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Part D Drugs / Part D Excluded Drugs

Category: Your Medicare plan coverage
Published: May, 29 2008 03:05:25
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This table provides Part D coverage clarifications for specific products/drugs/drug categories in accordance with statutory and regulatory requirements for Part D drugs.  This is not an exhaustive list but only addresses those products/drugs/drug categories that have been the subject of frequently asked questions. Specific products not identified in this table should always be evaluated against the statutory and regulatory definition of a "Part D drug" before drawing conclusions from this table. This table does not address B versus D coverage questions.

Product/Drug/Drug Category
(Listing is NOT all-inclusive) 		May be covered under basic Part D benefit
(when used for “medically accepted indication”1 and not covered under Medicare
Parts A or B) 		Comments
Advicor® Yes See Commercially Available Combination Product Policy
Agents when used for anorexia, weight loss, or weight gain No Prescription drug products being used to treat AIDS wasting and cachexia are not considered agents used for weight gain or agents used for cosmetic purposes, and therefore such products are NOT excluded under such exclusion categories.  
Agents when used for cosmetic purposes or hair growth No Treatments indicated for psoriasis, acne, rosacea, or vitiligo are NOT considered cosmetic.
Agents when used for symptomatic relief of cough and colds No All agents when used for symptomatic relief of cough, cold, or cough and cold are excluded from Part D
Antihistamine/Decongestant Combinations (RX) Yes, except when being used for symptomatic relief of cough and cold  
Barbiturates No  
Benzodiazepines No  
Blood glucose testing strips No NOT directly associated with injection of insulin
Commercially available combination prescription products  Yes, if it contains at least one Part D drug component and the product as a whole is not excluded from Part D for another reason (e.g. Used for cough and cold, Less-than-effective DESI drug) Commercially available combination prescription drug products that contain at least one Part D drug component are part D drugs when used for a "medically accepted" indication, unless CMS makes a determination that such product, as a whole, belongs in one of the categories of drugs excluded from coverage under Part D.  If CMS has not provided guidance to exclude a specific combination product, such combination product containing at least one part D drug component should be considered a Part D drug unless it is excluded from coverage under Part D for another reason.   
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 
Extemporaneous Compounds, including sterile compounding of IV’s and TPN Yes, but only costs for Part D drug components may be billed under Part D Dispensing fee may include labor costs associated with mixing a compounded 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) No See Commercially Available Combination Product Policy
Fioricet® with Codeine Yes See Commercially Available Combination Product Policy
Fiorinal® (Butalbital, ASA, Caffeine) No See Commercially Available Combination Product Policy
Fiorinal® with Codeine Yes See Commercially Available Combination Product Policy
Fosamax plus D Yes See Commercially Available Combination Product Policy
Guaifenesin (RX) Yes   
Heparin/Saline Flushes No CMS clarified in the preamble to the final rule that although heparin is a Part D drug, a heparin flush is not used to treat a patient for a medically accepted indication, but rather to dissolve possible blood clots around an infusion line. Therefore, heparin's use in this instance is not therapeutic but is, instead, necessary to make durable medical equipment work. It would therefore not be a Part D drug when used in a heparin flush.  (70 FR 4232)
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 Syringes are NOT covered for injection of other Part D drugs
IV Solutions for hydration therapy Yes  
Klonopin® (Clonazepam)  No Benzodiazepine
Lancets No NOT directly associated with injection of insulin
Less-than-effective DESI Drugs (and those drugs identical, related or similar) No  
Leucovorin Calcium Yes  
Librax® No Less-than-effective DESI drug
Limbitrol® (Amitriptyline/chlordiazepoxide) Yes See Commercially Available Combination Product Policy 
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 AIDS 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.
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 because it cannot be dispensed for this purpose upon a prescription at a retail pharmacy.
 Primidone (Mysoline®) Yes NOT considered a barbiturate
Nonprescription/Over-the-counter (OTC) drugs2 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
Omacor® Yes  
Phenobarbital No Barbiturate
PhosLo® Yes  
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 universally 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)
  • Vitamin K (phytonadione)
  • Vitamin D (ergocalciferol and cholecalciferol)
  • Zinc (sulfate, acetate)
  • Iron
  • Iodine
  • Multivitamin additives for parenteral nutrition
No  
Smoking cessation drugs (OTC) No  
Smoking cessation drugs (RX) Yes  
Sterile Saline/water for Irrigation Yes  
Suboxone®, Subutex® Yes  
Vitamin D Analogs (Calcitriol, doxercalciferol, paricalcitol, and dihydrotachsterol) Yes NOT considered prescription vitamins

1 Medically Accepted Indication for purposes of Part D is an FDA labeled indication or an indication supported by citation in either the American Hospital Formulary System (AHFS), USP-DI, or Drugdex.

2 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.


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