluded in the Modified Advisory Opinion 06-04 that CVC’s PAP was sufficiently low risk and the OIG would not impose CMPs or sanctions on CVC under the AKS.

What should stakeholders do with PAPs?

Stakeholders should also closely monitor federal and state legislative policy developments regarding PAPs, including copayment assistance and product coupons. K&L Gates regularly advises clients on health care fraud and abuse risk mitigation and compliance matters and facilitate stakeholder engagement with Congress and state legislators and HHS.

What are the two aspects of PAP?

The OIG has indicated that PAPs generally have two “remunerative aspects” that require scrutiny under the AKS: i) donor contributions , which the OIG stated can be analyzed as indirect remuneration to patients , and ii) financial assistance remuneration provided directly to patients. The OIG states that the AKS could be violated “if a donation is made to a PAP to induce the PAP to recommend or arrange for the purchase of the donor’s federally reimbursable items,” as well as if a PAP’s grant of financial assistance to a patient is made “to influence the patient to purchase (or induce the patient’s physician to prescribe) certain items.” [5]

When did the OIG change its advisory opinion?

Beginning in December 2015, the OIG modified five Advisory Opinions in order to update the analyses pursuant to certifications received. [9]

Does UT require a PAP review?

Unlike the Aegerion CIA, however, the UT CIA does not require the establishment of an independent PAP review program, and rather than requiring written agreements with PAPs to include certain provisions, the CIA requires UT to issue those guidelines as a policy for future interactions with PAPs. Recent IRS Scrutiny.

How to measure success of patient support?

There are many other relevant measures—such as patient and HCP satisfaction, efficiency of spend, etc.—however, once the HCP has made the decision to start an appropriate patient on a particular therapy, true success must be measured as what percentage of patients end up on that therapy, how long it takes them to get started, and if they are staying adherent to the therapy/regimen.

What is the age of patient consumerism?

The age of patient consumerism is upon us: “Patients are demanding more sophisticated, convenient, transparent, affordable, and personalized service,” according to a PwC consumer survey. With this shift in demand, digital services are the expectation. In fact, “more than 75% of all patients expect to use digital services in the future,” according to a McKinsey & Company report.

Why is integrated model important in PSP?

As a manufacturer, it’s important to think about real-world evidence (RWE) and how you can leverage the PSP to generate data insights and inform commercialization strategies . For example, tracking health-based outcomes to inform payer decisions, or reporting trends about a payer who has listed the treatment, are data points from a PSP that can inform a manufacturer’s decisions on the market and impact to the patient’s treatment experience. These insights can lead to more informed strategic decisions that ultimately benefit the patient and improve health outcomes.

Why is mapping the patient's journey important?

It also helps to drive innovation, facilitate behavior change, and ultimately achieve better health outcomes and an improved patient experience. To create an effective visualization of your patient’s interactions, gather insight not only into the patient and carer, but also the HCPs and other stakeholders within their journey, along with their environment and context.

How to measure success of a program?

A program’s success should be measured on the satisfaction of all the stakeholders involved, including patient, healthcare provider, and manufacturer. Patients want their medicine with the least amount of effort necessary and in a timely manner. Healthcare providers want a solution that doesn’t impact them or their staff’s time in treating their patients: It must be simple to use and reliable in assisting patients. This requires an easy way to enroll, track, and verify patients started on therapy. And finally, brands want to build equity with patients by delivering a high level of service for patients, which in turn brings goodwill for their brand and may help drive adherence. The key to ensuring all those are taking place are clear detailed metrics for all touchpoints in the patient journey, which can be used to measure the success and efficiency of the program as well as to diagnose areas where the process can be improved.

What are the challenges of designing a healthcare program?

One of the biggest challenges with designing great programs is the sheer variability of healthcare in the U.S.—in terms of the networks, how care is delivered, and what patients need and want. This makes any “custom solution”—as great as it may be—inherently only applicable to a small slice of the pie. And, it makes designing and rolling out patient-centric programs and services very challenging, given that there is no uniform or common system/data/standard underpinning how patients navigate the U.S. system. When designing programs, this translates into a tension between customization versus operational uniformity/consistency—which means it’s difficult to give lots of meaningful choices and to adapt for various customers, but that’s exactly what HCPs and patients want and need.

How to create a service that is fit for purpose?

The only way to create a service that is fit for purpose is to see the problems from the outside in—from the patients’ perspective. This means collecting insight from your target audience to identify the triggers and drivers of behavior, as well as needs and challenges.

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 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 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.

When did the DOJ issue subpoenas to Valeant Pharmaceuticals?

9 DOJ issued subpoenas to Valeant Pharmaceuticals in October 2015, and Horizon Pharmaceuticals in early 2016, requesting information on the drug makers’ relationships with independent PAPs, while investigating both companies for their relationships with specialty pharmacies.

Does a Hub representative have to inform the patient or the patient's provider that the referral to the independent PAP?

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.

Is it permissible for a charitable organization partly funded by kidney dialysis providers to pay Medicare Part B?

4 See OIG Adv. Op. 97-01 (June 11, 1997) (advising that it is permissible for a charitable organization partly funded by kidney dialysis providers to pay Medicare Part B, Medigap and other health insurance premiums for end-stage renal disease patients who are financially needy).

Is PAP independent?

Independence of PAP with Respect to Patient Eligibility: The company may not ex ert (directly or through any affiliate) any influence or control over the independent PAP’s process or criteria for determining eligibility of patients who qualify for assistance. Part Three: A Developing Risk Area — Free Drug Programs.

What is drug assistance?

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 ...

Who sponsors drug assistance programs?

Drug assistance programs are usually sponsored by life sciences organizations (manufacturer- sponsored), non-profit or charitable foundation-sponsored, or a combination of the two. Usually, they also fall into these categories:

Why are patients more likely to abandon their prescriptions at the pharmacy counter?

As out-of-pocket costs increase, patients are more likely to abandon their prescriptions at the pharmacy counter. To avoid this outcome and improve patient adherence, pharmaceutical manufacturers are more likely to sponsor patient assistance programs.

Can't afford medication?

According to a 2019 Keiser Family Foundation poll, one in four Americans can’t afford their medications, and 29% reported not taking their medications as prescribed due to cost. There are several types of drug assistance programs that can ensure the patients who need treatment gain timely access to therapy and continuity of care.

Can patients receive medication for little or no cost?

Patients who qualify for patient assistance programs can receive medication for little or no cost, helping the most in-need patients gain access to therapy if they cannot afford the typical drug pricing.

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