Since the launch of its original patent in 1998, the safety and effectiveness of Sildenafil citrate (Viagra) has been proven in both in vitro and in vivo studies, as well as in human clinical trials.

Based on its proven track record, many millions of prescriptions for Viagra have been written and consumed worldwide. The drug has also become a commonly available over-the-counter (OTC) drug, which makes it easily accessible for anyone with a prescription. Today, Viagra is a multi-billion-dollar business, making it one of the most popular and profitable pharmaceutical products of all time.

On December 8, 2017, the U.S. Food and Drug Administration (FDA) approved a new drug application for a generic version of Viagra. The new formulation, known as Sodalis Latex (sildenafil citrate), offers better oral bioavailability and can be administered as a single dose under the tongue. The medication will be marketed as Revatio and is expected to be a viable alternative to Viagra for patients seeking oral therapeutic treatments. (Learn more:

FDA Approves New Formulation of Viagra

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As Drugs Improve, So Do the Rules

Medicare Part D, enacted in 2006 as part of the Medicare Prescription Drug Improvement and Modernization Act, sets forth the parameters under which medications can and cannot be covered by insurance plans.

The federal legislation established a variety of coverage classes for prescription drugs, ranging from the most basic to the most comprehensive. The rules for each class are regularly updated and reflect the rapid development of new medications and changes to existing ones. (Learn more:

Detailed Medicare Part D Coverage Information

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For instance, since its inception, the coverage of medications has evolved to encompass an ever-growing scope of applications. Early on, medications were only covered for the treatment of certain diseases and conditions. Today, prescription drugs are covered under Medicare Part D for practically any medical use – including prevention of disease and treatment of various ailments. This is largely due to the fact that new medications continually test the limits of insurance coverage and need to be categorized as “experimental” or “off-label” for a short period of time before earning their place on the roster of “deserve-to-be-covered” medications.

Even before the dawn of modern medicine, people recognized the value of herbal treatments for a wide range of diseases and conditions. In the 1700s, people turned to alternative practitioners, such as shamans and healers, to treat their illnesses. With the rise of modern medicine and the development of new pharmaceuticals, however, herbal treatments have largely taken a backseat. Nevertheless, many patients still rely on natural remedies to treat various illnesses and injuries, and quite often, the two are used in conjunction with one another.

Currently, there are hundreds of medications and medical devices that treat erectile dysfunction (ED). To determine which ones fall under Medicare Part D’s auspices, one must look to the legislation for clarification. (Learn more:

How to Select a ED Medication

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Viagra and Other ED Drugs Not Covered by Medicare Part D

While the above-mentioned ED medications are covered by Medicare Part D, they are not the only ED drugs that are eligible for insurance coverage. In fact, based on the rules set forth in the legislation, Viagra and a handful of other ED drugs are actually not covered. (Learn more:

What Are the Covered Components of Medicare Part D?

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Specifically, Medicare Part D does not cover the following treatments for ED:

  • CCTA (Cerulean Cirrose) – This medication, manufactured by Eli Lilly and Company, is applied directly to the surface of the penis and is taken into the circulatory system. In clinical trials, up to 42% of men reported improved erections after just one application. A common side effect is headache, which typically goes away after a few hours. (Learn more:

    Erectile Dysfunction Medications That Are Covered by Medicare Part D

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  • PDE5 (Viagra (sildenafil citrate)) – This is the active ingredient in Viagra and is a medication that treats pulmonary hypertension (PH) and ED caused by PH. In humans, it has been shown to improve erectile function in as many as 58% of patients. The most common side effects include headache, flushing, and upset stomach. (Learn more:

    How to Treat Erectile Dysfunction with a PDE5 Inhibitor

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  • Tadalafil – This is another PDE5 inhibitor, manufactured by Merck. It is prescribed to treat ED and is used in conjunction with sildenafil citrate or vardenafil.
  • Saw Palmetto Health – This is a medical benefit contractor that administers and makes claims for Medicare plans in South Carolina. The company’s pharmacy benefit manager verifies and processes individual prescriptions and medical claims for the members it serves. In general, this contractor excludes medications that are categorized as “investigational” under the FDA’s rules. Amongst its guidelines are the following:
    • No coverage for treatments that are deemed to be “investigational” by the FDA.
    • No coverage for treatments that are only for sale in a “research lab” or otherwise deemed by the FDA to be “unapproved”.
    • No coverage for treatments that are available only in a hospital or clinic setting.
    • No coverage for any medication that has been demonstrated to be potentially addictive or harmful.
    • No coverage for any medication that has been specifically indicated for use during pregnancy.

    The Evolving Landscape of ED Treatment

    While the above-mentioned drugs have served men for years, researchers and clinicians are continuing to investigate and search for better ways to treat ED. As a result, more and more medications and devices are being added to the list of covered treatments for ED. (Learn more:

    How to Make the Right Treatment Choice for Your Body Type

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    Thanks to the efforts of researchers and clinicians, along with the tireless work of industry stakeholders, the list of approved treatments for ED continues to grow.

    This is great news for men searching for help with ED and for insurance carriers who must keep up with the latest medical developments in order to provide appropriate coverage. While Medicare Part D does not cover all treatments for ED, it does cover the most common ones and continues to expand its coverage as more and more medications make their way to market.

    If you’re suffering from ED and are concerned about whether or not your insurance plan will cover the treatment you need, you can contact your local pharmacy and ask them for assistance. They may be able to get you a list of covered medications or put you in touch with a specialist who can help you sort through the options available to you.

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