Why Doesn't Medicare Part D Cover ED Drugs?

In our latest question and answer, the pharmacist discusses why Medicare Part D doesn't cover erectile dysfunction drugs.

Question

Why won't Medicare cover tadalafil (Cialis) for ED?

Asked by golf On Mar 28, 2019

Answered by
Medical Content Reviewed By PharmacistAnswers Staff

On Mar 29, 2019
Prescription Bottle With Bill And Text Overlay

Overview

The simple answer as to why Medicare doesn't cover any drug for the treatment of erectile dysfunction is because they are specifically listed as excluded in the laws that govern Part D prescription drug coverage.[1]

In fact, there are several categories of drugs that are not covered under Medicare, including ones for weight loss, fertility, and cosmetic purposes, so erectile dysfunction drugs aren't the only ones.

Which drugs are covered, and which are excluded, is based on several factors, including:

  • Cost-effectiveness
  • Efficacy
  • Therapeutic advantage (over other drugs)
  • Safety
  • Medical Necessity

Unfortunately, drugs used to treat erectile dysfunction are excluded from Part D coverage not only due to their cost, but also the lack of medical necessity when it comes to overall health (although this point has been debated in many scholarly articles).[2]

Where In The Law Does It Say They Aren't Covered?

Coverage requirements for Medicare Part D drugs are defined in the Title XVIII of the Social Security Act. Also listed in the Social Security Act (section 1927(d)(2)) are drugs that are excluded from coverage.[3]

Drugs that are excluded from coverage (according to the SSA act) are:

  • Those used for anorexia, weight loss, or weight gain.
  • Those used to promote fertility.
  • Those used for cosmetic purposes or hair growth.
  • Those used for the symptomatic relief of cough and colds.
  • Those used to promote smoking cessation.
  • Prescription vitamins and mineral products, except prenatal vitamins and fluoride preparations.
  • Non-prescription drugs
  • Barbiturates
  • Benzodiazepines
  • Those used for the treatment of sexual or erectile dysfunction (unless used for a condition other than erectile dysfunction).

There are some exceptions to the above list.

Part D law states that benzodiazepines and barbiturates are now covered (as of 2016) when being used for FDA-approved indications. Smoking cessation products are covered as well.

Unfortunately, drugs for erectile dysfunction are still not covered. These include:

  • Viagra (sildenafil)
  • Cialis (tadalafil)
  • Levitra (vardenafil)

The following is an excerpt from the 'Medicare Prescription Drug Benefit Manual Chapter 6 – Part D Drugs and Formulary Requirements' regarding erectile dysfunction drugs:[4]

"Agents when used for the treatment of sexual or erectile dysfunction (ED) [are not covered Part D drugs]. 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)."

ED Drugs Covered By Medicare For Other Indications

An interesting point is that the above excerpt clearly states that drugs used to erectile dysfunction are not covered. However, if those same drugs are being used to treat another FDA-approved indication, they may be.

The active ingredient in Viagra, sildenafil, is FDA-approved to treat pulmonary arterial hypertension (PAH).[5] If you were prescribed sildenafil for the treatment of PAH, it would be covered under Part D law.

Another example is the use of Cialis daily, which is FDA-approved for the treatment of benign prostatic hyperplasia (BPH).[6] If you are prescribed Cialis for the treatment of BPH, it would likely be covered under Medicare Part D (as long as it is included in your specific formula).

So, as an overall point, it's not necessarily that ED drugs aren't covered, but rather drug treatments for ED itself aren't.

Summary

Drugs being used for the treatment of erectile dysfunction are not covered under Medicare Part D law. However, if they are being used for other FDA-approved indications (like BPH or pulmonary hypertension), they may be covered.

References
  1. ^ MEDICARE PRESCRIPTION DRUG, IMPROVEMENT, AND MODERNIZATION ACT OF 2003. Congress.gov
  2. ^ Where cost, medical necessity, and morality meet: should US government insurance programs pay for erectile dysfunction drugs? PubMed
  3. ^ Social Security Act Section 1927 Compilation Of The Social Security Laws
  4. ^ Medicare Prescription Drug Benefit Manual Chapter 6 – Part D Drugs and Formulary Requirements. CMS
  5. ^ Revatio Prescribing Information
  6. ^ Cialis Prescribing Information

About the Pharmacist

Dr. Brian Staiger Pharm.D

Dr. Brian Staiger is a licensed pharmacist in New York State and the founder of PharmacistAnswers.com. He graduated from the University At Buffalo with a Doctor of Pharmacy degree in 2010. He has been featured in numerous publications including the Huffington Post as well as a variety of health and pharmacy-related blogs. Please feel free to reach out to him directly if you have any inquiries or want to connect! He's answered thousands of medication and pharmacy-related questions and he's ready to answer yours! Brian.Staiger@PharmacistAnswers.com Office: 716-389-3076

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