LLS CO-PAY COMPLIANCE PROGRAM

LLS has a steadfast commitment to compliance.

LLS is committed to operating its Co-Pay Assistance Program to the highest standard of compliance, adhering to all applicable federal regulations and guidance issued by the U.S. Department of Health and Human Services, Office of Inspector General (OIG). The LLS Co-Pay Assistance Program operates free from any direct or indirect donor influence or control, and in accordance with LLS’s OIG Advisory Opinion #06-13 as well as all OIG Special Advisory Bulletins related to Independent Charity Patient Assistance Programs.

The LLS Co-Pay Program has never been investigated by the Office of Inspector General (OIG) or had to modify program operations for violation of the OIG.

What is a Compliance Program?

  • A Compliance Program is a procedural framework within an organization designed to prevent, detect and respond to illegal, improper or unethical conduct.
  • Compliance is doing what’s right and engaging in active oversight to ensure the organization is doing what’s right.

Goals of LLS’s Compliance Program

  • Establish a culture that promotes prevention, detection, and resolution of instances of conduct that does not conform to all applicable laws, LLS’s OIG Advisory Opinion, or policies and procedures.
  • Communicate and demonstrate LLS’s commitment to compliance.
  • Guide leadership and employees in efficient management and operations.
  • Provide ethical leadership and install systems to facilitate ethical and legal conduct.
  • Provide information, guidance, and education regarding ethics, regulatory requirements, and standards of practice.

7 Essential Elements of an Effective Compliance Program

The U.S. Department of Health and Human Services, Office of the Inspector General (the “OIG”) has identified seven (7) elements that are fundamental to any Compliance Program. LLS has a steadfast commitment to compliance and has implemented a Compliance Program based on the OIG’s 7 elements, as described in more detail below.

  1. Written Policies and Procedures
  2. Designated Committee Overseeing Compliance
  3. Effective Compliance Training and Education
  4. Established and Open Lines of Communication
  5. Internal Monitoring and Auditing
  6. Enforcement Protocols
  7. Prompt Response and Corrective Action Protocols

The LLS Compliance Program:

  1. Written Policies & Procedures
    • LLS has a written Co-Pay Assistance Program Compliance Standard Operating Procedures (“Co-Pay Compliance SOPs”) which All LLS Board of Directors, staff, external partners and vendors abide by.
  2. Designated Compliance Committees
    • LLS’s Co-Pay Program is overseen by LLS’s Co-Pay Compliance Committee and the Audit Committee of the Board of Directors.
    • Their responsibilities include; receipt of compliance program updates, including the results of the annual audits; review of proposed new funds or changes to existing funds; and receiving and investigating compliance-related complaints.
  3. Annual training on LLS’s Office of Inspector General (“OIG”) Advisory Opinion
    • All LLS Board of Directors, staff, external partners and vendors are requi to complete annual compliance training.
    • Their responsibilities include; receipt of compliance program updates, including the results of the annual audits; review of proposed new funds or changes to existing funds; and receiving and investigating compliance-related complaints.
    • The Co-Pay Training includes the following topics:
      • Review of OIG guidance, including LLS’s OIG Advisory Opinion
      • Review of potential fraud, waste, and abuse concerns
      • Laws and regulations applicable to LLS (e.g., Anti-Kickback Statute, privacy laws)
      • Elements of LLS’s Compliance Program
  4. Reporting channels, including anonymous reporting hotline
    • LLS employees have a duty to report any suspected violation. Anonymous reporting is available 24/7 through the AllVoices Platform.
    • Failure to report may lead to disciplinary actions.
    • LLS will not tolerate any form of retaliation for good-faith reporting.
  5. Annual Co-Pay Assistance Program audit and periodic, ongoing monitoring activities
    • LLS conducts quarterly internal audits and commissions annual independent compliance and financial audits to ensure that its Co-Pay Assistance Program operates within the guidelines established by its OIG Opinion and the OIG Special Advisory Bulletins Related to Independent Charitable Patient Assistance Programs.
    • Audit findings and issues identified through informal monitoring activities are reported to the Audit Committee every quarter.
    • The LLS Co-Pay Program has never been investigated by the Office of Inspector General (OIG) or had to modify program operations for violation of the OIG.
  6. Publicized disciplinary guidelines
    • LLS employees are subject to disciplinary action, up to and including termination of employment for violating applicable laws, regulations, guidance, LLS’s OIG Advisory Opinion, or other LLS policies or procedures.
  7. Mechanisms to respond to potential incidences of non-compliance and develop corrective action as necessary
    • All employees are obligated to cooperate with LLS in investigating suspected compliance violations.
    • A written corrective action plan is developed to address and prevent compliance issues.
    • The results of investigations into suspected compliance violations, along with recommended corrective actions are reported to the Audit Committee.

LLS Compliance Principles

LLS requires all staff, external partners, and vendors responsible for administering the program to abide by the following principles. Failure to abide by these principles may result in corrective action up to and including termination, if necessary.

  • Operate under the auspices of and in compliance with the LLS Office of Inspector General (OIG) Advisory Opinion.
  • Utilize an independent Scientific Advisory Committee to develop and approve clinically defined disease silos.
  • Require quarterly internal audits and commissions annual independent compliance and financial audits.
  • Conform program operations to internal policies and procedures, OIG requirements, and evolving charitable patient assistance program best practices.
  • Adopt a compliance program to ensure adequate operational oversight, employee training, and processes to facilitate the blinded reporting of employee concerns regarding operational compliance issues.
  • Operate in an independent manner, free from the influence of donors.
    • Implement a conflict-of-interest policy to ensure there is no connection between chains of stakeholders.
    • Ensure assistance is provided independently without regard to provider, supplier, product, or therapy.
  • Use consistent, uniformly applied, objective processes to establish and assess program and award criteria.
  • Seek funding from a variety of potential sponsors to include pharmaceutical/biotech companies, insurers, other foundations, or others.
  • Maintain 501(c)(3) public charity status.
  • Protect patients’ privacy and rights by adopting and maintaining adequate transparency and privacy policies.

LLS is committed to a best in class experience for patients, providers, and pharmacists.

Co-Pay Assistance Program Highlights

Instant Decision

Identity, residency and income are verified through a third-party. Applicants get a decision in real time and patients can access funds immediately!

Diagnosis Verification Form

Providers immediately attest to a diagnosis improving speed of application approval.

Pharmacy Benefit Card

Allows pharmacy to access Co-Pay Assistance electronically, reducing patient out-of-pocket cost burden while providing timely access to therapy.

Claims Specialists

Proactive outreach to educate patients on covered expenses and claims submission process.

“How-to” Videos:

Step-by-step guides for patients and their caregivers pertaining to application, covered expenses and claims submission.