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 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.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.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 find abbreviated 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-income Medicare beneficiaries who enroll in a Part D Plan. In general, an individual that meets requirements under Medicare's low income subsidy (LIS) rules is entitled to a reduction or elimination in the premium, a reduction or elimination in the annual deductible, a reduction in cost-sharing for all covered Part D drugs below the out-of-pocket limit, and a reduction or elimination in cost-sharing for covered Part D drugs above the out-of-pocket limit. The extent of reduction in these benefits depends on an individual's income and resources. Determinations of eligibility for subsidies are made either by the State (if the individual applies with the Medicaid agency) or by the Social Security Administration (if the individual applies with that agency). 42 CFR ?423.771 to 42 CFR ?423.782.According to enrollment records from the Centers for Medicare & Medicaid Services (CMS), you were determined to be entitled to a low-income subsidy (LIS), copay level 1, effective January 1 through December 31, 2020. For copay level 1, an enrollee is required to pay $8.95 for brand drugs.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 ?423.104.The Part D Plan contract states that Medicare provides extra help to pay prescription drug costs for people who have limited income and resources. If you qualify you will get help paying for any Medicare drug Plan's prescription copayments. 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 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, related compressor and FDA-approvedinhalation solutions are covered when medically necessary to administer acetylcysteine (J7608) forpersistent thick or tenacious pulmonary secretions (Reference the Diagnosis Codes that Support MedicalNecessity Group 7 Codes section of this rule for applicable diagnoses). You can find this rule at NoridianHealthcare Solutions, LLC, Local Coverage Determination (LCD) for Nebulizers (L33370) or CGSAdministrators, LLC, Local Coverage Determination (LCD) for Nebulizers (L33370) and Local CoverageArticle (LCA) for Nebulizers (A52466).Medicare law defines those drugs that may be covered under Part D. A covered prescription drug must beused for a medically accepted indication. A medically accepted indication means a use that is approvedby the Food and Drug Administration (FDA), or a use supported by one or more citations in the drugcompendia approved by Medicare. Medically accepted indications do not include uses in research or usesdescribed in peer-reviewed medical literature. Please refer to Social Security Act, Sections 1860D-2(e)(1)and 1927(k)(6); and 42 CFR Section 423.100.A Part D plan is permitted to use a number of different tools to manage its formulary. One of these tools isknown as prior authorization. This process requires an enrollee to obtain coverage approval for a drugbefore the drug is dispensed and covered by the plan. 70 Federal Register No. 18, issued January 28, 2005(Preamble to Final Rule).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. Please refer to the Plan's Evidence of Coverage.
Appeal type: unknown
Decision: unknown

Medicare rulesCitations 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.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 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 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 ?1860D-2(e)(2)(b) and 42 CFR ?423.100.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 ?410.30; Medicare Benefit Policy Manual, Chapter 15, ?50.5.1.Medicare Part B local policy states that prescription drugs used in immunosuppressive therapy are covered if I) they are prescribed following a transplant, II) the transplant met Medicare coverage criteria in effect with respect to the facility being approved for 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. CGS Administrators, LLC, Policy Article for Immunosuppressive Drugs (A52474).Medicare Part B local policy states that immunosuppressive drugs are covered only for the specific labeled indications and approval for marketing by the FDA (bp 102 c15, ?50.5.1). Parenteral Belatacept (Nulojix) is not proven to be safe when administered in the home setting and therefore will be denied as not medically necessary when provided in that setting. CGS Administrators, LLC, Local Coverage Determination for Immunosuppressive Drugs (L33824).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. The Plan requires prior approval (also called prior authorization) or formulary exception approval before covering some prescription drugs. If prior approval or formulary exception approval is not obtained, the Plan may not cover the drug. Please refer to the Plan's Evidence of Coverage.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).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 find abbreviated 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-income Medicare beneficiaries who enroll in a Part D Plan. In general, an individual that meets requirements under Medicare's low income subsidy (LIS) rules is entitled to a reduction or elimination in the premium, a reduction or elimination in the annual deductible, a reduction in cost-sharing for all covered Part D drugs below the out-of-pocket limit, and a reduction or elimination in cost-sharing for covered Part D drugs above the out-of-pocket limit. The extent of reduction in these benefits depends on an individual's income and resources. Determinations of eligibility for subsidies are made either by the State (if the individual applies with the Medicaid agency) or by the Social Security Administration (if the individual applies with that agency). 42 CFR ?423.771 to 42 CFR ?423.782.According to enrollment records from the Centers for Medicare & Medicaid Services (CMS), you were determined to be entitled to a low-income subsidy (LIS), copay level 4 effective January 1, 2019. For copay level 4, an enrollee is required to pay 15% coinsurance for all drugs until the enrollee reaches catastrophic coverage.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 ?423.104.The Part D Plan contract states that Medicare provides extra help to pay prescription drug costs for people who have limited income and resources. If you qualify you will get help paying for any Medicare drug Plan's prescription copayments. Please refer to the Plan's Evidence of Coverage.
Appeal type: unknown
Decision: unknown

Medicare rulesCitations 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 Part D law states that an enrollee is not allowed to request a tiering exception for a drug being covered under the non-formulary exception rules. 42 CFR Section 423.578(c)(4)(iii).The Part D Plan contract states that the Plan does not provide tiering exceptions for off-formulary drugs which it has approved coverage for through a formulary exception. 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 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 ?1860D-2(e)(2)(b) and 42 CFR ?423.100.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 ?410.30; Medicare Benefit Policy Manual, Chapter 15, ?50.5.1.Medicare Part B local policy states that prescription drugs used in immunosuppressive therapy are covered if I) they are prescribed following a transplant, II) the transplant met Medicare coverage criteria in effect with respect to the facility being approved for 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. CGS Administrators, LLC, Policy Article for Immunosuppressive Drugs (A52474).Medicare Part B local policy states that immunosuppressive drugs are covered only for the specific labeled indications and approval for marketing by the FDA (bp 102 c15, ?50.5.1). Parenteral Belatacept (Nulojix) is not proven to be safe when administered in the home setting and therefore will be denied as not medically necessary when provided in that setting. CGS Administrators, LLC, Local Coverage Determination for Immunosuppressive Drugs (L33824).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 contract states that its Part D drug coverage cannot cover a drug that would be covered under Medicare Part A or Part B. 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.
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 Medicare Part D law states that an enrollee is not allowed to request a tiering exception for a drug being covered under the non-formulary exception rules. 42 CFR Section 423.578(c)(4)(iii). 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.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 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.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 [please enter deductible amount $350, 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.During the initial coverage stage, the Plan will pay its share of the cost for covered drugs and the enrollee will pay the other part. The amount of the copayment or coinsurance will vary depending on the drug's tier and place of purchase. Jardiance is on Tier 3 of the Plan's 2019 formulary with a $47 copayment amount for up to a 30 day supply and a $141 copayment amount for up to a 90 day supply when purchased from a standard in-network retail pharmacy. Once total drug costs reach $3,820 the enrollee enters the coverage gap stage. Please refer to the Plan's Evidence of Coverage 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.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).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.