Medicare prescription drug coverage

The new prescription drug benefit added to the federal Medicare program, known as Medicare Part D. The prescription drug coverage will begin on January 1, 2006.

Centers for Medicare and Medicaid Services (CMS)

The federal agency that runs the Medicare program, including the Medicare Prescription Drug Benefit program. In addition, CMS works with the States to run the Medicaid program.

Medicare

The federal health insurance program for: people 65 years of age or older; certain younger people with disabilities; and people of any age with end-stage renal disease (permanent kidney failure with dialysis or a transplant), sometimes called ESRD. Part A pays for hospital care, Part B pays for doctor visits, Part C includes the managed care option, and Part D is the new prescription drug benefit.

Prescription Drug Plan (PDP)

A private insurance plan that offers coverage for prescription drugs under Medicare, also known as a Medicare prescription drug plan.

Premium

Regular monthly payment made to a health or prescription drug plan by beneficiaries for health care coverage. The lowest average premium for a Medicare prescription drug plan is expected to be about $32.

Medicare Advantage Perscription Drug Plan (MA-PD)

The Part D prescription drug plan that will be offered to enrollees in a Medicare Advantage managed care plan.

Limited Income

Under Medicare, limited income refers to income below 150% of the Federal Poverty Level. In 2005, the year Medicare prescription drug benefit goes into effect, this is equal to a yearly income of $14,355 for an individual and $19,245 for a couple, with other resources of no more than $11,500 for an individual and $23,000 for a couple.

Extra Help

The name that has been given to the low-income subsidy program for Medicare Part D. Extra Help will pay for part or all of the Medicare prescription drug premiums for Medicare beneficiaries who have incomes below 135% of the Federal Poverty Level (FPL) (including dual eligibles) and part of the premium for those who have incomes between 135% and 150 % of the FPL. The benefit will protect beneficiaries under 150 % of the FPL from the gap in coverage referred to as the "doughnut hole." Dual eligibles will get this benefit without applying. All others will need to apply for Extra Help.

Dual eligible (or duals)

A person who is eligible for both Medicare and Medicaid. CMS will automatically enroll dual eligibles in low-premium PDPs. If they choose to stay in a low-premium PDP, dual eligibles’ only cost for drugs will be a $1 co-pay for generic drugs and a $3 co-pay for brand-name drugs.

Supplemental Security Income (SSI)

A program to help aged, blind, and/or disabled people who have little or no income pay for basic needs such as food, clothing, and shelter.

Medicare Savings Plan

Medicaid programs that help pay for some or all of Medicare premiums and deductibles.

Partial dual eligible

Low-income individuals with Medicare, including Qualified Medicare Beneficiaries (QMB), Specified Low-Income Medicare Beneficiaries (SLMB), and Qualifying Individuals (QI), as well as Supplemental Security Income (SSI) recipients and individuals with Medicare Savings Plans. These individuals will have facilitated enrollment by CMS into prescription drug plans and will receive financial help with the costs of Medicare Part D.

Auto-enrollment

The process by which CMS will randomly assign individuals with both Medicare and Medicaid (dual eligibles) into prescription drug plans (PDPs).

Formulary

A list of medications that a prescription drug plan covers (prior authorization by the Medicare prescription drug plan may be required).

Deductible

A flat dollar amount a person must pay before Medicare will pay for prescription drugs costs. The standard yearly deductible for Medicare patients who don’t have a low-income subsidy is $250.

Co-payment

A dollar amount that a person must pay out-of-pocket for a medication or other health service. For example, a PDP may ask for a $3 co-payment for each generic prescription and $5 for brand name prescriptions. Co-pays may be further tiered by PDPs to discourage use of more expensive drugs.

Spend down

This option allows a person to spend down to Medicaid eligibility by having medical expenses that can be subtracted from their income. Subtracting medical expenses such as prescription drugs and eye glasses from your income can reduce a person’s income to a level below the maximum allowed by a particular state’s Medicaid plan.

Medigap Policy

A Medicare supplement insurance policy sold by private insurance companies to fill "gaps" in original Medicare coverage.

Medicaid

A joint federal and state program that provides medical coverage for people with low incomes and limited resources. Medicaid programs vary from state to state.

Qualified Medicare Beneficiary (QMB)

A person with an income equal to or below 100% of the Federal Poverty Level and limited financial resources who receives some assistance with Medicare costs but is not on Medicaid.

Qualified Individual (QI)

A person with an income between 120% and 135% of the Federal Poverty Level (FPL) and limited financial resources who receives some assistance with Medicare costs but is not on Medicaid.

Qualified Medicare Beneficiary (QMB)

A person with an income equal to or below 100% of the Federal Poverty Level and limited financial resources who receives some assistance with Medicare costs but is not on Medicaid.

Specefied Low-income Medicare Beneficiary (SLMB)

A person with an income between 100% and 120% of the Federal Poverty Level and limited financial resources who receives some assistance with Medicare costs but is not on Medicaid.

Prior authorization

Specific drugs on a formulary may require that the physician seek approval from the prescription drug plan (PDP) before the prescription can be filled.

Fail first

(Also known as "step therapy") This requires that a patient fail on one or more preferred formulary drugs—generally lower price, or generic drugs—before a prescription will be filled for the non-preferred drug a physician has determined would be most appropriate/effective for the patient.

Step therapy

(Also known as "fail first") This requires that a patient fail on one or more preferred formulary drugs—generally lower price, or generic drugs—before a prescription will be filled for the non-preferred drug a physician has determined would be most appropriate/effective for the patient.

True Out-of-Pocket Costs (TrOOP)

The government will pay most (or in some cases, all) of your drug costs for the rest of the year, once you pay $3,600 in out-of-pocket expenses (this amount may increase on a yearly basis and does not include premium payments). Out-of-pocket costs include all prescription drug costs paid by you or another person or organization, including the government (for example, Extra Help), State Pharmaceutical Assistance Programs (SPAPs), registered charities, and pharmaceutical manufacturer patient assistance programs. The out-of-pocket costs include payment of the deductible, co-insurance, co-payments, and medication costs that are not covered by other insurance. These costs do not include expenses paid by the individual with Medicare prescription drug coverage for medications that are not on a plan’s covered list of drugs or for medications excluded from the Medicare prescription drug benefit.

Coverage Determination

A written notice from the Medicare prescription drug plan informing the patient that they will or will not cover a prescribed medication.

Exception

The first phase of the appeals process; a formal decision by a Medicare prescription drug plan to cover a medication not on its formulary, or to reduce a co-payment for a drug not on the PDP’s preferred list. If the plan does not approve the exception, the appeals process can continue.

Medicare Appeals Council (MAC)

The fifth stage of the Medicare prescription drug benefit appeals process is conducted by the Medicare Appeals Council (part of the Centers of Medicare and Medicaid Services), after an Administrative Law Judge (ALJ) has denied a request to cover a medication.

Independent Review Entity (IRE)

The third stage of the Part D appeals process; an IRE reviews a plan’s decision not to cover a medication. An IRE is a review body that is under contract with the prescription drug plan to do such reviews.

Administrative Law Judge (ALJ)

A hearings officer who presides over appeal conflicts between providers of services or beneficiaries and Medicare contractors.

Reconsideration

The third stage of the appeals process; after a redetermination has been denied. This stage of the appeals process is conducted by an Independent Review Entity (IRE).

Non-formulary drugs

Drugs not on a prescription drug plan (PDP) approved list.

State Pharmaceutical Assistance Program (SPAP)

A state-financed and state-administered program that provides pharmaceutical assistance to certain populations, most often seniors. SPAPs usually work one of two ways: (1) by providing subsidies to qualified individuals for help with costs associated with prescription drugs, or (2) by providing drugs at a discount directly to individuals. At least 41 states have established or authorized some type of SPAP to provide pharmaceutical coverage or assistance, primarily to low-income elderly or persons with disabilities who do not qualify for Medicaid.

Beneficiary

Someone who has Medicare prescription drug coverage. (See also: dual eligible.)

State Health Insurance Assistance Program (SHIP)

A state program that gets money from the federal government to give free local health insurance counseling to people with Medicare.

Prescription Drug Plan Formularies

Each Medicare Prescription Drug Plan (PDP) must have a formulary that includes both generic and brand name medicines covered by the plan. CMS requires that the plans include at least two drugs in every pharmacologic class in a wide range of therapeutic categories based on the USP (U.S. Pharmacopeia) Model Guidelines for drug categories and classes. For the antidepressant, antipsychotic, anticonvulsant, anticancer, immunosuppressant, and HIV/AIDS categories, CMS is requiring that PDPs include “all or substantially all” of the drugs available. However, PDPs are not required to provide all doses and forms of these drugs.

Please click here for a form created by APA to assess prescription drug plan formularies based on a patient's current prescription drug use.

Psychiatric Medications: Therapeutic Categories and Pharmacologic Classes
(from USP)


Therapeutic Category

Pharmacologic Class

Analgesics

Opioid Analgesics

Anticonvulsants

Calcium Channel Modifying Agents

Gamma-aminobutyric Acid (GABA) Augmenting Agents

Glutamate Reducing Agents

Sodium Channel Inhibitors

Antidementia Agents

Cholinesterase Inhibitors

Glutamate Pathway Modifiers

Other (such as ergoloid mesylates)

Antidepressants

Monoamine Oxidase (Type A) Inhibitors

Reuptake Inhibitors

Other (such as bupropion, maprotiline, mirtazapine, trazodone)

Antipsychotics

Non-phenothiazines

Non-phenothiazines/atypicals

Phenothiazines

Anxiolytics

Antidepressants

Other (such as buspirone, meprobamate)

Bipolar Agents

No class listed

Deterrents/Replacements

Alcohol Deterrents

Sedatives/Hypnotics

No class listed

Toxicologic Agents

Opioid Antagonists

Questions Answered NEW What happens if an individual needs to access medications when they are out of their region? CMS is aware that there are instances in which a beneficiary may need to access drugs at an out-of-network pharmacy. Plans are required to assure that their enrollees have adequate access to drugs dispensed at out-of-network pharmacies when they cannot reasonably be expected to obtain covered Part D drugs at a network pharmacy. Provided that such access to out-of-network pharmacies is not routine, we expect that plans would guarantee out-of-network access to beneficiaries when, for example they are: (1) traveling outside their plan’s service area and run out of or lose their covered Part D drugs or become ill and need a covered Part D drug, and cannot access a network pharmacy; (2) not able to obtain a covered Part D drug in a timely manner within their service area because, for example, there is no network pharmacy within a reasonable driving distance that provides 24/7 service; (3) filling a prescription for a covered Part D drug and that particular drug (for example, an orphan drug or other specialty pharmaceutical) is not regularly stocked at accessible network retail or mail-order pharmacies); (4) administered a vaccine covered by Part D in a physician’s office; and (5) provided covered Part D drugs dispensed by an out-of-network institution-based pharmacy while in an emergency department, provider-based clinic, outpatient surgery, or other outpatient setting. We will closely monitor out-of-network access to ensure that plans are adequately meeting enrollees’ out-of-network access needs. Plans will have some flexibility to establish reasonable rules to assure that enrollees use out-of-network pharmacies appropriately. When an enrollee purchases a drug at an out-of-network pharmacy under these circumstances, he or she will pay the same cost-sharing as would have applied at a network pharmacy, plus the difference between the out-of-network pharmacy’s price and the network pharmacy price for that drug. NEW Are the Plan Finder and Formulary Finder fully functional? According to CMS, yes, and all information is accurate to what was provided to them by the plans. On November 7, detailed pricing data was added to the site, allowing users to compare drug costs and calculate total costs for the individual based on their medications. On November 14, the online enrollment center and a Spanish-language version of the Plan Finder tool were added to the site. There are still some issues: slow site, links not functioning, but generally it’s working. Some tips/new features: The online enrollment tool can assist in enrolling individuals in all plans except the 54 that chose not to participate in that option (waiting for clarification from CMS). Users can access the online enrollment form by clicking on an Enroll in a Plan button in five locations: On the Plan Finder homepage After searching the Plan Finder, each Plan detail page has a link to enroll On the Personalized search page On the detailed cost comparison page On the Medicare.gov personal plan finder page (for general Medicare plans) When doing a search based on medications, the tool will identify plans which cover the search medications and the user can click on the medication to get further detail about whether prior authorization, step therapy or quantity limits apply, and what copayment tier the medication is in. An ** in that box indicates a non-formulary medication. In late November, duals will be able to enter their personal information and automatically be able to compare the plan to which they’ve been autoenrolled to other plan options in their region. When conducting a personalized search for an individual, CMS admitted that dual eligibles are not differentiated from individuals eligible for the Extra Help, so the default information on copayments will show $2-5, rather than the $1-3 that will be applicable to most full benefit duals. The Plan Finder/Formulary Finder tool will only identify network pharmacies within a 50 mile radius of the individual. In rural states, this may (and is) limiting the choice of plans in some cases. When entering medications to conduct a personalized search, users are not able to enter the same medication in two different dosages (e.g., if an individual is on the same medication but different dosages in the morning and evening – and thus two separate prescriptions). CMS is aware and I await a response on how to get around that… Some plans are offering no copays – principally for generic medications only. Which medications used to treat mental illness won’t be included on the formularies? Several medications used in psychiatric care will not be included in the PDP formularies: Barbiturates and benzodiazepines are legally excluded from coverage by the Modernization Act (MMA), which created the prescription drug benefit. Other drugs used in psychiatric care that may be excluded per formulary guidance include: Escitalopram or citalopram (antidepressants) – only one must be included Fosphenytoin (anticonvulsant) may be excluded It is expected that most states will continue to provide the drugs that are legally excluded from coverage by Medicare for patients with both Medicare and (). The APA is currently conducting a survey of how state Medicaid programs will respond to the needs of dual eligibles. Will the formularies cover other medications used to treat mental illnes? CMS has recommended that “all or substantially all” of the drugs in the antidepressant, antipsychotic, and anticonvulsant therapeutic categories be included in plan formularies. This does not mean, however, that all forms and dosages of these drugs must be included, only that some version of the medication must be on the formulary. It should be noted that drugs used for the treatment of substance use disorders do not fall within the “all or substantially all” categories. The "all or substantially all" policy will be in place for 2006, and will be reviewed for 2007. How can my patients find out which plans include their current medications? CMS has indicated that starting in October 2005, information comparing different plans, including the medications on their formularies and the utilization management techniques they’ll employ, will be available through www.medicare.gov, 1-800-MEDICARE, and through . may also be able to provide assistance. (This will be updated as soon as plan information is released by CMS.) Will my patients have to switch medications if their current drugs aren’t on the plan’s formulary? CMS has said that it will assume patients already in treatment are stabilized on current medications and will expect PDPs to make those same medications available without restrictions. Therefore, a patient presenting for a refill on or after January 1, 2006, will be presumed to be clinically stabile and entitled to the refill medication on demand. It is unclear, however, whether the PDPs will have to provide the drugs in the same dosage and/or form the patient is currently taking. There is also some concern that if the drug is not available as prescribed, an request may be necessary to bypass utilization management protocols (See Utilization Management). These issues are currently being discussed with CMS, and it is hoped that these discussions will clarify what constitutes a valid refill request. What if I wish to prescribe a medication not on my patient’s PDP formulary? Physicians who wish to prescribe a medication that is not on the patient’s plan formulary, or which is restricted by utilization management techniques, can request an exception from the plan. Each plan is required to have a process in place for considering these exceptions. For more information, see section on Coverage Determinations, Exceptions, and Appeals Can the plans change formularies after enrollment? Yes, plans can change the medications on their formularies. For example, plans can discontinue coverage of a drug, or change their management techniques. However, they must provide at least 60 days notice to affected enrollees, physicians, and pharmacists, among others, before the changes take effect. During this time, plan enrollees should be able to seek an exception to the new formulary (see section on Coverage Determinations, Exceptions, and Appeals). How can my dual eligible patients, who currently receive drugs under Medicaid, get an emergency supply of medications after January 1, 2006?? In some states, physicians may be able to help ease their patients’ transition to the new plans by providing a prescription for a 30- to 90-day extended supply of needed drugs to be filled in December 2005. Each state will have its own policy on this. (The APA has undertaken a state-by-state analysis on this issue which will be available soon.) Should my patients refill their prescriptions by December 31, 2005? Yes. It is advisable for patients to play it safe and get a supply while it is certain the needed drug is available. Also, this gives time to start the exceptions process in January without potentially having the patient go without needed medications while the process takes its course. CMS recommends that Medicaid plans provide a refill supply of medication to see patients through the transition period, but this is likely to vary from state to state. While CMS doesn’t specify the time period the refill should cover, they say that at least 30 days is reasonable for patients who first visit a pharmacy with a prescription for a drug not on the formulary (a longer supply of 90-180 days is suggested for patients in long-term care facilities). The goal is to give the PDP and/or enrollee enough time to contact the physician about substituting another medication or requesting an exception to the new formulary if there is no acceptable substitution.

Current as of 9-26-2005

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