(Medicare Claims Processing Manual)

Information regarding CLIA test complexity categorization can be found by searching the U.S. Food and Drug Administration website ( www.fda.gov).  70.9 - HCPCS Subject To and Excluded From CLIA Edits  (Rev. 11463; Issued: 06-23- 22; Effective: 07 -25-22; Implementation: 07-25-22)  At this time, all claims submitted for laboratory tests subject to CLIA are edited at the CLIA certificate level.  However, the HCPCS codes that are considered a laboratory test under CLIA change each year.  The CMS identifies the new HCPCS (non -waived, non-provider-performed procedure) codes, including any modifiers that are subject to CLIA edits by providing an updated listing of these tests to the A/B MACs (A) and (B) on an annual basis via a Recurring Update Notification.  A facility that submits a claim for any test mentioned in the HCPCS codes that are subject to CLIA edits list must have either a valid, current CLIA certificate of registration (certificate type 9), a CLIA certificate of compliance (certificate type 1), or a CLIA certificate of accreditation (certificate type 3).   Information regarding CLIA test complexity categorization can be found by searching the U.S. Food and Drug Administration website ( www.fda.gov).  In addition, the CMS identifies the new HCPCS codes in the 80000 series that are excluded from CLIA edits by providing an updated listing of these tests to the A/B MACs (A) and (B) on an annual basis via a Recurring Update Notification.  No CLIA certificate is required for a claim submitted for any test mentioned in the HCPCS codes in the 80000 series that are excluded from CLIA edits list.  70.10 - CLIA Number Submitted on Claims from Independent Labs  (Rev. 3014, Issued: 08- 06-14, Effective: ICD - 10: Upon Implementation of ICD-10 ASC-X12: 01-01-12, Implementation: ICD- 10: Upon Implementation of ICD -10 ASC X12: 09 -08-14)  Effective with services provided October 1, 1997, any independent laboratory performing tests covered by CLIA must submit the CLIA number on the claim as provided below.  The CLIA number is reported in:   ASC X12 837 professional claim format REF segment as REF02, with qualifier of X4 in REF01, or   Field 23 of the paper CMS-1500.  The CLIA number is not required on the ASC X12 institutional claim data set or its related paper Form CMS -1450.  See Chapter 26 for detailed format instructions for the paper claim CMS -1500.  Laboratory claims submitted without the required CLIA number are returned as unprocessable.  If the CLIA number is submitted on the claim, but is inconsistent with the CLIA format, the A/B MAC (B) returns the claim as unprocessable.  If more than one CLIA number is submitted on the claim, except when a reference laboratory is on the same claim, the A/B MAC (B) returns the claim as unprocessable.   If the tests on one claim have been performed in more than one Physician Office Laboratory (POL) by the same physician, the appropriate CLIA number should be associated with the test that was performed in each laboratory.  In such a case, the physician mus t submit a separate claim for each location (CLIA number) where a test was performed.   70.10.1 - Physician Notification of Denials  (Rev.  3510, Issued: 04- 29-16, Effective:  10-01-16, Implementation; 10- 03-16)  If there is no CLIA number on the claim,  the contractor shall use the following remittance advice message and associated codes when rejecting/denying claims under this policy.  This CARC/RARC combination is compliant with CAQH CORE Business Scenario Two   Group Code: CO or PR  CARC: 16  RARC: MA120  MSN: N/A  70.11 - Reasons for Denial - Physician Office Laboratories Out -of-Compliance  (Rev.  3510, Issued: 04- 29-16, Effective:  10-01-16, Implementation; 10- 03-16)  The contractor shall use the following remittance advice message and associated codes when rejecting/denying claims under this policy.  This CARC/RARC combination is compliant with CAQH CORE Business Scenario Three.   Group Code: CO  CARC: B7  RARC: N/A  MSN: 14.1  80 - Issues Related to Specific Tests  (Rev. 1, 10- 01-03)  80.1 - Screening Services  (Rev. 1, 10- 01-03)  See chapter 18 for payment, edit and MSN requirements for the following screening services.    Screening Pap Smear and Pelvic Examination   Screening Prostate Tests   Colorectal Cancer Screening   80.2 - Anatomic Pathology Services (Rev. 1, 10- 01-03) A3-3628.1, SNF 541.1, HO -437.1, RHC -437, CIM 50.20.1, PM AB -98-7, AB -98-22, B-98-16, A -98-6, R103.CIM, A3- 4603.1   Clinical laboratory tests include some services described as anatomic pathology services in CPT (i.e., certain cervical, vaginal, or peripheral blood smears).  The CPT code 85060 is used only when a physician interprets an abnormal peripheral blood smear f or a hospital inpatient or a hospital outpatient, and the hospital is responsible for the technical component.  When an independent laboratory bills a physician interpretation of an abnormal peripheral blood smear, the service is considered a complete or g lobal service, and is not billed under the CPT code 85060.  A physician interpretation of an abnormal peripheral blood smear performed by an independent laboratory is considered a routine part of the ordered hematology service (i.e., those tests that include a different white blood count).  The HCPCS code 88150 (cervical or vaginal smears) included both screening and interpretation in CPT 1986 terminology while the CPT 1987 terminology includes only screening.  A new code, 88151, was added for those smears that require physician interpretatio n.  Code 88151 is treated and priced in the same manner as code 88150 was previously treated and priced.  Code 88151 with a  -26 modifier is paid when a physician performs an interpretation of an abnormal smear for a hospital inpatient or outpatient, and the hospital is responsible for the technical component.  The  -26 modifier for code 88150 is no longer recognized.  Code 88151(26) is priced as code 88150(26) would have been priced if the coding terminology had not been revised.  Independent laboratorie s bill under code 88150 for normal smears and under code 88151 for abnormal smears.  However, the fee schedule amount is equivalent.  80.2.1 - Technical Component (TC) of Physician Pathology Services to Hospital Patients  (Rev. 2714, Issued: 05- 24-13, Effective: 07 -01-12 Implementation: 06- 25, 13)   Section 542 of the Benefits Improvement and Protection Act of 2000 (BIPA) provides that the A/B MAC(B) can continue to pay for the TC of physician pathology services when an independent laboratory furnishes this service to an inpatient or outpatient of a covered hospital.  This provision applies to TC services furnished during the 2- year period beginning on January 1, 2001.  Administrative extensions of this provision, and new provisions established under Section 732 of the Medicare Modernization Act (MMA);  Section 104 of the Tax Relief and Health Care Act (TRHCA) of 2006; Section 104 of the Medicare, Medicaid and SCHIP Extension Act of 2007 (MMSEA); Section 136 of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA); Section 3104 of the Patient Protection and Affordable Care Act (PPACA); Section 105 of the Medicare & Medicaid Extenders Act of 2010 (MMEA); and Section 3006 of the Middle Class Tax Relief and Job Creation Act of 2012 (MCTRJCA) a llow the A/B MAC (B) to continue to pay for this service through June 30, 2012.  For this provision, covered hospital means a hospital that had an arrangement with an independent laboratory or other entity that was in effect as of July 22, 1999, under which the laboratory or other entity furnished the TC of physician pathology services to fee- for-service Medicare beneficiaries who were hospital inpatients or outpatients and submitted claims for payment for the TC to an A/B MAC (B).  The TC could have been submitted separately or combined with the professional component and reported as a combined service.   The term fee -for-service Medicare beneficiary means an individual who:   1. Is entitled to benefits under Part A or enrolled under Part B of title XVIII or both;   and  2. Is not enrolled in any of the following:  a. A Medicare + Choice plan under Part C of such title;   b. A plan offered by an eligible organization under 1876 of the Act;   c. A program of all- inclusive care for the elderly under 1894 of the Act; or  d. A social health maintenance organization demonstration project established under 4108(b) of the Omnibus Budget Reconciliation Act of 1987.  The following examples illustrate the application of the statutory provision to arrangements between hospitals and independent laboratories and/or other entities.  In implementing BIPA 542; MMA 732; TRHCA 104; MMSEA 104; MIPPA 136; and PPACA  3104; MMEA  105; and MCTRJCA  3006, the A/B MAC (B) should consider as independent laboratories any entity that it has previously recognized and paid as an independent laboratory as of July 22, 1999.  An independent laboratory that has acquired another independent laboratory that had an arrangement on July 22, 1999, with a covered hospital, can bill the TC of physician pathology services for that hospitals inpatients and outpatients under the physician fee schedule through June 30, 2012.   EXAMPLE 1:   Prior to July 22, 1999, independent laboratory A had an arrangement with a hospital in which this laboratory billed the A/B MAC (B) for the TC of physician pathology services.  In July 2000, independent laboratory B acquires independent laboratory A.  Independent laboratory B bills the A/B MAC (B) for the TC of physician pathology services for this hospitals patients in 2001 and forward.   If a hospital is a covered hospital, any independent laboratory that furnishes the TC of physician pathology services to that hospitals inpatients or outpatients can bill the A/B MAC (B) for these services furnished in 2001 and forward up to June 30, 2012 (see note below on last paragraph).   EXAMPLE 2:   As of July 22, 1999, the hospital had an arrangement with an independent laboratory, laboratory A, under which that laboratory billed the A/B MAC (B) for the TC of physician pathology service to hospital inpatients or outpatients.  In 2001, the hospital enters into an arrangement with a different independent laboratory, laboratory B, under which laboratory B wishes to bill its A/B MAC (B) for the TC of physician pathology services to hospital inpatients or outpatients.  Because the hospital is a covered hospital, independent laboratory B can bill its A/B MAC (B) for the TC of physician pathology services to hospital inpatients or outpatients.  If the arrangement between the independent laboratory and the covered hospital limited the provision of TC physician pathology services to certain situations or at particular times, then the independent laboratory can bill the A/B MAC (B) only for these li mited services.   An independent laboratory that furnishes the TC of physician pathology services to inpatients or outpatients of a hospital that is not a covered hospital may not bill the A/B MAC (B) for TC of physician pathology services furnished to patients of that hospital.   An independent laboratory or other entity that has an arrangement with a covered hospital should forward a copy of this agreement or other documentation to its A/B MAC (B) to confirm that an arrangement was in effect between the hospital and the independent laboratory as of July 22, 1999.  This documentation should be furnished for each covered hospital the independent laboratory or other entity services.  If the laboratory or other entity did not have an arrangement with the covered hospital as of July 22, 1999, but has subsequently entered into an arrangement, then it should obtain a copy of the arrangement between the predecessor laboratory or other entity and the covered hospital and furnish this to the A/B MAC (B).  The A/B MAC (B) maintains a hard copy of this documentation for postpayment reviews.