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. This trend is most recently exemplified by Jazz Pharmaceuticals PLC’s securities disclosure in May 2018 of its pending settlement with the U.S. Department of Justice, which comes only months after similar conduct was settled by United Therapeutics Corporation.1 In particular, these government investigations and settlements have examined whether donations to independent charity-run patient assistance programs, or independent PAPs, violate the Federal Anti-Kickback Statute, or AKS,2 by inducing patients to purchase certain products and forcing federal health care programs to subsidize the costs of such products. Settlements from these investigations are based on the government’s theory of liability that independent PAPs are being used as conduits to funnel impermissible financial support for the companies’ products.3
In light of this emerging enforcement trend, donating to independent PAPs should now be considered a high-risk activity for any pharmaceutical company — especially those companies with high-cost drugs. To help navigate these waters, this article offers: (1) brief history on the guidance applicable to independent PAP activities and recent enforcement activities; (2) practical guidance and tips on compliance controls that companies should consider in order to mitigate risk when engaging in these activities; and (3) additional guidance on applying these germane compliance lessons to the operation of free drug programs, which arguably carries a similar level of compliance risk.
Part One: History of Compliance Guidance and Enforcement for Independent PAP Donations
Compliance Guidance Applicable to Independent PAPs: Historically, donations to independent PAPs were viewed as a relatively low-risk proposition, so long as these donations were structured in accordance with guidance provided by the Office of Inspector General of the U.S. Department of Health and Human Services since 1997.4 In 2005, on the precipice of extending Medicare coverage for outpatient prescription drugs under Part D, OIG provided guidance in a special advisory bulletin, which outlined safeguards for company donations to independent PAPs to prevent violations of the AKS.5 OIG’s guidance focused on maintaining the independence of the independent charity, which required:
- No control: Structuring an independent PAP in a manner that ensures drug company donors cannot exert control or influence (directly or indirectly) over the independent PAP;
- Ensuring that the independent PAP awards financial assistance in “a truly independent manner that severs any link between the pharmaceutical manufacturer’s funding and the beneficiary,” such that “the assistance provided to the beneficiary cannot be attributed to” the donor;
- No steering: Determining patient eligibility for assistance without regard for a patient’s enrollment in a federal health care program or the patient’s choice of product, provider, practitioner or supplier;
- Uniform eligibility: Determining patient eligibility for assistance consistently in a “reasonable, verifiable and uniform manner” based on financial need; and
- No return on investment analysis: Ensuring that donors do not solicit data from the independent charity that would enable donors to correlate the amount or frequency of donations with actual use by patients receiving PAP assistance.6
To these ends, OIG admonished pharmaceutical companies from directly or indirectly influencing “the identification of disease or illness categories” supported by the independent PAP, and cautioned donors to limit their donations solely to independent PAPs that “define categories in accordance with widely recognized clinical standards and in a manner that covers a broad spectrum of available products,” as opposed to PAPs that “define their disease categories so narrowly that [providing a donation] effectively results in the subsidization of one (or a very few) of donor’s particular products.”7
In 2014, OIG supplemented the 2005 special advisory bulletin, and reaffirmed that certain independent PAPs will be subject to enhanced scrutiny under certain circumstances — specifically: (1) disease-specific PAPs with “improperly narrow approaches” to defining diseases; and (2) PAPs that “limit assistance to a subset of available products,” especially a subset of “expensive or specialty drugs,” instead of covering “all products approved by the Food and Drug Administration for treatment of the disease state(s),” including generic drugs.8
Surge in Government Enforcement
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.
The end of 2017 saw the first settlements resulting from these DOJ investigations with drug companies. In September 2017, as part of a larger resolution, Aegerion Pharmaceuticals Inc. agreed to pay $28.8 million for, among other things, unlawfully inducing patients to purchase its drugs by channeling donations to an independent PAP, Patient Services Inc., or PSI.10 The government alleged that Aegerion had participated in the creation of a specific PSI assistance fund and helped establish the criteria for awards of patient co-pay assistance from PSI for Aegerion’s product Juxtapid.11 Aegerion also entered into a five-year corporate integrity agreement, or CIA, with OIG, which was the first CIA to impose compliance requirements specifically related to interactions with independent PAPs.12
Shortly thereafter, in December 2017, United Therapeutics agreed to pay $210 million to settle allegations of purported False Claims Act liability predicated on Anti-Kickback Statute violations stemming from its use of Caring Voice Coalition, or CVC, an independent PAP, as “a conduit to pay the co-pay obligations of thousands of Medicare patients taking [United Therapeutics’] drugs.”13 The settlement documents pointed specifically to the fact that United Therapeutics prohibited Medicare patients from participating in United Therapeutics’ free drug program for financially needy patients, and instead referred Medicare patients to CVC.14 In addition, United Therapeutics had obtained data from CVC detailing the number of patients on each applicable drug, which United Therapeutics then used to determine its level of contributions to CVC.15 As with Aegerion, United Therapeutics entered into a five-year CIA with OIG with similar compliance obligations specific to interactions with independent PAPs.16
Most recently, in May 2018, Jazz’s announcement of its pending DOJ settlement for $57 million marks the first in a potential line of settlements that will be reached in 2018 related to similar independent PAP activities.17
Part Two: Implementation of Meaningful Compliance Controls and Safeguards
Given this surge in enforcement by both the DOJ and OIG, pharmaceutical companies that engage with independent PAPs should be carefully examining their compliance controls using OIG expectations and industry best practices. As with many other elements of compliance program design, CIAs provide useful insight into OIG’s expectations regarding the compliance controls that help assure legal and regulatory compliance.
Based on a detailed examination of CIAs that contain specific requirements on interactions with independent PAPs18 — as well as other historical guidance regarding charitable donations generally — we have identified controls that should be memorialized in a policy or procedure specifically addressing interactions with independent PAPs. This policy/procedure should implement procedural safeguards against the conduct that was cited by the DOJ in past enforcement actions, including standards for and separation of all independent PAP-related activities from commercial interests, as well as delineated standards for budgeting, review and submission of funding requests.
Policy and Procedure Requirements
A more detailed explanation of these policy and procedure requirements is as follows:
- 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. Once approved, donations to PAPs should be documented in a written agreement that is reviewed and approved by legal and compliance, which may include the following terms: (a) any data reporting from the charity to the company is limited to the aggregate number of applicants, the aggregate number of applicants qualifying for assistance, and the total amount of assistance distributed during a reporting period; (b) the company does not and shall not provide donations for a disease state fund that covers only a single product; and (c) the company does not provide donations for a disease state fund that covers only company products.
- Annual Budgeting: The company must develop an annual budget for donations to PAPs based on objective criteria, in accordance with general guidelines approved by legal, with input from compliance, and the annual budget must be approved at a level of the company above the commercial organization (e.g., the executive level). Consistent with the need for separation, the commercial function should have no influence or input into the budget process.
- 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. 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.
- Separation of PAP Activities from Commercial Functions: All activities relating to funding of independent PAPs, including budgeting, review and contracting, as well as any interactions with the independent PAP, should be separate from, and must operate without influence or involvement of, the company’s commercial functions (e.g., sales, marketing and other similar business functions). Ideally, these activities would be vested within a designated team made up of members from departments such as, medical affairs, corporate philanthropy (if applicable) and compliance.
- 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.
Consideration and Elimination of Suspect Factors: Apart from the PAP policy/procedure, which incorporates the specific compliance controls described above, and the monitoring and auditing of the effectiveness of those controls, companies should also consider implementing policy statements that address the suspect factors enumerated by the DOJ and OIG in past enforcement actions and historical OIG guidance on donations to independent PAPs. These suspect factors include:
- Prohibition on Providing Support for Suspect Funds: The company should not provide donations for a disease state fund that covers only a single product or that covers only company products.
- Independence of PAP with Respect to Disease or Treatment Selection: The company may not exert (directly or through any affiliate) any influence or control over the identification, delineation, establishment or modification of any specific disease state funds operated by the independent PAP. The company must not make (directly or through any affiliate) suggestions or requests to the independent PAP about the identification, delineation, establishment or modification of disease state funds.
- Independence of PAP with Respect to Patient Eligibility: The company may not exert (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
As an evolution of the government’s scrutiny of pharmaceutical company interactions with independent PAPs, prosecutors have recently identified company-sponsored free drug programs for indigent or uninsured patients as another risk area.19 Accordingly, companies should also consider an assessment of their own free drug programs and the compliance risks involved. Building on related efforts regarding activities involving independent PAPs, key features and controls applicable to company-sponsored free drug programs should include:
- Choice between independent PAP and free drug programs: A process to ensure eligible patients are not discouraged or prevented from obtaining free drugs from the company and instead referred to independent PAPs;
- Uniform eligibility criteria: Well-defined eligibility criteria based on patients’ financial need, using a reasonable, uniform and consistent methodology (e.g., percent of federal poverty level combined with percent of household revenues spent on drugs);
- Uniform application of assistance: A process to ensure assistance is provided uniformly based on established criteria, without consideration of a patient’s plan choice and/or benefit design, and without regard to the providers, practitioners or suppliers used by the patient or benefit plan;
- No future conditions: A process to ensure that the provision of free drugs is not contingent on any future purchases or orders of the company’s products or any other item or service;
- Application to Part D cost-sharing: Safeguards to ensure that free drugs are not billed to any federal health care program, counted toward a beneficiary’s Medicare Part D true out-of-pocket costs, resold or otherwise billed to a third-party payor, which may include: (1) entering into data sharing agreements with CMS to notify Part D plans that free drugs are being provided outside of the Part D benefit; (2) implementing procedures to notify patients and, if applicable, providers receiving the drugs on behalf of patients that no third-party payor should be billed for such drugs; and (3) in some cases, to obtain certifications from such providers that they will dispense the drugs only for use by designated patients;
- Duration of free drug supply: Guarantee of free drug for the entire plan year, even if the patient’s use of the free drug is periodic during the coverage year; and
- Maintenance of records: Maintenance of accurate and contemporaneous records of the free drugs provided to federal health care program beneficiaries.20
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.