Appeal type: unknown
Decision: unknown

Under Medicare rules, Part D does not cover drugs or classes of drugs, or their medical uses, which are excluded from coverage or otherwise restricted under Section 1927(d)(2) of the Social Security Act. Drugs Excluded from Part D coverage include: 1) Agents when used for anorexia, weight loss, or weight gain (even if used for a non-cosmetic purpose (i.e., morbid obesity)); 2) Agents when used to promote fertility; 3) Agents when used for cosmetic purposes or hair growth; 4) Agents when used for the symptomatic relief of cough and colds; 5) Prescription vitamins and mineral products, except prenatal vitamins and fluoride preparations; 6) Nonprescription drugs; 7) 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; 8) Agents when used for the treatment of sexual or erectile dysfunction. Erectile dysfunction drugs will meet the definition of a Part D drug when prescribed for medically-accepted indications approved by the Food and Drug Administration other than sexual or erectile dysfunction (such as pulmonary hypertension). However, erectile dysfunction 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 Social Security Act: American Hospital Formulary Service Drug Information, and DRUGDEX Information System. Drugs not excluded from coverage include: 1) Prescription drug products that otherwise satisfy the definition of a Part D drug are Part D drugs when used for acquired immune deficiency syndrome wasting and cachexia due to a chronic disease, if these conditions are medically-accepted indications as defined by Section 1927(k)(6) of the Social Security Act for the particular Part D drug. Specifically, the Centers for Medicare & Medicaid Services does not consider such prescription drug products being used to treat acquired immune deficiency syndrom wasting and cachexia due to a chronic disease as either agents used for weight gain or agents used for cosmetic purposes; 2) Part D drugs indicated for the treatment of psoriasis, acne, rosacea, or vitiligo are not considered cosmetic; 3) 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 Social Security Act, are not excluded because the Centers for Medicare & Medicaid Services interprets the exclusion of prescription vitamin D products as being limited to products consisting of ergocalciferol (vitamin D2) and/or cholecalciferol (vitamin D3); 4) Prescription-only smoking cessation products; 5) Prescription Niacin Products (Niaspan, Niacor); 6) 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, the Centers for Medicare & Medicaid Services does not consider these cough medications as excluded drugs and, therefore, these medications may 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; 7) Benzodiazepines; and 8) Barbiturates. [The Centers for Medicare & Medicaid Services Internet Only-Manual, Publication 100-18, Medicare Prescription Drug Benefit Manual, Chapter 6, Section 20.1]Medicare provides coverage for items and services that are reasonable and necessary to diagnose or treat an illness or injury or to improve a malformed body member. Payment is excluded if the medical necessity for the service cannot be substantiated. [Section 1862(a)(1)(A) of the Social Security Act]