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Access to Healthcare

PRODUCT DONATIONS FOR PATIENTS POLICY

General Policy

On occasion, SI-BONE may provide Product Donations to Health Care Professionals (HCPs) for the benefit of Indigent Patients in accordance with this policy and applicable U.S. laws, regulations, and industry guidance.

Definitions

  • Company Representative” has the meaning set forth in the SI-BONE Code of Conduct.
  • Health Care Professional” or “HCP” has the meaning set forth in the “Health Care Professional Interactions Policy” contained in the SI-BONE Code of Conduct.
  • Product Donation” or “Product” means SI-BONE product(s).
  • Indigent Patient” means a patient who has no insurance coverage and no financial resources to pay for the Product, based on the HCP’s written certification that it has a reasonable policy is in place for determining indigent status that includes but is not limited to requirements that (a) the patient is uninsured and (b) is unable to pay for any portion of the product and procedure.

This Policy is limited to Product Donations for Indigent Patients and does not address other charitable donations. For other Charitable Donations, see the SI-BONE Charitable Donation Policy.

Company Representatives are prohibited from selling or providing Product to anyone other than HCPs.

Company Representatives are prohibited from providing discounts relating to individual patients.

Requirements

The HCP must certify in writing that:

  1. The patient who will receive the Product qualifies for free services from the HCP pursuant to the HCP’s reasonable indigent patient policy;
  2. Neither the HCP nor anyone else will seek or receive any payment or reimbursement of any kind that is connected to the Product Donation, the procedure/product implantation, or other delivery of the product to the patient;
  3. The HCP is not excluded from participation in Medicare, Medicaid or other federal health care programs by the Department of Health and Human Services Office of Inspector General or barred from federal contracting by the General Services Administration;
  4. Donations are not solicited, accepted, offered or provided with the intent of, directly or indirectly, implicitly or explicitly, influencing or encouraging the recipient to use, purchase, lease, order, or arrange for or recommend the use, purchase, lease, or order of SI-BONE products or as a reward for past such behavior.;
  5. The Product Donation is for an on-label use of SI-BONE’s products and the HCP has determined that the Product is medically necessary for the Indigent Patient.
  6. No employee or other Company Representative is permitted to receive commissions relating to Product Donations.
  7. All Product Donations must be approved in writing by the Chief Compliance Officer before the product is provided to the Health Care Professional or Indigent Patient.

Documentation

Prior to providing any Product Donation, the HCP must (1) execute an Indigent Patient Donation Agreement (“Agreement”) in a form approved in advance by the Compliance and/or Legal Department and (2) provide a copy of the HCP’s indigent patient policy.

The Compliance department is responsible for maintaining records relating to this Policy.

Policy Violations

Violations of this Policy, applicable laws, regulations, the Code of Conduct and other Company policies (even if the intent is to benefit the Company) may result in disciplinary action up to and including termination. Company Representatives who condone or negligently fail to detect or report violations by their subordinates may also be subject to disciplinary action up to and including termination.

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