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Citations used in this letter come from Section 42 of the Code of Federal Regulations which you will findabbreviated as 42 CFR with the corresponding section numbers, i.e., 42 CFR Sections 423.578, 423.100.A Part D Plan may establish tiered cost-sharing for drugs on its formulary. The Plan groups covered drugsinto different cost-sharing levels or tiers. Medicare rules permit an enrollee to request a tiering exception tocover a higher cost-sharing tiered drug at a lower cost-sharing tier level so long as there is a drug on alower cost-sharing tier that is approved for treating the same condition that the requested higher costsharingtiered drug is being used to treat. However, Medicare rules also permit a Plan to design its tieringexception procedures so that a Plan does not have to grant a tiering exception for brand or biologic drugs ifthe lower cost-sharing tier or tiers only contain generic drugs approved for treating the same condition. 42CFR Sections 423.4; 423.578(a); 423.578(a)(6); 423.578(c)(3)(ii); Parts C & D Enrollee Grievances,Organization/Coverage Determinations, and Appeals Guidance Manual, Section 40.5.1.The prescription drug benefit offered by the Part D Plan must meet criteria requirements pertaining to theannual deductible, the initial coverage limit, the coverage gap and catastrophic coverage. For the initialcoverage limit, the rules provide for a benefit of shared coverage of costs between the enrollee and Plan.An enrollee in a Part D Plan may be subject to annual deductibles, coinsurance and copayments (includingtiered copayments) specified by the Plan. 42 CFR Section 423.104.Each drug on the Plan's formulary is assigned to a cost-sharing tier. The Part D Plan contract allows anenrollee to request an exception to the Plan's cost-sharing structure to pay less for a drug. This is called atiering exception. The prescriber must provide medical reasons to support a tiering exception. The Plancannot grant a tiering exception for any drug in the specialty cost-sharing tier. The Plan cannot grant atiering exception for a non-formulary drug being covered under an exception to the formulary. Please referto the Plan's Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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.If a plan sponsor does not have all of the information it needs to make a decision, the plan sponsor should make reasonable and diligent efforts to obtain the missing information within the standard timeframe for making a decision and notifying the enrollee of the decision (i.e., within 72 hours after receiving the request or physician's or other prescriber's supporting statement). When a plan sponsor could acquire missing information, such as a National Drug Code (NDC) number, by contacting the enrollee's pharmacist, physician, or other prescriber, it should do so instead of relying on the enrollee to provide the information. Prescription Drug Benefit Manual, Chapter 18, ?30.3.2.Occasionally, a plan sponsor will have enough information to determine that a reimbursement request is payable, but not enough to determine the exact amount. When this situation occurs, the plan sponsor could issue a favorable decision within the 72-hour timeframe (the plan sponsor is not required to say how much the payment will be in its notice to the enrollee), and utilize the remainder of the 30-day payment period described in ??40.2 and 130.1 of this chapter to determine how much the enrollee should be reimbursed and make payment. If a plan sponsor chooses to send the payment within the 30-day timeframe after notifying the enrollee of the favorable decision within the 72-hour timeframe, the initial notice to the enrollee must include the following information: 1) the plan sponsor is approving the request; 2) payment will be sent within 30 days after the request was received; 3) if the enrollee does not agree with the amount received, he or she can request an appeal with the plan sponsor; and 4) briefly explain that the member may not receive the entire amount he or she paid out-of-pocket because certain items (e.g., co-payment amounts) are not reimbursable, and include a brief summary of items that are generally subtracted. Prescription Drug Benefit Manual, Chapter 18, ?30.3.2.Medicare Part D does not cover a (1) drug used for anorexia, weight loss or weight gain; (2) drug used to promote fertility; (3) drug used for cosmetic purposes or to promote hair growth; (4) drug used for the symptomatic relief of coughs and colds; (5) prescription vitamin and mineral product; (6) non-prescription or over-the-counter drug; (7) drug subject to manufacturer tying arrangements; and (8) drug used to treat sexual or erectile dysfunction or (9) sexual or erectile dysfunction drug used to treat a condition other than sexual or erectile dysfunction for which the drug has not been approved by the FDA. Social Security Act, Sections 1860D-2(e)(2)(A), 1927(d)(2) and 1927(d)(4)(C).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. The Part D Plan does not cover those drugs excluded from Medicare Part D coverage. In addition, the Plan does not offer supplemental (additional) coverage for it. If you purchase drugs that are excluded, you must pay for them yourself. Please refer to the Plan's Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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.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 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.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 $435, 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. Tenivac is on the Plan's 2020 formulary and was classified as a Tier 3 drug. Please refer to the Plan's Evidence of Coverage (EOC) and formulary.

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 step therapy to manage its formulary. This is the process of beginning drug therapy for a medical condition with preferred (or more cost-effective) non-formulary drug alternative(s) and progressing to other drug therapies only as necessary. A Plan must grant an exception to its step therapy rules if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. The statement must show that the step therapy drug(s): has been ineffective in the treatment of the enrollee's disease or medical condition or, based on both sound clinical evidence and medical and scientific evidence and the known relevant physical or mental characteristics of the enrollee and known characteristics of the drug regimen, is likely to be ineffective or adversely affect the drug's effectiveness or patient compliance; or has caused or based on sound clinical evidence and medical and scientific evidence, is likely to cause an adverse reaction or other harm to the enrollee. 42 CFR Section 423.578(b)(5)(ii).The Plan requires certain drugs be tried first before it will cover the requested drug. This is called step therapy. However, the Part D Plan contract allows an enrollee to request an exception. The Plan will cover the requested drug without requiring step therapy 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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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.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.

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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. Treprostinil inhalation solution (J7686) and Iloprost (Q4074) are considered for coverage when all the following 1-3 are met:The beneficiary has a diagnosis of pulmonary artery hypertension (refer to the Group 11 Codes in the LCD-related Policy Article for applicable diagnoses); andThe pulmonary hypertension is not secondary to pulmonary venous hypertension (e.g., left sided atrial or ventricular disease, left sided valvular heart disease, etc.) or disorders of the respiratory system (e.g., chronic obstructive pulmonary disease, interstitial lung disease, obstructive sleep apnea or other sleep disordered breathing, alveolar hypoventilation disorders, etc.); andThe beneficiary has primary pulmonary hypertension or pulmonary hypertension which is secondary to one of the following conditions: connective tissue disease, thromboembolic disease of the pulmonary arteries, human immunodeficiency virus (HIV) infection, cirrhosis, anorexigens or congenital left to right shunts. If these conditions are present, the following criteria (a-d) must be met:The pulmonary hypertension has progressed despite maximal medical and/or surgical treatment of the identified condition; andThe mean pulmonary artery pressure is > 25 mm Hg at rest or > 30 mm Hg with exertion; andThe beneficiary has significant symptoms from the pulmonary hypertension (i.e., severe dyspnea on exertion, and either fatigability, angina, or syncope); andTreatment with oral calcium channel blocking agents has been tried and failed, or has been considered.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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 plan may exclude from qualified prescription drug coverage any covered part D drug--(A) for which payment would not be made if Section 1862(a) applied to this part; or (B) which is not prescribed in accordance with the plan or this part. Such exclusions are determinations subject to reconsideration and appeal pursuant to subsections (g) and (h), respectively, of Section 1860D-4. Social Security Act, Section 1860D-2(e)(3)(A). Notwithstanding any other provision of this title, no payment may be made under part A or part B for any expenses incurred for items or services--(1)(A) which, except for items and services described in a succeeding subparagraph, are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member,... Social Security Act, Section 1862(a)(1)(A). The following actions by a Part D plan are coverage determinations: (1) A decision not to provide or pay for a Part D drug (including a decision not to pay because the drug is not on the plan's formulary, because the drug is determined not to be medically necessary, because the drug is furnished by an out-of-network pharmacy, or because the Part D plan sponsor determines that the drug is otherwise excludable under section 1862(a) of the Act if applied to Medicare Part D) that the enrollee believes may be covered by the plan. 42 CFR Section 423.566(b)(1).Each Part D plan must have established, for covered Part D drugs furnished through a Part D plan, a drug utilization management program, quality assurance measures and systems, and a Medication Therapy Management Program (MTMP). 42 CFR Section 423.153(a). A Part D plan must have established a reasonable and appropriate drug utilization management program that addresses the following: incentives to reduce costs when medically appropriate; policies and systems to assist in preventing over-utilization and under-utilization of prescribed medications; providing CMS with information concerning the procedures and performance of its drug utilization management program, according to guidelines specified by CMS. 42 CFR Section 423.153(b). A Part D plan must have established quality assurance measures and systems to reduce medication errors and adverse drug interactions and improve medication use that include all of the following--(1) Representation that network providers are required to comply with minimum standards for pharmacy practice as established by the States. (2) Concurrent drug utilization review systems, policies, and procedures designed to ensure that a review of the prescribed drug therapy is performed before each prescription is dispensed to an enrollee in a sponsor's Part D plan, typically at the point-of-sale or point of distribution. The review must include, but not be limited to: Screening for potential drug therapy problems due to therapeutic duplication; Age/gender-related contraindications; Over-utilization and under-utilization; Drug-drug interactions; Incorrect drug dosage or duration of drug therapy; Drug-allergy contraindications; Clinical abuse/misuse. 42 CFR Section 423.153(c).A Part D sponsor must have established a MTMP that--(i) Is designed to ensure that covered Part D drugs prescribed to targeted beneficiaries described in paragraph (d)(2) of this section are appropriately used to optimize therapeutic outcomes through improved medication use. (ii) Is designed to reduce the risk of adverse events, including adverse drug interactions, for targeted beneficiaries described in paragraph (d)(2) of this section. (iii) May be furnished by a pharmacist or other qualified provider. (iv) May distinguish between services in ambulatory and institutional settings. (v) Must enroll targeted beneficiaries using an opt-out method of enrollment only. (vi) Must target beneficiaries for enrollment in the MTMP at least quarterly during each plan year. (vii) Must offer a minimum level of medication therapy management services for each beneficiary enrolled in the MTMP... 42 CFR Section 423.153(d). In accordance with Section 1860D-2(e)(3) of the Act, a Part D plan may exclude from qualified prescription drug coverage any Part D drug: 1) For which payment would not be made if items and services are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member (except for Part D vaccines); or 2) Which is not prescribed in accordance with the Part D plan. Such exclusions are coverage determinations subject to reconsideration and appeal. Medicare Prescription Drug Benefit Manual, Chapter 6, Section 20.4.The Plan conducts drug use reviews for enrollees to help make sure that they are getting safe and appropriate care. These reviews are especially important for enrollees who have more than one provider who prescribes their drugs. The Plan does a review each time an enrollee fills a prescription. During these reviews, the Plan looks for potential problems such as possible medication errors, drugs that may not be necessary because the enrollee is taking another drug to treat the same medical condition, drugs that may not be safe or appropriate due to the enrollee's age or gender, certain combinations of drugs that could harm the enrollee if taken at the same time, prescriptions written for drugs that have ingredients the enrollee is allergic to, or possible errors in the amount (dosage) of a drug the enrollee is taking. Please refer to Chapter 3 of the Plan's Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 for persistent thick or tenacious pulmonary secretions (refer to the Group 7 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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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.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. Diclofenac 1% Gel is on the Plan's 2020 Formulary and classified as a Tier 3 drug. 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 $435, the enrollee moves into the initial coverage stage.The Part D Plan enrollee may pay part of the cost of a covered drug during the initial coverage period as a copayment or coinsurance. The amount of the copayment or coinsurance will vary depending on the drug's tier and place of purchase. The Plan required a $47 copayment for up to a 30 day supply of a Tier 3 drug purchased in 2020 from a preferred retail pharmacy. Please refer to the Plan's Evidence of Coverage (EOC) and formulary.

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

unknown

Citations used in this letter come from Section 42 of the Code of Federal Regulations which you will find abbreviated as 42 CFR with the corresponding section numbers, i.e., 42 CFR Sections 423.578, 423.100.Medicare law defines those drugs that are eligible to be covered under the prescription drug benefit. Medicare law specifically excludes coverage for any drug for which payment would be available under Parts A or B of Medicare for that individual. Social Security Act, Section 1860D-2(e)(2)(B).Coverage is available under Medicare Part B for prescription drugs used in immunosuppressive therapy furnished to a beneficiary who has received an organ transplant, provided the beneficiary receiving the drug was enrolled in Medicare Part A at the time of the organ transplant. 42 CFR Section 410.30; Medicare Benefit Policy Manual, Chapter 15, Section 50.5.1.Medicare Part B local policy states that prescription drugs used in immunosuppressive therapy are covered if I) they are prescribed following a [Type of organ for transplant] transplant, II) the transplant met Medicare coverage criteria in effect with respect to the facility being approved for [Type of organ for transplant] 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).A Part D plan is permitted to use a number of different tools to manage its formulary, including prior authorization, step therapy and dose restriction, or quantity limits. 70 Federal Register No. 18, issued January 28, 2005 (Preamble to Final Rule); 42 CFR Section 423.578(b).For certain drugs, the Part D Plan has additional requirements for coverage or limits on its coverage. These additional requirements include prior authorization, step therapy and quantity limits. Please refer to the Plan's Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

unknown

Citations used in this letter come from Section 42 of the Code of Federal Regulations which you will find abbreviated as 42 CFR with the corresponding section numbers, i.e., 42 CFR Sections 423.578, 423.100.For a drug to be covered under Medicare Part D, it must meet the definition of a Part D drug. The Social Security Act generally defines a Part D drug as a drug product that meets the following requirements:-It requires a prescription for dispensing; and-It is approved by the Food and Drug Administration (FDA) for safety and effectiveness; and-It is prescribed for a medically accepted indication; and-It is not otherwise excluded from coverage under Part D law and rules.See Social Security Act, Sections 1860D-2(e)(1) and 1927(k)(2)(A)(i)-(iii); and Medicare Prescription Drug Benefit Manual, Chapter 6, Section 10.1.The definition of a Part D drug includes only those prescription drugs that are approved by the FDA for safety and effectiveness. For a drug to be approved by the FDA, the manufacturer of the drug must file a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) with the FDA's Center for Drug Evaluation and Research (CDER). Medicare Part D does not pay for drugs that are not FDA approved prescription drugs. See Social Security Act, Sections 1860D-2(e)(1), 1927(k)(2), and 1927(b)(3).The Plan does not cover drugs/items excluded from Medicare Part D coverage. If you purchase drugs/items that are excluded, you must pay for them yourself. Please refer to the Plan's Evidence of Coverage (EOC).Medicare law defines those drugs that may be covered under Part D. A covered prescription drug must be used for a medically accepted indication. A medically accepted indication means a use that is approved by the Food and Drug Administration (FDA), or a use supported by one or more citations in the drug compendia approved by Medicare. Medically accepted indications do not include uses in research or uses described in peer-reviewed medical literature. Please refer to Social Security Act, Sections 1860D-2(e)(1) and 1927(k)(6); and 42 CFR Section 423.100.A Part D drug must be used for a medically accepted indication that facilitates the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member (except for Part D vaccines). Consequently, if a drug works on medical equipment or devices and is not used for a medically accepted indication of therapeutic value on the body, it cannot satisfy the definition of a Part D drug. 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.A Part D plan is permitted to use a number of different tools to manage its formulary, including prior authorization, step therapy and dose restriction, or quantity limits. 70 Federal Register No. 18, issued January 28, 2005 (Preamble to Final Rule); 42 CFR Section 423.578(b).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. Please refer to the Plan's Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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.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).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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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). The Medicare Part A hospice benefit covers only drugs as defined in section 1861(t) of the Act and which are used primarily for the relief of pain and symptom control related to the individual's terminal illness. 42 CFR Section 418.202(f). For prescription drugs to be covered under Part D when the enrollee has elected hospice, the drug must be for treatment of a condition that is completely unrelated to the terminal condition(s) or related conditions; in other words, the drug is unrelated to the terminal prognosis of the individual. Part D Payment for Drugs for Beneficiaries Enrolled in Hospice - Request for Comments, issued December 6, 2013, CMS.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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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).The Medicare Part A hospice benefit covers only drugs as defined in section 1861(t) of the Act and which are used primarily for the relief of pain and symptom control related to the individual's terminal illness. 42 CFR Section 418.202(f).For prescription drugs to be covered under Part D when the enrollee has elected hospice, the drug must be for treatment of a condition that is completely unrelated to the terminal condition(s) or related conditions; in other words, the drug is unrelated to the terminal prognosis of the individual. Part D Payment for Drugs for Beneficiaries Enrolled in Hospice - Request for Comments, issued December 6, 2013, CMS.A Part D plan is permitted to use a number of different tools to manage its formulary, including prior authorization, step therapy and dose restriction, or quantity limits. 70 Federal Register No. 18, issued January 28, 2005 (Preamble to Final Rule); 42 CFR Section 423.578(b).The Part D Plan contract states that the Plan cannot cover a drug that would be covered under Medicare Part A or Part B. For certain drugs, the Part D Plan has additional requirements for coverage or limits on its coverage. These additional requirements include prior authorization, step therapy and quantity limits. Please refer to the Plan's Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 coverage includes oral anti-cancer drugs. For an oral anti-cancer drug to be covered, all of the following criteria (1-4) must be met (Medicare Claims Processing Manual, Chapter 17, Section 80.1):1. It is a drug or biological that has been approved by the Food and Drug Administration (FDA), and 2. It has the same active ingredients as a non-self-administrable anti-cancer chemotherapeutic drug or biological that is covered when furnished incident to a practitioner's service. The oral anti-cancer drug and the non-self-administrable drug must have the same chemical/generic name as indicated by the FDA's Approved Drug Products (Orange Book), Physician's Desk Reference (PDR), or an authoritative drug compendium, or it is a prodrug which, when ingested, is metabolized into the same active ingredient which is found in the non-self-administrable form of the drug, and 3. It is used for the same anti-cancer chemotherapeutic indications, including unlabeled or off-label uses, as the non-self-administrable form of the drug, and4. It is prescribed by a practitioner licensed under state law to prescribe such drugs as anti-cancer chemotherapeutic agents. If criteria 1-4 are not met, the drug will be denied as non-covered. A claim denied for the reason that the diagnosis does not fall in the covered diagnosis section of the Policy Article, titled ICD-10 Codes that Support Medical Necessity, will receive a statutory denial as non-covered, but may be covered at appeal if and only if it can be shown to be allowed under Medicare Benefit Policy Manual, Chapter 15, Section 50 and under the Social Security Act, Section 1861(s)(Q). Medicare Benefit Policy Manual, Chapter 15, Section 50.5.3; CGS Administrators, LLC, Local Coverage Article for Oral Anticancer Drugs (A52479) or Noridian Healthcare Solutions, LLC, Local Coverage Article for Oral Anticancer Drugs (A52479).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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 Part D Plan enrollee may pay part of the cost of a covered drug during the initial coverage period as a copayment or coinsurance. The amount of the copayment or coinsurance will vary depending on the drug's tier and place of purchase. 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. The Plan required a 37% for up to a 90 days day supply of a Tier 4 drug purchased in 2020 from a preferred pharmacy. Paroxetine HCL ER was on the Plan's 2020 formulary and was classified as a Tier 4 drug. Please refer to the Plan's Evidence of Coverage (EOC) and formulary.

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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.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 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.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 $200, 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. Vaqta is on the Plan's 2020 formulary and was classified as a Tier 3 drug. Please refer to the Plan's Evidence of Coverage (EOC) and formulary.

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 coverage includes oral anti-cancer drugs. For an oral anti-cancer drug to be covered, all of the following criteria (1-4) must be met (Medicare Claims Processing Manual, Chapter 17, Section 80.1):1. It is a drug or biological that has been approved by the Food and Drug Administration (FDA), and 2. It has the same active ingredients as a non-self-administrable anti-cancer chemotherapeutic drug or biological that is covered when furnished incident to a practitioner's service. The oral anti-cancer drug and the non-self-administrable drug must have the same chemical/generic name as indicated by the FDA's Approved Drug Products (Orange Book), Physician's Desk Reference (PDR), or an authoritative drug compendium, or it is a prodrug which, when ingested, is metabolized into the same active ingredient which is found in the non-self-administrable form of the drug, and 3. It is used for the same anti-cancer chemotherapeutic indications, including unlabeled or off-label uses, as the non-self-administrable form of the drug, and 4. It is prescribed by a practitioner licensed under state law to prescribe such drugs as anti-cancer chemotherapeutic agents.If criteria 1-4 are not met, the drug will be denied as non-covered. A claim denied for the reason that the diagnosis does not fall in the covered diagnosis section of the Policy Article, titled ICD-10 Codes that Support Medical Necessity, will receive a statutory denial as non-covered, but may be covered at appeal if and only if it can be shown to be allowed under Medicare Benefit Policy Manual, Chapter 15, Section 50 and under the Social Security Act, Section 1861(s)(Q). Medicare Benefit Policy Manual, Chapter 15, Section 50.5.3; CGS Administrators, LLC, Local Coverage Article for Oral Anticancer Drugs (A52479) or Noridian Healthcare Solutions, LLC, Local Coverage Article for Oral Anticancer Drugs (A52479).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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 Part D Plan enrollee may pay part of the cost of a covered drug during the initial coverage period as a copayment or coinsurance. The amount of the copayment or coinsurance will vary depending on the drug's tier and place of purchase. 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. The Plan required a $40 copayment amount a Tier 3 drug purchased in 2020 from a preferred retail pharmacy. Boostrix TDAP was on the Plan's 2020 formulary and was classified as a Tier 3 drug. Please refer to the Plan's Evidence of Coverage (EOC) and formulary.

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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).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).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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 step therapy to manage its formulary. This is the process of beginning drug therapy for a medical condition with preferred (or more cost-effective) non-formulary drug alternative(s) and progressing to other drug therapies only as necessary. A plan must grant an exception to its step therapy rules if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. The statement must show that the step therapy drug(s): has been ineffective in the treatment of the enrollee's disease or medical condition or, based on both sound clinical evidence and medical and scientific evidence and the known relevant physical or mental characteristics of the enrollee and known characteristics of the drug regimen, is likely to be ineffective or adversely affect the drug's effectiveness or patient compliance; or has caused or based on sound clinical evidence and medical and scientific evidence, is likely to cause an adverse reaction or other harm to the enrollee. 42 CFR Section 423.578(b)(5)(ii).The Plan requires certain drugs be tried first before it will cover the requested drug. This is called step therapy. However, the Part D Plan contract allows an enrollee to request an exception. The Plan will cover the requested drug without requiring step therapy 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).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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 Part D Plan enrollee may pay part of the cost of a covered drug during the initial coverage period as a copayment or coinsurance. The amount of the copayment or coinsurance will vary depending on the drug's tier and place of purchase. 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. The Plan required a $36 for up to a 90 day supply of a Tier 2 drug purchased in 2020 from a standard retail pharmacy. Hydroxychloroquine 200 mg is on the Plan's 2020 formulary and classified as a Tier 2 drug. Please refer to the Plan's Evidence of Coverage (EOC) and formulary.

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 Part D Plan enrollee may pay part of the cost of a covered drug during the initial coverage period as a copayment or coinsurance. The amount of the copayment or coinsurance will vary depending on the drug's tier and place of purchase. 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. The Plan required a $0 copayment for up to a 90 day supply of a Tier 1 and Tier 2 drug purchased in 2020 from a preferred network pharmacy. The Plan also required a $225 copayment for up to a 90 day supply of a Tier 4 drug purchased in 2020 from a preferred network pharmacy. Amlodipine Besylate 10 mg, Glipizide ER 10 mg, Simvastatin 20 mg, Valsartan-HCTZ 320-25 mg and Warfarin Sodium 7.5 mg are on the Plan's 2020 formulary and classified as Tier 1 drugs. Letrozole 2.5 mg is on the Plan's 2020 formulary and classified as a Tier 2 drug. Kombiglyze XR 2.5-2,000 mg is on the Plan's 2020 formulary and classified as a Tier 4 drug. Please refer to the Plan's Evidence of Coverage (EOC) and formulary.

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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, including prior authorization, step therapy and dose restriction, or quantity limits. 70 Federal Register No. 18, issued January 28, 2005 (Preamble to Final Rule); 42 CFR Section 423.578(b).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).For certain drugs, the Part D Plan has additional requirements for coverage or limits on its coverage. These additional requirements include prior authorization, step therapy and quantity limits. 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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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.The Part D Plan enrollee may pay part of the cost of a covered drug during the initial coverage period as a copayment or coinsurance. The amount of the copayment or coinsurance will vary depending on the drug's tier and place of purchase. additional reimbursement for Cyclobenzaprine HCL 10 mg tab purchased September 8, 2020 from Rite Aid Pharmacy is on Tier [X] with a [$XX copayment] OR [X% coinsurance]. Please refer to the Plan's Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 has the authority to establish a formulary to designate specific drugs that will be available for coverage and the ability to have a cost-sharing structure other than the standard Medicare drug benefit. An enrollee may be subject to annual deductibles, coinsurance, and copayments (including tiered copayments). 42 CFR Section 423.104.

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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).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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 step therapy to manage its formulary. This is the process of beginning drug therapy for a medical condition with preferred (or more cost-effective) non-formulary drug alternative(s) and progressing to other drug therapies only as necessary. A plan must grant an exception to its step therapy rules if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. The statement must show that the step therapy drug(s): has been ineffective in the treatment of the enrollee's disease or medical condition or, based on both sound clinical evidence and medical and scientific evidence and the known relevant physical or mental characteristics of the enrollee and known characteristics of the drug regimen, is likely to be ineffective or adversely affect the drug's effectiveness or patient compliance; or has caused or based on sound clinical evidence and medical and scientific evidence, is likely to cause an adverse reaction or other harm to the enrollee. 42 CFR Section 423.578(b)(5)(ii).The Plan requires certain drugs be tried first before it will cover the requested drug. This is called step therapy. However, the Part D Plan contract allows an enrollee to request an exception. The Plan will cover the requested drug without requiring step therapy 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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 $250, 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. Estradiol 0.01% Cream purchased on April 29, 2020 was on the Plan's 2020 formulary and was classified as a Tier 3 drug. Please refer to the Plan's Evidence of Coverage (EOC) and formulary.

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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, Section 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 Section 410.38; Medicare Benefit Policy Manual, Chapter 15, Section 110.3. Medicare Part B covers an external infusion pump for the administration of other drugs if either of the following sets of criteria (1) or (2) are met:Criteria set 1:- Parenteral administration of the drug in the home is reasonable and necessary. - An infusion pump is necessary to safely administer the drug - The drug is administered by a prolonged infusion of at least 8 hours because of proven improved clinical efficacy - The therapeutic regimen is proven or generally accepted to have significant advantages over intermittent bolus administration regimens or infusions lasting less than 8 hoursCriteria set 2:- Parenteral administration of the drug in the home is reasonable and necessary - An infusion pump is necessary to safely administer the drug - The drug is administered by intermittent infusion (each episode of infusion lasting less than 8 hours) which does not require the beneficiary to return to the physician's office prior to the beginning of each infusion- Systemic toxicity or adverse effects of the drug are unavoidable without infusing it at a strictly controlled rate as indicated in the Physicians Desk Reference, or the U.S. Pharmacopeia Drug InformationI. Levodopa-Carbidopa enteral suspension (J7340) is only covered for treatment of motor fluctuations in beneficiaries with Parkinson's disease (PD), who meet all of the following criteria (See Diagnosis Codes Group 4 that Support Medical Necessity section below):1. The beneficiary has been evaluated by a neurologist, who prescribes and manages treatment with the drug; and, 2. Idiopathic PD based on the presence of bradykinesia and at least one other cardinal PD features (tremor, rigidity, postural instability); and, 3. L-dopa responsive with clearly defined On periods; and, 4. Persistent motor complications with disabling Off periods for a minimum of 3 hours/day, despite medical therapy with levodopa-carbidopa, and at least one other class of anti-PD therapy i.e. COMT inhibitor or MAO-B inhibitor. CGS Local Coverage Determination (LCD) for External Infusion Pumps (L33794) and Local Coverage Article (LCA) for External Infusion Pumps (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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 Treprostinil for the management of pulmonary hypertension (Refer to Group 11 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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 ?423.104.Part D sponsors are required to coordinate with other providers of prescription drug coverage with respect to the payment of premiums and coverage, as well as coverage supplementing the benefits available under Part D. The Medicare Modernization Act (MMA) specified that these coordination requirements must relate to the following elements: (1) enrollment file sharing; (2) claims processing and payment; (3) claims reconciliation reports; (4) application of the protection against high out-of-pocket expenditures by tracking true out-of-pocket (TrOOP) expenditures; and (5) other processes that CMS determines. Medicare Prescription Drug Benefit Manual (CMS Pub. 100-18) Chapter 14, ?20.The Part D Plan enrollee may pay part of the cost of a covered drug during the initial coverage period as a copayment or coinsurance. The amount of the copayment or coinsurance will vary depending on the drug's tier and place of purchase. 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.The Plan contract states that they are required to follow rules set by Medicare to make sure that the enrollee is using all of their coverage in combination when they get covered drugs from the Plan. This is called coordination of benefits becauseit involves coordinating the drug benefits the enrollee gets from the Plan with any other drug benefits available. When the enrollee has additional coverage, how the Plan will coordinate depends on the situation. Sometimes, a group health plan must provide health benefits to the enrollee before the Part D Plan will provide benefits. Please refer to the Plan's Evidence of Coverage.

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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.The Part D Plan enrollee may pay part of the cost of a covered drug during the initial coverage period as a copayment or coinsurance. The amount of the copayment or coinsurance will vary depending on the drug's tier and place of purchase. Bumetanide 2 mg is on Tier 2 of the Plan's 2020 formulary. Please refer to the Plan's Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 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. Please refer to the Plan's Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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.

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

unknown

Citations used in this letter come from Section 42 of the Code of Federal Regulations which you will find abbreviated as 42 CFR with the corresponding section numbers, i.e., 42 CFR Sections 423.578, 423.100.Medicare law defines those drugs that are eligible to be covered under the prescription drug benefit. Medicare law specifically excludes coverage for any drug for which payment would be available under Parts A or B of Medicare for that individual. Social Security Act, Section 1860D-2(e)(2)(B). Coverage is available under Medicare Part B for prescription drugs used in immunosuppressive therapy furnished to a beneficiary who has received an organ transplant, provided the beneficiary receiving the drug was enrolled in Medicare Part A at the time of the organ transplant. 42 CFR Section 410.30; Medicare Benefit Policy Manual, Chapter 15, Section 50.5.1. Medicare Part B local policy states that prescription drugs used in immunosuppressive therapy are covered if I) they are prescribed following a kidney and liver transplant, II) the transplant met Medicare coverage criteria in effect with respect to the facility being approved for kidney and liver 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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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.If a plan sponsor does not have all of the information it needs to make a decision, the plan sponsor should make reasonable and diligent efforts to obtain the missing information within the standard timeframe for making a decision and notifying the enrollee of the decision (i.e., within 72 hours after receiving the request or physician's or other prescriber's supporting statement). When a plan sponsor could acquire missing information, such as a National Drug Code (NDC) number, by contacting the enrollee's pharmacist, physician, or other prescriber, it should do so instead of relying on the enrollee to provide the information. Prescription Drug Benefit Manual, Chapter 18, ?30.3.2.Occasionally, a plan sponsor will have enough information to determine that a reimbursement request is payable, but not enough to determine the exact amount. When this situation occurs, the plan sponsor could issue a favorable decision within the 72-hour timeframe (the plan sponsor is not required to say how much the payment will be in its notice to the enrollee), and utilize the remainder of the 30-day payment period described in ??40.2 and 130.1 of this chapter to determine how much the enrollee should be reimbursed and make payment. If a plan sponsor chooses to send the payment within the 30-day timeframe after notifying the enrollee of the favorable decision within the 72-hour timeframe, the initial notice to the enrollee must include the following information: 1) the plan sponsor is approving the request; 2) payment will be sent within 30 days after the request was received; 3) if the enrollee does not agree with the amount received, he or she can request an appeal with the plan sponsor; and 4) briefly explain that the member may not receive the entire amount he or she paid out-of-pocket because certain items (e.g., co-payment amounts) are not reimbursable, and include a brief summary of items that are generally subtracted. Prescription Drug Benefit Manual, Chapter 18, ?30.3.2.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. If an enrollee must use an out-of-network pharmacy, the enrollee will generally have to pay the full cost when the prescription is filled. The enrollee can ask the Plan to reimburse their share of the cost by submitting proof of payment with a request for reimbursement. In some cases the enrollee will be responsible for the difference between what the Plan normally pays and what the out-of-network pharmacy charges the enrollee. Please refer to the Plan's Evidence of Coverage.

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 Part D Plan enrollee may pay part of the cost of a covered drug during the initial coverage period as a copayment or coinsurance. The amount of the copayment or coinsurance will vary depending on the drug's tier and place of purchase. 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. The Plan required a $45 copayment for up to 100 day supply of a Tier 2 drug, a $94 copayment for up to a 60 day supply for a Tier 3 drug and a $15 copayment for a Tier 2 drug for up to a 30 day supply purchased in 2019 from a standard retail pharmacy. Acarbose 100 mg, Alvesco Aero 80 mcg and Ventolin HFA 108 mcg/act were on the Plan's 2019 formulary and were classified as Acarbose Tier 2 drug, Alvesco Aero Tier 3 drug and Ventolin HFA Tier 2 drug. Please refer to the Plan's Evidence of Coverage (EOC) and formulary.

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 ?423.104. A 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.The Part D Plan enrollee may pay part of the cost of a covered drug during the initial coverage period as a copayment or coinsurance. The amount of the copayment or coinsurance will vary depending on the drug's tier and place of purchase. There may be situations in which an enrollee will pay the full cost of the drug at the time of purchase or an enrollee may pay more than expected under the coverage rules of the Plan. In either case, an enrollee can ask the Plan to pay its share of the cost of the drug by sending the Plan a request for reimbursement along with the enrollee's prescription receipt(s) documenting proof of purchase. Please refer to the Plan's Evidence of Coverage.Pursuant to guidelines issued by the Centers for Medicare and Medicare Services (CMS), as of February 1, 2014, the Plan has enacted a policy in which an enrollee is responsible for the difference between the cash price paid and the Plan's contracted negotiated rate for a drug for any purchases made at an in-network pharmacy that are not automatically submitted online through the pharmacy.

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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. 42 CFR 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. Lenvima is on Tier 5 of the Plan's 2020 formulary. Once total drug costs reach $4,020 the enrollee enters the coverage gap stage. This amount is calculated by adding payments made by the Plan and by the enrollee (or other eligible payer). During the coverage gap stage, the enrollee pays 25% copayment. Once total out-of-pocket costs reach $6,350, the enrollee will qualify for catastrophic coverage. Please refer to the Plan's Evidence of Coverage.The catastrophic coverage stage is the last payment stage of the enrollee's drug coverage. During the catastrophic stage, the enrollee is required to pay either coinsurance or a copayment amount, whichever is the larger amount: either coinsurance of 5% of the cost of the drug or $3.30 for a generic drug or a drug that is treated like a generic and $8.25 for all other drugs. If an enrollee pays the full cost of a prescription, the enrollee may submit a request for reimbursement with proof of payment to ask the Plan to pay its share of the cost. Please refer to the Plan's Evidence of Coverage and formulary.

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 Part D Plan enrollee may pay part of the cost of a covered drug during the initial coverage period as a copayment or coinsurance. The amount of the copayment or coinsurance will vary depending on the drug's tier and place of purchase. 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. The Plan required a $1 copayment amount for a Tier 1 drug, a $4 copayment amount for a Tier 2 drug, and a $42 copayment amount for a Tier 3 drug, for up to a 30 day supply purchased in 2020 from a preferred retail pharmacy. Amoxicillin (classified as a Tier 1 drug), Chlorhexidine (classified as a Tier 2 drug) and Hydrocodone/Acetaminophen (Classified as a Tier 3 drug) were on the Plan's 2020 formulary. Please refer to the Plan's Evidence of Coverage (EOC) and formulary.

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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.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.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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 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. During the deductible stage, the enrollee is responsible for the full cost of the Tier 2, Tier 3, Tier 4, and Tier 5 drugs. The enrollee remains in the deductible stage until drug payments total $365. Once the enrollee has met the deductible amount of $365, the enrollee moves into the initial coverage stage. Everolimus 5 mg is on Tier 5 of the Plan's 2020 formulary with a 25% coinsurance amount for up to a 30 day supply when purchased from an in-network pharmacy. Once total drug costs reach $4,020, the enrollee enters the coverage gap stage. After your total drug costs reach the initial coverage limit, you, or others on your behalf, will pay 25% of the cost of generic drugs and 25% of the cost of brand drugs plus a portion of the dispensing fee 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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 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. During the deductible stage, the enrollee is responsible for the full cost of Tier 3, Tier 4 and Tier 5 drugs. The enrollee remains in the deductible stage until drug payments total $435. Once the enrollee has met the deductible amount of $435, the enrollee moves into the initial coverage stage. Lumigan 0.01% is on Tier 3 of the Plan's 2020 formulary with a $114-$129 copayment amount for up to a 90 day supply when purchased from a preferred retail pharmacy. Once total drug costs reach $4,020, the enrollee enters the coverage gap stage. Please refer to the Plan's Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 Enrollee 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).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 (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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.

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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).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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 Enrollee 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)..

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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).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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

unknown

Citations used in this letter come from Section 42 of the Code of Federal Regulations which you will findabbreviated as 42 CFR with the corresponding section numbers, i.e., 42 CFR Sections 423.578, 423.100.A Part D Plan may establish tiered cost-sharing for drugs on its formulary. The Plan groups covered drugsinto different cost-sharing levels or tiers. Medicare rules permit an enrollee to request a tiering exception tocover a higher cost-sharing tiered drug at a lower cost-sharing tier level so long as there is a drug on alower cost-sharing tier that is approved for treating the same condition that the requested higher costsharingtiered drug is being used to treat. However, Medicare rules also permit a Plan to design its tieringexception procedures so that a Plan does not have to grant a tiering exception for brand or biologic drugs ifthe lower cost-sharing tier or tiers only contain generic drugs approved for treating the same condition. 42CFR Sections 423.4; 423.578(a); 423.578(a)(6); 423.578(c)(3)(ii); Parts C & D Enrollee Grievances,Organization/Coverage Determinations, and Appeals Guidance Manual, Section 40.5.1.The prescription drug benefit offered by the Part D Plan must meet criteria requirements pertaining to theannual deductible, the initial coverage limit, the coverage gap and catastrophic coverage. For the initialcoverage limit, the rules provide for a benefit of shared coverage of costs between the enrollee and Plan.An enrollee in a Part D Plan may be subject to annual deductibles, coinsurance and copayments (includingtiered copayments) specified by the Plan. 42 CFR Section 423.104.Each drug on the Plan's formulary is assigned to a cost-sharing tier. The Part D Plan contract allows an enrolleeto 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 o 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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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).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 Enrollee 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.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.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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 services and supplies incident to the service of a physician (or another practitioner). Services and supplies must be furnished in a noninstitutional setting to noninstitutional patients; an integral, though incidental, part of the service of a physician in the course of diagnosis or treatment of an injury or illness; commonly furnished without charge or included in the bill of a physician; of a type that are commonly furnished in the office or clinic of a physician; and furnished under the direct supervision of the physician. In order to meet all the general requirements for coverage under the incident-to provision, an FDA approved drug or biological must be of a form that is not usually self-administered. 42 CFR Section 410.26(b); Medicare Benefit Policy Manual, Chapter 15, Section 50.3.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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 theannual deductible, the initial coverage limit, the coverage gap and catastrophic coverage. For the initialcoverage limit, the rules provide for a benefit of shared coverage of costs between the enrollee and plan. Anenrollee in a Part D Plan may be subject to annual deductibles, coinsurance, and copayments (includingtiered copayments) specified by the plan. 42 CFR ?423.104.Part D sponsors are required to coordinate with other providers of prescription drug coverage with respectto the payment of premiums and coverage, as well as coverage supplementing the benefits available underPart D. The Medicare Modernization Act (MMA) specified that these coordination requirements mustrelate to the following elements: (1) enrollment file sharing; (2) claims processing and payment; (3) claimsreconciliation reports; (4) application of the protection against high out-of-pocket expenditures by trackingtrue out-of-pocket (TrOOP) expenditures; and (5) other processes that CMS determines. MedicarePrescription Drug Benefit Manual (CMS Pub. 100-18) Chapter 14, ?20.The Part D Plan enrollee may pay part of the cost of a covered drug during the initial coverage period as acopayment or coinsurance. The amount of the copayment or coinsurance will vary depending on the drug'stier and place of purchase. If an enrollee pays the full cost of a prescription, the enrollee may submit arequest for reimbursement with proof of payment to ask the Plan to pay its share of the cost.The Plan contract states that they are required to follow rules set by Medicare to make sure that the enrolleeis using all of their coverage in combination when they get covered drugs from the Plan. This is calledcoordination of benefits because it involves coordinating the drug benefits the enrollee gets from the Planwith any other drug benefits available. When the enrollee has additional coverage, how the Plan willcoordinate depends on the situation. Sometimes, a group health plan must provide health benefits to theenrollee before the Part D Plan will provide benefits. Please refer to the Plan's Evidence of Coverage.

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

unknown

Citations used in this letter come from Section 42 of the Code of Federal Regulations which you will find abbreviated as 42 CFR with the corresponding section numbers, i.e., 42 CFR Sections 423.578, 423.100.Medicare law defines those drugs that may be covered under Part D. A covered prescription drug must be used for a medically accepted indication. A medically accepted indication means a use that is approved by the Food and Drug Administration (FDA), or a use supported by one or more citations in the drug compendia approved by Medicare. Medically accepted indications do not include uses in research or uses described in peer-reviewed medical literature. Please refer to Social Security Act, Sections 1860D-2(e)(1) and 1927(k)(6); and 42 CFR Section 423.100.A Part D Plan must grant an exception for a drug that is not on its formulary whenever it determines that the drug is medically necessary, consistent with the prescriber's statement, and that the drug would be covered but for the fact that it is not on the formulary. The statement must show that all of the covered drugs on any tier of the Plan's formulary for treatment of the enrollee's condition would not be as effective as the non-formulary drug or would have adverse effects for the enrollee. 42 CFR Sections 423.578(b) and 423.578(b)(5)(i).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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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.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).If a plan sponsor does not have all of the information it needs to make a decision, the plan sponsor should make reasonable and diligent efforts to obtain the missing information within the standard timeframe for making a decision and notifying the enrollee of the decision (i.e., within 72 hours after receiving the request or physician's or other prescriber's supporting statement). When a plan sponsor could acquire missing information, such as a National Drug Code (NDC) number, by contacting the enrollee's pharmacist, physician, or other prescriber, it should do so instead of relying on the enrollee to provide the information. Prescription Drug Benefit Manual, Chapter 18, ?30.3.2.Occasionally, a plan sponsor will have enough information to determine that a reimbursement request is payable, but not enough to determine the exact amount. When this situation occurs, the plan sponsor could issue a favorable decision within the 72-hour timeframe (the plan sponsor is not required to say how much the payment will be in its notice to the enrollee), and utilize the remainder of the 30-day payment period described in ??40.2 and 130.1 of this chapter to determine how much the enrollee should be reimbursed and make payment. If a plan sponsor chooses to send the payment within the 30-day timeframe after notifying the enrollee of the favorable decision within the 72-hour timeframe, the initial notice to the enrollee must include the following information: 1) the plan sponsor is approving the request; 2) payment will be sent within 30 days after the request was received; 3) if the enrollee does not agree with the amount received, he or she can request an appeal with the plan sponsor; and 4) briefly explain that the member may not receive the entire amount he or she paid out-of-pocket because certain items (e.g., co-payment amounts) are not reimbursable, and include a brief summary of items that are generally subtracted. Prescription Drug Benefit Manual, Chapter 18, ?30.3.2.

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 $405, 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. Shingrix Vaccine purchased at the Pharmacy on August 18, 2018 and November 5, 2018 was on the Plan's 2018 formulary and was classified as a Tier 4 drug. Please refer to the Plan's Evidence of Coverage (EOC) and formulary.

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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. 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 enrollee stays in this stage until drug payments for the year plus the Plan's payments total $4,020. Once total drug costs reach this amount, the enrollee enters the coverage gap stage. During the coverage gap stage, the enrollee pays 25% for brand name drugs plus a portion of the dispensing fee or 25% for generic drugs. Once total out-of-pocket costs reach $6,350, the enrollee will qualify for catastrophic coverage. Please refer to the Plan's Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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.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 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).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 $435, 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. Boostrix is on the Plan's 2020 formulary and classified as a Tier 3 drug. Please refer to the Plan's Evidence of Coverage (EOC) and formulary.

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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.The Part D Plan enrollee may pay part of the cost of a covered drug during the initial coverage period as a copayment or coinsurance. The amount of the copayment or coinsurance will vary depending on the drug's tier and place of purchase. Carbidopa-Levodopa ODT 25-100 mg is on Tier 2 of the Plan's 2020 Formulary. Please refer to the Plan's Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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.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, including prior authorization, step therapy and dose restriction, or quantity limits. 70 Federal Register No. 18, issued January 28, 2005 (Preamble to Final Rule); 42 CFR Section 423.578(b).For certain drugs, the Part D Plan has additional requirements for coverage or limits on its coverage. These additional requirements include prior authorization, step therapy and quantity limits. Please refer to the Plan's Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 Part D Plan enrollee may pay part of the cost of a covered drug during the initial coverage period as a copayment or coinsurance. The amount of the copayment or coinsurance will vary depending on the drug's tier and place of purchase. 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. The Plan required a $100 copayment amount for up to a 30-day supply of a Tier 4 drug purchased in 2020 from a preferred retail. Nystatin-Triamcinolone cream was on the Plan's 2020 formulary and was classified as a Tier 4 drug. Please refer to the Plan's Evidence of Coverage (EOC) and formulary.

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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.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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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.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 Part D Plan enrollee may pay part of the cost of a covered drug during the initial coverage period as a copayment or coinsurance. The amount of the copayment or coinsurance will vary depending on the drug's tier and place of purchase. 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. The Plan required a $1 copayment amount for up to a 30-day supply of a Tier 1 drug purchased in 2020 from a preferred retail pharmacy. Please refer to the Plan's Evidence of Coverage (EOC) and formulary.

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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. 42 CFR Section 423.104.The Part D Plan enrollee may pay part of the cost of a covered drug during the initial coverage period as a copayment or coinsurance. The amount of the copayment or coinsurance will vary depending on the drug's tier and place of purchase. 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. The Plan required a $5 copayment for up to a 90-day supply of a Tier 1 drug purchased in 2020 from a preferred retail or preferred mail-order pharmacy. The Plan required a $10 copayment for up to a 90-day supply of a Tier 2 drug purchased in 2020 from a preferred retail or preferred mail-order pharmacy.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 enrollee stays in this stage until drug payments for the year plus the Plan's payments total $4,020. Once total drug costs reach this amount, the enrollee enters the coverage gap stage. During the coverage gap stage, the enrollee pays 25% for brand name drugs or 25% for generic drugs. Once total out-of-pocket costs reach $6,350, the enrollee will qualify for catastrophic coverage. Please refer to the Plan's Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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.If a plan sponsor does not have all of the information it needs to make a decision, the plan sponsor should make reasonable and diligent efforts to obtain the missing information within the standard timeframe for making a decision and notifying the enrollee of the decision (i.e., within 72 hours after receiving the request or physician's or other prescriber's supporting statement). When a plan sponsor could acquire missing information, such as a National Drug Code (NDC) number, by contacting the enrollee's pharmacist, physician, or other prescriber, it should do so instead of relying on the enrollee to provide the information. Prescription Drug Benefit Manual, Chapter 18, ?30.3.2.Occasionally, a plan sponsor will have enough information to determine that a reimbursement request is payable, but not enough to determine the exact amount. When this situation occurs, the plan sponsor could issue a favorable decision within the 72-hour timeframe (the plan sponsor is not required to say how much the payment will be in its notice to the enrollee), and utilize the remainder of the 30-day payment period described in ??40.2 and 130.1 of this chapter to determine how much the enrollee should be reimbursed and make payment. If a plan sponsor chooses to send the payment within the 30-day timeframe after notifying the enrollee of the favorable decision within the 72-hour timeframe, the initial notice to the enrollee must include the following information: 1) the plan sponsor is approving the request; 2) payment will be sent within 30 days after the request was received; 3) if the enrollee does not agree with the amount received, he or she can request an appeal with the plan sponsor; and 4) briefly explain that the member may not receive the entire amount he or she paid out-of-pocket because certain items (e.g., co-payment amounts) are not reimbursable, and include a brief summary of items that are generally subtracted. Prescription Drug Benefit Manual, Chapter 18, ?30.3.2. 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.

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 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).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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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).Coverage determinations include a plan sponsor's decision on an enrollee's exceptions request. Enrollees may request an exception to a plan's tiered cost-sharing structure, or formulary. Once an exception is granted, the plan sponsor is prohibited from requiring the enrollee to request approval for a refill or new prescription to continue using the Part D prescription drug approved under the exceptions process for the remainder of the plan year, so long as the enrollee remains enrolled in the plan, the physician continues to prescribe the drug and it continues to be safe for treating the enrollee's condition. A plan sponsor may choose not to require an enrollee to resubmit an exceptions request at the beginning of a new plan year. For example, if a plan sponsor grants an exception request near the end of a plan year, it may choose not to require the enrollee to request a new exception when the new plan year begins. Medicare Prescription Drug Benefit Manual, Chapter 18, Section 30.2.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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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).Coverage determinations include a plan sponsor's decision on an enrollee's exceptions request. Enrollees may request an exception to a plan's tiered cost-sharing structure, or formulary. Once an exception is granted, the plan sponsor is prohibited from requiring the enrollee to request approval for a refill or new prescription to continue using the Part D prescription drug approved under the exceptions process for the remainder of the plan year, so long as the enrollee remains enrolled in the plan, the physician continues to prescribe the drug and it continues to be safe for treating the enrollee's condition. A plan sponsor may choose not to require an enrollee to resubmit an exceptions request at the beginning of a new plan year. For example, if a plan sponsor grants an exception request near the end of a plan year, it may choose not to require the enrollee to request a new exception when the new plan year begins. Medicare Prescription Drug Benefit Manual, Chapter 18, Section 30.2.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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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.Coverage determinations include a plan sponsor's decision on an enrollee's exceptions request. Enrollees may request an exception to a plan's tiered cost-sharing structure, or formulary. Once an exception is granted, the plan sponsor is prohibited from requiring the enrollee to request approval for a refill or new prescription to continue using the Part D prescription drug approved under the exceptions process for the remainder of the plan year, so long as the enrollee remains enrolled in the plan, the physician continues to prescribe the drug and it continues to be safe for treating the enrollee's condition. A plan sponsor may choose not to require an enrollee to resubmit an exceptions request at the beginning of a new plan year. For example, if a plan sponsor grants an exception request near the end of a plan year, it may choose not to require the enrollee to request a new exception when the new plan year begins. Medicare Prescription Drug Benefit Manual, Chapter 18, Section 30.2.The Part D Plan can only cover drugs prescribed for a medically accepted indication. Please refer to the Plan's Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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).Coverage determinations include a plan sponsor's decision on an enrollee's exceptions request. Enrollees may request an exception to a plan's tiered cost-sharing structure, or formulary. Once an exception is granted, the plan sponsor is prohibited from requiring the enrollee to request approval for a refill or new prescription to continue using the Part D prescription drug approved under the exceptions process for the remainder of the plan year, so long as the enrollee remains enrolled in the plan, the physician continues to prescribe the drug and it continues to be safe for treating the enrollee's condition. A plan sponsor may choose not to require an enrollee to resubmit an exceptions request at the beginning of a new plan year. For example, if a plan sponsor grants an exception request near the end of a plan year, it may choose not to require the enrollee to request a new exception when the new plan year begins. Medicare Prescription Drug Benefit Manual, Chapter 18, Section 30.2.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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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.Coverage determinations include a plan sponsor's decision on an enrollee's exceptions request. Enrollees may request an exception to a plan's tiered cost-sharing structure, or formulary. Once an exception is granted, the plan sponsor is prohibited from requiring the enrollee to request approval for a refill or new prescription to continue using the Part D prescription drug approved under the exceptions process for the remainder of the plan year, so long as the enrollee remains enrolled in the plan, the physician continues to prescribe the drug and it continues to be safe for treating the enrollee's condition. A plan sponsor may choose not to require an enrollee to resubmit an exceptions request at the beginning of a new plan year. For example, if a plan sponsor grants an exception request near the end of a plan year, it may choose not to require the enrollee to request a new exception when the new plan year begins. Medicare Prescription Drug Benefit Manual, Chapter 18, Section 30.2.The Part D Plan can only cover drugs prescribed for a medically accepted indication. Please refer to the Plan's Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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).Coverage determinations include a plan sponsor's decision on an enrollee's exceptions request. Enrollees may request an exception to a plan's tiered cost-sharing structure, or formulary. Once an exception is granted, the plan sponsor is prohibited from requiring the enrollee to request approval for a refill or new prescription to continue using the Part D prescription drug approved under the exceptions process for the remainder of the plan year, so long as the enrollee remains enrolled in the plan, the physician continues to prescribe the drug and it continues to be safe for treating the enrollee's condition. A plan sponsor may choose not to require an enrollee to resubmit an exceptions request at the beginning of a new plan year. For example, if a plan sponsor grants an exception request near the end of a plan year, it may choose not to require the enrollee to request a new exception when the new plan year begins. Medicare Prescription Drug Benefit Manual, Chapter 18, Section 30.2.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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

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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, Section 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 Section 410.38; Medicare Benefit Policy Manual, Chapter 15, Section 110.3.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).Coverage determinations include a plan sponsor's decision on an enrollee's exceptions request. Enrollees may request an exception to a plan's tiered cost-sharing structure, or formulary. Once an exception is granted, the plan sponsor is prohibited from requiring the enrollee to request approval for a refill or new prescription to continue using the Part D prescription drug approved under the exceptions process for the remainder of the plan year, so long as the enrollee remains enrolled in the plan, the physician continues to prescribe the drug and it continues to be safe for treating the enrollee's condition. A plan sponsor may choose not to require an enrollee to resubmit an exceptions request at the beginning of a new plan year. For example, if a plan sponsor grants an exception request near the end of a plan year, it may choose not to require the enrollee to request a new exception when the new plan year begins. Medicare Prescription Drug Benefit Manual, Chapter 18, Section 30.2.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. 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).

2024-02-03

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44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

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A Part D plan sponsor must grant an exception whenever it determines that the drug is medically necessary, consistent with the physician's or other prescriber's statement, and that the drug would be covered but for the fact that it is an off-formulary drug. A prescribing physician or other prescriber must provide an oral or written supporting statement that the requested prescription drug is medically necessary to treat the enrollee's disease or medical condition. The statement must support that all of the covered Part D drugs on any tier of a plan's formulary for treatment for the same condition would not be as effective for the enrollee as the non-formulary drug, and/or there would have adverse effects for the enrollee. [42 Code of Federal Regulations Section 423.578(b)]Medicare rules define drugs or biological products that may be covered under the Part D prescription drug benefit. One of the requirements for coverage is that the prescription drug or biological product must be prescribed for a use that is a 'medically accepted indication.' The term medically accepted indication means any use that is approved by the Federal Food, Drug, and Cosmetic Act, or which is supported by one or more citations included (or approved for inclusion) in one the following drug compendia: the American Hospital Formulary Service Drug Information] and the DRUGDEX Information System. [Sections 1860D-2(e)(1) and 1927(k)(6) of the Social Security Act; 42 Code of Federal Regulations Section 423.100; the Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-18, Medicare Prescription Drug Benefit Manual, Chapter 4, Section 10.6]

2024-02-03

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44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

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Medicare law defines those drugs or biological products that are eligible to be covered under the prescription drug benefit. A drug prescribed for a Part D eligible individual cannot be considered a covered Part D drug if payment for the drug is available under Medicare Part A or B for that individual (as prescribed and dispensed or administered for the individual). The Centers for Medicare & Medicaid Services interprets this to mean that if payment could be available under Part A (e.g., hospital inpatient, hospice benefit) 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) 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. [Section 1860D-2(e)(2)(B) of the Social Security Act; the Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-18, Medicare Prescription Drug Benefit Manual, Chapter 4, Section 20.2 and Appendix C] Medicare Part B pays for durable medical equipment, and supplies necessary for the effective use of durable medical equipment, if the equipment is used in the patient's home or in an institution that is used as a home. Supplies that may be covered, if determined to be medically necessary, include drugs and biologicals that are put directly into the equipment. [42 Code of Federal Regulations Section 410.38(a); the Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-02, Medicare Prescription Drug Benefit Manual, Chapter 15, Section 110.3]

2024-02-03

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44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

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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. 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.Under Medicare rules, each Part D plan sponsor that provides prescription drug benefits for Part D drugs, and manages the benefit through the use of a tiered formulary, must establish and maintain reasonable and complete exceptions procedures. These procedures must permit enrollees to obtain a covered non-preferred drug in a higher cost-sharing tier at the more favorable cost-sharing terms applicable to alternative drugs in a lower cost-sharing tier. A Part D plan sponsor is required to grant an exception whenever it determines that the requested non-preferred drug for treatment of the enrollee's condition is medically necessary, consistent with the physician's or other prescriber's statement. A prescribing physician or other prescriber must provide an oral or written supporting statement that the preferred drug(s) for the treatment of the enrollee's condition would not be as effective for the enrollee as the requested drug and/or would have adverse effects for the enrollee. Moreover, there are additional limitations permitted under the Medicare rules. Plans cannot be required to offer tiering exceptions for brand name drugs or biological products at the cost-sharing level of alternative drugs, where the alternatives include only generic or authorized generic drugs. Plans that maintain a specialty tier in which they place very high cost drugs and biological products may design its exception process so that Part D drugs placed on the specialty tier are not eligible for a tiering exception. [42 Code of Federal Regulations Section 423.578; Parts C & D Grievances, Organization/Coverage Determinations, and Appeals Guidance Manual, Section 40.5.1, Tiering Exceptions; the Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-18, Medicare Prescription Drug Manual, Chapter 4, Section 30.2.4]

2024-02-03

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44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

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Under Medicare rules, Part D does not cover drugs or classes of drugs, or their medical uses, which are excluded from coverage or otherwise restricted under Section 1927(d)(2) of the Social Security Act. Drugs Excluded from Part D coverage include: 1) Agents when used for anorexia, weight loss, or weight gain (even if used for a non-cosmetic purpose (i.e., morbid obesity)); 2) Agents when used to promote fertility; 3) Agents when used for cosmetic purposes or hair growth; 4) Agents when used for the symptomatic relief of cough and colds; 5) Prescription vitamins and mineral products, except prenatal vitamins and fluoride preparations; 6) Nonprescription drugs; 7) Covered outpatient drugs which the manufacturer seeks to require as a condition of sale that associated tests or monitoring services be purchased exclusively from the manufacturer or its designee; 8) Agents when used for the treatment of sexual or erectile dysfunction. Erectile dysfunction drugs will meet the definition of a Part D drug when prescribed for medically-accepted indications approved by the Food and Drug Administration other than sexual or erectile dysfunction (such as pulmonary hypertension). However, erectile dysfunction drugs will not meet the definition of a Part D drug when used off-label, even when the off label use is listed in one of the compendia found in Section 1927(g)(1)(B)(i) of the Social Security Act: American Hospital Formulary Service Drug Information, and DRUGDEX Information System. Drugs not excluded from coverage include: 1) Prescription drug products that otherwise satisfy the definition of a Part D drug are Part D drugs when used for acquired immune deficiency syndrome wasting and cachexia due to a chronic disease, if these conditions are medically-accepted indications as defined by Section 1927(k)(6) of the Social Security Act for the particular Part D drug. Specifically, the Centers for Medicare & Medicaid Services does not consider such prescription drug products being used to treat acquired immune deficiency syndrom wasting and cachexia due to a chronic disease as either agents used for weight gain or agents used for cosmetic purposes; 2) Part D drugs indicated for the treatment of psoriasis, acne, rosacea, or vitiligo are not considered cosmetic; 3) Vitamin D analogs such as calcitriol, doxercalciferol, and paricalcitol when used for a medically-accepted indication as defined by Section 1927(k)(6) of the Social Security Act, are not excluded because the Centers for Medicare & Medicaid Services interprets the exclusion of prescription vitamin D products as being limited to products consisting of ergocalciferol (vitamin D2) and/or cholecalciferol (vitamin D3); 4) Prescription-only smoking cessation products; 5) Prescription Niacin Products (Niaspan, Niacor); 6) Cough and cold medications are eligible to meet the definition of a Part D drug in clinically relevant situations other than those of symptomatic relief of cough and/or colds. For example, when cough medications are used to treat a medical condition that causes a cough, such as the use of bronchodilators for the treatment of bronchospasm in asthma, the Centers for Medicare & Medicaid Services does not consider these cough medications as excluded drugs and, therefore, these medications may be covered under Part D. However, antitussives used to treat cough symptoms, and not the underlying medical condition causing the cough, are excluded from basic Part D coverage regardless of the medical condition causing the cough; 7) Benzodiazepines; and 8) Barbiturates. [The Centers for Medicare & Medicaid Services Internet Only-Manual, Publication 100-18, Medicare Prescription Drug Benefit Manual, Chapter 6, Section 20.1]Medicare provides coverage for items and services that are reasonable and necessary to diagnose or treat an illness or injury or to improve a malformed body member. Payment is excluded if the medical necessity for the service cannot be substantiated. [Section 1862(a)(1)(A) of the Social Security Act]

2024-02-03

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44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

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Section 1860D-2(e)(4) of the Social Security Act defines medically-accepted indication, in part by reference to Section 1927(k)(6) of the Social Security Act, to any use of a covered Part D drug which is approved under the Federal Food, Drug, and Cosmetic Act, or the use of which is supported by one or more citations included or approved for inclusion in any of the compendia described in Section 1927(g)(1)(B)(i) of the Social Security Act. The recognized compendia are: 1) American Hospital Formulary Service Drug Information, and 2) DRUGDEX Information System.The definition of medically accepted indication also means, in the case of a covered Part D drug used in an anticancer chemotherapeutic regimen, the definition of medically accepted indication in Section 1861(t)(2)(B) of the Social Security Act. Thus, Part D sponsors will be required to thoroughly understand and apply Part Bs definition of an anti-cancer chemotherapeutic regimen, utilize Part B compendia, and consider peer reviewed medical literature when necessary. The Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50.4.5 (http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/bp102c15.pdf) will be the authoritative guidance for Part D sponsors in their consideration of medically accepted indications for Part D anti-cancer chemotherapeutic claims.Part D sponsors are responsible for ensuring that covered Part D drugs are prescribed for medically accepted indications using the tools and data available to them to make such determinations. Part D sponsors must reference all the Centers for Medicare & Medicaid Services recognized compendia to determine whether there are any supportive citations, prior to determining that a drug is not being used for a medically accepted indication. Part D sponsors may rely on utilization management policies and procedures, approved by the Centers for Medicare & Medicaid Services where required (see Medicare Prescription Drug Benefit Manual, Chapter 6, Section 30.2.2.1), to make such determinations. Dispensing pharmacists are not required to contact each prescriber to verify a prescription is being used for a medically accepted indication. Also, medically accepted indication refers to the diagnosis or condition for which a drug is being prescribed, not the dose being prescribed for such indication. Part D sponsors may have dose limitations based on Food and Drug Administration labeling, but an enrollee may request (and be granted) an exception to a dose restriction through the formulary exception process based on medical necessity criteria.Additionally 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, heparins use in this instance is not therapeutic but is, instead, necessary to make durable medical equipment work. Heparin would therefore not be a Part D drug when used in a heparin flush. [Sections 1860D-2(e)(4) and 1927(k)(6) of the Social Security Act; the Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-18, Medicare Prescription Drug Benefit Manual, Chapter 6, Section 10.6]

2024-02-03

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44124e33664f775b7b0985f6ae206368

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When a plan processes a coverage request that involves a prior authorization or other utilization management requirement, such as step therapy for Part B drugs, the plans determination on whether to grant approval of a service or a drug for an enrollee constitutes an initial determination and is subject to appeal. In addition, if a plan denies coverage of a service or a drug because the enrollee failed to seek prior authorization or failed to comply with similar limits on coverage, the denial also constitutes an initial determination and is subject to appeal. Thus, the adjudication timeframe, notice, and other requirements applicable to coverage determinations or organization determinations under 42 Code of Federal Regulations Parts 422 and 423, Subpart M apply to requests that involve a prior authorization or other utilization management requirement in the same manner that they apply to all coverage requests. If an enrollee requests coverage of a service, item, or drug that involves prior authorization, the plan must accept and process the request as a coverage determination or organization determination and should contact the physician or prescriber for information needed to satisfy the prior authorization, in accordance with the outreach guidance at Parts C & D Enrollee Grievances, Organization/Coverage Determinations, and Appeals Guidance, Section 10.6.

2024-02-03

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44124e33664f775b7b0985f6ae206368

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Regulations at 42 Code of Federal Regulations Section 423.578(a)(6 ) allow Part D sponsors to exempt a formulary tier, in which it places very high cost and unique items, from tiered cost-sharing exceptions. In order to ensure that a Part D sponsor does not substantially discourage enrollment by specific patient populations reliant upon these medications, the Centers for Medicare & Medicaid Services will only approve specialty tiers within formularies and benefit designs that comply with the following: 1) Only one tier is designated a specialty tier exempt from cost-sharing exceptions; 2) Cost-sharing associated with the specialty tier is limited to 25% after the standard deductible and before the initial coverage limit (or up to 33% for sponsors with decreased or no deductible under alternative prescription drug coverage designs). When applying a reduced deductible, sponsors are limited to the maximum specialty coinsurance levels as defined each year in the Bid User Manual. The deductible applied to the non-specialty tiers may not exceed the deductible that is applied to the specialty tier; 3) Only Part D drugs with sponsor negotiated prices that exceed the dollar-per-month amount established by the Centers for Medicare & Medicaid Services in the annual Call Letter may be placed in the specialty tier. The Centers for Medicare & Medicaid Services will apply an upfront evaluation across all plans for drugs that exceed the dollar-per-month threshold and are intended for inclusion in the specialty tier; and 4) If not all drugs (including all strengths) within a category or class meet the criteria for inclusion in the specialty tier, the sponsor must ensure that placement of the remaining drugs among the other tiers of the formulary does not substantially discourage enrollment. Part D sponsors will need to evaluate the negotiated prices at the drug product strength, package size, and formulation level in order to determine appropriate inclusion of the drug in the Part D plans specialty tier. In addition to cost calculations, the Centers for Medicare & Medicaid Services considers claims history in reviewing the placement of drugs on Part D sponsors specialty tiers. Except for newly approved drugs for which Part D sponsors would have little or no claims data, the Centers for Medicare & Medicaid Services will approve specialty tiers that only include drugs when their claims data demonstrates that the majority of the fills exceed the specialty tier cost criteria. Part D sponsors should be prepared to provide the Centers for Medicare & Medicaid Services with the applicable claims data during the formulary review process if requested. Also, if a Part D drug product is available in multiple strengths, package sizes, and formulations, the Centers for Medicare & Medicaid Services will only allow inclusion on the specialty tier of those strengths, package sizes, and formulations that would reasonably exceed the dollar-per-month threshold.Part D sponsors must evaluate the long acting nature of some drug formulations and calculate the monthly cost across the drug's full duration of action in considering possible specialty tier placement. For example, if the specialty tier threshold was $600 dollars, a long acting formulation with a plan negotiated price of $900 dollars that lasts for three months would not be eligible for the plan's specialty tier since the monthly cost is only $300 dollars. [The Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-18, Medicare Prescription Drug Benefit Manual, Chapter 6, Section 30.2.4]

2024-02-03

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44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

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Effective January 1, 1994, oral self administered versions of covered injectable cancer drugs furnished may be paid by Medicare Part B if other coverage requirements are met. To be covered the drug must have had the same active ingredient as the injectable drug. Effective January 1, 1999, this coverage was expanded to include Food and Drug Administration approved Prodrugs used as anti-cancer drugs. A Prodrug may have a different chemical composition than the injectable drug but body metabolizing of the Prodrug results in the same chemical composition in the body. [The Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-04, Medicare Claims Processing Manual, Chapter 17, Section 80.1]Medicare law defines those drugs or biological products that are eligible to be covered under the prescription drug benefit. A drug prescribed for a Part D eligible individual cannot be considered a covered Part D drug if payment for the drug is available under Medicare Part A or B for that individual (as prescribed and dispensed or administered for the individual). The Centers for Medicare & Medicaid Services interprets this to mean that if payment could be available under Part A (e.g., hospital inpatient, hospice benefit) 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) 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. [Section 1860D-2(e)(2)(B) of the Social Security Act; the Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-18, Medicare Prescription Drug Benefit Manual, Chapter 4, Section 20.2 and Appendix C]

2024-02-03

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44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

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Part D sponsors are required to coordinate with State Pharmaceutical Assistance Programs and other providers of prescription drug coverage with respect to the payment of premiums and coverage, as well as coverage supplementing the benefits available under Part D. The Medicare Modernization Act specified that these coordination requirements must relate to the following elements: 1) Enrollment file sharing; 2) Claims processing and payment; 3) Claims reconciliation reports; 4) Application of the protection against high out-of- pocket expenditures by tracking true out-of-pocket expenditures; and 5) Other processes that the Center for Medicare & Medicaid Services determines. When a Medicare Part D enrollee has other prescription drug coverage, Coordination of Benefits allows the plans that provide coverage for this same beneficiary to determine each of their payment responsibilities. This process is necessary in order to avoid duplication of payment and to prevent Medicare from paying primary when it is the secondary payer. The Coordination of Benefits within Part D provides the mechanism for support of the tracking and calculating of beneficiaries true out-of-pocket expenditures, or incurred costs as defined in the Medicare Modernization Act and the Centers for Medicare & Medicaid Services implementing regulations. Costs for covered Part D drugs are treated as incurred only if they were paid by the individual (or by another person, such as a family member, on behalf of the individual), paid by the Centers for Medicare & Medicaid Services on behalf of a low-income subsidy-eligible individual, or paid under a qualified entity such as State Pharmaceutical Assistance Programs, acquired immune deficiency syndrome Drug Assistance Programs, or a bona fide charity as defined in the Centers for Medicare & Medicaid Services regulations. Costs do not count as incurred when: 1) No benefits are provided because of the application of either a formulary or the Medicare Secondary Payer laws, or 2) When costs are reimbursed through insurance or otherwise, a group health plan, or other coverage. Therefore, only certain costs not paid for by the Part D sponsor count toward true out-of-pocket expenditures. [42 Code of Federal Regulations Section 423.464(f); the Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-18, Medicare Prescription Drug Benefit Manual, Chapter 14, Section 20 and Appendix E]

2024-02-03

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44124e33664f775b7b0985f6ae206368

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The Centers for Medicare & Medicaid Services considers it best practice for Part D sponsors to consider the proper listing of a drug product with the Food and Drug Administration as a prerequisite for making a Part D drug coverage determination. The Food and Drug Administration is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage determination process by confirming that a prescription drug product national drug code is properly listed with the Food and Drug Administration. The Food and Drug Administrations Comprehensive national drug code Structured Product Labeling Data Elements file is used as a source of national drug code information for Medicare Part D Formulary Reference File and prescription drug event editing. [The Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-18, Medicare Prescription Drug Benefit Manual, Chapter 6, Section 10.1]

2024-02-03

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44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

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In the case of a drug that would incur a copayment, the Part D sponsor must apply cost-sharing as calculated by multiplying the applicable daily cost-sharing rate by the days' supply actually dispensed when the beneficiary receives less than the approved month's supply. In the case of a drug that would incur a coinsurance percentage, the Part D sponsor must apply the coinsurance percentage for the drug to the days' supply actually dispensed. [42 Code of Federal Regulations Section 423.153(b)(4)(iii)]

2024-02-03

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44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

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Under Medicare rules, Part D sponsors must exclude Part D drugs from qualified prescription drug coverage if they are not sold in the United States. In addition, Part D sponsors may only pay for drugs that satisfy the definition of Part D drug. In general, such definition requires Food and Drug Administration approval for sale in the United States. Therefore, even if the manufacturer has Food and Drug Administration approval for a drug, the version produced for foreign markets usually does not meet all of the requirements of the United States approval, and thus it is considered to be unapproved. In the event of a drug shortage, in order to ensure access to critically needed drugs in conjunction with the actions taken by the Food and Drug Administration, the Center for Medicare & Medicaid Services will accept prescription drug event submissions with national drug codes for foreign versions of Part D drugs, imported under the Food and Drug Administrations exercise of its enforcement discretion. Prescription drug event allowances will be limited to the specific drug product(s), conditions, and the duration of the shortage as specified by the Food and Drug Administration. Such products cannot be discounted under the Medicare Coverage Gap Discount Program. [The Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-18, Medicare Prescription Drug Benefit Manual, Chapter 6, Section 10.7]

2024-02-03

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Under Medicare rules, there must be out-of-network access to covered Part D drugs at out-of-network pharmacies for when the enrollee cannot reasonably be expected to obtain such drugs at a network pharmacy, and does not have access to covered Part D drugs at an out-of-network pharmacy on a routine basis. A plan is required to establish reasonable rules to appropriately limit out-of-network access to covered prescription drugs. [42 Code of Federal Regulations Sections 423.120(a) and 423.124; the Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-18, Medicare Prescription Drug Benefit Manual, Chapter 5, Section 60.1]

2024-02-03

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44124e33664f775b7b0985f6ae206368

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Under Medicare rules, in order 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: 1) It requires a prescription for dispensing; 2) It is approved by the Food and Drug Administration for safety and effectiveness; 3) It is prescribed for a medically accepted indication; and 4) It is not otherwise excluded from coverage under Part D law and rules. For a drug to be approved by the Food and Drug Administration, the manufacturer of the drug must file a New Drug Application or Abbreviated New Drug Application with the Food and Drug Administrations Center for Drug Evaluation and Research. Current Food and Drug Administration law requires a manufacturer to prove that its drug is both safe and effective. Some drugs currently on the market were Food and Drug Administration approved for safety only. These drugs were approved prior to the passing of current Food and Drug Administration law. The Food and Drug Administration reviews these drugs to determine which are less than effective for their labeled indications. This review process is known as the Drug Efficacy Study Implementation program. This program has resulted in the Food and Drug Administration classifying some of these drugs as less than effective Drug Efficacy Study Implementation program drugs. Medicare Part D does not pay for prescription drug products classified by the Food and Drug Administrations Drug Efficacy Study Implementation program as less than effective for their labeled indications. Medicare Part D also does not pay for prescription drug products that are identical, related or similar to drugs that are classified as less than effective drugs. [Sections 1860D2(e)(1) and 1927(k)(2) of the Social Security Act; the Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-18, Medicare Prescription Drug Benefit Manual Chapter 6, Sections 10.1 and 10.9]

2024-02-03

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44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

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An at-risk determination is a decision made under a plan sponsors drug management program under the rules at 42 Code of Federal Regulations Section 423.153(f) that involves: 1) Identification of an individual as an at-risk enrollee for prescription drug abuse; 2) A limitation, or the continuation of a limitation, on access to coverage for frequently abused drugs [i.e., an enrollee specific point-of-sale edit or the selection of a prescriber and/or pharmacy for purposes of lock-in]; or 3) Information sharing for subsequent Part D plan enrollments. [Parts C & D Enrollee Grievances, Organization/Coverage Determinations, and Appeals Guidance, Section 40.3]

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

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Part D vaccines may be dispensed and administered in different settings (e.g., by pharmacists in pharmacies, by physicians in physician offices) depending on factors such as state laws regarding the administration of vaccines and product administration complexity. While access to Part D vaccines via a network pharmacy is likely the best method for improving enrollees access to Part D vaccines, Part D sponsors must ensure that enrollees have adequate access to Part D vaccines in physician offices when those Part D vaccines are appropriately dispensed and administered in physician offices. Such access is considered out-of-network access because sponsor networks are defined as pharmacy networks only. [42 Code of Federal Regulations Sections 423.100, 423.120(a), and 423.124; the Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-18, Medicare Prescription Drug Benefit Manual, Chapter 5, Sections 60.1 and 60.2]Since January 1, 2008, the Part D program covers vaccine administration costs associated with Part D vaccines. The Centers for Medicare & Medicaid Services interprets this statutory requirement to mean that the Part D vaccine administration costs are a component of the negotiated price for a Part D-covered vaccine. In other words, the negotiated price for a Part D vaccine will be comprised of the vaccine ingredient cost, a dispensing fee (if applicable), and a vaccine administration fee. This interpretation recognizes the intrinsic linkage that exists between the vaccine and its corresponding administration, since a beneficiary would never purchase a vaccine without the expectation that it would be administered. In general, the Centers for Medicare & Medicaid Services believes that Part D vaccines, including the associated administration costs, should be billed on one claim for both in- and out-of-network situations. For example, if an in-network pharmacy dispenses and administers the vaccine in accordance with state law, the pharmacy would process a single claim to the Part D sponsor and collect from the enrollee any applicable cost-sharing on the vaccine and its administration. Alternatively, if a vaccine is administered outside of the plans Part D pharmacy network, the provider would supply the vaccine, administer it, and then bill the beneficiary for the entire charge, including all components. The beneficiary would, in turn, submit a paper claim to the Part D sponsor for reimbursement for both the vaccine ingredient cost and administration fee. [The Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-18, Medicare Prescription Drug Benefit Manual, Chapter 6, Section 10.14]Part D sponsors may implement drug utilization management tools to determine if a vaccine is necessary; however, in the absence of any information showing previous immunization (i.e., claims data), the Part D sponsor should make payment available for a vaccine and its administration consistent with Advisory Committee on Immunization Practices recommendations. [The Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-18, Medicare Prescription Drug Benefit Manual, Chapter 6, Section 10.14.3]

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

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In order 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: 1) It requires a prescription for dispensing; 2) It is approved by the Food and Drug Administration for safety and effectiveness; 3) It is prescribed for a medically accepted indication; and 4) It is not otherwise excluded from coverage under Part D law and rules. Medical supplies directly associated with delivering insulin to the body, including syringes, needles, alcohol swabs, gauze, and insulin injection delivery devices not otherwise covered under Medicare Part B, such as insulin pens, pen supplies, and needle-free syringes, can satisfy the definition of a Part D drug. However, test strips, lancets and needle disposal systems are not considered medical supplies directly associated with the delivery of insulin for purposes of coverage under Part D. Insulin syringes equipped with a safe needle device, in their entirety (syringe and device), are also Part D drugs and should be managed like any other Part D drug the sponsor places on its formulary. Part D sponsors must make safety enabled insulin syringes available on their formularies for all of their institutionalized beneficiaries. [The Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-18, Medicare Prescription Drug Benefit Manual, Chapter 6, Section 10.5]Medicare defines those drugs or biological products that are eligible for coverage under the prescription drug benefit. A drug prescribed for a Part D eligible individual cannot be considered a covered Part D drug if payment for the drug is available under Medicare Part A or B for that individual (as prescribed and dispensed or administered for the individual). The Centers for Medicare & Medicaid Services interprets this to mean that if payment could be available under Part A (e.g., hospital inpatient, hospice benefit) 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) 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. [Section 1860D-2(e)(2)(B) of the Social Security Act; the Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-18, Medicare Prescription Drug Benefit Manual, Chapter 4, Section 20.2, and Appendix C]

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

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With respect to multi-ingredient compounds, a Part D sponsor must make a determination as to whether the compound is covered under Part D and establish consistent rules for beneficiary payment liabilities for both ingredients of the Part D compound that independently meet the definition of a Part D drug and non-Part D ingredients.A compound that contains at least one ingredient covered under Part B as prescribed and dispensed or administered is considered a Part B compound, regardless of whether other ingredients in the compound are covered under Part B as prescribed and dispensed or administered. Only compounds that contain at least one ingredient that independently meets the definition of a Part D drug, and that do not include at least one ingredient that would be covered under Part B, may be covered under Part D. For purposes of this paragraph, these compounds are referred to as Part D compounds.For a Part D compound to be considered on-formulary, all ingredients that independently meet the definition of a Part D drug must be considered on-formulary (even if the particular Part D drug would be considered off-formulary if it were provided separately that is, not as part of the Part D compound). For a Part D compound that is considered off-formulary, transition rules apply such that all ingredients in the Part D compound that independently meet the definition of a Part D drug must become payable in the event of a transition fill under Section 423.120(b)(3), and all ingredients that independently meet the definition of a Part D drug must be covered if an exception under Section 423.578(b) is approved for coverage of the compound.For low income subsidy beneficiaries, the copayment amount is based on whether the most expensive ingredient that independently meets the definition of a Part D drug in the Part D compound is a generic or brand name drug. For any non-Part D ingredient of the Part D compound, the Part D sponsor's contract with the pharmacy must prohibit balance billing the beneficiary for the cost of any such ingredients. [42 Code of Federal Regulations Section 423.120]Compounded prescription drug products can contain: 1) All Part D drug product components; 2) Some Part D drug product components; or 3) No Part D drug product components. As defined in 42 Code of Federal Regulations Section 423.120(d), only compounds that contain at least one ingredient that independently meets the definition of a Part D drug, and that do not contain any ingredients covered under Part B as prescribed and dispensed or administered, may be covered under Part D. Only costs associated with those components that satisfy the definition of a Part D drug are allowable costs under Part D because the compounded products as a whole do not satisfy the definition of a Part D drug. For a Part D compound to be considered on-formulary, all ingredients that independently meet the definition of a Part D drug must be considered on-formulary. Bulk powders (i.e., active pharmaceutical ingredients for compounding) do not satisfy the definition of a Part D drug and are not covered by Part D. For any non-Part D ingredient of the Part D compound, the Part D sponsors contract with the pharmacy must prohibit balance billing the beneficiary for the cost of any such ingredients. Sponsors treating compounds as non-formulary products should be applying the cost sharing associated with an exceptions tier, regardless of whether the compound contains brand name or generic products. For a Part D compound considered off-formulary, transition rules apply such that all ingredients that independently meet the definition of a Part D drug must become payable in the event of a transition fill and be covered if an exception under 42 Code of Federal Regulations Section 423.578(b) is approved for coverage of the compound. The labor costs associated with mixing a compounded product that contains at least one Part D drug component can be included in the dispensing fee (as defined in 42 Code of Federal Regulations Section 423.100). For compounds containing all generic products, the generic cost-sharing should be applied. If a compound contains any brand name products, the Part D sponsor may apply the higher brand name cost-sharing to the entire compound. For low income subsidy beneficiaries the copayment amount is based on whether the most expensive ingredient that independently meets the definition of a Part D drug in the Part D compound is a generic or brand name drug. [The Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-18, Medicare Prescription Drug Benefit Manual, Chapter 6, Section 10.4]

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

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