REMINDER: Our hotline team is working remotely and focusing their time on helping our patients.  We kindly ask pharmacies, providers, and their staff to use our Pharmacy and Provider Portals. Please note: if you are contacting us about a payment or grant, it is faster to email us at grants@healthwellfoundation.org. We appreciate your continued patience and look forward to continuing to serve you. Wishing you all safety and good health during this difficult time. The HealthWell Team

Dismiss alert

Our Commitment to Compliance

Since its inception, HealthWell has prioritized the importance of operating in compliance with all guidance and requirements of federal laws and regulations that govern charitable patient assistance programs (CPAPs). Indeed, HealthWell does its best to exceed these requirements in terms of ethics, compliance, and financial transparency in everything we do. It is the guiding principle under which we operate as an organization and under which our Board and staff operate as individuals. The way we define and manage our funds, develop and apply patient eligibility guidelines, maintain the anonymity of our donors and patients, and provide grant assistance continues to be a model for other CPAPs and allows us to focus on what is most important: helping patients access lifesaving medical treatments.

OIG Compliance: CPAP Compliance 101

CPAPs like HealthWell have been providing crucial financial assistance to eligible patients for decades. While the legal and regulatory landscape in which CPAPs operate continues to change, one fact remains: CPAPs provide vital and timely assistance to eligible patients and the need for our collective assistance and services continues to grow.

Photo of Stephen Weiner

Stephen Weiner, Board Chair

“HealthWell does its best to meet, and even exceed, the requirements of all applicable laws and regulatory requirements in everything we do; it is the guiding principle under which we operate as an organization and under which our Board and staff operate as individuals.”

 

David Knowlton, Chief Compliance Officer

“Full and strict regulatory compliance are, and will always to be, the cornerstone of our operations; we sit on a foundation of compliance and transparency.”

What is a CPAP?

CPAPs are independent, non-profit charitable organizations created to provide financial assistance to eligible patients.

How are CPAPs funded?

CPAPs are primarily funded by donations from the pharmaceutical industry and are required to operate independently and without undue influence from their donors.

Who oversees CPAP programs?

CPAPs must be structured, governed and operated in compliance with state and federal legal and regulatory requirements and are subject to oversight by the U.S. Department of Health and Human Services, Office of Inspector General (OIG), whose mission is to, among other things, protect the integrity of federal health care programs.

What is so important about CPAP advisory opinions?

Each CPAP should have its own, unique OIG advisory opinion. An OIG advisory opinion specifies the parameters within which the CPAP must operate; and if the CPAP operates within those parameters it will be deemed to be compliant with certain federal laws and regulations, and most importantly the Federal Anti-Kickback Statute. All CPAPs went through a recertification process pursuant to a Special Advisory Bulletin issued in May 2014, making many guidelines the same for all CPAPs.

Our Compliance History

HealthWell is committed to full cooperation with the OIG, DOJ and other state and federal regulatory authorities related to all organizational and program matters, including but not limited to: internal compliance activities, fund development, grant management, and donor interactions.

 

Krista Zodet, President

“Our patients, donors, alliance partners and the patient care community count on HealthWell to be at the forefront of CPAP compliance through strict adherence to all legal and regulatory requirements and our OIG advisory opinion, to stay on top of legal and regulatory developments as they arise, and to maintain an effective compliance program that requires ongoing new and refresher compliance and risk management training for all HealthWell Board members and staff.”

 

Photo of Robert D. Clark

Robert D. Clark, Legal Counsel

“HealthWell is required to operate in compliance with all applicable federal and state legal and regulatory requirements, and has received a favorable advisory opinion with respect to its operations from the U.S. Department of Health and Human Services, Office of Inspector General (OIG). Since its inception, HealthWell has prioritized the importance of strict legal and regulatory compliance, to include conducting its operations entirely within the scope of its favorable OIG advisory opinion.”

 

OIG Advisory Opinions

OIG Compliance News

The OIG has been providing legal and regulatory guidance and monitoring compliance in the CPAP space for decades, essentially coinciding with the first CPAP to provide financial assistance to eligible patients. The DOJ and OIG had concerns about CPAP practices and initiated investigations in 2016. The information provided below summarizes the DOJ’s findings related to the CPAPs and their arrangements with certain donors.

Which CPAPs have had enforcement actions taken against them?

Good Days

Action Taken: $2 million fine and Corporate Integrity Agreement (October 24, 2019)
Summary of Allegations: Coordinated requests for funding to donors based on donor product patient need; coordinated fund openings with donors/hubs that did not follow first come, first served requirement.
Government Communications: Integrity Agreement (PDF). Department of Justice press release.

Patient Advocate Network Foundation (PANF)

Action Taken: $4 million fine and Corporate Integrity Agreement (October 24, 2019)
Summary of Allegations: Narrow fund definitions benefiting donors.
Government Communications: Integrity Agreement (PDF). Department of Justice press release.

The Assistance Fund (TAF)

Action Taken: $4 million fine and Corporate Integrity Agreement (November 20, 2019)
Summary of Allegations: Coordinated requests for funding to donors based on donor product patient need; coordinated fund openings with donors/hubs that did not follow first come, first served requirement.
Government Communications: Integrity Agreement (PDF).

Patient Services, Inc. (PSI)

Action Taken: $3 million fine and Corporate Integrity Agreement (January 21, 2020)
Summary of Allegations: Coordinated requests for funding to donors based on donor product patient need; coordinated fund openings with donors/hubs that did not follow first come, first served requirement.
Government Communications: Integrity Agreement (PDF). Department of Justice press release.

Which CPAPs have been issued subpoenas by the DOJ?

To our knowledge, many CPAPs have received subpoenas.

What are some examples of the types of illegal behavior identified in recent CPAP enforcement actions?

  • CPAP inappropriately narrowly defining funds for the benefit manufacturer donors.
  • CPAP inappropriately allowing manufacturer donors access to prohibited data and information regarding patients and products.
  • CPAP inappropriately coordinating disease fund openings for the benefit of manufacturer donors.
  • General inappropriate influence exerted by manufacturer donors over independent CPAP fund definition and operations.

What About HealthWell?

We continue to run our programs in full compliance with federal laws, regulations and guidance that govern the copayment assistance industry and continue to follow the highest ethical standards. Our standards put the patient first over all else.

The HealthWell Foundation is, like other CPAPs, funded in majority by donations from the pharmaceutical industry, and we are required to operate independently from our donors. The OIG has provided strict guidance for how CPAPs should be structured to avoid potential fraud and abuse. As the government has announced a number of recent enforcement actions, we continue to follow that guidance to the letter and have focused on maintaining compliant, independent and transparent operations since our inception. As CPAPs continued to endure scrutiny from the national media and federal agencies, we remain steadfast to our commitment to lead by example. We operate within the parameters of our favorable OIG opinion and subsequent modifications to help ensure that patients follow their prescribing physician’s orders and access the best medical treatments for their conditions, regardless of manufacturer or cost. Full and strict regulatory compliance is, and will continue to be, the cornerstone of our operations.

HealthWell’s Compliance Best Practices

Compliance is the cornerstone of HealthWell’s operations. In preparation for its first fund launch in 2004, HealthWell chartered best practices related to fund establishment and management, donor relations, and grant administration. Over the years and with the receipt of our favorable OIG advisory opinion, as modified, we have continued to hone these best practices to reduce the risk of running afoul of CPAP legal and regulatory requirements. HealthWell’s implementation and strict adherence to these best practices set us apart from those CPAPs that have been sanctioned for their practices by governmental and regulatory authorities.

01: Appropriate Internal Fund Practices 02: Respecting Lapsed Donors 03: Managing the Patient Queue 04: Set Fund Parameters 05: Estimating Funding Needs 06: Limited Donor Reports 07: Inclusive Product Lists 08: Single Product or Manufacturer Funds 09: Compliant Fund Definitions
  • 1. Appropriate Internal Fund Practices

    HealthWell refers to funds by the disease area or a fund code which is an acronym for the disease area; HealthWell does not refer to funds by donor or product name.

  • 2. Respecting Lapsed Donors

    HealthWell has had donors cease making donations; but we do not allow that to impact the assistance we provide to our patients or the manner in which we manage their grants within the funds the donor supported.

  • 3. Managing the Patient Queue

    Anyone interested in tracking fund openings at HealthWell may sign up for Real-Time Fund Alerts through our Provider, Pharmacy, Patient, or Guest Portals.  HealthWell does not allow batch enrollments, or inappropriate coordination of fund openings/closings with donors. We open funds at 9 am Eastern on business days and close at 5 pm Eastern on business days.

  • 4. Set Fund Parameters

    HealthWell’s fund parameters are established internally, and independently from donors, and are generally the same fund to fund.

  • 5. Estimating Funding Needs

    HealthWell does not determine funding needs based on product volume and use. We use simple math: (average approvals/day) x (average grant utilization) x (number of business days/year or quarter).

  • 6. Limited Donor Reports

    HealthWell has standardized monthly reports for its donors that provide only such limited aggregate data as  permitted by law, and that does not directly or indirectly provide any patient-specific, product-level, or other prohibited information to any donor.

  • 7. Inclusive Product Lists

    Once HealthWell’s Board physicians define a fund, the definition is sent to an independent third party for product list development. Upon return of that product list, the list – in whole – is loaded into our database and provided to our pharmacy card vendor for GPI identification; all cards for any particular fund are open for application to all fund-associated product copays.

  • 8. Single Product or Manufacturer Funds

    If HealthWell establishes a fund for a disease for which the FDA has approved only one drug, or only the drugs made or marketed by one manufacturer or its affiliates, HealthWell will provide support for other medical needs of patients with the disease, in addition to copayment support for the FDA-approved treatment of the disease.

  • 9. Compliant Fund Definitions

    HealthWell has a standard fund definition process that starts – and ends – with its Board physicians, all of whom are well-versed in developing compliant fund definitions based on broadly accepted and recognized clinical diagnoses.

Pillars of an Effective CPAP Compliance Program

In an effort to help you choose the best CPAP for your philanthropy, we highly recommend that as part of your due diligence you fully address the questions posed in the following checklist.

Checklist for Evaluating CPAPs

 

Alan Klein, Chief Development Officer

“HealthWell Foundation’s OIG Advisory Opinion defines the parameters by which we communicate with our corporate donors. Our commitment to the hundreds of thousands of patients we serve each year and to all of our stakeholders requires us to ensure that those standards are always met.“

Close menu