Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Home Prothrombin Time Monitoring
Policy #:MA05.016f

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


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. 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. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

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 Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

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

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.


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.

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 DME 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.
Policy Guidelines

This policy is consistent with Medicare's coverage criteria. The Company's payment methodology may differ from Medicare.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, prothrombin time monitoring is covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this medical policy are met.

However, services that are identified in this policy as not medically necessary are not eligible for coverage or reimbursement by the Company.


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®).
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 August 8, 2019.

Centers for Medicare & Medicaid Services (CMS). ICD-10 and Other Coding Revisions to National Coverage Determinations (NCDs). MLN Matters Number: MM10318. 4/1/2018. Available at:
https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10318.pdf. Accessed August 8, 2019.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD).190.11: Home prothrombin time/International normalized ratio (PT/INR) monitoring for anticoagulation management. [CMS Web site]. 03/19/08. Available at:https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=269&ncdver=2&bc=AAAAgAAAAAAA&. Accessed August 8, 2019.

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 August 8, 2019.


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


HCPCS Level II Code Number(s)



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

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

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

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. 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.

Cross References

Attachment A: Home Prothrombin Time Monitoring
Description: ICD-10 codes used for Home Prothrombin Time Monitoring







Policy History

MA05.016e
11/04/2019The version of this policy will become effective 1/04/2019.
The intent of this policy has not changed, although it has been modified to add ICD-10 diagnoses codes: I80.219, I82.619 and I82.819 to the policy.



MA05.016d
07/02/2018This 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

MA05.016c
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

MA05.016b
10/01/2017This version of the policy will become effective 10/01/2017.

The following ICD-10 narratives have been revised to Attachment A in this policy.

I82.811:

FROM: Embolism and thrombosis of superficial veins of right lower extremities
TO: Embolism and thrombosis of superficial veins of right lower extremity

I82.812:

FROM: Embolism and thrombosis of superficial veins of left lower extremities
TO: Embolism and thrombosis of superficial veins of left lower extremity


MA05.016a
11/04/2016 This version of the policy will become effective 11/04/2016.

In accordance with Medicare, the following ICD-10 codes were added.

I48.91 Unspecified atrial fibrillation
I23.6 Thrombosis of atrium, auricular appendage, and ventricle as current complications following acute myocardial infarction
I27.82 Chronic pulmonary embolism
I67.6 Nonpyogenic thrombosis of intracranial venous system
I80.211 Phlebitis and thrombophlebitis of right iliac vein
I80.212 Phlebitis and thrombophlebitis of left iliac vein
I80.213 Phlebitis and thrombophlebitis of iliac vein, bilateral
I82.1 Thrombophlebitis migrans
I82.611 Acute embolism and thrombosis of superficial veins of right upper extremity
I82.612 Acute embolism and thrombosis of superficial veins of left upper extremity
I82.613 Acute embolism and thrombosis of superficial veins of upper extremity, bilateral
I82.711 Chronic embolism and thrombosis of superficial veins of right upper extremity
I82.712 Chronic embolism and thrombosis of superficial veins of left upper extremity
I82.713 Chronic embolism and thrombosis of superficial veins of upper extremity, bilateral
I82.719 Chronic embolism and thrombosis of superficial veins of unspecified upper extremity
I82.811 Embolism and thrombosis of superficial veins of right lower extremities
I82.812 Embolism and thrombosis of superficial veins of left lower extremities
I82.813 Embolism and thrombosis of superficial veins of lower extremities, bilateral
O22.51 Cerebral venous thrombosis in pregnancy, first trimester
O22.52 Cerebral venous thrombosis in pregnancy, second trimester
O22.53 Cerebral venous thrombosis in pregnancy, third trimester
O87.3 Cerebral venous thrombosis in the puerperium
Z86.718 Personal history of other venous thrombosis and embolism
Z95.4 Presence of other heart-valve replacement
D68.51 Activated protein C resistance

The following code was added to this policy:

I48.1 Persistent atrial fibrillation


This policy has been identified for the ICD-10 CM code update, effective 10/01/2016.

The following ICD-10 CM narratives have been revised in this policy:

CODE: T82.817A
FROM: Embolism of cardiac prosthetic devices, implants and grafts, initial encounter
TO: Embolism due to cardiac prosthetic devices, implants and grafts, initial encounter

CODE: T82.817D
FROM: Embolism of cardiac prosthetic devices, implants and grafts, subsequent encounter
TO: Embolism due to cardiac prosthetic devices, implants and grafts, subsequent encounter

CODE: T82.817S
FROM: Embolism of cardiac prosthetic devices, implants and grafts, sequela
TO: Embolism due to cardiac prosthetic devices, implants and grafts, sequela

CODE: T82.818A
FROM: Embolism of vascular prosthetic devices, implants and grafts, initial encounter
TO: Embolism due to vascular prosthetic devices, implants and grafts, initial encounter

CODE: T82.818D
FROM: Embolism of vascular prosthetic devices, implants and grafts, subsequent encounter
TO: Embolism due to vascular prosthetic devices, implants and grafts, subsequent encounter

CODE: T82.818S
FROM: Embolism of vascular prosthetic devices, implants and grafts, sequela
TO: Embolism due to vascular prosthetic devices, implants and grafts, sequela

MA05.016
03/29/2016The policy has been reviewed and reissued to communicate the Company’s continuing position on Home Prothrombin Time Monitoring.
08/19/2015The policy has been reviewed and reissued to communicate the Company’s continuing position on Home Prothrombin Time Monitoring.
01/01/2015This is a new policy.






Version Effective Date: 11/04/2019
Version Issued Date: 11/04/2019
Version Reissued Date: N/A