evekhm/cms_iom_500 huggingface dataset:
(Medicare Part D Manual)
10.9 - DESI Drugs  (Rev. 2, Issued:  07- 18-08; Effective/Implementation Date:  07- 18-08)  For a drug to be available for reimbursement by a Part D sponsor it must meet the definition of a Part D drug.  Secti on 1860D 2(e)(1) of the Social Security Act (the Act) generally defines a Part D drug to include those drugs that may be dispensed only upon a prescription and that meet the requirements of section 1927(k)(2) of the Act.  Section 1927(k)(2) generally requi res that the drug be approved by the FDA or otherwise described under sections 1927(k)(2)(A)(ii) or (A)(iii) of the Act.  These provisions address those drugs affected by the Drug Amendments of 1962 (amending the Federal Food, Drug & Cosmetic Act), which r equire that a new drug be proven effective, as well as safe.  FDAs Drug Efficacy Study Implementation (DESI) evaluates the effectiveness of those drugs that had been previously approved on safety grounds alone.  FDA indicates that these drugs, and those i dentical, related, and similar to them, may continue to be marketed until the administrative proceedings evaluating their effectiveness have been concluded, at which point continued marketing is permitted only if a new drug application (NDA) or abbreviated  new drug application (ANDA) is approved.  The vast majority of the DESI proceedings have been concluded, but a few are still pending.   The definition of a Part D drug does not include less than effective (LTE) DESI drugs or those identical, related or similar drugs to the LTE DESI drug.  As FDA continues to undertake reviews under the DESI program and announces results of its hearings, CMS would expect Part D sponsors to adjust their formularies accordingly, as they should with any other applicable FDA drug product announcement.  If a sponsor discovers the presence of any LTE DESIs on its formulary based on an FDA announcement or otherwise, it should remove these drugs from the formularies on accordance with section 30.3.1  10.10 - Over -the-Counter Products  (OTCs)  (Rev. 2, Issued:  07- 18-08; Effective/Implementation Date:  07- 18-08)
(Medicare Part D Manual)
10.10 - Over -the-Counter Products  (OTCs)  (Rev. 2, Issued:  07- 18-08; Effective/Implementation Date:  07- 18-08)  The definition of a Part D drug does not include OTCs.  Therefore, Part D sponsors cannot cover  OTCs under  their basic prescription drug benefit or as a supplemental benefit und er enhanced alternative  coverage.  However, CMS will allow Part D sponsors the option to provide OTCs  as part of their administrative costs structure.  Refer to chapter 7, s ection 60, of this manual for further discussion of this option.  When an existing formulary product switches to an OTC status during the contract year, any existing inventory of the previous legend product (manufactured under the legend New Drug Application (NDA) and possessing the legend National Drug Code (NDC) number ) will continue to satisfy the Part D drug definition.  Given the potential for beneficiaries requiring conversion to other therapeutically equivalent legend products, CMS strongly recommends immediate notification of affected enrollees using the notificat ion criteria outlined in section 30.3.4.  CMS will direct sponsors to remove the converted legend product from their formulary at the next formulary submission window after the OTC product becomes available.   Providing the OTC product at no cost to benefic iaries, as outlined in chapter 7, s ection 60, of this manual, will not satisfy CMS formulary requirements and Part D sponsors may need to add additional drugs when the OTC is removed  from its formulary.  However, adjudication of the legend product may continue as long as the market holds residual inventory.   10.11 - Common Home Infusion Drugs (Rev. 2, Issued:  07- 18-08; Effective/Implementation Date:  07- 18-08)
(Medicare Part D Manual)
10.11 - Common Home Infusion Drugs (Rev. 2, Issued:  07- 18-08; Effective/Implementation Date:  07- 18-08)  CMS has identified a list of acute care drugs that are most commonly utilized in the home infus ion setting.  The use of these drugs or drug classes often results in an earlier hospital discharge and reduced healthcare costs.  Rapid access to these agents is imperative for these health care transitions.  It is CMS expectation that Part D sponsors wi ll not implement policies that could potentially delay or restrict beneficiary access to these important agents.  In general, should prior authorization or other utilization management edits apply to any of these agents, CMS would expect that Part D sponsors handle these in an expedited manner in order to facilitate hospital discharge in appropriate time frames.  In addition, it is CMS expectation that Part D sponsors ensure appropriate beneficiary access to these drugs or drug classes via formulary inclus ion.  See Appendix A for a list of commonly utilized home infusion drugs.    1 If, based on an FDA announcement, a Part D sponsor recognizes and removes a non -Part D drug from its formulary; CMS expects that Part D sponsors will provide 60 days of advance  notice of the formulary removal.                                                    10.12 - Bundling of Home Infusion Drugs Under a Part C Supplemental Benefit (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)  Part D sponsors that offer Medicare Advantage (MA) prescription drug plans may choose to provide Part D home infusion drugs as part of a bundled service as a mandatory supplemental benefit under Part C, provided the sponsor consistently applies the option (i.e., in a given contract year, the plan either always covers a particular home infusion drug as part of a bundled service under Part C, or always covers a particular home infusion drug under Part D).  Given uniform benefits requirements, sponsors electing this option must also ensure that the bundled service is available to all enrollees of any MA -PD or cost plan in which it chooses to provide Part D home infusion drugs as a mandatory s upplemental benefit under Part C.
(Medicare Part D Manual)
Interest ed Part D sponsors must appropriately assign these costs to the Part C component of their bids to account for these bundled drugs.  They must also provide, through the Formulary Submission module, a file that clearly identifies the Part D home infusion drugs that will be offered as part of a mandatory supplemental benefit under Part C for the following contract year.  CMS will review sponsors home infusion drug files as part of our formulary review process to ensure that only home infusion drugs are included as part of the Part C supplemental benefit.   Effective with contract year 2010, CMS waived  the definition of a Part D drug at 42 CFR 423.100  with respect to Part D drugs c overed as part of a bundled benefit under a Part C supplemental benefit.  Waiver of the definition of a Part D drug will improve benefit coordination of home infusion therapy between Parts C and D, particularly since the services and supplies necessary for  home infusion are never covered under Part D but would be provided as part of a bundle of service under a Part C mandatory supplemental benefit.  However, this waiver is conditioned on the application of zero cost sharing for the bundle of home infusion s ervices provided under a Part C supplemental benefit.  Thus, sponsors will not qualify for the waiver and, in turn, will not qualify to cover Part D home infusion drugs as part of a bundle of services under a Part C supplemental benefit without indicating on their Plan Benefit Packages (PBPs) that the applicable cost sharing for this bundle of services is $0.
(Medicare Part D Manual)
In addition, the requirement that Part D sponsors formularies include at least two Part D drugs in each category and class of covered Part D drugs at 42 CFR 423.120(b)(2)(i) is waived for Part D sponsors for applicable formulary categories or classes when Part D home infusion drugs are provided  as part of a bundled service as a mandatory supplemental benefit under Part C.  Waiver of the requirement at 42 CFR 423.120 (b)(2)(i) will allow Pa rt D sponsors choosing to provide Part D home infusion drugs as a part of bundled service under a Part C mandatory supplemental benefit to improve benefit coordination of home infusion therapy between Part C and Part D.  This improved benefit coordination promotes continuity of care and cost avoidance of more expensive institutional care by facilitating continuous access to home infusion drugs, as well as the costs of administration and supplies associated with that therapy.   Part D sponsors choosing to provide Part D home infusion drugs as part of a bundled service must indicate on their marketed formularies that certain drugs may be covered under the sponsors medical, rather than its prescription, benefit.  For more information, consult the model formular y available at:  http://www.cms.gov/Medicare/Prescription -Drug -Coverage/PrescriptionDrugCovContra/Part -D-Model -Marketing -Materials.html .  10.13 - Inhaler Supplies  (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)  In general, only those accessories for meter dose inhalers (MDIs), Dry Powder Inhalers (DPIs), or Nasal Spray Inhalers (NS) that are included on the New Drug Application or  Abbreviated New Drug Application, listed on the package insert, and specifically pa ckaged 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 NDA or ANDA, they would not meet the definition of a Part D drug.   10.14 - Vaccine Administration  (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)
(Medicare Part D Manual)
10.14 - Vaccine Administration  (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)  Since  January 1, 2008, the Part D program covers  vaccine administration costs associated with Part D vaccines.  CMS interprets this statutory requirement to mean that the Part D vaccine administration costs are a component of the negotiated price for a Part D -covered vaccine.  In other words, the negoti ated price for a Part D vaccine will be comprised of the vaccine ingredient cost, a dispensing fee (if applicable), and a vaccine administration fee.  This interpretation recognizes the intrinsic linkage that exists between the vaccine and its correspondin g administration, since a beneficiary would never purchase a vaccine without the expectation that it would be administered.  In general, CMS believes that Part D vaccines, including the associated administration costs, should be billed on one claim for bot h in- and out -of-network situations.  For example, if an in-network pharmacy dispenses and administers the vaccine in accordance with State law, the pharmacy would process a single claim to the Part D sponsor and collect from the enrollee any applicable co st-sharing on the vaccine and its administration.  Alternatively, if a vaccine is administered  outside of the plans Part D pharmacy network , the provider would supply the vaccine, administer it, and then bill the beneficiary for the entire charge, includi ng all components.  The beneficiary would, in turn, submit a paper claim to the Part D sponsor for reimbursement for both the vaccine ingredient cost and administration fee.   10.14.1 - Elements of Vaccine Administration  (Rev. 2, Issued:  07- 18-08; Effective/Implementation Date:  07 -18-08)
(Medicare Part D Manual)
10.14.1 - Elements of Vaccine Administration  (Rev. 2, Issued:  07- 18-08; Effective/Implementation Date:  07 -18-08)  Vaccine administration fees should be subject to negotiations between Part D sponsors and pharmacies.  CMS expects that sponsors will take into consideration the elements reflected in existing Part B vaccine admin istration fees when establishing their own vaccine administration fees.  For example, Part B considers the immunizing professionals time in physically delivering the vaccine to a beneficiary, the resources encompassing the supplies (syringe, gauze, band- aid, alcohol prep pad, etc.), the indirect costs of the office, and professional liability.   10.14.2 - Establishment of Multiple Vaccine Administration Fees  (Rev. 2, Issued:  07- 18-08; Effective/Implementation Date:  07- 18-08)  Part D sponsors will have the  discretion to implement either a single vaccine administration fee for all vaccines or multiple administration fees based on type of vaccine, variance in provider type, and product administration complexity.  CMS plans to retrospectively review vaccine administration fees to look for outliers and potentially discriminatory practices that would impact beneficiary access to Part D vaccines.   10.14.3 - Other Vaccine Administration Considerations  (Rev. 2, Issued:  07- 18-08; Effective/Implementation Date:  07- 18-08)  Part D sponsors may implement drug utilization management tools to determine if a vaccine is necessary; however, in the absence of any information showing previous immunization (i.e., claims data), the Part D sponsor should make payment available for a vaccine and its administration consistent with Advisory Committee on Immunization Practices (ACIP) recommendations.  20 - Part D Exclusions  (Rev. 2, Issued:  07- 18-08; Effective/Implementation Date:  07- 18-08)  20.1 - Excluded Categories  (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)  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 Act.   Drugs Excluded  from Part D coverage :
(Medicare Part D Manual)
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 Act.   Drugs Excluded  from Part D coverage :   Agents when used for anorexia, weight loss, or weight gain (even if used for a non-cosmetic purpose (i.e., morbid obesity)).    Agents when used to promote fertility.    Agents when used for cosmetic purposes or hair growth.   Agents when used for the symptomatic relief of cough and colds.    Prescription vitamins and mineral products, except prenatal vitamins and fluoride preparations.   Nonprescription drugs.    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.    Agents when used for the treatment of sexual or erectile dysfunction (ED). ED drugs will meet the definition of a Part D drug when  prescribed for medically -accepted indications approved by the FDA other than sexual or erectile dysfunction (such as pulmonary hypertension).  However, ED 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 Act : American Hospital Formulary Service Drug Information, and DRUGDEX  Information System.   Drugs Not Excluded from Part D Coverage :   Prescription drug products that otherwise sat isfy the definition of a Part D drug are Part D drugs when used for AIDS wasting and cachexia due to a chronic disease, if these conditions are medically -accepted indications as defined by section 1927(k)(6) of the Act for the particular Part D drug.  Spec ifically, CMS does not consider such prescription drug products being used to treat AIDS wasting and cachexia due to a chronic disease as either agents used for weight gain or agents used for cosmetic purposes.    Part D drugs indicated for the treatment of psoriasis, acne, rosacea, or vitiligo are not considered cosmetic.
(Medicare Part D Manual)
 Part D drugs indicated for the treatment of psoriasis, acne, rosacea, or vitiligo are not considered cosmetic.    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 Act, are not excluded because CMS interprets the exclusion of prescription vitamin D products as being limited to products consisting of ergocalciferol (vitamin D2) and/or cholecalciferol (vitamin D3).    Prescription -only smoking cessation products.    Prescription Niacin Products (Niaspan, Niacor).    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, CMS does not consider these cough medications as excluded drugs and, therefore, these medications m ay 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.   Benzodiazepines    Barbiturates   See Appendix B for further clarification of Part D coverage or non- coverage of specific products/drugs/drug categories.   20.2 - Drugs Covered Under Medicare Part A or B  (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)
(Medicare Part D Manual)
20.2 - Drugs Covered Under Medicare Part A or B  (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)  The Social Security Act  specifies that a drug prescribed to a Part D eligible individual cannot be considered a covered Part D drug if payment for such drug ...is available (or would be available but for the application of a deductible) under part A or B  for that individual.  CMS 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 cover ed 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.   Two unique examples of drugs covered under Part A or B are (1) drugs and biological products  related to the terminal illness or related conditions for beneficiaries who have elected the Medicare hospice benefit , as these drugs should be covered under the M edicare Part A payment to a hospice, and (2) drugs used for ESRD beneficiaries receiving renal dialysis services , as these drugs are included in the Medicare Part B bundled payment to an ESRD di alysis facility.   Drugs and biological products paid for under  the Medicare Part A per -diem payments to a Medicare hospice program are excluded from coverage under Part D.  However, given access and operational issues, in lieu of placing a beneficiary -level PA on all drugs for beneficiaries who have elected hospice, CMS  strongly encourage s sponsors to only place beneficiary -level PA requirements on the following four categories: analgesics, antinauseants (antiemetics), laxatives, and antianxiety drugs (anxiolytics).
(Medicare Part D Manual)
Part D sponsors generally may use either PA requirements or a pay and chase approach to determine whether payment for drugs may be made under Part D .  However , given concerns regarding the impact on access to drugs for ESRD beneficiaries or for those beneficiaries who have elected hospice, sponsors are strongly encouraged to limit the use of PA to certain specific categories of drugs covered under the Medicare hospice benefit or drugs that are always used for the treatment of ESRD for ESRD beneficiaries rec eiving renal dialysis services.  Further, recent CMS guidance pertaining to these drugs indicates sponsors are not expected to take special measures beyond their normal compliance and utilization review activities to retrospectively review paid claims for purposes of determining whether drugs in the other categories were either unrelated to the hospice beneficiarys terminal illness or used for ESRD treatment.   However, if it is determined through routine utilization review or otherwise that a drug has been inappropriately billed to a Part D spons or, the Part D sponsor should seek recovery from the hospice provider, ESRD dialysis facility, or beneficiary, as appropriate.  See Appendix C for further explanation and clarification of specific issues regarding coverage under Medicare Part B.   20.2.1 - Exhausted Part A Benefits  (Rev. 2, Issued:  07- 18-08; Effective/Implementation Date:  07- 18-08)  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 (LTC) hosp itals, 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.
(Medicare Part D Manual)
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 he r 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 chapter 5, section 50.5.4, regarding sponsor contracting requirements when a beneficiary has exhausted inpatient Part A benefit days.   20.2.2 - Part D Sponsor Due Diligence in Prior Authorization of Part A or B Versus Part D Coverage Determination  (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)