Pending Policies - Administrative
Clinical Trial Treatment or Therapy
*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*
In general, services and/or items (devices, tests, procedures, medications, technology, etc.) that are provided within the context of an approved clinical trial (Refer to NOTE 1 below) are not considered routine care and therefore are considered experimental, investigational and/or unproven, when:
• The specific service(s) and/or item(s) are considered investigational; OR
• The specific service(s) and/or item(s) are provided solely to satisfy data collection and analysis for the clinical trial but are not required for clinical management of the patient’s diagnosis or condition; OR
• The specific service(s) and/or item(s) are inconsistent with generally accepted and established standards of care for a particular diagnosis or condition.
The usual and routine patient care for a condition that customarily would be provided outside of an approved clinical trial may be considered medically necessary for members who are enrolled or participating in a clinical trial.
NOTE 1: Definitions and information regarding approved clinical trials, including federally funded trials, are described in the Description below.
NOTE 2: Coverage should be consistent with requirements of the Patient Protection and Affordable Care Act and all applicable State legislative mandates.
A clinical trial (commonly referred to as a clinical study, research study, or research urgent treatment study) is one of the final steps in the extensive research process for confirming the effectiveness of new medical advances. These trials are crucial not only for finding ways to better treat conditions or diseases, but also finding improved ways to detect problems early as well as prevention in the first place. Trials allow doctors and researchers to gain information on the benefits, side effects, and possible applications to the new treatment modality. They may gain information on different combinations of treatments, doses of drugs, devices, and possible applications of therapies. As a result, the medical community may be able to determine new ways to detect, diagnose, avoid, and control clinical factors responsible for disease.
To determine the effectiveness of a particular strategy for fighting or preventing a disease, a clinical trial will compare its effect to that of the best existing alternative. To make the comparison as accurate as possible, researchers often randomly select which clinical trial participants receive the new agent or treatment and which participants receive the current standard. What the “standard” is depends on the type of trial. For a treatment trial, it might be the most commonly used drug, while for a prevention trial it might be no intervention at all.
Types of Clinical Trials
There are several different types of clinical trials:
• Community Trials – an entire community receives a treatment or preventative measure to determine if it works in the “real world”; or
• Diagnostic Trials – scrutinizes avenues to find better tests or procedures for diagnosing a particular disease or condition; or
• Interventional or Treatment Trials – evaluates the effectiveness of new drugs, new types or approaches of surgery or radiation/ancillary therapies, different combinations of therapies, and new methods of stopping or reversing the disease course; or
• Observational Trials – addresses health issues in large groups of people or populations in natural settings; or
• Prevention Trials – tests strategies for reducing the risk of acquiring the disease, which include strategies in taking medicines, vitamins supplements, vaccines, mineral supplements, learning new dietary or exercise strategies, or making lifestyle changes; or
• Quality of Life/Supportive Care Trials – examines ways to make the lives of people with terminal diseases as comfortable as possible and to help them maintain a high quality of living despite their condition; or
• Randomized Controlled Trials – a true experiment, in which the researcher randomly assigns some patients to at least one treatment and other patients to a placebo, or usual treatment; or
• Screening Trials – explores the best ways to find or detect the disease at the earliest and most treatable stage, such as comparing the effectiveness of a blood test in detecting a disease with that of a physical examination as a screening procedure.
Phases of a Clinical Trial
Clinical Trials are conducted in phases or stages. The trials at each phase have a different purpose and help scientists answer different questions:
• Phase I – researchers test a new drug or treatment in a small group of people (20 to 80, even as few as 10) at first to evaluate its safety, determine a safe dosage or modality range, and identify side effects.
• Phase II – the study drug or treatment is given to a larger group of people (100 to 300) to see if it is effective and to further evaluate its safety.
• Phase III – the study drug or treatment is given to large groups of people (1,000 to 3,000) to confirm its effectiveness, monitor side effects, compare to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
• Phase IV – post marketing studies delineate additional information including the risks, benefits, and optimal uses of the drug or treatment.
Pros and Cons of Participating in a Clinical Trial
In addition to receiving high-quality care, there are many benefits to enrolling in a clinical trial. A patient’s participation could potentially benefit others by increasing knowledge about a disease and its potential treatments. Also consider that, as a clinical trial participant, a patient may be one of the first patients to experience positive results from a new therapy. On the other hand, it is possible that new treatments may not be better than the standard care, and unknown side effects may be worse than those experienced with standard treatments. Also, the patient may be placed in a control group that receives the standard care instead of the experimental study treatment. These are the factors a patient needs to be comfortable with before deciding to join a clinical trial. The patient, whether in the clinical trial or control group, will receive the same close monitoring and evaluations. So no matter which group a patient is in, he or she will receive excellent care for the condition being treated by a team of researchers.
Rights and Measures that Protect Clinical Trial Participants
Clinical trials are regulated by a number of governing groups and processes to help protect patient safety and the ethicality of scientific research. The rights of clinical trial patients are notably protected by:
• Institutional Review Board (IRB) – All research organizations have an IRB which oversees the actions and documents related to the clinical trial process. This group is made up of medical specialists, nurses, social workers, medical ethicists, and sometimes patient advocates and clergy, who have no special interest in any specific trial. Each member is responsible for ensuring that all trials are conducted safely, fairly, ethically, and with full patient consent and involvement.
• Peer Review (PR) – Clinical trials are often reviewed by experts such as the National Cancer Institute, or a pharmaceutical company chosen by the study sponsor. Prior to IRB submission, these groups review the trials for scientific merit, patient safety, and ethical considerations. Many research organizations have peer review groups in addition to their IRBs.
• Informed Consent (IC) – IC is a process designed to inform the clinical trial patient and to help foster good communication between the patient and the research team. This process includes providing the patient with information about significant safety issues that might surface during the course of the study. The IC document will relate facts about the trial, such as its purpose, duration, required or alternative procedures, benefits and risks. Once the IC document and written material are given to the clinical trial patient, he or she will have time to think over the decision. If he or she elects to participate in the study, they will be asked to sign the IC document, verifying the clinical trial patient understands and agrees to its conditions. Once the clinical trial begins, the IC patient rights continue. Throughout the trial, the patient may receive new information which may affect their decision to remain in the trial study. The healthcare team will routinely evaluate how the treatment is affecting the patient and will inquire if the patient would like to continue participation. The clinical trial patient is free to leave a trial at any time.
Where do the ideas for trials come and who sponsors them?
Ideas for clinical trials usually come from researchers. After the researchers test new therapies and procedures in the laboratory and in animal studies, the treatment with the most promising laboratory results are moved into clinical trials. The clinical trials are then sponsored or funded by a variety of organizations or individuals, such as physicians, medical institutions, voluntary groups, and pharmaceutical companies. The studies will then be conducted in a variety of places, such as hospitals, universities, physician offices, or community clinics.
Approved Clinical Trials
The term approved clinical trials means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or condition, as determined by the treating physician. The following is a listing of federally sponsored, approved or funded (which may include funding through in-kind contributions), clinical trials:
Federally Funded Trials:
• The National Institutes of Health (NIH);
• The Centers for Disease Control (CDC) and Prevention;
• The Agency for Health Care Research and Quality (AHCRQ);
• The Centers for Medicare & Medicaid Services (CMS);
• The Department of Veterans Affairs (VA);
• The Department of Defense (DOD);
• The Department of Energy (DOE);
• Cooperative group or center of the entities listed above; or
• A qualified non-governmental research entity identified in the guidelines issued by the NIH for center support grants.
Review by Governmental Agency:
• The study or investigation is conducted under an investigational new drug application reviewed by the Food and Drug Administration (FDA).
• The study or investigation is a drug trial that is exempt from having such as an investigational new drug application.
Glossary of Terms
• Active Treatment – In a clinical trial, treatment that is intended to reduce or eliminate the disease in a patient.
• Adverse Event (AE) – An undesirable health event that occurs in a participant during a clinical trial. It may or may not be related to the treatment itself.
• Anecdotal Experience – Report of clinical experiences based on individual cases, rather than an organized investigation with appropriate controls.
• Arm or ARM – A group or subgroup of participants in a clinical trial that receives specific interventions, or no interventions, according to the study protocol, for which is decided prior to the beginning of the trial.
• Assurance – In a clinical trial, a formal written, binding commitment is submitted to a federal agency by an institution by which the institution agrees to comply with regulations governing research with human subjects. It specifies the procedures through which compliance will be achieved. The Federal Office of Human Research Protections reviews and issues “Assurances” for clinical trials.
• Benefit – In a clinical trial, the unlikely or unexpected favorable outcome for participants in a clinical trial.
• Biologic – A product derived from a living organism that is used in the diagnosis or treatment of disease. Examples include gene therapy, allergy shots, vaccines, and blood products.
• Blinded or Blinding – A method used in a clinical trial to prevent participants and/or researchers from knowing whether the patient is receiving the experimental or control treatment in a trial. Also, referred to as “masking.” Single blinding is when only the patient does not know which treatment he or she is receiving. Double blinding is when the patient and the researcher do not know which treatment is being provided.
• Case Report – An anecdotal experience, which could be a single experience, known also as Single Case Reports.
• Case Series or Studies – A collection of anecdotes of diseases of interest and no control group is involved, which could be completed just once or consecutively.
• Case-control Study – Identification of patients with a disease of interest and reviews their clinical history for exposure and effects of the disease. The history is compared to other patients with same disease of interest and those without the disease of interest in the same population grouping.
• Clinical Research – Studies performed in humans that are intended to increase knowledge about how well a diagnostic test or treatment works in a particular patient population.
• Clinical Trial – A prospectively planned scientific study of the effects of a diagnostic test or treatment on selected patients, usually with respect to safety, efficacy, and/or quality of life. Also, referred to as “Clinical Study.” Each Clinical Trial that is registered on ClinicalTrials.gov is given an identifying National Clinical Trial (NCT) Number.
• Cohort Study – A longitudinal study that begins with the gathering of two groups of patients, known as the cohorts, one which received the treatment and one which did not, and then follow the cohorts over time to measure the development of different outcomes.
• Compassionate Use – One of the mechanisms by which the FDA makes investigational new drugs and devices that are not yet approved for marketing available to very ill patients who have no other treatment options. This availability may also be considered Humanitarian Use.
• Conflict of Interest – In a clinical trial, a situation in which the interests of the researcher or institution are at odds with their professional obligation to the patient.
• Consent – A patient’s oral and written agreement to participate in a clinical trial. Consent is based on full disclosure about the treatment, its potential risks and benefits, alternative treatments, and any other information that a patient needs to make the decision. Patients enrolling in clinical trials must sign a consent form that explains what will happen in the trial. This agreement is also referred to as “Informed Consent.”
• Contract Research Organization (CRO) – A company with whom a drug or device manufacturer or sponsor contracts to perform clinical trial related activities. CROs may contract to develop protocols, recruit patients, collect and analyze data, and prepare documents to submit marketing applications to FDA.
• Control Group – In a clinical trial, the patient group(s) that does not receive the experimental treatment. The control group receives the standard treatment, placebo, or no treatment in accordance with the trial design, and the results of the control group(s) are compared to the results from the experimental group.
• Controlled Trial – A prospective clinical trial comparing two or more treatments, or placebo and treatment(s) in similar groups of patients or within patients. A controlled trial may or may not use randomization to assign patients to groups, and it may or may not use blinding to prevent them from knowing which treatment they get.
• Crossover Study Design – The administration of two or more experimental therapies one after the other to the same group of patients.
• Cross-sectional Study – A prevalence study to survey the entire population for the presence or absence of a disease as well as the potential risk factors at a particular point in time or interval.
• Data – Recorded observations about patients in a clinical trial. The parameters of the clinical trial can be included as recorded data.
• Data Safety Monitoring Board (DSMB) – A board set up by a clinical trial sponsor to evaluate trial progress, safety data, and significant outcomes according to FDA regulations. This committee, comprising of community representatives and clinical research experts, may also recommend revisions or discontinuation of a clinical trial if the trial objectives remain unmet or safety concerns arise.
• Department of Health and Human Services (DHHS) – Federal agency established to protect the health of the U.S. population. DHHS divisions include, among others, FDA, NIH, the Centers for Disease Control and Prevention (CDC, CDCP), and Centers for Medicare and Medicaid Services (CMMS).
• Device (Medical) – An instrument, apparatus, implement, machine, invention, implant, in vitro reagent, or other article intended for use in the diagnosis, treatment, or prevention of disease. A device is intended to affect the structure or function of the body, but it does not function through chemical action within or on the body.
• Double-Blind Placebo-Controlled Study – The most reliable form of research where half of the participants receives the actual treatment or substance being tested while the other half receives a placebo. The participants and researchers are kept in the blind about which group is being treated with the new treatment, thus making it a “double-blind” study. Generally, it should have 100 to 300 participants.
• Effectiveness – The degree to which a diagnostic test or treatment produces a desired result in patients in the daily practice of medicine.
• Efficacy – The degree to which a diagnostic test or treatment produces a desired result in patients under the idealized circumstances of a clinical trial.
• Enroll – To consent to and enter in a clinical trial.
• Ethics – Conforming to an accepted standard of human behavior.
• Evidence-Based Medicine – An approach to practicing medicine that involves consideration of results of clinical trials that are relevant to the disease or condition being treated when making decisions about how to treat patients.
• Exclusion Criteria – Factors used to determine whether an individual is ineligible for a trial.
• Expanded Access – The mechanism by which FDA makes it possible for doctors to use investigational new products for gravely ill patients outside the context of a clinical trial and before a product has received marketing approval.
• Experimental – Investigational or unproven, not yet proven safe or effective.
• Experimental Treatment Group – The group that receives the investigational treatment in a trial; the group to which the control group results are compared.
• Follow-up – A doctor’s or researcher’s examination of patient signs and symptoms after a test or treatment have been given.
• Food and Drug Administration (FDA) – The federal agency accountable for guaranteeing the safety and effectiveness of all drugs, biologics, vaccines, and medical devices used in the diagnosis, treatment, and prevention of human disease.
• Helsinki Declaration – Guidelines adopted in 1964 by the 18th World Medical Assembly (WMA) (Helsinki, Finland) and revised in 2000 by the 52nd WMA General Assembly, for physicians conducting biomedical research. This declaration outlines clinical trial procedures required to ensure patient safety, consent and ethics committee reviews in human subjects.
• Inclusion Criteria – The factors used to judge a participant’s eligibility for inclusion in a trial. There is an underlying rationale for the criteria selected. The rationale relates to the questions that the researchers are trying to answer by conducting the trial.
• Informed Consent Document – A document that describes the rights of study participants; this document states all the facts about the trial, such as its purpose, duration, required procedures, potential risks and benefits, alternative therapies, and key contacts.
• Institutional Review Board (IRB) – A specially constituted group of people established or designated by a research institution or clinical trial sponsor to protect the welfare of the human participants within the clinical research study, ensure trials adhere to federal regulations on the conduct of clinical research, to make sure that the risks are reasonable when compared to the potential benefits and make sure the study is ethical. IRB is made of medical specialists, nurses, social workers, medical ethicists, and patient advocates.
• Intention- to-Treat Analysis – In a randomized control trial, patients can be randomly assigned to different treatments. After the randomization, patients who were assigned to medical therapy may decide to have surgery or patients assigned to the surgical arm may elect not to undergo surgery. In this type of trial, patients would be analyzed for mortality according to the groups for which they were originally assigned.
• Investigational – Experimental or unproven, not yet proven safe or effective.
• Investigational New Drug (IND) – A novel chemical substance used to affect the function of the mind or body with the intention of diagnosing, preventing, or treating a disease, a condition, or its symptoms. An IND is not yet FDA approved for marketing to treat a particular condition, but it must be investigated in clinical trials to gather data that the FDA will consider for the marketing approval application.
• Investigator – A researcher responsible for conducting a clinical trial at a trial site.
• Life-Threatening Condition – As defined by Federal law, any disease or condition from which the likelihood of death is probable unless the course of the disease or condition is interrupted.
• Maneuver – Any exposure or treatment that acts upon patients to produce a result. (see Outcome)
• Medicare – A federal program of reimbursement to hospitals and physicians for healthcare provided to people 65 years of age and older, people eligible for Social Security disability payments for at least two years, and selected workers who need kidney transplantation or dialysis services.
• Monitoring – Activities to check patient’s health status during a trial. Also, activities to oversee the progress of a trial to ensure a researcher’s compliance with the protocol and regulatory requirements.
• Multicenter Trial – A clinical trial conducted at multiple sites using a common protocol.
• National Institutes of Health (NIH) – A federal agency consisting of many separate health research institutions. NIH conducts research in its own designated laboratories and funds billions of dollars in research in other facilities in the United States and abroad.
• New Drug Application (NDA) – An application made to the FDA that requests a license to market a new pharmaceutical in the United States. The application must include all appropriate clinical data from phase I through phase III clinical trials.
• Non-randomized Controlled Trials – Random assignment either may not be desired or sometimes impossible.
• Nuremberg Code – Code of human research ethics devised in 1947 after World War II. This code forms the foundation for current law and ethics on consent.
• Office for Human Research Protections (OHRP) – A federal agency under the umbrella of DHHS to help assure the protection of humans participating in clinical research. OHRP issues “Assurances” and supervises compliance with regulatory requirements by research institutions receiving federal funding. OHRP also provides initiatives on ethical issues in clinical research and coordinates interaction among federal agencies on these issues.
• Orphan Drug (OD) – Orphan Drug is defined in the 1984 amendments of the Orphan Drug Act as "a drug intended to treat a condition affecting fewer than 200,000 persons in the United States, or will not recover development cost plus a reasonable profit within seven years following FDA approval. The Orphan Drug Act was signed into law on January 4, 1983."
• Outcome – The ultimate result of a medical test or treatment given to a patient. Generally, patient-oriented outcomes are overall survival rates, disease-free survival rates, treatment-related morbidity, and mortality. (See Maneuver)
• Patient Characteristic – The medical (e.g., disease, stage of disease, hormone receptor status, prior treatments) or demographic (e.g., age, sex, marital status, race) qualities or traits of a patient. (See Population)
• Peer Review – A review of a clinical trial by experts chosen by the study sponsor; these groups review the trials for scientific merit, patient safety, and ethical considerations.
• Phase – A specific part of the clinical trial process, progressing from Phase I to IV, during which dosing, benefits, and side effects of a drug or treatment are studied.
• Placebo (Fake) – An inactive substance or treatment, such as a sugar pill, injection of sterile water, or sham medical device, that is given under the guise of treatment to separate the effects of the actual treatment being evaluated from psychological or other effects.
• Population – Every person who satisfies inclusion criteria for the study. (See Patient Characteristic)
• Preclinical Study – A laboratory or animal study of a drug, device, or procedure to find out if the new treatment shows enough promise to be studied in humans.
• Prospective Study – An epidemiologic study in which a cohort (group of patients), all free of a particular disease and varied in their exposure to a possible risk factor, is followed over a specific amount of time to determine the incidence rates of the disease of interest in the exposed and non-exposed groups.
• Protocol – The formal plan for the conduct of a clinical trial that defines the design, purpose, length, patient selection, methods, treatment, follow-up, clinical end points, and outcomes to be measured.
• Randomization (Random Assignment) – Any of the many methods used to assign subjects, by chance, to an experimental group or control group so that assignment is not influenced in any way by those making the assignments or by the researchers’ conduction the trial. Random assignment reduces the potential for bias in a trial.
• Randomized Controlled Trials (RCT) – A true experiment, in which the researcher randomly assigns some patients to at least one treatment and other patients to a placebo, or usual treatment.
• Recruitment – Processes used to attract and enroll trial participants according to eligibility criteria.
• Regulations – With respect to clinical research, the federal statutes, codes, and laws that govern the conduct of federally funded clinical trials and privately sponsored clinical trials for new drugs, devices, biologics, and procedures.
• Research Question – The best research question should specify a single measurable outcome, as well as all the conditions and important variables. The question contains the population, the maneuver or conditions affecting the study population, and the outcomes.
• Research Team – In clinical trials, the group of healthcare professionals who conduct the trial; it is typically includes a principal or primary investigator and a clinical research coordinator.
• Results – Analysis of the data collected during the trial.
• Retrospective Study – A review study of patients who have a disease of interest and the events leading up to the point of review.
• Risk – In a clinical trial, the probability of discomfort or harm to participants in a clinical trial.
• Routine Care Costs – Routine care costs typically include the medical care, encompassing all items and services a patient would need whether or not the patient was enrolled in a clinical trial. Examples of routine cost are tests needed for diagnosis and staging of a disease and interval check-ups to monitor disease status.
• Sample – The patients who satisfied the study’s inclusion criteria and who actually entered the study.
• Sham Treatment – An inactive device or device/procedure that mimics the actual device and can be used as a placebo in a clinical trial.
• Side Effect – Undesired effect of a treatment. Investigational new drugs and devices are evaluated for immediate and long-term side effects.
• Sponsor – An individual, company, institution, or organization that initiates, manages, and/or finances a clinical trial.
• Stage of Disease – The extent or severity of disease as designated by numerals or letters. For example, cancer is often designated as Stage I (earliest stage), II, III, or IV (most advanced stage). If the cancer is staged using letters, the disease is based on the features of the cancer tumor: the size/extent of the Tumor (T), Lymph Node Involvement (N), and the presence or absence of Metastases (M), known as the TNM system.
• Standard Treatment (Gold Standard) – The treatment that is currently thought to be effective in medical practice.
• Surveillance Study – Obtaining research data through registries, interviews, and/or surveys.
• Tangible Direct Costs – In a clinical trial, the participants may be responsible for the costs of the new drug or device used in the study.
• Tangible Indirect Costs – In a clinical trial, the participants may be responsible for the costs for travel, lodging, and additional lost time from work when participating in a trial.
• Toxicity – Degree of being poisonous to a living organism or person; ability to cause grave harm or death.
• University Medical Center – A health care institution that is part of a university that teaches medical students and conducts basic research (preclinical research) and clinical trials. Also referred to as an “Academic Medical Center.”
• Unproven – Experimental or investigative, not yet proven safe or effective.
• Voluntary – Free of coercion, duress, or undue inducement. In a clinical trial, refers to the participant’s decision to enroll.
• Withdraw – In a clinical trial, to end a patient’s participation before he or she reaches the designated end point.
This policy was originated in 2005 when benefits may have previously been provided on an exception basis for the participation in a clinical trial, as most benefit plans or health contracts specifically excluded coverage for the patient’s participation in a clinical trial. This exclusion extended to prescriptions or medications, and other patient care services and devices.
Coverage should be consistent with requirements of the Patient Protection and Affordable Care Act and all applicable State legislative mandates.
Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.
Disclaimer for coding information on Medical Policies
Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.
The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.
Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.
The following codes may be applicable to this Medical policy and may not be all inclusive.
G0293, G0294, G9057, S9988, S9990, S9991, S9992, S9994, S9996
ICD-9 Diagnosis Codes
Refer to the ICD-9-CM manual
ICD-9 Procedure Codes
Refer to the ICD-9-CM manual
ICD-10 Diagnosis Codes
Refer to the ICD-10-CM manual
ICD-10 Procedure Codes
Refer to the ICD-10-CM manual
The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.
The Centers for Medicare and Medicaid Services (CMS) does have a national Medicare coverage position.
A national coverage position for Medicare may have been changed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.
1. Stedman’s – Electronic Medical Dictionary – Version 5.0. 2000. Lippincott, Williams, and Wilcott Publisher. Available at <http://www.stedmans.org> (accessed May 1, 2006).
2. MUSC – Clinical Trials (January 1, 2001). Medical University of South Carolina. Available at <http://www.musc.edu> (accessed May 1, 2006).
3. Alternative Medicine – What is a Double-Blind Placebo-Controlled Study (January 8, 2001) Alternative Medicine. Available at <http://altmedicine.about.com> (accessed May 1, 2006).
4. Texas Cancer Online – Cancer Staging (September 5, 2001). Texas Cancer Online. Available at <http://www.jasper-web.com> (accessed May 1, 2006).
5. ECRI.org – Should I Enter a Clinical Trial? Summary of the Complete Patient Reference Guide. February 2002. American Association of Health Plans. Available at <http://www.ecri.org> (accessed May 1, 2006).
6. ECRI.org – Should I Enter a Clinical Trial? Glossary. February 2002. American Association of Health Plans. Available at <http://www.ecri.org> (accessed May 1, 2006).
7. ClinicalTrials.gov – An Introduction to Clinical Trials (June 30, 2003). National Institutes of Health and National Library of Medicine. Available at <http://clinicaltrials.gov> (accessed May 1, 2006).
8. Kelahan, A.M. Dissemination of information on legislative mandates and consensus-based programs addressing payment of the costs of routine care in clinical trials. Cancer. Mar 14 2004; 100(6):1238-45. PMID 15022292
9. iVillage – Clinical Trials (March 12, 2004). National Women’s Health Resource Centers, Inc. and iVillageHealth. Available at <http:www.ivillagehealth.com> (accessed May 1, 2006).
10. VirtuaHealth – Clinical Trials for Cancer Treatment (November 16, 2004). The Health On Net Foundation. Available at <http://www.virtua.org> (accessed May 1, 2006).
11. FDA.gov – OOPD Program Overview (December 2004). U.S. Food and Drug Administration. Available at <http://www.fda.gov> (accessed May 1, 2006).
12. FDA.gov – Good Clinical Practice in FDA – Regulated Clinical Trials (December 2004). U.S. Food and Drug Administration. Available at <http://www.fda.gov> (accessed May 1, 2006).
13. CRPF – Cancer Research and Prevention Foundation – Clinical Trials (December 3, 2004). Available at <http://www.preventcancer.org> (accessed May 1, 2006).
14. Genetech – Clinical Trial Education (December 3, 2004). Genetech, Inc. Available at <http://www.gene.com> (accessed May 1, 2006).
15. ClinicalTrials.gov – Glossary of Common Site Terms (August 2012). National Institutes of Health and National Library of Medicine. Available at <http://clinicaltrials.gov> (accessed on May 26, 2015).
16. NIMH.gov – A Participant’s Guide to Mental Health Clinical Research (January 25, 2013). National Institutes of Mental Health – National Institutes of Health. Available at <http://.nimh.nih.gov> (accessed January 25, 2013).
17. NIH.gov – The Basics (January 25, 2013). U.S. Department of Health and Human Services – National Institutes of Health. Available at <http://www.nih.gov> (accessed January 25, 2013).
18. The Affordable Care Act and Wellness Programs (February 25, 2013). Prepared by U.S. Federal Government. Available at <http://www.healthcare.gov> (accessed on February 25, 2013).
19. National Coverage Determination (NCD) for Routine Clinical Trials (310.1) (2007 July 9). Prepared by Centers for Medicare and Medicaid Services. Available at <http://www.cms.gov) (accessed on March 2, 2017).
|4/15/2018||Reviewed. No changes.|
|4/15/2017||Document updated with literature review. Coverage unchanged. The following was added to the Coverage section: “NOTE 1: Definitions and information regarding approved clinical trials, including federally funded trials, are described in the Description below.”|
|8/1/2016||Reviewed. No changes.|
|8/15/2015||Document updated with literature review. Coverage unchanged.|
|12/15/2014||Document updated with literature review. A note was added regarding the Patient Protection Affordable Care Act.|
|5/15/2013||Document updated. The following was added: 1) Service(s) and/or item(s) not considered routine care costs are considered experimental, investigational and unproven when the a) The specific service(s) and/or item(s) are considered investigational; OR b) The specific service(s) and/or item(s) are provided solely to satisfy data collection and analysis for the clinical trial but are not required for clinical management of the patient’s diagnosis or condition; OR c) The specific service(s) and/or item(s) inconsistent with generally accepted and established standards of care for a particular diagnosis or condition; and 2) When a patient is enrolled or participating in a clinical trial, the usual and routine patient care that customarily would be provided outside of the clinical trial may be considered medically necessary.|
|3/15/2013||Document updated with literature review. Coverage unchanged.|
|9/1/2009||Coverage revised to include Texas Contracts ONLY Legislative Mandate for allowance of routine patient care in clinical trials effective on|
|6/15/2008||Policy reviewed without literature review; new review date only. This policy is no longer scheduled for routine literature review and update.|
|5/1/2006||New medical document.|
|Title:||Effective Date:||End Date:|
|Clinical Trial Treatment or Therapy||04-15-2018||06-30-2019|
|Clinical Trial Treatment or Therapy||04-15-2017||04-14-2018|
|Clinical Trial Treatment or Therapy||08-01-2016||04-14-2017|
|Clinical Trial Treatment or Therapy||08-15-2015||07-31-2016|
|Clinical Trial Treatment or Therapy||12-15-2014||08-14-2015|
|Clinical Trial Treatment or Therapy||05-15-2013||12-14-2014|
|Clinical Trial Treatment or Therapy||03-15-2013||05-14-2013|
|Clinical Trial Treatment or Therapy||09-01-2009||03-14-2013|
|Clinical Trial Treatment or Therapy||06-15-2008||08-31-2009|
|Clinical Trial Treatment or Therapy||05-01-2006||06-14-2008|