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• • About the Part D Benefit
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Part D Coverage

In This Article:

• Getting Your Prescriptions Filled 101 - A Guide
• All Drugs in Certain Categories - All or Substantially All Coverage
• Formulary Changes During the Year
• Part D Prior Approval Rules
• Medicare B and Part D Drug Coverage
• Niacin Coverage
• Off Label Drugs and Part D Coverage

Getting Your Prescriptions Filled 101 - A Guide

About the Drugs Plans Must, May and Cannot Cover

 

Part D Plans Must Cover Certain Types of Drugs:

Plans are generally required to cover all drugs in certain categories:

• HIV/AIDS treatments,
• Antidepressants,
• Antipsychotic medications,
• Anticonvulsive treatments for seizure disorders,
• Immunosuppressant medications,
• Anticancer drugs, unless covered by Medicare Part B.

Part D Drugs: Classes of Drugs Plans May Cover:

Part D prescription drugs that plans may cover:

• Part D plans must cover a range of both generic and brand name drugs that are:
• Generally needed by populations on Medicare,
• Available only by prescription,
• Insulin preparations, even in states where a prescription is not required.
• Medical supplies are generally not covered,
• Except those associated with injection of insulin:
• Syringes, needles, alcohol swabs and gauze,
• Other medical supplies may be covered by Medicare Part B.

Access to drugs the plan covers:

• Plans may have rules about how drugs are covered. Most plans limit access to drugs by:
• Having a formulary:
• a formulary is a list of the drugs, strengths, dosages and routes of administration covered by a Part D plan.
• Covering drugs in tiers with different levels of co-payments or co-insurance:
• Cost-Sharing Tier Example:

• Tier 1, usually for generics, has lowest cost-sharing amounts,
• Tiers 2 and 3 are for name-brand and specialty drugs have higher cost-sharing amount.

• Most plans limit access to drugs by:
• Imposing utilization management requirements on covered drugs:
•  Prior authorization,
• Quantity Limits,
• Step Therapy,
• Generic substitution.

Part D Plans Cannot Cover Some Types of Drugs:

Plans are generally not allowed to cover certain types of drugs under Part D

• Medications prescribed for:
• anorexia, weight loss, or weight gain,
• symptomatic relief of cough and colds,
• Hair growth or cosmetic purposes,
• Fertility purposes.          
• Prescription vitamins and mineral products,
• Except for:
• Niacin if  prescribed for certain indications; but not as a dietary supplement, or to treat a vitamin deficiency,
• Prenatal vitamins,
• Fluoride.
• Non-prescription drugs,
• Drugs covered by Medicare Part A or Part B,
• Barbiturates,
• Used to control seizures, or provide sedation.
• Benzodiazepines,
• Minor tranquilizers used to control anxiety.
• Drugs that require testing only available from the manufacturer

Possible ways to obtain drugs that cannot be covered by Part D plans

• Patient Assistance Programs:
  • See the Medicare Website
  • Rx Assist Program Center
  • BenefitsCheckUp

• State Medicaid programs for people with both Medicare and Medicaid.
• Doctor office samples
• Alternative enhanced Part D plans that cover non-Part D drugs as a supplemental benefit.

Part D Plans can make limited changes to how they cover drugs during the year

• Plans can change only between March 1st and November 14th of each year, and only if they:
• Give notice to CMS, prescribing physicians, pharmacists and affected plan members, and
• Continue to cover drugs for members who were stabilized on a drug that were:
• removed from the formulary (unless declared unsafe or ineffective by FDA),
• “tiered up”, or
• on which new utilization management requirements are imposed that the plan removes through the end of the year

More information is availablr from CMS.

The changes plans are allowed to make during the year

• Plans can:
• Make changes when generic equivalents become onto the market to “tier up” brand name drugs,
• Remove drugs from their formulary,
• “tier up” drugs to a more experience level of cost-sharing, so that out-of-pocket expenditures rise, or
• Impose new utilization management requirements on formulary drugs.

 

Finding details about plan drug coverage

• Medicare Plan Finder
• The plan finder has
  • general information (searchable by prescription),
• Helpful for selecting plans and for helping plan members get coverage for the drugs they need.
• Links to plan Web sites,
  • What drugs are covered by each plan,
  • Prior approval and other utilization management requirements,
  • Transition policies for new plan members,
  • How to seek an exception and pursue an appeal to seek coverage of drugs if a plan denies coverage.
• Here is a My Medicare Matters Power Point presentation that gives a simple overview of which drugs are and are not generally covered by Part D, information about formularies, and how plans may limit coverage of drugs through use of prior approval and similar mechanisms, as well as hints on how to obtain those which are not covered.

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All Drugs in Certain Categories - All or Substantially All Coverage

All or substantially all drugs in six categories must be covered by Part D plans. The categories are as follows:

• Antidepressants,
• HIV/AIDS treatments,
• Antipsychotic medications,
• Anticonvulsive treatments for seizure disorders,
• Immunosuppressant medications, and
• Anticancer drugs that are not covered by Medicare Part B

The policy is explained in a CMS Memorandum.

Conversion of Prescription Medications to Over-the-Counter

Over-the-counter (OTC) medications, such as many cold and pain remedies, are not Part D drugs. This means that OTC products may not be covered by Part D plans except as extra benefits provided by enhanced Part D plans. CMS has explained that when a drug is newly converted to OTC status Part D plans must assure that the new OTC product is excluded from Part D coverage.  On the other hand, plans are allowed to continue to cover supplies of the prescription product while these last.  Plans are not allowed to change utilization management rules mid-year, so they may not make OTC drugs a “step” in a step therapy utilization management requirement during the current plan year. This means that unless plans modify their formulary rules for the next plan year, they cannot require that a member try an OTC medication before a prescription drug will be approved. Plans do need to make sure that any necessary adjustments are made to assure that they include at least two prescription medications in each category and class of drugs in their formularies. See Cynthia Tudor Memorandum, CMS, February 1, 2008, Attachment II, pages 4-5. 

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Formulary Changes During the Year

Between March 1 and October 15 each year, Part D plans have the limited authority to remove drugs from their formulary, or move them to a higher cost tier. Plans may remove drugs immediately if they are found to be dangerous or harmful. A CMS Memorandum explains this policy. This CMS Memorandum explains how this policy has been implemented in 2007.  Look especially at the answer to Question Number 2 on page three. (CY07FormularyChanges)

Plans are permitted to expand their formularies by adding newly approved drugs. They may move brand name drugs to a higher cost tier if a generic becomes available and is added to a lower tier.

Most significantly, plan members who are stabilized on a drug the plan wishes to remove from the formulary or move to a more expensive tier must be permitted to continue to fill prescriptions for the rest of the calendar year.

When plans are permitted to remove drugs or to place them on a higher tier, they must provide a 60-day advance notification to affected plan members, prescribing physicians, network pharmacists and CMS.

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Part D Prior Approval Rules

CMS has reminded Part D plans that they must make specific prior authorization criteria and other utilization management requirements available to current plan members, prospective enrollees and their physicians “on a timely basis.”

In a Memorandum dated June 14, 2007, CMS stated that plans must provide information regarding specific prior authorization criteria and other utilization management requirements. This information must be made available on a timely basis so that beneficiaries can make informed enrollment decisions, and so that physicians can access information that will help avoid delays at the pharmacy and potential interruptions in drug therapy.

Mid-Year Prior Authorization Changes

Part D plans are not permitted to make the prior authorization rules that limit access to formulary drugs more stringent during the plan year.  CMS notes that people with Medicare may have considered utilization management requirements, such as prior approval rules, during the Annual Enrollment Period to select a plan.  Allowing plans to impose stricter prior approvals during the year “could undermine beneficiaries’ enrollment decisions and anticipated drug coverage”, see Cynthia Tudor Memorandum, CMS, February 1, 2008, Attachment I, Answer 1, page 1.

Plans are always permitted to enlarge upon formularies by loosening utilization management rules such as by adding on new medically accepted uses to drugs already on formularies.

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Medicare Part B and Part D Drug Coverage

Whether a drug is covered by Part B or Part D is often referred to as a “B versus D” question.

• If a drug is covered by Part B, it is excluded from coverage by Part D.
• If a drug is not covered by Part B, Part D coverage might be available.

Determinations about whether specific drugs are covered under Medicare Part B or Medicare Part D may be based upon the diagnosis of the beneficiary, where the beneficiary resides, or the purpose for which the drug was prescribed.

Distinguishing Drug Coverage by Medicare Part B vs. Part D
This CMS document (18Kb PDF file) explains which drugs are covered by Medicare Part B and which by Part D.

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Niacin Coverage

Niacin is a vitamin and was therefore originally determined by the Centers for Medicare & Medicaid Services (CMS) to be excluded from Part D coverage. Niacin, however, in certain doses is an important therapeutic tool in the treatment of high cholesterol. CMS policy permits coverage of Niacin as an agent for the reduction of high cholesterol and not when used as a vitamin.

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Off Label Drugs and Part D Coverage

Coverage under Part D of Off-Label Drugs
The Medicare Modernization Act (MMA) restricts Part D plan coverage of off-label uses of drugs (25Kb Word file). The issues this can cause for people with Medicare have been the subject of considerable attention with a Good Morning America segment and an advocacy-oriented report, “Off-Base: The Exclusion of Off-Label Prescriptions from Medicare Part D Coverage,” (323Kb PDF file) from the Medicare Rights Center.

When your clients encounter such problems they often have no way of knowing that an off-label usage may be the root cause, or what to do to get the medicines they need; they rarely have enough information at the pharmacy counter to understand why their pharmacists cannot fill their prescriptions. Rather, your client is likely to only be told that their Part D plan doesn’t allow the prescription to be filled. All too often beneficiaries walk away perplexed and dismayed that they cannot get their prescription filled. Many will call their local trusted advocacy group – You.

While most benefits counselors are not medical professionals, there are steps you can take to help your clients. Your clients will appreciate your help ascertaining that an off-label use is the cause of the problem and helping them decide what to do in order to get the medication the doctor wants them to have.

Off-Label Usage and Part D: Background

Physicians may, and often do, prescribe medications for indications not expressly approved by the Federal Drug Administration (FDA) for inclusion on a drug’s label and patient insert information. These entirely legal prescribing practices are often the standard of care for important drug therapies for chronic and progressive medical conditions.

The MMA restricts Part D plan coverage of drugs for off-label use unless evidence is produced that the off-label use is recognized and sanctioned by one of several specified drug reference compilations, called drug compendia. Drug compendia are collections of information about peer-reviewed medical literature and clinical trials in order to explain clinical uses of drugs that might go beyond FDA approved uses for drugs. None of these compendia are easily accessible to the public and all are available only by expensive subscription. Citations to peer-reviewed medical literature generally will not suffice to reverse a coverage denial under Part D to establish coverage for an off-label use.

How You Can Help With Off-Label Denials

1. Help your clients understand why their prescription couldn’t be filled.

   You can help your clients contact the plan to get specific information about the problem. You can also help them ask the pharmacist to interpret the electronic messages and explain the nature of the problem.

2. Help your clients consider their options.

   Think about the medical and legal professions with whom you can partner in order to get your clients the medication therapies their doctors want them to have. You’ll probably want to consider many of these options simultaneously. Remember, your client’s doctor can be a supportive ally for your client and you; the pharmacist may also offer assistance.

   Here are some of their options:

   • Option One: Is the Off-Label Use in a Drug Compendium?

     Find out if the off-label use is addressed in one of the drug compendia referenced in the Medicare Modernization Act (MMA). You can ask your client’s doctor for help getting the compendia. They are also available at medical libraries, at medical schools or universities. Your client’s physician may be able to help you understand the drug compendia and you might be able to partner with doctors to present any drug compendia evidence to the plan in order to reverse the off-label denial.

   • Option Two: Can Your Client Get the Drug From a PAP?

     Find out whether a Patient Assistance Program (PAP) covers the drug for the off-label use. While the cost of drugs provided by a PAP do not count towards your client’s Part D or towards their true out of pocket expenses, or TrOOP, if a PAP will provide the drug, your client’s condition will be treated. Look at our PAP Tip Sheet. You can search for PAPs by drug at the Medicare Web site and you can download many PAP applications at Benefits CheckUp - click on "Apply for Benefits.

   • Option Three: Could the Drug Be Covered By Medicare Part A or Part B?

     You can explore whether your client’s off-label drugs could be covered by Medicare Part A or Part B. This may seem quite drastic, but sometimes, as in the Good Morning America story, the Medicare beneficiary must be hospitalized, and then the drug could be covered under Part A through the Medicare hospital benefit. Other off-label drugs are prescribed for cancer therapy or administered under the supervision of a physician and may be covered by Medicare Part B.

   • Option Four: Appeal?

     Ask for an exception to the formulary; if it is denied, file an appeal. You will be working in tandem with your client’s physician and can consider showing any medical evidence provided by the prescribing physician that no drug on a plan’s formulary would be effective and/or that every drug on the formulary would produce adverse side effects. This evidence might include articles from respected medical journals and the physician’s own research. Your local legal services or legal services for the elderly agency might be able to take cases involving Part D appeals

When Off-Label Uses are Discoved After Prescriptions Are Filled

Off-label uses are often discovered by plans after a prescription has been filled, upon audit or review, or because of a change in the dose or strength of a prescription. When Part D plans discover that a prescription was filled off-label, they must send the affected enrollee an adverse coverage determination describing the non-coverage and warning the enrollee that the prescription will not be filled in the future due to the off-label prohibition. In describing withdrawing coverage for off-label prescriptions, it is very important to note that CMS included the following directive to Part D plans: "We expect Part D plan sponsors to consider the enrollee’s health situation, and continue to cover the drug to the extent it determines that doing so is necessary to avoid risk to the enrollee’s health while providing for a transition to another form of treatment." See Cynthia Tudor Memorandum, CMS, February 1, 2008, Attachment III, Answer, page 7.

Want More Information?

Is this information new to you? Are you interested in learning how your colleagues handle the off-label hurdle? Ask your questions in the My Medicare Community Forum and get real-life answers and real-time solutions from your colleagues and your NCOA Moderators. Join the conversation already started about off-label usage. Remember you must be a logged-in member of the Community to view the Forums pages and join the conversations.

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