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.

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…

Prescription drug plans vary in which drugs are covered and how much a consumer has to pay. All plans must provide at least a standard level of coverage set by CMS and offer all drugs consumers are currently taking to ensure a smooth transition. All plans offering Medicare prescription drug coverage must provide drugs in all therapeutic classes, but they are not required to cover all new drugs in each class. It is important to make sure that most, if not all, a consumer’s medications are covered by their plan, as well as the correct dosages of those medications. Plans are not required to include all dosages of covered drugs. Each plan will only pay for the drugs that it covers, and only those drugs count toward the consumer’s deductible and out-of-pocket limit, also called TrOOP.

The drugs that will be included in prescription drug plans are “all or substantially all” of the brand name and generic drugs in the following categories:

• Antidepressant
• Antipsychotic
• Anticonvulsant
• Anticancer
• Immunosuppressant and HIV/AIDS

The drugs discussed in this section have been identified as items that may be excluded by the plan formularies. These drugs are over-the-counter drugs, weight gain and weight loss drugs, fertility drugs and cosmetic drugs, drugs to relieve cold and cough symptoms, vitamins and minerals (except prenatal vitamins and fluoride), outpatient drugs for which associated tests or monitoring must be purchased exclusively from the manufacturer, barbiturates (e.g., Pentobarbital), and benzodiazepines (e.g., Xanax, Klonopin).

Other drugs which may be excluded are:

• Iressa (for locally advanced or metastatic non-small-cell lung cancer) – not required to be on formularies
• Fuzeon (for HIV) – must be on formularies, but may require prior authorization for new users
• Escitalopram or citalopram (for depression) – one may be left off of the formulary, since escitalopram is the component of citalopram responsible for the antidepressant effects
• Fosphenytoin (anti-convulsant) – may be left off formularies

It is not required that multi-source brands of identical molecular structure be included, that extended release products be included, or that all dosages of covered drugs be included.

Note: State Pharmaceutical Assistance Programs could cover any of the above medications that may be excluded from drug lists, also called formularies. The State Medicaid Programs can cover barbiturates and benzodiazepines, and for those consumers who are full-benefit dual eligibles, states can receive federal financial participation.

In choosing a plan, one important consideration should be if the plan covers the enrollee’s existing medications.  Starting in October 2005, information comparing different plans, including the medications included on their formularies, will be available through www.medicare.gov, 1-800-MEDCARE or through State Health Insurance Assistance Programs (SHIPs).  State Pharmacy Assistance Programs (SPAPs) may also be able to provide assistance.

Medications needed urgently would be covered while a prompt exception process is completed. Plans are expected to supply to consumers at least a 30-day supply of medications. A physician or authorized representative can help the consumer with the appeals process. The provider should help facilitate the process.

Yes, plans can have different formularies (a list of drugs the plan will cover). It is important to make sure that the majority of the consumer's medications are included on their plan's list of drugs that are covered. Within a formulary, only newly prescribed medications can be tiered. Consumers currently receiving medications in the antidepressant, antipsychotic, anticonvulsant, anticancer, immunosuppressant, and HIV/AIDS categories will not have to go through utilization management protocols, such as step therapy, when they enroll in a Prescription Drug Plan. New medications prescribed can be Tier 1, 2, or 3. Medications on Tier 1 and 2 are considered preferred and have a lower co-payment. Medications on Tier 3 are covered by the plan but are not preferred and have the highest co-payments. In most cases, generic medications will be Tier 1 and brand name drugs will be Tier 2 or 3.

Formularies and drug lists are developed and reviewed by a pharmacy and therapeutic (P & T) committee. The committee should consist of a majority of practicing physicians and practicing pharmacists, and have at least one practicing physician and one practicing pharmacist who is an expert in the care of the elderly or the disabled. Drug lists are reviewed annually.

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 (including any change in the preferred or tiered cost-sharing of a drug). During this time, plan enrollees should be able to seek an exception to the new formulary (see "Exceptions and Appeals").

In addition, plans can change the overall therapeutic categories and classes on the formulary at the beginning of each year.