Government Scrutiny of Patient Assistance Programs
- Regulating prescription assistance Prescription Assistance Programs are donor sponsored initiatives aimed at helping patients with minimal or no coverage obtain prescription drug medications. ...
- Recent enforcement News outlets have been enthusiastic to report on the quick-spreading trend in federal scrutiny and corresponding loss of trust in pharmaceutical companies. ...
- Remaining compliant ...
Full Answer
What does the OIG say about Paps?
In numerous prior advisory opinions, the OIG has approved charitable programs that can help financially needy beneficiaries with health care expenses. In 2005, the OIG issued additional guidance in a special advisory bulletin that considered fraud and abuse concerns associated with PAPs.
What does the requestor provide for patients 26 and older?
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.
Does the promotes access to care exception to the beneficiary inducements CMP?
As the arrangement is designed to increase patient safety, the OIG found that it was permissible and satisfies the low-risk-of-harm provision of the Promotes Access to Care Exception to the Beneficiary Inducements CMP.
What should stakeholders do with PAPs?
What is the focus of PAPs?
What is the rescission of advisory opinion 06-04?
What is a rescinded OIG letter?
What is the OIG opinion on CVC?
What are the two aspects of PAP?
What is the purpose of PAPs?
See 4 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 drug companies offer copay assistance?
As drug costs continue to rise, drug manufacturers have designed ways to reduce the out-of-pocket costs for patients. Manufacturer copay assistance programs help insured patients afford expensive prescription drugs by covering part or all of a member's deductible and copay for certain medications.
What happens if you can't afford a prescription?
The first place to look for help are the drug patient assistance programs (PAPs). These are programs run by drug companies that give free medicine to people who can't afford to pay for them. Not everyone qualifies, but millions of people have been helped.
How do copay assistance programs make money?
This copay coupon scheme is both common and lucrative for pharmaceutical companies that sell expensive drugs. Here's how it works: Drug manufacturers, directly or through nonprofit foundations, disburse money to subsidize patient copays as a form of what they seek to characterize as charity.
Do copay assistance cards count towards deductible?
Summary. As a general rule, copays do not count towards a health plan's deductible. Copays typically apply to some services while the deductible applies to others.
Is copay assistance taxable?
Is the assistance I receive from the Co-Pay Assistance Program taxable? As a charity, LLS is exempt from federal income tax and individuals who receive assistance from a charity to meet their personal needs do not generally have to pay federal income tax on the value of the assistance they receive.
Do prescription copays count towards deductible?
Copays are a fixed fee you pay when you receive covered care like an office visit or pick up prescription drugs. A deductible is the amount of money you must pay out-of-pocket toward covered benefits before your health insurance company starts paying. In most cases your copay will not go toward your deductible.
How does copay accumulator work?
When a patient's health plan uses a copay adjustment program, also known as a copay accumulator or maximizer program, it restricts a manufacturer's assistance coupon from counting toward a patient's annual out-of-pocket maximums.
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 OIG opinion on Caring Voice?
The Office of Inspector General’s (OIG) advisory opinion protected Caring Voice Coalition from liability under the Anti-Kickback Statute for its work providing financially needy Medicare patients with premium and cost-sharing assistance. Drug companies are the primary donors to almost all charity patient assistance programs (PAPs), including Caring Voice Coalition, while some drug companies also create their own charity PAPs. The OIG’s 2006 opinion issued to Caring Voice Coalition was fact-specific, as are all advisory opinions, and in this case was predicated on commitments the charity made to implement certain safeguards regarding contributions from donors and grants to beneficiaries.
What is the alleged violation of the OIG?
According to the OIG, the alleged violations “materially increased the risk that [the charity] served as a conduit for financial assistance from a [drug company] donor to a patient,” and thus increased the risk that the charity’s Medicare patients would be steered to that company’s federally reimbursable drugs.
What is the OIG CIA?
The December 2017 OIG CIA was announced as part of a settlement between United Therapeutics and the Department of Justice (DOJ), which alleged that United Therapeutics induced patients to purchase its drugs by donating to charity PAPs over which it exerted some control.
Is Caring Voice Coalition offering financial assistance?
Last week, one of the largest charity patient assistance programs in the country, Caring Voice Coalition, announced that it would not be offering financial assistance for any of its disease funds in 2018.
Is United Therapeutics in the CIA?
Subsequent to entering the CIA with United Therapeutics, and on the same day Caring Voice Coalition announced it would not offer financial assistance in 2018, OIG released a letter it sent to a drug company trade group, dated January 4, 2018.
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.
Can the OIG impose administrative sanctions?
The OIG advised that it will not impose administrative sanctions under the above-listed sections of the Act for the specific scenario described but noted that similar circumstances could create prohibited remuneration under the anti-kickback statute if the requisite intent to induce or reward referrals of federal health care program business were present.
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).
Overview
The past several years have seen a distinct upward trend in enforcement actions against some Patient Assistance Programs (PAPs). PAPs assist patients with healthcare costs through various means, including pharmaceutical manufacturer-established foundations, independent charities, and direct pharmaceutical company assistance.
Speakers
Alan Balch , CEO, Patient Advocate Foundation Mark Gaydos, VP, NA Gen Med & US Advertising & Promotion, Global Regulatory Affairs, Sanofi Erica Jackson, Partner, K&L Gates Moderated by Alan Kirschenbaum, Director, Hyman, Phelps & McNamara, PC
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 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 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 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 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 ...
