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he rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case.
You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101.
Medicare guidance says the Centers for Medicare and Medicaid Services (CMS) has an established policy for
patients with ESRD indicating that the dialysis center is responsible for laboratory services related to the
treatment of ESRD. Section 20.2 in Chapter 11 of the Medicare Benefit Policy Manual entitled "End Stage
Renal Disease (ESRD)" states: "All laboratory services furnished to individuals for the treatment of ESRD are
included in the ESRD PPS as Part B services and are not paid separately as of January 1, 2011. The laboratory
services include but are not limited to: Laboratory tests included under the composite rate as of December 31,
2010 (discussed below); and &bull; Former separately billable Part B laboratory tests that were billed by ESRD
facilities and independent laboratories for ESRD patients." Further clarification of the CMS policy is found
later in Section 20.2: "The distinction of what is considered to be a renal dialysis laboratory test is a clinical
decision determined by the ESRD patient's ordering practitioner. If a laboratory test is ordered for the
treatment of ESRD, then the laboratory test is not paid separately." "Payment for all renal dialysis laboratory
tests furnished under the ESRD PPS is made directly to the ESRD facility responsible for the patient's care.
The ESRD facility must furnish the laboratory tests directly or under arrangement and report renal dialysis
laboratory tests on the ESRD facility claim (with the exception of composite rate laboratory services)."
"Certain laboratory services will be subject to Part B consolidated billing requirements and will no longer be
separately payable when provided to ESRD beneficiaries by providers other than the ESRD facility. The list
below includes the renal dialysis laboratory tests that are routinely performed for the treatment of ESRD.
Payment for the laboratory tests identified on this list is included in the ESRD PPS. The laboratory tests listed
in the table are used to enforce consolidated billing edits to ensure that payment is not made for renal dialysis
laboratory tests outside of the ESRD PPS. The list of renal dialysis laboratory tests is not an all-inclusive list. If
any laboratory test is ordered for the treatment of ESRD, then the laboratory test is considered to be included in
the ESRD PPS and is the responsibility of the ESRD facility." To allow for separate reporting of laboratory
tests that are not related to ESRD treatment, CMS instructs provider to report modifier AY as specified in
Section 20.2.B of the same policy manual. CMS notes that "The AY modifier serves as an
attestation that the item or service is medically necessary for the patient but is not being used for the treatment
of ESRD. Refer to the NCD for Laboratory Tests - CRD Patients (190.10) (Accessed January 7, 2021),
Manual, Chapter 11, Section 20.2 - Laboratory Services. (Accessed January 7, 2021). You can find this guidance in the Centers for Medicare & Medicaid Services Medicare Processing Manual, Chapter 11 End Stage
Renal Disease (ESRD).
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com.