CMS Pub. 100-18, ch. 6, App. B

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 Part B versus Part 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”3 and not

covered under

Medicare Parts A or B)

Comments

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

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 may be

3 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), or DRUGDEX®. Exceptions may be possible

when used as part of an anti-cancer chemotherapeutic regimen.

Product/Drug/Drug Category

(Listing is NOT all-inclusive)

May be covered under

basic Part D benefit

(when used for

“medically accepted

indication”3 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 condition 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 erectile 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 as

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

indication”3 and not

covered under

Medicare Parts A or B)

Comments

IV’s 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

indication”3 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 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.

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

indication”3 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 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)

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

indication”3 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