Medicare’s Six Protected Class policy has long assured patients that their access to all available medicines will never be compromised. Millions of Americans rely daily on Medicare Part D program benefits to manage health challenges.

Patients with these conditions respond differently to different medicines. Hence, the availability of the full range of effective medication is a critical factor in successful treatment and recovery. Continue reading below to learn more about Medicare Six Protected Classes.

Medicare’s six protected classes

Medicare Part D is an optional prescription drug insurance program private insurance companies offer. In addition to the premium, Medicare Part D members pay the cost of prescriptions up to the deductible. They then are responsible for the co-insurance portion throughout the different phases of coverage.

With these payments, participants tend to save on prescription drug costs. Beneficiaries can enroll in a standalone prescription drug plan (PDP) or a Medicare Advantage Prescription Drug Plan (MA-PD) that complements the federal government’s Medicare program. Medicare Advantage health insurance plans are primarily HMOs and PPOs that cover all Medicare benefits, including drugs.

Since Medicare Part D started, seniors and people with disabilities have had reasonable access to six specific classes. Six Protected Classes help ensure patient access to medicines. This guarantee often allows patients to maintain extensive or complex disease-related treatments.

The Six Protected Class policy allows patients access to all or substantially all drugs to treat their particular condition. This rule enables physicians to select the most clinically appropriate medication among various treatment options.

Patients often respond differently to the same drug. Treatments for specific conditions also have complex interactions, side effects, and other factors. These factors must be considered for the care of these patients, making these classes of drugs incompatible. Therefore, patients with these conditions should have access to the medicines that are most effective in treating their conditions.

Furthermore, many patients living with these conditions need to try different therapies so that they and their doctors decide on the most suitable treatment.

Why should the six protected classes be protected?

These six protected classes help Medicare beneficiaries who need lifesaving medications. Below are a few specifics about the six protected classes. The Medicare Modernization Act was implemented in 2003 and established the Part D program. The Trump administration proposed a rule limiting access to some of these Medications.

Six protected class policy protects vulnerable beneficiaries

Many prescription drugs aren’t necessarily equivalent to products within the same therapeutic class. These therapeutic classes of medicines are essential for individuals with mental illness, organ transplants, epilepsy, Parkinson’s disease, lupus, cancer, and HIV.

Six protected classes ensure the availability of drugs

If the Six Protected Class policy is eliminated, Part D plans would be allowed to exclude some of the drugs in the classes. Suppose a medication isn’t on the part D plan’s formulary. In that case, the beneficiary could file an appeal to obtain coverage for the drug.

Part D plans already have flexibility

While Part D plan sponsors aren’t currently permitted to remove a drug within the Six Protected Classes from its formulary. Sponsors may tier these drugs on their plan’s formularies, giving plan sponsors some leverage in price negotiations. Part D plans already have more restricted formularies for medications covered under the Six Protected Classes than commercial plans.

Eliminating the six protected class policy could increase program costs.

Even setting aside the negative impact on beneficiaries who rely on this valuable protection, eliminating the six protected classes designation can increase Part and Part B costs. Suppose beneficiaries can’t access the most medically appropriate prescription drugs for their condition. In that case, they will likely incur higher charges elsewhere in the program, such as additional physician services or emergency room utilization.

The six protected classes should be protected due to the following reasons

First, for humanitarian reasons, the proposed changes target vulnerable populations, including the elderly, those with multiple chronic conditions, and the sickest people in the country. They need access to medications that work for them as their doctors prescribe.

Second, when a patient, family, or health care providers make decisions, the selected treatment is most likely to meet the patient’s priorities and preferences and is more likely to be maintained.

Third, not everyone responds to medication in the same way. Difficult-to-treat cases require access to a variety of medications. These drugs should not be available only to those with the financial means or who must endure trials for ineffective medicines two meet their requirements for more expensive medications.

Fourth, even if this were a cost-saving measure, the adverse health effects and costs would outweigh the potential savings. People who don’t get the proper medication don’t get well and often get sicker, and their emergency department visits and hospital admissions increase.

Medicare’s six protected classes rule protects these individuals.

Drugs included in the six protected classes:

The Centers for Medicare & Medicaid Services implemented a policy that Part D plans include all six classes of drugs in their prescriptions. This protected classes policy aims to ensure enrollees with chronic diseases receive the necessary care.

Part D’s protected class drugs include:

  • Antidepressants (used to treat depression)
  • Antipsychotics (used to manage psychosis)
  • Anticonvulsants (used to treat seizures)
  • Immunosuppressants (drugs or medicine to reject a transplanted organ)
  • Antiretroviral (used to manage HIV/AIDS)
  • Antineoplastic (used in chemotherapy to kill cancer cells)

By ensuring access to these prescriptions, patients are in a better position to continue treatment for conditions such as epilepsy, mental illness, cancer, HIV/AIDS, and organ transplantation. People with access to medications are likelier to live healthier lives.

Part D plans include utilization management, step therapy, and prior authorization. The drugs in the six protected classes require pre-approval forms. The only drug class that doesn’t require step therapy is the antiretroviral drugs that treat HIV and AIDS patients. Step therapy consists of patients trying cheaper prescriptions first.

If this prescription is ineffective or the patient experiences side effects, they can get a more expensive drug. This purpose is to see if a lower-cost medication suffices so the plans can control costs.


Can I still buy a Medicare Part D prescription drug plan when I have a Medicare Advantage Plan?

No. You can’t enroll in a Part D drug and Medicare Advantage plans. Medicare Part C coverage usually includes prescription drug benefits.

Do I have to renew my Medicare Part D every year?

No. If you like your current Part D drug plan, you can keep it without further action. The exception will be if your current plan no longer participates with Medicare.

How do I know what drugs are on my plan formulary?

You can get a list of your plan’s formulary by calling the number on the back of your id card. The formulary tier the particular drug is classified determines the drug prices and cost-sharing.

What drugs doesn’t Medicare Part D cover?

Medicare prescription drug coverage doesn’t cover the drugs below:

  • Medications used for the treatment of anorexia, weight loss, or weight gain
  • Fertility drug
  • Drugs used for hair growth and cosmetic purposes
  • Medicines used for the relief of cold or cough symptoms
  • Medications used for the treatment of Erectile Dysfunction
  • Vitamin and mineral prescription (except prenatal vitamins and fluoride preparations)
  • Non-prescription drugs (over-the-counter drugs)

How many Medicare Part D plans are there?

The average Medicare beneficiary in can choose from 54 Medicare plans that cover Part D drugs. This includes 23 standalone Medicare Part D drug plans and 31 Medicare Advantage Drug Plans. Keep in mind that coverage options differ depending on where you live.

What are some of the costs for Medicare Part D coverage?

Medicare Part D costs vary by plan and income. Plan costs may vary depending on the number of drugs covered and copayments for generic and brand-name drugs. In addition to your monthly premium, you may be required to pay an annual deductible and copayments or co-insurance for certain medications.

What health conditions do the six protected classes affect the most?

These six conditions require medications that fall under the protected classes.

  • Mental illness
  • Organ transplants
  • Epilepsy
  • Parkinson’s disease
  • Lupus
  • Cancer
  • HIV

What is the Medicare donut hole for ?

The Medicare Part D donut hole or coverage gap is the phase of Part D coverage after the initial coverage period. Once you’ve reached the coverage gap of $4,660, you pay 25% for both your generic and brand-name drugs.

Does my drug plan help me in the Coverage Gap?

Most Part D plans don’t have coverage in the Coverage Gap. For help in the Donut Hole you can find a Part D or Medicare Advantage plan with enhanced coverage to help in the coverage gap, use a prescription discount card, or consider Mark Cuban’s Cost Plus pharmacy.

Getting help with Medicare Part D

Medicare drug insurance can help pay for prescription drugs you need. You should consider Medicare drug coverage even if you’re not taking prescription drugs to avoid a potential late-enrollment penalty.

Our licensed insurance agents are standing by to help with any questions or concerns about the Medicare program. First, they’ll assess your situation and educate you on your options. Then, they’ll help guide you through each step of the process. Please fill out our online request form, or call us at the number above.

Written By:
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Lindsay Malzone, Lindsay Malzone is the Medicare editor for She's been contributing to many well-known publications since 2017. Her passion is educating Medicare beneficiaries on all their supplemental Medicare options so they can make an informed decision on their healthcare coverage.
Reviewed By:
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Rodolfo Marrero, Rodolfo Marrero is one of the co-founders at He has been helping consumers find the right coverage since the site was founded in 2013. Rodolfo is a licensed insurance agent that works hand-in-hand with the team to ensure the accuracy of the content.