Notification

Home Prothrombin Time Monitoring


Notification Issue Date: 04/03/2018

This version of the policy will become effective 07/02/2018.

The following ICD-10 CM codes have been added to this policy:

  • I27.24 Chronic thromboembolic pulmonary hypertension
  • I80.8 Phlebitis and thrombophlebitis of other sites

The following ICD-10 CM code has been removed from this policy:
  • I48.91 Unspecified atrial fibrillation



Medical Policy Bulletin


Title:Home Prothrombin Time Monitoring

Policy #:05.00.26g

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

Prothrombin time monitor for home anticoagulation management, when prescribed by a treating professional provider, is considered medically necessary and, therefore, covered when all of the following criteria are met:
  • The individual has one of the following that requires chronic oral anticoagulation: a mechanical heart valve (which is not porcine), chronic atrial fibrillation, or venous thromboembolism (which includes deep venous thrombosis [DVT] and pulmonary embolism).
  • The individual must have been anticoagulated on warfarin (Coumadin®) for at least 3 months immediately preceding the use of the home monitor.
  • The professional provider must ensure that the individual will undergo a face-to-face educational program on anticoagulation management and the use of the monitor and supplies prior to its use in the home. The individual agrees to continue to correctly use the monitor and supplies following the initiation of home monitoring.
  • Self-testing with a prothrombin time monitor for home will not need to occur more frequently than once a week

Test materials, as well as professional provider review, interpretation, and individual management, are limited to one unit of service (4 tests) every four weeks. Test materials, as well as professional provider review, interpretation, and individual management performed more frequently than once every four weeks, are considered not medically necessary, and, therefore, not covered.

All other uses for the prothrombin time monitor for home anticoagulation are considered not medically necessary and, therefore, not covered because the available published peer-reviewed literature does not support their use in the diagnosis or treatment of illness or injury.

REQUIRED DOCUMENTATION

The Company may conduct reviews and audits of services to our members regardless of the participation status of the provider. Medical record documentation must be maintained on file to reflect the medical necessity of the care and services provided. These medical records may include but are not limited to: records from the professional provider’s office, hospital, nursing home, home health agencies, therapies, and test reports. This policy is consistent with Medicare's documentation requirements, including the following required documentation:

PRESCRIPTION (ORDER) REQUIREMENTS
Before submitting a claim to the Company, the supplier must have on file a timely, appropriate, and complete order for each item billed that is signed and dated by the professional provider who is treating the member. Requesting a provider to sign a retrospective order at the time of an audit or after an audit for submission as an original order, reorder, or updated order will not satisfy the requirement to maintain a timely professional provider order on file.

PROOF OF DELIVERY
Medical record documentation must include a contemporaneously prepared delivery confirmation or member’s receipt of supplies and equipment. The medical record documentation must include a copy of delivery confirmation if delivered by a commercial carrier and a signed copy of delivery confirmation by member/caregiver if delivered by the supplier/provider. All documentation is to be prepared contemporaneous with delivery and be available to the Company upon request.

CONSUMABLE SUPPLIES
The durable medical equipment (DME) supplier must monitor the quantity of accessories and supplies an individual is actually using. Contacting the individual regarding replenishment of supplies should not be done earlier than approximately seven days prior to the delivery/shipping date. Dated documentation of this contact with the individual is required in the individual’s medical record. Delivery of the supplies should not be done earlier than approximately five days before the individual would exhaust their on-hand supply.

If required documentation is not available on file to support a claim at the time of an audit or record request, the durable medical equipment (DME) supplier may be required to reimburse the Company for overpayments.

BILLING REQUIREMENTS

Inclusion of a code in this policy does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

Healthcare Common Procedure Coding System (HCPCS) code G0249 includes payment for both the device and the supplies. These items may not be separately billed. Procedure code G0249 includes materials for four tests. Therefore, this code must not be billed more than once every four weeks.

Healthcare Common Procedure Coding System (HCPCS) code G0250 is per four tests. Therefore, this code must not be billed more than once every four weeks.
Guidelines

The prothrombin time monitor for home anticoagulation management cannot be used for routine prothrombin time (PT)/international normalized ratio (INR) monitoring in the office setting.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, a prothrombin time monitor for home anticoagulation management is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

There are numerous devices approved by the FDA for in-home monitoring of chronic anticoagulation therapy.

Description

Oral therapy with warfarin (Coumadin®) is the most common method of achieving anticoagulation. Frequent blood testing is needed to balance maintenance of therapeutic blood levels against possible side effects with warfarin (Coumadin®). The blood tests used to monitor coagulation include the partial thromboplastin time (PTT), prothrombin time (PT), and international normalized ratio (INR).

One method of keeping individuals within therapeutic range is to encourage them to monitor their INR. Studies show that individuals who perform INR self-testing spend a higher proportion of time within their target INR range and have fewer adverse side effects. The US Food and Drug Administration (FDA) has approved several devices for in-home monitoring of chronic anticoagulation therapy. These devices are used as an in vitro diagnostic system that provides a quantitative PT result expressed in seconds as an INR.

A prothrombin time monitor for home anticoagulation management is a small, battery-operated instrument that can determine the PT/INR from a small amount of blood obtained through a finger-stick to assist with the management of high-risk individuals on warfarin (Coumadin®).

Several well-designed, randomized controlled trials (RCT) were performed, with most individuals self-testing and self-managing their anticoagulation therapy. The studies revealed that participants with mechanical heart valves who required long-term anticoagulation therapy and performed self-testing and self-managing using home PT/INR monitoring displayed therapeutic target range (TTR) results at least equivalent to laboratory testing or physician office testing. Additional literature focusing mainly on atrial fibrillation and venous thromboembolism demonstrated that in some populations the use of home PT/INR monitoring is at least equivalent to laboratory testing. There were no studies showing that the use of home prothrombin time monitoring resulted in decreased therapeutic target range (TTR). It was concluded that a home prothrombin time monitor is most appropriate for individuals with mechanical heart valves, chronic atrial fibrillation, or venous thromboembolism (e.g., deep venous thrombosis [DVT] and pulmonary embolism).

The American College of Cardiology (ACC) supports the use of home prothrombin time monitoring in individuals with chronic atrial fibrillation and DVT, in addition to those with mechanical heart valves. The ACC reports that testing may be justified beyond once a week for individuals on warfarin (Coumadin®) who have congenital thrombophilic disorders.
References


Centers for Medicare & Medicaid Services (CMS). Decision Memorandum.CAG-00087R: Prothrombin time (INR) monitor for home anticoagulation management. [CMS Web site]. 03/19/08. Available at: http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=209&NcaName=Prothrombin+Time+(INR)+Monitor+for+Home+Anticoagulation+Management&NCDId=269&ncdver=2&IsPopup=y&bc=AAAAAAAAEAAA&. Accessed January 29, 2018.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD).190.11: Home prothrombin time INR monitoring for anticoagulation management. [CMS Web site]. 03/19/08. Available at:http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=269&bc=AgAAQAAAAAAA&ncdver=2. Accessed January 29, 2018.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Rubicon Prothrombin Time Monitoring System. 510(k) summary. [FDA Web site]. 09/03/02. Available at:http://www.accessdata.fda.gov/cdrh_docs/pdf2/k022922.pdf. Accessed January 29, 2018.





Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

93792, 93793


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

See Attachment A for ICD-10 codes.


HCPCS Level II Code Number(s)



THE FOLLOWING CODE REPRESENTS PATIENT TRAINING:

G0248 Demonstration, prior to initiation of home INR monitoring, for patient with either mechanical heart valve(s), chronic atrial fibrillation, or venous thromboembolism who meets Medicare coverage criteria, under the direction of a physician; includes: face-to-face demonstration of use and care of the INR monitor, obtaining at least one blood sample, provision of instructions for reporting home INR test results, and documentation of patient’s ability to perform testing and report results

THE FOLLOWING CODE REPRESENTS METER AND STRIPS:

G0249 Provision of test materials and equipment for home INR monitoring of patient with either mechanical heart valve(s), chronic atrial fibrillation, or venous thromboembolism who meets Medicare coverage criteria; includes: provision of materials for use in the home and reporting of test results to physician; testing not occurring more frequently than once a week; testing materials, billing units of service include 4 tests

THE FOLLOWING CODE REPRESENTS PHYSICIAN REVIEW:

G0250 Physician review, interpretation, and patient management of home INR testing for patient with either mechanical heart valve(s), chronic atrial fibrillation, or venous thromboembolism who meets Medicare coverage criteria; testing not occurring more frequently than once a week; billing units of service include 4 tests



Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References

Attachment A: Home Prothrombin Time Monitoring
Description: ICD-10-CODING




Policy History

Revisions from 05.00.26g
07/02/2018 The following ICD-10 CM codes have been added to this policy:
  • I27.24 Chronic thromboembolic pulmonary hypertension
  • I80.8 Phlebitis and thrombophlebitis of other sites

The following ICD-10 CM code has been removed from this policy:
  • I48.91 Unspecified atrial fibrillation

Revisions from 05.00.26f
01/01/2018This version of the policy will become effective 01/01/2018.

This policy has been identified for the CPT code update, effective 01/01/2018.


The following CPT codes have been added to this policy:

  • 93792, 93793

Effective 10/05/2017 this policy has been updated to the new policy template format.
Version Effective Date: 07/02/2018
Version Issued Date: 07/02/2018
Version Reissued Date: N/A

Connect with Us        


© 2017 Independence Blue Cross.
Independence Blue Cross is an independent licensee of the Blue Cross and Blue Shield Association, serving the health insurance needs of Philadelphia and southeastern Pennsylvania.