Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Artificial Hearts and Ventricular Assist Devices (VADs)
Policy #:MA11.011c

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.

ARTIFICIAL HEARTS

COVERAGE WITH EVIDENCE DEVELOPMENT (CED)
Total Artificial Hearts (SynCardia™ Temporary Total Artificial Heart and AbioCor® Implantable Replacement Heart) will be covered under Medicare's Coverage with Evidence Development (CED) when individuals are enrolled in a clinical study that fulfills ALL of the requirements as stated in Centers for Medicare & Medicaid Services (CMS) National Coverage Determination (NCD) for Artificial Hearts and Related Devices (20.9).

Claims for artificial hearts used for destination therapy should be submitted to the Medicare Advantage plan.

VENTRICULAR ASSIST DEVICE (VAD)

MEDICALLY NECESSARY
Postcardiotomy

A Food and Drug Administration (FDA)-approved ventricular assist device (VAD) is considered medically necessary and, therefore, covered, when both of the following criteria are met:
  • The VAD is being used in accordance with the FDA labeling.
  • The VAD is being used for support of blood circulation post-cardiotomy.

Bridge-to-Transplant

The VADs used for bridge-to-transplant are covered only if they have received approval from the FDA for that purpose, and the VADs are used according to the FDA-approved labeling instructions. A VAD used as a bridge-to-transplant is considered medically necessary and, therefore, covered, when all of the following criteria are met:
  • The individual is approved and listed as a candidate for heart transplantation by a Medicare-approved heart transplant center, and the individual must be active on the waitlist maintained by the Organ Procurement and Transplantation Network (OPTN).
  • The implanting site, if different than the Medicare-approved heart transplant center, must receive written permission from the Medicare-approved heart transplant center under which the individual is listed prior to implantation of the VAD.

Destination Therapy

VADs used for destination therapy are medically necessary and, therefore, covered, only if they have received approval from the FDA for that purpose.

Destination therapy is for individuals that require mechanical cardiac support.

Ventricular assist devices (VADs) are considered medically necessary and, therefore, covered, for individuals who have chronic end-stage heart failure (New York Heart Association Class IV end-stage left ventricular failure) who are not candidates for heart transplantation at the time of VAD implant, and who meet all of the following conditions:
  • Have failed to respond to optimal medical management (including beta-blockers and ACE inhibitors if tolerated) for at least 45 of the last 60 days, or have been balloon pump-dependent for 7 days, or IV inotrope-dependent for 14 days;
  • Have a left ventricular ejection fraction (LVEF) < 25%;
  • Have demonstrated functional limitation with a peak oxygen consumption of 14 ml/kg/min unless balloon pump- or inotrope-dependent or physically unable to perform the test.

Facility criteria must be met.

A list of approved facilities and their approval dates are listed and maintained on the CMS Coverage website at http://www.cms.hhs.gov/MedicareApprovedFacilitie/VAD/list.asp#TopOfPage and published in the Federal Register.

All other indications for the use of VADs or artificial hearts not otherwise listed remain noncovered, except in the context of a Category B investigational device exemption clinical trial.

SUPPLIES IN THE OUTPATIENT SETTING

VAD replacement supplies, as defined by the coding table in this policy, for use in the outpatient setting are eligible for separate reimbursement when the individual meets the medical necessity criteria for a VAD that has been approved by the FDA for use in the outpatient setting.

The HCPCS codes in the coding table represent replacement equipment, with the exception of Q0478, Q0507, and Q0508, which are also eligible for separate reimbursement when the individual meets the medical necessity criteria for a VAD that has been approved by the FDA for use in the outpatient setting. HCPCS codes Q0507 and Q0508 can represent initial or replacement equipment, and requests for authorization must include a detailed description of the Supply or Accessory being billed under Q0507 or Q0508. Reimbursement is limited to supplies and accessories for use with an external or implanted VAD, and not for a maintenance service for such equipment and supplies.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care 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.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
Policy Guidelines

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

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, artificial hearts and ventricular assist devices (VADs) are covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this medical policy are met.

Description

A ventricular assist device (VAD) or left ventricular assist device (LVAD) is surgically attached to one or both intact ventricles and is used to assist a damaged or weakened native heart in pumping blood. Improvement in the performance of the native heart may allow the device to be removed. VADs are used as either a bridge to a heart transplant, destination therapy, or for support of blood circulation postcardiotomy, which is the period following open-heart surgery.

VADs used for the indications listed on this policy are covered only if they have received approval from the FDA for that purpose, and the VADs are used according to the FDA-approved labeling instructions.

An artificial heart is a biventricular replacement device that requires removal of a substantial part of the native heart, including both ventricles. Removal of this device is not compatible with life, unless the individual has a heart transplant.
References

Centers for Medicare & Medicaid Services (CMS). Coverage with Evidence Development: Artificial Hearts. Page last updated 10/15/2015. [CMS website]. Available at: https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/Artificial-Hearts.html. Accessed March 23, 2018.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD) for Ventricular Assist Devices (20.9.1). 10/30/2013. [CMS website]. Available at: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=360&ver=1. Accessed March 23, 2018.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD) for Artificial Hearts and Related Devices (20.9).10/30/2013. [CMS website]. Available at: https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=246&ncdver=6&DocID=20.9&bc=gAAAAAgAAEAAAA%3d%3d&. Accessed March 23, 2018.

Novitas Solutions, Inc. Local Coverage Article . A54910: Ventricular assist device (VAD) supply or accessory. [Novitas Solutions Web site]. 08/03/2017. Available at: https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=54910&ver=8&NCAId=246&NcaName=Magnetic+Resonance+Imaging+(MRI)&NCDId=246&ncdver=4&SearchType=Advanced&CoverageSelection=Both&NCSelection=NCA%7cCAL%7cNCD%7cMEDCAC%7cTA%7cMCD&ArticleType=Ed%7cKey%7cSAD%7cFAQ&PolicyType=Final&s=-%7c5%7c6%7c66%7c67%7c9%7c38%7c63%7c41%7c64%7c65%7c44&KeyWord=ventricular+assist+devices&KeyWordLookUp=Doc&KeyWordSearchType=And&kq=true&bc=IAAAACAAAAAA& Accessed March 23, 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)

33927, 33928, 33929, 33975, 33976, 33977, 33978, 33979, 33980, 33981, 33982, 33983, 33990, 33991, 33992, 33993, 93750


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)

Report the most appropriate diagnosis code in support of medically necessary criteria as listed in the policy.


HCPCS Level II Code Number(s)



MEDICALLY NECESSARY

L8698 Miscellaneous component, supply or accessory for use with total artificial heart system

Q0477 Power module patient cable for use with electric or electric/pneumatic ventricular assist device, replacement only

Q0478 Power adapter for use with electric or electric/pneumatic ventricular assist device, vehicle type

Q0479 Power module for use with electric or electric/pneumatic ventricular assist device, replacement only

Q0480 Driver for use with pneumatic ventricular assist device, replacement only

Q0481 Microprocessor control unit for use with electric ventricular assist device, replacement only

Q0482 Microprocessor control unit for use with electric/pneumatic combination ventricular assist device, replacement only

Q0483 Monitor/display module for use with electric ventricular assist device, replacement only

Q0484 Monitor/display module for use with electric or electric/pneumatic ventricular assist device, replacement only

Q0485 Monitor control cable for use with electric ventricular assist device, replacement only

Q0486 Monitor control cable for use with electric/pneumatic ventricular assist device, replacement only

Q0487 Leads (pneumatic/electrical) for use with any type electric/pneumatic ventricular assist device, replacement only

Q0488 Power pack base for use with electric ventricular assist device, replacement only

Q0489 Power pack base for use with electric/pneumatic ventricular assist device, replacement only

Q0490 Emergency power source for use with electric ventricular assist device, replacement only

Q0491 Emergency power source for use with electric/pneumatic ventricular assist device, replacement only

Q0492 Emergency power supply cable for use with electric ventricular assist device, replacement only

Q0493 Emergency power supply cable for use with electric/pneumatic ventricular assist device, replacement only

Q0494 Emergency hand pump for use with electric or electric/pneumatic ventricular assist device, replacement only

Q0495 Battery/power pack charger for use with electric or electric/pneumatic ventricular assist device, replacement only

Q0496 Battery, other than lithium-ion, for use with electric or electric/pneumatic ventricular assist device, replacement only

Q0497 Battery clips for use with electric or electric/pneumatic ventricular assist device, replacement only

Q0498 Holster for use with electric or electric/pneumatic ventricular assist device, replacement only

Q0499 Belt/vest/bag for use to carry external peripheral components of any type ventricular assist device, replacement only

Q0500 Filters for use with electric or electric/pneumatic ventricular assist device, replacement only

Q0501 Shower cover for use with electric or electric/pneumatic ventricular assist device, replacement only

Q0502 Mobility cart for pneumatic ventricular assist device, replacement only

Q0503 Battery for pneumatic ventricular assist device, replacement only, each

Q0504 Power adapter for pneumatic ventricular assist device, replacement only, vehicle type

Q0506 Battery, lithium-ion, for use with electric or electric/pneumatic ventricular assist device, replacement only

Q0507 Miscellaneous supply or accessory for use with an external ventricular assist device

Q0508 Miscellaneous supply or accessory for use with an implanted ventricular assist device

NOT ELIGIBLE FOR REIMBURSEMENT

Q0509 Miscellaneous supply or accessory for use with any implanted ventricular assist device for which payment was not made under Medicare Part A



Revenue Code Number(s)

N/A

Coding and Billing Requirements






Policy History

MA11.011c
12/18/2019This policy has been reissued in accordance with the Company's annual review process.
01/01/2019This version of the policy will become effective 01/01/2019.

The following HCPCS code has been added to this policy:

L8698 Miscellaneous component, supply or accessory for use with total artificial heart system

MA11.011b
04/25/2018The policy has been reviewed and reissued to communicate the Company’s continuing position on artificial hearts and ventricular assist devices (VADs)
01/01/2018This policy has been identified for the CPT code update, effective 01/01/2018.

The following CPT codes have been added to this policy:

33927, 33928, 33929

The following CPT codes have been deleted from this policy:

0051T, 0052T, 0053T

The following HCPCS code has been added to this policy:

Q0477 Power module patient cable for use with electric or electric/pneumatic ventricular assist device, replacement only

MA11.011a
06/21/2017The policy has been reviewed and reissued to communicate the Company’s continuing position on total artificial hearts (TAHs) and ventricular assist devices (VADs)
08/12/2016The policy has been reviewed and reissued to communicate the Company’s continuing position on Ventricular Assist Devices (VADs).

ICD-10 codes that were previously contained in Attachment A have been removed as it was not an all inclusive list.

MA11.011
08/19/2015ICD-10-CM codes have been added and clinically reviewed considering the scope and intent of the policy document and the appropriateness of the codes for the policy.

The following ICD-10 CM codes have been added to this policy:
I01.2; I09.0; I09.81; I11.0; I13.0; I13.2; I40.0; I40.1; I40.8; I40.9; I41 I42.0; I42.1; I42.2; I42.3; I42.4; I42.5; I42.6; I42.7; I42.8; I42.9; I43; I46.2; I46.8; I46.9; I50.1; I50.20; I50.21; I50.22; I50.23; I50.30; I50.31; I50.32; I50.33; I50.40; I50.41; I50.42; I50.43; I50.9; I51.4; I51.5; I51.7; I51.81; I51.89; I51.9; I52; I97.0; I97.110; I97.111; I97.120; I97.121; I97.130; I97.131; I97.190; I97.191; I97.710; I97.711; I97.790; I97.791; O90.3; Q23.4; Q24.8; R57.0; T81.11XA; T81.11XD; T81.11XS; T82.518A; T82.518D; T82.518S; T82.519A; T82.519D; T82.519S; T82.528A; T82.528D; T82.528S; T82.529A; T82.529D; T82.529S; T82.598A; T82.598D; T82.598S; T82.599A; T82.599D; T82.599S; T82.7XXA; T82.7XXD; T82.7XXS; T82.867A; T82.867D; T82.867S; T82.897A; T82.897D; T82.897S; T82.9XXA; T82.9XXD; T82.9XXS; T86.20; T86.21; T86.22; T86.31; T86.32; Z76.82; Z95.1; Z95.811.
02/04/2015The policy has been reviewed and reissued to communicate the Company’s continuing position on Artificial Hearts and Ventricular Assist Devices (VADs).
01/01/2015This is a new policy.

The following sections in the notification draft have been amended to align policy MA11.011 with National Coverage Determination (NCD).20.9 and Decision Memo for Ventricular Assist Devices for Bridge-to-Transplant and Destination Therapy (CAG-00432R):
  • Bridge-to-Transplant
  • Destination Therapy





Version Effective Date: 01/01/2019
Version Issued Date: 01/03/2019
Version Reissued Date: 12/19/2019