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:
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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;
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The proposed therapy has been reviewed and approved by a qualified
institutional review board;
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The facility and personnel providing the treatment are capable of doing
so by virtue of their experience or training;
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There is no non-investigational therapy that is clearly superior to the
protocol treatment; and
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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-23)
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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