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.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 plan must grant an exception for a drug that is not on its formulary whenever it determines that the drug is medically necessary, consistent with the prescriber's statement, and that the drug would be covered but for the fact that it is not on the formulary. The statement must show that all of the covered drugs on any tier on the plan's formulary for treatment of the enrollee's condition would not be as effective as the non-formulary drug or would have adverse effects for the enrollee. 42 CFR Sections 423.578(b) and 423.578(b)(5)(i).The Part D Plan can only cover drugs prescribed for a medically accepted indication. Please refer to the Plan's Evidence of Coverage.The Part D Plan contract states that if the Plan agrees to make an exception and cover a drug that is not on the formulary, the Plan cannot grant an additional exception to the copayment or coinsurance amount. 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.Medicare Part D does not cover a (1) drug used for anorexia, weight loss or weight gain; (2) drug used to promote fertility; (3) drug used for cosmetic purposes or to promote hair growth; (4) drug used for the symptomatic relief of coughs and colds; (5) prescription vitamin and mineral product; (6) non-prescription or over-the-counter drug; (7) drug subject to manufacturer tying arrangements; and (8) drug used to treat sexual or erectile dysfunction or (9) sexual or erectile dysfunction drug used to treat a condition other than sexual or erectile dysfunction for which the drug has not been approved by the FDA. Social Security Act, Sections 1860D-2(e)(2)(A), 1927(d)(2) and 1927(4)(C).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 plan must grant an exception for a drug that is not on its formulary whenever it determines that the drug is medically necessary, consistent with the prescriber's statement, and that the drug would be covered but for the fact that it is not on the formulary. The statement must show that all of the covered drugs on any tier of the plan's formulary for treatment of the enrollee's condition would not be as effective as the non-formulary drug or would have adverse effects for the enrollee. 42 CFR Section 423.578(b).If a drug is not on the formulary (drug list), an enrollee can ask the Plan to make an exception and cover the drug. The Plan will make an exception for coverage if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. 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.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 includes only those prescription drugs that are approved by the FDA forsafety and effectiveness. For a drug to be approved by the FDA, the manufacturer of the drug must file aNew Drug Application (NDA) or Abbreviated New Drug Application (ANDA) with the FDA's Center forDrug Evaluation and Research (CDER). Medicare Part D does not pay for drugs that are not FDA approvedprescription drugs. See Social Security Act, Sections 1860D-2(e)(1), 1927(k)(2), and 1927(b)(3).The Plan does not cover drugs/items excluded from Medicare Part D coverage. If you purchase drugs/i temsthat are excluded, you must pay for them yourself. 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.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 services and supplies incident to the service of a physician (or other practitioner).Services and supplies must be furnished in a noninstitutional setting to noninstitutional patients; an integral,though incidental, part of the service of a physician in the course of diagnosis or treatment of an injury orillness; commonly furnished without charge or included in the bill of a physician; of a type that arecommonly furnished in the office or clinic of a physician; and furnished under the direct supervision of thephysician. In order to meet all the general requirements for coverage under the incident -to provision, anFDA approved drug or biological must be of a form that is not usually self-administered. 42 CFR Section410.26(b); Medicare Benefit Policy Manual, Chapter 15, Section 50.3.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.
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.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 includes only those prescription drugs that are approved by the FDA forsafety and effectiveness. For a drug to be approved by the FDA, the manufacturer of the drug must file aNew Drug Application (NDA) or Abbreviated New Drug Application (ANDA) with the FDA's Center forDrug Evaluation and Research (CDER). Medicare Part D does not pay for drugs that are not FDA approvedprescription drugs. See Social Security Act, Sections 1860D-2(e)(1), 1927(k)(2), and 1927(b)(3).The Plan does not cover drugs/items excluded from Medicare Part D coverage. If you purchase drugs/i temsthat are excluded, you must pay for them yourself. 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.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 step therapy to manage its formulary. This is the process of beginningdrug therapy for a medical condition with preferred (or more cost-effective) non-formulary drugalternative(s) and progressing to other drug therapies only as necessary. A plan must grant an exception toits step therapy rules if it determines that the requested drug is medically necessary, consistent with theprescriber's statement. The statement must show that the step therapy drug(s): has been ineffective in thetreatment of the enrollee's disease or medical condition or, based on both sound clinical evidence andmedical and scientific evidence and the known relevant physical or mental characteristics of the enrolleeand known characteristics of the drug regimen, is likely to be ineffective or adversely affect the drug'seffectiveness or patient compliance; or has caused or based on sound clinical evidence and medical andscientific evidence, is likely to cause an adverse reaction or other harm to the enrollee. 42 CFR Section423.578(b)(5)(ii).The Plan requires certain drugs be tried first before it will cover the requested drug. This is called steptherapy. However, the Part D Plan contract allows an enrollee to request an exception. The Plan will coverthe requested drug without requiring step therapy if it determines that the requested drug is medicallynecessary, consistent with the prescriber's statement. 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.Medicare Part D does not cover a (1) drug used for anorexia, weight loss or weight gain; (2) drug used topromote fertility; (3) drug used for cosmetic purposes or to promote hair growth; (4) drug used for thesymptomatic relief of coughs and colds; (5) prescription vitamin and mineral product; (6) non-prescriptionor over-the-counter drug; (7) drug subject to manufacturer tying arrangements; and (8) drug used to treatsexual or erectile dysfunction or (9) sexual or erectile dysfunction drug used to treat a condition other thansexual or erectile dysfunction for which the drug has not been approved by the FDA. Social Security Act,Sections 1860D-2(e)(2)(A), 1927(d)(2) and 1927(d)(4)(C).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.The Part D Plan does not cover those drugs excluded from Medicare Part D coverage. In addition, the Plandoes not offer supplemental (additional) coverage for it. If you purchase drugs that are excluded, you mustpay for them yourself. Please refer to the Plan's Evidence of Coverage.The Part D Plan can only cover drugs prescribed for a medically accepted indication. Please refer to thePlan'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.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, related compressor and FDA-approved inhalation solutions are covered when medically necessary to administer albuterol, arformoterol (Brovana), budesonide, cromolyn, formoterol, ipratropium, levalbuterol, or metaproterenol for the management of obstructive pulmonary disease (Reference the Diagnosis Codes that Support Medical Necessity Group 8 Codes section of this rule 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).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.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.
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.The prescription drug benefit offered by the Part D Plan must meet certain requirements pertaining to theannual deductible, the initial coverage limit, the coverage gap and catastrophic coverage. For the initialcoverage limit, the rules provide for a benefit of shared coverage of costs between the enrollee and plan. Anenrollee in a Part D Plan may be subject to annual deductibles, coinsurance, and copayments (includingtiered copayments) specified by the plan. 42 CFR Section 423.104.The deductible stage is the first payment stage of the enrollee's drug coverage. During the deductible stage,the Plan requires that the enrollee pays the full cost of Tier 3, Tier 4 and Tier 5 drugs before the Plan willpay a share of the cost. Once the enrollee has met the deductible amount of $415, the enrollee moves intothe initial coverage stage. If an enrollee pays the full cost of a prescription, the enrollee may submit arequest for reimbursement with proof of payment to ask the Plan to pay its share of the cost. Xarelto 20 mgwas on the Plan's 2019 formulary and was classified as a Tier 3 drug. Please refer to the Plan's Evidence ofCoverage and formulary.
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 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 covers vaccinations or inoculations directly related to the treatment of an injury or direct exposure to a disease or condition, such as tetanus antitoxin or booster vaccine. In the absence of injury or direct exposure, preventive immunization (vaccination or inoculation) is not covered. 42 CFR Section 411.15; Medicare Benefit Policy Manual, Chapter 15, Section 50.4.4.2.The Part D Plan contract states that its Part D drug coverage cannot cover a drug that would be covered under 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 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, related compressor and FDA-approved inhalation solutions are covered when medically necessary to administer albuterol, arformoterol (Brovana), budesonide, cromolyn, formoterol, ipratropium, levalbuterol, or metaproterenol for the management of obstructive pulmonary disease (Reference the Diagnosis Codes that Support Medical Necessity Group 8 Codes section of this rule 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). 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.The Part D Plan contract states that the Plan cannot cover drugs that would be covered under Medicare Part A or Part B. The Part D Plan can only cover drugs prescribed for a medically accepted indication. 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.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.The Part D Plan can only cover drugs
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.The Part D Plan can only cover drugs prescribed for a medically accepted indication. Please refer to thePlan'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 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 includes only those prescription drugs that are approved by the FDA forsafety and effectiveness. For a drug to be approved by the FDA, the manufacturer of the drug must file aNew Drug Application (NDA) or Abbreviated New Drug Application (ANDA) with the FDA's Center forDrug Evaluation and Research (CDER). Medicare Part D does not pay for drugs that are not FDA approvedprescription drugs. See Social Security Act, Sections 1860D-2(e)(1), 1927(k)(2), and 1927(b)(3).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.