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 has the authority to establish a formulary to designate specific drugs that will be available for coverage and the ability to have a cost-sharing structure other than the standard Medicare drug benefit. An enrollee may be subject to annual deductibles, coinsurance, and copayments (including tiered copayments). 42 CFR Section 423.104.The Plan will pay part of the costs for covered drugs and the enrollee will pay the other part during the initial coverage period. The amount an enrollee pays when filling a covered prescription is called the copayment or coinsurance. The copayment or coinsurance will vary depending on the drug and where the prescription is filled. The Plan may also have other rules regarding issues such as when a refill will be covered. 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 an external infusion pump is covered for administration of subcutaneous immune globulin if the subcutaneous immune globulin preparation is a pooled plasma derivative which is approved for the treatment of primary immune deficiency disease; and the patient has a diagnosis of primary immune deficiency disease. You can find this rule at CGS Administrators, LLC, Local Coverage Determination (LCD) for External Infusion Pumps (L33794) and (A52507) or Noridian Healthcare 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 Part A 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.Medicare law defines those drugs that may be covered under Part D. A covered prescription drug must be usedfor a medically accepted indication. A medically accepted indication means a use that is approved by theFood and Drug Administration (FDA), or a use supported by one or more citations in the drug compendiaapproved by Medicare. Medically accepted indications do not include uses in research or uses described in peerreviewedmedical literature. Please refer to Social Security Act, Sections 1860D-2(e)(1) and 1927(k)(6); and 42CFR Section 423.100.The Part D Plan can only cover drugs prescribed for a medically accepted indication. Please refer to the Plan'sEvidence 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 dose restriction to manage its formulary. This process limits the numberof doses that may be dispensed during a specific period of time (usually per month). A plan must grant anexception to its dose restriction rules if it determines that the requested dosage is medically necessary,consistent with the prescriber's statement. The statement must show that the number of doses availableunder a dose restriction has been or is likely to be ineffective in treating the enrollee or adversely impactsthe drug's effectiveness or patient compliance. 42 CFR Sections 423.578(a), 423.578(b), and423.578(b)(B)(iii).The Part D Plan may cover limited quantities of some drugs. However, the Plan allows an exception for agreater amount of the drug if it determines that the requested dosage is medically necessary, consistent withthe 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.An enrollee in a Part D plan may be subject to annual deductibles, coinsurance, and copayments (includingtiered copayments) specified by the plan. 42 CFR ?423.104.The Part D Plan enrollee may pay part of the cost of a covered drug during the initial coverage period as acopayment or coinsurance. The amount of the copayment or coinsurance will vary depending on the drug'stier and place of purchase. There may be situations in which an enrollee will pay the full cost of the drug atthe time of purchase or an enrollee may pay more than expected under the coverage rules of the Plan. Ineither case, an enrollee can ask the Plan to pay its share of the cost of the drug by sending the Plan a requestfor reimbursement along with the enrollee's prescription receipt(s) documenting proof of purchase. Pleaserefer 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.An enrollee in a Part D plan may be subject to annual deductibles, coinsurance, and copayments (including tiered copayments) specified by the plan. 42 CFR Section 423.104.The Part D Plan enrollee may pay part of the cost of a covered drug during the initial coverage period as a copayment or coinsurance. The amount of the copayment or coinsurance will vary depending on the drug's tier and place of purchase. If an enrollee pays the full cost of a prescription, the enrollee may submit a request for reimbursement with proof of payment to ask the Plan to pay its share of the cost. 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.The prescription drug benefit offered by the Part D Plan must meet certain requirements pertaining to the annual deductible, the initial coverage limit, the coverage gap and catastrophic coverage. For the initial coverage limit, the rules provide for a benefit of shared coverage of costs between the enrollee and plan. An enrollee in a Part D Plan may be subject to annual deductibles, coinsurance, and copayments (including tiered copayments) specified by the plan. 42 CFR Section 423.104.The Part D Plan enrollee may pay part of the cost of a covered drug during the initial coverage period as a copayment or coinsurance. The amount of the copayment or coinsurance will vary depending on the drug's tier and place of purchase. If an enrollee pays the full cost of a prescription, the enrollee may submit a request for reimbursement with proof of payment to ask the Plan to pay its share of the cost. The Plan required a $47 copay for up to a 30 day supply of a Tier 3 drug purchased in 2020 from a standard retail. Hydrocodone/Acetaminophen 5-325mg was on the Plan's 2020 formulary and was classified as a Tier 3 drug. Please refer to the Plan's Evidence of Coverage (EOC) 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 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.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).The Part D Plan can only cover drugs prescribed for a medically accepted indication. Please refer to thePlan's Evidence of Coverage (EOC).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 (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.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 Plan will pay its share of the cost for covered drugs and the enrollee will pay the other part during theinitial coverage stage. The amount of the copayment or coinsurance will vary depending on the drug's tierand place of purchase. During the deductible stage, the Plan requires that the enrollee pays the full cost ofTier 3, Tier 4 and Tier 5 drugs before the Plan will pay a share of the cost. Once the enrollee has met thedeductible amount of $250. Once the enrollee has met the deductible amount of $250, the enrollee movesinto the initial coverage stage. While in the initial coverage limit stage of coverage, the Plan required a $47copayment for up to a 30 day supply of a Tier 3 drug purchased in 2019 from a standard retail pharmacy.Shingrix was on the Plan's 2019 formulary and was classified as a Tier 3 drug. Please refer to the Plan'sEvidence of Coverage (EOC) 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 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 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 a small volume nebulizer and related compressor are considered forcoverage when medically necessary to administer albuterol, arformoterol (Brovana), budesonide, cromolyn,formoterol, ipratropium, levalbuterol, metaproterenol or revefenacin for the management of obstructivepulmonary disease (Refer to Group 8 Codes in the LCD-related Policy Article for applicable diagnoses).You can find this rule at Noridian Healthcare Solutions, LLC, Local Coverage Determination (LCD) forNebulizers (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 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.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 Part D Plan enrollee may pay part of the cost of a covered drug during the initial coverage period as acopayment or coinsurance. The amount of the copayment or coinsurance will vary depending on the drug'stier and place of purchase. 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. The Planrequired a $45 copayment for up to a 90 day supply of a Tier 1 drug purchased in 2020 from a standardretail pharmacy. Lisinopril 20 mg and Atorvastatin 10 are on the Plan's 2020 formulary and classified asTier 1 drugs. Please refer to the Plan's Evidence of Coverage (EOC) 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 findabbreviated as 42 CFR with the corresponding section numbers, i.e., 42 CFR Sections 423.578, 423.100.An enrollee 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 Part D Plan enrollee may pay part of the cost of a covered drug during the initial coverage period as acopayment or coinsurance. The amount of the copayment or coinsurance will vary depending on the drug'stier and place of purchase. 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 ?423.120(a) and ?423.124; Medicare Prescription Drug Benefit Manual, Chapter 5, ?60.1.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 ?? 1860D-2(e)(1) and 1927(k)(2)(A)(i)-(iii); Medicare regulation 42 CFR?423.100 (Definition of a Part D drug); and Medicare Prescription Drug Benefit Manual, Chapter 6, ?? 10(Definition of a Part D drug) and 20 (Part D Exclusions).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, ?10.10 and Chapter 7, ?60.2.
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.The Medicare Coverage Gap Discount Program provides manufacturer discounts on brand name prescription drugs to Part D enrollees who have reached the coverage gap. These are enrollees who are in the donut hole and are not participating in the Extra Help program with Medicare. However, brand name drugs are only eligible for coverage under Part D if their manufacturers have signed agreements with the Centers for Medicare & Medicaid Services (CMS) to provide a discount on all of their brand name drugs. If a drug manufacturer does not sign a discount agreement with CMS, its brand name drugs will not be covered under Part D. Social Security Act, Sections 1860D-14A and 1860D-43.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 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. 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 rules set forth the requirements and limitations for payments by and on behalf of low-incomeMedicare beneficiaries who enroll in a Part D Plan. In general, an individual that meets requirements underMedicare's low income subsidy (LIS) rules is entitled to a reduction or elimination in the premium, areduction or elimination in the annual deductible, a reduction in cost-sharing for all covered Part D drugsbelow the out-of-pocket limit, and a reduction or elimination in cost-sharing for covered Part D drugsabove the out-of-pocket limit. The extent of reduction in these benefits depends on an individual's incomeand resources. Determinations of eligibility for subsidies are made either by the State (if the individualapplies with the Medicaid agency) or by the Social Security Administration (if the individual applies withthat agency). 42 CFR ?423.771 to 42 CFR ?423.782.According to enrollment records from the Centers for Medicare & Medicaid Services (CMS), you weredetermined to be entitled to a low-income subsidy (LIS), copay level 2, effective January 2020 throughcurrent. For copay level 2, in 2020 an enrollee is required to pay $1.30 for generic drugs and $3.90 forbrand drugs.An enrollee in a Part D plan may be subject to annual deductibles, coinsurance, and copayments (includingtiered copayments) specified by the plan. 42 CFR ?423.104.
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 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).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 (EOC).