Andrew Narva MD FASN amp Amy Barton Pai PharmD MHI FASN FCCP FNKF Andrew Narva MD FASN No financial disclosuresconflicts of interest Amy Barton Pai PharmD MHI FASN FCCP FNKF ID: 904334
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Module 6: The Transition from Chronic Kidney Disease (CKD) to Kidney Failure
Andrew
Narva
, MD, FASN &
Amy Barton
Pai
, PharmD, MHI, FASN, FCCP, FNKF
Slide2Andrew Narva
, MD, FASN
No financial disclosures/conflicts of interestAmy Barton Pai, PharmD, MHI, FASN, FCCP, FNKFDisclosure: Consultant for Keryx
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Faculty Disclosure Information
Slide3About NKDEP
This professional development opportunity was created by the National Kidney Disease Education Program (NKDEP), an initiative of the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health. With the goal of reducing the burden of chronic kidney disease (CKD), especially among communities most impacted by the disease, NKDEP works in collaboration with a range of government, nonprofit, and health care organizations to:
raise awareness among people at risk for CKD about the need for testing;
educate people with CKD about how to manage their disease;provide information, training, and tools to help health care providers better detect and treat CKD; andsupport health system change to facilitate effective CKD detection and management.To learn more about NKDEP, please visit: http://www.nkdep.nih.gov. For additional materials from NIDDK, please visit: http://www.niddk.nih.gov.
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Slide4Meet our Presenters
Amy Barton Pai, PharmD, MHI, FASN, FCCP, FNKF
Dr. Barton Pai is Chair of the National Kidney Disease Education Program’s Pharmacy Working Group
Dr. Amy Barton Pai, Pharm.D., MHI, FASN, FCCP, FNKF is Associate Professor of Clinical Pharmacy at the University of Michigan College of Pharmacy. She obtained her Bachelor of Science in Pharmacy from Albany College of Pharmacy in 1996 and then completed a Pharmacy Practice Residency at St. Peter’s Hospital in Albany, New York. She received her Doctor of Pharmacy from Albany College of Pharmacy in 1999. From 1999-2001 she was a Nephrology Research Fellow at the University of Illinois at Chicago. Dr. Pai was on faculty at the University of New Mexico College of Pharmacy and School of Medicine from 2001 to 2008 and at Albany College of Pharmacy and Health Sciences from 2008 to 2016. She earned a Master's degree in Healthcare Innovation in 2018.
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Slide5Andrew S. Narva, M.D., F.A.C.P.
Dr. Narva is the Director of the National Kidney Disease Education Program (NKDEP) at the National Institutes of Health. Prior to joining the NKDEP in 2006, he served as Director of the Kidney Disease Program for the Indian Health Service (IHS). Dr. Narva continues to serve as the Chief Clinical Consultant for Nephrology for IHS and to provide care for patients at Zuni Pueblo through a telemedicine clinic. Dr. Narva is a member of the American Board of Internal Medicine Nephrology Subspecialty Board. He has served as a member of the Eighth Joint National Committee (JNC 8) Expert Panel, the National Quality Forum Renal Steering Committee, the Kidney Disease Outcomes Quality Initiative Work Group on Diabetes in Chronic Kidney Disease, and the Medical Review Board of End Stage Renal Disease Network 15.
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Meet our Presenters
Slide6After completing this module, you will be able to:
Describe key elements of the patient experience during the transition from CKD to end-stage renal disease (ESRD) including dialysis
Identify the four treatment options for kidney failure
Identify common medication-related problems that occur in transitions of care
Review health policy implications on medication reconciliation and management for kidney failure
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An informed patient is better prepared
Education may help patients to be successful in their self-management efforts.
People with kidney disease may see many providers. Consistent messages are less confusing.
Patients may ask you questions about treatment options.
Slide8Kidney disease education is a Medicare benefit
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Covers up to 6 sessions
eGFR < 30 Medicare Part B Requires referral Pharmacists may be invited to participate in interdisciplinary education
https://
www.medicare.gov
/coverage/kidney-disease-education
Slide9The topics include many of the ones
covered in this program
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Slide10Four options for treating kidney failure
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Renal replacement therapy (RRT)
HemodialysisIn-center or home, three times a week or more frequentlyPeritoneal dialysisDaily, at homeKidney transplantationNo RRTSupportive/Conservative Care
Active medical management
Slide11Trends in ESRD prevalence by modality, 1996-2014
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USRDS 2016
Slide12Almost 90% of people initiating renal replacement therapy start on hemodialysis
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Trends in ESRD incidence by modality, 1999-2014
USRDS 2016
Slide13Transition to ESRD is associated with increased costs of care and mortality is high in the first year
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Kalantar
-Zadeh, K et al.
Nephrol
Dial Transplant 2017 Apr 1;32(suppl_2):ii91-ii98
Slide14Most people are not prepared for kidney failure
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People who are not prepared do not have much choice in treatment and often start hemodialysis using a temporary vascular access (catheter).
In 2014, more than 80% of people started hemodialysis with a temporary vascular access. Discuss treatment choices early with progressive kidney disease.“Early” depends on the eGFR and the rate of decline.
Slide15Coping with kidney disease and failure is challenging
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“I feel fine.”
The signs and symptoms may not be obvious until kidney disease is advanced. “Why me?”Acceptance of any chronic illness including kidney disease takes time for most people.Kidney disease may progress to kidney failure.Kidney “failure” or “end stage renal disease” sound scary.
Grief, fear and depression are not uncommon.
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Options
RENAL REPLACEMENT THERAPY
Slide17Dialysis involves diffusion of substances across a semipermeable membrane
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Hemodialysis uses a dialyzer (artificial kidney) as the membrane.
Peritoneal dialysis uses the peritoneum as the membrane.Substances diffuse down a gradient from high to low concentrations and are removed.
Slide18Types of dialysis
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HEMODIALYSIS (HD)
Typical scheduleTraditional hemodialysis (in-center)3-5 hours 3 days per weekStandard home hemodialysis
3-5 hours
3 days per
week (or every other day)
Extended
hours
hemodialysis
6-10 hours
3-6 nights per week
Short daily
hemodialysis
2.5-4
hours
5-7 days per week
PERITONEAL
DIALYSIS (PD)
Continuous
Continuous
cycler-assisted (CCPD)
Cycler is programmed
to perform 3
to 5 exchanges
during the night.
Must know how to do manual exchanges
Continuous ambulatory (CAPD)
4 to 6 exchanges per day (manual)
Slide19Dialysis replaces only a fraction of normal kidney function
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A normal kidney works “
24/7.”Damaged kidneys (in CKD) still work nonstop but at a reduced level.Hemodialysis is an intermittent treatment; blood is filtered only during dialysis.
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Hemodialysis
Slide21A vascular access is needed for hemodialysis
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Temporary access is usually a catheter placed in a central vein.
Permanent access types include arteriovenous (AV) fistula or graft.Access is usually placed in the non-dominant arm.Protect blood vessels in both arms; avoid venipuncture and IV catheter placement above the wrist.
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An AV fistula is the preferred access
The artery is connected to a vein.
A fistula takes 2 to 3 months to mature before it can be used. During maturation, the vein dilates and thickens.A fistula is less likely to become infected or clot, and provides better blood flow rates.
Slide23An AV graft is another option
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A synthetic tube connects the artery and vein.
A graft takes 2 to 3 weeks before it can be used.Grafts are more likely to become infected or clot than fistulas.
Slide24Temporary access use should be minimized
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A venous catheter is inserted into a vein in the neck, chest, or leg near the groin, for short-term dialysis.
This is only option when patient is not prepared and needs immediate hemodialysis.Catheters are associated with increased risk of infection, clotting, and inadequate dialysis.
Catheter for temporary access
Slide25The dialyzer is the artificial kidney
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Removal is based on molecular size.
Protein-bound substances are not usually removed.Medications can be removed if they have low plasma protein binding and smaller volumes of distribution.Amino acids are small enough to be dialyzed out of the blood.Glucose is removed.Water-soluble vitamins are removed to some degree.
Slide26The hemodialysis prescription is individualized
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The goal is to achieve metabolic balance.
Adequate dialysis depends on numerous factors including:Type and size of the dialyzerBlood flow rateDialysate composition (similar to normal serum levels)Sodium, potassium, calcium, bicarbonateTimeIndividual patient factors such as body size and diet
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Home hemodialysis allows longer,
more frequent dialysis
Increased dialysis allows a more normal diet and fluid intake. Most dialysis centers require a trained partner at home during treatment. Partner burn-out may be an issue.
Slide28Peritoneal dialysis (PD) options
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PD requires surgery for catheter placement.
PD is a continuous therapy providing a “steady state” which may be better tolerated than intermittent hemodialysis. Continuous ambulatory peritoneal dialysis (CAPD) is done manually.Continuous cycler-assisted peritoneal dialysis (CCPD) is automated.
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The peritoneal membrane is the
semipermeable “filter” in PD
Clearance affected by: Concentration gradient SizePermeability of the peritoneal membrane
Osmotic gradient helps move water from the intravascular space into the peritoneal cavity.
Dextrose is the most common osmotic agent used in dialysate.
Slide30The peritoneal dialysis exchange
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PD prescription is individualized
Dextrose solutions are used as osmotic agent.
1.25%, 2.5%, 4.25% concentrationsExchanges are 2–3 liters in volume.Dwell time and number of exchanges vary depending on peritoneal membrane characteristics.
Slide32CAPD requires 4 or more manual exchanges per day
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Slide33The cycler does 3–5 automated exchanges
during the night in CCPD
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Slide34Calories count in dextrose solutions
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Reference: McCann, 2009
Dextrose concentrations vary
1.25%, 2.5%, 4.25%
Bag sizes vary
2-liter, 2.5-liter, 3-liter
In CAPD, 60–70% is absorbed. The amount is higher due to longer dwell times.
In CCPD, 40–50% is absorbed.
Slide35Kidney transplantation is a treatment, not a cure
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A deceased or living donor kidney is required.
The transplant workup takes time; eligibility is strict.Requires major surgery.Need to take anti-rejection medications daily.
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The transplanted kidney is usually placed in the groin
Slide37A kidney transplant from a living donor may be better than other treatments
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Number (out of 100) alive at the end of time period by treatment
Preparing for Kidney Treatment You Have a Choice: http://ckddecisions.org/
wp
-content/themes/
jhm
/flipbook/Prepared2/HTML/
index.html
Slide38Immunosuppressive medications should be taken every day – and may have side effects
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Prednisone
MycophenolateAzathioprineWeight gainHyperglycemiaHypertension
Hyperlipidemia
Mood
changes
Osteoporosis
Poor wound healing
Decreased
blood counts
Diarrhea
Upset stomach
Stomach
upset
Muscle pain
High doses may be prescribed
right after the transplant occurs; dose may be reduced over time.
Take on a
regular schedule
1 hour before or 2 hours after
eating or drinking, about 12 hours apart.
Take once or twice
a day after meals, about the same time every day.
Remember: Medicare coverage expires 36 months post-transplant.
Slide39A few more immunosuppressive medications
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Tacrolimus
SirolimusCyclosporineHyperglycemiaHypertensionTremors, headachesDiarrheaHair loss
Trouble
sleeping
Hyperkalemia
Hypophosphatemia
Kidney toxicity
Swelling
Hyperlipidemia
Poor wound healing
Proteinuria
Hypertension
Hyperlipidemia
Tremors, headaches
Excess gum growth
Excess hair
growth
Hyperkalemia
Kidney toxicity
Take on an empty stomach and regular schedule daily
.
Do not eat grapefruit or drink grapefruit juice.
Take
once a day, take it the same way, with or without food.
Do not take with grapefruit juice.
Take on a regular schedule at
the same time each day.
Do not eat grapefruit
or drink grapefruit
juice.
Slide40New onset diabetes after a kidney transplant may be medication related
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Risk factors include:
Immunosuppressant medication Corticosteroids (prednisone)Tacrolimus > cyclosporineOlder ageEthnicity African Americans and Hispanics > Whites
Family history of diabetes
Weight
Positive Hepatitis C
Ghisdal
et al, Diabetes Care 2012:35:181-188
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Supportive/conservative care is active medical management with no RRT
Choosing whether to start RRT is the patient’s decision.
Encourage patient to inform family. Without RRT, uremic toxins accumulate.Complications can be treated.Provide comfort and palliative care.
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Be Proactive
MEDICATION-RELATED PROBLEMS IN KIDNEY FAILURE
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Transition to dialysis worsens clinical indicators
Slide44Common medication-related problems
(MRPs) in advanced CKD
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Intolerance of renin-angiotensin-aldosterone inhibitors due to increased serum creatinine or hyperkalemiaManagement of acidosis may allow continuation of treatmentDifficult to control hypertension requiring multiple agentsLast line agents (clonidine, hydralazine, minoxidil) frequently used
Slide45More common MRPs in advanced CKD
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Hypoglycemia due to reduced insulin metabolism or accumulation of sulfonylurea active metabolites (glyburide)
Challenges with fluid management - Aggressive diuresis must be balanced with risk of AKIMedication dosing changes are often requiredAnemia management may be challenging to manage if patient is intolerant of oral iron
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Risk factors for MRPs are common in ESRD
> 3 concurrent disease states
Medication regimen changed > 4 times in the past year> 5 medications> 12 doses per dayHistory of non-adherenceCardone KE et al. Adv Chronic Kidney Dis. 2010;17:404-412
Slide47Examples of MRPs in dialysis patients
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Pai
AB et al. Clin J Am Soc Nephrol. 2013;11:1988-1999
MRP
Description
Examples
Drug without an indication
Use of a medication without a valid indication
Failure to discontinue a diuretic in an
anuric
patient
Overdose
Medical problem treated with drug at too high of a dose
Failure to reduce gabapentin to appropriate dialysis dose
Adverse drug reaction
Drug effects that are unwanted, unpleasant or harmful
Clonidine causing dry mouth leading to excessive fluid intake a large interdialytic weight gain
Failure to receive drug
Patient is not receiving prescribed medications
Medication (e.g. ferric citrate) not available on Part D formulary
Slide48Implications of MRPs in ESRD
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Harchowal
JT, Br J Renal Med 2: 22–24, 1997Pai AB et al. Pharmacotherapy 2009, 29:1443-1440Manley HJ et al. Semin Dial 2002;15:45-49In one study of patients with stage 5 CKD, MRPs were implicated in nearly 50% of hospitalizations—they were the sole reason for 18% of hospitalizations, and they were determined to have contributed to 29% of hospitalizations
Medication management in dialysis units has been associated with reduced hospitalizations, medication number and cost and total cost of care.
Slide49Case Study
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A 45 year old female patient on dialysis has the following medication list. She complains of dry mouth and her interdialytic weight gain has increased in the past week..
Epoetin alfa 5,000 units IV three times per weekDoxercalciferol 8 mcg IV three times per weekCalcium carbonate 500 mg TID with meals Hydroxyzine 25 mg TID started for pruritis 2 weeks agoLevofloxacin 500 mg daily for 7 days started 2 days ago
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Question
Which of the following are medication-related problems?
Adverse drug reaction: calcium carbonate causes itchingAdverse drug reaction: hydroxyzine causes dry mouthOverdose: levofloxacin not renally dosedb and c only
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Answer
Which of the following are medication-related problems?
Adverse drug reaction: calcium carbonate causes itchingAdverse drug reaction: hydroxyzine causes dry mouthOverdose: levofloxacin not renally dosedb and c onlyAnswer: b and c only. hydroxyzine is an anti-cholinergic and can cause dry mouth which may lead to increased fluid intake and higher interdialytic weight gains. Levofloxacin is dosed every 48 hours for hemodialysis patients.
Slide52Medication Therapy Management
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Most dialysis patients in the United States are Medicare beneficiaries, and almost 70% are enrolled in a Part D plan
ESRD patients meet criteria for MTM: Targeted beneficiaries for MTM services are enrollees in a Part D plan who: (1) have multiple chronic diseases, (2) are taking multiple Part D drugs, and (3) are likely to incur $4,044 annual Part D drug costs in 2019 and subsequent years [drug cost threshold specified by CMS]ESRD is identified as one of nine core conditions that can be targeted by MTM Part D programs Only about 10% of Part D programs targeted ESRD in 2012https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/Downloads/CY2018-MTM-Fact-Sheet.pdfPai
AB et al.
Clin
J Am
Soc
Nephrol
. 2013;11:1988-1999
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HEALTH POLICY IN KIDNEY FAILURE
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ESRD Conditions for Coverage
In 1967, the nephrologist Carl W. Gottschalk, MD chaired a U.S. government committee that recommended government coverage for dialysis and transplant.
In October of 1972, Section 299I of Public Law 92–603 created the US National ESRD Program. This law extended Medicare A and B coverage to individuals with ESRD (including those < 65 years) who require either dialysis or transplantation to maintain life.People with end-stage renal disease were considered disabled under this legislation. Mapes, D., (2010). Shunting death. Retrieved from http://www.washington.edu/alumni/columns/march10/shunt.html
Slide55ESRD Conditions for Coverage
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Led to establishment of the ESRD Conditions for Coverage under Medicare Part B which underwent its first major revision in 2005 with the final rule finalized in 2008.
Currently social workers and dieticians are included in the Conditions for CoverageCoverage of pharmacists was considered in the 2005 update but was not universally supported and coverage was not included on the final rule.Federal Register. Vol. 73, No. 73. April 15, 2008. Retrieved from https://www.cms.gov/Regulations-and-Guidance/Legislation/CFCsAndCoPs/downloads/esrdfinalrule0415.pdf
Slide56Prospective Payment System (PPS)
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Referred to as the “bundle”- a change from fee-for-service to pay-for-performance
Effective January 1, 2011The bundled payment under the ESRD PPS includes all renal dialysis services furnished for outpatient maintenance dialysis, including drugs and biologics (with the exception of oral-only ESRD drugs until 2025) and other renal dialysis items and services that were formerly separately payable under the previous payment methodologies.With the approval of the IV calcimimetic etelcalcetide, oral cinacalcet is now defined as a dialysis service.
Both drugs will be outside the bundle in 2018 and 2019
Some Medicare Advantage plans will pay under Part B currently
Slide57ESRD Quality Incentive Program
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https://
www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/ESRDQIP/The Centers for Medicare & Medicaid Services (CMS) administers the End-Stage Renal Disease (ESRD) Quality Incentive Program (QIP) to promote high-quality services in outpatient dialysis facilities treating patients with ESRD. The ESRD QIP is first of its kind in Medicare. This program changes the way CMS pays for the treatment of patients with ESRD by linking a portion of payment directly to facilities’ performance on quality of care measures. These types of programs are known as “pay-for-performance” or “value-based purchasing” (VBP) programs.
Slide58Medication-related QIPs
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Anemia Management
Number of months for which facility reports ESA dosage (as applicable) and hemoglobin/hematocrit for each Medicare patient at least once per month.Mineral and Bone DiseaseProportion of patient-months with 3-month rolling average of total uncorrected serum or plasma calcium greater than 10.2 mg/dL.
https://
www.cms.gov
/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/ESRDQIP/061_TechnicalSpecifications.html
Slide59ESRD Seamless Care Organizations (ESCO)
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In this comprehensive ESRD care model, dialysis clinics, nephrologists and other providers join together to create an ESCO to coordinate care for matched beneficiaries.
ESCOs are accountable for clinical quality outcomes and financial outcomes measured by Medicare Part A and B spending, including all spending on dialysis services for their aligned ESRD beneficiaries. This model encourages dialysis providers to think beyond their traditional roles in care delivery and supports them as they provide patient-centered care that will address beneficiaries’ health needs, both in and outside of the dialysis clinichttps://innovation.cms.gov
/initiatives/comprehensive-
esrd
-care/
Slide60ESCO Project: Reduction in hospitalizations with MTM
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Multidisciplinary MTM was provide to 3 ESCOs with 27 dialysis clinics after patients were discharged from the hospital.
1,276 discharges were evaluated25 percent (n=293) of the patient discharges received the MTM intervention, resulting in a 30-day hospital readmission rate of 14 percent, compared to 28 percent (a 48% reduction) for those discharge events that did not receive MTM interventionsManley HJ, Aweh GN, Lacson
Jr EK. (2018). Multidisciplinary medication therapy management (MTM) program impact on 30-day hospital readmissions. Am J Kidney Dis 2018;71(4):565.
Slide61Summary
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Dialysis options should be discussed early and often with patients.
Medications will change during transition to dialysis and when dialysis is initiated. Hemodialysis patients are at high risk for medication-related problems. Medication management has improved relevant clinical outcomes.Several ongoing CMS initiatives are promoting innovative ESRD payment models including provider incentives.
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Kidney
Failure
https://www.niddk.nih.gov/health-information/kidney-disease/kidney-failure Choosing a Treatment for Kidney Failurehttps://www.niddk.nih.gov/health-information/kidney-disease/kidney-failure/choosing-treatment Hemodialysis https://www.niddk.nih.gov/health-information/kidney-disease/kidney-failure/hemodialysis
Home Hemodialysis
https://www.niddk.nih.gov/health-information/kidney-disease/kidney-failure/hemodialysis/home-hemodialysis
Eating & Nutrition for
Hemodialysis
https://www.niddk.nih.gov/health-information/kidney-disease/kidney-failure/hemodialysis/eating-nutrition
NIDDK links for kidney failure (patients)
https://www.niddk.nih.gov/health-information/communication-programs/nkdep
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NIDDK links for kidney failure (patients)
https://www.niddk.nih.gov/health-information/communication-programs/nkdep
Peritoneal Dialysishttps://www.niddk.nih.gov/health-information/kidney-disease/kidney-failure/peritoneal-dialysis Kidney Transplant
https://www.niddk.nih.gov/health-information/kidney-disease/kidney-failure/kidney-transplant
Financial Help for Treatment of Kidney Failure
https://www.niddk.nih.gov/health-information/kidney-disease/kidney-failure/financial-help-treatment
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