(Medicare Claims Processing Manual)

In this example,  the laboratory would use the per-mile travel  allowance basis  because the trained  technician traveled more than 20 eligible miles to one location for specimen collection.   To calculate the per -mile travel allowance amount, the laboratory would sum the eligible miles traveled to the  location  of Medicare beneficiaries  receiving  specimen  collection  services,  which, in this case is 45 miles from the laboratory to the SNF and 45 miles from the SNF returning to the laboratory, for a total of 90 eligible miles.   The eligible  miles  would then be  multiplied  by the travel  allowance mileage rate  of $1.13, yielding a  total of $101.70. This total amount  would then be prorated by dividing by the number  of Medicare beneficiaries  for whom a specimen collection fee is paid (6), yielding a per -beneficiary amount of $16.95 ($101.70/6 = $16.95) . To bill for the travel  allowance,  the laboratory would  submit  one claim  for each beneficiary  in the amount of $16.95 HCPCS code P9603.  Example  2: In another example, a trained technician travels 40 miles from a laboratory to the location of a Medicare beneficiary  to collect  a blood specimen  through venipuncture, then  travels 10  miles  to the location  of a non-  Medicare patient to collect a blood specimen through venipuncture, then travels 20 miles to the location of two Medicare  beneficiaries  to collect  urine  specimens  by catheterization,  and then travels  20 miles  to return to the laboratory.   In this example,  the laboratory would use the per-mile travel  allowance basis  because the trained  technician traveled to more than one location for specimen collection.   To calculate the per -mile travel allowance amount, the laboratory would sum the eligible miles, which would include the miles traveled from the laboratory to the locations of Medicare beneficiaries to collect specimens plus the miles back to the laboratory for specimen drop- off. Eligible miles would not include the 10 miles  traveled  to the location  of the non-Medicare patient  to collect  a specimen,  but would include  the 40 miles traveled from the laboratory to the location of the first Medicare beneficiary, the 20 miles to the location  of the two Medicare beneficiaries,  and the return  trip to the laboratory of 20 miles,  for a  total of  80 eligible miles.   The eligible  miles  would then be  multiplied  by the travel  allowance mileage rate  of $1.13, yielding a  total of $90.40. This total would then be prorated by dividing by three (3) Medicare beneficiaries for whom a specimen  collection  fee is paid, yielding an amount  of $30.13. The laboratory would  then submit  a claim using HCPCS code P9603 for travel allowance for each of the Medicare beneficiaries in the amount of $30.13. The laboratory would receive payment  for the eligible  miles  traveled  by the trained  technician, apportioned equally to each Medicare beneficiary for whom a specimen collection fee is paid.   Neither  the annual  deductible  nor the 20 percent  coinsurance  for Medicare apply to the travel  allowance amount for CDLTs.   70 - Clinical Laboratory Improvement Amendments (CLIA) Requirements  (Rev. 1, 10- 01-03) A3-3628.2, RHC -640, ESRD 322, HO -306, HHA -465, SNF 541, HO -437.2,  PM B -97-3  70.1 - Background  (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)  The Clinical Laboratory Improvements Amendments of 1988 (CLIA), Public Law 100-578, amended 353 of the Public Health Service Act (PHSA) to extend jurisdiction of the Department of Health and Human Services to regulate all laboratories that examine human s pecimens to provide information to assess, diagnose, prevent, or treat any disease or impairment.  The purpose of the CLIA program is to assure that laboratories testing specimens in interstate commerce consistently provide accurate procedures and services .  As a result of CLIA, any laboratory soliciting or accepting specimens in interstate commerce for laboratory testing is required to hold a valid license or letter of exemption from licensure issued by the Secretary of HHS.  The term interstate commerce means trade, traffic, commerce, transportation, or communication between any state, possession of the United States, the Commonwealth of Puerto Rico, or the District of Columbia, and any place outside thereof, or within the District of Columbia.   The CLIA mandates that virtually all laboratories, including physician office laboratories (POLs), meet applicable Federal requirements and have a CLIA certificate in order to receive reimbursement from Federal programs.  CLIA also lists requirements for laboratories performing only certain tests to be eligible for a certificate of waiver or a certificate for Physician Performed Microscopy Procedures (PPMP).  Since 1992, A/B MACs (B) have been instructed to deny clinical laboratory services billed by indepe ndent laboratories which did not meet the CLIA requirements.  POLs were excluded from the 1992 instruction but included in 1997.  The CLIA number must be included on each claim billed on the ASC X12 837 professional format or Form CMS -1500 claim for laboratory services by any laboratory performing tests covered by CLIA.  See 70.2 and 70.10 for more information.  70.2 - Billing (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)  See 70.10 for instructions for reporting the CLIA number.   70.3 - Verifying CLIA Certification  (Rev. 865, Issued:  02- 17-06; Effective:  01 -01-06; Implementation:  07 -03-06)  CWF edits A/B MAC (B) claims to ascertain that the laboratory identified by the CLIA number is certified to perform the test.  (CWF uses data supplied from the certification process.)  See Chapter 27 for related specifications.   Providers that bill A/B MACs (A) are responsible for verifying CLIA certification prior to ordering laboratory services under arrangement.  The survey process validates that these providers have procedures in place to insure that laboratory services are pr ovided by CLIA approved laboratories.   Refer to the Medicare State Operations Manual for information about CLIA license or the CLIA licensure exemptions.  70.4 - CLIA Numbers (Rev. 1, 10- 01-03) A3-3628.2.D   The structure of the CLIA number follows:   Positions 1 and 2 contain the State code (based on the laboratorys physical location at time of registration);  Position 3 contains the letter D"; and   Positions 4- 10 contain the unique CLIA system assigned number that identifies the laboratory.  (No other laboratory in the country has this number.)   Initially, providers are issued a CLIA number when they apply to the CLIA program.  Independent dialysis facilities must obtain a CLIA certificate in order to perform clotting time tests.   70.5 - CLIA Categories and Subcategories  (Rev. 11463; Issued: 06-23- 22; Effective: 07 -25-22; Implementation: 07 -25-22)  A laboratory may be licensed or exempted from licensure in several major categories of procedures.  These major categories are:   Category Number  Category/Subcategory Name  010 Histocompatibility  100 Microbiology  110 Bacteriology  115 Mycobacteriology  120 Mycology  130 Parasitology  140 Virology  150 Other Microbiology  200 Diagnostic Immunology  210 Syphilis Serology  220 General Immunology  300 Chemistry  310 Routine  320 Urinalysis  330 Endocrinology  340 Toxicology  350 Other  400 Hematology  500 Immuno -hematology  510 ABO Group and RH Type  520 Antibody Detection (Transfusion)  530 Antibody Detection (Non Transfusion)  540 Antibody Identification  550 Compatability Testing  560 Other  600 Pathology  610 Histopathology  620 Oral Pathology  630 Cytology  800 Radioassay  900 Clinical Cytogenics   Information regarding CLIA test complexity categorization can be found by searching the U.S. Food and Drug Administration website ( www.fda.gov).   70.6 - Certificate for Provider -Performed Microscopy Procedures  (Rev. 865, Issued:  02- 17-06; Effective:  01 -01-06; Implementation:  07- 03-06)  Effective January 19, 1993, a laboratory that holds a certificate for provider -performed microscopy procedures may perform only those tests specified as provider -performed microscopy procedures and waived tests, as described below, and no others.  HCPCS Code  Test Q0111 Wet mounts, including preparations of vaginal, cervical or skin specimens  Q0112 All potassium hydroxide (KOH) preparations  Q0113 Pinworm examinations  Q0114 Fern test  Q0115 Post-coital direct, qualitative examinations of vaginal or cervical mucous  81015 Urinalysis; microscopic only  81000 Urinalysis, by dipstick or tablet reagent for bilirubin, glucose, hemoglobin, ketones, leukocytes, nitrite, pH, protein, specific gravity, urobilinogen, any number of these constituents; non- automated, with microscopy  81001 Urinalysis, by dipstick or tablet reagent for bilirubin, glucose, hemoglobin, ketones, leukocytes, nitrite, pH, protein, specific gravity, urobilinogen, any number of these constituents; automated, with microscopy (NOTE: May only be used when the lab is using an automated dipstick urinalysis instrument approved as waived.)  81020 Urinalysis; two or three glass test 89055 Fecal leukocyte examination  89190 Nasal smears for eosinophils  G0027 Semen analysis; presence and/or motility of sperm excluding Huhner   70.7 - Deleted - Held for Expansion  (Rev. 1, 10- 01-03)  70.8 - Certificate of Waiver  (Rev. 11463; Issued: 06- 23-22; Effective: 07 -25-22; Implementation: 07 -25-22)  Effective September 1, 1992, all laboratory testing sites (except as provided in 42 CFR 493.3(b)) must have either a CLIA certificate of waiver, certificate for provider -performed microscopy procedures, certificate of registration, certificate of compliance, or certificate of accreditation to legally perform clinical laboratory testing on specimens from individuals in the United States.   The Food and Drug Administration approves CLIA waived tests on a flow basis.  The CMS identifies CLIA waived tests by providing an updated list of waived tests to the A/B MACs (A) and (B) on a quarterly basis via a Recurring Update Notification.  To be recognized as a waived test, some CLIA waived tests have unique HCPCS procedure codes and some must have a QW modifier included with the HCPCS code.  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).