Clinical Trials CIM Revision Added

Original Effective Date: 07/01/2001
Revision Effective Date: 11/01/2013

Coverage Issues Manual, Section 30-1, Routine Costs of Clinical Trials, created a new section to implement new policy to cover routine costs in clinical trials. This policy is in accordance with the June 7, 2000, executive memorandum from the President of the United States to provide coverage of routine patient care costs in clinical trials.

This national coverage policy is based on the authority found in §1862(a)(1)(E) of the Social Security Act (the Act). It is binding on all Medicare carriers, intermediaries, peer review organizations, health maintenance organizations, competitive medical plans, health care prepayment plans, and Medicare+Choice organizations (§1852(a)(1)(A) of the Act). In addition, an administrative law judge may not disregard, set aside, or otherwise review a national coverage decision issued under §1862(a)(1) of the Act. 42 C.F.R. §405.860.

See Chapter 10 of the DMERC Region D Supplier Manual for the complete text of this national policy. The policy is effective for services rendered on or after September 19, 2000.

            Last Updated Fri, 05 May 2017 13:14:51 +0000