Subject:
Definition of Investigational/Experimental Procedure
Description:
_______________________________________________________________________________________
IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
__________________________________________________________________________________________________________________________
Not applicable to this policy.
Policy:
(NOTE: For Medicare Advantage, Medicaid and FIDE-SNP, please refer to the Coverage Sections below for coverage guidance.)
Any treatment, procedure, equipment, device, supply, or drug (collectively referred to as "technology") which fails to satisfy any one of the following criteria is considered investigational/experimental:
1. The technology must be approved by the appropriate federal regulatory agency and be used for the purpose defined in that approval (unless it is considered an off-label use or otherwise meets the generally accepted standards of medical practice).
- This criterion applies to drugs, biological products, devices, and any other product or procedure that must have final approval to market from the U.S. Food and Drug Administration (FDA) or any other federal government body with authority to regulate the technology. However, approval by the FDA or other federal regulatory agency does not imply that the technology is automatically considered by Horizon BCBSNJ as medically necessary or the accepted standard of care.
[INFORMATIONAL NOTE: For the off-label use of certain prescription drugs, please refer to a separate policy on Off-Label Use of Prescription Drugs (Policy #008) in the Drugs Section.]
2. There is sufficient evidence published in peer-reviewed scientific literature to assess the effectiveness of the treatment.
- The evidence should consist of well-designed and well-documented investigations published in peer-reviewed journals. Each clinical trial or study should be considered based on its individual merits (e.g., length of time involved and follow-up, mortality and morbidity rates, etc.) along with any unique factors.
- When evidence is not sufficient or is questionable, opinions and evaluations from appropriate specialty advisory committees and/or specialty consultants will be considered.
3. There is measurable improvement (progress toward a normal or functional state of health) in health outcome and the therapeutic benefit outweighs the risk, as shown in scientific studies.
- There should be evidence based on published data that the technology improves health outcomes.
- The technology's therapeutic benefit on health outcomes should outweigh any harmful effects.
4. The treatment provided is as safe and effective as any established modality.
- When alternative therapy is not available, opinions and evaluations from appropriate specialty advisory committees and/or specialty consultants may be considered.
5. The treatment must demonstrate effectiveness when applied outside of the investigative research setting.
- When the technology is utilized under the usual conditions of medical practice, it should be reasonably expected to satisfy criteria #3 and #4 in this policy.
The investigational technology, as well as, services and procedures that are provided in relation to an investigational technology, are NOT covered unless otherwise indicated in the member's/enrollee's plan or coverage document. This includes, but is not limited to, services and procedures that would otherwise be covered, and hospital admissions solely for the purpose of administering or performing an investigational technology. A clinical trial is not covered unless it meets the requirements set forth in the informational note below or is otherwise indicated in the member's/enrollee's plan or coverage document.
[INFORMATIONAL NOTE: The Affordable Care Act (ACA) requires all non-grandfathered self-funded and fully insured health plans to provide coverage for routine patient costs furnished in connection with a qualified individual's participation in an approved clinical trial. This requirement does not apply to grandfathered health plans.
The phrase "routine patient costs" means all items and services consistent with coverage that is typically covered for an individual who is not enrolled in a clinical trial.
The phrase "routine patient costs" does not include the investigational item, device, or service itself; items and services that are provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patient; or a service that is clearly inconsistent with widely accepted and established standards of care for a particular diagnosis.
A qualified individual is one who is eligible to participate in an approved clinical trial for cancer or other life-threatening disease and either 1) the referring provider is a participating provider and has concluded that the individual's participation would be appropriate, or 2) the individual provides medical and scientific information establishing that the individual's participation in the trial would be appropriate.
An approved clinical trial is defined as a phase I, II, III, or IV clinical trial conducted for the treatment of cancer or other life-threatening disease and is either a federally funded trial, a trial conducted under an investigational new drug application reviewed by the FDA, or a trial exempt from having an investigational new drug application. A "life-threatening" disease is one from which the likelihood of death is probable unless the course of the disease in interrupted.
A health plan may require that a qualified individual participate in a clinical trial with a provider that is in-network, if an in-network provider is participating. However, the plan must provide coverage for routine costs for a qualified individual in an approved clinical trial that is taking place outside the state in which the qualified individual resides.
The law does not require that a group health plan or health insurance issuer offering group or individual health insurance coverage, provide benefits for routine patient care services provided outside of the plan's network unless out-of-network benefits are otherwise provided under the plan or coverage.]
Please note that coverage for services and procedures provided to treat the member suffering from complications of an investigational technology, research protocol or clinical trial is determined by the member's specific contract benefits. When they are not excluded from the member's contract, these services and procedures as well as other medically necessary services that would be required by the member independent of the technology or trial participation, are eligible for payment.
Medicare Coverage:
Medicare Advantage Products follow CMS National Coverage Determinations, Local Coverage Determinations and other CMS Guidance (eg, Medicare Benefit Policy Manual, Medicare Learning Network Articles (MLN Matters Articles), Medicare Claims Processing Manual)). If CMS does not have a coverage or noncoverage position on a service, Medicare Advantage Products will follow Horizon BCBSNJ Medical Policy.
Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.
Medicaid Coverage:
For members enrolled in Medicaid and NJ FamilyCare plans, Horizon BCBSNJ applies the above medical policy.
FIDE SNP:
For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.
________________________________________________________________________________________
Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
___________________________________________________________________________________________________________________________
Index:
Definition of Investigational/Experimental Procedure
Cancer Clinical Trials, Routine Patient Costs
Clinical Trials, Cancer or Other Life-Threatening Disease, Routine Patient Costs
Experimental, Definition of
Investigational, Definition of
Phase I, II, III, or IV Clinical Trial, Routine Patient Costs
Routine Patient Costs in Connection with Approved Clinical Trials
Costs in Connection with Approved Clinical Trials
Patient Costs in Connection with Approved Clinical Trials
Approved Clinical Trials, Routine Patient Costs
References:
1. Blue Cross Blue Shield Association. Medical Policy Reference Manual. Investigational Definition.
2. Blue Cross Blue Shield Association. Technology Evaluation Center (TEC) Criteria.
3. Eddy M. Investigational treatments. How strict should we be? JAMA 1997 Jul;278(3):179-85.
4. Affordable Care Act (ACA): Section 2709. "Coverage for individuals participating in approved clinical trials".
_________________________________________________________________________________________
Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
____________________________________________________________________________________________________________________________ |