Facilitating patient-physician communication or compliance with a treatment plan is a safe zone. The new rule favors remuneration that acts to improve patient-physician communication and the patient’s involvement in managing their care and health conditions, with the apparent goal of better health outcomes.
Full Answer
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 are the eligibility requirements for patient assistance programs?
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 sources of prescription coverage.
What are the costs associated with patient assistance programs?
In most cases, there is no cost associated with patient assistance programs. If there are any costs for the program, it will be displayed in the profile for the pharmaceutical company whose medication you are inquiring about. Many PAP's provide their medication completely free or at a significant discount off the uninsured cost.
Are patient assistance programs (Paps) for drug manufacturers worth it?
We are all familiar with the patient assistance programs (PAPs) primarily sponsored by drug manufacturers or a partner organization and generally consider them a good thing for assisting patients with high out-of-pocket costs for expensive specialty drugs, especially in this era of high-deductible insurance plans.
Where do patient assistance programs come from?
How to sign up for a med program?
Can a patient assistance card help you?
Does GlaxoSmithKline offer assistance?
See 1 more
About this website
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.
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 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.
What is Texas prescription assistance program?
Description: Texas Drug Card is the state's free prescription assistance program. While providing uninsured residents with savings up to 80% on medications, Texas Drug Card also provides comparable savings to those with insurance on their non-covered medications.
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.
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.
Is GoodRx a government program?
GoodRx Holdings, Inc. is an American healthcare company that operates a telemedicine platform and a free-to-use website and mobile app that track prescription drug prices in the United States and provide free drug coupons for discounts on medications. GoodRx checks more than 75,000 pharmacies in the United States.
Does Texas have a prescription monitoring program?
The Texas Prescription Monitoring Program (PMP) collects and monitors prescription data for all Schedule II, III, IV, and V Controlled Substances (CS) dispensed by a pharmacy in Texas or to a Texas resident from a pharmacy located in another state.
Does Texas have a SPAP program?
The Texas SPAP was developed to help HIV-positive individuals with their out-of-pocket costs associated with Medicare Part D prescription drug plans, including co-payments, deductibles, coinsurance, and premiums during the coverage gap (the “donut hole”).
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 and Types of Assistance - AssistRx
Using the e-support services available in iAssist—the most comprehensive therapy initiation platform—healthcare providers can quickly enroll patients into patient assistance programs with real-time PAP screening and approval.. Using iAssist, your office can electronically and proactively capture required information, screen and receive approval for eligible patients and even generate a PAP ...
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.
Pharmaceutical Manufacturer Patient Assistance Program Information | CMS
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.
Why is it important to connect patients with PAPs?
Many health care systems have gone so far as to develop organized programs to connect patients with PAPs as a means of enhancing access to medications and reducing their financial burden. This is also potentially beneficial for the institution because it reduces bad debt . At my organization, we have a new job category called medication access specialists, who, among other things, are responsible for connecting patients to PAPs and helping families and patients navigate the sometimes confusing process. Therefore, at the micro level, this is a good thing.
Why is not participating in PAP bad?
In fact, to not participate in a PAP can be interpreted as overpaying for a drug, somewhat like paying the list price for a new car. Of course, the exclusion of governmental insurance plans is unfortunate because these patients are often the ones in greatest need of financial assistance.
How much is the maximum out of pocket cost for PAP?
For example, if the maximum allowable on the PAP is $15,000 per year, the patient’s out-of-pocket cost will be $1250 per month . That is, the co-pay becomes very flexible, based on the dollars available from the PAP, and the company takes every dollar available. Thus, if the patient does not sign up to participate in the maximizer program, their outof- pocket cost would be $15,000 per year under this example, because it is their “co-pay” for a nonessential health service. Under the maximizer arrangement, the patient’s out-of-pocket cost for treatment is $0, so there is no contribution to the deductible or maximum outof- pocket cost from their drug therapy.
Can you use PAP money to pay down deductible?
Understandably, employers and payers do not appreciate that PAP dollars are being used by patients to pay down their deductible and maximum out-of-pocket expense while the plan experiences escalating pharmacy benefit costs because of these expensive agents.
What is EOB billing?from mckesson.com
The provider faxes a claim form, along with the patient’s commercial insurance evidence of benefits (EOB), to bill the program. Each claim gets reviewed for compliance with the program rules. (This step ensures only eligible providers and patients receive reimbursement for covered products.)
What is a pharmacy?from npino.com
A pharmacy is a facility whose primary function is to store, prepare and legally dispense prescription drugs under the professional supervision of a licensed pharmacist.
Is a mail order pharmacy a nonresident pharmacy?from npino.com
Mail order pharmacies are licensed as a Mail Order Pharmacy in the state where they are located and may also be licensed or registered as nonresident pharmacies in other states. Non-Pharmacy Dispensing Site.
Does missed cash collections hurt health systems?from mckesson.com
Missed cash collections can hurt your health systems’ bottom line. See how much you can save using McKesson RxO’s Patient Assistance Program (PAP) Reimbursement and Revenue Recovery Management solution.
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.
Who sponsors drug assistance programs?from assistrx.com
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:
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.
What is the complaint against PSI?
district court for the Eastern District of Virginia, alleging that the OIG’s recent guidance prohibits PSI’s protected free speech with donors and potential donors, jeopardizing PSI’s ability to operate. [29] .
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 a rescinded OIG letter?
However, on November 28, 2017, the OIG issued a letter rescinding Advisory Opinion 06-04 (“Rescission Letter”), based on the charity’s “failure to fully, completely, and accurately disclose all relevant and material facts to OIG,” and CVC’s alleged failure to comply with certain factual certifications made to the OIG. Specifically, the OIG states that it determined that the charity “provided patient-specific data to one or more donors that would enable the donor (s) to correlate the amount and frequency of their donations with the number of subsidized prescriptions or orders for their products, and (ii) allowed donors to directly or indirectly influence the identification or delineation of Requestor’s disease categories.” [14] The Rescission Letter indicates that CVC’s failure to comply with the certifications “materially increased the risk” that CVC served as a conduit for financial assistance from a drug manufacturer donor to a patient, and thus inappropriate steerage to the donor’s drugs.
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]
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 an eligible patient?
Eligible patients are patients who have been prescribed the drug for an FDA-approved indication and have a household income that does not exceed 600 percent of the federal poverty level, who live more than two hours driving distance or 100 miles from the nearest center accepting patients and who have no insurance for non-emergency medical travel. The requestor offers the arrangement to eligible patients regardless of their provider or insurance status. To participate in the arrangement, the patient and caregiver (s) must agree not to request reimbursement from federal health care programs for costs covered under the arrangement. The requestor certified that it does not bill or otherwise shift the costs of the arrangement to the federal health care programs.
What is OIG opinion 20-02?
On Jan. 15, 2020, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued Advisory Opinion No. 20-02 which addresses whether a pharmaceutical manufacturer providing financial assistance to patients constitutes grounds for the imposition of sanctions under the civil monetary penalty provision prohibiting inducements to beneficiaries, section 1128A (a) (5) of the Social Security Act (the Act), the exclusion authority at section 1128 (b) (7) of the Act or the civil monetary penalty provision at section 1128A (a) (7) of the Act. These sections relate to the commission of acts described in section 1128B (b) of the Act, the federal anti-kickback statute.
What is a drug infusion requestor?
Under the arrangement, the requestor assists eligible patients, between the ages of 18-25 years old, and up to two caregivers with travel, lodging, meals and certain out-of-pocket expenses they incur during and after the patient’s drug infusion. For patients 26 and older, the requestor provides the same support for a patient and one caregiver. The requestor does not provide assistance with patient travel or expenses associated with initial patient consultations, leukapheresis or follow-up visits beyond the post-infusion monitoring required by the drug’s prescribing information. The requestor does not authorize lodging under the arrangement to a patient treated by a center when the requestor has knowledge that the patient is eligible to receive lodging from the center, and such lodging is available for that patient’s use. The requestor also certified that it does not advertise the arrangement. Patients do not learn about, or become eligible for, the arrangement until they have been diagnosed with the appropriate disease and are prescribed treatment with the drug. Under the arrangement, the requestor provides reimbursement for gas and tolls or arranges for transportation via bus, rail, rental car or air travel for a patient and caregiver (s) to and from the closest center accepting patients using a third-party travel vendor.
How long does a patient have to be monitored after an infusion?
Patients receive assistance for four weeks post-infusion; however, if the patient’s physician determines that it is medically necessary to monitor the patient for risks of negative outcomes for longer than four weeks , the requestor provides assistance for the duration of monitoring deemed necessary by the physician.
Does a requestor authorize lodging under an arrangement?
The requestor does not authorize lodging under the arrangement to a patient treated by a center when the requestor has knowledge that the patient is eligible to receive lodging from the center, and such lodging is available for that patient’s use. The requestor also certified that it does not advertise the arrangement.
Do you have to agree to reimburse for a health care arrangement?
To participate in the arrangement, the patient and caregiver (s) must agree not to request reimbursement from federal health care programs for costs covered under the arrangement. The requestor certified that it does not bill or otherwise shift the costs of the arrangement to the federal health care programs.
Who should be mindful of PAP?
Any person or entity wishing to implement or participate in a PAP should be mindful of this previous guidance and the limited situations in which the OIG has blessed such arrangements (as in Advisory Opinion 20-02).
What are Patient Assistance Programs?
Commonly referred to as PAPs, Patient Assistance Programs are services offered by pharmaceutical companies for those who cannot afford their medication. Patient assistance programs are available to low-income individuals or families who are under-insured or uninsured and are provided to those who meet the eligibility guidelines. Assistance may range from reduced cost of drugs to free medicine. Each drug that a company offers will have its own unique program and may even have a different eligibility requirement than the other drugs they offer. As there is no unified standard of designation for these programs, you may also see them referred to as medication assistance programs, indigent drug programs, and charitable drug programs.
How to obtain a patient enrollment form?
Some enrollment forms can only be acquired by having the physician contact the pharmaceutical company directly. By making contact with your physician, the company can determine eligibility before the form has been submitted. Please see the profile for the patient assistance program you're inquiring about for further details on what is required from your physician.
What other material will I need to provide besides the enrollment form?
Many pharmaceutical companies will require additional material to be submitted along with your completed enrollment form. As stated before, there are no unified guidelines for what each company requests, but you can expect that many of them will require similar information. Below you will find a list of the information most commonly requested by patient assistance programs.
What is required of my physician during the enrollment process?
While they're are some enrollment processes that do not require interaction from your physician; many request that they provide answers to question on the form or directly sign it. Each patient assistance program enrollment will detail what information they will need from your physician. As stated before, there are no unified guidelines for what each company requests, however you can expect that many will require similar information. Below you will find a list of the information most commonly requested from your physician.
What documents do companies request for proof of income?
The following are examples of acceptable material to submit for this request: Federal or State tax statements, pay stubs, or bank statements.
When is a diagnosis required?
Patient Diagnosis: Required in the same manor as an insurance company requests when authorizing medication for a patient. The diagnosis is used to determine if the specific medicine in question is the best option for the patient.
Is patient assistance mandated?
Patient Assistance Programs are not mandated or managed by the federal government and are offered as a free service by the pharmaceutical industry.
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 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.
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.
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.
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.
