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Part D Drugs / Part D Excluded Drugs

Published on 2008-05-29 15:50:25Category: Your Medicare plan Coverage

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) drugs 2

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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