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 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. 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 [influenza / pneumonia] virus vaccine and its administration. 42 CFR Section 410.57.
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. 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 Plan does not provide tiering exceptions for brand or biologic drugs if the lower cost-sharing tier or tiers contain only generic drugs approved for treating the same condition. Please refer to the Plan's Evidence of Coverage (EOC).
Appeal type: unknown
Decision: unknown

Citations used in this letter come from Section 42 of the Code of Federal Regulations which you will find abbreviated as 42 CFR with the corresponding section numbers, i.e., 42 CFR Sections 423.578, 423.100. Medicare law defines those drugs that are eligible to be covered under the prescription drug benefit. Medicare law specifically excludes coverage for any drug for which payment would be available under Parts A or B of Medicare for that individual. Social Security Act, Section 1860D-2(e)(2)(B). Medicare Part B pays for durable medical equipment (DME) if the equipment is used in the patient's home or in an institution that is used as a home. Payment may be made for supplies necessary for the effective use of DME. Such supplies include those drugs and biologicals which must be put directly into the equipment in order to achieve the therapeutic benefit of the DME. 42 CFR Section 410.38(a); Medicare Benefit Policy Manual, Chapter 15, Section 110.3. Medicare Part B local policy states that a small volume nebulizer and related compressor are considered for coverage when medically necessary to administer albuterol, arformoterol (Brovana), budesonide, cromolyn, formoterol, ipratropium, levalbuterol, metaproterenol or revefenacin for the management of obstructive pulmonary disease (Refer to Group 8 Codes in the LCD-related Policy Article for applicable diagnoses). You can find this rule at Noridian Healthcare Solutions, LLC, Local Coverage Determination (LCD) 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. 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 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. Part D specifies that a drug prescribed to a Part D eligible individual cannot be considered a covered Part D drug if payment for such drug ...is available (or would be available but for the application of a deductible) under part A or B for that individual. CMS interprets this to mean that if payment could be available under Part A or Part B to the individual for such drug, then it will not be covered under Part D. Consequently, drugs covered under Parts A and B are considered available (and excluded from Part D) even if a beneficiary chooses not to pay premiums or if a beneficiary has enrolled in Part B but that coverage has not yet taken effect. Medicare Prescription Drug Benefit Manual, Chapter 6, Section 20.2.Medicare Part B local policy states that prescription drugs used in immunosuppressive therapy are covered if I) they are prescribed following a kidney transplant, II) the transplant met Medicare coverage criteria in effect with respect to the facility being approved for kidney 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).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).   Effective January 1, 2011, Medicare law requires that all drugs and biologicals used in the treatment of end stage renal disease (ESRD) be included in the ESRD prospective payment system (PPS) payment bundle, including drugs formerly paid under Medicare Part D. The law identifies categories of drugs that either are, or may be, ESRD-related. Drugs that are always considered ESRD-related include access management drugs, anemia management drugs, anti-infectives to treat site access infection, bone and mineral metabolism drugs and cellular management drugs. Social Security Act, Section 1881(b)(14); 42 CFR Section 413.171; Medicare Benefit Policy Manual, Chapter 11, Section 20.3; and 75 Federal Register No. 155, issued August 12, 2010 (Preamble to Final Rule). Effective February 20, 2018, Medicare law also provides coverage of related drugs under the PPS bundle for treatment of acute kidney injury (AKI). Medicare Benefit Policy Manual, Chapter 11, Section 100.6. For drugs that are always considered ESRD-related, it is important to note that the ESRD bundle includes all ESRD-related drugs and biologicals, regardless of whether or not these are furnished by a dialysis facility. Thus, effective January 1, 2011, any claims for a drug included in the five categories of drugs that are always considered renal dialysis drugs when furnished to an ESRD patient and used as specified in Table 4 of the Preamble to the Final Rule would not be payable under Part D when the beneficiary is an ESRD patient in dialysis, regardless of why the drug is being furnished. Medicare Program; End-Stage Renal Disease Prospective Payment System, 75 Fed. Reg. 49030, 49050 (August 12, 2010); CMS memo: Clarification of Exclusion of Part D Payment for Drugs included in the End-Stage Renal Disease Prospective Payment dated February 17, 2011. 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. 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 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 albuterol, arformoterol (Brovana), budesonide, cromolyn, formoterol, ipratropium, levalbuterol, metaproterenol or revefenacin for the management of obstructive pulmonary disease (Refer to Group 8 Codes in the LCD-related Policy Article for applicable diagnoses). You can find this rule at Noridian Healthcare Solutions, LLC, Local Coverage Determination (LCD) 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.  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. A Part D plan is permitted to use dose restriction to manage its formulary. This process limits the number of doses that may be dispensed during a specific period of time (usually per month). A plan must grant an exception to its dose restriction rules if it determines that the requested dosage is medically necessary, consistent with the prescriber's statement. The statement must show that the number of doses available under a dose restriction has been or is likely to be ineffective in treating the enrollee or adversely impacts the drug's effectiveness or patient compliance. 42 CFR Sections 423.578(a), 423.578(b), and 423.578(b)(B)(iii).  The Part D Plan may cover limited quantities of some drugs. However, the Plan allows an exception for a greater amount of the drug if it determines that the requested dosage 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. 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. 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 amount of the copayment or coinsurance will vary depending on the drug's tier and place of purchase. Invokana is on Tier 3 of the Plan's 2020 formulary with a $141 copayment for up to a 90 day supply. Once your total drug costs reach $4,020, you will reach your initial coverage limit. Your initial coverage limit is calculated by adding payments made by the Plan and you. After your total drug costs reach the initial coverage limit, you, or others on your behalf, will pay 25% of the price for your drugs until your total out-of-pocket costs reach $6,350, and you 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.  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 (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.  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. For detailed information on how vaccines are reimbursed, please refer to the Plan's Evidence of Coverage (EOC).