Medicare Regulations
42 Code of Federal Regulations
Part 414 – Medicare Part B
- See Word Doc in Cloud here.
- As amended, OPPS final rule, November 2019 for CY2020
42 CFR 414 Part “G” – Clinical Laboratory Diagnostic Tests
42 CFR 414.510 DATE OF SERVICE
§414.510 Laboratory date of
service for clinical laboratory and pathology specimens.
The date of service for either a clinical laboratory test or the
technical component of physician pathology service is as follows:
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(a) Except as provided under paragraph (b) of this section,
the date of service of the test must be the date the specimen was collected.
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(b)(1) If a specimen was collected over a period that spans
2 calendar days, then the date of service must be the date the collection
ended.
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(2) In the case of a test
performed on a stored specimen, if a specimen was stored for—
(i) Less than or equal to 30 calendar days from the date it was
collected, the date of service of the test must be the date the test was
performed only if—
(A) The test is ordered by the patient's physician at least 14
days following the date of the patient's discharge from the hospital;
(B) The specimen was collected while the patient was undergoing
a hospital surgical procedure;
(C) It would be medically inappropriate to have collected the
sample other than during the hospital procedure for which the patient was
admitted;
(D) The results of the test do not guide treatment provided
during the hospital stay; and
(E) The test was reasonable and medically necessary for the
treatment of an illness.
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(ii) More than
30 calendar days before testing, the specimen is considered to have been
archived and the date of service of the test must be the date the specimen
was obtained from storage.
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(3) In the case of a chemotherapy
sensitivity test performed on live tissue, the date of service of the test
must be the date the test was performed only if—
(i) The decision regarding the specific chemotherapeutic agents
to test is made at least 14 days after discharge;
(ii) The specimen was collected while the patient was undergoing
a hospital surgical procedure;
(iii) It would be medically inappropriate to have collected the
sample other than during the hospital procedure for which the patient was
admitted;
(iv) The results of the test do not guide treatment provided
during the hospital stay; and,
(v) The test was reasonable and medically necessary for the
treatment of an illness.
(4) For purposes of this section, “chemotherapy sensitivity
test” means a test identified by the Secretary as a test that requires a
fresh tissue sample to test the sensitivity of tumor cells to various
chemotherapeutic agents. The Secretary identifies such tests through program
instructions.
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(5) In the case of a molecular
pathology test
or a test designated by CMS as an
ADLT under paragraph (1) of the definition of an advanced diagnostic
laboratory test in §414.502, the date of service of the test must be the date
the test was performed only if—
(i) The test was performed following a hospital outpatient's
discharge from the hospital outpatient department;
(ii) The specimen was collected from a hospital outpatient
during an encounter (as both are defined in §410.2 of this chapter);
(iii) It was medically appropriate to have collected the sample
from the hospital outpatient during the hospital outpatient encounter;
(iv) The results of the test do not guide treatment provided
during the hospital outpatient encounter; and
(v) The test was reasonable and medically necessary for the
treatment of an illness.
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(5) In the case of
a molecular pathology test
^ PERFORMED BY A LABORATORY
OTHER THAN A BLOOD BANK OR CENTER,
[continues unchanged]
or a test designated by CMS as an
ADLT under paragraph (1) of the definition of an advanced diagnostic
laboratory test in §414.502, the date of service of the test must be the date
the test was performed only if—
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