Persius/hicric huggingface dataset:
Appeal type: unknown
Decision: 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]
Appeal type: unknown
Decision: 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]
Appeal type: unknown
Decision: 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)]
Appeal type: unknown
Decision: 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]
Appeal type: unknown
Decision: 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.
Appeal type: unknown
Decision: unknown

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]
Appeal type: unknown
Decision: unknown

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]
Appeal type: unknown
Decision: unknown

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.
Appeal type: unknown
Decision: unknown

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)]
Appeal type: unknown
Decision: unknown

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]
Appeal type: unknown
Decision: 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 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]
Appeal type: unknown
Decision: unknown

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]
Appeal type: unknown
Decision: 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 & Medicaid Services, Parts C & D Enrollee Grievances, Organization/Coverage Determinations, and Appeals Guidance Manual, Section 10.6.
Appeal type: unknown
Decision: 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 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]
Appeal type: unknown
Decision: 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 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]