Breaking Down Medicare Self-Administered Drugs

• Self-administered drugs (SAD) are outpatient prescription drugs that Medicare beneficiaries are able to take at home without assistance from a health care professional person. This means they dispense medical services (drug administration) on their own.

• Medicare does not cover the majority of SAD. However, there are a few exceptions for drugs that are covered by Medicare Part B.

• Supplemental Medicare plans such as Medicare Advantage plans, Medigap plans, etc. assist with coverage and cost of certain drugs. To know which self-administered medication Medicare covers, one should always check their plan’s formulary for the particular drug they need coverage for.

• A wide range of programs is available to provide additional cost assistance for prescription drug costs on self-administered medications.

Many drugs are self administered based on a prescription and instructions from a healthcare provider. This category includes topical medications, oral medications, and some injectable drugs. Medicare beneficiaries undergoing outpatient treatment and in need of self administered drugs may be wondering if they are covered and how much they can expect to pay.

Medicare Part B covers a few drugs prescribed in hospital outpatient settings when used for reasonable and necessary indications. However, the drugs covered are limited, which is why many in the Medicare population opt for an optional Part D plan. Here’s everything you need to know about each part of Medicare as well as other important details, like how Medicare is determining self administration drugs to cover and how to read self administration instructions. 

At times, outpatient hospital treatments and telehealth physician’s services require patients to use self-administered prescription drugs or biologicals, such as Tylenol. Drugs or biologicals are deemed ​“self-administered” Drugs or biologicals in the Medicare Benefit Policy Manual, because the patient can take them or use them without assistance from health care industry professionals. At times, self-administered drugs are abbreviated ​“SAD” for convenience.

Difference Between Conventional Drugs and Biologicals

The term ​“biological” is an umbrella term that encompasses a vast range of products from vaccines, allergenics, gene therapy, and more. These products tend to be more complex than standard prescription drugs as their structures are not easily identified or characterized. Most biologicals are heat sensitive and highly susceptible to microbial contamination, causing them to be manufactured differently than standard drugs.

Criteria for Labeling a Drug ​“Self-Administered”

In order for a drug to be labeled ​“self-administered,” it is evaluated via route of administration, status of condition, and frequency of administration.

• Route of Administration: Essentially, this factor determines how the drug will be administered to the beneficiary. Intravenous, intramuscular, and subcutaneous administrations are often not deemed ​“self-administered”. However, drugs that can be administered orally, topically, or suppository are usually self-administered.

• Status of Condition: When determining whether a drug can be self-administered, providers will evaluate how long the condition or treatment is expected to last. ​“Acute” conditions are expected to last less than two weeks while ​“chronic” conditions are expected to last longer than 2 weeks.

• Frequency of Administration: Another aspect that is looked at in evaluation is how often the drug administered would be taken by the beneficiary. ​“Infrequent” is viewed as being a monthly administration while ​“frequent” is when a drug needs to be administered once or more times weekly.

In short, Original Medicare (Parts A and B) does not usually cover self-administered drugs for beneficiaries. However, in certain circumstances with outpatient procedures, self-administered drugs may be covered.

Part A (Hospital Coverage)

Medicare Part A (hospital coverage) works to cover any inpatient services a beneficiary receives including any medication taken while spending time in a hospital, skilled nursing facility, or other inpatient settings.

Outpatient medications prescribed upon leaving the facility will not be covered under Part A.

Part B (Medical Coverage)

Unlike Part A, Part B coverage may include a select list of medication. Medicare Part B (medical coverage) is used to cover outpatient treatment, procedures, and medical services such as:

• Annual Provider Visits

• Necessary Medical Screenings

• Diagnostic Tests

In most cases, Part B does not cover self-administered drugs or biologics. However, while visiting an emergency room, observation stay, or outpatient surgery center, one may receive medications to take during their stay. The cost of the medications taken during one’s visit may be reimbursed if the beneficiary files a claim.

In order to receive Medicare Part B coverage, a beneficiary must sign-up and pay a monthly premium. From there, Medicare covers 80% of the Medicare-approved cost, leaving beneficiaries to cover a 20% copayment for their outpatient services.

Note: To learn more about Medicare coverage and the various Medicare parts, visit this source. To learn more about filing a claim to Medicare, visit this source. To learn more about filing an appeal to Medicare, visit this source.

Drugs Covered By Part B

Self-administered drugs are not normally covered by Medicare. However, certain self-administered drugs highlighted by the Medicare statute are covered by Medicare Part B, including:

• Blood-Clotting Factors

• Immunosuppressive Therapy Drugs

• Erythropoietin (used for dialysis patients)

• Osteoporosis Drugs

• Select Oral Drugs Used for Cancer Treatment

Drugs Not Covered By Part B

The Centers for Medicare and Medicaid Services (CMS) has highlighted that prescription drugs or biologicals that are self-administered by Medicare beneficiaries more than 50% of the time are excluded from Medicare coverage. The majority of prescription drugs are outlined on the CMS list of SAD cost exclusions.

Note: To see the full list of self-administered drugs excluded from coverage, visit this source.
 

Medicare supplement plans work to assist with the coverage gaps of Original Medicare. While not all supplemental plans cover the cost of prescription drugs, most provide cost assistance with out-of-pocket payments and fees.

Medicare Advantage (MA) Plans

Medicare Advantage plans often referred to as Medicare Part C, bundle Part A and Part B coverage. Most plans also offer additional benefits such as Part D coverage for prescription drugs and coverage for dental, hearing, and/​or vision services. MA plans are provided to beneficiaries through Medicare-approved private insurance companies and therefore have different coverage guidelines than Original Medicare.

Coverage for self-administered drugs will depend on the MA plan a beneficiary has chosen and which drugs are included in that plan’s formulary list. To avoid unwanted costs, beneficiaries should always review their plan’s prescription drug formulary list and/​or speak with a licensed insurance agent from their health insurance company.

Medigap Plans

Medigap plans, also known as MedSupp plans, work to fill the gaps in standard Medicare coverage. Often, Medigap plans do not include coverage for prescription drugs of any kind. However, they are able to assist with copayments and out-of-pocket costs depending on which MedSupp plan is chosen.

To uncover how one’s Medigap plan can assist with uncovered Medicare costs and fees, a beneficiary should speak with a licensed insurance agent from their health insurance company.

Dual Eligibles Plan

A Dual Eligibles plan, sometimes referred to as a D‑SNP or Dual Eligibles-Special Needs Plan, combines Medicare and Medicaid coverage into one health insurance plan. Individuals must be eligible for both federal programs in order to have this Medicare plan. If a beneficiary has a Dual Eligibles plan, Medicare acts as their primary insurance while Medicaid acts as their secondary insurance.

Oftentimes, Medicaid covers the cost of prescription drugs. However, it’s important to review the list of drugs included in one’s formulary in order to avoid any unwanted costs or fees.

Note: For more information on the prescription drugs covered by Medicaid, visit this source.

Part D Prescription Drug Plans

Medicare Part D plans are available to beneficiaries who want prescription drug coverage. Similar to MA plans, Part D plans are offered to beneficiaries through Medicare-approved private insurance companies.

When it comes to Part D plans and self-administered drugs, most are covered unless they are over-the-counter (OTC) medications like aspirin or laxatives. In order to ensure a drug is covered, one should check their Part D plan formulary or contact an insurance agent from their health insurance company.

It’s important to note that most plans will not cover drugs bought from pharmacies that are out-of-network, this includes medications bought at hospital pharmacies. If a beneficiary uses an out-of-network pharmacy, even if it’s a hospital pharmacy, they may have to pay for the cost of their SAD medication upfront and later submit a claim for reimbursement to their medical insurance.
 

When it comes to self-administered drugs, there are a wide variety of programs available to assist beneficiaries with out-of-pocket drug expenses. Check out the programs below that work to aid beneficiaries with their unpaid self-administered drugs.

Extra Help Program

Some beneficiaries qualify for what is known as the ​“Extra Help Program.” Extra Help assists those with limited income or resources in paying for premiums, deductibles, or copayments involved with prescription drug expenses.

Note: To learn more about the Extra Help Program or see if a beneficiary is eligible, visit this source.

State Health Insurance Assistance Program (SHIP)

The State Health Insurance Assistance Program (SHIP) is a national program that works to educate Medicare beneficiaries about their benefits, including drug coverage. SHIP assistance is available in-person and via telephone.

Note: To learn more about SHIP, visit this source.

GoodRx

GoodRx provides discounts and deals on OTC and prescription medications. Beneficiaries can search their self-administered drug on the GoodRx website or on their mobile app to see if any discounts are available to use.

Note: To learn more about GoodRx or to download their mobile app, visit this source.

Program of All-Inclusive Care for the Elderly (PACE)

PACE is a Medicare and Medicaid program that works to pull community resources and caregivers for elderly patients so they can avoid going to a nursing home or other care facility. Coverage and cost assistance for drugs is included in the PACE program.

Note: To learn more about who is eligible for PACE and how the program functions, visit this source.
 

Whether a drug is covered by Part B, a part D plan, or a Medicare Advantage plan, there is a review process to ensure the drug is the right option for an individual patient. When a healthcare provider believes a medication is necessary, they must submit a request to the Medicare provider detailing why, which usually includes details on the immediate effect and expected long-term improvement for an individual’s health, and if the condition is treated separately by other approaches, as well as previous treatments administered or if they’ve taken equivalent drugs before. Sometimes this information is referred to as presumptive evidence about why a drug is medically necessary.

They also submit information about their prescription on the same dates, such as if the drug will be taken in the oral form or the total injections or pills prescribed.

The insurance provider will then approve or reject the claim. If the select beginning decision is a disapproval, there are multiple routes for a provider to submit an appeal. This process applies for any new prescription, but a doctor, not the patient, is responsible for collecting and submitting appropriate patient data.

Evidentiary Criteria and the Sad List

Most self administered drugs are not covered by Medicare Part B because they are on the Self-Administered Drug Exclusion List (sad list). Part D plans and some Medicare Advantage providers may cover these.

Whether a drug is one the sad list or not, it must have peer reviewed medical literature to support its benefits and be FDA-approved for the prescribed purpose and revenue code. Often, one drug will have one or multiple indications, and Medicare usually won’t cover a drug, even if it’s on the sad list, unless it’s for one of those uses.

When administering one’s own medication, it’s important to be safe and hygienic. Some tips on safely administering drugs at home include:

• Washing one’s hands before handling medications.

• Using a pill organizer to ensure one is taking the correct dosage and pills on the appropriate days or times.

• Install a reminder app or tool to make sure one is taking medication at the appropriate time daily.

• Reading any directions or procedures carefully prior to administering the drug. Always consult a doctor prior to using a new medication.