The 14-day rule or Date of Service rule is generally unpopular with oncologists and cancer patients and societies. Here are some recent (2024) positions from ASCO, AMA, CAP.
The topic is found on page 22 of a 40 page summary document from AMA.
The topic is also found on pages 136-137 of the longer meeting handbook.
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2024 AMA Governing Council Report (40pp)
https://www.ama-assn.org/system/files/i24-omss-report-a.pdf
See page 22 of 40 (aka Item 18).
RESOLVED, that our American Medical Association actively lobby the federal government to readdress and change laboratory date of service rules under Medicare, e.g. the Medicare 14-Day Laboratory Date of Service Rule (Medicare 14-Day Rule), such that complex laboratory services performed on pathologic specimens collected from an inpatient hospital procedure be paid separately from inpatient bundled payments, consistent with Outpatient rules. (Directive to Take Action).
Whereas, our American Medical Association adopted D-330.903 at I-17, which asks our AMA “actively lobby the federal government to change laboratory Date of Service rules under Medicare such that complex diagnostic laboratory services performed on pathologic specimens collected from a hospital procedure be paid separately from inpatient and outpatient bundled payments”; and
Whereas, AMA advocacy on the CY 2018 Medicare Outpatient Prospective Payment System Rule was successful in getting complex molecular testing unbundled from outpatient diagnostic procedures – such as outpatient interventional radiology biopsies; and
Whereas, the Medicare 14-Day Laboratory Date of Service Rule (Medicare 14-Day Rule) provides billing requirements for diagnostic tests ordered for Medicare patients and determines whether the clinical laboratory performing the tests will directly bill Medicare or bill the hospital where the specimen was collected; and
Whereas, the Medicare 14-Day Rule was not changed for specimens collected during an inpatient encounter, with complex molecular tests ordered within 14 days of hospital discharge continuing to be bundled into inpatient Medicare payments; and
Whereas, performing complex molecular tests on inpatient samples parallel the criteria established for unbundling testing of outpatient samples: including it being medically appropriate to have been collected during the hospital inpatient encounter, the results of the test not guiding treatment during the hospital inpatient encounter, and the test being reasonable and medically necessary for the treatment of an illness; and
Whereas, the real-world effect of an inpatient Medicare 14-Day Rule is to routinely delay the initiation, until 14 days after discharge, of complex molecular tests on pathologic samples collected during an acute hospitalization, such as cytology from an inpatient thoracentesis for a new diagnosis of lung cancer; and
Whereas, diagnostic delay of pivotal molecular data due to the inpatient Medicare 14-Day Rule causes harm to patients, such as forcing an initial round of an inferior cytotoxic chemotherapy on newly diagnosed lung cancer patients while awaiting candidacy for a more efficacious targeted agent; therefore be it
RESOLVED, that our American Medical Association actively lobby the federal government to readdress and change laboratory date of service rules under Medicare, e.g. the Medicare 14-Day Laboratory Date of Service Rule (Medicare 14-Day Rule), such that complex laboratory services performed on pathologic specimens collected from an inpatient hospital procedure be paid separately from inpatient bundled payments, consistent with Outpatient rules. (Directive to Take Action).
Fiscal Note: Modest – between $1,000 - $5,000
Received: 9/24/2024
REFERENCES
1. American
Medical Association. Follow-Up on Implementation of Resolutions and Report
Recommendations, AMA House of
Delegates Interim Meeting - November 8-11, 2017. https://www.ama-assn.org/system/files/2018-11/i17-followup-status-
report_0.pdf
2. Centers for Medicare
& Medicaid Services. Laboratory Date of Service Policy. https://www.cms.gov/medicare/payment/fee- 
schedules/clinical-laboratory-fee-schedule-clfs/date-service-policy
3. Foundation Medicine. 14-Day Rule Billing
Requirements for Foundation Medicine Tests.
https://www.foundationmedicine.com/sites/default/files/media/documents/2024-
08/14%20Day%20Medicaid%20Rule_One%20Pager_LaboratoryDateOfService_June%202024_US-PF-2200092_R4.pdf
RELEVANT AMA POLICY
Elimination of Laboratory 14-Day Rules Under Medicare
D-330.903
Medicare such that complex diagnostic laboratory services performed on pathologic specimens collected from a hospital procedure be paid separately from inpatient and outpatient bundled payments
