Persius/hicric huggingface dataset:
Appeal type: unknown
Decision: unknown

Citations used in this letter come from Section 42 of the Code of Federal Regulations which you will find abbreviated as 42 CFR with the corresponding section numbers, i.e., 42 CFR Sections 423.578, 423.100.A Part D plan must have enough contracted retail pharmacies in its network to ensure that enrollees have adequate access to covered prescription drugs. Access to covered drugs from an out-of-network pharmacy is required when enrollees: (1) cannot reasonably be expected to obtain such drugs at a network pharmacy and (2) do not access covered drugs at out-of-network pharmacies on a routine basis. A plan is required to establish reasonable rules to appropriately limit out-of-network access to covered prescription drugs. 42 CFR ?423.120 and ?423.124; Medicare Prescription Drug Benefit Manual, Chapter 5, ?60.1.The Plan will generally cover prescriptions only if they are filled at a Plan network pharmacy. Prescriptions filled at an out-of-network pharmacy may only be covered when a network pharmacy is not available. The Plan will typically cover prescriptions filled at an out-of-network pharmacy when the prescription is for a medical emergency or urgent care, when there are no 24-hour network pharmacies within a reasonable driving distance or when the prescription is for a drug that is out of stock at an accessible network pharmacy. Please refer to the Plan's Evidence of Coverage.For a drug to be covered under Medicare Part D, it must meet the definition of a Part D drug. The Social Security Act generally defines a Part D drug as a drug product that meets the following requirements: -It requires a prescription for dispensing; and -It is approved by the Food and Drug Administration (FDA) for safety and effectiveness; and -It is prescribed for a medically accepted indication; and -It is not otherwise excluded from coverage under Part D law and rules. See Social Security Act, Sections 1860D-2(e)(1) and 1927(k)(2)(A)(i)-(iii); and Medicare Prescription Drug Benefit Manual, Chapter 6, Section 10.1. The definition of a Part D drug does not include over-the-counter (OTC) products. OTC drug products are those drugs that are available to consumers without a prescription. The FDA's Center for Drug Evaluation and Research (CDER) is the entity that oversees the designation and marketing of OTC drugs. Medicare Part D does not pay for OTC drug products. See rules noted above; and Medicare Prescription Drug Benefit Manual, Chapter 6, Section 10.10 and Chapter 7, Section 60.2.The Plan does not cover drugs/items excluded from Medicare Part D coverage. If you purchase drugs/items that are excluded, you must pay for them yourself. Please refer to the Plan's Evidence of Coverage (EOC).
Appeal type: unknown
Decision: unknown

Citations used in this letter come from Section 42 of the Code of Federal Regulations which you will findabbreviated as 42 CFR with the corresponding section numbers, i.e., 42 CFR Sections 423.578, 423.100.A Part D plan is permitted to use a number of different tools to manage its formulary, including priorauthorization, step therapy and dose restriction, or quantity limits. 70 Federal Register No. 18, issuedJanuary 28, 2005 (Preamble to Final Rule); 42 CFR Section 423.578(b).For certain drugs, the Part D Plan has additional requirements for coverage or limits on its coverage. Theseadditional requirements include prior authorization, step therapy and quantity limits. Please refer to thePlan's Evidence of Coverage (EOC).
Appeal type: unknown
Decision: unknown

Citations used in this letter come from Section 42 of the Code of Federal Regulations which you will findabbreviated as 42 CFR with the corresponding section numbers, i.e., 42 CFR Sections 423.578, 423.100.Medicare law defines those drugs that may be covered under Part D. A covered prescription drug must beused for a medically accepted indication. A medically accepted indication means a use that is approvedby the Food and Drug Administration (FDA), or a use supported by one or more citations in the drugcompendia approved by Medicare. Medically accepted indications do not include uses in research or usesdescribed in peer-reviewed medical literature. Please refer to Social Security Act, Sections 1860D-2(e)(1)and 1927(k)(6); and 42 CFR Section 423.100.A Part D Plan is permitted to use a number of different tools to manage its formulary. One of these tools isknown as prior authorization. This process requires an enrollee to obtain coverage approval for a drugbefore the drug is dispensed and covered by the plan. 70 Federal Register No. 18, issued January 28, 2005(Preamble to Final Rule).Formulary use includes the application of cost utilization tools, including step-therapy, dosage limitationsand therapeutic substitution. 42 CFR Section 423.578(b)(iii). The exceptions process extends to coveragerequests to set aside cost utilization rules for non-formulary drugs. A Part D plan must grant an exceptionwhenever it determines that the drug is medically necessary, consistent with the prescriber's statement, andthat the drug would be covered but for the fact that it is subject to cost utilization rules. 42 CFR Section423.578(b). The statement must show that all of the covered drugs on any tier of the plan's formulary fortreatment of the enrollee's condition would not be as effective as the drug at issue, or would have adverseeffects for the enrollee. Parts C & D Enrollee Grievances, Organization/Coverage Determinations, andAppeals Guidance Manual, Section 40.5.3.The Part D Plan can only cover drugs prescribed for a medically accepted indication. The Plan requiresprior approval (also called prior authorization) before covering some prescription drugs. If prior approval isnot obtained, the Plan may not cover the drug. A Plan must grant an exception to prior approval rules if itdetermines that the requested drug is medically necessary, consistent with the prescriber's statement. Pleaserefer to the Plan's Evidence of Coverage (EOC).The Part D Plan can only cover drugs prescribed for a medically accepted indication. Please refer to thePlan's Evidence of Coverage (EOC).
Appeal type: unknown
Decision: unknown

Citations used in this letter come from Section 42 of the Code of Federal Regulations which you will findabbreviated as 42 CFR with the corresponding section numbers, i.e., 42 CFR Sections 423.578, 423.100.Medicare law defines those drugs that are eligible to be covered under the prescription drug benefit.Medicare law specifically excludes coverage for any drug for which payment would be available underParts A or B of Medicare for that individual. Social Security Act, Section 1860D-2(e)(2)(B).Effective January 1, 2011, Medicare law requires that all drugs and biologicals used in the treatment of endstage renal disease (ESRD) be included in the ESRD prospective payment system (PPS) payment bundle,including drugs formerly paid under Medicare Part D. The law identifies categories of drugs that either are,or may be, ESRD-related. Drugs that are always considered ESRD-related include access managementdrugs, anemia management drugs, anti-infectives to treat site access infection, bone and mineralmetabolism drugs and cellular management drugs. Social Security Act, Section 1881(b)(14); 42 CFRSection 413.171; Medicare Benefit Policy Manual, Chapter 11, Section 20.3; and 75 Federal Register No.155, issued August 12, 2010 (Preamble to Final Rule).Effective February 20, 2018, Medicare law also provides coverage of related drugs under the PPS bundlefor treatment of acute kidney injury (AKI). Medicare Benefit Policy Manual, Chapter 11, Section 100.6.For drugs that are always considered ESRD-related, it is important to note that the ESRD bundle includesall ESRD-related drugs and biologicals, regardless of whether or not these are furnished by a dialysisfacility. Thus, effective January 1, 2011, any claims for a drug included in the five categories of drugs thatare always considered renal dialysis drugs when furnished to an ESRD patient and used as specified i nTable 4 of the Preamble to the Final Rule would not be payable under Part D when the beneficiary is anESRD patient in dialysis, regardless of why the drug is being furnished. Medicare Program; End-StageRenal Disease Prospective Payment System, 75 Fed. Reg. 49030, 49050 (August 12, 2010); CMS memo:Clarification of Exclusion of Part D Payment for Drugs included in the End-Stage Renal DiseaseProspective Payment dated February 17, 2011.The Part D Plan contract states that its Part D drug coverage cannot cover a drug that would be coveredunder Medicare Part A or Part B. Please refer to the Plan's Evidence of Coverage.
Appeal type: unknown
Decision: unknown

Citations used in this letter come from Section 42 of the Code of Federal Regulations which you will findabbreviated as 42 CFR with the corresponding section numbers, i.e., 42 CFR Sections 423.578, 423.100.A Part D Plan must cover the prescription drug benefits described in its subscriber agreement. A Plan ispermitted to manage its prescription drug benefit by establishing a formulary that identifies specific drugsthat are covered through the Plan. A Plan is permitted to use a number of different tools or approaches tomanage the coverage of drugs on its formulary. One of these tools is known as prior authorization. Thisprocess requires an enrollee to obtain coverage approval for a drug before the drug is dispensed andcovered by the Plan. 70 Federal Register No. 18, issued January 28, 2005 (Preamble to Final Rule).Medicare law defines those drugs that are eligible to be covered under the prescription drug benefit.Medicare law specifically excludes coverage for any drug for which payment would be available underParts A or B of Medicare for that individual. Social Security Act, Section 1860D-2(e)(2)(B).Medicare Part B pays for durable medical equipment (DME) if the equipment is used in the patient's homeor in an institution that is used as a home. Payment may be made for supplies necessary for the effectiveuse of DME. Such supplies include those drugs and biologicals which must be put directly into theequipment in order to achieve the therapeutic benefit of the DME. 42 CFR Section 410.38(a); MedicareBenefit Policy Manual, Chapter 15, Section 110.3.Medicare Part B local policy states that an external infusion pump is covered for administration ofsubcutaneous immune globulin if the subcutaneous immune globulin preparation is a pooled plasmaderivative which is approved for the treatment of primary immune deficiency disease; and the patient has adiagnosis of primary immune deficiency disease. You can find this rule at CGS Administrators, LLC, LocalCoverage Determination (LCD) for External Infusion Pumps (L33794) and (A52507) or NoridianHealthcare Solutions, LLC LCD for External Infusion Pumps (L33794) and (A52507).The Part D Plan contract states that the Plan cannot cover drugs that would be covered under Medicare PartA or Part B. Please refer to the Plan's Evidence of Coverage (EOC).
Appeal type: unknown
Decision: unknown

Citations used in this letter come from Section 42 of the Code of Federal Regulations which you will find abbreviated as 42 CFR with the corresponding section numbers, i.e., 42 CFR Sections 423.578, 423.100.Medicare law defines those drugs that may be covered under Part D. A covered prescription drug must be used for a medically accepted indication. A medically accepted indication means a use that is approved by the Food and Drug Administration (FDA), or a use supported by one or more citations in the drug compendia approved by Medicare. Medically accepted indications do not include uses in research or uses described in peer-reviewed medical literature. Please refer to Social Security Act, Sections 1860D-2(e)(1) and 1927(k)(6); and 42 CFR Section 423.100. A Part D drug must be used for a medically accepted indication that facilitates the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member (except for Part D vaccines). Consequently, if a drug works on medical equipment or devices and is not used for a medically accepted indication of therapeutic value on the body, it cannot satisfy the definition of a Part D drug. For example, a Heparin flush is not used to treat a patient for a medically accepted indication, but rather to dissolve possible blood clots around an infusion line. Therefore, Heparin's use in this instance is not therapeutic but is, instead, necessary to make durable medical equipment work. It would therefore not be a Part D drug when used in a Heparin flush. Medicare Prescription Drug Benefit Manual, Chapter 6, ?10.6.The Part D Plan can only cover drugs prescribed for a medically accepted indication. Please refer to the Plan's Evidence of Coverage (EOC).
Appeal type: unknown
Decision: unknown

Citations used in this letter come from Section 42 of the Code of Federal Regulations which you will findabbreviated as 42 CFR with the corresponding section numbers, i.e., 42 CFR Sections 423.578, 423.100.Medicare law defines those drugs that are eligible to be covered under the prescription drug benefit.Medicare law specifically excludes coverage for any drug for which payment would be available underParts A or B of Medicare for that individual. Social Security Act, Section 1860D-2(e)(2)(B) and 42 CFRSection 423.100.Medicare law says that Medicare Part B pays for hemophilia clotting factors. Medicare rules state the bloodclotting factors are a category of drug that are not eligible for coverage under the Part D benefit and shouldnot be included on a Part D sponsor's formulary. 42 CFR Section 410.63; Medicare Benefit Policy Manual,Chapter 15, Section 50.5.5; Medicare Prescription Drug Benefit Manual, Chapter 6, Appendix C.The Part D Plan contract states that the Plan cannot cover drugs that would be covered under Medicare PartA or Part B. Please refer to the Plan's Evidence of Coverage (EOC).
Appeal type: unknown
Decision: unknown

Citations used in this letter come from Section 42 of the Code of Federal Regulations which you will findabbreviated as 42 CFR with the corresponding section numbers, i.e., 42 CFR Sections 423.578, 423.100.A Part D plan must have enough contracted retail pharmacies in its network to ensure that enrollees haveadequate access to covered prescription drugs. Access to covered drugs from an out-of-network pharmacyis required when enrollees: (1) cannot reasonably be expected to obtain such drugs at a network pharmacyand (2) do not access covered drugs at out-of-network pharmacies on a routine basis. A plan is required toestablish reasonable rules to appropriately limit out-of-network access to covered prescription drugs. 42CFR Sections 423.120(a) and 423.124; Medicare Prescription Drug Benefit Manual, Chapter 5, Section60.1.The Plan will generally cover prescriptions only if they are filled at a Plan network pharmacy. Prescriptionsfilled at an out-of-network pharmacy may only be covered when a network pharmacy is not available. ThePlan will typically cover prescriptions filled at an out-of-network pharmacy when the prescription is for amedical emergency or urgent care, when there are no 24-hour network pharmacies within a reasonabledriving distance or when the prescription is for a drug that is out of stock at an accessible networkpharmacy. Please refer to the Plan's Evidence of Coverage (EOC).For a drug to be covered under Medicare Part D, it must meet the definition of a Part D drug. The SocialSecurity Act generally defines a Part D drug as a drug product that meets the following requirements:-It requires a prescription for dispensing; and-It is approved by the Food and Drug Administration (FDA) for safety and effectiveness; and-It is prescribed for a medically accepted indication; and-It is not otherwise excluded from coverage under Part D law and rules.See Social Security Act, Sections 1860D-2(e)(1) and 1927(k)(2)(A)(i)-(iii); and Medicare PrescriptionDrug Benefit Manual, Chapter 6, Section 10.1.The definition of a Part D drug does not include over-the-counter (OTC) products. OTC drug products arethose drugs that are available to consumers without a prescription. The FDA's Center for Drug Evaluationand Research (CDER) is the entity that oversees the designation and marketing of OTC drugs. MedicarePart D does not pay for OTC drug products. See rules noted above; and Medicare Prescription Drug BenefitManual, Chapter 6, Section 10.10 and Chapter 7, Section 60.2.The Plan does not cover drugs/items excluded from Medicare Part D coverage. If you purchase drugs/itemsthat are excluded, you must pay for them yourself. Please refer to the Plan's Evidence of Coverage (EOC).
Appeal type: unknown
Decision: unknown

Citations used in this letter come from Section 42 of the Code of Federal Regulations which you will findabbreviated as 42 CFR with the corresponding section numbers, i.e., 42 CFR Sections 423.578, 423.100.Medicare law defines those drugs that may be covered under Part D. A covered prescription drug must beused for a medically accepted indication. A medically accepted indication means a use that is approvedby the Food and Drug Administration (FDA), or a use supported by one or more citations in the drugcompendia approved by Medicare. Medically accepted indications do not include uses in research or usesdescribed in peer-reviewed medical literature. Please refer to Social Security Act, Sections 1860D-2(e)(1)and 1927(k)(6); and 42 CFR Section 423.100.A Part D plan must grant an exception for a drug that is not on its formulary whenever it determines thatthe drug is medically necessary, consistent with the prescriber's statement, and that the drug would becovered but for the fact that it is not on the formulary. The statement must show that all of the covereddrugs on any tier of the plan's formulary for treatment of the enrollee's condition would not be as effectiveas the non-formulary drug or would have adverse effects for the enrollee. 42 CFR Sections 423.578(b) and423.578(b)(5)(i).If a drug is not on the formulary (drug list), an enrollee can ask the Plan to make an exception and cover thedrug. The Plan will make an exception for coverage if it determines that the requested drug is medicallynecessary, consistent with the prescriber's statement. Please refer to the Plan's Evidence of Coverage(EOC).
Appeal type: unknown
Decision: unknown

Citations used in this letter come from Section 42 of the Code of Federal Regulations which you will findabbreviated as 42 CFR with the corresponding section numbers, i.e., 42 CFR Sections 423.578, 423.100.A Part D plan must have enough contracted retail pharmacies in its network to ensure that enrollees haveadequate access to covered prescription drugs. Access to covered drugs from an out -of-network pharmacyis required when enrollees: (1) cannot reasonably be expected to obtain such drugs at a network pharmacyand (2) do not access covered drugs at out-of-network pharmacies on a routine basis. A plan is required toestablish reasonable rules to appropriately limit out-of-network access to covered prescription drugs. 42CFR Sections 423.120(a) and 423.124; Medicare Prescription Drug Benefit Manual, Chapter 5, Section60.1.The Plan will generally cover prescriptions only if they are filled at a Plan network pharmacy. Prescriptionsfilled at an out-of-network pharmacy may only be covered when a network pharmacy is not available. ThePlan will typically cover prescriptions filled at an out-of-network pharmacy when the prescription is for amedical emergency or urgent care, when there are no 24-hour network pharmacies within a reasonabledriving distance or when the prescription is for a drug that is out of stock at an accessible networkpharmacy. If an enrollee must use an out-of-network pharmacy, the enrollee will generally have to pay thefull cost when the prescription is filled. The enrollee may submit a request for reimbursement with proof ofpayment to ask the Plan to pay its share of the cost. Please refer to the Plan's Evidence of Coverage.
Appeal type: unknown
Decision: unknown

Citations used in this letter come from Section 42 of the Code of Federal Regulations which you will find abbreviated as 42 CFR with the corresponding section numbers, i.e., 42 CFR Sections 423.578, 423.100.For a drug to be covered under Medicare Part D, it must meet the definition of a Part D drug. The Social Security Act generally defines a Part D drug as a drug product that meets the following requirements: -It requires a prescription for dispensing; and-It is approved by the Food and Drug Administration (FDA) for safety and effectiveness; and-It is prescribed for a medically accepted indication; and-It is not otherwise excluded from coverage under Part D law and rules.See Social Security Act, Sections 1860D-2(e)(1) and 1927(k)(2)(A)(i)-(iii); and Medicare Prescription Drug Benefit Manual, Chapter 6, Section 10.1.The definition of a Part D drug does not include over-the-counter (OTC) products. OTC drug products are those drugs that are available to consumers without a prescription. The FDA's Center for Drug Evaluation and Research (CDER) is the entity that oversees the designation and marketing of OTC drugs. Medicare Part D does not pay for OTC drug products. See rules noted above; and Medicare Prescription Drug Benefit Manual, Chapter 6, Section 10.10 and Chapter 7, Section 60.2.The Plan does not cover drugs/items excluded from Medicare Part D coverage. If you purchase drugs/items that are excluded, you must pay for them yourself. Please refer to the Plan's Evidence of Coverage (EOC).
Appeal type: unknown
Decision: unknown

Citations used in this letter come from Section 42 of the Code of Federal Regulations which you will find abbreviated as 42 CFR with the corresponding section numbers, i.e., 42 CFR Sections 423.578, 423.100.Medicare law defines those drugs that are eligible to be covered under the prescription drug benefit. Medicare law specifically excludes coverage for any drug for which payment would be available under Parts A or B of Medicare for that individual. Social Security Act, Section 1860D-2(e)(2)(B). Medicare Part B pays for durable medical equipment (DME) if the equipment is used in the patient's home or in an institution that is used as a home. Payment may be made for supplies necessary for the effective use of DME. Such supplies include those drugs and biologicals which must be put directly into the equipment in order to achieve the therapeutic benefit of the DME. 42 CFR Section 410.38(a); Medicare Benefit Policy Manual, Chapter 15, Section 110.3. Medicare Part B local policy states that a small volume nebulizer and related compressor are considered for coverage when medically necessary to administer tobramycin (J7682) to a beneficiary with cystic fibrosis or bronchiectasis (refer to the Group 10 Codes in the LCD-related Policy Article for applicable diagnoses. You can find this rule at Noridian Healthcare Solutions, LLC, Local Coverage Determination (LCD) for Nebulizers (L33370) or CGS Administrators, LLC, Local Coverage Determination (LCD) for Nebulizers (L33370) and Local Coverage Article (LCA) for Nebulizers (A52466).The Part D Plan contract states that the Plan cannot cover drugs that would be covered under Medicare Part A or Part B. Please refer to the Plan's Evidence of Coverage (EOC).