Care Management > Experimental Drugs, New Drugs or Medical Technologies
We are committed to providing members with current, safe, appropriate and effective medical care consistent with the professional standard of care available in our service area. We are dedicated to holding premium costs at low levels for all subscribers. To achieve these goals, we generally exclude coverage for treatments of an experimental or investigational nature that have not been proven safe and/or effective.
To make a coverage determination in an individual patient case, the professional staff in EmblemHealth's Care Management department consults with the physicians involved in the member's care. Together, we make a coverage determination using the policy provisions and the various information sources set forth in the guidelines that follow.
Any coverage decisions reached are subject to review according to our grievance and appeal procedures.
We also have a Technologies & Bioethics Committee composed of an interdisciplinary team of medical professionals and EmblemHealth department representatives. This committee meets a minimum of 10 times a year to decide when certain technologies previously considered experimental and investigational have come to satisfy the general medical standards in effect in our service area at the time of our evaluation. In doing so, the committee accesses all available resources and information on a particular developing technology and measures it against the criteria described in EmblemHealth's contract provisions.
A drug, treatment, device or procedure is considered experimental and investigational if any of the following applies:
- It cannot be lawfully marketed without the approval of the Food and Drug Administration (FDA) and such approval has not been granted at the time of its use or proposed use.
Exception: If FDA approval of a drug has been granted for treatment of a certain type of cancer, the law may require coverage of that drug even if it is prescribed for treatment of a different type of cancer.
- It is the subject of a current investigational new drug (IND) or new device application (NDA) on file with the FDA.
- It is being provided pursuant to a Phase I or Phase II clinical trial or as the experimental or research arm of a Phase III clinical trial.
- It is being provided pursuant to a written protocol that describes among its objectives, determinations of safety, efficacy or efficacy compared with conventional alternatives, and toxicity.
- It is being delivered, or should be delivered, subject to the approval and supervision of an Institutional Review Board (IRB) as required and defined by federal regulations, particularly those of the FDA or the Department of Health and Human Services (HHS).
- The predominant opinion among experts as expressed in the published authoritative literature is that usage should be substantially confined to research settings.
- If the predominant opinion among experts as expressed in the published authoritative literature is that further research is necessary to define safety, maximum tolerated dose, toxicity, effectiveness or effectiveness compared with conventional alternatives.
- It is not investigational in itself pursuant to the above, and would not be medically necessary, but for the provision of a drug, device, treatment or procedure that is investigational or experimental.
In determining whether any drug, treatment, device or procedure is considered experimental or investigational, the Plan relies on the following sources of information:
- The member's medical records
- The protocol(s) pursuant to which the treatment is to be delivered
- Any consent document the member has executed or will be asked to execute to undergo the treatment
- The published authoritative medical or scientific literature regarding the treatment as applied to the member's injury or illness
- Regulations and other actions and publications issued by the FDA and HHS
Clinical Trials for Medicare Members
Fee-for-service Medicare covers the routine costs of qualifying clinical trials if a Medicare member elects to participate in a CMS-approved clinical trial, and claims should be sent to fee-for-service Medicare. If a member wishes to enroll in a qualifying clinical trial, EmblemHealth Case Management must be notified.
Glossary terms found on this page:
An activity of EmblemHealth or its subcontractor that results in:
- Denial or limited authorization of a service authorization request, including the type or level of service
- Reduction, suspension or termination of a previously authorized service
- Denial, in whole or in part, of payment for a service
- Failure to provide services in a timely manner
- Failure of EmblemHealth to act within the time frames for resolution and notification of determinations regarding complaints, action appeals and complaint appeals
Oral or written request from a member or their designee for EmblemHealth to review or reconsider a decision made by the plan.
A program that assists the patient in determining the most appropriate and cost-effective treatment plan, including coordinating and monitoring the care with the ultimate goal of achieving the optimum health care outcome.
An itemized statement of health care services and their costs provided by a hospital, physician's office or other health care facility. Claims are submitted to the insurer or managed care plan by either the plan member or the provider for payment of the costs incurred.
The government agency responsible for administering the Medicare and Medicaid programs.
A legal agreement between an individual member or an employer group and a health plan that describes the benefits and limitations of the coverage.
The US government's principal agency for protecting the health of all Americans and providing essential human services. Also called the DHHS.
Treatment, procedure, drug, biological product or medical device that has not been of proven benefit for the particular diagnosis or treatment of the particular condition or is not generally recognized by the medical community, as reflected in the published peer-reviewed medical literature, as effective or appropriate for the particular diagnosis or treatment of the particular condition.
A payment method in which the insurer will reimburse the member or provider directly for each covered medical expense.
A request to change an adverse determination that was based on administrative policies, procedures or guidelines.
The group of individuals who provide person-centered care coordination and care management to participants in a FIDA plan. Each participant will have an interdisciplinary team (IDT). Each IDT will be comprised, first and foremost, of the participant and/or his or her designee, and the participant’s designated care manager, primary care physician, behavioral health professional, home care aide, and other providers either as requested by the participant or his or her designee or as recommended by the care manager or primary care physician and approved by the participant and/or his or her designee. The IDT facilitates timely and thorough coordination between a FIDA plan and the IDT, primary care physician and other providers. The IDT makes coverage determinations. Accordingly, the IDT’s decisions serve as service authorizations, may not be modified by a FIDA plan outside of the IDT, and are appealable by the participant, their providers and their representatives. IDT service planning, coverage determinations, care coordination and care management are delineated in the participant’s person-centered service plan and are based on the assessed needs and articulated preferences of the participant.
An organization comprised of individual physicians or physicians in group practices that contracts with the managed care organization on behalf of its member physicians to provide health care services. Also called an Independent Practice Association.
Acronym for Medicare Advantage. An alternative to the traditional Medicare program in which private plans run by health insurance companies provide health care benefits that eligible beneficiaries would otherwise receive directly from the Medicare program.
Professional services rendered by a physician for the treatment or diagnosis of an illness or injury.
Health care that is rendered by a hospital or a licensed or certified provider and is determined by EmblemHealth to meet all of the criteria listed below:
- It is provided for the diagnosis or direct care or treatment of the condition, illness, disease, injury or ailment.
- It is consistent with the symptoms or proper diagnosis and treatment of the medical condition, disease, injury or ailment.
- It is in accordance with accepted standards of good medical practice in the community.
- It is furnished in a setting commensurate with the member's medical needs and condition.
- It cannot be omitted under the standards referenced above.
- It is not in excess of the care indicated by generally accepted standards of good medical practice in the community.
- It is not furnished primarily for the convenience of the member, the member's family or the provider.
- In the case of a hospitalization, the care cannot be rendered safely or adequately on an outpatient basis or in a less intensive treatment setting and, therefore, requires the member receive acute care as a bed patient.
The fact that a provider has prescribed a service or supplies care does not automatically mean the service or supply will qualify for reimbursement under the EmblemHealth plan. To be eligible for reimbursement by EmblemHealth, all covered services must meet EmblemHealth's medical necessity criteria, described above.
Medically necessary with respect to Medicaid and Family Health Plus members means health care and services that are necessary to prevent, diagnose, manage or treat conditions that cause acute suffering, endanger life, result in illness or infirmity, interfere with a person's capacity for normal activity or threaten some significant handicap.
A nationwide insurance program for the disabled and people age 65 and over, created by the 1965 amendments to the Social Security Act and operated under the provisions of the Act. It consists of two separate but coordinated programs, Part A and Part B.
An individual and each of his or her eligible dependents, including Medicare beneficiaries who are enrolled or participate in a benefit program and who are entitled to receive covered services from the practitioner pursuant to such benefit program and the terms of the practitioner's agreement.
A type of health benefit plan that allows enrollees to go outside the health plan's provider network for care, but requires enrollees to pay higher out-of-pocket fees when they do. Also called Point of Service.
A prepaid payment or series of payments made to a health plan by purchasers and often plan members for health insurance coverage.
The geographic area in which a health plan is prepared to deliver health care through a contracted network of participating providers.
An active member enrolled under an EmblemHealth group Certificate or an individual enrolled under a direct payment contract. A "retiree" may also be a subscriber under a group Certificate.