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Coverage of Medical Devices
05.00.04e

Policy

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

Coverage of a medical device is based on the following:
  • Classification, as determined by the US Food and Drug Administration (FDA)
  • FDA approval/clearance
  • Medical necessity, as determined by the Company, based on demonstration of product effectiveness
  • The individual's benefits
  • The setting in which the device is provided or used
Medical devices that require FDA classification but have not been classified and/or have not received FDA clearance for marketing are considered experimental/investigational and are not covered by the Company's products. In addition, a device that has FDA marketing clearance is considered experimental/investigational if available published literature determines that the safety and/or effectiveness of the device have not been established.

HUMANITARIAN USE DEVICES AND HUMANITARIAN DEVICE EXEMPTIONS

Certain medical devices are considered humanitarian use devices (HUD) by the FDA and may be covered and eligible for reimbursement consideration by the Company in accordance with the labeled indication(s) approved by the FDA. A HUD will only be covered 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 that are used outside of the Humanitarian Device Exemption (HDE) are considered experimental/investigational and, therefore, not covered.

The coverage position described here for a HUD 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, and therapies, as well as 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, medical devices may be covered under the medical benefits of the Company's products when medical necessity criteria are met.

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, may be covered under the medical benefits of the Company's products.

Supporting medical necessity documentation must be maintained in medical records and made available to the Company upon request.

Description

According to the US Food and Drug Administration (FDA), a medical device is an instrument, apparatus, implement, machine, implant, in vitro reagent, or other similar or related article, including a component part or accessory, which is all of the following:
  • Recognized in the official National Formulary, or the United States (US) Pharmacopoeia, or any supplement to them;
  • Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in human beings;
  • Intended to affect the structure or any bodily function of a human being, but does not achieve any of its primary intended purposes through chemical action within or on the body and is not dependent upon being metabolized for the achievement of any of its primary intended purposes.
Medical devices go through the following three step process to obtain marketing clearance from the FDA's Center for Devices and Radiological Health (CDRH):
  • STEP ONE: Verification that the manufacturer's product meets the definition of a medical device according to Section 201(h) of the Food, Drug, and Cosmetic (FD&C) Act. For example, if the product is a medical device that is an electronic radiation-emitting product, it may have additional requirements for FDA approval.
  • STEP TWO: Requirement of the device manufacturer to determine how the FDA will classify the device. The classification identifies the level of regulatory control that is necessary to ensure the safety and effectiveness of a medical device. Depending on its classification status, the device is required to receive either premarket notification (510[k]) or premarket approval (PMA) from the FDA in order to be cleared for marketing. Devices that do not require classification by the FDA are considered exempt (e.g., manual stethoscopes, mercury thermometers, and bedpans). The various FDA medical device classifications are described below.
    • CLASS I (GENERAL CONTROLS)
      Devices for which the general controls of the FD&C Act, such as adherence to good manufacturing practice regulations, are sufficient to provide a reasonable assurance of safety and effectiveness. Class I devices are typically not intended for a use that is of substantial importance in preventing impairment of human health; they do not present a potential unreasonable risk of illness or injury. As such, most Class I devices are exempt by law from any premarket notification (510[k]) requirements and/or Quality System regulations. Examples include blood donor chairs, elastic bandages, examination gloves, hand-held surgical instruments, nasal oxygen cannula, stomal bags, and traction accessories.
    • CLASS II (GENERAL CONTROLS AND SPECIAL CONTROLS)
      Devices that, in addition to general controls, require special controls, such as performance standards or post-market surveillance, to provide a reasonable assurance of safety and effectiveness. Because they may be important in preventing impairment of human health or may present a risk of illness or injury if they are not used appropriately,       Class II devices are usually not exempt from premarket notification or Quality System regulations. Examples include infusion pumps, potassium flame photometry, power wheelchairs, pregnancy test kits, primary calibrators, surgical drapes, and vascular grafts less than 6 mm in diameter.
    • CLASS III (GENERAL CONTROLS AND SPECIAL CONTROLS AND premarket APPROVAL)
      Devices that cannot be identified as Class I or Class II are designated as Class III because insufficient information exists to determine that either special or general controls would provide a reasonable assurance of the safety and effectiveness of the device. Class III devices support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential, unreasonable       risk of illness or injury. Class III devices require premarket approval; however, not all Class III devices require an approved premarket approval application in order to be marketed. Class III devices that are considered substantial equivalents to devices legally marketed before May 28, 1976 may be marketed through the premarket notification (510[k]) process until the FDA publishes a requirement for manufacturers of that device type to submit premarket approval data. Examples of Class III devices requiring premarket approval include catheter balloon repair kits, expandable cervical dilators, implantable pacemaker pulse generators, and spherical contact lenses.
  • STEP THREE: Development of data and/or information necessary to submit a marketing application in order to obtain FDA clearance to market the device. For some 510(k) submissions and most PMA applications, clinical performance data is also required to obtain clearance to market the device. In these cases, a clinical trial must be done in accordance with the FDA's Investigational Device Exemption (IDE) regulations.
Information about the safety and effectiveness of a device is used to determine how a device is classified and what performance standards must be met for Class II devices and premarket Approval of Class III devices. The FDA defines safety and effectiveness as follows:
    There is reasonable assurance that a device is safe when it can be determined, based upon valid scientific evidence, that the probable benefits to health from use of the device for its intended uses and conditions of use, when accompanied by adequate directions and warnings against unsafe use, outweigh any probable risks. The valid scientific evidence used to determine the safety of a device shall adequately demonstrate the absence of unreasonable risk of illness or injury associated with the use of the device for its intended uses and conditions of use.
    There is reasonable assurance that a device is effective when it can be determined, based upon valid scientific evidence, that in a significant portion of the target population, the use of the device for its intended uses and conditions of use, when accompanied by adequate directions for use and warnings against unsafe use, will provide clinically significant results.
Certain devices may require clinical trials to prove both their safety and their effectiveness.

REGULATORY ROUTES TO MARKET
  • Premarket Approval (PMA) is the FDA's process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Due to the level of risk associated with Class III devices, the FDA has determined that general and special controls are insufficient to ensure the safety and effectiveness of such devices. Therefore, these devices require a premarket approval (PMA) application in order to obtain marketing clearance.
    • Devices approved through the PMA process often use randomized controlled clinical studies that produce high-quality data demonstrating the safety and effectiveness of the device. Such devices, however, may require further evaluation for clinical efficacy, as investigations required for the PMA process typically focus on intermediate results rather than final patient outcomes.
  • Premarket Notification (510[k]) approval process enables the FDA to approve medical devices that are similar to devices that are currently on the market (known as predicate devices). Prior to marketing the new device, the manufacturer submits a notification to the FDA to demonstrate that the device to be marketed is as safe and effective as (or is substantially equivalent [SE] to) a predicate device that has been legally marketed prior to May 28, 1976, when devices were not subject to premarket approval (PMA). Applicants must compare their device to one or more similar devices currently available on the US market and support their claims of substantial equivalency.
    • FDA approval of medical devices under the 510(k) process is based on the assumption of the similarity of the underlying technology of the device rather than demonstrated efficacy and proven clinical applicability.
    • Premarket Notification (510[k]) contains the following components:
      • Predicate Device, which is the legally marketed device to which equivalence is drawn. The new device does not need to be identical to the predicate device that is already on the market; however, the manufacturer must establish a degree of substantial equivalence between the new device and the predicate device.
      • Substantial equivalence*, which a device is determined to have if, in comparison to a predicate device, it has the same intended use as the predicate device and has been demonstrated by the sponsor to be as safe and effective as the legally marketed device, and has one of the following:
        • Same technological characteristics as the predicate device;
        • Different technological characteristics, but those characteristics do not raise new questions of safety and effectiveness.
        *A claim of substantial equivalence does not mean the new device must be identical to the predicate device. Substantial equivalence is established with respect to intended use, design, energy used or delivered, materials, performance, safety, effectiveness, labeling, bio-compatibility, standards, and other applicable characteristics.
Additional information regarding the FDA requirements for the classification and marketing approval of medical devices can be found at the following website: http://www.fda.gov.

HUMANITARIAN USE DEVICES AND HUMANITARIAN DEVICE EXEMPTIONS

The Humanitarian Use Device (HUD) program was established in 1990 by the US federal government with passage of the Safe Medical Devices Act. It creates an alternative pathway for getting market approval for medical devices that may help people with rare diseases or conditions. A HUD is a “medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8,000 individuals in the United States per year.” The US Food and Drug Administration (FDA) evaluates HUDs through the Humanitarian Device Exemption (HDE) process. A device that is granted an HDE indicates that the device is approved for marketing, but the approval is based on evidence of safety and probable benefit rather than the higher standard of reasonable assurance and effectiveness.

Because clinical investigation demonstrating a HUD'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, a 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 the following website: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfHDE/HDEInformation.cfm.

References

Centers for Medicare & Medicaid Services (CMS). Medicare Benefit Policy Manual. Chapter 14: Medical devices. §10: Coverage of medical devices. [CMS Web site]. 11/06/2014. Available at: https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c14.pdf.
Accessed September 7, 2021.

Company Benefit Contracts.

Novitas Solutions. Humanitarian device exemption (HDE). [www.novitas-solutions.com]. 6/6/2017. Available at: http://www.novitas-solutions.com/webcenter/portal/MedicareJL/pagebyid?_afrLoop=409731662242152&_adf.ctrl-state=onhhh9fwz_140&contentId=00080348#!. Accessed September 7, 2021.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Medical Devices. Device advice: Comprehensive Regulatory Assistance - How to Study and Market Your Device. [FDA Web site]. Page last updated 05/16/2019. Available at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. Accessed September 7, 2021.

US Food and Drug Administration. 21CFR§860.7. Content current as of 04/01/2018. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?FR=860.7. Accessed September 7, 2021.

US Food and Drug Administration. 21 USC §321. Available at: http://uscode.house.gov/view.xhtml?req=(title:21 section:321 edition:prelim) OR (granuleid:USC-prelim-title21-section321)&f=treesort&edition=prelim&num=0&jumpTo=true. Accessed September 7, 2021.

US Food and Drug Administration (FDA). "Off-Label" and Investigational Use Of Marketed Drugs, Biologics, and Medical Devices. 07/12/2018. Available at:https://www.fda.gov/regulatory-information/search-fda-guidance-documents/label-and-investigational-use-marketed-drugs-biologics-and-medical-devices. Accessed September 7, 2021.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Medical Devices. Device advice: Comprehensive Regulatory Assistance - How to Study and Market Your Device - Premarket Submission - Premarket notification (510k). [FDA Web site]. Page last updated 09/27/2018. Available at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm. Accessed September 7, 2021.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Medical Devices. Device advice: Comprehensive Regulatory Assistance - Overview of Medical Device Regulation - Classify your medical device. [FDA Web site]. Page last updated 08/31/2018. Available at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/default.htm. Accessed September 7, 2021.

US Food and Drug Administration (FDA). Is The Product a Medical Device? [FDA Website]. Page last updated 03/22/2018. Available at:
https://www.fda.gov/medical-devices/classify-your-medical-device/product-medical-device. Accessed September 7, 2021.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Humanitarian use devices. Listing of CDRH Humanitarian Device Exemptions. [FDA Web site]. Page last updated 09/13/2019. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfHDE/HDEInformation.cfm. Accessed September 7, 2021.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Medical Devices. Medical Device Innovation Initiative White Paper. [FDA Web site]. Page last updated 09/13/2019. Available at: https://www.fda.gov/about-fda/cdrh-innovation/medical-device-innovation-initiative-white-paper. Accessed September 7, 2021.

US Food and Drug Administration (FDA). Designating Humanitarian Use Device (HUD). [FDA Web site]. Page last updated 10/24/2017. Available at:
https://www.fda.gov/industry/developing-products-rare-diseases-conditions/designating-humanitarian-use-device-hud. Accessed September 7, 2021.

US Food and Drug Administration (FDA). Humanitarian device exemption definition. [FDA Web site]. Page last updated 09/05/2019. Available at:
https://www.fda.gov/medical-devices/premarket-submissions/humanitarian-device-exemption. Accessed September 7, 2021.

US Food and Drug Administration (FDA). Guidance for Industry and Food and Drug Administration Staff: Humanitarian Use Device (HUD) Designations. Issued 09/05/2019. Available at: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM336515.pdf. Accessed September 7, 2021.​

Coding

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Coding and Billing Requirements

Policy History

Revisions From​ 05.00.04e:
10/06/2021This version of the policy becomes effective 10/11/2021. It communicates the Company's continued position on coverage of medical devices, and it communicates the Company's continued position on coverage and reimbursement eligibility consideration for devices that are considered Humanitarian Use Devices by the US Food and Drug Administration (FDA).

​The adoptable sources for this policy are company benefit contracts, CMS, and FDA.

Revisions From 05.00.04d:
11/04/2019
    This version of the policy becomes effective 11/04/2019. It communicates the Company's continued position on coverage of medical devices, and it communicates the Company's continued position on coverage and reimbursement eligibility consideration for devices that are considered Humanitarian Use Devices by the US Food and Drug Administration.

Effective 10/05/2017 this policy has been updated to the new policy template format.​
11/4/2019
11/4/2019
10/6/2021
05.00.04
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