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1 Kidney Medicare Drugs Awareness and Education Initiative Medicare: How It’s Changing To Help More People Helping to Fill the Coverage Gap Presented by: Kidney Medicare Drugs Awareness and Education Initiative www.kidneydrugcoverage.org

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1 Kidney Medicare Drugs Awareness and Education Initiative

Medicare: How It’s Changing To Help More People

Helping to Fill the Coverage Gap

Presented by: Kidney Medicare Drugs

Awareness and Education Initiativewww.kidneydrugcoverage.org

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2 Kidney Medicare Drugs Awareness and Education Initiative

KIDNEY MEDICARE DRUGS AWARENESS AND EDUCATION

INITIATIVE

A kidney community effort to help professionals and

people with kidney disease understand Medicare prescription drug coverage

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3 Kidney Medicare Drugs Awareness and Education Initiative

Participating OrganizationsAbbott Laboratories American Association of Kidney Patients, Inc. American Kidney Fund American Nephrology Nurses’ Association The American Society of Nephrology Amgen Astellas Pharma US, Inc. Centers for Medicare & Medicaid Services Central Florida Kidney Center, Inc. DaVita, Inc. DaVita Patient Citizens The ESRD Network of New York Fresenius Medical Care North America Gambro Healthcare US Genzyme Corporation Kidney Care Partners Nabi BiopharmaceuticalsNational Kidney Foundation, Inc.• Council of Nephrology Nurses and Technicians• Council of Nephrology Social Workers• Council on Renal Nutrition• People Like Us

National Minority Health Month FoundationNational Renal Administrators Association Novartis Pharmaceuticals Corporation Pfizer Inc. Pharmaceutical Research and Manufacturers of

America PKD FoundationRenal Care Group, Inc. The Renal Network, Inc. Renal Physicians Association Renal Support Network Roche Pharmaceuticals Sigma-Tau Pharmaceuticals, Inc. Social Security Administration Transplant News The Transplant Pharmacy Coalition UnitedHealth Group/Ovations Washington Hospital Center Wyeth Pharmaceuticals

Abbott Laboratories American Association of Kidney Patients, Inc. American Kidney Fund American Nephrology Nurses’ Association The American Society of Nephrology Amgen Astellas Pharma US, Inc. Centers for Medicare & Medicaid Services Central Florida Kidney Center, Inc. DaVita, Inc. DaVita Patient Citizens The ESRD Network of New York Fresenius Medical Care North America Gambro Healthcare US Genzyme Corporation Kidney Care Partners Nabi BiopharmaceuticalsNational Kidney Foundation, Inc.• Council of Nephrology Nurses and Technicians• Council of Nephrology Social Workers• Council on Renal Nutrition• People Like Us

National Minority Health Month FoundationNational Renal Administrators Association Novartis Pharmaceuticals Corporation Pfizer Inc. Pharmaceutical Research and Manufacturers of

America PKD FoundationRenal Care Group, Inc. The Renal Network, Inc. Renal Physicians Association Renal Support Network Roche Pharmaceuticals Sigma-Tau Pharmaceuticals, Inc. Social Security Administration Transplant News The Transplant Pharmacy Coalition UnitedHealth Group/Ovations Washington Hospital Center Wyeth Pharmaceuticals

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4 Kidney Medicare Drugs Awareness and Education Initiative

Prior Teleconferences in Series

• August 16 teleconference – upcoming changes and extra help for those with limited income and resources

• September 20–coverage coordination• October 18–choosing a Medicare drug plan• November 15—formularies, exceptions, and

coverage determinations• December 20—filing appeals and grievances• For past teleconferences, see teleconference

archive on www.kidneydrugcoverage.org

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5 Kidney Medicare Drugs Awareness and Education Initiative

Goal of Teleconference Series

• Help patients make the best decision about:– Whether they need a Medicare drug plan– Which plan will help them take the drugs they

need

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6 Kidney Medicare Drugs Awareness and Education Initiative

Our Experts…Moderator:• Sandie Dean, Fresenius Medical Care of North

AmericaSpeakers• Janet Miller, Centers for Medicare and Medicaid

Services• Marge Watchorn, Centers for Medicare and

Medicaid Services• Bob Whitlock, Missouri Kidney Program• John O’Brien, Pharmaceutical Research and

Manufacturers of America• Phylis Ermann, American Kidney Fund

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7 Kidney Medicare Drugs Awareness and Education Initiative

How Is the Standard Medicare Drug Plan Structured?

Type Coverage What patient spends…

Premium* Average $32.20/ mo

Deductible* Up to $250 out-of-pocket

Coinsurance* Up to $500 from $251-$2,250 (25%)

Coverage Gap* Up to $2,850 from $2,251-$5,100 (100%)

Catastrophic

(rest of calendar year)

5% of covered drug costs or $2 (generic) or $5 (brand name) after drug cost of $5,100 ($3,600 spent)

*Plans vary by region and coverage.

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8 Kidney Medicare Drugs Awareness and Education Initiative

What About Enhanced Plans?

• Any Medicare beneficiary can join one.

• Enhanced plans may cover:– Drugs during the coverage gap– More drugs, including standard Plan excluded

drugs

• Premiums may be higher.

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9 Kidney Medicare Drugs Awareness and Education Initiative

Who Gets “Extra Help?”

• Patients may qualify with limited income and resources to get help to pay prescription drug costs.

• Medicare mailed letters in May and June to those automatically eligible (Medicare/Medicaid, Medicare Savings Programs, SSI without Medicaid).

• SSA mailed applications to those with limited Social Security or Railroad Retirement benefits.

• Those who received applications should fill it out and send it to Social Security.

• Anyone who might be eligible can apply at SSA in person, at 1-800-772-1213, at www.socialsecurity.gov or at state Medicaid office.

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10 Kidney Medicare Drugs Awareness and Education Initiative

Facts About Reach of Part D

• Over 6 million were enrolled in Medicare drug plans in late 2005 or early 2006.

• 1 million prescriptions have been filled per day.

• As plans process applications, the eligibility program for pharmacists and the Medicare Drug Plan Finder at www.medicare.gov are updated.

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11 Kidney Medicare Drugs Awareness and Education Initiative

How Can You Find Out Part D Plan Status?

• CSR can give beneficiary plan name, other drug coverage and extra help status.

• CSR can only give plan name if caller other than beneficiary gives:– Beneficiary’s last name– Date of birth– Medicare number– Effective dates of Part A and B– Zip code

• These data elements can be used to access beneficiary information in Drug Plan Finder at www.medicare.gov.

• CSR cannot disclose additional information without beneficiary’s verbal or written authorization unless caller is beneficiary’s personal representative.

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12 Kidney Medicare Drugs Awareness and Education Initiative

What Can Be Done for Emergency Need During Transition Period?

• Pharmacist should call 1-800-MEDICARE and state it’s an emergency.

• CSR will refer to regional office to get necessary information so plan member can get prescription as soon as possible.

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13 Kidney Medicare Drugs Awareness and Education Initiative

What Help Is There for Those Without Proof of Plan?

• CMS contracted with a company to validate dual eligibility and enrollment status.

• CMS contracted with Wellpoint to accept claims and enroll duals who weren’t in plans into Wellpoint’s. These duals can change later and new plan takes effect the next month.

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14 Kidney Medicare Drugs Awareness and Education Initiative

What Help Is Available for Those Needing Drugs Now?

• Take these forms of ID to pharmacy: – Medicare card or other proof of Medicare

(Medicare explanation of benefits)– Any cards used to pay for drugs, like Medicaid

ID card– Picture ID

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15 Kidney Medicare Drugs Awareness and Education Initiative

How Can PharmacistsCheck Eligibility?

• By computer 24/7• By calling 1-800-MEDICARE 24/7• By calling dedicated Pharmacy Helpline

24/7– Staffing was increased from 150 to 4,500

CSRs to handle call volume and reduce wait times.

– CSRs can tell pharmacist enrollment status and low-income subsidy co-pay amount.

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16 Kidney Medicare Drugs Awareness and Education Initiative

What Special Help Is There for Katrina Evacuees?

• Flagged in the Medicare beneficiary database• They should show pharmacist:

– Medicare number or Medicaid card (if available) or– Give name, Medicare number, date of birth– Picture ID

• Katrina auto-enrollees– If in national plan, go to any network pharmacy anywhere in US

to get Part D covered drugs– If in regional plan, go to any pharmacy where they are to get

Part D covered drugs, pharmacy can apply to be in network

• Dual Katrina evacuees pay $1 or $3 co-pay for covered drugs and can get one time fill of non-covered drug.

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17 Kidney Medicare Drugs Awareness and Education Initiative

How Will CMS Reduce Coverage Gaps for New Duals?

• Will auto-enroll those with Medicare who get Medicaid if they’re not already enrolled

• Will auto-enroll those with full Medicaid who are expected to get Medicare before Medicaid drug coverage ends

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18 Kidney Medicare Drugs Awareness and Education Initiative

What Are Duals’ Options If Plans Don’t Cover Their Drugs?

• Ask doctor if another covered drug works as well;

• File an exception request with medical justification to get prescribed drug:– 72 hours for standard exception request;– 24 hours for expedited exception request;

• Plans should give “first fill” prescriptions at network pharmacies for non-covered drug to allow time to talk with MD, file exception, or switch plans.

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19 Kidney Medicare Drugs Awareness and Education Initiative

What’s the Transition Plan for Those in Long-Term Care?

• Plan will fill resident’s prescriptions at network pharmacies for non-covered drugs for at least 30 days, sometimes longer.

• Duals living in long-term care have no co-pays for covered drugs.

• Preliminary reports show those in long-term care are getting their drugs with minimal problems.

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20 Kidney Medicare Drugs Awareness and Education Initiative

How Can a Plan Member Find a Network Pharmacy?

• Pharmacist can use the eligibility database to find out beneficiary’s plan.

• If pharmacy is not in-network, pharmacist must give beneficiary plan’s phone number to find network pharmacy.

• To avoid paying full price, Medicare beneficiaries should go to in-network pharmacy.

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21 Kidney Medicare Drugs Awareness and Education Initiative

What Are Standard Part D Excluded Drugs?

• Anorexia, weight loss, weight gain• Fertility drugs• Cosmetic purposes, like hair growth• Cold and cough medicines• Vitamins and minerals

– Except Vitamin D analogs (hormone), prenatal vitamins, fluoride

• Non-prescription or over-the-counter• Benzodiazepines• Barbiturates

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22 Kidney Medicare Drugs Awareness and Education Initiative

What Will Medicaid Coverof Part D Excluded Drugs?

• If state covers Part D excluded drugs for Medicaid only recipients, state must cover same drugs for those with Part D.

• The state will receive federal matching funds for excluded drugs provided to those with Part D.

• Read about Medicaid coverage of Part D excluded drugs by state at www.cms.hhs.gov/States/EDC/list.asp – All means all in the category Medicaid covered – None means none in the category Medicaid covered– Some means those listed are Medicaid covered

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23 Kidney Medicare Drugs Awareness and Education Initiative

36 State Pharmacy Assistance Programs (SPAPs) Effective 1/1/06• Alaska• California• Connecticut• Delaware• Florida• Illinois• Indiana• Massachusetts• Maine• Maryland• Missouri• Montana

• New Jersey• Nevada• New York• North Carolina • Rhode Island• South Carolina• Texas• U.S. Virgin Islands• Vermont• Washington• Wisconsin• Wyoming

Michigan and Minnesota terminated their SPAPs 1/1/06Wyoming is terminating its SPAP for those with Medicare 5/31/06

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24 Kidney Medicare Drugs Awareness and Education Initiative

How Can SPAPs Help Those with Part D?

• SPAPs can offer wrap-around benefits to fill gaps in Medicare drug coverage to medically needy.

• Qualified SPAPs can offer same or better coverage and beneficiaries should pay less.

• The pharmacist bills Part D then the SPAP.• Qualified SPAP payments count toward true out-

of-pocket costs (TrOOP); plan member reaches Medicare’s catastrophic coverage sooner.

• Qualified SPAP can require plans it coordinates with to cover SPAP formulary drugs.

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25 Kidney Medicare Drugs Awareness and Education Initiative

When Can Some SPAPs’ Help Not Count Toward TrOOP?

• MMA was intended to promote competition among plans and give beneficiaries freedom of choice.

• If SPAP steers members to plan and only helps those on that plan, SPAP is not qualified.

• Help from non-qualified SPAP doesn’t count toward TrOOP.

• No current SPAPs steer people to plans.• There are no non-qualified SPAPs now.

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26 Kidney Medicare Drugs Awareness and Education Initiative

How Do Medicare Beneficiaries Learn about SPAPs?

• MMA provided $125 million over 2 years to educate enrollees about Part D.

• CMS awarded grants to 21 SPAPs to help Medicare beneficiaries enroll in plans– to offer telephone – To provide in-person counseling

• Read about SPAPs at www.cms.hhs.gov/States/07_SPAPs.asp

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Missouri Kidney Program

• State-funded, housed in University of Missouri-Columbia School of Medicine

• $4 million budget for multiple benefits including– Mail order centralized drug program – Paying spenddowns for qualified MoKP patients to

give them continuous Medicaid• Working with MissouriRx (SPAP) and Medicaid

– Medicaid pays for some excluded drugs– MissouriRx pays 50% of duals’ co-pays– As budget allows MoKP pays 50% of co-pays

• State kidney programs, also qualified SPAPs: Delaware, Maryland, Texas, Wisconsin

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28 Kidney Medicare Drugs Awareness and Education Initiative

What Is the History of Patient Assistance Programs?

• PAPs have offered a safety net by providing medicines to those with low income people and no drug coverage.

• PAPs filled 22 million prescriptions for several million patients for Medicare and non-Medicare patients in 2004.

• Although structures differ, PAPs provide drugs at no or very low cost.

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29 Kidney Medicare Drugs Awareness and Education Initiative

What Are Benefits of Medicare Part D?

• Medicines play an important role in health care.• Insurance is a key to access to care.• Pharmaceutical industry believes seniors will

benefit from successful Medicare drug program. • Medicare drug program provides private-sector

insurance and most with low-income get nearly 100% coverage for drugs and large savings from– Enhanced insurance coverage– Negotiated discounts on medicines

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30 Kidney Medicare Drugs Awareness and Education Initiative

What Are the Burdens of Medicare Part D?

• Low income individuals may have out-of-pocket expenses.

• Companies hoped to use PAPs to wrap around Part D at least for coverage gap, but companies may need to change help provided to Medicare beneficiaries under OIG interpretations.

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31 Kidney Medicare Drugs Awareness and Education Initiative

What Are Barriers to PAPs?

• Fraud and abuse laws provide civil and criminal penalties.

• Prior OIG opinions limited Part B cost sharing.

• PhRMA and member companies believed assistance could be provided consistent with fraud and abuse laws, particularly for coverage gap.

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32 Kidney Medicare Drugs Awareness and Education Initiative

PhRMA, the OIG andPAP Continuation

• PhRMA asked for OIG guidance to let PAPs provide free drugs to low-income beneficiaries with Part D during coverage gap if structured to protect Medicare.

• PhRMA provided the OIG a detailed White Paper explaining how PAPs could do this.

• Many patient and provider groups asked the OIG to allow continued assistance.

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33 Kidney Medicare Drugs Awareness and Education Initiative

OIG Special Advisory Bulletin

• Manufacturer programs providing direct help to Part D enrollees for cost sharing or coverage gap pose substantial risk of violating anti-kickback laws.

• Manufacturers may provide financial support—not donated drugs—to independent foundations.

• Companies may need to request OIG advisory opinion describing details of particular program that may take months or longer to obtain.

To read OIG Special Advisory Bulletin of November 7, 2005 on PAPs, see:http://oig.hhs.gov/publications/docs/press/2005/patientassistancesabrelD.pdf

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34 Kidney Medicare Drugs Awareness and Education Initiative

What Are Manufacturers Doing?

• PhRMA cannot collect information or discuss with members what individual companies may be doing with PAPs.

• Manufacturers are evaluating recent guidance.• Each manufacturer must decide what to do for 2006.• Guidance only affects Medicare beneficiaries, not others

with low income.• PhRMA and member companies are working with

organizations and government agencies to– Support Medicare drug benefit – look for ways PAPs can help Medicare Part D enrollees

consistent with federal law

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35 Kidney Medicare Drugs Awareness and Education Initiative

How Can You Learn What Drug Companies Are Doing?

• Volunteers in Health Care has a chart of PAPs, eligibility, and help for those with Part D.

• Visit www.rxassist.org

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36 Kidney Medicare Drugs Awareness and Education Initiative

American Kidney Fund

• Founded in 1971 before Medicare to help one patient pay for dialysis

• Provided 105,000 grants – For nearly $57 million – To 55,000 patients – To pay for medication, medication co-pays,

dialysis-related transportation, health insurance premiums, living donor expenses

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37 Kidney Medicare Drugs Awareness and Education Initiative

How Will American Kidney Fund Help Those with Part D?

• Establishing a funding pool to help with out-of-pocket drug costs;

• Asking pharmaceutical companies to contribute;• Sought OIG opinion to be sure program doesn’t violate

anti-fraud provisions;• Will give individual grants of $175 to those on dialysis

whose income is 135 to 150% of federal poverty level;• Accepting applications from social workers and doctors• As funding pool grows, will evaluate expanding grant

size or extending grants to transplant recipients and those with CKD who do not have kidney failure.

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38 Kidney Medicare Drugs Awareness and Education Initiative

What Are Some Other Charities?

• HealthWell helps with Part D co-pays, coinsurance and/or premiums for those taking oral drugs for anemia of CKD or ESRD and secondary hyperparathyroidism.www.healthwellfoundation.org

• Patient Services, Inc. helps existing Medicare only clients with the Part B 20% co-pay for Aranesp® or Procrit ® for those with anemia of CKD and helps those with transplants taking anti-proliferative drugs. Hopes to open enrollment in 2006.www.uneedpsi.org

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39 Kidney Medicare Drugs Awareness and Education Initiative

What About TrOOP?

• Payments made for drugs by charities, qualified SPAPs, families friends, personal health savings vehicles (medical savings accounts etc.) can count toward TrOOP.

• Insurance payments don’t count toward TrOOP.

• Plans track and report TrOOP balances to members at least monthly if they’re using Part D.

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40 Kidney Medicare Drugs Awareness and Education Initiative

What If Pharmacist Can’t or Won’t Check Eligibility?

• CMS has these taken steps to reduce/eliminate people from being turned away at pharmacy:– Increasing support for the pharmacist helpline;– Improving the response times from web based tools;– Providing extra guidance to pharmacists on web based tools to

improve match rates;– Working with drug plans to reiterate CMS policy and asking them

to enforce their transition plans; – Holding weekly conferences with pharmacy associations;– Establishing system for CSR at 1-800-MEDICARE to refer

individual problems to caseworkers to work on case-by-case basis;

– Providing duals who declare an emergency need help through CSR or referral to caseworker.

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41 Kidney Medicare Drugs Awareness and Education Initiative

Preparing Those Who Face Facilitated Enrollment in June

• Problems arose when auto-enrollees later changed plans. • Number to be transitioned on June 1 will be smaller.• This spring Medicare will send notice to those with SSI and

Medicare Savings Programs about enrollment in Part D. • Notice will come with letter, list of plans with premiums at or

below benchmark and Q&A’s that Medicare will enroll them in Part D: – One notice for full subsidy– One notice for partial subsidy

• Advocacy groups can review, comment on notice before mailing.

• Tell patients about letters; 1-800-MEDICARE can explain.• NKF to keep CMS posted on concerns to help pinpoint trends.

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42 Kidney Medicare Drugs Awareness and Education Initiative

Take Away Messages• Enhanced Medicare drug plans pay more or cover more than

standard plans.• Medicaid may cover all or some Medicare excluded drugs.• SPAPs offer partial or full wrap around benefits.• Some states have state kidney programs. Four are qualified

SPAPs.• The OIG advisory limits help pharmaceutical companies can give

to Part D members without risking sanctions under the Social Security Act anti-kickback statute. Companies can contribute to charities with less risk.

• Charities and foundations are working to develop programs to help pay all or part of eligible individuals’ premiums and cost shares.

• Medicare is addressing issues with the duals and is proactively planning with advocacy groups for how to transition those who will be facilitated enrolled in June.

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43 Kidney Medicare Drugs Awareness and Education Initiative

Thank You• Sandie Dean, Fresenius Medical Care of North

America

Speakers• Janet Miller, Centers for Medicare and Medicaid

Services• Marge Watchorn, Centers for Medicare and

Medicaid Services• Bob Whitlock, Missouri Kidney Program• John O’Brien, Pharmaceutical Research and

Manufacturers of America• Phylis Ermann, American Kidney Fund

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44 Kidney Medicare Drugs Awareness and Education Initiative

Key Messages

• Medicare drug plan will help some.• Others may not need it.• Most of what you read is for the “average” person with

Medicare.• Kidney Medicare Drugs Awareness and Education

Initiative provides kidney-specific information.• Choose a plan that covers most drugs for the most help.• Ask patients to bring notices to review, explain if

coverage is creditable, copy and hold for safekeeping.• Patients have right to not bring notice and to not join a

Part D plan.

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45 Kidney Medicare Drugs Awareness and Education Initiative

The right information at the right time…

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46 Kidney Medicare Drugs Awareness and Education Initiative

Thank You For Participating…• Visit www.kidneydrugcoverage.org for today’s materials.• Register on site for updates and activities:

– 4 booklets for patients (NEW)– Compare Drug Plans packet (NEW)– 40 individualized fact sheets (Coming Soon)

• Print your certificate of attendance and complete evaluation.

• Ask your licensing board if you can use certificate for continuing education credit.

• Submit questions about Medicare Part D to [email protected].

• Today’s teleconference concludes our teleconference series.

• Please complete evaluation and give us feedback on whether you want future teleconferences and topics.