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Employer Health Care Reform Guide

Clinical Trials FAQ

What are the new coverage requirements?

Most clinical trials involve drugs or devices, generally provided without cost during the trial period. Effective January 1, 2014, the Affordable Care Act (ACA) requires the following provisions:

If a “qualified individual” is in an “approved clinical trial,” the plan may not:

  1. Deny the individual participation in an approved clinical trial.
  2. Deny or limit, or impose additional conditions on the coverage of routine patient costs for items or services furnished in connection with participation in the approved clinical trial.
  3. Discriminate against the individual on the basis of their participation in the approved clinical trial.
What is an “approved clinical trial”?

The term “approved clinical trial” is defined as a phase I, phase II, phase III, or phase IV clinical trial conducted in relation to the prevention, detection or treatment of cancer or other life-threatening disease or condition. In addition, an approved clinical trial must also be classed as one of the following:

  1. A federally funded or federally approved trial.
  2. A clinical trial conducted under a U.S. Food and Drug Administration (FDA) investigational new drug application.
  3. A drug trial that is exempt from the requirement of an FDA investigational new drug application.
Who is a “qualified individual”?

A qualified individual is an individual eligible to take part in an approved clinical trial according to the trial protocol with respect to treatment of cancer or another life-threatening disease or condition. To be a qualified individual, there is an additional requirement that a determination be made by the individual’s doctor that participation in the approved clinical trial is appropriate to treat the individual’s disease or condition.

This determination must offer medical and scientific information establishing that the individual’s participation is appropriate.

What is a “life-threatening condition”?

A "life-threatening condition” means any disease or condition which is likely to result in death unless the course of the disease or condition is interrupted.

What are “routine patient costs”?

Routine patient costs include all items and services typically covered by the Plan for a member who is not enrolled in a clinical trial. This does not include the following:

  • Investigational items, devices or services;
  • Items and services provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patient; or
  • Any services clearly inconsistent with widely accepted and established standards of care for a particular diagnosis.
Does a member need prior authorization from the Plan to take part in a clinical trial?

Yes. A member or their doctor must ask for approval, known as prior authorization, from the Plan before they take part in a clinical trial. The Plan will review the case to make sure the rules are followed.

Is the member required to participate in an approved clinical trial through an in-network provider?

If a member wishes to participate in an approved clinical trial, the Plan may require the member to participate through an in-network provider. This also requires that an in-network provider is holding an approved clinical trial and that they accept the member as a patient in the trial.

Is there coverage for an out-of-network or out-of-state approved clinical trial?

If the Plan already provides coverage for out-of-network services, then clinical trials may also be covered out-of-network. Some plans do not cover any services received out-of-network.

Out-of-state clinical trials may only be covered if there are no clinical trials available in the patient’s primary state of residence.

Are there state laws that apply to coverage of approved clinical trials?

Yes. If a state law has requirements that are more generous or provide more protections to patients, health insurance plans in that state will need to comply with the state law as well as the ACA requirements.

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General Purpose
Health Net's National Medical Policies (the "Policies") are developed to assist Health Net in administering plan benefits and determining whether a particular procedure, drug, service, or supply is medically necessary. The Policies are based upon a review of the available clinical information including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the drug or device, evidence-based guidelines of governmental bodies, and evidence-based guidelines and positions of select national health professional organizations. Coverage determinations are made on a case-by-case basis and are subject to all of the terms, conditions, limitations, and exclusions of the Member's contract, including medical necessity requirements. Health Net may use the Policies to determine whether, under the facts and circumstances of a particular case, the proposed procedure, drug, service, or supply is medically necessary. The conclusion that a procedure, drug, service, or supply is medically necessary does not constitute coverage. The Member's contract defines which procedure, drug, service, or supply is covered, excluded, limited, or subject to dollar caps. The policy provides for clearly written, reasonable and current criteria that have been approved by Health Net's National Medical Advisory Council (MAC). The clinical criteria and medical policies provide guidelines for determining the medical necessity criteria for specific procedures, equipment and services. In order to be eligible, all services must be medically necessary and otherwise defined in the Member's benefits contract as described in this "Important Notice" disclaimer. In all cases, final benefit determinations are based on the applicable contract language. To the extent there are any conflicts between medical policy guidelines and applicable contract language, the contract language prevails. Medical policy is not intended to override the policy that defines the Member's benefits, nor is it intended to dictate to providers how to practice medicine.

Policy Effective Date and Defined Terms.
The date of posting is not the effective date of the Policy. The Policy is effective as of the date determined by Health Net. All policies are subject to applicable legal and regulatory mandates and requirements for prior notification. If there is a discrepancy between the policy effective date and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. In some states, prior notice or posting on the website is required before a policy is deemed effective. For information regarding the effective dates of Policies, contact your provider representative. The Policies do not include definitions. All terms are defined by Health Net. For information regarding the definitions of terms used in the Policies, contact your provider representative.

Policy Amendment without Notice.
Health Net reserves the right to amend the Policies without notice to providers or Members. In some states, prior notice or website posting is required before an amendment is deemed effective.

No Medical Advice.
The Policies do not constitute medical advice. Health Net does not provide or recommend treatment to Members. Members should consult with their treating physician in connection with diagnosis and treatment decisions.

No Authorization or Guarantee of Coverage.
The Policies do not constitute authorization or guarantee of coverage of any particular procedure, drug, service, or supply. Members and providers should refer to the Member contract to determine if exclusions, limitations and dollar caps apply to a particular procedure, drug, service, or supply.

Policy Limitation: Member's Contract Controls Coverage Determinations.
Statutory Notice to Members: The materials provided to you are guidelines used by this plan to authorize, modify or deny care for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract. The determination of coverage for a particular procedure, drug, service, or supply is not based upon the Policies, but rather is subject to the facts of the individual clinical case, terms and conditions of the Member's contract, and requirements of applicable laws and regulations. The contract language contains specific terms and conditions, including pre-existing conditions, limitations, exclusions, benefit maximums, eligibility, and other relevant terms and conditions of coverage. In the event the Member's contract (also known as the benefit contract, coverage document, or evidence of coverage) conflicts with the Policies, the Member's contract shall govern. The Policies do not replace or amend the Member contract.

Policy Limitation: Legal and Regulatory Mandates and Requirements
The determinations of coverage for a particular procedure, drug, service, or supply is subject to applicable legal and regulatory mandates and requirements. If there is a discrepancy between the Policies and legal mandates and regulatory requirements, the requirements of law and regulation shall govern.

Reconstructive Surgery
California Health and Safety Code 1367.63 requires health care service plans to cover reconstructive surgery. "Reconstructive surgery" means surgery performed to correct or repair abnormal structures of the body caused by congenital defects, developmental abnormalities, trauma, infection, tumors, or disease to do either of the following:

1. To improve function; or
2. To create a normal appearance, to the extent possible.

Reconstructive surgery does not mean "cosmetic surgery," which is surgery performed to alter or reshape normal structures of the body in order to improve appearance.

Requests for reconstructive surgery may be denied, if the proposed procedure offers only a minimal improvement in the appearance of the enrollee, in accordance with the standard of care as practiced by physicians specializing in reconstructive surgery.

Reconstructive Surgery after Mastectomy
California Health and Safety Code 1367.6 requires treatment for breast cancer to cover prosthetic devices or reconstructive surgery to restore and achieve symmetry for the patient incident to a mastectomy. Coverage for prosthetic devices and reconstructive surgery shall be subject to the copayment, or deductible and coinsurance conditions, that are applicable to the mastectomy and all other terms and conditions applicable to other benefits. "Mastectomy" means the removal of all or part of the breast for medically necessary reasons, as determined by a licensed physician and surgeon.

Policy Limitations: Medicare and Medicaid
Policies specifically developed to assist Health Net in administering Medicare or Medicaid plan benefits and determining coverage for a particular procedure, drug, service, or supply for Medicare or Medicaid Members shall not be construed to apply to any other Health Net plans and Members. The Policies shall not be interpreted to limit the benefits afforded Medicare and Medicaid Members by law and regulation.


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