(Medicare Part D Manual)

Product/Drug/Drug Category  (Listing is NOT all- inclusive)  May be covered under basic Part D benefit (when used for medically accepted indication3 and not covered under Medicare Parts A or B)  Comments  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 condit ion causing the cough.  Antihistamine/Decongestant Combinations (RX)  Yes, except when being used for symptomatic relief of cough and cold   Barbiturates  Yes Covered for all medically accepted indications as of 2014  Benzodiazepines  Yes Covered for all medically accepted indications as of 2013  Blood glucose testing strips  No NOT directly associated with injection of insulin  Electrolytes/Replenishers:   *Potassium  Sodium  Calcium  Magnesium  Yes *Potassium Iodide products are excluded from Part D as Iodine products (minerals) because they are not used for potassium supplementation. Erectile (ED) Dysfunction Drugs  No Agents when used for the treatment of sexual or erectile dysfunction, unless such agents are used to treat a condition, other than sexual or er ectile dysfunction, for which the agents have been approved by the FDA .  In addition, 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 a s pulmonary hypertension.  However, ED drugs will not meet the definition of a Part D drug when used off -label, even if the off label use is listed in one of the compendia found in section 1927(g)(1)(B)(i) of the Act . Extemporaneous Compounds, including sterile compounding of Yes, but only costs for Part D drug components Dispensing fee may include labor costs associated with mixing a compounded Product/Drug/Drug Category  (Listing is NOT all- inclusive)  May be covered under basic Part D benefit (when used for medically accepted indication3 and not covered under Medicare Parts A or B)  Comments  IVs and total parenteral nutrition  may be billed under Part D drug product  that contains at least one Part D drug component   Part D drug components used solely as vehicles in a compound may be covered under Part D (e.g., D5W, Normal Saline)  Fioricet (Bultalbital, APAP, Caffeine)  Yes See Commercially Available Combination Product Policy  Section 10.3  Fioricet with Codeine  Yes See Commercially Available Combination Product Policy  Section 10.3  Fiorinal (Butalbital, ASA, Caffeine)  Yes See Commercially Available Combination Product Policy  Section 10.3  Fiorinal with Codeine  Yes See Commercially Available Combination Product Policy  Section 10.3  Fosamax plus D  Yes See Commercially Available Combination Product Policy  Section 10.3  Galzin  No  Heparin/Saline Flushes  No See Section 10.6.  Injectable or IV Iron products such as Iron Dextran, Iron Sucrose and Sodium ferric gluconate  No Prescription vitamin/mineral product  Insulin  Yes  Insulin syringes  Yes Covered only for injection of insulin  IV Solutions for hydration therapy  Yes  Lancets  No NOT directly associated with injection of insulin  Less-than-effective DESI Drugs (and those drugs identical, related or similar)  No See Section 10.9  Leucovorin Calcium  Yes  Librax  No Less-than-effective DESI drug  Product/Drug/Drug Category  (Listing is NOT all- inclusive)  May be covered under basic Part D benefit (when used for medically accepted indication3 and not covered under Medicare Parts A or B)  Comments  Limbitrol (Amitriptyline/chlordiazepoxide)  Yes See Commercially Available Combination Product Policy  Section 10.3  Lovaza  Yes  Medical foods  No Defined as a food that is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation, and that are not regulated as drugs under section 505 of the Federal Food, Drug, and Cosmetic Act. Megestrol Acetate and Growth Hormone when used for AIDS wasting and cachexia Yes Prescription drug products that otherwise satisfy the definition of Part D drug are Part D drugs when used for AIDS wasting and cachexia if these conditions are "medically accepted" indications, as defined by section 1927(k)(6) of the Social Security Act (SSA), for the particular Part D drug.   Specifically, CMS does not consider such prescription drug products being used to treat A IDS wasting and cachexia as either agents used for weight gain or agents used for cosmetic purposes, and therefore such products cannot be excluded from the Medicare Prescription Drug Benefit by reference to section 1927(d)(2) of the SSA.  Mephyton  No Prescription vitamin/mineral product  Methadone  Yes, except when indicated for the treatment of opioid dependence  A Part D drug is partially defined as a drug that may be dispensed only upon a prescription. . . . Consequently, Methadone is not a Part D drug when used for treatment of opioid dependence Product/Drug/Drug Category  (Listing is NOT all- inclusive)  May be covered under basic Part D benefit (when used for medically accepted indication3 and not covered under Medicare Parts A or B)  Comments  because it cannot be dispensed for this purpose upon a prescription at a retail pharmacy.  Nonprescription/Over -the-counter (OTC) drugs 4 No, except insulin and supplies associated with the injection of insulin  Supplies associated with the injection of insulin include syringes, alcohol wipes, insulin pens and pen needles, gauze, and alcohol  PhosLo  Yes  Phytonadione  No Prescription vitamin/mineral product  Polysaccharide Iron Complex  No Prescription vitamin/mineral product  Prescription niacin products  Yes Prescription niacin products are approved by the Food and Drug Administration as safe and effective drugs, are used therapeutically for the treatment of dyslipidemia, and do not serve as nutritional supplements or address a vitamin deficiency.  These products are used at dosages much higher than appropriate for nutritional supplementation.  For these reasons, CMS has concluded that these products should not be considered prescription vitamins for purposes of Part D coverage, and therefore, are not universal ly excluded from coverage under the Medicare prescription drug program.  Prescription vitamins and mineral products, except prenatal vitamins and fluoride preparations   Examples : B vitamins (Folic Acid, Cyanocobalamin)  No  4 Part D plans may include OTC drugs in step therapy protocols as part of their cost effective drug utilization management program.  However, OTC drugs included in these step therapy protocols are considered administrative costs, not Part D drugs.                                                   Product/Drug/Drug Category  (Listing is NOT all- inclusive)  May be covered under basic Part D benefit (when used for medically accepted indication3 and not covered under Medicare Parts A or B)  Comments  Vitamin K (phytonadione)  Vitamin D ( ergocalciferol and cholecalciferol)  Zinc (sulfate, acetate)  Iron Iodine  Multivitamin additives for parenteral nutrition  Smoking cessation drugs (OTC)  No  Smoking cessation drugs (RX)  Yes  Sterile Saline/water for Irrigation  Yes  Suboxone, Subutex  Yes  Vitamin D Analogs (Calcitriol, doxercalciferol, and paricalcitol)  Yes NOT considered prescription vitamins     Chapter 6  Appendix C - Summary of Coverage Policy  MEDICARE PART B VERSUS PART D COVERAGE I SSUES  (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)   This document is not a statement or promise of coverage, but rather a high level summary of when something may be covered under Parts A, B or D, if all other coverage requirements are met.  Appropriate coverage policies and guidance must be consulted for final coverage determinations.   Introduction   This document provides an overview of outpatient prescription drug coverage policies under Medicare.  Beneficiaries who are inpatients of hospitals or skilled nursing  facilities (SNF) during covered stays may receive drugs as part of their treatment.  Typically, the payment for drugs is bundled into the Medicare Part A payments made to these types of facilities.5  Under the hospice benefit, beneficiaries receive drugs that are medically necessary for symptom control or for pain relief.  In general, references are seen to five major categories of Medicare Part B drug spending:  1. drugs billed by physicians and typically provided in physicians  offices (such as chemother apy drugs); 2. drugs billed by pharmacy suppliers and administered through durable medical equipment (DME), such as respiratory drugs given through a nebulizer; 3. drugs billed by pharmacy suppliers and self -administered by the patient (such as immunosuppr essive drugs and some oral anti -cancer drugs); 4. separately billable drugs provided in hospital outpatient departments; and 5. separately billable End Stage Renal Disease ( ESRD) drugs such as erythropoietin (EPO).  Regional differences in Part B coverage policies for drugs can occur in the absence of a national coverage decision.  A drug for which coverage is available under Part A or Part B, as it is being prescribed and dispensed or administered with respect to the individual, is excluded from the defi nition of a Part D drug and, therefore, cannot be included in Part D basic coverage.   Medicare Part A and Part B Covered Drugs   Part A/B Covered Drugs Set by Statute   Traditional Medicare (Part A/B) does not cover most outpatient prescription drugs.  Medic are bundled payments made to hospitals and skilled nursing facilities generally cover all drugs provided during a stay.  Medicare also makes payments to physicians for drug or biological products that are not usually self -administered.  This means that coverage is usually  limited to 5  If these drugs are provided as part of a Medicare Part A covered inpatient hospital or skilled nursing facility stay, they are generally bundled  in the Medicare Part A payment to the facility.  The exception with regard to inpatient hospital services is cl otting factor which is paid separately.  For covered SNF stays certain high cost chemotherapy drugs are billed separately along with preventive injections (e.g. flu shots).  If a beneficiary does not have Part A coverage, if Part A coverage for the stay has run out or if a stay is non -covered, hospitals and SNFs can be paid for most categories of Part B covered drugs.                                                   drugs or biological products  administered by infusion or injection.  However, if the injection is generally self -administered (e.g., Imitrex), it is not covered.   Despite the general limitation on coverage for outpatient drugs under Part B, the law specifically authorizes coverage for the following:    Durable Medical Equipment (DME) Supply Drugs.  These are drugs that require administration by the use of a piece of covered DME (e.g., a nebulizer, external or implantable pump).  The statute does not explicitly cover DME drugs; they are covered as a supply necessary for the DME to perform its function.  The largest Medicare expenditures for drugs furnished as a DME supply are for inhalation drugs, which are administered in the home t hrough the use of a nebulizer (e.g., albuterol sulfate, ipratropium bromide).  The other category of drugs Medicare covers as a DME supply are drugs for which administration with an infusion pump in the home is medically necessary (e.g. some chemotherapeut ic agents).    Immunosuppressive Drugs.  Drugs used in immunosuppressive therapy (such as cyclosporine) for a beneficiary who has received a Medicare covered organ transplant.   Hemophilia clotting factors.  Hemophilia clotting factors for hemophilia patients  competent to use such factors to control bleeding without medical supervision, and items related to the administration of such factors.    Oral Anti -Cancer Drugs.  Drugs taken orally during cancer chemotherapy provided they have the same active ingredients and are used for the same indications as chemotherapy drugs that would be covered if they were not self -administered and were administered as incident to a physicians professional service.    Oral Anti -emetic Drugs. Oral anti -nausea drugs used as part of an  anti-cancer chemotherapeutic regimen as a full therapeutic replacement for an intravenous anti -emetic drug within 48 hours of chemotherapy administration.   Pneumococcal vaccine.  The vaccine and its administration to a beneficiary if ordered by a physician.