Clinical 2.1 Provides comprehensive evidence based nursing care to patients including assessment, intervention and evaluation.
Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.
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
Durable Medical Equipment (DME), Medical Supplies, Prosthetic Devices, Enteral Formula or Food, and Hair Prosthesis (Wigs) This plan covers durable medical equipment and supplies, prosthetic devices and enteral formula or food as described in this section. Durable Medical Equipment (DME) DME is equipment which: • can withstand repeated use; • is primarily and customarily used to serve a medical purpose; • is not useful to a person in the absence of an illness or injury; and • is for use in the home. DME includes supplies necessary for the effective use of the equipment. This plan covers the following DME: • wheelchairs, hospital beds, and other DME items used only for medical treatment; and • replacement of purchased equipment which is needed due to a change in your medical condition or if the device is not functional, no longer under warranty, or cannot be repaired. DME may be classified as a rental item or a purchased item. In most cases, this plan only pays for a rental DME up to our allowance for a purchased DME. Repairs and supplies for rental DME are included in the rental allowance. Preauthorization may be required for certain DME and replacement or repairs of DME. Medical Supplies Medical supplies are consumable supplies that are disposable and not intended for re- use. Medical supplies require an order by a physician and must be essential for the care or treatment of an illness, injury, or congenital defect. Covered medical supplies include: • essential accessories such as hoses, tubes and mouthpieces for use with medically necessary DME (these accessories are included as part of the rental allowance for rented DME); • catheters, colostomy and ileostomy supplies, irrigation trays and surgical dressings; and • respiratory therapy equipment. Diabetic Equipment and Supplies This plan covers diabetic equipment and supplies for the treatment of diabetes in accordance with R.I. General Law §27-20-30. Covered diabetic equipment and supplies include: • therapeutic or molded shoes and inserts for custom-molded shoes for the prevention of amputation; • blood glucose monitors including those with special features for the legally blind, external insulin infusion pumps and accessories, insulin infusion devices and injection aids; and • lancets and test strips for glucose monitors including those with special features for the legally blind, and infusion sets for external insulin pumps. The amount you pay differs based on whether the equipment and supplies are bought from a durable medical equipment provider or from a pharmacy. See the Summary of Pharmacy Benefits and the Summary of Medical Benefits for details. Coverage for some diabetic equipment and supplies may only be available from either a DME provider or from a pharmacy. Visit our website to determine if this is applicable or call our Customer Service Department. Prosthetic Devices Prosthetic devices replace or substitute all or part of an internal body part, including contiguous tissue, or replace all or part of the function of a permanently inoperative or malfunctioning body part and alleviate functional loss or impairment due to an illness, injury or congenital defect. Prosthetic devices do not include dental prosthetics. This plan covers the following prosthetic devices as required under R.I. General Law § 27-20-52: • prosthetic appliances such as artificial limbs, breasts, larynxes and eyes; • replacement or adjustment of prosthetic appliances if there is a change in your medical condition or if the device is not functional, no longer under warranty and cannot be repaired; • devices, accessories, batteries and supplies necessary for prosthetic devices; • orthopedic braces except corrective shoes and orthotic devices used in connection with footwear; and • breast prosthesis following a mastectomy, in accordance with the Women’s Health and Cancer Rights Act of 1998 and R.I. General Law 27-20-29. The prosthetic device must be ordered or provided by a physician, or by a provider under the direction of a physician. When you are prescribed a prosthetic device as an inpatient and it is billed by a provider other than the hospital where you are an inpatient, the outpatient benefit limit will apply. Enteral Formulas or Food (Enteral Nutrition) Enteral formula or food is nutrition that is absorbed through the intestinal tract, whether delivered through a feeding tube or taken orally. Enteral nutrition is covered when it is the sole source of nutrition and prescribed by the physician for home use. In accordance with R.I. General Law §27-20-56, this plan covers enteral formula taken orally for the treatment of: • malabsorption caused by Crohn’s Disease; • ulcerative colitis; • gastroesophageal reflux; • chronic intestinal pseudo obstruction; and • inherited diseases of amino acids and organic acids. Food products modified to be low protein are covered for the treatment of inherited diseases of amino acids and organic acids. Preauthorization may be required. The amount that you pay may differ depending on whether the nutrition is delivered through a feeding tube or taken orally. When enteral formula is delivered through a feeding tube, associated supplies are also covered. Hair Prosthesis (Wigs) This plan covers hair prosthetics (wigs) worn for hair loss suffered as a result of cancer treatment in accordance with R.I. General Law § 27-20-54 and subject to the benefit limit and copayment listed in the Summary of Medical Benefits. This plan will reimburse the lesser of the provider’s charge or the benefit limit shown in the Summary of Medical Benefits. If the provider’s charge is more than the benefit limit, you are responsible for paying any difference. Early Intervention Services (EIS) This plan covers Early Intervention Services in accordance with R.I. General Law §27- 20-50. Early Intervention Services are educational, developmental, health, and social services provided to children from birth to thirty-six (36) months. The child must be certified by the Rhode Island Department of Human Services (DHS) to enroll in an approved Early Intervention Services program. Services must be provided by a licensed Early Intervention provider and rendered to a Rhode Island resident. Members not living in Rhode Island may seek services from the state in which they reside; however, those services are not covered under this plan. Early Intervention Services as defined by DHS include but are not limited to the following: • speech and language therapy; • physical and occupational therapy; • evaluation; • case management; • nutrition; • service plan development and review; • nursing services; and • assistive technology services and devices.
Radiation Therapy/Chemotherapy Services This plan covers chemotherapy and radiation services. Respiratory Therapy This plan covers respiratory therapy services. When respiratory services are provided in your home, as part of a home care program, durable medical equipment, supplies, and oxygen are covered as a durable medical equipment service.
Durable Medical Equipment (DME), Medical Supplies Prosthetic Devices, Enteral Formula or Food, and Hair Prosthesis (Wigs) • Items typically found in the home that do not need a prescription and are easily obtainable such as, but not limited to: o adhesive bandages; o elastic bandages; o gauze pads; and o alcohol swabs. • DME and medical supplies prescribed primarily for the convenience of the member or the member’s family, including but not limited to, duplicate DME or medical supplies for use in multiple locations or any DME or medical supplies used primarily to assist a caregiver. • Non-wearable automatic external defibrillators. • Replacement of durable medical equipment and prosthetic devices prescribed because of a desire for new equipment or new technology. • Equipment that does not meet the basic functional need of the average person. • DME that does not directly improve the function of the member. • Medical supplies provided during an office visit. • Pillows or batteries, except when used for the operation of a covered prosthetic device, or items for which the sole function is to improve the quality of life or mental wellbeing. • Repair or replacement of DME when the equipment is under warranty, covered by the manufacturer, or during the rental period. • Infant formula, nutritional supplements and food, or food products, whether or not prescribed, unless required by R.I. Law §27-20-56 for Enteral Nutrition Products, or delivered through a feeding tube as the sole source of nutrition. • Corrective or orthopedic shoes and orthotic devices used in connection with footwear, unless for the treatment of diabetes. Experimental or Investigational Services • Treatments, procedures, facilities, equipment, drugs, devices, supplies, or services that are experimental or investigational except as described in Section 3. Gender Reassignment Services • Reversal of gender reassignment surgery.
Product ACCEPTANCE Unless otherwise provided by mutual agreement of the Authorized User and the Contractor, Authorized User(s) shall have thirty (30) days from the date of delivery to accept hardware products and sixty (60) days from the date of delivery to accept all other Product. Where the Contractor is responsible for installation, acceptance shall be from completion of installation. Failure to provide notice of acceptance or rejection or a deficiency statement to the Contractor by the end of the period provided for under this clause constitutes acceptance by the Authorized User(s) as of the expiration of that period. The License Term shall be extended by the time periods allowed for trial use, testing and acceptance unless the Commissioner or Authorized User agrees to accept the Product at completion of trial use. Unless otherwise provided by mutual agreement of the Authorized User and the Contractor, Authorized User shall have the option to run testing on the Product prior to acceptance, such tests and data sets to be specified by User. Where using its own data or tests, Authorized User must have the tests or representative set of data available upon delivery. This demonstration will take the form of a documented installation test, capable of observation by the Authorized User, and shall be made part of the Contractor’s standard documentation. The test data shall remain accessible to the Authorized User after completion of the test. In the event that the documented installation test cannot be completed successfully within the specified acceptance period, and the Contractor or Product is responsible for the delay, Authorized User shall have the option to cancel the order in whole or in part, or to extend the testing period for an additional thirty (30) day increment. Authorized User shall notify Contractor of acceptance upon successful completion of the documented installation test. Such cancellation shall not give rise to any cause of action against the Authorized User for damages, loss of profits, expenses, or other remuneration of any kind. If the Authorized User elects to provide a deficiency statement specifying how the Product fails to meet the specifications within the testing period, Contractor shall have thirty (30) days to correct the deficiency, and the Authorized User shall have an additional sixty (60) days to evaluate the Product as provided herein. If the Product does not meet the specifications at the end of the extended testing period, Authorized User, upon prior written notice to Contractor, may then reject the Product and return all defective Product to Contractor, and Contractor shall refund any monies paid by the Authorized User to Contractor therefor. Costs and liabilities associated with a failure of the Product to perform in accordance with the functionality tests or product specifications during the acceptance period shall be borne fully by Contractor to the extent that said costs or liabilities shall not have been caused by negligent or willful acts or omissions of the Authorized User’s agents or employees. Said costs shall be limited to the amounts set forth in the Limitation of Liability Clause for any liability for costs incurred at the direction or recommendation of Contractor.
Biological Samples If so specified in the Protocol, Institution and Principal Investigator may collect and provide to Sponsor or its designee Biological Samples (“Biological Samples”). 12.2.
Pharmacy Pharmacy hereby represents that neither Pharmacy, nor, to the best of Pharmacy’s knowledge, Pharmacist, Pharmacy’s employees, agents or independent contractors involved in the provision of services have been excluded from participation in any Federally-funded health care programs, including, but not limited to, Medicare and Medicaid.
Pharmacy Benefits - Prescription Drugs and Diabetic Equipment or Supplies from a Pharmacy This plan covers prescription drugs listed on our formulary and diabetic equipment or supplies bought from a pharmacy as a pharmacy benefit. These benefits are administered by our Pharmacy Benefit Manager (PBM). Our formulary includes a tiered copayment structure and indicates that certain prescription drugs require preauthorization. If a prescription drug is not on our formulary, it is not covered. For specific coverage information or a copy of the most current formulary, please visit our website or call our Customer Service Department. Prescription drugs and diabetic equipment or supplies are covered when dispensed using the following guidelines: • the prescription must be medically necessary, consistent with the physician’s diagnosis, ordered by a physician whose license allows him or her to order it, filled at a pharmacy whose license allows such a prescription to be filled, and filled according to state and federal laws; • the prescription must consist of legend drugs that require a physician’s prescription under law, or compound medications made up of at least one legend drug requiring a physician’s prescription under law; • the prescription must be dispensed at the proper place of service as determined by our Pharmacy and Therapeutics Committee. For example, certain prescription drugs may only be covered when obtained from a specialty pharmacy; and • the prescription is limited to the quantities authorized by your physician not to exceed the quantity listed in the Summary of Pharmacy Benefits. Prescription drugs are subject to the benefit limits and the amount you pay shown in the Summary of Pharmacy Benefits.
