Investigational Medicinal Product Storage Preparation and Accountability
Investigational Medicinal Product Storage Preparation and Accountability Sample Clauses
Related to Investigational Medicinal Product Storage Preparation and Accountability
Traditional Medicine Cooperation 1. The aims of Traditional Medicine cooperation will be: (a) to build on existing agreements or arrangements already in place for Traditional Medicine cooperation; and (b) to promote information exchanges on Traditional Medicine between the Parties. 2. In pursuit of the objectives in Article 149 (Objectives), the Parties will encourage and facilitate, as appropriate, the following activities, including, but not limited to: (a) encouraging dialogue on Traditional Medicine policies and promotion of respective Traditional Medicine; (b) raising awareness of active effects of Traditional Medicine; (c) encouraging exchange of experience in conservation and restoration of Traditional Medicine; (d) encouraging exchange of experience on management, research and development for Traditional Medicine; (e) encouraging cooperation in the Traditional Medicine education field, mainly through training programs and means of communication; (f) having a consultation mechanism between the Parties' Traditional Medicine authorities; (g) encouraging cooperation in Traditional Medicine therapeutic services and products manufacturing; and (h) encouraging cooperation in research in the fields of Traditional Medicine in order to contribute in efficacy and safety assessments of natural resources and products used in health care.
Authorized User Overview and Mini-Bid Process Project Based IT Consulting Services Contracts enable Authorized Users to use a competitive Mini-bid Process to acquire Services on an as-needed basis, for qualified IT Projects. Project Based IT Consulting Services may include, but will not be limited to projects requiring: analysis, data classification, design, development, testing, quality assurance, security and associated training for Information Technology based applications. See section 1.3 Out of Scope Work for a listing of projects expressly excluded from the scope of this Contract. An Authorized User Agreement for Project Based IT Consulting Services will be governed first by the terms and conditions specified in the OGS Centralized Contract and second by terms and conditions added to the Authorized User Statement of Work. Additional terms and conditions shall not conflict with or modify the terms and conditions of the OGS Centralized Contract. NYS Executive Agencies must adhere to all internal processes and approvals including, as required, approval from NYS Office of Information Technology Services. Other Authorized Users must adhere to their own internal processes and approvals. In accordance with Appendix B, section 28, Modification of Contract Terms, an Authorized User may add additional required terms and conditions to this Mini-Bid and resultant Authorized User Agreement only if such terms and conditions (1) are more favorable to the Authorized User and (2) do not conflict with or supersede the OGS Centralized Contract terms and conditions. Examples of additional terms and conditions include: • Expedited delivery timeframe; • Additional incentives, such as discount for expedited payment/Procurement Card use; and • Any additional requirements imposed by the funding source or Federal law.
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.
COVID-19 Protocols Contractor will abide by all applicable COVID-19 protocols set forth in the District’s Reopening and COVID-19 Mitigation Plan and the safety guidelines for COVID-19 prevention established by the California Department of Public Health and the Ventura County Department of Public Health.
OUT OF STOCK, PRODUCT RECALLS, AND DISCONTINUED PRODUCTS H-GAC does NOT purchase the products sold pursuant to a Solicitation or Agreement. Contractor is responsible for ensuring that notices and mailings, such as Out of Stock or Discontinued Notices, Safety Alerts, Safety Recall Notices, and customer surveys, are sent directly to the Customer with a copy sent to H-GAC. Customer will have the option of accepting any equivalent product or canceling the item from Customer’s Purchase Order. Contractor is not authorized to make substitutions without prior approval.
Behavioral Health Services – Mental Health and Substance Use Disorder Inpatient - Unlimited days at a general hospital or a specialty hospital including detoxification or residential/rehabilitation per plan year. Preauthorization may be required for services received from a non-network provider. 0% - After deductible 40% - After deductible Outpatient or intermediate careservices* - See Covered Healthcare Services: Behavioral Health Section for details about partial hospital program, intensive outpatient program, adult intensive services, and child and family intensive treatment. Preauthorization may be required for services received from a non-network provider. 0% - After deductible 40% - After deductible Office visits - See Office Visits section below for Behavioral Health services provided by a PCP or specialist. Psychological Testing 0% - After deductible 40% - After deductible Medication-assisted treatment - whenrenderedby a mental health or substance use disorder provider. 0% - After deductible 40% - After deductible Methadone maintenance treatment - one copayment per seven-day period of treatment. 0% - After deductible 40% - After deductible Cardiac Rehabilitation Outpatient - Benefit is limited to 18 weeks or 36 visits (whichever occurs first) per coveredepisode. 0% - After deductible 40% - After deductible Chiropractic Services In a physician's office - limited to 12 visits per plan year. 0% - After deductible 40% - After deductible Dental Services - Accidental Injury (Emergency) Emergency room - When services are due to accidental injury to sound natural teeth. 0% - After deductible The level of coverage is the same as network provider. In a physician’s/dentist’s office - When services are due to accidental injury to sound natural teeth. 0% - After deductible 40% - After deductible Dental Services- Outpatient Services connected to dental care when performed in an outpatient facility * 0% - After deductible 40% - After deductible Dialysis Services Inpatient/outpatient/in your home 0% - After deductible 40% - After deductible Covered Benefits - See Covered Healthcare Services for additional benefit limits and details. Network Providers Non-network Providers (*) Preauthorization may be required for this service. Please see Preauthorization in Section 5 for more information. You Pay You Pay Durable Medical Equipment (DME), Medical Supplies, Diabetic Supplies, Prosthetic Devices, and Enteral Formula or Food, Hair Prosthetics Outpatient durable medical equipment* - Must be provided by a licensed medical supply provider. 20% - After deductible 40% - After deductible Outpatient medical supplies* - Must be provided by a licensed medical supply provider. 20% - After deductible 40% - After deductible Outpatient diabetic supplies/equipment purchasedat licensed medical supply provider (other than a pharmacy). See the Summary of Pharmacy Benefits for supplies purchased at a pharmacy. 20% - After deductible 40% - After deductible Outpatient prosthesis* - Must be provided by a licensed medical supply provider. 20% - After deductible 40% - After deductible Enteral formula delivered through a feeding tube. Must be sole source of nutrition. 20% - After deductible 40% - After deductible Enteral formula or food taken orally * 20% - After deductible The level of coverage is the same as network provider. Hair prosthesis (wigs) - The benefit limit is $350 per hair prosthesis (wig) when worn for hair loss suffered as a result of cancer treatment. 20% - After deductible The level of coverage is the same as network provider. Early Intervention Services (EIS) Coverage provided for members from birth to 36 months. The provider must be certified as an EIS provider by the Rhode Island Department of Human Services. 0% - After deductible The level of coverage is the same as network provider. Education - Asthma Asthma management 0% - After deductible 40% - After deductible Emergency Room Services Hospital emergency room 0% - After deductible The level of coverage is the same as network provider.
Designated Prescription Drug Prescribers and Pharmacies We may limit your selection of a pharmacy to a single pharmacy location and/or a single prescribing provider or practice. Those members subject to this designation include, but are not limited to, members that have a history of: • being prescribed prescription drugs by multiple providers; • having prescriptions drugs filled at multiple pharmacies; • being prescribed certain long acting opioids and other controlled substances, either in combination or separately, that suggests a need for monitoring due to: o quantities dispensed; o daily dosage range; or o the duration of therapy exceeds reasonable and established thresholds. The Amount You Pay for Prescription Drugs Our formulary includes a tiered copayment structure, which means the amount you pay for a prescription drug will vary by tier. See the Summary of Pharmacy Benefits for your copayment structure, benefit limits and the amount you pay. When you buy covered prescription drugs and diabetic equipment and supplies from a retail network pharmacy, you will be responsible for the copayment and deductible (if any) at the time of purchase. You will be responsible for paying the lower of your copayment, the retail cost of the drug, or the pharmacy allowance. Specialty prescription drugs are generally obtained from a specialty pharmacy. If you buy a specialty prescription drug from a retail network pharmacy, you will be responsible for a significantly higher out of pocket expense than if you bought the specialty drug from a specialty pharmacy. The amount you pay for the following prescription drugs is not subject to the tiered copayment structure: • Contraceptive methods; • Over-the-counter (OTC) preventive drugs; • Nicotine replacement therapy (NRT) and smoking cessation prescription drugs; • Infertility specialty prescription drugs; and • Covered diabetic equipment or supplies bought at a network pharmacy. See the Summary of Pharmacy Benefits for benefit limits and the amount you pay. This plan allows for medication synchronization in accordance with R.I. General Law
Research Use Reporting To assure adherence to NIH GDS Policy, the PI agrees to provide annual Progress Updates as part of the annual Project Renewal or Project Close-out processes, prior to the expiration of the one (1) year data access period. The PI who is seeking Renewal or Close-out of a project agree to complete the appropriate online forms and provide specific information such as how the data have been used, including publications or presentations that resulted from the use of the requested dataset(s), a summary of any plans for future research use (if the PI is seeking renewal), any violations of the terms of access described within this Agreement and the implemented remediation, and information on any downstream intellectual property generated from the data. The PI also may include general comments regarding suggestions for improving the data access process in general. Information provided in the progress updates helps NIH evaluate program activities and may be considered by the NIH GDS governance committees as part of NIH’s effort to provide ongoing stewardship of data sharing activities subject to the NIH GDS Policy.
Treatment Program Testing The Employer may request or require an employee to undergo drug and alcohol testing if the employee has been referred by the employer for chemical dependency treatment or evaluation or is participating in a chemical dependency treatment program under an employee benefit plan, in which case the employee may be requested or required to undergo drug or alcohol testing without prior notice during the evaluation or treatment period and for a period of up to two years following completion of any prescribed chemical dependency treatment program.
Prescription Drugs and Diabetic Equipment or Supplies Biological products for allergen immunotherapy and vaccinations. • Blood fractions. • Compound prescription drugs that are not made up of at least one legend drug. • Bulk powders and chemicals used in compound prescriptions that are not FDA approved, are not covered unless listed on our formulary. • Prescription drugs prescribed or dispensed outside of our dispensing guidelines. • Prescription drugs ordered or prescribed based solely on online questionnaires, telephonic interviews, surveys, emails, or any other marketing solicitation methods, whether alone or in combination. • Prescription drugs that have not proven effective according to the FDA. • Prescription drugs used for cosmetic purposes. • Prescription drugs purchased from a non-designated pharmacy, if a pharmacy has been designated for you through the Pharmacy Home Assignment program. • Experimental prescription drugs including those placed on notice of opportunity hearing status by the Federal Drug Efficacy Study Implementation (DESI). • Prescription drugs provided to you that are not dispensed by a network pharmacy or covered under your medical plan. • Prescription drugs and diabetic equipment and supplies purchased at a non-network pharmacy unless indicated as covered in the Summary of Pharmacy Benefits. • Prescription drug related medical supplies except for diabetic, regardless of the reason prescribed, the intended use, or medical necessity. Examples include, but are not limited to, alcohol pads, bandages, wraps or pill holders. • Off-label use of prescription drugs except as described in Experimental or Investigational Services in Section 3; • Prescribed weight-loss drugs. • Replacement of prescription drugs resulting from a lost, stolen, broken or destroyed prescription order or refill. • Therapeutic devices and appliances, including hypodermic needles and syringes except when used to administer insulin. • Prescription drugs, therapeutic equivalents, or any other pharmaceuticals used to treat sexual dysfunctions. • Vitamins, unless specifically listed as a covered healthcare service. • A prescription drug refill greater than the refill number authorized by your physician, more than a year from the date of the original prescription, or limited by law. • Long acting opioids and other controlled substances, nicotine replacement therapy, and specialty prescription drugs when purchased from a mail order pharmacy. • Prescription drugs and specialty prescription drugs when the required prescription drug preauthorization is not obtained. • Certain prescription drugs that have an over-the-counter (OTC) equivalent. • Prescriptions filled through an internet pharmacy that is not a verified internet pharmacy practice site certified by the National Association of Boards of Pharmacy. • Illegal drugs, including medical marijuana, which are dispensed in violation of state and/or federal law. Private Duty Nursing Services • Services of a nurse's aide. • Services of a private duty nurse: o when the primary duties are limited to bathing, feeding, exercising, homemaking, giving oral medications or acting as companion or sitter; o after the caregiver or patient have demonstrated the ability to carry out the plan of care; o provided outside the home. Examples include at school, or in a nursing or assisted living facility; o that are duplication or overlap of services. Examples include when a person is receiving hospice care services or for the same hours of a skilled nursing home care visit; o that are for observation only; and o provided as part-time/intermittent and not continuous care. • Maintenance care when the condition has stabilized including routine ostomy care or tube feeding administration or if the anticipated need is indefinite. • Twenty-four (24) hour private duty nursing care for a person without an available caregiver in the home. • Respite care (e.g., care during a caregiver vacation) or private duty nursing so that the caregiver may attend work or school. Surgery Services • Abdominoplasty. • Brow ptosis surgery. • Cervicoplasty. • Chemical exfoliations, peels, abrasions, dermabrasions, or planing for acne, scarring, wrinkling, sun damage or other benign conditions. • Correction of variations in normal anatomy including augmentation mammoplasty, mastopexy, and correction of congenital breast asymmetry. • Dermabrasion. • Ear piercing or repair of a torn earlobe. • Excision of excess skin or subcutaneous tissue except for panniculectomy. • Genioplasty. • Hair transplants. • Hair removal including electrolysis epilation, unless in relation to gender reassignment services or skin grafting. • Inverted nipple surgery. • Laser treatment for acne and acne scars. • Osteoplasty - facial bone reduction. • Otoplasty. • Procedures to correct visual acuity including but not limited to cornea surgery or lens implants. • Removal of asymptomatic benign skin lesions. • Repeated cauterizations or electrofulguration methods used to remove growths on the skin. • Rhinoplasty.
