Transcript of the educational session

Here is a complete transcript of Prescription Assistance Options for People With Medicare Part D:

PRESCRIPTION ASSISTANCE OPTIONS FOR PEOPLE
IN MEDICARE PART D

Ladies and gentlemen, thank you for standing by, and welcome to the Prescription Assistance Options for Medicare Part D Conference Call. At this time all participants are in the listen-only mode. If you should require assistance during today’s conference, please press * then 0 on your touch-tone telephone. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Ms. Sandy Leonard. You may begin.

Welcome and Introductory remarks

Sandy Leonard: Thank you, Tomeka. Good morning everyone. I’d like to thank everyone for joining us for today’s briefing on Prescription Assistance Options for People in Medicare Part D. My name is Sandy Leonard, and I’m with AstraZeneca Pharmaceuticals; and we’re happy to be hosting today’s teleconference.

I’d like to welcome everybody. We have representation from numerous community health organizations across the country and states from New Jersey all the way to New Mexico. And we welcome all of you to the call today.

Let me say that AstraZeneca is proud to host this event, and we appreciate the presenters and the participants who are able to join us today. For nearly 30 years we’ve offered patient assistance programs side by side with our medicine, and our supportive education and outreach on Medicare Part D is an extension of our commitment that patients have safe, affordable options for getting their medicine. From our work in this arena, we recognize that there is a need to keep getting information out there on what help is available for those Medicare beneficiaries with more limited financial resources.

Our agenda for this session is designed to give you the most current information together with some practical guidance that you will find helpful as you gear up for the start of the annual enrollment period. But before we get started, I’d like to review some of the logistics for today’s events. The conference call line is a one-way line, which means in listen-only mode unless you’re a presenter. If you do experience difficulty on the conference line, please call 1-800-932-1100. I’d like to ask all of our presenters that when you’re not presenting or answering a question to please keep your phone lines on mute.

All of you should be able to see the presentation via your computer. Now these slides will automatically progress as the presenters move through their presentation. If you’re having trouble locking onto the WebEx portion of the telebriefing, please call 1-866-229-3239.

After each presentation there will be some time to address questions, and we sure hope that you do so. It’s a great opportunity. To ask a question, please refer to the lower right-hand portion of your computer screen labeled “Help.” You can submit questions throughout each presentation, and at the end we will take a few minutes to get as many of those questions answered as we can. I’ll take a moment to refer to how to submit a question when we get to that portion of the agenda. At the end of the teleconference, there will also be a brief online poll. And that will present up onto your computer screen as well.

So at this point, I’d like to go ahead and introduce our very first speaker, Kay Pokrzywa. Kay is a Health Insurance Specialist in the Center for Beneficiary Choices at CMS. She has the lead on developing policies and procedures for the low income subsidy, the extra help known as LIS for Medicare Part D. Just one moment, and I’m going to transfer this over to Kay. And thank you very much.

LIS Update

Kay Pokrzywa: Thank you, Sandy.

Sandy Leonard: You’re very welcome.

Kay Pokrzywa: On our first slide, we see that the LIS, the low income subsidy, is extra help for beneficiaries with limited income and resources that will cover most of their expenses in a Medicare Part D plan, including premiums and deductible and cost sharing.

Folks with the lowest income get the most help. As their income increases over 135% of poverty, the premium assistance can go down; and the deductible liability may go up as does the cost sharing.

To actually get the benefit of the extra help, the person must be enrolled in a Medicare drug plan including MAPD. Those are Medicare Advantage Plans that offer prescription drugs or a PACE plan to receive this assistance. Okay, we’ve just covered what the low income subsidy is, and in the next slide we will cover who qualifies for the low income subsidy.

As you can see, the top section are the population who automatically qualify for LIS. They’re also known as the deemed population, and they are people with full Medicaid benefits from their state or who have one of the Medicare savings programs which are QMB, SLMB, and QI which will pay their Medicare Part B premium and in the case of the QMB individual, copays and deductibles as well.

Also, individuals who are eligible for SSI cash benefit without Medicaid are included in the deemed population. We will deem them for a full calendar year or at least the remainder of the current calendar year if their record comes in in the middle of the year. And their LIS level will only change to a better level if we get data from their state that indicates they’re entitled to a more favorable copay level for instance.

Anyone who is in the deemed population would have to file an application to get their LIS. And the vast majority of people do so with SSA. There are a variety of subsidy-changing events that could impact the level of their low income subsidy during the year. The ones that actually will change status midyear are changes in marital status. Changes in financial circumstances and household composition will be evaluated during the year, but they will not impact the level of subsidy until the beginning of the next calendar year.

LIS levels are subject to redetermination each year. In other words, CMS through the deemed population will review individuals’ eligibility to remain in deemed status. We do that by looking at current data from state and SSA to determine if people continue to have a status that will allow them to be deemed into the next calendar year. We started this process in August. It is ongoing, and every month as we receive state data and SSA data, we add people into the deemed population for the remainder of this year and all 2008. Even those who have been found not to qualify for 2008 are deemed through the end of 2007. They will retain that status until the end of the year.

The annual election period is almost upon us. This is the period during the year when beneficiaries have the most leeway to enroll in, disenroll from, and switch plans. And that can include Medicare Advantage Plans. This period runs from November 15 through December 31, and changes made during this period take effect on January 1 of 2008.

And that in a nutshell is LIS. So I’m ready to take any questions that may be coming in.

Sandy Leonard: Okay, at this time if you have any questions for Kay, please go ahead and look at the bottom right-hand side of your screen; and there you will see the Task box. You can type in your question, and send that over, and we will gather together those questions.

I did have some questions come up during your presentation, Kay, just about some logistics; and one big question was around obtaining the presentation. At the end of this call, I will give out the Web site where you can request these presentations.

We’ve got some questions coming in, so let’s hold on one second as we take a look and get some answers for you.

Okay, we’ve got a question here, which is what are the LIS income limits for 2008?

Kay Pokrzywa: That’s an excellent question, and the answer is that we don’t have those levels yet. We will not have those levels until the Federal Poverty Level for 2008 is published, probably in the month of January. But as soon as those levels are available, we will update our income standards for 2008. They do not come out prior to January because they are based on the January Consumer Price Index that’s published by the Department of Labor. But for the last two years we’ve been very successful in putting out the new standards very quickly after that Consumer Price Index is released to the public.

Sandy Leonard: Thank you. One of the next questions that we’ve received is what would cause someone to be ineligible for LIS?

Kay Pokrzywa: Okay, in the case of the deemed population, it would be because their state is no longer reporting them as Medicaid eligible or eligible for one of the Medicare savings programs or SSA is no longer reporting them as an SSI eligible recipient.

In the case of the LIS decision made by Social Security, it is likely to be that their income or resources are too high, their household compensation has changed. Maybe their income has not. But now fewer people are being counted in their household composition. Those are likely to be the changes that would accept the LIS level or make the person ineligible.

Sandy Leonard: Kay, we’ve received numerous questions for you. And I want to let all of the participants know that we are taking down all of the questions so if your question isn’t answered during the call because we do want to make sure we get to all of our speakers today, that we will be working with our presenters to get those answers for you and relay those back to you.

But the last question we have for you, Kay, is can you give a general turnover time for enrollment in LIS. About how long could someone expect for an application to go through the process?

Kay Pokrzywa: That is really a question that only Social Security can answer. They are working these applications. At this point in the year when they may have a large volume of people applying to regain eligibility for January 1, the turnaround time may be greater than it might be at other times of year.

So I really don’t want to speak for Social Security. Certainly they’re going to make sure that all the applications they’re receiving in the autumn get worked in time for those beneficiaries to know whether they qualify for January 1.

Sandy Leonard: Wonderful. Thank you very much, Kay. I appreciate your presenting to the group, and I’m sure the group does as well. And as I mentioned, we did receive many other questions that we will work to get answers and the answers relayed out to all the participants.

The next speakers we have coming up are both Bill Decker and Vanessa Duran. Bill joined the Office of Financial Management and CMS in 2005. He is a Health Systems Analyst and a Group Team Leader for the Data Sharing Agreement Program or DSA within CMS and has more than 20 years of experience working with all aspects of health system financing.

Vanessa in her six years at CMS has worked in various positions associated with the development and implementation of the Medicare Prescription Drug Card Program and Part D. In her current position in the Medicare Drug Benefit Group, she is responsible for a variety of Medicare Part D benefits and beneficiary protection policy and operation issues.

And at this point I would go ahead and transfer over to both Bill and Vanessa the presentation, and you should have control of it now. Thank you.

How PAPs Work with Part D

Vanessa Duran: Thanks, Sandy. Together with my colleague, Bill Decker, I’m going to be giving you a quick primer on the interface between Patient Assistance Programs which are called PAPs for short and Part D. And since we have only a few minutes, we’re really going to focus our presentation on three issues. The first is what counts and what doesn’t count toward true out-of-pocket costs, which we also call TrOOPs for shorthand under the Medicare Part D benefit. The second topic is the ways in which Patient Assistant Programs can provide assistance to needy Part D enrollees. And the last is an issue with regards to eligibility and data sharing with CMS which is a tool that we offer to facilitate the provision of assistance to Part D enrollees.

I’m going to focus on the first two, and then Bill’s going to take over and focus on the last. In the first slide of the presentation, as you know, we focus on what is the true out-of-pocket calculation. And in a nutshell, it’s the total amount of out-of-pocket spending that a Part D enrollee has to incur in order to qualify for catastrophic cost sharing under the Part D benefit.

The TrOOP amounts are indexed every year. For 2008 that TrOOP amount is going to be $4,050. And the slide basically lays out for you how much in TrOOP the beneficiary would have to pay in each benefit saved of the standard Part D benefit. Just as a point of clarification, the Part D premium does not count towards the TrOOP calculation.

Payments count toward TrOOP, depending on who makes them. Out-of-pocket spending, first of all, has to be for a covered drug. But there are certain parties that may pay the cost sharing on the beneficiaries we have or alternatively may reimburse the beneficiary for that cost sharing and have those amounts count as though the beneficiary had paid out of pocket himself or herself.

One of those entities can be Medicare when it pays plans for low income subsidies for LIS-eligible individuals. Also, qualified state pharmaceutical assistance can wrap around the Part D benefit and have those payments count towards TrOOP. And, lastly, and really the focus I think of this presentation is when another person pays on behalf of a beneficiary. And when we say person, we mean a physical person but also a person defined in the legal sense of the word, which includes most charities, provided that they’re not affiliated with an employer or academia.

Payments do not count toward TrOOP when certain parties either pay that cost sharing on behalf of a beneficiary or they reimburse the beneficiary for costing sharing that the beneficiary has paid. These parties are group health plans, insurance, government-funded health programs, and other third-party payment arrangements.

Many of you in the field might be aware when Medicare Part D was implemented, there was a significant impact on the operation of patient assistance programs because many of the folks they were providing assistance to had no prescription drug coverage. And after 2006 they were enrolled in a Part D plan or a Medicare Advantage Plan with prescription drug coverage and now have coverage under a federal insurance program.

That raised some issues for our Department of Health & Human Services, Office of the Inspector General. They’re the entity that enforces the Federal Fraud and Abuse Laws. So in November 2005, they released some guidance. It’s what’s called the special advisory board since the industry, and I’ve provided the link on the slide, but it was really meant to provide some guidance to patient assistance programs in terms of how they could structure themselves to minimize the risk of implicating some of those subtle fraud and abuse statutes.

In order to sort of help the industry figure out a way to stay in the game for Part D enrollees, what we didn’t want was for the PAPs not to provide assistance to individuals who were enrolled in Part D. Together with the Office of the Inspector General, we devised a way that manufacturer PAPs could stay in the game. And this method is what we call outside the Part D option, and it allows PAPs to provide assistance to Part D enrollees but completely outside the Part D benefits. And, therefore, it has no impact on the TrOOP calculation. And this is really the model of the manufacturer sponsored-Patient Assistance Programs being offered currently.

Another model for charitable assistance is the cost sharing assistance model. To the extent that a charity makes drug payments on behalf of a Part D enrollee, so they wrap around like another payor would, it can operate within the benefit. We are going to focus primarily on this outside the Part D benefit option.

And just to give you a little more meat around that concept, for PAPs who choose to operate outside the Part D, the assistance that they provide to Part D enrollees has to be provided in such a way that the beneficiaries’ Part D benefit is not impacted. And what that means is that the TrOOP balance and the total drug spending totals are not impacted by the assistance for drugs that they provide.

There’s one small exception to that, and that’s if a PAP charges a beneficiary a small cost-sharing amount for its assistance, we allow those amounts that are paid by beneficiaries to count toward TrOOP, provided that the beneficiaries submit proof of payment to their Part D plans. The Part D plans then have to go back and aggregate those amounts for their TrOOP balance.

And that ends my piece of it. I’m going to turn things over to Bill Decker now, who’s going to explain our data sharing process. Take it away, Bill.

Bill Decker: Thanks, Vanessa. Hi, my name is Bill Decker, and I’m with the part of CMS that manages the data sharing agreements programs we have with outside entities. It’s a way for CMS to share information with people from the outside world and help to coordinate benefits, help move information back and forth between us and the outside world.

My focus here is on the data sharing agreements we have with pharmaceutical manufacturer Patient Assistance Program or PAP. And we have a variety of PAP entities who are assigned with us now, a data sharing agreement. We also have data sharing agreements with SPAPs – state PAPs. We have data sharing agreements with AVAPs. We have PBMs – pharmacy benefit managers - and we have most of our data sharing agreements with employers or insurers acting on behalf of employers.

Specifically, why should a PAP have a data sharing agreement with us? A data sharing agreement, or DSA, does permit us to share information about healthcare coverage with another entity. The DSA partner when sharing data with us will be able to find out who among his own clients are Medicare beneficiaries. That’s an advantage to most of our partners.

Medicare can also learn from its partners if a group of beneficiaries has other benefit coverage. Both Medicare and the DSA partner can then adjust their coverage of activities to be sure that the human beings involved, the patients or the clients on both sides, get the best benefit from the programs that are available through these operations.

I just want to make two quick points for you folks this morning. As Vanessa described, Medicare beneficiaries can make a nominal payment to a Patient Assistance Program for the drug and citizen’s coverage. We don’t ask the PAPs to report that. That is a function that the beneficiary is asked to do. We do, however, ask PAPs to give us a telephone number that we can then pass on to Part D plan providers so that the Part D plan can contact the Patient Assistance Program if the plan finds it necessary or useful to do so on behalf of the beneficiary. That’s both to check to be sure that the nominal payments that are coming in and being reported are actually accurate; and, more importantly, to be sure that pharmaceutical management of the benefit is actually known to both sides. We want to make sure that our beneficiaries are receiving appropriate drugs in appropriate amounts, and we do have to have some coordination between the people who are actually supplying pharmaceuticals to our beneficiaries. That’s why we have that set up that way.

And that is basically my very quick presentation on the data sharing process. There’s a lot more to it, and I expect some of you may wish to know more about it. We’ll be happy to provide whatever other information you would like at any time. Thanks.

Sandy Leonard: Thank you, Vanessa and Bill. We appreciate that presentation. Right now again if you have any questions, feel free to submit those via the Task question on your screen. Our first question for you is, what is considered a nominal payment for patient assistance?

Vanessa Duran: We have not defined nominal copayment. We do ask Patient Assistance Programs that are sharing data with us to describe their programs when we’re entering into a DSA with them. And we sort of look at them as they come. Our main goal is to make sure that the beneficiaries are not getting a raw deal.

Sandy Leonard: Thank you. Again, if there are additional questions for any of our speakers, you can feel free to submit them anytime throughout the presentations today. Vanessa and Bill, thank you very much for participating today and for sharing this information.

At this point I’m going to now introduce our next speaker, Janet Walton. Janet is Deputy Program Director of Volunteers in Health Care, which operates RxAssist.org which is a Web-based resource center on prescription assistance.

Janet has been working with programs providing healthcare to vulnerable populations for more than 15 years. She has assisted national and community-based organizations in addressing issues of medical, dental, and pharmaceutical assistance. Janet, thank you so much for joining the call today. I have provided you access to your slides now.

The PAP Landscape for People with Medicare Part D

Janet Walton: Great, thank you. So for those of you who don’t know RxAssist, we’ve been around since 1999. And the Web site is designed both for providers, advocates, and professionals as well as for patients and consumers. So we have two different areas which have the same information, and we certainly encourage everyone to take a look at what we have there.

And I do want to say that one of the things that makes us unique is that we actually have staff that backs up RxAssist so people can send us questions, people can call us on the phone. So we certainly have the experience of helping many, many hundreds of people directly who are confronting issues around needing prescription medication and not being able to afford it.

So there are many reasons why people might need assistance, and I mention this because I think it’s very important to keep an open mind if you’re looking at all of the options available to folks. It’s really critical to understand what position the person is in that brings him or her to need some help. As we heard earlier, people might be ineligible for the low income subsidy because of income or asset issues. Premiums and copays might be too high in a plan that people have selected, and certainly what we have found is that people might tend to keep the same plan they’ve had from year to year. Copays might go up, drugs might move into another tier, or the patient might have new medication or different medication that brings on costs that he or she didn’t expect. And so they need some assistance.

And then their supplies might not be on a plan’s formulary. These are unexpected issues that might come up for individuals, people finding themselves certainly in the coverage gap, also known as the donut hole. And this is something we confront all of the time with people who are contacting us.

And the other issue that has come to light recently is regarding off-label use. For example, I was working with a woman whose daughter was on a medication, an antinausea medication which was covered by Medicare Part D but only covered for certain indications. And what she was using it for was not one of the indications. Therefore, she was not able to afford the payments for her drugs.

So, again, it’s important to understand the situation when you speak with someone. Patients can be confused, people can misunderstand the details of what they’ve been told. So we may come to you with information that’s incorrect or that’s somehow garbled. Advocates sometimes might give wrong information to patients. You know, there’s a great range in terms of people’s comfort level with the regulations around Part D and around what’s available.

Prescribers may be unaware of a patient having a particular problem, and they may not be thinking about the cost issues that are involved with the patient’s medications. And the insurers are often unclear in the verbal communication that they give to patients. I don’t know how many people have read some of the letters that have come from insurers, but they can be very, very complicated to understand — even if you are part of the Part D universe.

So there are basically four options for assistance. First, there are pharmaceutical company Patient Assistance Programs, which we call PAPs. There are discount generic drug programs. There are State Pharmaceutical Assistance Programs, or SPAPs, and there are disease-specific assistance programs. I will go through each of these and give a little more information on them.

So the pharmaceutical company Patient Assistance Programs, and Vanessa mentioned back when we knew that Medicare Part D was being implemented, there was a lot of turmoil in the advocate community about what would happen when Part D was implemented, what patient assistance programs would look like, whether they could still proceed. The OIG got involved and it was very, very complicated and a bit nail-biting for a while. However, we’ve come a long way since 2005 and early ‘06 when the plan was just being implemented and all of the pharmaceutical companies were trying to sort out what they were going to do.

However, it is still the case that more than half of pharmaceutical companies think that Medicare Part D’s are ineligible for their PAPs. So it’s really very difficult to try to provide assistance for those individuals whose drugs are on programs that are not covered.

So 34 companies are now encouraging Part D enrollees to apply, and this number includes companies that have restrictions. So some of the restrictions include only certain drugs being covered, drugs only being covered if they’re not on the individual’s plan’s formulary. The individual might have to demonstrate a particular hardship. Some drugs that are commonly prescribed such as insulin, or Kepro for seizures are not available through PAPs. So it’s really critical to understand which programs provide which medications and what kind of assistance they offer.

There are only four programs that are designed specifically for Part D enrollees. And these are AstraZeneca, Eli Lilly, GlaxoSmithKline, and Genzyme which just makes one of its medications available for Part D enrollees.

And for those that do allow Part D enrollees to apply, there’s really no standardization; and this reflects the general PAP universe. But it can be very complicated to try to keep track of all of the different requirements for the various programs.

So for some of the programs, you can use a regular application. For some you need an LIS denial letter. For some you need to apply, be denied, and then appeal. For some you need to apply, submit a letter of hardship and wait while the company sends their application to a Part D review committee. Some provide coverage only in the donut hole. Some provide coverage for everything except being in the donut hole. So they’re really all across the board in terms of what they’re looking for from applicants who are looking for assistance with their medication.

And the programs are highly changeable. RxAssist.org has a chart of the various policies that different programs have regarding Part D. And I can’t tell you how many times we’ve had to change both the format of the chart and the content that’s been on the chart in order to try to keep current with the information that’s out there. And sometimes it can still be very difficult to know what a program’s policy really is.

The next option are the discount generic drug programs, which is a pretty stable universe at this time. Rx Outreach and Xubex are two generic patient assistance programs. They actually call themselves that. Rx Outreach is operated by Express Scripts, and Xubex is its own standalone company. And together they have nearly 200 generic medications that they make available. Of these, approximately 80 appear on both formularies; and 120 are on one of the two companies’ formularies.

So it leaves us a pretty wide range of generics that are available in this way. And to be eligible, an individual needs to meet income requirements which are about 250% of the federal poverty level for both programs.

Another option in this drug program universe are retail store generic programs. These include K-Mart, Wal-Mart, and Target which are all national programs. And there are some regional programs or chains or stores that might be matching the prices of these national chains.

Rx Outreach and actually Xubex — I forgot to put cost ranges in here. The generic costs ranged from $20 to $40 for three months. And so patients can get medication supplies in 90-day, 180-day, or et cetera chunks of time as they make their applications. And finally retail store generics range from $14 for a 30-day supply to $16 for a 3-month supply. And you have to look pretty carefully to see whether or not when they talk about a 30-day supply if that’s just really one pill per day or if that’s what a physician would consider to be a 30-day supply.

We then have state-sponsored prescription assistance programs. Again, a pretty stable universe. Twenty states have wraparound Part D services, and by wraparound I mean that they work to supplement Part D benefits. Some states provide prescription coverage as well for individuals who are in their two-year waiting period for Medicare coverage to begin. So it’s very important to look at the specifics of what the states offer.

All have income requirements, and it certainly varies by state. Some have age requirements. So for some of these programs, they only cover Medicare enrollees who are over 65. So this would really eliminate the population of younger people with disabilities. So, again, it’s important to pay attention to the details.

And these programs cover all other parts — the premiums, deductibles, copays, drugs in the donut hole, drugs not covered by Part D. Again, these are very state specific. So you can’t ever make general statements about who does what. And then finally there are four states that have state-sponsored discount cards which may provide some price advantage for some medications. For those of us who’ve been trying to assist people for some time, the discount cards usually offer modest savings, if any.

Then we have another group which are the disease-specific assistance programs. These are nonprofit organizations that are offering financial assistance towards copays, insurance premiums, or other out-of-pocket expenses for specific diseases. And there are about 60 or so diseases that are covered by these organizations, some of which are probably familiar to most people such as asthma, various kinds of cancer, Hodgkin’s disease. Others are less well known — Wilms’ tumor, Pompe disease. So you really need to make sure that a client has the specifications of the disease that these various programs cover.

The model varies in these programs, some provide reimbursement directly to the patient, some directly to the provider. For some, patients may need to submit receipts in order to get reimbursement or submit a bill for payment by the organization. This is important because you really want the patient to know up front what’s expected of him or her in terms of responsibilities and if there’s any cash outlay, that needs to be known. This is sometimes hard when people are in financial straits.

Certainly these funds may run out of money. The way that these organizations work is that each disease has a fund associated with it to pay for certain expenses for applicants that are determined to be eligible. So, obviously, unless the fund is replenished in some way, the money will run out and those programs can close.

And sometimes the Web sites that are represented by these programs may not have the most current information on which funds are still available to be tapped into. Sometimes if the organization is expecting new funds, it will start a waiting list. So we certainly have had the experience of people calling these organizations to find out that money is not available in a particular area and that a patient needs to be put on a waiting list.

These are the disease-specific assistance programs, and I have to apologize. The first one is not the American Kidney Foundation, but the American Kidney Fund. And the asterisk next to the listing would mean that the organization has indicated that it does counseling and provides other services in addition to financial assistance. So most really just provide financial assistance, but there are some that will provide additional services to families and individuals.

So here are some things to keep in mind when you’re really trying to help your patient. You need to understand the environment in which prescribers, insurance, and assistance programs operate. And I say this because we have to assume that everyone is really an honest player and that it’s important for the advocate to really understand the environment in which these different players operate.

So example, for prescribers, each prescriber has their own way of making prescription decisions. But these are not set in stone. So I think one option is to really work with prescribers around the possibility of changing medication. Insurers operate in a highly regulated universe, especially within the Part D. And they have exclusive rules and procedures for reviews, appeals, etc. So I think it’s important that someone know the basics of Part D and then decide whether it makes sense to try to navigate within the insurer labyrinth to try to get some exceptions or appeals made in a particular person’s case.

The same is with patient assistance programs where they have more flexibility than insurers do. So we always tell people never to be afraid to appeal a decision, to have a physician make a phone call or write a letter, or to go higher up in the program hierarchy on behalf of your patient.

It’s important to familiarize yourself with the content of key Web sites and other sources of information since this is a universe that tends to change with some frequency, especially if you’re trying to cobble together lots of different programs. So I think you need to identify those places or sources that you feel are really critical in helping you keep on top of things.

And it’s important to develop or borrow tools to help manage the information and streamline the assistance process. It is very complicated to try to figure out all the programs that are available and which ones your individual patient might be eligible for. So I think it makes sense to do what you can to organize whatever you have efficiently in the way that works best for you.

And then finally I want us to note that RxAssist has some tools available. Our Web site is free. We ask people who are using the database of patient assistance program information to register, but it’s a very short registration process. And, again, it is free. But we have many, many materials. For example, we have a chart with the pharmaceutical company, Part D, PAP eligibility policies. We have a combined list of all the generics available through Rx Outreach. And we do that with which offers what and how much it costs. We have all the diseases and organizations that provide copay assistance. We have a list of resources for low cost diabetic and other medical supplies. We have a chart on the state-specific pharmaceutical assistance programs and many other resources as well. So I certainly encourage people to visit the Web site. And if you have ideas about other resources, you might need to E-mail or call us with that information.

And that is where we end. So if there are any questions, I’ll take them.

Sandy Leonard: Well, Janet, I have to say we received many, many questions during your presentation; and I think this final slide answers many of them. One of the most frequent questions we received was where can people get specific information on the states that have specific programs, and on the specific pharmaceutical companies that have programs. And I believe this final slide will help and direct people to RxAssist.org to get a lot of the other information. Is that correct?

Janet Walton: Yes. And there are two areas — the patient area and a provider area. And people are certainly free to look through both of those areas because, as I said, we tend to have the same information in each area.

Sandy Leonard: Wonderful. I wanted to share some information that was submitted via the chat regarding a specific new discount card by medbankUS. It’s www.medbankus.org. And they’re accepted nationally, have no income requirements, and offers an average of 40% off of all generics.

A couple of other questions for you, Janet. How do we assist patients taking drugs that are not on the formulary? There’s something about formulary, can patient assistance programs help?

Janet Walton: Yes. Most patient assistance programs, unless they have specific regulations, will provide assistance for drugs that are, have been prescribed for off-label use. I think the best thing is, in those cases, is just to have a physician’s letter that the company, the application that explains why it is that this particular medication is being used by that patient.

Sandy Leonard: Wonderful. I did have a couple of notes here, Janet, for you. Many people are singing the praises of your Web site and how much it assists them in helping patients every day. So I thought that would be important for you to hear at this point.

Janet Walton: Yes, thank you.

Sandy Leonard: And I also wanted to quickly repeat the Web site mentioned as a resource. It’s www.medbankus. M-E-D-B-A-N-K-U-S.O-R-G.

Okay, well thank you very much, Janet. At this point, I am going to switch over to Tom Behan. Tom is a Senior Manager for Patient Assistance Programs and Medicare Part D at AstraZeneca. He’s one of my colleagues. He sits in on a variety of teams dedicated to AstraZeneca’s commitment of ensuring that cost is not a barrier for patients getting the AstraZeneca medicine they need.

Tom has more than 27 years experience in the pharmaceutical industry in a variety of positions. So, Tom, I’m passing the ball over to you.

Manufacturer’s Perspective on Patient Assistance for People with Medicare: AZ & Me Prescription Savings for People in Medicare Part D

Tom Behan: Thank you very much, Sandy. Good afternoon everybody. I’m really glad to be here and appreciate having the opportunity to share with you some information and some insights that I hope you’ll find helpful for your patients and also your clients that have Medicare Part D coverage.

Our approach to patient assistance for people with Medicare Part D coverage is really grounded in our company’s commitment to access, our commitment of access to medicines. It’s a commitment which goes back nearly 30 years, almost when I started with the company with the introduction of tamoxifen back in 1978.

AstraZeneca’s Patient Assistance Programs since then have evolved and really grown over the years, and I’m proud to say that these programs are really making a difference in the lives of literally hundreds of thousands of people each and every year. These people would not have any other means of coverage, and some people even with the Part D coverage still find financial challenges. And this would prevent them from being able to afford their AstraZeneca medicines as well.

But we also realize that for every person that we help, we know there are many more who could be using these programs. And they’re not doing so probably for a variety of reasons. Maybe they don’t know about them or there are barriers for them to successfully complete the application process. What we’re really trying to do is overcome those barriers, and I think that’s a really big reason why we’re here discussing this today.

AstraZeneca has a suite of Patient Assistance Programs currently in place. One of them is for qualifying healthcare facilities to assist their patients. The other two are for patients enrolled directly. Our first program is for people who don’t have insurance who need financial help in affording the medicines their physicians prescribe. This program, as you can see on the slide, is called the AZ & Me Prescription Savings Program for People Without Insurance. Quite a mouthful, but we think it really does describe what the program is trying to address.

The second program is for those patients enrolled in the Medicare Part D drug benefit but who may still be having difficulties with affording their copays. And this is the program that we’ll spend the rest of the time discussing today.

We began offering this program in November of 2006. The program is designed for individuals who are enrolled in Medicare Part D, but who still need help affording their AstraZeneca medicines. As you can see from the slide, there are several criteria which they have to meet. And these are fairly consistent across all of our assistance programs.

You’ll now see on the screen a list of the drugs that are available through this program for people who are enrolled in Medicare Part D. And, as always, as we add new products or products fall off patent or are no longer available, this list of medications may adjust.

So for patients who do qualify, there are several benefits to the AZ & Me Prescription Savings Program for the people enrolled in Medicare Part D. First, their AstraZeneca medicines will cost either $15 or $25, based on typical 30-day prescription. And the difference really depends upon whether or not or depends upon what their annual income is. Enrollment can be done over the phone or via the AZ & Me Web site, and it really just takes a few minutes to get enrolled.

Online applications, in fact, are processed in real time. And if the patient is approved, the patient will receive their membership ID; and they can bring that, along with their prescription, to the pharmacy in as little as 20 to 30 minutes after enrolling.

Having worked with this program for nearly a year now, we have a pretty good understanding of what the most commonly asked questions are — both by beneficiaries and their advocates. So I thought it might be helpful to run through our top six or seven questions. And then if you have any further questions after I finish, we can address them.

So the first one, is it possible for a patient to sign up and get their prescriptions on the same day? As I said, yes. They can actually make a phone call right there while they’re in the pharmacy, get connected with a system specialist, and after determining whether or not the patient qualifies, in about 20 minutes they will get a number that they can use with the pharmacy and have their prescription adjudicated right there at the pharmacy.

Second question is what information will patients have to provide in order to qualify? And this is pretty simple and straightforward. As you might expect, the address, telephone number, Social Security number. They need to verify their income and also their out-of-pocket expenses.

Now after they’re prequalified, they will get an enrollment package in about 7 to 10 days. That will come in the mail, and they will have to sign a certification, and mail it in along with their proof of out-of-pocket expenses, and a copy of their Part D plan or their Medicare Part D plans. An Explanation of Benefits would suffice in order to document their out-of-pocket expenses.

We often get asked if this is a one-time fill program or can people get as many refills as they need? And once they are enrolled in the AZ & Me Prescription Savings Program for people with Medicare Part D, they can get their AstraZeneca medicines for the remainder of the year, up until the end of the calendar year which coincides with the Medicare Part D plan.

Additionally, once we receive all their completed enrollment information, they can get either a 30-, 60-, or 90-day refill based on what their physician has prescribed.

If patients are on multiple AstraZeneca medicines, will the program cover all of them; or are there any limitations to how many products can be filled? And this program does cover all the AstraZeneca products that were listed on that earlier slide. They can get a typical 30day supply for either $15 or $25 based on their income.

How about reenrollment in the program each year? Yes, just like the Medicare Part D program, there is reenrollment required in our program every year. That is, the program does expire at the end of the year. Patients who qualify again can enroll the following year.

And then does the healthcare professional need to assist with enrollment? We recognize that physicians and their office staff are extremely busy. So we’ve tried to make it as simple as possible, even to the extent that a patient can just be given the 800 number by their physician or somebody in their office. And if that patient calls, they will be given assistance through our assistance specialists, even to the extent that they could have their forms filled out for them over the phone. So we really want to take the burden off the physician office.

At this point I think I’d like to pause and see if there are any other questions.

Sandy Leonard: Thanks, Tom. We did get a question here already, and that is how are out-of-pocket expenses verified?

Tom Behan: It’s relatively easy. If a patient just goes to the pharmacy where they’ve been having their prescriptions filled, they can ask the pharmacist for a printout. Obviously, if they have been visiting several pharmacies, they would have to go to each pharmacy to get a printout. But what I think is probably the easiest way is generally on a monthly basis the enrollees Part D plan sends them an Explanation of Benefits. And right there on that form, it does indicate what their out-of-pocket expenses to date have been.

Sandy Leonard: Okay. Another question that we received was around the copay. And you’d mentioned about 60- or 90-day. Does the copay vary if it’s a 30- versus a 60- or 90-day prescription?

Tom Behan: That’s a good question. There is an additional reduction in the out-of-pocket cost share for the larger quantity fills.

Sandy Leonard: Okay. If there are other questions, please feel free to submit them via the chat function.

Tom Behan: And let me just put up my last slide which is where people can find out more information about this program. The best place to go is our Web site, AZandMe.com. And for people who do want to enroll or get additional information, they can feel free to call 1-800-AZandMe.

Sandy Leonard: Tom, we just had an additional question. At the beginning of your presentation you mentioned the patient assistance for the free clinics. I don’t know if you have any of that information available with you right now. Otherwise, we can provide some of that information through the Q&A process as we share those answers out to the participants. But I wanted to put that out there and see if you were able to give any further information on the free clinic program.

Tom Behan: Sure. Right now we are enrolling clinics that have been on our waiting list. Every clinic that is applying to the program does have to go through a prescreening and then an onsite audit.

If there are facilities that would like to be considered for the program, I do have the 800 number. It is 1-866-325-8198. That’s 866-325-8198. If you call that, one of our system specialists can answer any additional questions and also get a facility on the waiting list if it appears that they might qualify for the program.

Sandy Leonard: Okay, thank you very much, Tom.

Now I’d like to go ahead and introduce our final presenter for the day, Michelle Holzer. Michelle is the Program Manager for the Maryland State Department of Aging, Senior Health Insurance Assistance Program, or SHIP, and the Senior Medicare Patrol or SMP. The SHIP is a volunteer-based program featuring claims assistance, counseling, education, and legal advocacy services for older persons. The SMP is a volunteer-based program focused on healthcare fraud, waste, and abuse issues. And so with that, I would like to welcome Michelle.

Community Advocate’s Perspective: Practical Guidance for Identifying and Enrolling Patients

Michelle Holzer: Hi everybody, and thank you very much to our host and to the other speakers. I also want to say thanks and hello to all of the SHIPs around the country who are on the call right now and also to the other community-based organizations that are helping our Medicare beneficiaries work through this very difficult subject.

I would be remiss if I didn’t say that I’m really proud to speak on behalf of the SHIP network. I’ve been involved in SHIP for 19 years now, and I’m extremely proud to be part of the network. And I’ve been asked to talk a few minutes about what the SHIPs are to those people who are on the line who are not part of this network and how they can get in touch with their local SHIP program and the types of work that we do.

The SHIP programs are housed either through the State Departments of Aging or the State Departments of Insurance in this country. There are 54 SHIP programs. Every state has a SHIP program, along with Guam, the District of Columbia, Virgin Islands, and Puerto Rico. They all have SHIP programs.

This is a volunteer-based program, meaning we train volunteers to work with clients and their family members on all areas relating to Medicare, and particularly now in our upcoming busy season of the Medicare Part D annual enrollment period. We focus very strongly on the prescription drug issue.

I think I’m part of the wrap-up of this session, and I’m a little bit on the warm and fuzzy side of the presentations today because you’re looking for some practical guidance. Well, this is a very complicated world out there. The prescription issues that we have to deal with are complex. The governmental plans that are out there are either more complex, and certainly we look towards prescription assistance programs for help to fill in a lot of the gaps in services that our clients will face.

And as I think Janet Walton said very clearly, talking about the patient assistance landscape, some of the devil is in the details. Each drug manufacturer has their own set of regulations and rules and what’s covered and what’s not and for how long. So a very complex land out there, and we’re looking to seniors or Medicare beneficiaries who are disabled and their family members and agencies that serve them to try to walk them through the maze.

So it’s a very confusing area, and it’s also equally difficult for professionals, as you all are in this field, to keep up to date, to keep your volunteers trained, to keep your volunteers motivated, and to work on behalf of all of our beneficiaries.

I think in terms of some practical guidance in all of this would be that, first of all, take a deep breath because it’s very confusing; and it’s a very busy time. We can only help one client at a time, one problem at a time, and the clients and the problems keep on coming faster and faster.

So I think the first point of practical advice would be to hang in there and, as you well know, you’ll get through it. Your volunteers will get through it, and you’ll feel really good about what you’re doing.

It’s very important for the SHIPs and anyone who’s working with a client to screen for all of the available programs first before turning towards the Patient Assistance Programs. So it is really crucial to screen for the low income subsidy. It’s crucial to understand if your state has a state pharmacy assistance program, what that covers and what it doesn’t, what types of discount programs are out there, what types of disease-specific programs. All we’re seeing is that Janet talked about, it’s really important to try to guide your clients to all of these programs before turning towards a pharmaceutical Patient Assistance Program. You don’t want to give your clients and patients false hope as to what’s out there. There’s eligibility requirements on virtually every program. So although they may feel that they cannot afford a particular drug or a copayment, they may not qualify for the program. And that’s probably one of the most frustrating areas that we as advocates deal with is, you know, we ask you to go through everything, and then what do you do?

Sometimes your state or county or local organizations may have an emergency fund to fill prescriptions or to help pay for prescriptions when you’ve truly exhausted everything else that’s out there. Again, just keep on persevering and trying to go through it as much as possible.

There’s some questions that were raised earlier when talking about the TrOOP and the Prescription Assistance Programs. You know, that’s one thing that can be a negative about the Prescription Assistance Programs that if it doesn’t count towards the TrOOP, you never get to the other side of the donut hole where the person may get catastrophic coverage through their Part D plan.

So that’s something to think about and whether or not the patient is able to get through the donut hole and then have the catastrophic coverage. You might want to look at that really carefully to see what’s best on behalf of your client.

In Maryland we are lucky in some ways I believe. We have a Medbank program, and our medbank program helps people with some of the Prescription Assistance Programs that the pharmaceutical companies offer in the hopes to cut through some of the red tape. Because, as Janet mentioned, there’s a lot to know about each and every company — what they offer, what medicines are covered.

So in Maryland we do have a program that kind of acts as an intermediate between the advocate, between the advocate and the doctor’s office and the patient and filling out those forms directly to the pharmaceutical company. They do a lot of the legwork. They do a lot of the work with the doctors, to help the doctors see the process and get them to do what they need to do on behalf of their patients and our clients.

I think that’s about all I really have to say except that we will get through the next couple of months with Medicare Part D and with all of the resources and the tools that are available to us and our wonderful volunteers and our partners out there. We will get through it, and I’m just glad that I’m part of this effort and on behalf of this SHIP network, I’m just going to say to everybody out there, good luck and together we’ll get there.

Sandy Leonard: Thank you very much, Michelle. It definitely is a lot of information out there, and it can be challenging. And I know as a child and a stepchild of patients and beneficiaries in Medicare, I appreciate all the SHIP directors, the SHIP programs, and all that the community partners are doing out there. It is definitely a needed resource, and you make a difference every day in everyone’s lives. And I think that today we have the opportunity to hear a lot of the different resources, both through the government and through the agencies as well as through some private and public opportunities out there for all of the community workers as well as caretakers of our Medicare beneficiaries.

So thank you very much for sharing some of your insights and some practical guidance as to how to get through the open enrollment process and to help beneficiaries get the prescriptions and the coverage, what they need.

If you want to provide some information, I did get a note here that New Mexico also has a Medbank program. So if you’re in New Mexico, please note that.

Conclusion

I’d like to wrap up today by thanking all of our presenters who are with us today. Also thanks to all our participants, for the active participation in asking the questions.

I think this is a great demonstration of public, private, and community organizations coming together to focus an important topic that affects all of our organizations, and reflects our shared focus on helping Medicare beneficiaries.

Before the conference call closes, I would like to ask all of you to take a few moments to complete a brief online poll. It should present itself up on your computer screen. The questions will appear in the polling box, and when they do, you simply need to move your arrow and click the appropriate buttons and select your responses.

When you’re done, just click the submit button; and your responses will be recorded. We really appreciate having your feedback, and this information helps us to evaluate the value of this session and really helps us to determine the interest in these kinds of communication vehicles in the future: what works, what doesn’t work, and how we can improve this type of a program to make sure that we’re helping to get the best information out to the folks that need it most.

Some final housekeeping notes while we’re taking the poll. The presentations, along with a complete set of Q&As, will be posted on the mymedicarecommunity.org Web site

A quick plug here to let you know about mymedicarecommunity.org. If you’ve not been there, it is a wonderful Web site, and it is intended to be a resource for individuals who are working with Medicare beneficiaries — professionals and volunteers alike. It provides you an opportunity to get this type of information and there’s an opportunity to engage with others around the country who may have similar questions or guidance or feedback to share with you as well.

In addition, if you’d like to listen to a playback of this telebriefing by phone, you can call 1-800-475-6701. Please use the access code 892054. This playback will be available until December 26.

Also for all of you participating, you will receive an E-mail that will provide the Web site as well as the playback phone numbers so that you’ll be able to access the information in case you haven’t been able to write it down because I know there’s been a lot of information shared today. We want to make sure that nothing gets lost.

So you will receive an E-mail with the Web site, and that’s where you will be able to then access and get the Q&A documents with all the questions answered from our speakers and presenters today as well as the presentations that our presenters shared today.

The poll will remain open for the next five minutes or so, and I hope that you’ll take the time to submit your answers. If you do have any additional questions, take this time now to fill those out on the task box; and type those in so we can get those responses out to you.

Lastly, I just want to thank everyone again for taking the time out of their Friday. We appreciate you being engaged, and definitely a final thank you out to all of our presenters for sharing their expertise and insights with all of us. Again, have a great day.

Operator: Ladies and gentlemen, this conference will be available for replay after October 26, 2007, at 4:45 PM Eastern Time through December 26, 2007 at 11:59 PM Eastern Time. You may access the AT&T teleconference replay system at any time by dialing 1-800-475-6701 and entering the access code, 892054. International participants dial 320-365-3844. Those numbers again are 1-800-475-6701 and international participants dial 320-365-3844, and the access code is 892054.

That does conclude our conference for today. Thank you for your participation and using AT&T Executive Teleconference. You may now disconnect.

Operator: Thank you for calling the AT&T Teleconference Replay System.

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