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.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 includes only those prescription drugs that are approved by the FDA for safety and effectiveness. For a drug to be approved by the FDA, the manufacturer of the drug must file a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) with the FDA's Center for Drug Evaluation and Research (CDER). Medicare Part D does not pay for drugs that are not FDA approved prescription drugs. See Social Security Act, Sections 1860D-2(e)(1), 1927(k)(2), and 1927(b)(3).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. The Plan does not cover those drugs excluded from Medicare Part D coverage. If you purchase drugs that are excluded, you must pay for them yourself. Please refer to the Plan's Evidence of Coverage.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). The Medicare Part A hospice benefit covers only drugs as defined in section 1861(t) of the Act and which are used primarily for the relief of pain and symptom control related to the individual's terminal illness. 42 CFR Section 418.202(f). For prescription drugs to be covered under Part D when the enrollee has elected hospice, the drug must be for treatment of a condition that is completely unrelated to the terminal condition(s) or related conditions; in other words, the drug is unrelated to the terminal prognosis of the individual. Part D Payment for Drugs for Beneficiaries Enrolled in Hospice - Request for Comments, issued December 6, 2013, CMS.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).A Part D plan is permitted to use a number of different tools to manage its formulary, including prior authorization, step therapy and dose restriction, or quantity limits. 70 Federal Register No. 18, issued January 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. These additional requirements include prior authorization, step therapy and quantity limits. 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 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 will pay a share of the cost. Once the enrollee has met the deductible amount of $435, the enrollee moves into the initial coverage stage. 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. Shingrix Vaccine is 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 find abbreviated as 42 CFR with the corresponding section numbers, i.e., 42 CFR Sections 423.578, 423.100.Medicare law defines a covered prescription drug as a drug available only by prescription, approved by the FDA, used and sold in the United States, and used for a medically accepted indication. In general, for Part D drugs used in an anticancer chemotherapeutic regimen, a 'medically accepted indication' means a use that is:-Approved by the FDA, or -Supported by citation in one of several specified drug compendia, including the American Hospital Formulary Service-Drug Information (AHFS-DI), National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium, Thomson Micromedex DrugDex, and Clinical Pharmacology; or -Supported by clinical research that appears in the peer reviewed medical literature, specifically in journals or publications as specified by the Centers for Medicare and Medicaid Services (CMS). Social Security Act, Sections 1860D-2(e)(1) and 1861(t)(2)(B); and Medicare Benefit Policy Manual, Chapter 15, Section 50.4.5.A Part D plan is permitted to use a number of different tools to manage its formulary. One of these tools is known as prior authorization. This process requires an enrollee to obtain coverage approval for a drug before the drug is dispensed and covered by the plan. 70 Federal Register No. 18, issued January 28, 2005 (Preamble to Final Rule).The Part D Plan can only cover drugs prescribed for a medically accepted indication. The Plan requires prior approval (also called prior authorization) before covering some prescription drugs. If prior approval is not obtained, the Plan may not cover the drug. Please refer to the Plan's Evidence of Coverage (EOC).
Appeal type: unknown
Decision: unknown

A Part D plan is permitted to use a number of different tools to manage its formulary. One of these tools is known as prior authorization. This process requires an enrollee to obtain coverage approval for a drug before the drug is dispensed and covered by the plan. 70 Federal Register No. 18, issued January 28, 2005 (PreCitations 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. 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).amble to Final Rule).
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 a covered prescription drug as a drug available only by prescription, approved by the FDA, used and sold in the United States, and used for a medically accepted indication. In general, for Part D drugs used in an anticancer chemotherapeutic regimen, a 'medically accepted indication' means a use that is:-Approved by the FDA, or -Supported by citation in one of several specified drug compendia, including the American Hospital Formulary Service-Drug Information (AHFS-DI), National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium, Thomson Micromedex DrugDex, and Clinical Pharmacology; or -Supported by clinical research that appears in the peer reviewed medical literature, specifically in journals or publications as specified by the Centers for Medicare and Medicaid Services (CMS).Social Security Act, Sections 1860D-2(e)(1) and 1861(t)(2)(B); and Medicare Benefit Policy Manual, Chapter 15, Section 50.4.5.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 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.
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 acetylcysteine for persistent thick or tenacious pulmonary secretions (Refer to Group 7 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).
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). Coverage is available under Medicare Part B for prescription drugs used in immunosuppressive therapy furnished to a beneficiary who has received an organ transplant, provided the beneficiary receiving the drug was enrolled in Medicare Part A at the time of the organ transplant and the transplant was paid for by Medicare. 42 CFR Section 410.30; Medicare Benefit Policy Manual, Chapter 15, Section 50.5.1. A Part D plan is permitted to use a number of different tools to manage its formulary. One of these tools is known as prior authorization. This process requires an enrollee to obtain coverage approval for a drug before the drug is dispensed and covered by the plan. 70 Federal Register No. 18, issued January 28, 2005 (Preamble to Final Rule).The Part D Plan can only cover drugs prescribed for a medically accepted indication. The Plan requires prior approval (also called prior authorization) before covering some prescription drugs. If prior approval is not obtained, the Plan may not cover the drug. 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 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, Section 10.6. Compounded prescription drug products can contain (1) all Part D drug product components; (2) some Part D drug product components; or (3) no Part D drug product components. Only costs associated with those components that satisfy the definition of a Part D drug are allowable costs under Part D because the compounded products as a whole do not satisfy the definition of a Part D drug. The labor costs associated with mixing a compounded product that contains at least one Part D drug component can be included in the dispensing fee (as defined in 423.100). Medicare Prescription Drug Benefit Manual, Chapter 6, ?? 10 (Definition of a Part D drug).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 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 Sections 423.120(a) and 423.124; Medicare Prescription Drug Benefit Manual, Chapter 5, Section 60.1.Vaccines administered in a physician's office or by other non-network providers may be covered under the out-of-network access rules. A Part D enrollee may self-pay for the vaccine cost and its administration and submit a paper claim for reimbursement to his or her Part D sponsor. 42 CFR Section 423.124; Prescription Drug Benefit Manual, Chapter 5, Section 60.3.4.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 law says that Medicare Part B pays for the pneumonia virus vaccine and its administration. 42 CFR Section 410.57.The Part D Plan covers a number of vaccines (including vaccine administration) under the Part D benefit. The Plan's coverage of a vaccine depends on the type of vaccine, where the enrollee gets the vaccine and who administers the vaccine. Note that in some cases, an enrollee may receive a vaccine outside of the Plan's pharmacy network and may have to pay for the entire cost of the vaccine and its administration. The enrollee can then ask the Plan to pay its share of the vaccine costs. The Part D Plan contract states that the Plan cannot cover drugs that would be covered under Medicare Part A or Part B. For detailed information on how vaccines are reimbursed, 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. 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 the initial coverage stage. The enrollee stays in this stage until drug payments for the year plus the Plan's payments total $4,020. Once total drug costs reach this amount, the enrollee enters the coverage gap stage. During the coverage gap stage, the enrollee pays 25% for brand name drugs (plus a portion of the dispensing fee) or 25% for generic drugs. Once total out-of-pocket costs reach $6,350, the enrollee will qualify for catastrophic coverage. 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.A Part D Plan may establish tiered cost-sharing for drugs on its formulary. The Plan groups covered drugs into different cost-sharing levels or tiers. Medicare rules permit an enrollee to request a tiering exception to cover a higher cost-sharing tiered drug at a lower cost-sharing tier level so long as there is a drug on a lower cost-sharing tier that is approved for treating the same condition that the requested higher cost-sharing tiered drug is being used to treat. However, Medicare rules also permit a Plan to design its tiering exception procedures so that a Plan does not have to grant a tiering exception for brand or biologic drugs if the lower cost-sharing tier or tiers only contain generic drugs approved for treating the same condition. 42 CFR Sections 423.4; 423.578(a); 423.578(a)(6); 423.578(c)(3)(ii); Parts C & D Grievances, Organization/Coverage Determinations, and Appeals Guidance Manual, Section 40.5.1. The prescription drug benefit offered by the Part D Plan must meet criteria 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 contract allows an enrollee to request an exception to the Plan's cost-sharing tier to pay less for a drug. The prescriber must provide medical reasons to support an exception to the Plan's cost-sharing rules. The Plan will pay its share of the cost for covered drugs and the enrollee will pay the other part during the initial coverage stage. The enrollee stays in this stage until drug payments for the year, plus the Plan's payments, total $4,020. Once total drug costs reach this amount, the enrollee enters the coverage gap stage. During the coverage gap stage, the enrollee pays 25% of the price of brand name drugs (plus a portion of the dispensing fee) and 25% of the price of generic drugs. Please refer to the Plan's Evidence of Coverage (EOC).