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.A Part D Plan must cover the prescription drug benefits described in its subscriber agreement. A Plan is permitted to manage its prescription drug benefit by establishing a formulary that identifies specific drugs that are covered through the Plan. A Plan is permitted to use a number of different tools or approaches to manage the coverage of drugs on 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).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 an external infusion pump is covered for administration of subcutaneous immune globulin if the subcutaneous immune globulin preparation is a pooled plasma derivative which is approved for the treatment of primary immune deficiency disease; and the patient has a diagnosis of primary immune deficiency disease. You can find this rule at CGS Administrators, LLC, Local Coverage Determination (LCD) for External Infusion Pumps (L33794) and (A52507) or Noridian Healthcare Solutions, LLC LCD for External Infusion Pumps (L33794) and (A52507).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.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.During the initial coverage phase of your benefit, you pay a $117 copayment for up to a 90 day supply of Tier 3 drugs obtained through preferred retail pharmacy. 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% (plus a portion of the dispensing fee) for your brand 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 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.  During the initial coverage phase of your benefit, you pay a $100 copayment for up to a 30 day supply of Tier 4 drugs obtained through in-network retail pharmacy. 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 cost of 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.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 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 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 ?1860D-2(e)(2)(B).  Medicare Part B pays for the rental or purchase of 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 410.38; Medicare Benefit Policy Manual, Chapter 15, ?110.3.  Medicare Part B local policy states that an external infusion pump is covered for administration of subcutaneous immune globulin if the subcutaneous immune globulin preparation is a pooled plasma derivative which is approved for the treatment of primary immune deficiency disease; and the patient has a diagnosis of primary immune deficiency disease. You can find this rule at CGS Administrators, LLC, Local Coverage Determination (LCD) for External Infusion Pumps (L33794).  A Part D plan is permitted to use a number of different tools to manage its formulary. One of these tools is known as prior authorization. This process requires an enrollee to obtain coverage approval for a drug before the drug is dispensed and covered by the plan. 70 Federal Register No. 18, issued January 28, 2005 (Preamble to Final Rule).  The Part D Plan can only cover drugs prescribed for a medically accepted indication. The Plan requires prior approval (also called prior authorization) before covering some prescription drugs. If prior approval is not obtained, the Plan may not cover the drug. Please refer to the Plan's Evidence of Coverage (EOC).
Appeal type: unknown
Decision: unknown

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 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 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 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 dornase alfa (J7639) to a beneficiary with cystic fibrosis (refer to the Group 9 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.  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 (EOC).
Appeal type: unknown
Decision: unknown

Citations used in this letter come from Section 42 of the Code of Federal Regulations which you will find abbreviated as 42 CFR with the corresponding section numbers, i.e., 42 CFR Sections 423.578, 423.100.  An enrollee in a Part D plan may be subject to annual deductibles, coinsurance, and copayments (including tiered copayments) specified by the plan. 42 CFR Section 423.104.  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.  A Part D Plan must cover the prescription drug benefits described in its subscriber agreement. A Plan is permitted to manage its prescription drug benefit by establishing a formulary that identifies specific drugs that are covered through the Plan. A Plan is permitted to use a number of different tools or approaches to manage the coverage of drugs on 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).   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 an external infusion pump is covered for administration of subcutaneous immune globulin if the subcutaneous immune globulin preparation is a pooled plasma derivative which is approved for the treatment of primary immune deficiency disease; and the patient has a diagnosis of primary immune deficiency disease. You can find this rule at CGS Administrators, LLC, Local Coverage Determination (LCD) for External Infusion Pumps (L33794) and (A52507) or Noridian Healthcare Solutions, LLC LCD for External Infusion Pumps (L33794) and (A52507).  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).
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 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 must grant an exception for a drug that is not on its formulary whenever it determines thatthe drug is medically necessary, consistent with the prescriber's statement, and that the drug would becovered but for the fact that it is not on the formulary. The statement must show that all of the covereddrugs on any tier of the plan's formulary for treatment of the enrollee's condition would not be as effectiveas 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 thedrug. The Plan will make an exception for coverage if it determines that the requested drug is medicallynecessary, consistent with the prescriber's statement. Please refer to the Plan's Evidence of Coverage (EOC).