Reimbursement and Coverage Implications of

The Washington State Medical Association recommends that the Centers for Medicare and Medicaid Services (CMS) and other third-party payers not deny coverage and reimbursement for the costs of medical care to patients entered in qualifying clinical trials of therapeutic regiments at any phase. Covered costs should include those usually covered (hospital care and physician and other health care services), as well as the costs of all FDA-approved agents utilized in the trial, regardless of whether use is for an on-label or off-label indication. Qualifying clinical trials must satisfy all of the following inclusion criteria:

1. Treatment is being provided pursuant to a clinical trial which has been approved by the Food and Drug Administration in the form of an investigational new drug exemption, the Department of Veterans Affairs, or a qualified nongovernmental research entity;
2. The proposed therapy has been reviewed and approved by a qualified institutional review board;
3. The facility and personnel providing the treatment are capable of doing so by virtue of their experience or training;
4. There is no non-investigational therapy that is clearly superior to the protocol treatment; and
5. The available clinical or preclinical data provide a reasonable expectation that the protocol treatment will be at least as efficacious as non-investigational therapy. (Res C-2, A-93) (Amended A-17)

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Abbreviations for House of Delegates report origination:

EC – Executive Committee; BT – Board of Trustees; CPA – Council on Professional Affairs; JC – Judicial Council; CHS – Community and Health Services