Investigational Sample Clauses

Investigational. For the purposes of the Agreement, a drug, treatment, device, or procedure is Investigational if:  it cannot be lawfully marketed without the approval of the Food and Drug Administration (“FDA”) and final approval has not been granted at the time of its use or proposed use;  it is the subject of a current Investigational new drug or new device application on file with the FDA;  the predominant opinion among experts as expressed in medical literature is that usage should be substantially confined to research settings;  the predominant opinion among experts as expressed in medical literature is that further research is needed in order to define safety, toxicity, effectiveness or effectiveness compared with other approved alternatives; or  it is not investigational in itself, but would not be Medically Necessary except for its use with a drug, device, treatment, or procedure that is investigational. In determining whether a drug, treatment, device or procedure is investigational, the following information may be considered:  the Member’s medical records;  the protocol(s) pursuant to which the treatment or procedure is to be delivered;  any consent document the patient has signed or will be asked to sign, in order to undergo the treatment or procedure;  the referred medical or scientific literature regarding the treatment or procedure at issue as applied to the injury or illness at issue;  regulations and other official actions and publications issued by the federal government; and  the opinion of a third party medical expert in the field, obtained by Xxxxxxxx, with respect to whether a treatment or procedure is investigational. Keystone Health Plan Central (“Keystone” or “the HMO”): A health maintenance organization providing access to comprehensive health care to Members. Keystone’s Approved Service Area: The geographical area consisting of the following twenty-one (21) Pennsylvania counties within which Keystone is approved to operate as an HMO: Adams, Berks, Centre, Columbia, Cumberland, Dauphin, Franklin, Fulton, Juniata, Lancaster, Lebanon, Lehigh, Mifflin, Montour, Northampton, Northumberland, Perry, Schuylkill, Xxxxxx, Union and York. Limiting Age For Dependents: The end of the month in which a child reaches age 26.
Sample 1
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Related to Investigational

  • Investigational Services This plan covers certain experimental or investigational services as described in this section. Clinical Trials This plan covers clinical trials as required under R.I. General Law § 27-20-60. An approved clinical trial is a phase I, phase II, phase III, or phase IV clinical trial that is being performed to prevent, detect or treat cancer or a life-threatening disease or condition. In order to qualify, the clinical trial must be: • federally funded; • conducted under an investigational new drug application reviewed by the Food and Drug Administration (FDA); or • a drug trial that is exempt from having such an investigational new drug application. To qualify to participate in a clinical trial: • you must be determined to be eligible, according to the trial protocol; • a network provider must have concluded that your participation would be appropriate; and • medical and scientific information must have been provided establishing that your participation in the clinical trial would be appropriate. If a network provider is participating in a clinical trial, and the trial is being conducted in the state in which you reside, you may be required to participate in the trial through the network provider. Coverage under this plan includes routine patient costs for covered healthcare services furnished in connection with participation in a clinical trial. The amount you pay is based on the type of service you receive. Coverage for clinical trials does not include: • the investigational item, device, or service itself; • items or services provided solely to satisfy data collection and that are not used in the direct clinical management; or • a service that is clearly inconsistent with widely accepted standards of care.

  • Labeling Upon request, Lessee will xxxx the Equipment indicating Lessor's interest with labels provided by Lessor. Lessee will keep all Equipment free from any other marking or labeling which might be interpreted as a claim of ownership.

  • Alcohol and Drug Testing Employee agrees to comply with and submit to any Company program or policy for testing for alcohol abuse or use of drugs and, in the absence of such a program or policy, to submit to such testing as may be required by Company and administered in accordance with applicable law and regulations.

  • Complaints Investigation ‌ An employee who complains of harassment under the provisions of the Human Rights Code of British Columbia may refer the complaint to either one or other of the following processes:

  • Random Drug Testing All employees covered by this Agreement shall be subject to random drug testing in accordance with Appendix D.

  • How to File an Appeal of a Prescription Drug Denial For denials of a prescription drug claim based on our determination that the service was not medically necessary or appropriate, or that the service was experimental or investigational, you may request an appeal without first submitting a request for reconsideration. You or your physician may file a written or verbal prescription drug appeal with our pharmacy benefits manager (PBM). The prescription drug appeal must be submitted to us within one hundred and eighty (180) calendar days of the initial determination letter. You will receive written notification of our determination within thirty (30) calendar days from the receipt of your appeal. How to File an Expedited Appeal Your appeal may require immediate action if a delay in treatment could seriously jeopardize your health or your ability to regain maximum function, or would cause you severe pain. To request an expedited appeal of a denial related to services that have not yet been rendered (a preauthorization review) or for on-going services (a concurrent review), you or your healthcare provider should call: • our Grievance and Appeals Unit; or • our pharmacy benefits manager for a prescription drug appeal. Please see Section 9 for contact information. You will be notified of our decision no later than seventy-two (72) hours after our receipt of the request. You may not request an expedited review of covered healthcare services already received.

  • DRUG/ALCOHOL TESTING 11.1 The parties agree that the maintenance of a drug/alcohol free work place is a goal of both the College and the Union. Employees are prohibited from possession, consumption and/or being under the influence of a controlled substance/alcohol while on the College’s premises or during time paid by the employer. Violations of this prohibition may result in a disciplinary action up to and including termination.

  • Regulatory Filing In the event that this Interconnection Construction Service Agreement contains any terms that deviate materially from the form included in Attachment P or from the standard terms and conditions in this Appendix 2, the Transmission Provider shall file the executed Interconnection Construction Service Agreement on behalf of itself and the Interconnected Transmission Owner with FERC as a service schedule under the Tariff. Interconnection Customer may request that any information so provided be subject to the confidentiality provisions of Section 17 of this Appendix

  • Drug Testing (A) The state and the PBA agree to drug testing of employees in accordance with section 112.0455, F.S., the Drug-Free Workplace Act.

  • Regulatory Authority If any regulatory authority having jurisdiction (or any successor boards or agencies), a court of competent jurisdiction or other Governmental Authority with the appropriate jurisdiction (collectively, the ''Regulatory Body'') issues a rule, regulation, law or order that has the effect of cancelling, changing or superseding any term or provision of this Agreement (the ''Regulatory Requirement''), then this Agreement will be deemed modified to the extent necessary to comply with the Regulatory Requirement. Notwithstanding the foregoing, if a Regulatory Body materially modifies the terms and conditions of this Agreement and such modification(s) materially affect the benefits flowing to one or both of the Parties, as determined by either of the Parties within twenty (20) business days of the receipt of the Agreement as materially modified, the Parties agree to attempt in good faith to negotiate an amendment or amendments to this Agreement or take other appropriate action(s) so as to put each Party in effectively the same position in which the Parties would have been had such modification not been made. In the event that, within sixty (60) days or some other time period mutually agreed upon by the Parties after such modification has been made, the Parties are unable to reach agreement as to what, if any, amendments are necessary and fail to take other appropriate action to put each Party in effectively the same position in which the Parties would have been had such modification not been made, then either Party shall have the right to unilaterally terminate this Agreement forthwith.

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