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Under Medicare rules, a Part D sponsor must provide enrollees with standard prescription drug coverage. The benefits may be provided directly by the Part D sponsor or through arrangements with other entities. Standard prescription drug coverage includes access to negotiated prices, provides coverage of Part D drugs, and annual deductible requirements. For 2006, $250; or for years subsequent to 2006, the amount specified in this paragraph for the previous year, increased by the annual percentage increase, and rounded to the nearest multiple of $5. The annual percentage increase for each year is equal to the annual percentage increase in average per capita aggregate expenditures for Part D drugs in the United States for Part D eligible individuals and is based on data for the 12-month period ending in July of the previous year. [42 Code of Federal Regulations 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

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The Medicare Coverage Gap Discount Program Agreement (or Discount Program Agreement) between the manufacturer and the Centers for Medicare & Medicaid Services must contain the provisions specified in paragraph (b) of this section, and may contain such other provisions as are established in a model agreement consistent with section 1860D-14A (a)(1) of the Act. [42 Code of Federal Regulations, Section 423.2315]

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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Medicare rules state that an applicable beneficiary is defined as an individual who, on the date of dispensing a covered Part D drug: 1) Is enrolled in a prescription drug plan or an MA-PD plan; 2) Is not enrolled in a qualified retiree prescription drug plan; 3) Is not entitled to an income-related subsidy under section 1860D-14(a) of the Social Security Act; 4) Has reached or exceeded the initial coverage limit under section 1860D-2(b)(3) of the Act during the year; 5) Has not incurred costs for covered Part D drugs in the year equal to the annual out-of-pocket threshold specified in section 1860D-2(b)(4)(B) of the Social Security Act; and 6) Has a claim that- (i) Is within the coverage gap; (ii) Straddles the initial coverage period and the coverage gap; (iii) Straddles the coverage gap and the annual out-of-pocket threshold; or (iv) Spans the coverage gap from the initial coverage period and exceeds the annual out-of-pocket threshold. [Medicare Prescription Drug Benefit Manual, Chapter 5, Section 10.2]

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

Under Medicare rules, a Part D sponsor must provide enrollees with standard prescription drug coverage. The benefits may be provided directly by the Part D sponsor or through arrangements with other entities. Standard prescription drug coverage includes access to negotiated prices, provides coverage of Part D drugs, and includes protection against high out-of-pocket expenditures. After an enrollee's incurred costs exceed the annual out-of-pocket threshold described in paragraph (d)(5)(iii) of this Section, the cost-sharing amount is equal to the greater of: 1) In 2006, $2 for a generic drug or preferred drug that is a multiple source drug and $5 for any other drug; and 2) For subsequent years, the copayment amounts specified in this paragraph for the previous year increased by the annual percentage increase and rounded to the nearest multiple of five cents; or for coinsurance, it is five percent of actual cost. A Part D plan may substitute for cost-sharing an amount that is actuarially equivalent to expected cost-sharing. [42 Code of Federal Regulations Section 423.104]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

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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The Part D plan sponsor grants 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: 1) Would not be as effective for the enrollee as the requested drug; 2) Would have adverse effects for the enrollee; or 3) Both.If the physician or other prescriber provides an oral supporting statement, the Part D plan sponsor may require the physician or other prescriber to subsequently provide a written supporting statement. The Part D plan sponsor may require the prescribing physician or other prescriber to provide additional supporting medical documentation as part of the written follow-up. [42 Code of Federal Regulations Section 423.578(a)(4)-(5)]

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

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A Part D sponsor must provide enrollees with standard prescription drug coverage. The benefits may be provided directly by the Part D sponsor or through arrangements with other entities. Standard prescription drug coverage includes access to negotiated prices, provides coverage of Part D drugs, and includes cost-sharing in the coverage gap for applicable beneficiaries. Coinsurance in the coverage gap for costs for covered Part D drugs that are not applicable drugs under the Medicare coverage gap discount program that is: A) Equal to the generic gap coinsurance percentage; or B) Actuarially equivalent to an average expected coinsurance for covered Part D drugs that are not applicable drugs under the Medicare coverage gap discount program. The generic gap coinsurance percentage is equal to: A) For 2011, 93 percent; B) For years 2012 through 2019, the amount specified in this paragraph for the previous year, decreased by seven percentage points; or C) For 2020 and each subsequent year, 25 percent. The applicable gap coinsurance percentage is equal to: 1) For 2013 and 2014, 97.5 percent; 2) For 2015 and 2016, 95 percent; 3) For 2017, 90 percent; 4) For 2018, 85 percent; 5) For 2019, 80 percent; or 6) For 2020 and subsequent years, 75 percent. [42 Code of Federal Regulations Section 423.104]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

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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Full subsidy eligible individuals are entitled to elimination or the annual deductible and reduction in cost-sharing for all covered Part D drugs under the prescription drug plan or Medicare Advantage prescription drug plan below the out-of-pocket limit, including Part D drugs covered under the prescription drug plan or Medicare Advantage prescription drug plan obtained after the initial coverage limit. Copayment amounts are not to exceed the copayment amounts specified in the Code of Federal Regulations Section 423.104(d)(5)(A). This applies to both full-benefit dual eligible individuals who are not institutionalized and who have income above 100 percent of the federal poverty line applicable to the individual's family size, and individuals who have income under 135 percent of the federal poverty line applicable to the individual's family size who meet the resources test described at Section 423.773(b)(2). Full-benefit dual-eligible individuals who are institutionalized or who are receiving home and community-based services have no cost-sharing for Part D drugs covered under their prescription drug plan or Medicare Advantage prescription drug plans. Full-benefit dual eligible individuals with incomes that do not exceed 100 percent of the federal poverty line applicable to the individual's family size are subject to cost-sharing for covered Part D drugs equal to the lesser of: 1) A copayment amount of not more than $1 for a generic drug, biological product for which an application under Section 351(k) of the Public Health Service Act [42 United States Code 262(k)] is approved, or preferred drugs that are multiple source [as defined under section 1927(k)(7)(A)(i) of the Social Security Act]; or 2) $3 for any other drug in 2006, or for years after 2006 the amounts specified in this paragraph (a)(2)(iii)(A) for the percentage increase in the Consumer Price Index, rounded to the nearest multiple of 5 cents or 10 cents, respectively; or 3) The copayment amount charged to other individuals under this paragraph (a)(2)(i) of this Section. Full-subsidy eligible individuals are entitled to elimination of all cost-sharing for covered Part D drugs covered under the prescription drug plan or Medicare Advantage prescription drug plan above the out-of-pocket limit.Other low-income subsidy eligible individuals are entitled to the following: 1) In 2006, reduction in the annual deductible to $50. This amount is increased each year beginning in 2007 by the annual percentage increase in average per capita aggregate expenditures for Part D drugs, rounded to the nearest multiple of $1; 2) Fifteen percent coinsurance for all covered Part D drugs obtained after the annual deductible under the plan up to the out-of-pocket limit; 3) For covered Part D drugs above the out-of-pocket limit in 2006, copayments not to exceed $2 for a generic drug, biological product for which an application under Section 351(k) of the Public Health Service Act [42 United States Code 262(k)] is approved, or preferred drugs that are multiple source drugs [as defined under Section 1927(k)(7)(A)(i) of the Social Security Act] and $5 for any other drug. For years beginning in 2007, the amounts specified in this paragraph for the previous years increased by the annual percentage increase in average per capita aggregate expenditures for covered Part D drugs, rounded to the nearest multiple of 5 cents.When the out-of-pocket cost for a covered Part D drug under a Part D sponsor's plan benefit package is less than the maximum allowable copayment, coinsurance or deductible amounts for subsidy eligible individuals, the Part D sponsor may only charge the lower benefit package amount. [42 Code of Federal Regulations Section 423.782]

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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Under Medicare rules, 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. A Part D plan must also 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; and providing the Center for Medicare & Medicaid Services with information concerning the procedures and performance of its drug utilization management program, according to guidelines specified by Center for Medicare & Medicaid Services. 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; and 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; and clinical abuse/misuse.A Part D sponsor must have established a Medication Therapy Management Program that: 1) Is designed to ensure that covered Part D drugs prescribed to targeted beneficiaries previously described are appropriately used to optimize therapeutic outcomes through improved medication use; 2) Is designed to reduce the risk of adverse events, including adverse drug interactions, for targeted beneficiaries previously described; 3) May be furnished by a pharmacist or other qualified provider; 4) May distinguish between services in ambulatory and institutional settings; 5) Must enroll targeted beneficiaries using an opt-out method of enrollment only; 6) Must target beneficiaries for enrollment in the Medication Therapy Management Program at least quarterly during each plan year; and 7) Must offer a minimum level of medication therapy management services for each beneficiary enrolled in the Medication Therapy Management Program. [42 Code of Federal Regulations Section 423.153(a)-(d)]A Part D sponsor is 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 Center 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 Center for Medicare & Medicaid Services where required (see Medicare Prescription Drug Benefit Manual, Chapter 6, Section 30.2.2.1), to make such determinations. A medically accepted indication is defined 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 Act. The recognized compendia are: 1) American Hospital Formulary Service Drug Information, and 2) DRUGDEX Information System. [Section 1860D-2(e)(4) of the Social Security Act and 42 Code of Federal Regulations Section 423.100]

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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A covered Part D drug means a Part D drug that is included in a Part D plans formulary, or treated as being included in a Part D plans formulary as a result of a coverage determination or appeal, and obtained at a network pharmacy or an out-of-network pharmacy. [Title 42 Code of Federal Regulations Section 423.100]The term drugs and the term biologicals, include only such drugs (including contrast agents) and biologicals, respectively, as are included (or approved for inclusion) in the United States Pharmacopoeia, the National Formulary, or the United States Homeopathic Pharmacopoeia, or in New Drugs or Accepted Dental Remedies (except for any drugs and biologicals unfavorably evaluated therein), or as are approved by the pharmacy and drug therapeutics committee (or equivalent committee) of the medical staff of the hospital furnishing such drugs and biologicals for use in such hospital. For purposes of paragraph, the term drugs also includes any drugs or biologicals used in an anticancer chemotherapeutic regimen for a medically accepted indication.The term medically accepted indication, with respect to the use of a drug, includes any use which has been approved by the Food and Drug Administration for the drug, and includes another use of the drug if: 1) The drug has been approved by the Food and Drug Administration; and 2) Such use is supported by one or more citations which are included (or approved for inclusion) in one or more of the following compendia: the American Hospital Formulary Service-Drug Information, the American Medical Association Drug Evaluations, the United States Pharmacopoeia-Drug Information, and other authoritative compendia as identified by the Secretary, unless the Secretary has determined that the use is not medically appropriate or the use is identified as not indicated in one or more such compendia, or 3) The carrier involved determines, based upon guidance provided by the Secretary to carriers for determining accepted uses of drugs, that such use is medically accepted based on supportive clinical evidence in peer reviewed medical literature appearing in publications which have been identified for purposes of this subclause by the Secretary. [Section 1861(t) of the Social Security Act]

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

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Under Medicare rules, Part D sponsors must provide enrollees with access to negotiated prices for covered Part D drugs as part of their qualified prescription drug coverage. This access to negotiated prices must be provided even when no benefits are otherwise payable on behalf of an enrollee due to the application of a deductible or other cost-sharing. Negotiated prices will take into account negotiated price concessions for covered Part D drugs that are passed through to enrollees at the point of sale, such as: 1) Discounts; 2) Direct or indirect subsidies; 3) Rebates; and 4) Other direct or indirect remunerations. In addition, negotiated prices must include any applicable dispensing fees. Although negotiated prices do not have to be made available for drugs that are not covered Part D drugs, they must be made available throughout the benefit including in any phase of the benefit, such as the deductible, in which an enrollee is responsible for 100 percent cost-sharing for all covered Part D drugs. The Part D sponsors must ensure that their payment systems are set up to charge beneficiaries the lesser of a drugs negotiated price or applicable copayment amount in all phases of the benefit. In addition, uniform negotiated prices must be available to plan enrollees for a particular covered Part D drug when purchased from the same pharmacy. In other words, the negotiated price for a particular covered Part D drug purchased at a particular pharmacy must always be the same regardless of what phase of the Part D benefit an enrollee is in. [The Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-18, Medicare Prescription Drug Benefit Manual, Chapter 5, Section 20.6]Medicare rules specifically address the requirement for Part D sponsors to issue standardized cards that may be used by an enrollee to ensure access to negotiated prices. The only way that an enrollee can be assured access to the negotiated price at the point of sale is through online adjudication of the prescription drug claim. Therefore, to ensure access to these negotiated prices, the billing information on the standardized cards issued by the Part D sponsor must be used by the pharmacies at which beneficiaries fill their prescriptions to submit claims to an enrollees plan sponsor (or its intermediary). Thus, another price available to the beneficiary at the point of sale, for instance, the pharmacys cash price, would not be the negotiated price because it is not accessed by the use of the standardized card. Part D sponsors must require their network pharmacies to submit claims to the Part D sponsor or its intermediary whenever the Part D member identification card is presented or is on file at the pharmacy unless the enrollee expressly requests that a particular claim not be submitted to the sponsor or its intermediary. Many benefits accrue to on-line adjudication of prescription drug claims. Not only is it the only way to ensure that enrollees have access to the plans negotiated price at the point of sale, it also: 1) Ensures that proper concurrent drug utilization review (including safety checks) is performed; 2) Promotes accurate true out-of-pocket accounting; 3) Minimizes administrative costs to the Part D sponsors and the Medicare program; and 4) Limits opportunities for fraudulent duplicative claim reimbursements. For cash purchases made at in-network pharmacies, the Centers for Medicare & Medicaid Services expects the enrollee to be responsible for the difference between the cash price and the plans negotiated price. Part D sponsors must provide enrollees with access to negotiated prices used for payment of covered Part D drugs. This requirement limits sponsor reimbursement to the negotiated price for the drug. Although the Centers for Medicare & Medicaid Services believes that use of the Part D benefit is in the best interests of beneficiaries and the Medicare program, the agency also recognizes there may be circumstances when a cash purchase is reasonablesuch as when the pharmacy offers discounted prices through, for example, loyalty programs or pharmacy coupon offers that are not subsidized by purchases of drugs covered by Part D and these prices may be lower than a Part D sponsors negotiated price. Beneficiaries may take advantage of such offers, but the receipt must reflect the actual price paid and the member must submit a request for reimbursement to the plan. In these instances, the plan sponsors reimbursement will be based on the amount paid for the covered Part D drug if purchased at either a network pharmacy or an out-of-network pharmacy. [42 Code of Federal Regulations Section 423.120 and the Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-18, Medicare Prescription Drug Benefit Manual, Chapter 14, Sections 50.4.3 and 50.4]

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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A drug management program must meet all requirements. A sponsor must document its drug management program in written policies and procedures that are approved by the applicable Pharmacy and Therapeutics Committee and reviewed and updated as appropriate. These policies and procedures must address all aspects of the sponsor's drug management program, including but not limited to the following: 1) The appropriate credentials of the clinical staff conducting case management, including that the staff must have a current and unrestricted license to practice within the scope of his or her profession in a state, territory, commonwealth of the United States (that is, Puerto Rico), or the District of Columbia; 2) The necessary and appropriate contents of files for case management, which must include documentation of the substance of prescriber and beneficiary contacts; 3) Monitoring reports and notifications about incoming enrollees who meet the definition of an at-risk beneficiary or a potential at-risk beneficiary in Section 423.100 of the Code of Federal Regulations and responding to requests from other sponsors for information about at-risk beneficiaries and potential at-risk beneficiaries who recently disenrolled from the sponsor's prescription drug benefit plan.The sponsor's clinical staff must conduct case management for each potential at-risk beneficiary for the purpose of engaging in clinical contact with the prescribers of frequently abused drugs and verifying whether a potential at-risk beneficiary is an at-risk beneficiary. The sponsor must do all of the following: A) Send written information to the beneficiary's prescribers that the beneficiary met the clinical guidelines and is a potential at risk beneficiary; B) Elicit information from the prescribers about any factors in the beneficiary's treatment that are relevant to a determination that the beneficiary is an at-risk beneficiary, including whether prescribed medications are appropriate for the beneficiary's medical conditions or the beneficiary is an exempted beneficiary; C) In cases where prescribers have not responded to the inquiry, make reasonable attempts to communicate with the prescribers telephonically and/or by another effective communication method designed to elicit a response from the prescribers within a reasonable period after sending the written information.If a beneficiary was identified as a potential at-risk or an at-risk beneficiary by his or her most recent prior plan and such identification has not been, the sponsor meets the requirements outlined above, so long as the sponsor obtains case management information from the previous sponsor and such information is still clinically adequate and up to date.Aa Part D plan sponsor may do any or all of the following: 1) Implement a point-of-sale claim edit for frequently abused drugs that is specific to an at-risk beneficiary; 2) Limit an at-risk beneficiary's access to coverage for frequently abused drugs to those that are prescribed for the beneficiary by one or more prescribers, dispensed to the beneficiary by one or more network pharmacies, or both.If the sponsor implements an edit as specified above, the sponsor must not cover frequently abused drugs for the beneficiary in excess of the edit, unless the edit is terminated or revised based on a subsequent determination, including a successful appeal.If the sponsor limits the at-risk beneficiary's access to coverage, the sponsor must cover frequently abused drugs for the beneficiary only when they are obtained from the selected pharmacy(ies) or prescriber(s) or both, as applicable: 1) In accordance with all other coverage requirements of the beneficiary's prescription drug benefit plan, unless the limit is terminated or revised based on a subsequent determination, including a successful appeal; and 2) Except as necessary to provide reasonable access. [42 Code of Federal Regulations Sections 423.153(f)(1)-(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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The issue of applicability of Part D coverage has also arisen in the context of inpatients in acute care hospital settings (including long-term care) hospitals, which are certified as acute care hospitals) who have exhausted their Part A inpatient stay benefit, but who require and continue to receive a level of care that qualifies them for a Part A inpatient stay. Drugs provided in an inpatient setting to an individual who has exhausted his or her lifetime inpatient hospital benefit under Part A are not drugs that could be covered under Part A for that individual. Unlike a beneficiary who, for example, chooses not to buy into Part B, there is no way for an individual who has exhausted his or her Part A inpatient stay benefit to obtain coverage under Part A for his or her drugs; therefore, Part D coverage may be available to a Part D enrollee who has exhausted his or her Part A inpatient stay benefit and who remains in that inpatient setting (provided the drug would otherwise be covered under Part D). See Medicare Prescription Drug Benefit Manual, Chapter 5, Section 50.5.4, regarding sponsor contracting requirements when a beneficiary has exhausted inpatient Part A benefit days. [The Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-18, Medicare Prescription Drug Benefit Manual, Chapter 6, Section 20.2.1]

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

Under Medicare rules, a Part D sponsor must provide enrollees with standard prescription drug coverage. The benefits may be provided directly by the Part D sponsor or through arrangements with other entities. Standard prescription drug coverage includes access to negotiated prices, provides coverage of Part D drugs, and includes protection against high out-of-pocket expenditures. The annual out-of-pocket threshold equals: A) For 2006, $3,600; B) For each year 2007 through 2013, the amount specified in this paragraph for the previous year, increased by the annual percentage; C) For years 2014 and 2015, the amount specified in this paragraph for the previous year, increased by the annual percentage increase, minus 0.25 percentage point; D) For each year 2016 through 2019, the amount specified in this paragraph for the previous year, increased by the lesser of the annual percentage increase plus two percentage points, or the annual percentage increase; E) For 2020, the amount specified in this paragraph for 2013 increased by the annual percentage increases for 2014 through 2020, and rounded to the nearest $50; or F) For 2021 and subsequent years, the amount specified in this paragraph for the previous year, increased by the annual percentage increase, and rounded to the nearest $50. The annual percentage increase for each year is equal to the annual percentage increase in average per capita aggregate expenditures for Part D drugs in the United States for Part D eligible individuals and is based on data for the 12-month period ending in July of the previous year. [42 Code of Federal Regulations Section 423.104]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 Centers for Medicare & Medicaid Services determines. While this is the principal purpose of Coordination of Benefits within the contexts of Medicare Parts A and B, Coordination of Benefits also serves an additional function within the Part D context: it 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, AIDS Drug Assistance Programs, or a bona fide charity as defined in the Centers for Medicare & Medicaid Services regulations. Costs do not count 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. [The Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-06, Medicare Prescription Drug Benefit Manual, Chapter 14, Section 20]

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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Potential at-risk beneficiaries and at-risk beneficiaries are identified by the Centers for Medicare & Medicaid Services or a Part D sponsor using clinical guidelines that: 1) Are developed with stakeholder consultation; 2) Are based on the acquisition of frequently abused drugs from multiple prescribers, multiple pharmacies, the level of frequently abused drugs used, or any combination of this factors; 3) Are derived from expert opinion and an analysis of Medicare data; and 4) Include a program size estimate. [42 Code of Federal Regulations Section 423.153(f)(16)]

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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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

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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A sponsor may not limit the access of an at-risk beneficiary to coverage for frequently abused drugs unless the sponsor has done all of the following: A) Conducted case management and updated it, if necessary; B) Except in the case of a pharmacy limitation imposed, obtained the agreement of at least one prescriber of frequently abused drugs for the beneficiary that the specific limitation is appropriate; and C) Provided the notices to the beneficiary in compliance with the rules set forth in the Code of Federal Regulations. Except when involving a prescriber limitation, if the sponsor has complied with the requirements involving attempts to reach prescribers, and the prescribers were not responsive after three attempts by the sponsor to contact them within 10 business days, then the sponsor has met the requirement for eliciting information from the prescribers. The sponsor may not implement a prescriber limitation if no prescriber was responsive. [42 Code of Federal Regulations Section 423.153(f)(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

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Under Medicare rules, 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. A Part D plan must also 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; and providing the Center for Medicare & Medicaid Services with information concerning the procedures and performance of its drug utilization management program, according to guidelines specified by Center for Medicare & Medicaid Services. 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; and 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; and clinical abuse/misuse.A Part D sponsor must have established a Medication Therapy Management Program that: 1) Is designed to ensure that covered Part D drugs prescribed to targeted beneficiaries previously described are appropriately used to optimize therapeutic outcomes through improved medication use; 2) Is designed to reduce the risk of adverse events, including adverse drug interactions, for targeted beneficiaries previously described; 3) May be furnished by a pharmacist or other qualified provider; 4) May distinguish between services in ambulatory and institutional settings; 5) Must enroll targeted beneficiaries using an opt-out method of enrollment only; 6) Must target beneficiaries for enrollment in the Medication Therapy Management Program at least quarterly during each plan year; and 7) Must offer a minimum level of medication therapy management services for each beneficiary enrolled in the Medication Therapy Management Program. [42 Code of Federal Regulations Section 423.153(a)-(d)]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. [42 Code of Federal Regulations Sections 423.578(a)(4) and 423.578(a)(6); Center for Medicare & Medicaid Services Internet-Only Manual, Publication 100-18, Medicare Prescription Drug Manual, Chapter 4, Section 30.2.4]A Part D sponsor is 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 Center 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 Center for Medicare & Medicaid Services where required (see Medicare Prescription Drug Benefit Manual, Chapter 6, Section 30.2.2.1), to make such determinations. A medically accepted indication is defined 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 Act. The recognized compendia are: 1) American Hospital Formulary Service Drug Information, and 2) DRUGDEX Information System. [Section 1860D-2(e)(4) of the Social Security Act and 42 Code of Federal Regulations Section 423.100]

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

Clinical trials that meet the qualifying criteria will receive Medicare coverage of routine costs after the trial's lead principal investigator certifies that the trial meets the criteria. This process will require the principal investigator to enroll the trial in a Medicare clinical trials registry, currently under development. Some clinical trials are automatically qualified to receive Medicare coverage of their routine costs because they have been deemed by Agency for Healthcare Research and Quality (AHRQ), in consultation with the other agencies represented on the multi-agency panel to be highly likely to have the above listed seven desirable characteristics of clinical trials. The principal investigators of these automatically qualified trials do not need to certify that the trials meet the qualifying criteria, but must enroll the trials in the Medicare clinical trials registry for administrative purposes, once the registry is established. Effective September 19, 2000, clinical trials that are deemed to be automatically qualified are: 1) Trials funded by National Institutes of Health, Centers for Disease Control and Prevention, AHRQ, the Centers for Medicare & Medicaid Services, Department of Defense, and the Department of Veterans Affairs; 2) Trials supported by centers or cooperative groups that are funded by the NIH, CDC, AHRQ, CMS, DOD and VA; 3)Trials conducted under an investigational new drug application (IND) reviewed by the Food and Drug Administration; and 4) Drug trials that are exempt from having an IND under 21 Code of Federal Regulations Section 312.2(b)(1) will be deemed automatically qualified until the qualifying criteria are developed and the certification process is in place. At that time the principal investigators of these trials must certify that the trials meet the qualifying criteria in order to maintain Medicare coverage of routine costs. This certification process will only affect the future status of the trial and will not be used to retroactively change the earlier deemed status. [Section 1142 of the Social Security Act; 21 Code of Federal Regulations Section 312.2(b)(1)]

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

The Centers for Medicare & Medicaid Services is aware that it may be difficult for Part D sponsors to distinguish between new prescriptions for non-formulary Part D drugs and refills for ongoing drug therapy involving non-formulary Part D drugs. The Centers for Medicare & Medicaid Services believes a minimum of a 108-day look-back (consistent with other reviews) is typically needed to adequately document ongoing drug therapy. Although Part D sponsors may be able to access prior drug claims history for an enrollee of an affiliated plan, or may attempt to follow up with prescribing physicians and pharmacies to ascertain the status of a prescription presented during the transition period, the Centers for Medicare & Medicaid Services clarifies that if a sponsor is unable to make this distinction at the point of sale, the sponsor is required to provide the enrollee with a transition fill. In other words, for transition purposes, a brand-new prescription for a non-formulary drug will not be treated any differently than an ongoing prescription for a non-formulary drug when a distinction cannot be made at the point of sale. Generally, a sponsor may apply any Centers for Medicare & Medicaid Services approved prior authorization or step therapy after the transition fill has been satisfied if the sponsor determines that the transition fill was the first fill. However, for protected class drugs that are subject to prior authorization or step therapy on new starts only, in accordance with the Medicare Prescription Drug Benefit Manual, Chapter 6, Section 30.2.5, if a sponsor allows an initial fill because it cannot determine at the point of sale that an enrollee is not currently taking the protected class drug (during transition or otherwise), the sponsor shall treat such enrollees as currently taking the drug. Therefore, any protected class PA or ST requirements for new starts are no longer applicable after the first fill has been provided. [The Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-18, Medicare Prescription Drug Benefit Manual, Chapter 6, Section 30.4.3]

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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A Part D sponsor must provide enrollees with standard prescription drug coverage. The benefits may be provided directly by the Part D sponsor or through arrangements with other entities. Standard prescription drug coverage includes access to negotiated prices, provides coverage of Part D drugs, and includes cost-sharing under the initial coverage limit. Subject to cost-sharing in the coverage gap for applicable beneficiaries, coinsurance for actual costs for covered Part D drugs covered under the Part D plan above the annual deductible, and up to the initial coverage limit, that is: A) Equal to 25 percent of actual cost; or B) Actuarially equivalent to an average expected coinsurance of no more than 25 percent of actual cost, as determined through processes and methods established under 42 Code of Federal Regulations Section 423.265(c) and (d). A Part D plan providing actuarially equivalent standard coverage may apply tiered copayments, provided that any tiered copayments are consistent with Medicare rules and are approved as described in 42 Code of Federal Regulations Section 423.272(b)(2). Tiered cost sharing may not exceed levels annually determined by the Centers for Medicare & Medicaid Services to be discriminatory. [42 Code of Federal Regulations Section 423.104]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

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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Medicare rules set forth the requirements and limitations for payments by and on behalf of low-income Medicare beneficiaries who enroll in a Part D plan. In general, an individual that meets requirements under Medicare's low income subsidy rules is entitled to a reduction or elimination in the premium, a reduction or elimination in the annual deductible, a reduction in cost-sharing for all covered Part D drugs below the out-of-pocket limit, and a reduction or elimination in cost-sharing for covered Part D drugs above the out-of-pocket limit. The extent of reduction in these benefits depends on an individual's income and resources. Determinations of eligibility for subsidies are made either by the state (if the individual applies with the Medicaid agency) or by the Social Security Administration (if the individual applies with that agency). [42 Code of Federal Regulations Sections 423.771 through 423.782] A subsidy eligible individual is a Part D eligible individual residing in a state who is enrolled in, or seeking to enroll in a Part D plan and meets the following requirements: 1) Has income below 150 percent of the federal poverty line applicable to the individual's family size; 2) Has resources at or below the resource thresholds for full subsidy or low-income subsidy as described below.Low income subsidy individuals are subsidy eligible individuals who have income less than 150 percent of the federal poverty line applicable to the individual's family size and have resources that do not exceed: 1) For 2006, $10,000 if single or $20,000 if married (including the assets or resources of the individual's spouse); 2) For subsequent years, the resource amount allowable for the previous year, increased by the annual percentage increase in the consumer price index (all items, United States city average) as of September of the previous year, rounded to the nearest multiple of $10. The nearest multiple will be rounded up if it is equal to or greater than $5 and down if it is less than $5.For an individual deemed eligible between January 1 and June 30 of a calendar year, the individual is deemed eligible for a full subsidy for the remainder of the calendar year. For an individual deemed eligible between July 1 and December 31 of a calendar year, the individual is deemed eligible for the remainder of the calendar year and the following calendar year. [42 Code of Federal Regulations Section 423.773]

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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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 Enrollee 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

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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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 the Centers for Medicare and Medicaid Services, Parts C & D Enrollee Grievances, Organization/Coverage Determinations, and Appeals Guidance, Section 10.6.

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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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 6, 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

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

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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 Enrollee 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 6, Section 30.2.4]

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

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 6, Section 10.6]

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

Under Medicare rules, 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. A Part D plan must also 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; and providing the Center for Medicare & Medicaid Services with information concerning the procedures and performance of its drug utilization management program, according to guidelines specified by Center for Medicare & Medicaid Services. 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; and 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; and clinical abuse/misuse.A Part D sponsor must have established a Medication Therapy Management Program that: 1) Is designed to ensure that covered Part D drugs prescribed to targeted beneficiaries previously described are appropriately used to optimize therapeutic outcomes through improved medication use; 2) Is designed to reduce the risk of adverse events, including adverse drug interactions, for targeted beneficiaries previously described; 3) May be furnished by a pharmacist or other qualified provider; 4) May distinguish between services in ambulatory and institutional settings; 5) Must enroll targeted beneficiaries using an opt-out method of enrollment only; 6) Must target beneficiaries for enrollment in the Medication Therapy Management Program at least quarterly during each plan year; and 7) Must offer a minimum level of medication therapy management services for each beneficiary enrolled in the Medication Therapy Management Program. [42 Code of Federal Regulations Section 423.153(a)-(d)]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. [42 Code of Federal Regulations Sections 423.578(a)(4) and 423.578(a)(6); Center for Medicare & Medicaid Services Internet-Only Manual, Publication 100-18, Medicare Prescription Drug Manual, Chapter 6, Section 30.2.4]A Part D sponsor is 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 Center 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 Center for Medicare & Medicaid Services where required (see Medicare Prescription Drug Benefit Manual, Chapter 6, Section 30.2.2.1), to make such determinations. A medically accepted indication is defined 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 Act. The recognized compendia are: 1) American Hospital Formulary Service Drug Information, and 2) DRUGDEX Information System. [Section 1860D-2(e)(4) of the Social Security Act and 42 Code of Federal Regulations Section 423.100]

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

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 6, 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

unknown

unknown

Medicare rules state that an applicable beneficiary is defined as an individual who, on the date of dispensing a covered Part D drug: 1) Is enrolled in a prescription drug plan or an MA-PD plan; 2) Is not enrolled in a qualified retiree prescription drug plan; 3) Is not entitled to an income-related subsidy under section 1860D-14(a) of the Social Security Act; 4) Has reached or exceeded the initial coverage limit under section 1860D-2(b)(3) of the Act during the year; 5) Has not incurred costs for covered Part D drugs in the year equal to the annual out-of-pocket threshold specified in section 1860D-2(b)(4)(B) of the Social Security Act; and 6) Has a claim that- (i) Is within the coverage gap; (ii) Straddles the initial coverage period and the coverage gap; (iii) Straddles the coverage gap and the annual out-of-pocket threshold. [the Centers for Medicare and Medicaid Services Internet-Only Manual (IOM), Publication 100-18, Medicare Prescription Drug Benefit Manual, Chapter 5, Section 10.2]

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

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 6, 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

unknown

unknown

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 syndrome 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

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

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 Enrollee 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 6, Section 30.2.4]

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

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

unknown

unknown

Medicare rules state that an applicable beneficiary is defined as an individual who, on the date of dispensing a covered Part D drug: 1) Is enrolled in a prescription drug plan or an MA-PD plan; 2) Is not enrolled in a qualified retiree prescription drug plan; 3) Is not entitled to an income-related subsidy under section 1860D-14(a) of the Social Security Act; 4) Has reached or exceeded the initial coverage limit under section 1860D-2(b)(3) of the Act during the year; 5) Has not incurred costs for covered Part D drugs in the year equal to the annual out-of-pocket threshold specified in section 1860D-2(b)(4)(B) of the Social Security Act; and 6) Has a claim that- (i) Is within the coverage gap; (ii) Straddles the initial coverage period and the coverage gap; (iii) Straddles the coverage gap and the annual out-of-pocket threshold. [the Centers for Medicare and Medicaid Services Internet-Only Manual Publication 100-18, Medicare Prescription Drug Benefit Manual, Chapter 5, Section 10.2]

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

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; The Centers for Medicare & Medicaid Services, Parts C & D Enrollee 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 Benefit Manual, Chapter 6, Section 30.2.4]

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

An enrollee who is dissatisfied with the redetermination of a Part D plan sponsor has a right to a reconsideration by an independent review entity that contracts with the Centers for Medicare & Medicaid Services. The prescribing physician or other prescriber (acting on behalf of an enrollee), upon providing notice to the enrollee, may request an independent review entity reconsideration. The enrollee, or the enrollee's prescribing physician or other prescriber (acting on behalf of the enrollee) must file a written request for reconsideration with the IRE within 60 calendar days of the date of the redetermination by the Part D plan sponsor. [42 Code of Federal Regulations Section 423.600(a)]

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

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 Enrollee 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 Benefit Manual, Chapter 6, Section 30.2.4]

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

Under Medicare rules, 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. A Part D plan must also 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; and providing the Center for Medicare & Medicaid Services with information concerning the procedures and performance of its drug utilization management program, according to guidelines specified by Center for Medicare & Medicaid Services. 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; and 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; and clinical abuse/misuse.A Part D sponsor must have established a Medication Therapy Management Program that: 1) Is designed to ensure that covered Part D drugs prescribed to targeted beneficiaries previously described are appropriately used to optimize therapeutic outcomes through improved medication use; 2) Is designed to reduce the risk of adverse events, including adverse drug interactions, for targeted beneficiaries previously described; 3) May be furnished by a pharmacist or other qualified provider; 4) May distinguish between services in ambulatory and institutional settings; 5) Must enroll targeted beneficiaries using an opt-out method of enrollment only; 6) Must target beneficiaries for enrollment in the Medication Therapy Management Program at least quarterly during each plan year; and 7) Must offer a minimum level of medication therapy management services for each beneficiary enrolled in the Medication Therapy Management Program. [42 Code of Federal Regulations Section 423.153(a)-(d)]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. [42 Code of Federal Regulations Sections 423.578(a)(4) and 423.578(a)(6); Center for Medicare & Medicaid Services Internet-Only Manual, Publication 100-18, Medicare Prescription Drug Benefit Manual, Chapter 6, Section 30.2.4]A Part D sponsor is 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 Center 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 Center for Medicare & Medicaid Services where required (see Medicare Prescription Drug Benefit Manual, Chapter 6, Section 30.2.2.1), to make such determinations. A medically accepted indication is defined 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 Act. The recognized compendia are: 1) American Hospital Formulary Service Drug Information, and 2) DRUGDEX Information System. [Section 1860D-2(e)(4) of the Social Security Act and 42 Code of Federal Regulations Section 423.100]

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

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 applies 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 the Centers for Medicare and Medicaid Services, Parts C & D Enrollee Grievances, Organization/Coverage Determinations, and Appeals Guidance, Section 10.6.

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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Under Medicare rules, 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. A Part D plan must also 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; and providing the Centers for Medicare & Medicaid Services with information concerning the procedures and performance of its drug utilization management program, according to guidelines specified by the Centers for Medicare & Medicaid Services. 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; and 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; and clinical abuse/misuse.A Part D sponsor must have established a Medication Therapy Management Program that: 1) Is designed to ensure that covered Part D drugs prescribed to targeted beneficiaries previously described are appropriately used to optimize therapeutic outcomes through improved medication use; 2) Is designed to reduce the risk of adverse events, including adverse drug interactions, for targeted beneficiaries previously described; 3) May be furnished by a pharmacist or other qualified provider; 4) May distinguish between services in ambulatory and institutional settings; 5) Must enroll targeted beneficiaries using an opt-out method of enrollment only; 6) Must target beneficiaries for enrollment in the Medication Therapy Management Program at least quarterly during each plan year; and 7) Must offer a minimum level of medication therapy management services for each beneficiary enrolled in the Medication Therapy Management Program. [42 Code of Federal Regulations Section 423.153(a)-(d)]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. [42 Code of Federal Regulations Sections 423.578(a)(4) and 423.578(a)(6); the Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-18, Medicare Prescription Drug Benefit Manual, Chapter 6, Section 30.2.4]A Part D sponsor is 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. A medically accepted indication is defined 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 Act. The recognized compendia are: 1) American Hospital Formulary Service Drug Information, and 2) DRUGDEX Information System. [Section 1860D-2(e)(4) of the Social Security Act and 42 Code of Federal Regulations Section 423.100]

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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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 6, 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 Benefit Policy Manual, Chapter 15, Section 110.3]

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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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 42 Code of Federal Regulations 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 42 Code of Federal Regulations 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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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 Centers 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

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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Management Program. A Part D plan must also 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; and providing the Centers for Medicare & Medicaid Services with information concerning the procedures and performance of its drug utilization management program, according to guidelines specified by the Centers for Medicare & Medicaid Services. 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; and 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; and clinical abuse/misuse.A Part D sponsor must have established a Medication Therapy Management Program that: 1) Is designed to ensure that covered Part D drugs prescribed to targeted beneficiaries previously described are appropriately used to optimize therapeutic outcomes through improved medication use; 2) Is designed to reduce the risk of adverse events, including adverse drug interactions, for targeted beneficiaries previously described; 3) May be furnished by a pharmacist or other qualified provider; 4) May distinguish between services in ambulatory and institutional settings; 5) Must enroll targeted beneficiaries using an opt-out method of enrollment only; 6) Must target beneficiaries for enrollment in the Medication Therapy Management Program at least quarterly during each plan year; and 7) Must offer a minimum level of medication therapy management services for each beneficiary enrolled in the Medication Therapy Management Program. [42 Code of Federal Regulations Section 423.153(a)-(d)]A Part D sponsor is 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 the Centers for Medicare & Medicaid Services Internet-Only Manual, 100-18 Medicare Prescription Drug Benefit Manual, Chapter 6, Section 30.2.2.1), to make such determinations. A medically accepted indication is defined 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 Act. The recognized compendia are: 1) American Hospital Formulary Service Drug Information, and 2) DRUGDEX Information System. [Section 1860D-2(e)(4) of the Social Security Act and 42 Code of Federal Regulations Section 423.100]

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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Under Medicare rules, 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 Code of Federal Regulations Section 423.104). Please refer to the Plan's Evidence of Coverage for their specific rules related to enrollee cost sharing responsibilities.

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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The identification of an at-risk beneficiary as such must terminate as of the earlier of the following: 1) The date the beneficiary demonstrates through a subsequent determination, including but not limited to, a successful appeal, that the beneficiary is no longer likely, in the absence of the limitation under this paragraph, to be an at-risk beneficiary; or 2) The end of a one year period calculated from the effective date of the limitation, unless the limitation was extended; or 3) The end of a two year period calculated from the effective date of the limitation, which is subject to the following requirements: A) The plan sponsor determines at the end of the one year period that there is a clinical basis to extend the limitation; B) Except in the case of a pharmacy limitation, the plan sponsor has obtained the agreement of a prescriber of frequently abused drugs for the beneficiary that the limitation should be extended; C) The plan sponsor has provided another notice to the beneficiary in compliance regulatory requirements; D) If the prescribers were not responsive after three attempts by the sponsor to contact them within 10 business days, then the sponsor has met the regulatory requirements; and E) The sponsor may not extend a prescriber limitation if no prescriber was responsive. [42 Code of Federal Regulations Section 423.153(f)(14)]

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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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 Centers 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

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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A Part D plan must also 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; and providing the Centers for Medicare & Medicaid Services with information concerning the procedures and performance of its drug utilization management program, according to guidelines specified by the Centers for Medicare & Medicaid Services. 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; and 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; and clinical abuse/misuse.A Part D sponsor must have established a Medication Therapy Management Program that: 1) Is designed to ensure that covered Part D drugs prescribed to targeted beneficiaries previously described are appropriately used to optimize therapeutic outcomes through improved medication use; 2) Is designed to reduce the risk of adverse events, including adverse drug interactions, for targeted beneficiaries previously described; 3) May be furnished by a pharmacist or other qualified provider; 4) May distinguish between services in ambulatory and institutional settings; 5) Must enroll targeted beneficiaries using an opt-out method of enrollment only; 6) Must target beneficiaries for enrollment in the Medication Therapy Management Program at least quarterly during each plan year; and 7) Must offer a minimum level of medication therapy management services for each beneficiary enrolled in the Medication Therapy Management Program. [42 Code of Federal Regulations Section 423.153(a)-(d)]A Part D sponsor is 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 the Centers for Medicare & Medicaid Services Internet-Only Manual, 100-18 Medicare Prescription Drug Benefit Manual, Chapter 6, Section 30.2.2.1), to make such determinations. A medically accepted indication is defined 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 Act. The recognized compendia are: 1) American Hospital Formulary Service Drug Information, and 2) DRUGDEX Information System. [Section 1860D-2(e)(4) of the Social Security Act and 42 Code of Federal Regulations Section 423.100]

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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Medicare rules state that an applicable beneficiary is defined as an individual who, on the date of dispensing a covered Part D drug: 1) Is enrolled in a prescription drug plan or an MA-PD plan; 2) Is not enrolled in a qualified retiree prescription drug plan; 3) Is not entitled to an income-related subsidy under section 1860D-14(a) of the Social Security Act; 4) Has reached or exceeded the initial coverage limit under section 1860D-2(b)(3) of the Social Security Act during the year; 5) Has not incurred costs for covered Part D drugs in the year equal to the annual out-of-pocket threshold specified in section 1860D-2(b)(4)(B) of the Social Security Act; and 6) Has a claim that- (i) Is within the coverage gap; (ii) Straddles the initial coverage period and the coverage gap; (iii) Straddles the coverage gap and the annual out-of-pocket threshold. [The Centers for Medicare and Medicaid Services Internet-Only Manual (IOM), Publication 100-18, Medicare Prescription Drug Benefit Manual, Chapter 5, Section 10.2]

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

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A subsidy eligible individual is a Part D eligible individual residing in a state who is enrolled in, or seeking to enroll in a Part D plan and meets the following requirements: 1) Has income below 150 percent of the federal poverty line applicable to the individual's family size; 2) Has resources at or below the resource thresholds for full subsidy or low-income subsidy as described below.A full subsidy eligible individual is a subsidy eligible individual who has income below 135 percent of the federal poverty line applicable to the individual's family size and has resources that do not exceed: A) For 2006, three times the amount of resources an individual may have and still be eligible for benefits under the Supplemental Security Income program under title XVI of the Social Security Act (including the assets or resources of the individual's spouse); B) For subsequent years, the amount of resources allowable for the previous year increased by the annual percentage increase in the consumer price index (all items, United States city average) as of September of that previous year, rounded to the nearest multiple of $10. The nearest multiple are rounded up if it is equal to or greater than $5 and down if it is less than $5. An individual must be treated as meeting the eligibility requirements for full subsidy eligible individuals if the individual is a: a) Full-benefit dual eligible individual; b) Beneficiary of Supplemental Security Income benefits under title XVI of the Social Security Act; or c) Eligible for Medicaid as a Qualified Medicare Beneficiary, Specified Low Income Medicare Beneficiary, or a Qualifying Individual under a state's plan.For an individual deemed eligible between January 1 and June 30 of a calendar year, the individual is deemed eligible for a full subsidy for the remainder of the calendar year. For an individual deemed eligible between July 1 and December 31 of a calendar year, the individual is deemed eligible for the remainder of the calendar year and the following calendar year. [42 Code of Federal Regulations Section 423.773]

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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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 the Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-18, 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

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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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 applies 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 the Centers for Medicare & Medicaid Services, Parts C & D Enrollee Grievances, Organization/Coverage Determinations, and Appeals Guidance Manual, Section 10.6.

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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Under Medicare rules, 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. A Part D plan must also 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; and providing the Centers for Medicare & Medicaid Services with information concerning the procedures and performance of its drug utilization management program, according to guidelines specified by the Centers for Medicare & Medicaid Services. 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; and 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; and clinical abuse/misuse.A Part D sponsor must have established a Medication Therapy Management Program that: 1) Is designed to ensure that covered Part D drugs prescribed to targeted beneficiaries previously described are appropriately used to optimize therapeutic outcomes through improved medication use; 2) Is designed to reduce the risk of adverse events, including adverse drug interactions, for targeted beneficiaries previously described; 3) May be furnished by a pharmacist or other qualified provider; 4) May distinguish between services in ambulatory and institutional settings; 5) Must enroll targeted beneficiaries using an opt-out method of enrollment only; 6) Must target beneficiaries for enrollment in the Medication Therapy Management Program at least quarterly during each plan year; and 7) Must offer a minimum level of medication therapy management services for each beneficiary enrolled in the Medication Therapy Management Program. [42 Code of Federal Regulations Section 423.153(a)-(d)]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. [42 Code of Federal Regulations Sections 423.578(a)(4) and 423.578(a)(6); the Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-18, Medicare Prescription Drug Benefit Manual, Chapter 6, Section 30.2.4]A Part D sponsor is 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 the Centers for Medicare & Medicaid Services Internet Only Manual Publication 100-18, Medicare Prescription Drug Benefit Manual, Chapter 6, Section 30.2.2.1), to make such determinations. A medically accepted indication is defined 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 Act. The recognized compendia are: 1) American Hospital Formulary Service Drug Information, and 2) DRUGDEX Information System. [Section 1860D-2(e)(4) of the Social Security Act and 42 Code of Federal Regulations Section 423.100]

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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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

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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Under Medicare rules, a Part D sponsor must provide enrollees with standard prescription drug coverage. The benefits may be provided directly by the Part D sponsor or through arrangements with other entities. Standard prescription drug coverage includes access to negotiated prices, provides coverage of Part D drugs, and initial coverage limits. Except as previously provided, the initial coverage limit is equal to $2,250 for 2006; and for years subsequent to 2006,the amount specified in this paragraph for the previous year, increased by the annual percentage increase, and rounded to the nearest multiple of $10. The annual percentage increase for each year is equal to the annual percentage increase in average per capita aggregate expenditures for Part D drugs in the United States for Part D eligible individuals and is based on data for the 12-month period ending in July of the previous year. [42 Code of Federal Regulations 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

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Medicare rules state that an applicable beneficiary is defined as an individual who, on the date of dispensing a covered Part D drug: 1) Is enrolled in a prescription drug plan or an MA-PD plan; 2) Is not enrolled in a qualified retiree prescription drug plan; 3) Is not entitled to an income-related subsidy under section 1860D-14(a) of the Social Security Act; 4) Has reached or exceeded the initial coverage limit under section 1860D-2(b)(3) of the Social Security Act during the year; 5) Has not incurred costs for covered Part D drugs in the year equal to the annual out-of-pocket threshold specified in section 1860D-2(b)(4)(B) of the Social Security Act; and 6) Has a claim that- (i) Is within the coverage gap; (ii) Straddles the initial coverage period and the coverage gap; (iii) Straddles the coverage gap and the annual out-of-pocket threshold. [The Centers for Medicare & Medicaid Services Internet-Only Manual (IOM), Publication 100-18, Medicare Prescription Drug Benefit Manual, Chapter 5, Section 10.2]

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

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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. [The Centers for Medicare & Medicaid Services, Parts C & D Enrollee Grievances, Organization/Coverage Determinations, and Appeals Guidance Manual, 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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A drug management program must meet all requirements. A sponsor must document its drug management program in written policies and procedures that are approved by the applicable Pharmacy and Therapeutics Committee and reviewed and updated as appropriate. These policies and procedures must address all aspects of the sponsor's drug management program, including but not limited to the following: 1) The appropriate credentials of the clinical staff conducting case management, including that the staff must have a current and unrestricted license to practice within the scope of his or her profession in a state, territory, commonwealth of the United States (that is, Puerto Rico), or the District of Columbia; 2) The necessary and appropriate contents of files for case management, which must include documentation of the substance of prescriber and beneficiary contacts; 3) Monitoring reports and notifications about incoming enrollees who meet the definition of an at-risk beneficiary or a potential at-risk beneficiary in Section 423.100 of the Code of Federal Regulations and responding to requests from other sponsors for information about at-risk beneficiaries and potential at-risk beneficiaries who recently disenrolled from the sponsor's prescription drug benefit plan.The sponsor's clinical staff must conduct case management for each potential at-risk beneficiary for the purpose of engaging in clinical contact with the prescribers of frequently abused drugs and verifying whether a potential at-risk beneficiary is an at-risk beneficiary. The sponsor must do all of the following: A) Send written information to the beneficiary's prescribers that the beneficiary met the clinical guidelines and is a potential at risk beneficiary; B) Elicit information from the prescribers about any factors in the beneficiary's treatment that are relevant to a determination that the beneficiary is an at-risk beneficiary, including whether prescribed medications are appropriate for the beneficiary's medical conditions or the beneficiary is an exempted beneficiary; C) In cases where prescribers have not responded to the inquiry, make reasonable attempts to communicate with the prescribers telephonically and/or by another effective communication method designed to elicit a response from the prescribers within a reasonable period after sending the written information.If a beneficiary was identified as a potential at-risk or an at-risk beneficiary by his or her most recent prior plan and such identification has not been, the sponsor meets the requirements outlined above, so long as the sponsor obtains case management information from the previous sponsor and such information is still clinically adequate and up to date.A Part D plan sponsor may do any or all of the following: 1) Implement a point-of-sale claim edit for frequently abused drugs that is specific to an at-risk beneficiary; 2) Limit an at-risk beneficiary's access to coverage for frequently abused drugs to those that are prescribed for the beneficiary by one or more prescribers, dispensed to the beneficiary by one or more network pharmacies, or both.If the sponsor implements an edit as specified above, the sponsor must not cover frequently abused drugs for the beneficiary in excess of the edit, unless the edit is terminated or revised based on a subsequent determination, including a successful appeal.If the sponsor limits the at-risk beneficiary's access to coverage, the sponsor must cover frequently abused drugs for the beneficiary only when they are obtained from the selected pharmacy(ies) or prescriber(s) or both, as applicable: 1) In accordance with all other coverage requirements of the beneficiary's prescription drug benefit plan, unless the limit is terminated or revised based on a subsequent determination, including a successful appeal; and 2) Except as necessary to provide reasonable access. [42 Code of Federal Regulations Sections 423.153(f)(1)-(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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Clinical trials that meet the qualifying criteria will receive Medicare coverage of routine costs after the trial's lead principal investigator certifies that the trial meets the criteria. This process will require the principal investigator to enroll the trial in a Medicare clinical trials registry, currently under development. Some clinical trials are automatically qualified to receive Medicare coverage of their routine costs because they have been deemed by Agency for Healthcare Research and Quality (AHRQ), in consultation with the other agencies represented on the multi-agency panel to be highly likely to have the above listed seven desirable characteristics of clinical trials. The principal investigators of these automatically qualified trials do not need to certify that the trials meet the qualifying criteria, but must enroll the trials in the Medicare clinical trials registry for administrative purposes, once the registry is established. Effective September 19, 2000, clinical trials that are deemed to be automatically qualified are: 1) Trials funded by National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), the Agency for Healthcare Research and Quality's (AHRQ), the Centers for Medicare & Medicaid Services (CMS), Department of Defense (DOD), and the Department of Veterans Affairs (VA); 2) Trials supported by centers or cooperative groups that are funded by the NIH, CDC, AHRQ, CMS, DOD and VA; 3)Trials conducted under an investigational new drug application (IND) reviewed by the Food and Drug Administration (FDA); and 4) Drug trials that are exempt from having an IND under 21 Code of Federal Regulations Section 312.2(b)(1) will be deemed automatically qualified until the qualifying criteria are developed and the certification process is in place. At that time the principal investigators of these trials must certify that the trials meet the qualifying criteria in order to maintain Medicare coverage of routine costs. This certification process will only affect the future status of the trial and will not be used to retroactively change the earlier deemed status. [Section 1142 of the Social Security Act; 21 Code of Federal Regulations Section 312.2(b)(1)]

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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Under Medicare rules, a Part D sponsor must provide enrollees with standard prescription drug coverage. The benefits may be provided directly by the Part D sponsor or through arrangements with other entities. Standard prescription drug coverage includes access to negotiated prices, provides coverage of Part D drugs, and includes protection against high out-of-pocket expenditures. The annual out-of-pocket threshold equals: A) For 2006, $3,600; B) For each year 2007 through 2013, the amount specified in this paragraph for the previous year, increased by the annual percentage; C) For years 2014 and 2015, the amount specified in this paragraph for the previous year, increased by the annual percentage increase, minus 0.25 percentage point; D) For each year 2016 through 2019, the amount specified in this paragraph for the previous year, increased by the lesser of the annual percentage increase plus two percentage points, or the annual percentage increase; E) For 2020, the amount specified in this paragraph for 2013 increased by the annual percentage increases for 2014 through 2020, and rounded to the nearest $50; or F) For 2021 and subsequent years, the amount specified in this paragraph for the previous year, increased by the annual percentage increase, and rounded to the nearest $50. The annual percentage increase for each year is equal to the annual percentage increase in average per capita aggregate expenditures for Part D drugs in the United States for Part D eligible individuals and is based on data for the 12-month period ending in July of the previous year. [42 Code of Federal Regulations Section 423.104]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 Centers for Medicare & Medicaid Services determines. While this is the principal purpose of Coordination of Benefits within the contexts of Medicare Parts A and B, Coordination of Benefits also serves an additional function within the Part D context: it 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, AIDS Drug Assistance Programs, or a bona fide charity as defined in the Centers for Medicare & Medicaid Services regulations. Costs do not count 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. [The Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-18, Medicare Prescription Drug Benefit Manual, Chapter 14, Section 20]

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 general, only those accessories for meter dose inhalers, dry powder inhalers, or nasal spray inhalers that are included on the new drug application or abbreviated new drug application, listed on the package insert, and specifically packaged with the drug product itself are eligible to meet the definition of a Part D drug. If the accessories (i.e., actuator, chamber) are sold separately or are not included on the drug products new drug application or abbreviated new drug application, they would not meet the definition of a Part D drug. [The Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-18, Medicare Prescription Drug Benefit Manual, Chapter 6, Section 10.13]

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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The Centers for Medicare & Medicaid Services is aware that it may be difficult for Part D sponsors to distinguish between new prescriptions for non-formulary Part D drugs and refills for ongoing drug therapy involving non-formulary Part D drugs. The Centers for Medicare & Medicaid Services believes a minimum of a 108-day look-back (consistent with other reviews) is typically needed to adequately document ongoing drug therapy. Although Part D sponsors may be able to access prior drug claims history for an enrollee of an affiliated plan, or may attempt to follow up with prescribing physicians and pharmacies to ascertain the status of a prescription presented during the transition period, the Centers for Medicare & Medicaid Services clarifies that if a sponsor is unable to make this distinction at the point of sale, the sponsor is required to provide the enrollee with a transition fill. In other words, for transition purposes, a brand-new prescription for a non-formulary drug will not be treated any differently than an ongoing prescription for a non-formulary drug when a distinction cannot be made at the point of sale. Generally, a sponsor may apply any Centers for Medicare & Medicaid Services approved prior authorization or step therapy after the transition fill has been satisfied if the sponsor determines that the transition fill was the first fill. However, for protected class drugs that are subject to prior authorization or step therapy on new starts only, in accordance with the Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-18, Medicare Prescription Drug Benefit Manual, Chapter 6, Section 30.2.5, if a sponsor allows an initial fill because it cannot determine at the point of sale that an enrollee is not currently taking the protected class drug (during transition or otherwise), the sponsor shall treat such enrollees as currently taking the drug. Therefore, any protected class PA or ST requirements for new starts are no longer applicable after the first fill has been provided. [The Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-18, Medicare Prescription Drug Benefit Manual, Chapter 6, Section 30.4.3]

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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Medicare rules state that an applicable beneficiary is defined as an individual who, on the date of dispensing a covered Part D drug: 1) Is enrolled in a prescription drug plan or a Medicare Advantage Prescription Drug plan; 2) Is not enrolled in a qualified retiree prescription drug plan; 3) Is not entitled to an income-related subsidy under section 1860D-14(a) of the Social Security Act; 4) Has reached or exceeded the initial coverage limit under section 1860D-2(b)(3) of the Social Security Act during the year; 5) Has not incurred costs for covered Part D drugs in the year equal to the annual out-of-pocket threshold specified in section 1860D-2(b)(4)(B) of the Social Security Act; and 6) Has a claim that- (i) Is within the coverage gap; (ii) Straddles the initial coverage period and the coverage gap; (iii) Straddles the coverage gap and the annual out-of-pocket threshold. [The Centers for Medicare & Medicaid Services Internet-Only Manual (IOM), Publication 100-18, Medicare Prescription Drug Benefit Manual, Chapter 5, Section 10.2]

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

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Part D sponsors will be required to provide medically necessary prescription drug treatments for enrollees in the general Medicare population, as well as those enrollees who reside in long term care facilities. For example, it is the Centers for Medicare & Medicaid Services expectation that sponsors provide coverage of dosage forms of drugs that are widely utilized in the long term care setting, such as unit dose products and liquid, chewable, and parenteral preparations. Further, while nebulized solutions may not be required on all formularies, the Centers for Medicare & Medicaid Services would expect sponsors to also cover these dosage forms under circumstances in which Part B coverage is not available. When determining days supplies for residents in long term care facilities, Part D sponsors should follow industry best practices and allow for at least 31 days per fill. [The Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-18, Medicare Prescription Drug Benefit Manual, Chapter 6, Section 30.2.3]

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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The issue of applicability of Part D coverage has also arisen in the context of inpatients in acute care hospital settings (including long-term care) hospitals, which are certified as acute care hospitals) who have exhausted their Part A inpatient stay benefit, but who require and continue to receive a level of care that qualifies them for a Part A inpatient stay. Drugs provided in an inpatient setting to an individual who has exhausted his or her lifetime inpatient hospital benefit under Part A are not drugs that could be covered under Part A for that individual. Unlike a beneficiary who, for example, chooses not to buy into Part B, there is no way for an individual who has exhausted his or her Part A inpatient stay benefit to obtain coverage under Part A for his or her drugs; therefore, Part D coverage may be available to a Part D enrollee who has exhausted his or her Part A inpatient stay benefit and who remains in that inpatient setting (provided the drug would otherwise be covered under Part D). See the Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-18, Medicare Prescription Drug Benefit Manual, Chapter 5, Section 50.5.4, regarding sponsor contracting requirements when a beneficiary has exhausted inpatient Part A benefit days. [The Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-18, Medicare Prescription Drug Benefit Manual, Chapter 6, Section 20.2.1]

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

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