Notification



Notification Issue Date:



Claim Payment Policy


Title:Food and Drug Administration (FDA) Approval of Medical Devices

Policy #:05.00.04d

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.

Coverage of a medical device is based on:
  • Classification, as determined by the US Food and Drug Administration (FDA)
  • FDA approval/clearance
  • Medical necessity, as determined by the Company
  • 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 has not been established.

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 medical device is 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.

Information on the FDA Product classification of medical devices can be found at the following database:


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:
  • 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 postmarket 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 U.S. 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 is 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, biocompatibility, standards, and other applicable characteristics.

HUMANITARIAN DEVICE EXEMPTION (HDE)

Certain medical devices intended to be used for humanitarian purposes are evaluated by the FDA through the HDE process. The FDA’s humanitarian use device designation is intended to benefit individuals by permitting 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. Since 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 to the usual premarket approval process and allows marketing of the device for the FDA-labeled HDE indication(s). Under FDA requirements, a humanitarian use device 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 indications under the HDE.

Additional information regarding the FDA requirements for the classification and marketing approval of medical devices can be found at: http://www.fda.gov/.

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 October 3, 2016.

Company Benefit Contracts.

Hayes, Inc. The FDA’s Approval Process for New Devices. [White Paper]. 2011.

Rados C. FDA Consumer Magazine. FDA works to reduce preventable medical device injuries. July 2003.

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 09/16/2015. Available at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. Accessed October 3, 2016.

US Food and Drug Administration. 21CFR§860.7. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?FR=860.7. Accessed October 3, 2016.US Food and Drug Administration.

US Food and Drug Administration. 21 USC §321. Available at: http://uscode.house.gov/view.xhtml?req=(title:21%20section:321%20edition:prelim)%20OR%20(granuleid:USC-prelim-title21-section321)&f=treesort&edition=prelim&num=0&jumpTo=true. Accessed October 3, 2016.

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 9/15/2016. Available at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm. Accessed October 3, 2016.

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 7/29/2014. Available at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/default.htm. Accessed October 3, 2016.

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 05/10/2016. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfHDE/HDEInformation.cfm. Accessed October 3, 2016.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. The 510(k) Process “What You Need to Know”. 9/25/2013. Available at: http://www.fda.gov/downloads/drugs/developmentapprovalprocess/smallbusinessassistance/ucm377596.pdf. Accessed October 3, 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 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.