Persius/hicric huggingface dataset:
Appeal type: unknown
Decision: unknown

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]
Appeal type: unknown
Decision: 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 (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)]
Appeal type: unknown
Decision: unknown

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

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]
Appeal type: unknown
Decision: unknown

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]