PART 1 TRANSPLANT SERVICES & CMS PROGRAMS COVERAGE

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1 PART 1 TRANSPLANT SERVICES & CMS PROGRAMS COVERAGE ELIGIBILITY & COVERAGE RULES

2 DISCLAIMER This information is current as of September 6, Any changes or new information superseding this webcast is provided in articles with publication dates after September 6, 2018, posted on our website at: CPT only copyright 2018 American Medical Association. All rights reserved. The Code on Dental Procedures and Nomenclature is published in Current Dental Terminology (CDT), Copyright 2018 American Dental Association (ADA). All rights reserved. September

3 AGENDA - PART I Part I: Transplant Services & CMS Programs Coverage Medicare Transplant Coverage Overview End Stage Renal Disease (ESRD) Eligibility and Coverage September

4 TRANSPLANT COVERAGE OVERVIEW

5 TRANSPLANT PROGRAM DEFINED A transplant program is defined as a component within a transplant hospital that provides transplantation of a particular type of organ to include; heart, lung, liver, kidney, pancreas or intestine September

6 TRANSPLANTS Organ transplant programs must be in certified transplant hospital Medicare provider agreement Meet transplant Conditions of Participation Comply with hospital Conditions of Participation Specified in 42 CFR through September

7 TRANSPLANTS Approved Transplant Programs: Heart Lung Heart/lung Must have existing Medicare-approved heart and Medicare-approved lung program September

8 TRANSPLANTS Approved Transplant programs: Kidney Pancreas Must have a Medicare-approved kidney program Includes combined kidney/pancreas transplants September

9 TRANSPLANTS Approved Transplant programs: Liver Intestine Must have a Medicare-approved liver program Includes multi-visceral and combined liver-intestine transplants September

10 ORGAN PROCUREMENT ORGANIZATIONS September

11 ORGAN PROCUREMENT Organ procurement = obtaining of organs for transplantation; Includes methods of obtaining through programs, systems or organizations Includes transporting of donor organs, after surgical removal, to the hospital for processing & transplant September

12 ORGAN PROCUREMENT Section 1138 of the SSA 42 U.S.C. 1320b-8 provides the statutory qualifications and requirements an OPO must meet in order for organ procurement costs to be reimbursed under the Medicare or Medicaid programs September

13 ORGAN PROCUREMENT OPO and HCL providers do not file claims A published rate is available to give transplant centers an initial payment for those services Organ procurement is reimbursed on the Medicare cost report September

14 ORGAN PROCUREMENT Information on a Medicare cost report is subject to audit and review Determine if additional funds are owed to the transplant center or owed to the program CMS adjust the transplant DRG rates to remove organ acquisition costs September

15 HEART TRANSPLANT Artificial heart is covered only as part of a CMS approved study Ventricular Assist Device (VAD) May be covered if used as bridge to transplant Not covered when used as an artificial heart September

16 HEART TRANSPLANT FDA approved VAD used as a temporary mechanical circulatory support bridge to cardiac transplant Patient approved and listed as heart transplant candidate VAD as Destination therapy (DT) Only covered as a mechanical cardiac support if approved by FDA for that purpose September

17 HEART TRANSPLANT Heart acquisition services billed to implant (transplant) hospital by excising hospital Excising hospital does not bill MAC directly Transplant hospital keeps itemized statement of services rendered and whether this is a potential transplant donor or recipient September

18 KIDNEY TRANSPLANT Transplant hospitals acquire cadaver kidneys: Excising kidneys in its own or other hospitals Under arrangements Participating community hospitals Kidney procurement organizations Kidney Transplant CMS IOM 100-4, Chapter 3, Section September

19 KIDNEY TRANSPLANT Acquisition standard charges for acquiring a live donor or cadaver kidney is: Charge that reflects average cost associated with each type of kidney acquisition Not a charge representing acquisition cost Kidney acquisition charges revenue codes 0811 Living Donor Kidney Acquisition 0812 Cadaver Donor Kidney Acquisition September

20 KIDNEY TRANSPLANT Blood and tissue typing Entitlement of who will receive transplant is not considered in donor services No bill is submitted directly to Medicare All charges for donor services prior to admission for excision are billed indirectly Through live donor acquisition charge of transplanting hospitals September

21 PANCREAS TRANSPLANT Whole-organ pancreas transplant is covered by Medicare when: Performed simultaneously kidney transplant (SPK) Performed after a kidney transplant (PAK) Immunosuppressive therapy will begin with the date of discharge from the pancreas transplant For a list of facilities approved to perform SPK or PAK: lianc/20_transplant.asp#topofpage September

22 PANCREAS TRANSPLANT ALONE (PTA) Limited coverage for patients with severe secondary complications of type 1 diabetes Facility must be approved for kidney transplant Patient must be able to understand risks of surgery and immunosuppressive drugs needs Patient must be suitable transplant candidate September

23 LIVER TRANSPLANT Acquisition charges are billed by the excising hospital to the transplant hospital Adult liver transplantation is covered for patient s with end-stage liver disease Other malignancies remain excluded from coverage Coverage for facility is effective as of the date of the facility s approval from CMS September

24 INTESTINAL AND MULTI-VISCERAL TRANSPLANTATION Covered for restoring intestinal function in patients with irreversible intestinal failure Covered for patients who have failed Total Parenteral Nutrition (TPN) Multi-Visceral transplantation includes organs in the digestive system Stomach, duodenum, pancreas, liver, intestine and colon September

25 OTHER TRANSPLANTS Under certain conditions, Medicare may cover: Stem Cell Transplant CMS IOM 100-4, Chapter 3, Section 90.3 Cornea Transplant - Keratoplasty CMS IOM 100-3, Chapter 1, Section Not limited to Medicare-approved transplant centers September

26 LABORATORY SERVICES Clinical diagnostic laboratory services Physician orders Medically reasonable and necessary Medicare Part B benefit No cost to beneficiary for Medicare-approved covered clinical diagnostic laboratory services September

27 IMMUNOSUPPRESSIVE TRANSPLANT DRUGS Transplant drug therapy for a covered organ transplant is covered under Medicare Part B Part D may cover other transplant drugs not covered under the Part B benefit Even if Medicare did not pay for transplant If beneficiary has ESRD and Original Medicare, they may join a Medicare drug plan September

28 TRANSPLANT DRUGS If Medicare entitlement is only due to ESRD - Coverage ends 36 months after month of transplant Medicare pays for the transplant drugs with no time limit if patient: Already is entitled to Medicare because of age or disability before ESRD Became entitled to Medicare because of age or disability after a transplant paid by Medicare or a primary insurer in a Medicare-certified facility September

29 TRANSPLANT DRUGS Part B drugs in a physician office or pharmacy Beneficiary pays 20% of the Medicare-approved amount, the Part B deductible applies Physician or pharmacy must accept assignment for Part B drugs Part B drugs in a hospital outpatient setting Beneficiary pays a copayment Non-covered = beneficiary pays 100% September

30 END-STAGE RENAL DISEASE (ESRD) Eligibility and Coverage

31 END-STAGE RENAL DISEASE (ESRD) BASICS ESRD is permanent kidney failure Stage V chronic kidney disease requiring a regular course of dialysis or kidney transplant May be eligible for Medicare based on ESRD Coverage for people with ESRD began in 1973 September

32 MEDICARE PART A ELIGIBILITY BASED ON ESRD May receive Medicare regardless of age if: Kidneys no longer work, and Need regular dialysis or had a kidney transplant, and one of these applies: Worked the required amount of time under Social Security, Railroad Retirement Board (RRB), or as a government employee Already getting or are eligible for Social Security or RRB benefits A spouse or dependent child of a person who meets either of the requirements listed above September

33 MEDICARE PART B ELIGIBILITY If entitled to Part A - may enroll in Part B Beneficiary pays the monthly Part B premium May have to pay a lifetime monthly late enrollment penalty if beneficiary delayed in enrolling for Part B Need both Part A & B for complete coverage Beneficiary information available through: SSA at (TTY: ) RRB at (TTY: ) September

34 MEDICARE ENROLLMENT BASED ON ESRD Enrolling in Medicare Medicare and Group Health Plan (GHP) Coverage Enrollment considerations Rules for ESRD coverage When it starts, continues, resumes, and ends September

35 ENROLLING IN MEDICARE PART B Enrollment based on ESRD may eliminate the Part B penalty if beneficiary already had Medicare due to age or disability If they didn t enroll when first eligible If beneficiary has Medicare due to ESRD and 65 They have continuous coverage Those not enrolled in Part B will be enrolled September

36 DELAYING MEDICARE PART B If enrolled in Part A & delay enrolling in Part B Must wait for General Enrollment Period to enroll January 1 to March 31 each year, coverage effective July 1 of the same year May have to pay a higher premium for as long as they have Part B 10% for each 12-month period eligible, but not enrolled No Special Enrollment Period for those with ESRD September

37 HOW TO ENROLL IN PART A & PART B Enroll at Social Security office Doctor/dialysis facility = Form CMS-2728 If beneficiary has a Group Health Plan (GHP) (employer), may want to delay enrolling Near the end of 30-month coordination period Won t have to pay Part B premium until needed September

38 MEDICARE & GHP COVERAGE If enrollment is based solely on ESRD GHP is only payer during first 3 months of dialysis Medicare is secondary payer during 30-month coordination period - begins when first eligible for Medicare even if not enrolled Separate coordination period each time enrolled based on ESRD No 3-month waiting period New 30-month coordination period if GHP coverage September

39 ENROLLMENT CONSIDERATIONS May want Medicare during coordination period To pay GHP deductible/coinsurance Receiving a transplant soon Affects coverage for immunosuppressive drugs Coverage for living donor Delaying Part B or Part D could mean Waiting for applicable enrollment period to enroll Possible penalty for late enrollment September

40 IMMUNOSUPPRESSIVE DRUGS If beneficiary Are entitled to Part A at time of transplant and Medicare paid for transplant & transplant took place in a Medicare-approved facility, or Medicare was secondary payer but made no payment Immunosuppressive Drugs Are covered by Part B Medicare pays 80% Bene pay 20% If have Part D, Part B coinsurance costs don t count toward catastrophic coverage under Part D Didn t meet the transplant conditions above May be covered by Part D (unless has Part B) Costs vary by plan Helps cover drugs needed for other conditions September

41 WHEN MEDICARE COVERAGE STARTS BASED ON ESRD Your Coverage Starts First day of fourth month First day of the month of the first month of dialysis Under the Following Circumstances Get a regular course of dialysis in a facility Participate in a home dialysis training program during the first 3 months of regular course of dialysis (with expectation of completion) First day of the month Get a kidney transplant First day of the month Admitted to Medicare-approved transplant facility for kidney transplant or procedures before kidney transplant if transplant takes place in same month or within following 2 months Two months before the month of transplant Transplant is delayed more than 2 months after admitted to the hospital for transplant or for health care services needed for transplant September

42 WHEN COVERAGE FOR ESRD ENDS, CONTINUES, OR RESUMES When Coverage Ends Entitlement based solely on ESRD Coverage ends 12 months after the month no longer require a regular course of dialysis, or 36 months after the month of kidney transplant When Coverage Continues No coverage interruption if starts regular course of dialysis again within 12 months after regular dialysis stopped, or Have a kidney transplant, or Regular course of dialysis starts within 36 months after transplant, or Received another kidney transplant within 36 months When Coverage Resumes Must file new application & no waiting period if Start a regular course of dialysis again or get kidney transplant more than 12 months after stopped getting regular course of dialysis Have another kidney transplant more than 36 months later September

43 WHAT MEDICARE COVERS Medicare coverage related to End-Stage Renal Disease (ESRD) includes Dialysis services and supplies Home dialysis training Transplant coverage September

44 WHAT MEDICARE COVERS FOR PEOPLE WITH ESRD All services covered by Original Medicare Medicare Part A (Hospital Insurance) Medicare Part B (Medical Insurance) Special services for ESRD (dialysis & transplant patients) Immunosuppressive drugs (under certain conditions) Other special services September

45 COVERED DIALYSIS SERVICES Paid under Part A Inpatient dialysis treatments Paid under Part B Outpatient dialysis treatments and doctors services Home dialysis training Home dialysis equipment and supplies Some support services and drugs for home dialysis Medical nutrition therapy September

46 HOME DIALYSIS Two types can be done at home Hemodialysis Peritoneal dialysis Most common drugs covered by Medicare Heparin to slow blood clotting Drug to help clotting when necessary Topical anesthetics Erythropoietin Stimulating Agents (ESA) for anemia management September

47 HOME DIALYSIS TRAINING & EQUIPMENT Home dialysis training Doctor approval needed for home dialysis Occurs at Medicare-certified facility during dialysis Home dialysis equipment/supplies are covered If bene completes home dialysis training, Medicare coverage starts the month they begin regular dialysis Services such as fistula placement could be covered September

48 HOME DIALYSIS SERVICES NOT COVERED UNDER PART B Paid dialysis aides Lost pay Place to stay during your treatment Blood for home dialysis (some exceptions) Non-treatment-related medicines September

49 AMBULANCE TRANSPORTATION FOR DIALYSIS Covered by Medicare in some cases Need written order from your doctor For non-emergency, scheduled, repetitive ambulance services, it must be Medically necessary Dated no earlier than 60 days before service If in a Medicare Advantage (MA) Plan, it may cover some non-ambulance transportation to dialysis centers & doctors September

50 PART A TRANSPLANT PATIENT COVERAGE Inpatient hospital services in a Medicareapproved transplant center Transplant (living or deceased donor) All medically necessary care related to a donation for a living donor Preparation for transplant Organ procurement & transplantation network registry fee Laboratory tests to evaluate medical condition & potential kidney donor September

51 MEDICARE PART B TRANSPLANT PATIENT COVERAGE Doctor s services for patient and donor No deductible for donor Immunosuppressive drugs For a limited time after bene leaves the hospital following a transplant Blood September

52 COVERAGE OPTIONS FOR PEOPLE WITH ESRD Medicare Supplement Insurance (Medigap) Policies Medicare Advantage (MA) Plans Special Needs Plans (SNPs) Medicare Prescription Drug Plans (PDPs) Medicare & Health Insurance Marketplace September

53 ESRD & MEDIGAP POLICIES Medigap policies Help fill the gaps in Original Medicare coverage People with ESRD may not be able to buy a Medigap policy Some states require insurance companies to sell to people under 65 If available, may cost more Another Medigap Open Enrollment Period (OEP) At 65 when bene can buy any policy for sale in state September

54 ESRD & MEDICARE ADVANTAGE (MA) PLANS Original Medicare is usually the only option if bene has ESRD Possible exceptions Successful kidney transplant GHP is in the same organization as an MA Plan Can have no break in coverage Medicare SNP for people with ESRD September

55 ESRD & MEDICARE ADVANTAGE (MA) PLANS If already in an MA Plan & develop ESRD, bene can Stay in plan Join another plan from same company in same state Join an MA Plan if you ve had a successful kidney transplant Join another plan if plan leaves Medicare September

56 SPECIAL NEEDS PLANS (SNP) Limit membership to certain groups of people Some serve people with ESRD by providing some benefits such as Special provider expertise Focused care management Provide prescription drug coverage Made available in limited areas Visit Medicare.gov/find-a-plan to see if SNP for ESRD is available September

57 ESRD AND MEDICARE PRESCRIPTION DRUG COVERAGE Medicare prescription drug coverage (Part D) Available for all people with Medicare Covers drugs not covered under Part B Enroll in a plan to get coverage Pay a monthly premium and a share of prescription drug costs Extra Help available for certain people with limited income and resources As of January 1, 2018, Medicare Part B covers calcimimetic medications under ESRD PPS. Calcimimetic medications include intravenous medication, Parsabiv, & oral medication, Sensipar September

58 MEDICARE AND THE HEALTH INSURANCE MARKETPLACE Medicare isn t part of Health Insurance Marketplace If bene has Medicare Part A, considered covered No matter Original Medicare or an MA Plan, need to return to Marketplace when you become eligible for Medicare & end any subsidies, such as premium tax credits or cost sharing reductions, being paid May have both a Qualified Health Plan (QHP) through Marketplace & Medicare only if signed up for the QHP first September

59 ESRD AND STATE HIGH-RISK POOLS Exception for people with Medicare & ESRD In limited situations, issuers may sell individual market health insurance policies to people with Medicare under 65 who obtained supplemental coverage through a state high-risk pool but lost that coverage Inside & outside the Health Insurance Marketplace September

60 ADDITIONAL SOURCES OF INFORMATION Dialysis Facility Compare End-Stage Renal Disease (ESRD) Networks Fistula First September

61 DIALYSIS FACILITY COMPARE STAR RATINGS September

62 ESRD NETWORKS ESRD Networks Develop standards related to quality & appropriateness of care for ESRD patients Your local ESRD Network can help with Understanding dialysis or kidney transplants Obtaining help from other kidney-related agencies Reporting problems with quality of care at the facility Patients are no longer required to begin complaint process at the facility Locating dialysis facilities and transplant centers September

63 FISTULA FIRST National Vascular Access Improvement Initiative To increase use of fistulas for hemodialysis Improved outcomes A fistula is a surgical connection joining a vein & artery in the forearm Provides access for dialysis September

64 KEY POINTS TO REMEMBER Eligible for Medicare Part A, with required work credits & medical documentation, no matter how old, if kidneys no longer function, & get a regular course of dialysis, or have had a kidney transplant Original Medicare is usually the only choice for people with ESRD having Part A, Part B, and Part D provide the most comprehensive coverage There s a period of time when group health plan will pay first on your health care bills and Medicare will pay second Immunosuppressive drug therapy is only covered by Medicare Part B for people who were entitled to Part A at the time of a kidney transplant ESRD Networks handle quality of care concerns September

65 ESRD RESOURCE GUIDE Medicare.gov Centers for Medicare and Medicaid Services Medicare.gov/people-likeme/esrd/dialysis-information.html Call MEDICARE ( ); TTY: Medicare.gov CMS.gov Social Security Call ; TTY: State Health Insurance Assistance Programs & State Insurance Departments socialsecurity.gov shiptacenter.org ESRD National Coordinating Center esrdncc.org September

66 ESRD RESOURCE GUIDE National Kidney Disease Education Program ESRD Networks contact information Fistula First Catheter Last National Kidney Foundation American Kidney Fund United Network for Organ Sharing Medical Evidence Form (CMS 2728) esrdncc.org/en/resources/professional s/about-the-networks esrdncc.org/ffcl kidney.org akfinc.org unos.org niddk.nih.gov/healthinformation/health-communicationprograms/nkdep/pages/default.aspx CMS.gov/Medicare/CMS-Forms/CMS- Forms/downloads/cms2728.pdf September

67 ESRD RESOURCE GUIDE MEDICARE PRODUCTS 1. Medicare Coverage of Kidney Dialysis & Kidney Transplant Services 2. Medicare for Children with End-Stage Renal Disease 3. Medicare s Coverage of Dialysis & Kidney Transplant Benefits: Getting Started (CMS Product No ) (CMS Product No ) (CMS Product No ) 4. Medicare Coverage of Ambulance Services (CMS Product No ) To access other helpful products: View or download at Medicare.gov/Publications Order multiple copies (partners only) at Productordering.cms.hhs.gov. You must register your organization. September

68 STAY TUNED FOR PART II September

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