Common use of Label Drugs Clause in Contracts

Label Drugs. When prescribed for an individual with a life-threatening or chronic and disabling condition or disease benefits are provided for the following: • Off-label drugs; and • Medically Necessary services associated with the administration of such a drug. An off-label drug is one that is prescribed for a use that is different from the use for which that drug has been approved for marketing by the U.S. Food and Drug Administration (FDA). All off-label drugs must be pre-approved by Alliant Health Plans. OTHER PROGRAM PROVISIONS Should the Member, on his or her own accord, choose a Brand Name Drug over a generic drug, regardless of whether a generic equivalent is available and even if the Physician orders the drug to be “dispensed as written,” the Member will pay the Copayment for the Brand Drug as outlined in the Summary of Benefits and Coverage, PLUS the difference in the cost of the two drugs. OUTPATIENT PRESCRIPTION DRUG BENEFITS DO NOT INCLUDE THE FOLLOWING: • Prescription Drug products for any amount dispensed which exceeds the FDA clinically recommended dosing schedule; • Prescription Drugs received through an Internet pharmacy provider or mail-order provider except for Our designated mail order provider; • Newly approved FDA drugs that have not been approved for at least 180 days; • Non-legend vitamins; • Over-the-counter items; • Cosmetic drugs; • Appetite suppressants; • Weight loss products; • Diet supplements; • Syringes (for use other than insulin) except when in coordination with an approved injectable; • Injectables (except with Prior Authorization as required); • The administration or injection of any Prescription Drug or any drugs or medicines; • Prescription Drugs which are entirely consumed or administered at the time and place where the prescription order is issued; • Prescription refills in excess of the number specified by the Physician, or any refill dispensed after one year from the date of the prescription order; • Prescription Drugs for which there is no charge; • Charges for items such as therapeutic devices, artificial appliances, or similar devices, regardless of their intended use; • Prescription Drugs for use while an Inpatient or Outpatient of a Hospital. • Prescription Drugs provided for use in a convalescent care facility or nursing home which are ordinarily furnished by such facility for the care and treatment of Inpatients; • Charges for delivery of any Prescription Drugs; • Drugs and medicines which do not require a prescription, and which are not Prescription Drugs; • Prescription Drugs provided by a Physician whether or not a charge is made for such Prescription Drugs. • Prescription Drugs which are not Medically Necessary or which We determine are not consistent with the diagnosis (See the Off-Label Drugs section for exceptions); • Prescription Drugs which We determine are not provided in accordance with accepted professional medical standards in the United States. • Any services or supplies, which are not specifically listed as covered under this Prescription Drug program. • Prescription Drugs which are Experimental or Investigational in nature as explained in the General Limitations and Exclusions section. • Prescription medicine for nail fungus except for immunocompromised or diabetic patients. • Non-formulary drugs except as described in this Prescription Drug Program section. This section describes the services and supplies available to covered persons up to but not including the age of 19. These services and supplies must be provided and billed by Providers and must be Medically Necessary unless otherwise specified. The following Routine Vision Care Services are covered: • A case history • General patient observation • Glinical and diagnostic testing and evaluation • Inspection of conjunctivae and sclera • Examination of orbits • Test visual acuity • Gross visual field testing • Ocular motility • Binocular testing • Examination of irises, cornea(s), lenses, and anterior xxxxxxxx • Examination of pupils • Measurement of intraocular pressure (tonometry) • Ophthalmoscopic examinations • Determination of refract status • Color vision testing • Stereopsis testing • Case presentation including summary findings and recommendations including prescribing Lenses • Facial measurements and determination of interpupillary distance • Assistance in choosing Frames • Verification of Lenses as prescribed • After-care for a reasonable period of time for fitting and adjustment In addition to those non-covered items listed in the General Limitations and Exclusions section of this Certificate, PediatricVision Coverage is not provided for: • An eye examination or materials ordered as a result of an eye examination prior to Your Effective Date; • Lenses which are not prescribed; • The replacement of Lenses or Frames except as specified in the Summary of Benefits and Coverage; • Safety glass, safety goggles and sports glasses; • Services that Alliant determines are special or unusual; such as orthoptics, vision training and low vision aids; • Tints other than Number One or Two; • Tints with photosensitive or antireflective properties; • Progressive Lenses; • Spectacle lens treatments or "add-ons", except for tints Number One or Two; • Any surgical procedure forthe correction of a visual refractive problem including, but not limited to, radial keratotomy and LASIK (laser in situ keratomileusis); • Non-Covered Services or services specifically excluded in the text of this Certificate WHAT IS NOT COVERED Your coverage does not provide benefits for: to correct gynecomastia and breast augmentation procedures, and otoplasties. Reduction mammoplasty and services for the correction of asymmetry, except when determined to be Medically Necessary by Alliant, is not covered. ° This exclusion does not apply to surgery to restore function if anybody area has been altered by disease, trauma, Congenital/developmental Anomalies, or previous therapeutic processes. This exclusion does not apply to surgery to correct the results of Injuries when performed within two years of the event causing the impairment, or as a continuation of a staged reconstruction procedure, or congenital defects necessary to restore normal bodily functions, including but not limited to, cleft lip and cleft palate. massage equipment, air purifiers, central or unit air conditioners, humidifiers, dehumidifiers, escalators, elevators, ramps, stair glides, emergency alert equipment, handrails, heat appliances, improvements made to a Member’s house or place of business, and adjustments made to vehicles. Computer equipment to aid in speech or hearing loss. • Durable Medical Equipment – The following items related to Durable Medical Equipment are specifically excluded: ° Air conditioners, humidifiers, dehumidifiers, or purifiers; ° Arch supports and orthopedic or corrective shoes and shoe molds (except when an orthopedic shoe is joined to a brace or for the care of the diabetic foot); all shoe inserts and orthotics (except for the care of the diabetic foot); and support stockings; ° Heating pads, hot water bottles, home enema equipment, or rubber gloves; ° Sterile water; ° TENS units; ° Sequential stimulators; ° Conductive garments; ° Deluxe equipment or premium services, such as motor driven chairs or beds, when standard equipment is adequate; ° Rental or purchase of equipment if You are in a facility which provides such equipment; ° Electric stair or elevator chairs; ° Physical fitness, exercise, or ultraviolet/tanning equipment; light-box therapy for SADS; ° Residential structural modification to facilitate the use of equipment; ° Other items of equipment which do not meet the listed criteria; ° Duplicate medical equipment. ° determined to be court-ordered, custodial, or solely for the purpose of environmental control; ° rendered in a home, halfway house, school, or domiciliary institution; ° associated with the diagnosis(es) of acute stress reaction, childhood or adolescent adjustment reaction, and/or related marital, social, cultural or work situations ° the treatment is for maintenance therapy; or ° the Member has no restorative potential; or ° the treatment is for congenital learning or neurological disability/disorder; or ° the treatment is for communication training, educational training or vocational training.

Label Drugs. When prescribed for an individual with a life-threatening or chronic and disabling condition or disease benefits are provided for the following: • Off-label drugs; and • Medically Necessary services associated with the administration of such a drug. An off-label drug is one that is prescribed for a use that is different from the use for which that drug has been approved for marketing by the U.S. Food and Drug Administration (FDA). All off-label drugs must be pre-approved by Alliant Health Plans. OTHER PROGRAM PROVISIONS • Should the Member, on his or her own accord, choose a Brand Name Drug over a generic drug, regardless of whether a generic equivalent is available and even if the Physician orders the drug to be “dispensed as written,” the Member will pay the Copayment for the Brand Drug as outlined in the Summary of Benefits and Coverage, PLUS the difference in the cost of the two drugs. OUTPATIENT PRESCRIPTION DRUG BENEFITS DO NOT INCLUDE THE FOLLOWING: • Prescription Drug products for any amount dispensed which exceeds the FDA clinically recommended dosing schedule; • Prescription Drugs received through an Internet pharmacy provider or mail-order provider except for Our designated mail order provider; • Newly approved FDA drugs that have not been approved for at least 180 days; • Non-legend vitamins; • Over-the-counter items; • Cosmetic drugs; • Appetite suppressants; • Weight loss products; • Diet supplements; • Syringes (for use other than insulin) except when in coordination with an approved injectable; • Injectables (except with Prior Authorization as required); • The administration or injection of any Prescription Drug or any drugs or medicines; • Prescription Drugs which are entirely consumed or administered at the time and place where the prescription order is issued; • Prescription refills in excess of the number specified by the Physician, or any refill dispensed after one year from the date of the prescription order; • Prescription Drugs for which there is no charge; • Charges for items such as therapeutic devices, artificial appliances, or similar devices, regardless of their intended use; • Prescription Drugs for use while an Inpatient or Outpatient of a Hospital. • Prescription Drugs provided for use in a convalescent care facility or nursing home which are ordinarily furnished by such facility for the care and treatment of Inpatients; • Charges for delivery of any Prescription Drugs; • Drugs and medicines which do not require a prescription, and which are not Prescription Drugs; • Prescription Drugs provided by a Physician whether or not a charge is made for such Prescription Drugs. • Prescription Drugs which are not Medically Necessary or which We determine are not consistent with the diagnosis (See the Off-Label Drugs section for exceptions); • Prescription Drugs which We determine are not provided in accordance with accepted professional medical standards in the United States. • Any services or supplies, which are not specifically listed as covered under this Prescription Drug program. • Prescription Drugs which are Experimental or Investigational in nature as explained in the General Limitations and Exclusions section. • Prescription medicine for nail fungus except for immunocompromised or diabetic patients. • Non-formulary drugs except as described in this Prescription Drug Program section. This section describes the services and supplies available to covered persons up to but not including the age of 19. These services and supplies must be provided and billed by Providers and must be Medically Necessary unless otherwise specified. The following Routine Vision Care Services are covered: • A case history • General patient observation • Glinical Clinical and diagnostic testing and evaluation • Inspection of conjunctivae and sclera • Examination of orbits • Test visual acuity • Gross visual field testing • Ocular motility • Binocular testing • Examination of irises, cornea(s), lenses, and anterior xxxxxxxx • Examination of pupils • Measurement of intraocular pressure (tonometry) • Ophthalmoscopic examinations • Determination of refract status • Color vision testing • Stereopsis testing • Case presentation including summary findings and recommendations including prescribing Lenses • Facial measurements and determination of interpupillary distance • Assistance in choosing Frames • Verification of Lenses as prescribed • After-care for a reasonable period of time for fitting and adjustment In addition to those non-covered items listed in the General Limitations and Exclusions section of this Certificate, PediatricVision Pediatric Vision Coverage is not provided for: • An eye examination or materials ordered as a result of an eye examination prior to Your Effective Date; • Lenses which are not prescribed; • The replacement of Lenses or Frames except as specified in the Summary of Benefits and Coverage; • Safety glass, safety goggles and sports glasses; • Services that Alliant determines are special or unusual; such as orthoptics, vision training and low vision aids; • Tints other than Number One or Two; • Tints with photosensitive or antireflective properties; • Progressive Lenses; • Spectacle lens treatments or "add-ons", except for tints Number One or Two; • Any surgical procedure forthe for the correction of a visual refractive problem including, but not limited to, radial keratotomy and LASIK (laser in situ keratomileusis); • Non-Covered Services or services specifically excluded in the text of this Certificate WHAT IS NOT COVERED Your coverage does not provide benefits for: to correct gynecomastia and breast augmentation procedures, and otoplasties. Reduction mammoplasty and services for the correction of asymmetry, except when determined to be Medically Necessary by Alliant, is not covered. ° This exclusion does not apply to surgery to restore function if anybody area has been altered by disease, trauma, Congenital/developmental Anomalies, or previous therapeutic processes. This exclusion does not apply to surgery to correct the results of Injuries when performed within two years of the event causing the impairment, or as a continuation of a staged reconstruction procedure, or congenital defects necessary to restore normal bodily functions, including but not limited to, cleft lip and cleft palate. massage equipment, air purifiers, central or unit air conditioners, humidifiers, dehumidifiers, escalators, elevators, ramps, stair glides, emergency alert equipment, handrails, heat appliances, improvements made to a Member’s house or place of business, and adjustments made to vehicles. Computer equipment to aid in speech or hearing loss. • Durable Medical Equipment – The following items related to Durable Medical Equipment are specifically excluded: ° Air conditioners, humidifiers, dehumidifiers, or purifiers; ° Arch supports and orthopedic or corrective shoes and shoe molds (except when an orthopedic shoe is joined to a brace or for the care of the diabetic foot); all shoe inserts and orthotics (except for the care of the diabetic foot); and support stockings; ° Heating pads, hot water bottles, home enema equipment, or rubber gloves; ° Sterile water; ° TENS units; ° Sequential stimulators; ° Conductive garments; ° Deluxe equipment or premium services, such as motor driven chairs or beds, when standard equipment is adequate; ° Rental or purchase of equipment if You are in a facility which provides such equipment; ° Electric stair or elevator chairs; ° Physical fitness, exercise, or ultraviolet/tanning equipment; light-box therapy for SADS; ° Residential structural modification to facilitate the use of equipment; ° Other items of equipment which do not meet the listed criteria; ° Duplicate medical equipment. ° determined to be court-ordered, custodial, or solely for the purpose of environmental control; ° rendered in a home, halfway house, school, or domiciliary institution; ° associated with the diagnosis(es) of acute stress reaction, childhood or adolescent adjustment reaction, and/or related marital, social, cultural or work situations ° the treatment is for maintenance therapy; or ° the Member has no restorative potential; or ° the treatment is for congenital learning or neurological disability/disorder; or ° the treatment is for communication training, educational training or vocational training.

Label Drugs. When prescribed for an individual with a life-threatening or chronic and disabling condition or disease benefits are provided for the following: • Off-label drugs; and • Medically Necessary services associated with the administration of such a drug. An off-label drug is one that is prescribed for a use that is different from the use for which that drug has been approved for marketing by the U.S. Food and Drug Administration (FDA). All off-label drugs must be pre-approved by Alliant Health Plans. OTHER PROGRAM PROVISIONS Should the Member, on his or her own accord, choose a Brand Name Drug over a generic drug, regardless of whether a generic equivalent is available and even if the Physician orders the drug to be “dispensed as written,” the Member will pay the Copayment for the Brand Drug as outlined in the Summary of Benefits and Coverage, PLUS the difference in the cost of the two drugs. OUTPATIENT PRESCRIPTION DRUG BENEFITS DO NOT INCLUDE THE FOLLOWING: • Prescription Drug products for any amount dispensed which exceeds the FDA clinically recommended dosing schedule; • Prescription Drugs received through an Internet pharmacy provider or mail-order provider except for Our designated an in-network mail order provider; • Newly approved FDA drugs that have not been approved and made available in the US market for at least 180 days; • Non-legend vitamins; • Over-the-counter items; • Cosmetic drugs; • Appetite suppressants; • Weight loss products; • Diet supplements; • Syringes (for use other than insulin) except when in coordination with an approved injectable; • Injectables (except with Prior Authorization as required); • The administration or injection of any Prescription Drug or any drugs or medicines; • Prescription Drugs which are entirely consumed or administered at the time and place where the prescription order is issued; • Prescription refills in excess of the number specified by the Physician, or any refill dispensed after one year from the date of the prescription order; • Prescription Drugs for which there is no charge; • Charges for items such as therapeutic devices, digital therapeutics, artificial appliances, or similar devices, regardless of their intended use; • Prescription Drugs for use while an Inpatient or Outpatient of a Hospital. • Prescription Drugs provided for use in a convalescent care facility or nursing home which are ordinarily furnished by such facility for the care and treatment of Inpatients; • Charges for delivery of any Prescription Drugs; • Drugs and medicines which do not require a prescription, and which are not Prescription Drugs; • Prescription Drugs provided by a Physician whether or not a charge is made for such Prescription Drugs. • Prescription Drugs which are not Medically Necessary or which We determine are not consistent with the diagnosis (See the Off-Label Drugs section for exceptions); • Prescription Drugs which We determine are not provided in accordance with accepted professional medical standards in the United States. • Any services or supplies, which are not specifically listed as covered under this Prescription Drug program. • Prescription Drugs which are Experimental or Investigational in nature as explained in the General Limitations and Exclusions section. • Prescription medicine for nail fungus except for immunocompromised or diabetic patients. • Non-formulary drugs except as described in this Prescription Drug Program section. This section describes the services and supplies available to covered persons up to but not including the age of 19. These services and supplies must be provided and billed by Providers and must be Medically Necessary unless otherwise specified. The following Routine Vision Care Services are covered: • A case history • General patient observation • Glinical and diagnostic testing and evaluation • Inspection of conjunctivae and sclera • Examination of orbits • Test visual acuity • Gross visual field testing • Ocular motility • Binocular testing • Examination of irises, cornea(s), lenses, and anterior xxxxxxxx • Examination of pupils • Measurement of intraocular pressure (tonometry) • Ophthalmoscopic examinations • Determination of refract status • Color vision testing • Stereopsis testing • Case presentation including summary findings and recommendations including prescribing Lenses • Facial measurements and determination of interpupillary distance • Assistance in choosing Frames • Verification of Lenses as prescribed • After-care for a reasonable period of time for fitting and adjustment In addition to those non-covered items listed in the General Limitations and Exclusions section of this Certificate, PediatricVision Pediatric Vision Coverage is not provided for: • An eye examination or materials ordered as a result of an eye examination prior to Your Effective Date; • Lenses which are not prescribed; • The replacement of Lenses or Frames except as specified in the Summary of Benefits and Coverage; • Safety glass, safety goggles and sports glasses; • Services that Alliant determines are special or unusual; such as orthoptics, vision training and low vision aids; • Tints other than Number One or Two; • Tints with photosensitive or antireflective properties; • Progressive Lenses; • Spectacle lens treatments or "add-ons", except for tints Number One or Two; • Any surgical procedure forthe correction of a visual refractive problem including, but not limited to, radial keratotomy and LASIK (laser in situ keratomileusis); • Non-Covered Services or services specifically excluded in the text of this Certificate WHAT IS NOT COVERED Your coverage does not provide benefits for: to correct gynecomastia and breast augmentation procedures, and otoplasties. Reduction mammoplasty and services for the correction of asymmetry, except when determined to be Medically Necessary by Alliant, is not covered. ° This exclusion does not apply to surgery to restore function if anybody area has been altered by disease, trauma, Congenital/developmental Anomalies, or previous therapeutic processes. This exclusion does not apply to surgery to correct the results of Injuries when performed within two years of the event causing the impairment, or as a continuation of a staged reconstruction procedure, or congenital defects necessary to restore normal bodily functions, including but not limited to, cleft lip and cleft palate. massage equipment, air purifiers, central or unit air conditioners, humidifiers, dehumidifiers, escalators, elevators, ramps, stair glides, emergency alert equipment, handrails, heat appliances, improvements made to a Member’s house or place of business, and adjustments made to vehicles. Computer equipment to aid in speech or hearing loss. common first-aid supplies, disposable sheets and bags, unless Medically Necessary. • Durable Medical Equipment – The following items related to Durable Medical Equipment are specifically excluded: ° Air conditioners, humidifiers, dehumidifiers, or purifiers; ° Arch supports and orthopedic or corrective shoes and shoe molds (except when an orthopedic shoe is joined to a brace or for the care of the diabetic foot); all shoe inserts and orthotics (except for the care of the diabetic foot); and support stockings; ° Heating pads, hot water bottles, home enema equipment, or rubber gloves; ° Sterile water; ° TENS units; ° Sequential stimulators; ° Conductive garments; ° Deluxe equipment or premium services, such as motor driven chairs or beds, when standard equipment is adequate; ° Rental or purchase of equipment if You are in a facility which provides such equipment; ° Electric stair or elevator chairs; ° Physical fitness, exercise, or ultraviolet/tanning equipment; light-box therapy for SADS; ° Residential structural modification to facilitate the use of equipment; ° Other items of equipment which do not meet the listed criteria; ° Duplicate medical equipment. ° determined to be court-ordered, custodial, or solely for the purpose of environmental control; ° rendered in a home, halfway house, school, or domiciliary institution; ° associated with the diagnosis(es) of acute stress reaction, childhood or adolescent adjustment reaction, and/or related marital, social, cultural or work situations ° the treatment is for maintenance therapy; or ° the Member has no restorative potential; or ° the treatment is for congenital learning or neurological disability/disorder; or ° the treatment is for communication training, educational training or vocational training.