procedure Code Description
85610 Prothrombin time
CMS (Medicare) has determined that Prothrombin Time (procedure Code 85610) is only medically necessary and, therefore, reimbursable by Medicare when ordered for patients with any of the diagnostic conditions listed below in the “ICD-9-CM Codes Covered by Medicare Program.” If you are ordering this test for a diagnostic condition other than those listed below, please have your patient sign and date an Advanced Beneficiary Notice (ABN). All ICD-9-CM codes provided must be consistent with the documentation in the patient’s medical records for the date of service.
NOTE: Please be aware that it is not enough to link the procedure code to a correct, payable ICD-9-CM diagnosis code. The diagnosis must be present for the procedure to be paid. In addition, the procedure must be reasonable and necessary for that diagnosis. Documentation within the beneficiary's medical record must support the necessity for the test(s) provided for each date of service. For additional information, see the “Limited Coverage Guidebook Information” provided in this section.
Note: Since the INR is a calculation, it will not be paid separately from or in addition to the PT, but is considered part of the conventional prothrombin time, 85610.
Description
Basic plasma coagulation function is readily assessed with a few simple laboratory tests: the Partial Thromboplastin Time (PTT), Prothrombin Time (PT), Thrombin Time (TT), or a quantitative fibrinogen determination. The PT test is one in-vitro laboratory test used to assess coagulation. While the PTT assesses the intrinsic limb of the coagulation system, the PT assesses the extrinsic or tissue factor dependent pathway. Both tests also evaluate the common coagulation pathway involving all the reactions that occur after the activation of factor X. Extrinsic pathway factors are produced in the liver and their production is dependent on adequate vitamin K activity. Deficiencies of factors may be related to decreased production or increased consumption of coagulation factors. The PT/INR is most commonly used to measure
the effect of warfarin and regulate its dosing. Warfarin blocks the effect of vitamin K on hepatic production of extrinsic pathway factors.
A PT is expressed in seconds and/or as an international normalized ratio (INR). The INR is the PT ratio that would result if the WHO reference thromboplastin was used in performing the test. Current medical information does not clarify the role of laboratory PT testing in patients who are self monitoring. Therefore, the indications for testing apply regardless of whether or not the patient is also PT self-testing.
What is the payment amount for PT/INR testing in those instances in which Medicare coverage in available?
Medicare payment will be based on the Part B Clinical Laboratory Fee Schedule amount. In 2016, the Medicare NLA for PT/INR testing (85610) is $5.36. See page 11 for the 2016 payment amount for specific states.
A nurse in a physician’s office performs a PT/INR test as ordered by the treating physician with a CoaguChek XS System for Professional Use. During the encounter, the nurse briefly examines the patient and observes that the patient has a number of bruises. The PT/INR result is outside of the target range for the patient. On brief history, the patient advises the nurse that he has changed his diet recently and has reduced his intake of green leafy vegetables. The nurse reviews the necessary dietary restrictions and treatment regimen with the patient, discusses necessary changes in warfarin dosing, and documents the discussion and the provision of these services in the patient’s medical record. The treating physician, who is on site but does not see the patient, is supervising the nurse and agrees with the recommended changes in the patient’s course of treatment.
In addition to reporting the PT/INR test—CPT code 85610—the physician may be able to bill for the incident to E/M services provided by the nurse, as long as the E/M services were medically necessary. Only one E/M code may be billed for a visit. Because the nurse is a nonphysician employee as specified by Medicare, the low level E/M code, 99211, if substantiated, may be appropriate to report. Only one E/M code may be billed for a visit.
CLIA: Laboratory Tests related denials - CO-B7
Denial Reason, Reason/Remark Code(s):
• CO-B7: This provider was not certified/eligible to be paid for this procedure/service on this date of service
• procedure codes include: 82947 and 85610
Resolution
• HCPCS modifier QW must be submitted with certain clinical laboratory tests that are waived from the Clinical Laboratory Improvement Amendments of 1988 (CLIA) list. The Food and Drug Administration (FDA) determines which laboratory tests are waived.
• Note: Not all CLIA-waived tests require HCPCS modifier QW
• Determine if the CPT code is a waived test by accessing the CMS CLIA Web page
• Palmetto GBA will publish information on tests newly classified as 'waived' on our Web site. Please note, the list of CLIA-waived procedures is updated as often as quarterly.
• The CLIA certificate number is also required on claims for CLIA waived tests. Submit this information in Loop 2300 or 2400, REF/X4, 02 for electronic claims. For paper claims, submit the CLIA certification number in Item 23 of the CMS-1500 claim form.
• Access complete instructions for correctly submitting HCPCS modifier QW in the Palmetto GBA Modifier Lookup tool:
o Jurisdiction 1: Select 'Articles' on the left side of the Palmetto GBA Web page
o Ohio, South Carolina and West Virginia: Select 'Browse by Topic' on the left side of the Palmetto GBA Web page
85610 Prothombintime
85610QW April 15, 2010 CoaguSense Self-Test Prothrombin Time/INR Monitoring System (Prescription Home Use)
CMS (Medicare) has determined that Prothrombin Time (CPT Code 85610) is only medically necessary and, therefore, reimbursable by Medicare when ordered for patients with any of the diagnostic conditions listed below in the “ICD-9-CM Codes Covered by Medicare Program.” If you are ordering this test for a diagnostic condition other than those listed below, please have your patient sign and date an Advanced Beneficiary Notice (ABN). All ICD-9-CM codes provided must be consistent with the documentation in the patient’s medical records for the date of service.
NOTE: Please be aware that it is not enough to link the procedure code to a correct, payable ICD-9-CM diagnosis code. The diagnosis must be present for the procedure to be paid. In addition, the procedure must be reasonable and necessary for that diagnosis. Documentation within the beneficiary's medical record must support the necessity for the test(s) provided for each date of service. For additional information, see the “Limited Coverage Guidebook Information” provided in this section.
Note: Since the INR is a calculation, it will not be paid separately from or in addition to the PT, but is considered part of the conventional prothrombin time, 85610.
Modifier QW
Description CLIA-waived test
The QW modifier is generally required on Medicare reimbursement claims when performing CLIA-waived tests.
Laboratories with a CLIA certificate of waiver are permitted to perform only CLIA-waived tests. May a provider bill an additional code for obtaining a blood sample by means of capillary (finger, heel ear) access?No. Medicare does not reimburse for finger stick specimen collection. Note: Medicare does reimburse for venous blood sample access, when necessary and appropriate.
Scenario B
A nurse in a physician’s office performs a PT/INR test as ordered by the treating physician with a CoaguChek XS System for Professional Use. During the encounter, the nurse briefly examines the patient and observes that the patient has a number of bruises. The PT/INR result is outside of the target range for the patient. On brief history, the patient advises the nurse that he has changed his diet recently and has reduced his intake of green leafy vegetables. The nurse reviews the necessary dietary restrictions and treatment regimen with the patient, discusses necessary changes in warfarin dosing, and documents the discussion and the provision of these services in the patient’s medical record. The treating physician, who is on site but does not see the patient, is supervising the nurse and agrees with the recommended changes in the patient’s course of treatment.
In addition to reporting the PT/INR test—CPT code 85610—the physician may be able to bill for the incident to E/M services provided by the nurse, as long as the E/M services were medically necessary. Only one E/M code may be billed for a visit. Because the nurse is a nonphysician employee as specified by Medicare, the low level E/M code, 99211, if substantiated, may be appropriate to report. Only one E/M code may be billed for a visit.
This scenario applies to any nonphysician employee of the physician, working within the scope of practice allowed in their state. Medically necessary PT/ INR testing and significant, separately identifiable and medically necessary face-to-face E/M services are eligible for reimbursement under Medicare.
Contrast this with the previous scenario, in which staff members had to receive the results, assess the risk factors, review the results and treatment regimen with the treating physician, call the patient to report the results and any change of regimen, and document and review the additional complaints presented during the phone call with the treating physician--all with no potential for additional reimbursement because the requirements to report a separately, identifiable E/M service were not met.
CPT CODE(S) TEST NAME MANUFACTURER USE 85018QW
4. Clarity HbCheck Hemoglobin Testing System Acon Laboratories, Inc. Measures hemoglobin level in whole blood
5. HemoCue Donor Hemoglobin Checker System HemoCue HemoCue, Inc.
6. HemoCue Hemoglobin System HemoCue, Inc.
7. HemoCue Hemoglobin 201+ (Capillary, Venous, Arterial Whole Blood) HemoCue, Inc.
8. HemoCue Hemoglobin 201+/HemoCue Hemoglobin Microcuvette System HemoCue, Inc.
9. HemoCue Hb 301 System HemoCue, Inc.
10. GDS Diagnostics HemoSite Meter - for hemoglobin GDS Technology, Inc.
11. GDS Technology STAT-Site MHgb Test System
GDS Technology
85576QW Accumetrics VerifyNow Aspirin Assay Accumetrics Inc. Qualitative assay to measure platelet aggregation
85610QW (Contact your Medicare carrier for claims instructions.)
1. AlereINRatio®2 PT/INR Home Monitoring System {Prescription Home Use} Alere San Diego, Inc. Aid in screening for congenital deficiencies of Factors II, V, VII, X; screen for deficiency of prothrombin; evaluate heparin effect, coumadin or warfarin effect; screen for Vitamin K deficiency
2. AvoSure PT System (prescription home use) Avocet Medical, Inc.
3. AvoSure Pro (professional use) Avocet Medical, Inc.
4. CoaguChek PST for Prothrombin Time Boehringer Mannheim Corporation
5. Coag-Sense Prothrombin Time (PT/INR) Monitoring system (Professional use) CoaguSense, Inc. 85610QW (cont.) (Contact your Medicare carrier for claims instructions.)
6. CoaguSense Self-Test Prothrombin Time/INR Monitoring System (Prescription Home Use) CoaguSense, Inc. Aid in screening for congenital deficiencies of Factors II, V, VII, X; screen for deficiency of prothrombin; evaluate heparin effect, coumadin or warfarin effect; screen for Vitamin K deficiency
7. HemoSense INRatio System HemoSense, Inc.
8. ITC Protime Microcoagulation System for Prothrombin Time International Technidyne Corporation (ITC)
9. International Technidyne ProTime Microcoagulation System (ProTime 3 Cuvette) Prescription Home Use International Technidyne Corporation
10. International Technidyne ProTime Microcoagulation System (ProTime 3 Cuvette) Professional Use International Technidyne Corporation
11. Lifescan Harmony? INR Monitoring System -- Prescription Home Use and Professional Use Lifescan, Inc.
12. Roche/Boehringer Mannheim CoaguChek System for Professional Use Roche Diagnostics/ Boehringer Mannheim Corporation
13. Roche Diagnostics Coaguchek PST Roche Diagnostics
14. Roche Diagnostics Coagu Chek S Systems Test (for prothrombin time) Roche Diagnostics
15. Roche Diagnostics CoaguChek XS Roche Diagnostics
16. Roche Diagnostics CoaguChek XS
85610 Prothrombin time
CMS (Medicare) has determined that Prothrombin Time (procedure Code 85610) is only medically necessary and, therefore, reimbursable by Medicare when ordered for patients with any of the diagnostic conditions listed below in the “ICD-9-CM Codes Covered by Medicare Program.” If you are ordering this test for a diagnostic condition other than those listed below, please have your patient sign and date an Advanced Beneficiary Notice (ABN). All ICD-9-CM codes provided must be consistent with the documentation in the patient’s medical records for the date of service.
NOTE: Please be aware that it is not enough to link the procedure code to a correct, payable ICD-9-CM diagnosis code. The diagnosis must be present for the procedure to be paid. In addition, the procedure must be reasonable and necessary for that diagnosis. Documentation within the beneficiary's medical record must support the necessity for the test(s) provided for each date of service. For additional information, see the “Limited Coverage Guidebook Information” provided in this section.
Note: Since the INR is a calculation, it will not be paid separately from or in addition to the PT, but is considered part of the conventional prothrombin time, 85610.
Description
Basic plasma coagulation function is readily assessed with a few simple laboratory tests: the Partial Thromboplastin Time (PTT), Prothrombin Time (PT), Thrombin Time (TT), or a quantitative fibrinogen determination. The PT test is one in-vitro laboratory test used to assess coagulation. While the PTT assesses the intrinsic limb of the coagulation system, the PT assesses the extrinsic or tissue factor dependent pathway. Both tests also evaluate the common coagulation pathway involving all the reactions that occur after the activation of factor X. Extrinsic pathway factors are produced in the liver and their production is dependent on adequate vitamin K activity. Deficiencies of factors may be related to decreased production or increased consumption of coagulation factors. The PT/INR is most commonly used to measure
the effect of warfarin and regulate its dosing. Warfarin blocks the effect of vitamin K on hepatic production of extrinsic pathway factors.
A PT is expressed in seconds and/or as an international normalized ratio (INR). The INR is the PT ratio that would result if the WHO reference thromboplastin was used in performing the test. Current medical information does not clarify the role of laboratory PT testing in patients who are self monitoring. Therefore, the indications for testing apply regardless of whether or not the patient is also PT self-testing.
PROTHROMBIN TIME (PT) (procedure 85610)
ICD-10 Description ICD-10 ICD-9
Abnormal Coagulation Profile R79.1 790.92
Atherosclerotic Heart Disease of Native Coronary Artery without Angina
Pectoris I25.10 414
Encounter for Therapeutic Drug Level Monitoring Z51.81 V58.83
Heart Failure, Unspecified I50.9 428
Long-Term (Current) Use of Anticoagulants Z79.01 V58.61
Nutritional Anemia, Unspecified D53.9 281.9
Unspecified Atrial Fibrillation I48.91 427.31
UnitedHealthcare Community Plan reimburses for Prothrombin Time (procedure code 85610), when the claim indicates a code found on the list of approved diagnosis codes for this test. UnitedHealthcare Community Plan will not reimburse when the treatment rendered is without inclusion of one of the ICD-9-CM and ICD- 10CM diagnostic codes being included on the claim accurately reflecting the member's condition.
Modifiers are often added to a procedure code to provide further information about a service provided. The QW modifier indicates that the laboratory test performed was CLIA-waived.
The QW modifier is generally required on Medicare reimbursement claims when performing CLIA-waived tests.
ICD-10 Description ICD-10 ICD-9
Abnormal Coagulation Profile R79.1 790.92
Atherosclerotic Heart Disease of Native Coronary Artery without Angina
Pectoris I25.10 414
Encounter for Therapeutic Drug Level Monitoring Z51.81 V58.83
Heart Failure, Unspecified I50.9 428
Long-Term (Current) Use of Anticoagulants Z79.01 V58.61
Nutritional Anemia, Unspecified D53.9 281.9
Unspecified Atrial Fibrillation I48.91 427.31
UnitedHealthcare Community Plan reimburses for Prothrombin Time (procedure code 85610), when the claim indicates a code found on the list of approved diagnosis codes for this test. UnitedHealthcare Community Plan will not reimburse when the treatment rendered is without inclusion of one of the ICD-9-CM and ICD- 10CM diagnostic codes being included on the claim accurately reflecting the member's condition.
Modifiers are often added to a procedure code to provide further information about a service provided. The QW modifier indicates that the laboratory test performed was CLIA-waived.
The QW modifier is generally required on Medicare reimbursement claims when performing CLIA-waived tests.
What is the payment amount for PT/INR testing in those instances in which Medicare coverage in available?
Medicare payment will be based on the Part B Clinical Laboratory Fee Schedule amount. In 2016, the Medicare NLA for PT/INR testing (85610) is $5.36. See page 11 for the 2016 payment amount for specific states.
A nurse in a physician’s office performs a PT/INR test as ordered by the treating physician with a CoaguChek XS System for Professional Use. During the encounter, the nurse briefly examines the patient and observes that the patient has a number of bruises. The PT/INR result is outside of the target range for the patient. On brief history, the patient advises the nurse that he has changed his diet recently and has reduced his intake of green leafy vegetables. The nurse reviews the necessary dietary restrictions and treatment regimen with the patient, discusses necessary changes in warfarin dosing, and documents the discussion and the provision of these services in the patient’s medical record. The treating physician, who is on site but does not see the patient, is supervising the nurse and agrees with the recommended changes in the patient’s course of treatment.
In addition to reporting the PT/INR test—CPT code 85610—the physician may be able to bill for the incident to E/M services provided by the nurse, as long as the E/M services were medically necessary. Only one E/M code may be billed for a visit. Because the nurse is a nonphysician employee as specified by Medicare, the low level E/M code, 99211, if substantiated, may be appropriate to report. Only one E/M code may be billed for a visit.
CLIA: Laboratory Tests related denials - CO-B7
Denial Reason, Reason/Remark Code(s):
• CO-B7: This provider was not certified/eligible to be paid for this procedure/service on this date of service
• procedure codes include: 82947 and 85610
Resolution
• HCPCS modifier QW must be submitted with certain clinical laboratory tests that are waived from the Clinical Laboratory Improvement Amendments of 1988 (CLIA) list. The Food and Drug Administration (FDA) determines which laboratory tests are waived.
• Note: Not all CLIA-waived tests require HCPCS modifier QW
• Determine if the CPT code is a waived test by accessing the CMS CLIA Web page
• Palmetto GBA will publish information on tests newly classified as 'waived' on our Web site. Please note, the list of CLIA-waived procedures is updated as often as quarterly.
• The CLIA certificate number is also required on claims for CLIA waived tests. Submit this information in Loop 2300 or 2400, REF/X4, 02 for electronic claims. For paper claims, submit the CLIA certification number in Item 23 of the CMS-1500 claim form.
• Access complete instructions for correctly submitting HCPCS modifier QW in the Palmetto GBA Modifier Lookup tool:
o Jurisdiction 1: Select 'Articles' on the left side of the Palmetto GBA Web page
o Ohio, South Carolina and West Virginia: Select 'Browse by Topic' on the left side of the Palmetto GBA Web page
85610 Prothombintime
85610QW April 15, 2010 CoaguSense Self-Test Prothrombin Time/INR Monitoring System (Prescription Home Use)
CMS (Medicare) has determined that Prothrombin Time (CPT Code 85610) is only medically necessary and, therefore, reimbursable by Medicare when ordered for patients with any of the diagnostic conditions listed below in the “ICD-9-CM Codes Covered by Medicare Program.” If you are ordering this test for a diagnostic condition other than those listed below, please have your patient sign and date an Advanced Beneficiary Notice (ABN). All ICD-9-CM codes provided must be consistent with the documentation in the patient’s medical records for the date of service.
NOTE: Please be aware that it is not enough to link the procedure code to a correct, payable ICD-9-CM diagnosis code. The diagnosis must be present for the procedure to be paid. In addition, the procedure must be reasonable and necessary for that diagnosis. Documentation within the beneficiary's medical record must support the necessity for the test(s) provided for each date of service. For additional information, see the “Limited Coverage Guidebook Information” provided in this section.
Note: Since the INR is a calculation, it will not be paid separately from or in addition to the PT, but is considered part of the conventional prothrombin time, 85610.
Modifier QW
Description CLIA-waived test
The QW modifier is generally required on Medicare reimbursement claims when performing CLIA-waived tests.
Laboratories with a CLIA certificate of waiver are permitted to perform only CLIA-waived tests. May a provider bill an additional code for obtaining a blood sample by means of capillary (finger, heel ear) access?No. Medicare does not reimburse for finger stick specimen collection. Note: Medicare does reimburse for venous blood sample access, when necessary and appropriate.
Scenario B
A nurse in a physician’s office performs a PT/INR test as ordered by the treating physician with a CoaguChek XS System for Professional Use. During the encounter, the nurse briefly examines the patient and observes that the patient has a number of bruises. The PT/INR result is outside of the target range for the patient. On brief history, the patient advises the nurse that he has changed his diet recently and has reduced his intake of green leafy vegetables. The nurse reviews the necessary dietary restrictions and treatment regimen with the patient, discusses necessary changes in warfarin dosing, and documents the discussion and the provision of these services in the patient’s medical record. The treating physician, who is on site but does not see the patient, is supervising the nurse and agrees with the recommended changes in the patient’s course of treatment.
In addition to reporting the PT/INR test—CPT code 85610—the physician may be able to bill for the incident to E/M services provided by the nurse, as long as the E/M services were medically necessary. Only one E/M code may be billed for a visit. Because the nurse is a nonphysician employee as specified by Medicare, the low level E/M code, 99211, if substantiated, may be appropriate to report. Only one E/M code may be billed for a visit.
This scenario applies to any nonphysician employee of the physician, working within the scope of practice allowed in their state. Medically necessary PT/ INR testing and significant, separately identifiable and medically necessary face-to-face E/M services are eligible for reimbursement under Medicare.
Contrast this with the previous scenario, in which staff members had to receive the results, assess the risk factors, review the results and treatment regimen with the treating physician, call the patient to report the results and any change of regimen, and document and review the additional complaints presented during the phone call with the treating physician--all with no potential for additional reimbursement because the requirements to report a separately, identifiable E/M service were not met.
CPT CODE(S) TEST NAME MANUFACTURER USE 85018QW
4. Clarity HbCheck Hemoglobin Testing System Acon Laboratories, Inc. Measures hemoglobin level in whole blood
5. HemoCue Donor Hemoglobin Checker System HemoCue HemoCue, Inc.
6. HemoCue Hemoglobin System HemoCue, Inc.
7. HemoCue Hemoglobin 201+ (Capillary, Venous, Arterial Whole Blood) HemoCue, Inc.
8. HemoCue Hemoglobin 201+/HemoCue Hemoglobin Microcuvette System HemoCue, Inc.
9. HemoCue Hb 301 System HemoCue, Inc.
10. GDS Diagnostics HemoSite Meter - for hemoglobin GDS Technology, Inc.
11. GDS Technology STAT-Site MHgb Test System
GDS Technology
85576QW Accumetrics VerifyNow Aspirin Assay Accumetrics Inc. Qualitative assay to measure platelet aggregation
85610QW (Contact your Medicare carrier for claims instructions.)
1. AlereINRatio®2 PT/INR Home Monitoring System {Prescription Home Use} Alere San Diego, Inc. Aid in screening for congenital deficiencies of Factors II, V, VII, X; screen for deficiency of prothrombin; evaluate heparin effect, coumadin or warfarin effect; screen for Vitamin K deficiency
2. AvoSure PT System (prescription home use) Avocet Medical, Inc.
3. AvoSure Pro (professional use) Avocet Medical, Inc.
4. CoaguChek PST for Prothrombin Time Boehringer Mannheim Corporation
5. Coag-Sense Prothrombin Time (PT/INR) Monitoring system (Professional use) CoaguSense, Inc. 85610QW (cont.) (Contact your Medicare carrier for claims instructions.)
6. CoaguSense Self-Test Prothrombin Time/INR Monitoring System (Prescription Home Use) CoaguSense, Inc. Aid in screening for congenital deficiencies of Factors II, V, VII, X; screen for deficiency of prothrombin; evaluate heparin effect, coumadin or warfarin effect; screen for Vitamin K deficiency
7. HemoSense INRatio System HemoSense, Inc.
8. ITC Protime Microcoagulation System for Prothrombin Time International Technidyne Corporation (ITC)
9. International Technidyne ProTime Microcoagulation System (ProTime 3 Cuvette) Prescription Home Use International Technidyne Corporation
10. International Technidyne ProTime Microcoagulation System (ProTime 3 Cuvette) Professional Use International Technidyne Corporation
11. Lifescan Harmony? INR Monitoring System -- Prescription Home Use and Professional Use Lifescan, Inc.
12. Roche/Boehringer Mannheim CoaguChek System for Professional Use Roche Diagnostics/ Boehringer Mannheim Corporation
13. Roche Diagnostics Coaguchek PST Roche Diagnostics
14. Roche Diagnostics Coagu Chek S Systems Test (for prothrombin time) Roche Diagnostics
15. Roche Diagnostics CoaguChek XS Roche Diagnostics
16. Roche Diagnostics CoaguChek XS
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