Specimen Collection Fee

60.1 - Specimen Collection Fee (Rev. 13576; Issued: 01-08-26, Effective: 01-01-2026: Implementation: 01-05-2026) Section 1833(h)(3) of the Act specifies that the Secretary shall provide for and establish a nominal fee in addition to the payment amounts for CDLTs on the CLFS to cover the appropriate costs of collecting the sample on which a clinical diagnostic laboratory test (CDLT) was performed and for which payment is made with respect to samples collected in the same encounter. The nominal fee is intended to cover the appropriate costs in collecting the sample, which could include the costs related to drawing, collecting, or handling a specimen. Specimen Collection Fee Eligibility To be eligible for a specimen collection fee, the specimen must be: • used to perform a CDLT paid under the CLFS regulations at 42 CFR part 414, subpart G, § 414.523; • collected by a trained technician from a Medicare beneficiary who is homebound, as described in § 424.22(a)(1)(ii), or is a non-hospital inpatient, but only when no qualified personnel are available at the facility to collect the specimen; and, • of the following type—a blood specimen collected through venipuncture or a urine sample collected by catheterization. Trained Technician The phrase “trained technician” refers to those staff providing specimen collection services. However, “trained technician” does not mandate certain educational requirements and for the purposes of the specimen collection provisions, the term includes a phlebotomist. Specimen Collection Type A specimen collection fee is allowed in two circumstances: (1) drawing a blood sample through venipuncture (i.e., inserting into a vein a needle with syringe or vacutainer to draw the specimen) or (2) collecting a urine sample by catheterization. A specimen collection fee is not payable for any other specimen types, including blood samples where the cost of collecting the specimen is minimal (such as a throat culture or a routine capillary puncture for clotting or bleeding time). This fee will not be paid to anyone who has not extracted the specimen. Only one collection fee is allowed for each type of specimen for each patient encounter, regardless of the number of specimens drawn. This means that, if different types or multiple specimens are drawn from one patient, only one specimen collection fee would be allowed. Additionally, when a series of specimens is required to complete a single test (e.g., glucose tolerance test), the series is treated as a single encounter. Specimen Collection Fee Rate Effective January 1, 2026, CMS pays a general specimen collection fee of $9.34 for all specimens collected in one patient encounter. This fee is increased by $2 ($11.34) for specimen collection from a Medicare beneficiary in a skilled nursing facility (SNF) or on behalf of a home health agency (HHA) for all specimens collected in one patient encounter. Specimen Collection Fee Annual Update Beginning January 1, 2024, the specimen collection fee amount will update for each calendar year (CY) by the percent change in the Consumer Price Index for All Urban Consumers (CPI-U) (U.S city average) for the 12-month period ending June 30th of the year preceding the update year. CMS issues these updates to the specimen collection fee amounts through subregulatory guidance, specifically the existing CMS change request process, on an annual basis.