evekhm/cms_iom_500 huggingface dataset:
(Medicare Claims Processing Manual)
Calculation:  Per-mile Travel  Allowance  Basis   The calculation  for the per-mile travel  allowance amount  is equal  the number  of eligible  miles  multiplied  by the travel allowance mileage rate, divided by the number of beneficiaries for whom a specimen collection fee is paid.   To calculate the per-mile travel  allowance amount, the laboratory would first calculate the total number  of eligible miles that the trained technician traveled  this would be the total number of miles traveled by the trained technician to locations where one or more Medicare beneficiaries received specimen collection services and back to the laboratory where the technician returns the specimen(s) for testing.  The eligible  miles  would be multiplied  by the travel  allowance mileage  rate as described  above, then divided by the number of beneficiaries for whom a specimen collection fee is paid.  This quotient yields a prorated travel allowance amount for each beneficiary.  The laboratory receives payment for the total number of eligible miles traveled for specimen collection, apportioned equally to each Medicare beneficiary for whom a specimen collection fee is paid.  The laboratory then submits a claim billing HCPCS code P9603 for payment of the per -mile travel allowance amount for each beneficiary for whom a specimen collection fee is paid.  Examples:  Per-mile Travel  Allowance  Amount  Calculation Example 1:  For an example of the per-mile travel  allowance amount  calculation,  consider  a trained  technician  traveling 45 miles  from  a laboratory in a city to a rural SNF,  collecting  blood specimens  through venipuncture  from  6 Medicare beneficiaries, and then driving 45 miles to return to the laboratory.  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.
(Medicare Claims Processing Manual)
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.
(Medicare Claims Processing Manual)
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.
(Medicare Claims Processing Manual)
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
(Medicare Claims Processing Manual)
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)
(Medicare Claims Processing Manual)
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.
(Medicare Claims Processing Manual)
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).
(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).  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.
(Medicare Claims Processing Manual)
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
(Medicare Claims Processing Manual)
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)
(Medicare Claims Processing Manual)
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
(Medicare Claims Processing Manual)
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: