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).Medicare Part B provides coverage of intravenous immune globulin (IVIG) for the treatment of primary immune deficiency diseases (ICD-10 diagnosis codes D80.0, D80.2, D80.3, D80.4, D80.5, D80.6, D80.7, D81.0, D81.1, D81.2, D81.5, D81.6, D81.7, D81.89, D81.9, D82.0, D82.1, D82.4, D83.0, D83.1, D83.2, D83.8, D83.9, G11.3) in the home. IVIG is covered under this benefit when the patient has a diagnosed primary immune deficiency disease, it is administered in the home of a patient with a diagnosed primary immune deficiency disease, and the physician determines that administration of the derivative in the patient's home is medically appropriate. Medicare Benefit Policy Manual, Chapter 15, Section 50.6; Cigna Government Services Article for Intravenous Immune Globulin (A52509). National Government Services Article for Intravenous Immune Globulin (A52509). Noridian Administrative Services Article for Intravenous Immune Globulin (A52509).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.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.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.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. 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. You can find this rule at Noridian Healthcare Solutions, LLC, Local Coverage Determination (LCD) for Nebulizers (L33370) or CGS Administrators, LLC, Local Coverage Determination (LCD) for Nebulizers (L33370) and Local Coverage Article (LCA) for Nebulizers (A52466). Medicare law defines those drugs that may be covered under Part D. A covered prescription drug must be used for a medically accepted indication. A medically accepted indication means a use that is approved by the Food and Drug Administration (FDA), or a use supported by one or more citations in the drug compendia approved by Medicare. Medically accepted indications do not include uses in research or uses described in peer-reviewed medical literature. Please refer to Social Security Act, Sections 1860D-2(e)(1) and 1927(k)(6); and 42 CFR Section 423.100. A Part D plan must grant an exception for a drug that is not on its formulary whenever it determines that the drug is medically necessary, consistent with the prescriber's statement, and that the drug would be covered but for the fact that it is not on the formulary. The statement must show that all of the covered drugs on any tier of the plan's formulary for treatment of the enrollee's condition would not be as effective as the non-formulary drug or would have adverse effects for the enrollee. 42 CFR Section 423.578(b). The Part D Plan contract states that the Plan cannot cover drugs that would be covered under Medicare Part A or Part B. If a drug is not on the formulary (drug list), an enrollee can ask the Plan to make an exception and cover the drug. The Plan will make an exception for coverage if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. Please refer to the Plan's Evidence of Coverage (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 beused 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 thePlan'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 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.  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 does not include over-the-counter (OTC) products. OTC drug products are those drugs that are available to consumers without a prescription. The FDA's Center for Drug Evaluation and Research (CDER) is the entity that oversees the designation and marketing of OTC drugs. Medicare Part D does not pay for OTC drug products. See rules noted above; and Medicare Prescription Drug Benefit Manual, Chapter 6, Section 10.10 and Chapter 7, Section 60.2.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 Part D Plan limits coverage to drugs covered under Medicare Part D.
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).
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 does not include over-the-counter (OTC) products. OTC drug products are those drugs that are available to consumers without a prescription. The FDA's Center for Drug Evaluation and Research (CDER) is the entity that oversees the designation and marketing of OTC drugs. Medicare Part D does not pay for OTC drug products. See rules noted above; and Medicare Prescription Drug Benefit Manual, Chapter 6, Section 10.10 and Chapter 7, Section 60.2.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).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.The Plan will generally cover prescriptions only if they are filled at a Plan network pharmacy. Prescriptions filled at an out-of-network pharmacy may only be covered when a network pharmacy is not available. The Plan will typically cover prescriptions filled at an out-of-network pharmacy when the prescription is for a medical emergency or urgent care, when there are no 24-hour network pharmacies within a reasonable driving distance or when the prescription is for a drug that is out of stock at an accessible network pharmacy. 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 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).  Formulary use includes the application of cost utilization tools, including step-therapy, dosage limitations and therapeutic substitution. 42 CFR Section 423.578(b)(iii). The exceptions process extends to coverage requests to set aside cost utilization rules for non-formulary drugs. A Part D plan must grant an exception 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 subject to cost utilization rules. 42 CFR Section 423.578(b). 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 drug at issue, or would have adverse effects for the enrollee. Parts C & D Enrollee Grievances, Organization/Coverage Determinations, and Appeals Guidance Manual, Section 40.5.3.  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. A Plan must grant an exception to prior approval rules 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 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 Section 423.578(b).If a drug is not on the formulary (drug list), an enrollee can ask the Plan to make an exception and cover the drug. The Plan will make an exception for coverage if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. Please refer to the Plan's Evidence of Coverage (EOC).