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Medical Policy

Policy Num:       10.001.013
Policy Name:     Clinical Trials
Policy ID:          [10.001.013][Ar L M _P+ ][0.00.00]

Last Review:       November 14,2018
Next Review:      N/A
Issue:                   11:2018

Related Policies:

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Clinical Trials 

Summary

A clinical trial is a research study that is used in the medical field to find new avenues to improve health. Clinical trials can:

• Try new treatments for certain conditions or diseases to determine if they are better than the current one

• Try treatments or change lifestyles to see if they prevent or lower the chance of acquiring certain diseases

• Develop new tests for the diagnosis of diseases.

Objective

Characteristics of a Clinical Trial

• The purpose of the investigation should be to evaluate a service or product considered a benefit (eg, medical services, durable medical equipment, diagnostic tests) and not excluded from coverage (eg, cosmetic surgery).

• The clinical trial should not be for evaluation of toxicity or pathophysiology

exclusively, it must have therapeutic intent.

• The therapeutic clinical trial should recruit patients with established diagnoses, should not recruit healthy people; Diagnostic interventions can recruit healthy people to provide a control group

• The main purpose of the plan should be to investigate if health is improved.

• The clinical trial should not duplicate existing studies.

Clinical Trial must be endorsed by one of the following entities:

• NIH (National Institutes of Health)

• CDC (Centers for Disease Control)

• AHRQ (Agency For Healthcare Research & Quality)

• CMS (Centers for Medicare & Medicaid Services)

• DOD (Department of Defense)

• VA (Department of Veterans Affairs)

• FDA (Food and Drug Administration)

Policy Statements

Triple-S covers for payment all medically necessary and routine services provided in a clinical trial (Clinical Trial) in a manner, manner and according to the terms, limitations and restrictions of the policy to any other insured in the regular plan

Policy Guidelines

The usual and routine costs of a clinical trial include all the services and products that would normally be available to the beneficiaries of the plan, according to the existing payment policies. They will be covered in the experimental arm or in the control arm of the clinical trial except: 

• Research services or products unless coverage is outside the scope of the clinical trial;

• Services or products that are provided for data collection and analysis, other than for direct patient management (eg, monthly CT for a condition that normally requires only one);

• Services or products commonly provided by the research sponsor

Free of charge for any participant. 

Routine costs in a clinical trial include: 

• Services or products that are typically provided in conventional management.

• Services or products to administer or facilitate the research service or product (eg administration of a non-covered chemotherapeutic product), monitoring the effects of said service or product and preventing complications.

Benefit Application

BlueCard/National Account Issues

The services to diagnose and treat the complications resulting from the Clinical trials are covered in accordance with the limitations in policy, medical and payment policies established by Triple-S Salud for the billed service codes.

Triple-S is not responsible for any adverse incident followed during a clinical trial.

Background

The Centers for Medicare and Medicaid Services (CMS) undertook the task of defining the routine costs of a clinical trial and identifying the clinical trials for which these costs would be paid.

Regulatory Status

On June 7, 2000 the president of the United States of America originated an executive memorandum ordering the Secretary of Health and Human Services to authorize payment by Medicare for the costs of routine medical care services and for costs arising from medical complications related to participation in clinical trials (Clinical Trial).

Rationale

Clinical trials advance through four phases to test a treatment, find the appropriate dosage, and look for side effects. If, after the first three phases, researchers find a drug or other intervention to be safe and effective, the FDA approves it for clinical use and continues to monitor its effects.

Clinical trials of drugs are usually described based on their phase. The FDA typically requires Phase I, II, and III trials to be conducted to determine if the drug can be approved for use.

• A Phase I trial tests an experimental treatment on a small group of often healthy people (20 to 80) to judge its safety and side effects and to find the correct drug dosage.
• A Phase II trial uses more people (100 to 300). While the emphasis in Phase I is on safety, the emphasis in Phase II is on effectiveness. This phase aims to obtain preliminary data on whether the drug works in people who have a certain disease or condition. These trials also continue to study safety, including short-term side effects. This phase can last several years.
• A Phase III trial gathers more information about safety and effectiveness, studying different populations and different dosages, using the drug in combination with other drugs. The number of subjects usually ranges from several hundred to about 3,000 people. If the FDA agrees that the trial results are positive, it will approve the experimental drug or device.
• A Phase IV trial for drugs or devices takes place after the FDA approves their use. A device or drug's effectiveness and safety are monitored in large, diverse populations. Sometimes, the side effects of a drug may not become clear until more people have taken it over a longer period of time.

Population Reference No. 1 Policy Statement

For evaluation of toxicity or pathophysiology of a service or product in a selected population

Population Reference No. 2 Policy Statement

For targeted individuals with specific diagnosis for therapeutic intent 

Population Reference No. 3 Policy Statement

For targeted individuals with specific diagnosis and healthy people for control with diagnostic intent

Supplemental Information

N/A

Practice Guidelines and Position Statements

N/A

Medicare National Coverage

N/A

References

1.   Villar J, Carroli G, Belizán JM. Predictive ability of meta-analyses of randomised controlled trials. Lancet 1995; 345:772.

2.     Clarke MJ, Stewart LA. Principles of and procedures for systematic reviews. In: Systematic reviews in health care: meta-analysis in context, Egger M, Smith G, Altman D (Eds), BMJ Publishing Group, London 2001. p.23.

3.     http://www.ncbi.nlm.nih.gov/pubmed (Accessed on May 5, 2015)

4.     DerSimonian R, Laird N. Meta-analysis in clinical trials. Control Clin Trials 1986; 7:177.

5.     Moher D, Jadad AR, Nichol G, et al. Assessing the quality of randomized controlled trials: an annotated bibliography of scales and checklists. Control Clin Trials 1995; 16:62.

6.     Up to Date, April 2015

7.     ClinicalTrials.gov; May 17, 2017
www.clinicaltrials.gov 

Codes

Applicable Modifiers

N/A

Policy History