Notification



Notification Issue Date:



Claim Payment Policy


Title:Humanitarian Use Devices (HUD) and the Humanitarian Device Exemption (HDE) Process

Policy #:00.10.37b

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.

Application of Claim Payment Policy is determined by benefits and contracts. Benefits may vary based on product line, group or contract. Medical necessity determination applies only if the benefit exists and no contract exclusions are applicable. Individual member benefits must be verified.

In products where members are able to self-refer to providers for care and services, members are advised to use participating providers in order to receive the highest level of benefits.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.

For more information on how Claim Payment 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.

Humanitarian use devices (HUD) are covered and eligible for reimbursement consideration by the Company when they are considered medically necessary in accordance with the labeled indication(s) approved by the US Food and Drug Administration (FDA). An HUD may only be used in facilities that have an institutional review board (IRB) to oversee the clinical application of such devices. The IRB must approve the application of the device to ensure that it will be used in accordance with the FDA-labeled indication(s). In addition, documentation of IRB approval may be requested by the Company to ensure compliance with the FDA-labeled indication(s).

HUDs requested for off-label uses (i.e., outside of their FDA-labeled Humanitarian Device Exemption indications) are considered experimental/investigational and, therefore, not covered because their safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature.

The coverage position described in this policy does not supersede a Company policy on a specific device or benefit limitations or exclusions of an individual's group product for a specific device. Individual benefits must be verified, as coverage may vary between products and/or groups.

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.
Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, a humanitarian use device (HUD) that was granted a humanitarian device exemption (HDE) by the US Food and Drug Administration (FDA), and is used in accordance with the approved labeling, is covered under the medical benefits of the Company's products.

Subject to the terms and conditions of the applicable benefit contract, HUDs used for off-label uses (ie, outside of their FDA-labeled HDE indications) are not eligible for payment under the medical benefits of the Company’s products because the devices are considered experimental/investigational and, therefore, not covered.

Services that are experimental/investigational are a benefit contract exclusion for all products of the Company.

Description

Certain medical devices intended to be used for humanitarian purposes are evaluated by the US Food and Drug Administration (FDA) through the Humanitarian Device Exemption (HDE) process. The FDA’s humanitarian use device (HUD) designation permits the humanitarian use of certain medical devices when there is no comparable device available to treat or diagnose a disease or condition affecting fewer than 4,000 individuals in the United States annually. Because clinical investigation demonstrating the device's efficacy is not feasible (given the low prevalence of the disease in the population), an FDA-approved HDE grants manufacturers an exemption from the usual premarket approval process and allows marketing of the device only for the FDA-labeled HDE indication(s). Under FDA requirements, an HUD may only be used after institutional review board (IRB) approval has been obtained for the use of the device in accordance with the FDA-labeled indication(s) under the HDE.

A comprehensive list of devices and their respective FDA-labeled HDE indication(s) is available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfHDE/HDEInformation.cfm.
References


Novitas Solutions. Humanitarian device exemption (HDE). [http://www.novitas-solutions.com/]. 4/12/2016. Avaialble at: http://www.novitas-solutions.com/webcenter/portal/MedicareJL/pagebyid?_afrLoop=409731662242152&_adf.ctrl-state=onhhh9fwz_140&contentId=00080348#!. Accessed September 30, 2016.

US Department of Health and Human Services. US Food and Drug Administration (FDA). Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors: Frequently Asked Questions About Medical Devices. Issued 01/2006. Available at: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM127067.pdf. Accessed September 30, 2016.

US Department of Health and Human Services. US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Guidance for HDE holders, institutional review boards (IRBs), clinical investigators, and Food and Drug Administration staff: humanitarian device exemption (HDE) regulation: questions and answers. Issued 7/8/2010. [FDA Web site] Page last updated 05/27/2015. Available at:http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm110194.htm. Accessed September 30, 2016.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Listing of CDRH Humanitarian use devices. [FDA Web site]. Page last updated 5/10/2016. Available at: 2016http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfHDE/HDEInformation.cfm. Accessed September 30, .

US Department of Health and Human Services. US Food and Drug Administration (FDA). Guidance for Industry and Food and Drug Administration Staff: Humanitarian Use Device (HUD) Designations. Issued 01/24/2013. Available at:http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM336515.pdf. Accessed September 30, 2016.



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)

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 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)

N/A


HCPCS Level II Code Number(s)

N/A


Revenue Code Number(s)

N/A


Coding and Billing Requirements


Cross References

 Policy: 05.00.04d:Food and Drug Administration (FDA) Approval of Medical Devices

 Policy: 11.02.11g:Transcatheter Closure of Cardiac Septal Defects

 Policy: 11.02.12i:Percutaneous Transluminal Angioplasty (PTA) Concurrent with or without Stenting of the Extracranial Carotid Artery or Intracranial Artery

 Policy: 11.02.16r:Ventricular Assist Devices (VADs)

 Policy: 11.02.19f:Total Artificial Hearts (TAHs)

 Policy: 11.03.15h:Gastric Electrical Stimulation (Enterra™), Gastric Pacing

 Policy: 11.05.11c:Implantation of Intrastromal Corneal Ring Segments (ICRS)

 Policy: 11.08.20s:Wound Care: Skin Substitutes for the Treatment of Burns and Chronic, Non-Healing Wounds

 Policy: 11.15.20o:Deep Brain Stimulation (DBS)

 Policy: 09.00.48f:Radioembolization for Primary and Metastatic Tumors of the Liver (Independence Administrators)


Policy History

Effective 10/05/2017 this policy has been updated to the new policy template
format.
Version Effective Date: 02/22/2017
Version Issued Date: 02/22/2017
Version Reissued Date: N/A

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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.