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  1. 1. Medicare: How It’s Changing To Help More People Coverage Determinations, Drug Utilization Management, and Medical Therapy Management Presented by: Kidney Medicare Drugs Awareness and Education Initiative
  2. 2. KIDNEY MEDICARE DRUGS AWARENESS AND EDUCATION INITIATIVE A kidney community effort to help professionals and people with kidney disease understand Medicare prescription drug coverage
  3. 3. Participating Organizations <ul><li>Abbott Laboratories </li></ul><ul><li>American Association of Kidney Patients, Inc. </li></ul><ul><li>American Kidney Fund </li></ul><ul><li>American Nephrology Nurses’ Association </li></ul><ul><li>The American Society of Nephrology </li></ul><ul><li>Amgen </li></ul><ul><li>Astellas Pharma US, Inc. </li></ul><ul><li>Centers for Medicare & Medicaid Services </li></ul><ul><li>Central Florida Kidney Center, Inc. </li></ul><ul><li>DaVita, Inc. </li></ul><ul><li>DaVita Patient Citizens </li></ul><ul><li>The ESRD Network of New York </li></ul><ul><li>Fresenius Medical Care North America </li></ul><ul><li>Gambro Healthcare US </li></ul><ul><li>Genzyme Corporation </li></ul><ul><li>Kidney Care Partners </li></ul><ul><li>National Kidney Foundation, Inc. </li></ul><ul><ul><li>Council of Nephrology Nurses and Technicians </li></ul></ul><ul><ul><li>Council of Nephrology Social Workers </li></ul></ul><ul><ul><li>Council on Renal Nutrition </li></ul></ul><ul><li>National Minority Health Month Foundation </li></ul><ul><li>National Renal Administrators Association </li></ul><ul><li>Novartis Pharmaceuticals Corporation </li></ul><ul><li>People Like Us, National Kidney Foundation </li></ul><ul><li>Pfizer Inc. </li></ul><ul><li>Pharmaceutical Research and Manufacturers of America </li></ul><ul><li>PKD Foundation </li></ul><ul><li>Renal Care Group, Inc. </li></ul><ul><li>The Renal Network, Inc. </li></ul><ul><li>Renal Physicians Association </li></ul><ul><li>Renal Support Network </li></ul><ul><li>Roche Pharmaceuticals </li></ul><ul><li>Sigma-Tau Pharmaceuticals, Inc. </li></ul><ul><li>Social Security Administration </li></ul><ul><li>Transplant News </li></ul><ul><li>The Transplant Pharmacy Coalition </li></ul><ul><li>UnitedHealth Group/Ovations </li></ul><ul><li>Washington Hospital Center </li></ul><ul><li>Wyeth Pharmaceuticals </li></ul>
  4. 4. Prior Teleconferences in Series <ul><li>August 16 teleconference – upcoming changes and extra help for those with limited income and resources </li></ul><ul><li>September 20 teleconference – coverage coordination </li></ul><ul><li>October 18 teleconference – choosing a Medicare drug plan </li></ul><ul><li>Archived materials from teleconferences on </li></ul>
  5. 5. Medicare Part D Overview <ul><li>November 15, 2005 (Today): First date to join a Medicare drug plan </li></ul><ul><li>Dual eligibles can stick with the plan Medicare chose for them (yellow letter) or choose a different plan by December 31, 2005 for January 1, 2006 </li></ul><ul><li>May 15, 2006: Last date for people with Medicare now to join </li></ul><ul><li>Patients who spend a lot on drugs can start saving from Day 1 if they join a plan by December 31, 2005 </li></ul>
  6. 6. Our Experts… <ul><li>Moderator: </li></ul><ul><li>Deborah Collinsworth , Dialysis Clinic Inc. social worker, past executive committee member of the National Kidney Foundation’s Council of Nephrology Social Workers </li></ul><ul><li>Speakers </li></ul><ul><li>Bryan Becker, MD, nephrologist, affiliate assistant professor in the Division of Transplantation and Associate Professor of Medicine, University of Wisconsin </li></ul><ul><li>Aaron Eaton, pharmacist, Division of Finance and Operations, Center for Medicare & Medicaid Services </li></ul><ul><li>Babette Edgar , Director of the Division of Finance and Operations in the Medicare Drug Benefit Group, Centers for Medicare & Medicaid Services </li></ul>
  7. 7. What Is a Formulary and Why Should Patients Care? <ul><li>A list of drugs a plan will cover. </li></ul><ul><li>Medicare drug plans </li></ul><ul><ul><li>Don’t have to cover all drugs </li></ul></ul><ul><ul><li>Must cover two drugs per category or class (floor not ceiling) </li></ul></ul><ul><ul><li>Other requirements in sub-regulatory guidance </li></ul></ul><ul><li>Patients will save money by choosing a plan that covers their drugs </li></ul>
  8. 8. How Did Medicare Review of Plan Formularies? <ul><li>Medicare reviewed best practices in private plans, Medicaid, Federal Employees Health Benefits Plans </li></ul><ul><li>US Pharmacopoeia </li></ul><ul><li>American Hospital Formulary Service </li></ul><ul><li>Two drugs per category and class </li></ul><ul><li>Tier placement </li></ul><ul><li>Treatment guidelines </li></ul><ul><li>Therapeutic categories or pharmacologic classes requiring uninterrupted access </li></ul><ul><li>Commonly used drugs in Medicare population </li></ul><ul><li>Quantity limits </li></ul><ul><li>Prior authorization </li></ul><ul><li>Step therapy </li></ul><ul><li>Insulin supplies & vaccines </li></ul><ul><li>Long-term care accessibility </li></ul>
  9. 9. What Did Medicare Require of Formularies? <ul><li>To get CMS approval, all plans must </li></ul><ul><ul><li>Have flexibility in formularies and payment structure </li></ul></ul><ul><ul><li>Allow people to get medically necessary drugs </li></ul></ul><ul><ul><li>Not discourage any group from joining Part D by formulary or tiering structure </li></ul></ul><ul><ul><li>Follow USP model (2 drugs per category/class) to pass 1 st discrimination test </li></ul></ul><ul><ul><li>Give 60-day notice of a change to affected people or provide a 60-day supply when a beneficiary refills a prescription. </li></ul></ul><ul><li>CMS must approve all changes. </li></ul>
  10. 10. Drugs and Plan Formularies <ul><li>Patients with chronic illnesses should be sure their drugs are on any plan formulary they join </li></ul><ul><li>Medicare drug plan formularies are robust so most beneficiaries will find a plan that covers their drugs </li></ul><ul><li>If a plan doesn’t cover all drugs, the beneficiary should use the exceptions process </li></ul><ul><li>CMS reviewed and approved all exceptions processes </li></ul>
  11. 11. What Drugs are Covered by Standard Medicare Part D Plans? <ul><li>Must cover “all or substantially all” </li></ul><ul><ul><li>Cancer medicines </li></ul></ul><ul><ul><li>HIV/AIDS drugs </li></ul></ul><ul><ul><li>Anti-depressants </li></ul></ul><ul><ul><li>Anti-psychotics </li></ul></ul><ul><ul><li>Anti-convulsants </li></ul></ul><ul><ul><li>Immunosuppressants to prevent organ rejection </li></ul></ul><ul><li>Plans do not have to cover every brand name or all doses </li></ul>
  12. 12. What Drugs Are Excluded from Standard Medicare Part D Plans? <ul><li>Drugs used for anorexia, weight loss or gain </li></ul><ul><li>Fertility drugs </li></ul><ul><li>Drugs used for cosmetic purposes (hair growth) </li></ul><ul><li>Cold and cough medicines </li></ul><ul><li>Non-prescription or over-the-counter </li></ul><ul><li>Barbiturates (e.g. Seconal ® , Nembutal ® ) </li></ul><ul><li>Benzodiazepines (e.g. Restoril ® , Ativan ® ) </li></ul><ul><li>Vitamins and minerals </li></ul><ul><ul><li>Except prenatal vitamins, fluoride preparations, Vitamin D </li></ul></ul><ul><li>“ Enhanced” plans may cover excluded drugs </li></ul>
  13. 13. What Can a Plan Choose Under the Medicare Modernization Act <ul><li>What drugs to cover </li></ul><ul><li>What strengths and dosage to cover </li></ul><ul><li>What co-payments or coinsurance </li></ul>
  14. 14. How Do Plans Choose Drugs To Include On Their Formulary? <ul><li>Pharmacy & Therapeutics Committee </li></ul><ul><ul><li>Physicians and pharmacists </li></ul></ul><ul><ul><li>1 physician must have experience in care of elderly or disabled </li></ul></ul><ul><ul><li>1 physician or pharmacist on P&T committee without any relationship to plan or pharmaceutical manufacturer </li></ul></ul>
  15. 15. What Are Some Things Plans Can Require? <ul><li>Co-payment or coinsurance </li></ul><ul><li>Prior authorization </li></ul><ul><li>Step therapy </li></ul><ul><li>Quantity limits </li></ul><ul><li>Generic substitution </li></ul><ul><li>Therapeutic interchange </li></ul><ul><li>Tiered cost sharing </li></ul>
  16. 16. What Is Prior Authorization? When Should Someone Request It? <ul><li>If a drug is not listed on the plan’s CMS-approved formulary </li></ul><ul><li>Physician must obtain approval for prescribed drug before plan will provide it. </li></ul><ul><li>Request prior authorization right away when new drug needed </li></ul>
  17. 17. What Can Physicians Do When A Plan Requires Prior Authorization? <ul><li>Complete paperwork or phone plan </li></ul><ul><li>Provide medical justification for drug not on plan formulary or at preferred drug level </li></ul><ul><li>MD should request exception before prescribing new drug if prior authorization is needed </li></ul><ul><li>MD should request exception right away if pharmacist says prior authorization is needed </li></ul>
  18. 18. What Is Step Therapy? <ul><li>Step therapy requires a patient to try other drugs before the prescribed drug is approved. </li></ul>
  19. 19. What Can a Physician Do When a Plan Requires Step Therapy? <ul><li>Acceptable if never on drug before </li></ul><ul><ul><li>New patient </li></ul></ul><ul><ul><li>Existing patient </li></ul></ul><ul><li>May not be cost effective </li></ul><ul><ul><li>If requires switching patient from effective drug </li></ul></ul><ul><li>Physician needs to know if step therapy is required </li></ul>
  20. 20. What Can New Plan Member Do to Get Needed Drug? <ul><li>Transition process </li></ul><ul><ul><li>For new plan members stabilized on non-formulary drug prior to joining a plan </li></ul></ul><ul><ul><li>Allows those who didn’t know drug wasn’t on formulary to get 30-day refill to ask MD: </li></ul></ul><ul><ul><ul><li>If a formulary drug would work as well </li></ul></ul></ul><ul><ul><ul><li>To write medical justification for an exception </li></ul></ul></ul>
  21. 21. What Is Tiered Cost Sharing? <ul><li>Formulary drugs have co-pays, coinsurance </li></ul><ul><li>Plan can have any number of tiers, e.g. </li></ul><ul><ul><li>Tier 1: Generics </li></ul></ul><ul><ul><li>Tier 2: Preferred brand name drugs </li></ul></ul><ul><ul><li>Tier 3: Non-preferred brand name drugs </li></ul></ul><ul><li>Look at tier and co-payment – one plan’s Tier 3 may cost less than another’s Tier 2 </li></ul><ul><li>Plans may give 60 days notice of tiering change to those affected </li></ul><ul><li>CMS must approve tiering change at least 60 days before it takes effect </li></ul>
  22. 22. What Is Standard Medicare Part D Plan? *Plans vary by region and coverage. 5% of covered drug costs after drug cost of $5,100 ($3,600 spent) Catastrophic (rest of year) Up to $2,850 from $2,251-$5,100 Coverage Gap* Up to $500 from $251-$2,250 Coinsurance* Up to $250 out-of-pocket Deductible* ≤ $37/mo ( average $32.20/ mo) Premium* What patient spends… Type Coverage
  23. 23. Where Can You Get an Idea of Costs? <ul><li>Medicare & You </li></ul><ul><li>Prescription Drug Plan Finder </li></ul><ul><li>Formulary Finder </li></ul>
  24. 24. What If Medically Necessary Drug Is At Unaffordable Tier? <ul><li>Patients should show formulary to MD </li></ul><ul><li>Patients should ask MD if lower tier drugs would work as well </li></ul><ul><li>MD could request exception to get drug at lower tier </li></ul>
  25. 25. What If Medically Necessary Drug Is On a High Tier or Not on Plan? <ul><li>Medicare stand-alone prescription drug plans and Medicare Advantage drug plans must have exceptions process </li></ul><ul><ul><li>To request plan to allow patient to get drug and pay less (lower tier) </li></ul></ul><ul><ul><li>To request plan to allow patient to take non-formulary drug </li></ul></ul><ul><li>Rules for coverage determinations apply </li></ul>
  26. 26. What Is Therapeutic Substitution? <ul><li>Therapeutic substitutions replace a prescribed drug with another therapeutically or biologically equivalent and cheaper drug. </li></ul><ul><li>Brand name drug  Generic drug </li></ul>
  27. 27. What Are Concerns About Therapeutic Substitution? <ul><li>Substitutions may be upsetting to patients </li></ul><ul><li>If MD is concerned about generic substitution for brand name drugs for certain patients or drugs: </li></ul><ul><ul><li>MD should check “no substitution” box </li></ul></ul><ul><ul><li>MD should know whether his/her state law allows the pharmacist to substitute a generic if the doctor does not check that box (40 states allow) </li></ul></ul><ul><li>Patients need to be sure drugs prescribed are the same as drugs filled </li></ul><ul><li>MD and nurses can help with exceptions </li></ul>
  28. 28. How Does MD Justify a Formulary Exception? <ul><li>Describe medical need </li></ul><ul><li>State why formulary drug would not be effective or cause adverse consequences </li></ul><ul><li>State whether patient took other drugs before that didn’t control condition or produced harmful side effects </li></ul><ul><li>People with kidney disease don’t do well on some drugs and should avoid others </li></ul><ul><li>Network 8 Demo Project informed CMS </li></ul>
  29. 29. What Is the Appeals Process? <ul><li>Several steps of appeal available if exception denied </li></ul><ul><li>Learn steps Medicare – How It’s Changing to Help More People: Grievances and Appeals at noon ET on December 20, 2005 </li></ul>
  30. 30. How Long Can Exception Decision Take? <ul><li>For those with serious health conditions – up to 24 hours </li></ul><ul><li>For standard decisions – up to 72 hours </li></ul><ul><li>If plan doesn’t meet deadline, independent review entity must review the request and decide </li></ul>
  31. 31. What Happens If Plan Changes Tier Structure During Plan Year? <ul><li>CMS must approve all formulary changes </li></ul><ul><li>Patients must have 60-days notice </li></ul><ul><li>Exceptions process must address tier co-pay changes </li></ul><ul><li>If plan has generic tier, it doesn’t have to provide non-preferred drugs at generic tier co-pay </li></ul><ul><li>Beneficiaries can’t request exception to tiering structure for 4 th Tier or higher drug (high cost, unique, genomic and biotech products) </li></ul><ul><li>May have to request exception yearly </li></ul>
  32. 32. Why Care About A Pharmacy? <ul><li>Retail pharmacies may be near to your home </li></ul><ul><ul><li>Preferred retail pharmacies – low cost shares </li></ul></ul><ul><ul><li>Non-preferred retail pharmacies – higher cost shares </li></ul></ul><ul><li>Mail order pharmacies can save money and time </li></ul><ul><ul><li>Preferred mail order pharmacies – lowest cost shares </li></ul></ul><ul><ul><li>Non-preferred mail order pharmacies – higher cost shares </li></ul></ul><ul><li>Specialty pharmacies may serve transplant patients </li></ul><ul><ul><li>Must contract with plan </li></ul></ul><ul><ul><li>Check with pharmacy or plan to see if in network </li></ul></ul>
  33. 33. What Is Medication Therapy Management Program? <ul><li>Design of MTM program left up to plan </li></ul><ul><li>Targeted to certain Medicare beneficiaries </li></ul><ul><ul><li>Multiple chronic conditions </li></ul></ul><ul><ul><li>Taking multiple covered Part D drugs </li></ul></ul><ul><ul><li>Likely to incur costs exceeding $4,000 </li></ul></ul><ul><li>Private MTM programs include education, consultation with pharmacist </li></ul><ul><ul><li>Review drugs </li></ul></ul><ul><ul><li>Develop plan </li></ul></ul><ul><ul><li>Offer tips/reminders </li></ul></ul><ul><li>Available at no cost to targeted beneficiaries </li></ul>
  34. 34. Are Renal Vitamins Covered? <ul><li>Excluded by standard Part D </li></ul><ul><li>May be covered by enhanced plan </li></ul><ul><li>May be covered by Medicaid </li></ul><ul><li>MD may recommend OTC vitamin </li></ul><ul><li>Cost of non-covered drug is not counted toward $3,600 in true out-of-pocket (TrOOP) expenses </li></ul><ul><li>[NOTE: Vitamin D analogs are not excluded] </li></ul>
  35. 35. What If Transplant Drug Is At Higher Tier? <ul><li>Check other plans for tiering and co-pays </li></ul><ul><li>Apply for extra help with Social Security </li></ul><ul><ul><li> </li></ul></ul><ul><ul><li>(800) 772-1213 </li></ul></ul><ul><li>Ask MD to request exception to get drug at lower tier </li></ul>
  36. 36. Thank You <ul><li>Moderator: </li></ul><ul><li>Deborah Collinsworth , Dialysis Clinic Inc. social worker, past member of National Kidney Foundation Council of Nephrology Social Workers Executive Committee </li></ul><ul><li>Speakers </li></ul><ul><li>Bryan Becker, MD, nephrologist, Division of transplantation and Associate Professor of Medicine, University of Wisconsin </li></ul><ul><li>Aaron Eaton, Center for Medicare & Medicaid Services </li></ul><ul><li>Babette Edgar , Division of Medicare Drug Benefit Group, Centers for Medicare & Medicaid Services </li></ul>
  37. 37. Key Messages <ul><li>Medicare drug plan will help some; others may not need it </li></ul><ul><li>Most information you read is for the “average” person with Medicare </li></ul><ul><li>Kidney Medicare Drugs Awareness and Education Initiative provides kidney-specific information </li></ul><ul><li>“ Kidney friendly” plans provide the most help </li></ul><ul><li>Ask patients to bring notices to review, advise about creditable coverage, keep for appeals </li></ul>
  38. 38. The right information at the right time…
  39. 39. Thank You For Participating… <ul><li>Listen at noon ET on December 20, 2005 for information grievances and appeals </li></ul><ul><li>Visit for today’s materials </li></ul><ul><li>Complete evaluation </li></ul><ul><li>Print your certificate of attendance </li></ul><ul><li>Ask your licensing board if certificate can be used for continuing education credit </li></ul><ul><li>Submit questions about Medicare Part D to [email_address] </li></ul>