The U.S. Justice Department has pulled yet another Big Biotech into its probe of pharma’s ties to patient assistance programs. Revlimid maker Celgene disclosed last week that it had received a federal subpoena about its relationships with the charities, which help cover patients’ expenses for the company’s pricey therapies.
Full Answer
What is the Patient Assistance Program (PAP)?
The Patient Assistance Program provides medication at no cost to those who qualify. Patients who are approved for the PAP may qualify to receive free diabetes medicine from Novo Nordisk. There is no registration charge or monthly fee for participating.
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.
How do I submit a Trulance patient assistance form?
Stick to these simple guidelines to get Trulance Patient Assistance prepared for submitting: Choose the sample you will need in the collection of legal forms. Open the form in the online editor. Go through the recommendations to determine which details you will need to provide. Choose the fillable fields and include the requested info.
How do I fill out a patient assistance form online?
Our platform provides you with a rich library of templates that are offered for filling out online. It only takes a couple of minutes. Stick to these simple guidelines to get Trulance Patient Assistance prepared for submitting: Choose the sample you will need in the collection of legal forms. Open the form in the online editor.
What is the focus of PAPs?
What are the two aspects of PAP?
What is the rescission of advisory opinion 06-04?
What is a rescinded OIG letter?
What is the OIG opinion on CVC?
What should stakeholders do with PAPs?
What is the purpose of PAPs?
See 4 more
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Patient Assistance Programs: The Good, the Bad, and the Ugly
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.
Emerging Enforcement Trends For Patient Support Programs
This article by former partner Brett Friedman, counsel Alison Fethke and associate Jamie Darch was published by Law360 on May 15, 2018. Over the past year, a growing number of governmental investigations and settlements call into question the practice of pharmaceutical companies donating to independent charities that provide financial assistance with out-of-pocket drug costs to patients.
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 ...
HHS OIG Approves Narrowly-Tailored Patient Assistance Program
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 ...
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 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 rescission of advisory opinion 06-04?
Senate Finance Committee regarding the rescission of Advisory Opinion 06-04, including how the OIG came to learn about the misrepresentations that the charity made, and whether the OIG plans to audit or review other PAPs and similar advisory opinions.
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 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 ...
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
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.
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What drugmaker was the first to disclose a DOJ inquiry about its patient assistance activities?
Valeant Pharmaceuticals ($VRX) was the first drugmaker to disclose a DOJ inquiry about its patient-assistance activities; last October, amid harsh criticism of its price hikes and a separate investigation into its ties with specialty pharmacies, Valeant said it had received subpoenas for materials related to its patient-assistance programs.
Why can't drugmakers correlate donations with support for their own drugs?
Government regulations prohibit drugmakers from trying to correlate their donations with support for their own drugs, because that would indicate that donors were trying to channel financial support in ways that could violate antikickback laws, court documents contend.
How much money does Celgene donate?
Its donations--which amounted to between $50 million and $100 million per year , according to a Celgene expert witness in the Brown lawsuit, come with no strings attached, the company says.
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.
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 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.
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).
How many prescriptions were filled in 2005?
Two out of every three visits to the doctor end with a prescription being written. Nearly 3.4 billion prescriptions were filled in the U.S. in 2005.
Do pharmaceutical companies offer PAPs?
Most pharmaceutical companies voluntarily offer PAPs. It is important for health care providers, patients and caregivers to research and understand the eligibility criteria and application process for specific PAPs as they differ considerably from one program to the next.
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 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 rescission of advisory opinion 06-04?
Senate Finance Committee regarding the rescission of Advisory Opinion 06-04, including how the OIG came to learn about the misrepresentations that the charity made, and whether the OIG plans to audit or review other PAPs and similar advisory opinions.
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 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 ...
