(Medicare Part D Manual)

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.    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)  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).   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.   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)  A drug approved or denied through prior authorization constitutes a coverage determination, subject to all applicable coverage determination standards, timelines, and requirements.  However, Part D spons ors should rely upon (1) information included by the physician with the prescription, (2) information communicated by the pharmacist or included with the submitted claim , such as diagnosis information (e.g., to determine whether the prescription is related to a Medicare covered transplant) , (3) information captured by the plan sponsor previously, such as diagnosis information from previous PAs, and (4)  location of administration (e.g., to determine if the prescription is being dispensed for a beneficiary in a nursing home) when available to avoid the need for a separate coverage determination request to obtain the needed information whenever  possible .  Assuming the available information is sufficient to  correctly assign payment to Part A or B or Part D , ther e is no need in such cases to require additional information to be obtained from the physician.  To the extent that the Part D sponsor requires its contracted pharmacies to report the information provided on the prescription to assist in the determination of Part A or B versus Part D coverage, the sponsor should rely on the pharmacists report of appropriate information to appropriately adjudicate the claim under Part D.  For example, for cases in which prednisone is prescribed for a condition other than im munosuppression secondary to a Medicare -covered transplant, and this is either documented  on the prescription, or evident based on the prescribers specialty, a known diagnosis, or concomitant therapies, a sponsor may cover the drug under Part D without se eking further information from the prescribing physician.  This clarification should not be construed to indicate that a Part D sponsor may not impose prior authorization or other procedures to ensure appropriate coverage under the Medicare drug benefit.  Part D sponsors may apply prior authorization to establish appropriate payment under Part A or B or Part D, even if the beneficiary is currently taking the drug.   However, CMS believes that the sponsor will have met appropriate due diligence standards wit hout further contacting a physician if necessary and sufficient information is available , and the contracted pharmacy is able to communicate this information to the sponsor in order to make the coverage determination.  Refer to section 30.2.2.3 for additional guidance on the application of PAs. For more information on Coverage Determination requirements, see Medicare Prescription Drug Benefit Manual, chapter 18, available at https://www.cms.gov/Medicare/Appeals -and-Grievances/MedPrescriptDrugApplGriev/Downloads/Chapter18.zip .  20.3 - Coverage of Supplemental Drugs Under Enhanced Alternative Coverage  (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)  A Part D sponsor may only include coverage of drugs that would meet the definition of a Part D drug but for the application of section 20.1 (these are known as supplemental drugs, as provided in chapter 5, section 10.2 of this manual) as a supplemental benefit under enhanced alternative coverage.   20.4 - Application of General Exclusion Provisions  (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)  In accordance with section 1860D -2(e)(3) of the Act,  a Part D sponsor may exclude from qualified prescription drug coverage any Part D drug:    For which payment would not be made if items and services are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the funct ioning of a malformed body member (except for Part D vaccines); or    Which is not prescribed in accordance with the Part D plan.  Such exclusions are coverage determinations or redeterminations pursuant to chapter 18 of this manual, and are subject to appea l.  Unlike other Part D drugs that may be excluded when not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, Part D vaccines may only be excluded when their administration is not reasonable and necessary for the prevention of illness.  30 - Formulary Requirements  (Rev. 2, Issued:  07- 18-08; Effective/Implementation Date:  07- 18-08)  A Part D sponsor that uses a formulary under its qualified prescription drug coverage must meet requirements for the following:    Pharmacy and Therapeutics committee;   Provision of an adequate formulary;   Transition process;   Limitation on changes in therapeutic classification;  Provision of notice regarding formulary changes;   Limitation of formulary  changes prior to beginning of contract year;   Provider and patient education; and   Formulary changes during the contract year.   30.1 - Pharmacy and Therapeutics (P&T) Committee  (Rev. 2, Issued:  07- 18-08; Effective/Implementation Date:  07- 18-08)  A Part D sponsors formulary must be developed and reviewed by a P&T committee that meets specific requirements with respect to:    Membership;   Conflict of interest;  P&T member disclosure to CMS;   Meeting administration;  Formulary management;   Formulary exceptions; and  P&T committee role.