Encouragement of clinical trial accessibility through support of clinical trial cost-sharing

The payment of patient cost-sharing obligations associated with participation in a clinical trial (as defined in subsection (d) of the first section 2709 of the Public Health Service Act) or for which a diversity action plan is required pursuant to sections 505(z) or 520(g)(9) of the Federal Food, Drug, and Cosmetic Act by drug or device manufacturers or their agents for their clinical trial participants shall not be considered a violation of section 1128A of the Social Security Act (42 U.S.C. 1320a–7a) (commonly known as the Civil Monetary Penalties Law), section 1128B of the Social Security Act (42 U.S.C. 1320a–7b), or sections 3729 through 3733 of title 31, United States Code (commonly known as the False Claims Act), provided that the following requirements are met: (1) The trial and any coverage of items or services provided in the trial is consistent with all applicable coverage rules by any Federal health care programs providing coverage and reimbursement for beneficiaries participating in the trial as study subjects, including but not limited to, any existing trial qualification requirements imposed by the Centers for Medicare & Medicaid Services for Medicare coverage of the trial. (2) The proposed arrangement for the payment of patient cost-sharing obligations is a reasonable means of facilitating enrollment of an underrepresented set of subjects or reducing the likelihood of attrition in the trial by removing a potential financial barrier to participation in the trial. (3) Any sponsor payments of participating patient cost-sharing obligations must be available throughout the entirety of the clinical trial. (4) Any sponsor payments of participating patient cost-sharing obligations are not contingent on the future use or purchase of any product or service. (5) Any sponsor payments of participating patient cost-sharing obligations will not be provided in excess of the patient’s cost-sharing obligations under relevant Federal health care programs. (6) A participating patient receiving cost-sharing assistance from a sponsor will be required to agree not to accept other financial assistance to cover the patient’s cost-sharing obligations. (7) Any sponsor payments of participating patient cost-sharing obligations will cease upon the patient’s disenrollment from the clinical trial or the conclusion of the clinical trial, whichever is first. (8) The proposed arrangement for the payment of patient cost-sharing obligations includes the following elements to protect against improper increased costs or inappropriate utilization of items and services reimbursed in whole or in part under Federal health care programs: (A) The availability of cost-sharing subsidies will not be advertised, but may be disclosed as required or permitted by law in the informed consent forms, protocol, or other documentation associated with the study. (B) Participating Federal health care program beneficiaries must satisfy formal, objective, and predetermined enrollment criteria and execute an informed consent document. (C) The sponsor must enter into a written agreement with investigators that requires the investigators to comply with the written protocol for the study and to be subject to oversight and monitoring by an institutional review board or other similar body providing independent oversight for the trial. (D) Total enrollment for the trial is capped.