Compliance

“Full and strict regulatory compliance is, and will continue to be, the cornerstone of our operations.”

—David L Knowlton, Board Chair

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.

HealthWell’s Compliance Best Practices

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.

Stephen Weiner, Board Member & Chief Compliance Officer

(former 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, Board Chair

(former Chief Compliance Officer)

“Full and strict regulatory compliance is, 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.

Robert D. Clark Esq., Managing Member, ClarkLaw PLLC

“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

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. 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 other CPAPs.

Funds are defined by clinicians on the HealthWell Board, who determine whether a new fund is needed and how it should be defined. Donors cannot and do not play any role in this process.
An independent third party determines the product list for each new fund. The list includes all products that a patient enrolled in the fund could use, including all FDA-approved and compendia-listed brand, generic and biologic products.
Special rules apply where a fund is for a disease for which there is only one FDA approved drug or for which only one manufacturer makes or markets the drug. Other medical needs of enrolled patients will be covered as well.
Simple math is used to estimate the donations a fund needs — (average approvals/day) x (average grant utilization) x number of business days, year or quarter. Product volume or use and especially the volume of drugs manufactured or marketed by a donor are not considered.
Parameters for each fund are clear and include applicable percentage of Federal Poverty Level for eligibility, caps on grants and initial grant amounts, whether the fund is for copay and/or premium assistance, and the type of insurance coverage a grant recipient needs to have (Medicare-only or all third-party coverage). HealthWell also has procedures for verifying the patient’s diagnosis.
HealthWell publicizes the availability of its funds widely. Eligibility does not depend on the identity of the patient’s provider, supplier or treatment or the identity of a donor to the fund. HealthWell does not try to influence a patient’s choice of physician, pharmacy or other provider.
HealthWell maintains independence from its pharma donors. Donors’ identities are not made public. HealthWell’s Board has no financial or other interest in pharma. Pharma plays no role in the definition or establishment of funds.

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