Investigational and Experimental Treatment

Overview

Medi-Cal indicate:

• Experimental services are not covered
• Investigational services are not covered except when it is clearly documented that all of the following apply:

1. Conventional therapy does not adequately treat the intended patient's condition.
2. Conventional therapy does not prevent progressive disability or premature death.
3. The provider of the proposed service has a record of safety and success with it equivalent or superior to that of other providers of the investigational service.
4. The investigational service is the lowest cost item or service that meets the patient's medical needs and is less costly than all conventional alternatives.
5. The service is not being performed as a part of a research study protocol.
6. There is a reasonable expectation that the investigational service significantly prolongs the intended patient's life or maintains or restores a range of physical and social function suited to activities of daily living.

All investigational services require prior authorization. Payment is not authorized for investigational services that do not meet the above criteria, or for associated inpatient care when a member needs to be in the hospital primarily because she or he is receiving such nonapproved investigational services.

The limits above do not apply to Medicare/Medi-Cal program covered crossover services. Crossover services are services paid via claims billed to Medi-Cal for Medicare deductible and coinsurance. These claims have been approved or paid by Medicare.

Participating physician groups (PPGs) are required to notify Health Net immediately of member requests or proposed services for expedited investigational or experimental treatment for terminal illness. PPGs are required to submit requests for experimental and investigational treatment to Health Net. Terminal illness is not a requirement for experimental and investigational treatment.

Medicare benefits are available for all services that are covered by Part A and Part B of Medicare and that are reasonable and necessary and available to members residing in Health Net's service area. Services may be provided outside of the Health Net service area if the services are not accessible and available to members within Health Net's service area. Health Net and its PPGs must, when delegated to review prior authorization, comply with:

• Centers for Medicare & Medicaid Services (CMS's) National Coverage Determinations (NCDs).
• General coverage guidelines included in original Medicare manuals, such as Medicare National Coverage Determination Manual (100-03) and instructions, unless superseded by federal regulations.
• Written coverage decisions of local Medicare contractors (LCDs) with jurisdiction in the plan's geographic area (such as Northern California and Southern California) in which services are covered by Health Net.

If no NCD, Medicare National Coverage Determination Manual, or LCD guidelines exists, Health Net may apply its Hierarchy of Medical Resources and access national medical policies or other evidence-based guidelines (such as Hayes).

PPG Responsibilities

PPGs must immediately forward all pertinent documentation for investigational or experimental treatment service requests via fax to Health Net's Prior Authorization Department. Health Net's Prior Authorization Department has a dedicated fax number to receive and process prior authorization requests.

Medicare Exception

If a treatment, service or supply is specifically listed as not reasonable and not necessary (and therefore excluded from CMS benefits), for Cal MediConnect members, evaluation of Medi-Cal's covered services needs to be considered prior to assuming the services are not covered.

Investigational and Experimental Devices

Health Net abides by Medicare Benefit Policy Manual (100-2), Chapter 14, Medical Devices, and notes devices that may be covered under Medicare include the following categories:

• Devices approved by the Food and Drug Administration (FDA) through the pre-market approval process
• Devices cleared by the FDA through the 510(k) process
• FDA-approved investigation device exemption (IDE) Category B devices
• Hospital Institutional Review Board (IRB)-approved IDE devices

CMS outlines treatments that are not covered based on rules in the NCD manual (100-03). If a treatment, service or supply is specifically listed by CMS as not reasonable and not necessary, which over the years has been interpreted as medically unproven, experimental or investigational, and a review of the Medi-Cal provider operations manuals reveals the service may be experimental or investigational, participating providers must then immediately inform Health Net when there is a request for investigational or experimental treatment. All pertinent documentation for investigational or experimental treatments must be sent to the Health Net Prior Authorization Department.