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 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. 42 CFR Section 410.30; Medicare Benefit Policy Manual, Chapter 15, Section 50.5.1.Medicare Part B local policy states that prescription drugs used in immunosuppressive therapy are covered if I) they are prescribed following an organ transplant, II) the transplant met Medicare coverage criteria in effect with respect to the facility being approved for an organ transplant, III) the patient was enrolled in Medicare Part A at the time of the transplant, IV) the patient is enrolled in Medicare Part B at the time the drugs are dispensed and V) the drugs are furnished on or after the date of discharge. Assuming criteria I, II and III are met, a transplant is considered a covered transplant for purposes of this Medicare policy whether payment for the transplant was made by Medicare or another insurer. You can find this rule at Noridian Healthcare Solutions, LLC, Policy Article for Immunosuppressive Drugs (A52474) or CGS Administrators, LLC, Policy Article for Immunosuppressive Drugs (A52474).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 (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.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.A Part D drug does not include medical foods. A medical food is defined as a food that is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation, and that are not regulated as drugs under section 505 of the Federal Food, Drug, and Cosmetic Act. 42 CFR Section 423.100.The Part D 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 (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.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).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).Part D sponsors must coordinate benefits with SPAPs, other entities providing prescription drug coverage, beneficiaries, and others paying on the beneficiaries' behalf for a period of 3 years from the date on which the prescription for a covered Part D drug was filled. 42 CFR ?423.466(b).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. 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.
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 provide its enrollees with coverage of prescription drug benefits as per the Medicare rules and as approved by CMS. The prescription drug benefit offered by the Plan must meet certain requirements. The requirements that must be met pertain 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.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 must have enough contracted retail pharmacies in its network to ensure that enrollees have adequate access to covered prescription drugs. To ensure that beneficiaries have access to negotiated prices for covered Part D drugs, a Part D Plan must issue and reissue, as necessary, a card or other type of technology that may be used by enrollees. A Part D plan must require its network pharmacies to submit claims to the Part D Plan or its intermediary whenever the card issued by the Plan is presented or is on file at the pharmacy unless the enrollee specifically requests that a particular claim not be submitted to the Part D Plan. A Part D Plan should establish policies and procedures to ensure that claims are submitted online in real time and restrict the use of beneficiary-submitted paper claims to those situations in which online claims processing is not available to the beneficiary at the point-of-sale (such as out-of-network pharmacies). For cash purchases made at in-network pharmacies an enrollee will be responsible for the difference between the cash price and the Part D Plan's negotiated price. There may be situations when a cash purchase of a covered drug is reasonable. Social Security Act ?1860D-2(d); 42 CFR ?423.120(a); 42 CFR ?423.120(c)(1) and ?423.120(c)(3); Medicare Prescription Drug Benefit Manual, Chapter 14, Coordination of Benefits, ?50.4.3.
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.The Part D Plan can only cover drugs prescribed for a medically accepted indication. 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 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).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.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.Medicare rules state that the definition of a Part D drug includes medical supplies directly associated with the injection of insulin, including syringes, needles, alcohol swabs, gauze, and insulin injection delivery devices not otherwise covered under Medicare Part B, such as insulin pens, pen supplies, and needle-free syringes. Medicare Prescription Drug Benefit Manual, Chapter 6, Section 10.5.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.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).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).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.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.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 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 (EOC).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 (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 may establish tiered cost-sharing for drugs on its formulary. The Plan groups covered drugsinto different cost-sharing levels or tiers. Medicare rules permit an enrollee to request a tiering exception tocover a higher cost-sharing tiered drug at a lower cost-sharing tier level so long as there is a drug on alower cost-sharing tier that is approved for treating the same condition that the requested higher costsharingtiered drug is being used to treat. However, Medicare rules also permit a Plan to design its tieringexception procedures so that a Plan does not have to grant a tiering exception for brand or biologic drugs ifthe lower cost-sharing tier or tiers only contain generic drugs approved for treating the same condition. 42CFR 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 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.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.Each drug on the Plan's formulary is assigned to a cost-sharing tier. The Part D Plan contract allows an enrollee to request an exception to the Plan's cost-sharing structure to pay less for a drug. This is called a tiering exception. The prescriber must provide medical reasons to support a tiering exception. The Plan cannot grant a tiering exception for any drug in the specialty cost-sharing tier. The Plan cannot grant a tiering exception for a non-formulary drug being covered under an exception to the formulary. Please refer to the Plan's Evidence (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.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.Medicare rules state that the definition of a Part D drug includes medical supplies directly associated with the injection of insulin, including syringes, needles, alcohol swabs, gauze, and insulin injection delivery devices not otherwise covered under Medicare Part B, such as insulin pens, pen supplies, and needle-free syringes. Medicare Prescription Drug Benefit Manual, Chapter 6, Section 10.5.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.
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).