Medicare Program Integrity Manual (Pub. 100-08), Ch. 6 § 6.9.1
Medical Review of Diagnostic Laboratory Tests
6.9.1 – Medical Review of Diagnostic Laboratory Tests
(Rev. 850, Issued: 12-14-18; Effective: 12-17-18; Implementation: 12-17-18)
42 CFR §410.32 states that all diagnostic x-ray tests, diagnostic laboratory tests, and
other diagnostic tests must be ordered by the physician who is treating the beneficiary
and that tests not ordered by the physician who is treating the beneficiary are not
reasonable and necessary.
Pub. 100-02, Chapter 15, Section 80.6.1 states that while a physician order is not required
to be signed, the physician must clearly document, in the medical record, his or her intent
that the test be performed.
Contractors shall consider order requirements for diagnostic laboratory tests met if there
is:
1. A signed order or signed requisition listing the specific test; or
2. An unsigned order or unsigned laboratory requisition listing the specific tests to
be performed AND an authenticated medical record that supports the
physician/practitioner’s intent to order the tests (e.g. “order labs”, “check
blood”, “repeat urine”); or
3. An authenticated medical record that supports the physician/practitioner’s intent
to order the specific tests.
See Pub. 100-08, Chapter 3, Section 3.3.2.4 for authentication requirements.
Regardless of how the order requirements are met, contractors shall verify that the
supporting authenticated medical record documentation contains sufficient information
supporting the ordered/provided tests are reasonable and necessary per 42 CFR §410.32.
Note: As noted in Pub. 100-02, Chapter 15, Section 80.6.1, if the order is communicated
via telephone, both the treating physician/practitioner or his/her office, and the testing
facility must document the telephone call in their respective copies of the beneficiary’s
medical records.