Investigational or Experimental definition

Investigational or Experimental means a service, drug or device that meets one or more of the following criteria at the time it is provided, as determined by Us. The service, drug, or device: ▪ Cannot be legally marketed in the United States without the approval of the FDA and such approval has not been granted;▪ Is subject to a New Drug or New Device Application on file with the FDA;▪ Is provided as part of a Phase I or Phase II clinical trial, as the experimental or research arm of a Phase III clinical trial, or in any other manner that is intended to evaluate the safety, toxicity or efficacy of the service;▪ Is provided pursuant to a written protocol or other document that lists an evaluation of the safety, toxicity or efficacy of the service, drug or device among its objectives;▪ Is subject to the review or approval of an Institutional Review Board or other body that reviews or approves research concerning the safety, toxicity or efficacy of services, drugs or devices; or▪ Is provided pursuant to informed consent documents that describe the service, drug or device as Investigational or Experimental, or in other terms that indicate that the service, drug or device is being evaluated for its safety, toxicity or efficacy.
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Investigational or Experimental means a service, drug or device that meets one or more of the following criteria at the time it is provided, as determined by Us. The service, drug, or device:
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Examples of Investigational or Experimental in a sentence

  • There is no requirement that you participate in Health Net’s grievance or appeals process before requesting IMR for denials based on the Investigational or Experimental nature of the therapy.

  • Services or supplies or drugs that are Investigational or Experimental.

  • Transplant surgery and related expenses for which You have obtained prior medical necessity review are Covered Services subject to all applicable limitations and exceptions including the $250,000 lifetime maximum set forth in Section IV.B. If the transplant surgery is determined to be Investigational or Experimental, no benefits are payable for such procedure or other Covered Services or supplies related to the transplant.

  • Transplant surgery and related expenses for which You have obtained prior medical necessity review are Covered Services subject to all applicable limitations and exceptions, including the $250,000 lifetime maximum set forth in Section IV.B. If the transplant surgery is determined to be Investigational or Experimental, no benefits are payable for such procedure or other Covered Services or supplies related to the transplant.

  • Services – Services, supplies or drugs that are Investigational or Experimental.

  • For information regarding requesting an Independent Medical Review of a denial of coverage see the “Independent Medical Review of Investigational or Experimental Therapies” portion of the “General Provi- sions.” The SELECT Plan does not cover personal or comfort items.

  • The type of drug for which benefits are provided is limited to anticancer drugs that are not in an Investigational or Experimental stage to include antineoplastic agents (such as anticancer drugs) or agents used to destroy microorganisms (such as antibiotic drugs).

  • If the Claim was denied on the basis of a medical judgment (such as a determination that the treatment or service was not Medically Necessary, or was Investigational or Experimental), a health care professional who has appropriate training and experience in a relevant field of medicine will be consulted.

  • Investigational or Experimental procedures, which are proven to be safe and efficacious for a particular Illness or Injury, may be covered.

  • Investigational or Experimental Services, as determined by us, including but not limited to, Dorsal Rhizotomy (cutting spinal nerve roots) in the treatment of spasticity (increased tone or tension in a muscle such as a leg.

Related to Investigational or Experimental

  • EXPERIMENTAL OR INVESTIGATIONAL means any healthcare service that has progressed to limited human application, but has not been recognized as proven and effective in clinical medicine. See Experimental or Investigational Services in Section 3 for a more detailed description of the type of healthcare services we consider experimental or investigational.

  • Experimental or Investigative means treatments, devices or prescription medications which are recommended by a Physician, but are not considered by the medical community as a whole to be safe and effective for the condition for which the treatments, devices or prescription medications are being used. This includes any treatments, procedures, facilities, equipment, drugs, drug usage, devices, or supplies not recognized as accepted medical practice, and any of those items requiring federal or other governmental agency approval not received at the time services are rendered.

  • Complaint Investigation means an investigation of any complaint that has been made to a proper authority that is not covered by an abuse investigation.

  • clinical investigation means any systematic investigation in one or more human subjects, undertaken to assess the safety or performance of a device;

  • Investigation means the Bureau’s decision to hold and not process the Company’s license renewal applications identified in Appendix A due to the Company’s inability to certify compliance with its public file obligations.

  • Background investigation means the investigation conducted by a licensee or applicant to support the determination of trustworthiness and reliability.

  • Remedial investigation means a process to determine the nature and extent of a discharge of a contaminant at a site or a discharge of a contaminant that has migrated or is migrating from the site and the problems presented by a discharge, and may include data collected, site characterization, sampling, monitoring, and the gathering of any other sufficient and relevant information necessary to determine the necessity for remedial action and to support the evaluation of remedial actions if necessary;

  • Investigating Committee means any Officer/Committee appointed by Competent Authority to conduct investigation.

  • Investigations The Xxxxxxx, when requested by one or a number of employees whom he/she represents, may investigate the basis for any dispute arising under this Agreement and may, at any stage, assist the employee(s) in seeking resolution of such dispute through the grievance procedure provided herein. A representative of the Union may substitute in place of the Xxxxxxx.

  • Study means the investigation to be conducted in accordance with the Protocol.

  • Investigation Committee means the Investigation Committee appointed by the Board under Regulation 5 of these Regulations;

  • Investigational Product means the Study Drug identified above and the control material, as further detailed in the Protocol;

  • Evaluation means an appraisal of an individual’s professional performance in relation to his or her job description and professional standards and based on, when applicable, the individual’s evaluation rubric.

  • Victim or target of Nazi persecution means any individual persecuted or targeted for persecution by

  • Evaluation Team means the team appointed by the City; “Information Meeting” has the meaning set out in section 2.2;

  • Abuse Investigation and Protective Services means reporting and investigation activities as required by OAR 407-045-0300 and any subsequent services or supports necessary to prevent further abuse as required by OAR 407-045-0310.

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • Collaboration Know-How means all Know-How conceived, discovered, developed or otherwise made by or on behalf of a particular Party or any of its Affiliates or permitted subcontractors of any of the foregoing (solely or jointly by or on behalf of a particular Party or any of its Affiliates or permitted subcontractors of any of the foregoing) in the course of [***].

  • investigating authority means an authority that in terms of national legislation may investigate unlawful activities;

  • Threatened species means endangered species, including flora and fauna, listed in the European Red List or the IUCN Red List, as referred to in Section 7 of Annex II to Delegated Regulation (EU) 2021/2139;

  • Threatened or endangered species means all spe- cies of wildlife listed as "threatened" or "endangered" by the United States Secretary of the Interior or Commerce, and all species of wildlife designated as "threatened" or "endan- gered" by the Washington fish and wildlife commission.

  • Studies means activities needed to prepare project implementation, such as preparatory, mapping, feasibility, evaluation, testing and validation studies, including in the form of software, and any other technical support measure, including prior action to define and develop a project and decide on its financing, such as reconnaissance of the sites concerned and preparation of the financial package;

  • Threatened litigation as used herein shall include governmental investigations and civil investigative demands. “Litigation” as used herein shall include administrative enforcement actions brought by governmental agencies. The Grantee must also disclose any material litigation threatened or pending involving Subcontractors, consultants, and/or lobbyists. For purposes of this section, “material” refers, but is not limited, to any action or pending action that a reasonable person knowledgeable in the applicable industry would consider relevant to the Work under the Grant Agreement or any development such a person would want to be aware of in order to stay fully apprised of the total mix of information relevant to the Work, together with any litigation threatened or pending that may result in a substantial change in the Xxxxxxx’s financial condition.

  • Acute toxicity means concurrent and delayed adverse effects that result from an acute exposure and occur within any short observation period, which begins when the exposure begins, may extend beyond the exposure period, and usually does not constitute a substantial portion of the life span of the organism.

  • Mental or Nervous Disorder means any disease or condition, regardless of whether the cause is organic, that is classified as a Mental or Nervous Disorder in the current edition of International Classification of Diseases, published by the U.S. Department of Health and Human Services, is listed in the current edition of Diagnostic and Statistical Manual of Mental Disorders, published by the American Psychiatric Association or other relevant State guideline or applicable sources.

  • Environmental Review means the Federal