Terms & Conditions

The purpose of a coverage manual is to provide guidelines for determining coverage criteria for specific medical, behavioral health, and pharmaceutical technologies, including procedures, equipment, and services. In order to be eligible for coverage, all services must be medically necessary (unless otherwise provided in the member's benefits contract). To the extent there are any conflicts between coverage policy guidelines and applicable contract language, the contract language takes precedence. Coverage policy is not intended to override the health insurance contract that defines the insured’s benefits, nor is it intended to dictate to providers how to practice medicine. Physicians and other health care providers are expected to exercise their medical judgment in providing the most appropriate care. The terms of an individual's particular coverage plan document [Group Service Agreement (GSA), Evidence of Coverage, Certificate of Coverage (CoC), Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard coverage plans upon which these coverage policies are based. If these coverage policies are inconsistent with the terms of the individual's specific coverage plan, then the terms of the individual's specific coverage plan always takes precedence. Coverage determinations in each specific instance require consideration of:

• The terms of the applicable coverage plan document in effect on the date of service
• Any applicable laws/regulations
• Any relevant collateral source materials, including coverage policies
• The specific facts of the particular situation

How Policies are Developed

Selection of Technologies for Policy Development

Issues are selected for coverage policy development through referrals from staff, physicians, provider communities, and members. Priority may be given to the following:

• New diagnostic tests, therapeutic procedures, or medical devices for which no other good alternatives exist
• Medical technologies that may have a safety concern
• Medical technologies that are considered lifesaving
• Medical technologies that are controversial with respect to their clinical utility
• Medical technologies that have generated a high level of interest
• New information published in the peer-reviewed scientific literature that may change the status of a technology from investigational to medically necessary

Research Sources

The following sources are considered in the development and revision of coverage policy:

• Technology assessments publicly published and based on a systematic review of the evidence (e.g., Hayes Inc., PubMed, UpToDate, Agency for Healthcare Research and Quality, PCORI, various national health technology assessment agencies [NICE in UK, CADTH in Canada, etc.])
• Peer-reviewed publications
• Evidence-based clinical practice guidelines developed by national organizations and other recognized authorities
• Generally accepted standards of medical practice
• External practicing physician review
• Government approval status

Plan Definitions

The Plan has defined for its contracting purposes specific areas such as Medical Necessity and Investigational Services. The following are those Plan definitions used in coverage policies.

Medical Necessity

Medically Necessary or Medical Necessity means treatment, services, medicines, or supplies that are necessary and appropriate for the diagnosis or treatment of a Covered Person's illness, injury, or medical condition according to accepted standards of medical practice; which includes:

• Clinically appropriate, in terms of type, frequency, extent, site and duration, and considered effective for the covered person's illness, injury or disease
• Not primarily for the convenience of the covered person, physician or other health care provider
• Not more costly than an alternative service or sequence of services or supply, and at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the covered person's illness, injury or disease

Investigational Services

"Investigational Service" means surgical procedures or medical procedures, supplies, devices, or drugs which at the time provided, or sought to be provided, are—in the judgement of U of U Health Plans not recognized as conforming to accepted medical practice or the procedure, drug, or device:

• Has not received the required final approval to market from appropriate government bodies; is one about which the peer-reviewed medical literature does not permit conclusions concerning its effect on health outcomes
• Is not demonstrated to be as beneficial as established alternatives
• Has not been demonstrated to improve the net health outcomes
• Is one in which the improvement claimed is not demonstrated to be obtainable outside the investigational or experimental setting

FDA Definitions

Many individuals are uncertain as to what “FDA approved” means. There exist different FDA classifications for devices with different implications as to the rigor by which the devices have been studied prior to being available to practitioners. This section is intended to provide clarification on these different classifications and limits to each of these classifications.

• Premarket Approval (PMA): Class III devices that are high risk devices and pose a significant risk of illness or injury, or devices found not substantially equivalent to Class I and II predicate through the 510(k) process. The PMA process is more involved and includes the submission of clinical data to support claims made for the device.
• Premarket Notification 510(k): A device that requires the submission of a Premarket Notification 510(k), it cannot be commercially distributed until you receive a letter of substantial equivalence from FDA authorizing you to do so. A 510(k) must demonstrate that the device is substantially equivalent to one legally in commercial distribution in the United States.
• Investigational Device Exemption (IDE): An investigational device allowed to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification 510(k) submission to FDA. Before clinical studies can begin, devices of significant risk must be approved by FDA and by an Institutional Review Board (IRB); devices of nonsignificant risk only need IRB approval.
• Humanitarian Use Device (HUD): 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.
• Humanitarian Device Exemption (HDE): A marketing application for a HUD, although HDE is exempt from the effectiveness requirements of Sections 514 and 515 of the FD&C Act and is subject to certain profit and use restrictions.

The FDA also assigns generic types of devices to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device.

Device Class and Regulatory Controls:

• Class I General Controls
  
  • With Exemptions
  • Without Exemptions
• Class II General Controls and Special Control
  
  • With Exemptions
  • Without Exemptions
• Class III General Controls and Premarket Approval
  
  • The class to which a device is assigned determines, among other things, the type of premarketing submission/application required for FDA clearance to market. If the device is classified as Class I or II, and if it is not exempt, a 510k will be required for marketing. All devices classified as exempt are subject to the limitations on exemptions. Limitations of device exemptions are covered under 21 CFR xxx.9, where xxx refers to Parts 862 to 892. For Class III devices, a premarket approval application (PMA) will be required unless the device is a preamendments device (on the market prior to the passage of the medical device amendments in 1976, or substantially equivalent to such a device) and PMA's have not been called for. In that case, a 510k will be the route to market.
    Device classification depends on the intended use of the device and also upon indications for use. For example, a scalpel's intended use is to cut tissue. A subset of intended use arises when a more specialized indication is added in the device's labeling such as, "for making incisions in the cornea". Indications for use can be found in the device's labeling, but may also be conveyed orally during sale of the product. A discussion of the meaning of intended use is contained in The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notification [510(k)].
    In addition, classification is risk based, that is, the risk the device poses to the patient and/or the user is a major factor in the class it is assigned. Class I includes devices with the lowest risk and Class III includes those with the greatest risk.
    As indicated above, all classes of devices are subject to General Controls. General Controls are the baseline requirements of the Food, Drug and Cosmetic (FD&C) Act that apply to all medical devices, Class I, II, and III.

Policy Updates and External Physician Review

Coverage policies are submitted for review to external practicing physicians as part of the development and ongoing policy review process. Existing policies are reviewed on a routine schedule which approximates an annual review. Policies may be reviewed prior to their scheduled annual review date if new scientific evidence becomes available that would change the policy criteria or to reflect changing regulatory or legislative mandates.

Approval Process

All policy drafts are presented to the Medical Policy Committee for final approval. The Committee consists of professional medical policy staff, physician medical directors and other department directors who have a stake in policy determination.

Coverage Policy Dissemination

Coverage policies are published online and available to members, providers and the general public at https://uhealthplan.utah.edu/medicalpolicy. Significant policy changes are communicated through provider newsletters and as appropriate through direct personal, electronic or written communication. If you have any questions or concerns related to our published policies located on this site, please email us at: coveragepolicies@hsc.utah.edu.