For more information about insurance coverage of clinical trial costs, see this feature's main page: States That Require Health Plans to Cover Patient Care Costs in Clinical Trials.
Legislation: Senate Bill 42 (Chapter 212)
Effective: July 6, 2009
What clinical trials are covered?
Insurers are required to provide coverage for routine patient care costs in clinical trials provided that the trial:
- Is undertaken for the prevention of cancer or the reoccurrence of cancer or for the early detection, treatment, or palliation of cancer for which no equally or more effective standard treatment exists
- Is not designed exclusively to test toxicity or disease pathophysiology and has a therapeutic intent
- Is provided in the state of New Mexico as part of a scientific study that includes:
- specific goals
- a rationale and background
- specific direction for administering the therapy or intervention and for monitoring patients
- a definition of quantitative measures for determining treatment response
- methods for documenting and treating adverse reactions
- a reasonable expectation that the treatment will be at least as efficacious as standard cancer treatment
- Is being conducted with the approval of at least one of the following:
- One of the National Institutes of Health
- U.S. Department of Defense
- U.S. Food and Drug Administration under an investigational new drug application
- U.S. Department of Veteran Affairs
- A qualified research entity that meets criteria established by the National Institutes of Health for grant eligibility
- Has been approved by an institutional review board that has an active federal-wide assurance of protection for human subjects.
Who is required to pay?
Group health plans, including health maintenance organizations and the state's medical assistance program.
Other key provisions
- "Routine patient care costs" means the costs of:
- medical services or treatment that would be covered if the patient were receiving standard cancer treatment
- a drug provided to a patient during a cancer clinical trial if the drug has been approved by the FDA, whether or not it has been approved for use in treating the patient's particular condition, but only to the extent that the drug is not paid for by its manufacturer, distributor, or provider
- Routine costs do not include:
- the cost of an investigational drug, device, or procedure
- the cost of a non-health care service the patient is required to receive as a result of participation in the trial
- the costs of managing the research associated with the trial
- costs that would not be covered by the patient's health plan if non-investigational treatments were provided
- costs of extra tests that would not be performed except for participation in the trials
- costs paid or not charged for by the clinical trial providers
- Routine costs also do not include items or services that are:
- required solely to provide the drug, device, or service being tested
- required solely for clinically appropriate monitoring of the drug, device, or service being tested
- required solely to prevent, diagnose, or treat complications arising from the drug, device, or service being tested
- provided solely for data collection and analysis purposes
- customarily provided by the trial sponsor free of charge to any participant
- not covered by the health plan outside of a clinical trial.
- Personnel conducting the clinical trial must:
- be doing so within the scope of their practice, experience, and training
- agree to accept reimbursement at the plan's established rates as payment in full
- provide written notice to the health plan when a patient enters or leaves a clinical trial.
- There must be no non-investigational treatment equivalent to the clinical trial.
- The available clinical or preclinical data must provide a reasonable expectation that the medical treatment provided in the clinical trial will be as least as efficacious as any non-investigational alternative.
- No third party is liable for damages associated with the treatment provided during a cancer clinical trial.
- A patient may appeal a decision to deny coverage of routine patient care costs in a clinical trial. The appeal must be resolved within 30 days from the date it is filed.
- A health plan shall not provide benefits that supplant a portion of a cancer clinical trial that is customarily paid for by government or industry sources.
- A health plan may impose deductibles, coinsurance, or other standard cost-sharing provisions on benefits provided to a patient participating in a clinical trial.
- A health plan will not be responsible for out-of-state or out-of-network costs unless it pays for standard treatment out-of-state or out-of-network. In no event will a health plan be responsible for out-of-state costs for trials undertaken to prevent cancer or the reoccurrence of cancer.