Prepare Your Lab for PAMA: Understand How Your Costs Compare to New Reimbursements! Brad Brimhall, MD, MPH March 21, 2017

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Prepare Your Lab for PAMA: Understand How Your Costs Compare to New Reimbursements! Brad Brimhall, MD, MPH March 21, 2017

Financial Center Schizophrenia in the Lab Revenue Center Inpatient Expense/Cost Center Profit Center Outpatient Investment Center

How Medicare Pays for Care Inpatient Prospective Payment Acute inpatient Home health Inpatient psychiatric facility Inpatient rehabilitation facility Long-term care hospital Skilled nursing facility Hospice center Payment by Episode of Care Outpatient Fee For Service Physician fee schedule (PFS) Clinical laboratory (CLFS) Ambulance fee schedule (AFS) Durable medical equipment, prosthetics/orthotic & supplies fee schedule (DMEPOSFS) Payment by Specified Service (Test)

FFS: Biopsy Reimbursement Changes $100 TC -26 Global $80 $60 $40 $20 $0 HCPCS 88305 Real 2000 USD (adjusted for CPI); MAC = Rest of Texas

Office of Inspector General (OIG) Studies

OIG Study (2011) Compare Medicare payments to lowest of the following rates: Medicaid (all state programs) Federal employee health benefits program 1 (FEHB-1) Federal employee health benefits program 2 (FEHB-2) Federal employee health benefits program 3 (FEHB-3) Levinson DR (2013). Comparing Lab Test Payment Rates: Medicare Could Achieve Substantial Savings. US Office of Inspector General, Department of Health & Human Services

Potential Savings to Medicare HCPCS Description Medicare Allowed Tests (2011) Potential Savings to Medicare 80048 Metabolic panel, total calcium 8,870,790 $36,412,622 80053 Comprehensive metabolic panel 27,406,336 $130,632,849 80061 Lipid panel 20,620,917 $125,993,031 81001 Urinalysis, automated with microscopy 6,804,619 $9,801,294 81002 Urinalysis, nonautomated without microscopy 4,312,499 $4,427,415 81003 Urinalysis, automated without microscopy 5,078,609 $4,383,224 82306 Vitamin D, 25-hydroxy 5,394,421 $87,398,016 82570 Assay of urine creatinine 4,649,643 $10,457,972 82607 Vitamin B12 3,363,543 $25,252,596 82728 Assay of ferritin 2,401,360 $15,613,616 83036 Glycosylated hemoglobin test 12,678,817 $51,406,983 83540 Assay of iron 2,625,017 $10,256,188 83550 Iron binding test 2,043,112 $9,228,580 83880 Natriuretic peptide 1,079,558 $15,970,434 83970 Assay of parathormone 1,154,872 $22,934,465 84153 Assay of prostate specific antigen, total 3,616,338 $32,784,887 84443 Thyroid stimulating hormone 14,761,102 $140,148,947 85025 Complete blood count with automated diff 30,827,609 $136,848,356 85610 Prothrombin time 20,291,205 $24,637,107 87086 Urine culture colony count 4,703,518 $15,296,087 182,683,885 $909,884,669 Levinson DR (2013). Comparing Lab Test Payment Rates: Medicare Could Achieve Substantial Savings. US Office of Inspector General, Department of Health & Human Services

PAMA: Data Collection on Private Payers Collect payment data for private payers Data collected for each test Payment rate paid by each private payer Volume HCPCS code Source: Murrin S (2016). HHS OIG Data Brief: Medicare Payments for Clinical Diagnostic Laboratory Tests in 2015: Year 2 of Baseline Data. US Department of Health & Human Services, Office of Inspector General

PAMA Timeline 2016 2017 2018 Data Collection Data Reporting Payment System Implementation

PAMA: Labs Required to Report By Laboratory Lab Status Independent Labs Physician Office Labs Hospital Labs Required (Est) 1,398 11,149 0 Total (Est) 3,211 235,298 6,994 Percent 43.5% 4.7% 0.0% By Medicare Payments/Yr Lab Status Independent Labs Physician Office Labs Hospital Labs Required (Est) $3.8B $1.0B $0 Total (Est) $3.9B $1.4B $1.7B Percent 97.4% 71.4% 0.0%

PAMA Payment Target & Reduction Limits Weighted median of private payer payments sets target payment (beginning 2018) Plan to re-evaluate every 3 years Maximum annual payment reduction (until payment = weighted median payment) 10% per year (2018-2020) 15% per year (2021-2023) Source: Murrin S (2016). HHS OIG Data Brief: Medicare Payments for Clinical Diagnostic Laboratory Tests in 2015: Year 2 of Baseline Data. US Department of Health & Human Services, Office of Inspector General

UNIT COST Test Cost Categories $9 $8 $7 $6 $5 $4 $3 $2 $1 Variable Materials Direct Labor Local Fixed Institutional Overhead $0 Test

UNIT PAYMENT/COST Contribution Analysis (Current) Volume (Annual) 26,393 Unit Aggregate Net Revenue $11.07 $292,171 Less Reagents, Consumables, Other Variable Costs $2.25 $59,384 Contribution to Labor & Fixed Costs $8.82 $232,786 Less Direct Labor $2.56 $67,566 Contribution to Local Fixed Costs $6.26 $165,220 Service Contracts, Proficiency Tests, Other Local Fixed $18,211 Contribution to Overhead Costs $147,009 Less Institutional Overhead Costs $60,968 Excess of Net Revenue over Expenses $86,041.18 $12 $10 $8 $6 $4 $2 $0 Test

UNIT PAYMENT/COST Contribution Analysis (2018) Volume (Annual) 26,393 Unit Aggregate Net Revenue $9.96 $262,874 Less Reagents, Consumables, Other Variable Costs $2.25 $59,384 Contribution to Labor & Fixed Costs $7.71 $203,490 Less Direct Labor $2.56 $67,566 Contribution to Local Fixed Costs $5.15 $135,924 Service Contracts, Proficiency Tests, Other Local Fixed $18,211 Contribution to Overhead Costs $117,713 Less Institutional Overhead Costs $60,968 Excess of Net Revenue over Expenses $56,744.95 $12 $10 $8 $6 $4 $2 $0 Test

UNIT PAYMENT/COST Contribution Analysis (2023) Volume (Annual) 26,393 Unit Aggregate Net Revenue $4.96 $130,909 Less Reagents, Consumables, Other Variable Costs $2.25 $59,384 Contribution to Labor & Fixed Costs $2.71 $71,525 Less Direct Labor $2.56 $67,566 Contribution to Local Fixed Costs $0.15 $3,959 Service Contracts, Proficiency Tests, Other Local Fixed $18,211 Contribution to Overhead Costs ($14,252) Less Institutional Overhead Costs $60,968 Excess of Net Revenue over Expenses ($75,220) $12 $10 $8 $6 $4 $2 $0 Test

Examination of Five Common Lab Tests Current payments: Medicare CLFS 2017 Low target estimates: Lowest payer Average target estimate: 3 payers Timetable of changes to Medicare payments: PAMA rule to date Healthcare costing: Reference lab operation, hospital testing operation Lab costing categories: variable, labor, fixed (local & overhead)

UNIT PAYMENT/COST Payments & Costs: Regional Reference Lab $25 $20 $15 Vbl Local Payment Low Target Labor Overhead Target $10 $5 $0 TSH CMP CBC PT Urine Cx TEST

UNIT PAYMENT/COST Payments & Costs: Hospital Lab $25 Vbl Local Labor Overhead $20 $15 Payment Low Target Target $10 $5 $0 TSH CMP CBC PT Urine Cx TEST

UNIT PAYMENT/COST Payments 2018 $25 $20 Vbl Local Payment Labor Overhead Target $15 $10 $5 $0 TSH CMP CBC PT Urine Cx TEST

UNIT PAYMENT/COST Payments 2019 $25 $20 Vbl Local Payment Labor Overhead Target $15 $10 $5 $0 TSH CMP CBC PT Urine Cx TEST

UNIT PAYMENT/COST Payments 2020 $25 $20 Vbl Local Payment Labor Overhead Target $15 $10 $5 $0 TSH CMP CBC PT Urine Cx TEST

UNIT PAYMENT/COST Payments 2021 $25 $20 Vbl Local Payment Labor Overhead Target $15 $10 $5 $0 TSH CMP CBC PT Urine Cx TEST

UNIT PAYMENT/COST Payments 2022 $25 $20 Vbl Local Payment Labor Overhead Target $15 $10 $5 $0 TSH CMP CBC PT Urine Cx TEST

UNIT PAYMENT/COST Payments 2023 $25 $20 Vbl Local Payment Labor Overhead Target $15 $10 $5 $0 TSH CMP CBC PT Urine Cx TEST

Annual Revenue Changes (5 Tests) TSH CMP CBC PT U Cx Total Δ (YoY) Volume 7,418 30,281 36,630 7,029 6,334 87,692 N/A Baseline $170,985 $437,258 $390,476 $37,886 $70,117 $1,106,722 N/A 2018 $153,886 $393,532 $351,428 $34,098 $63,106 $996,050 ($110,672) 2019 $138,498 $354,179 $316,285 $30,688 $56,795 $896,445 ($99,605) 2020 $124,648 $318,761 $284,657 $27,619 $51,116 $806,800 ($89,644) 2021 $105,951 $270,947 $241,958 $26,288 $43,448 $688,593 ($118,208) 2022 $90,058 $230,305 $205,665 $26,288 $36,931 $589,247 ($99,346) 2023 $76,549 $195,759 $174,815 $26,288 $31,391 $504,803 ($84,444) 30 Outpatient Clinics 4 Outpatient Dialysis Centers 2 Ambulatory Surgery Centers 1 Outpatient Rehabilitation Center >980,000 Outpatient Visits/Yr 24% Medicare

Estimated Tests with Increased Payments Number of Tests in Top 25 0 1 2 3 4 5 6 7

PAMA Other Changes 57 local fee schedules Single fee schedule New category of Advanced Diagnostic Laboratory Tests with a separate fee schedule (details to be determined) Source: Murrin S (2016). HHS OIG Data Brief: Medicare Payments for Clinical Diagnostic Laboratory Tests in 2015: Year 2 of Baseline Data. US Department of Health & Human Services, Office of Inspector General

DHHS Goals for 2018 7.5% Value-Based Alternative Payment Models 42.5% Value-Based FFS 50.0% Traditional FFS Source: Department of HHS. Better, Smarter, Healthier: In historic announcement, HHS sets clear goals and timeline for shifting Medicare reimbursements from volume to value.

How Medicare Plans to Pay for Care Value-Based Payment Models New Payment Models Medicare shared savings models Accountable care organization (ACO) Alternate payment models (APM) Payment adjusted for quality measurements/index Move risk to healthcare systems / provider networks

Value-Based Purchasing (VBP) Rewards acute-care hospitals with incentive payments for the quality of care they provide to people with Medicare. CMS rewards hospitals based on the Quality of care provided to Medicare patients, how closely best clinical practices are followed, and how well hospitals enhance patients experiences of care during hospital stays. Hospitals are no longer paid solely based on the quantity of services they provide. [2011, CMS]

Percent of Payment Withheld Value-Based Purchasing: Percent Withheld 2.5% 2.0% 1.5% 1.0% 0.5% 0.0% 2013 2014 2015 2016 2017 2018 Year Note: 2% of typical large hospital patient service revenue would be approximately $10M ($500M x 2%) Source: CMS. Hospital Value-Based Purchasing. Dept. of Health & Human Services. September 2015.

Domain Weight (%) Domains: Value-Based Purchasing 100% 90% Safety 80% 70% 60% 50% 40% Efficiency & Cost Reduction Outcomes 30% 20% 10% 0% 2013 2014 2015 2016 2017 2018 Year Source: CMS. Hospital Value-Based Purchasing. Dept. of Health & Human Services. September 2015. Patient & Caregiver- Centered Experience of Care/Care Coordination Clinical (Process of) Care

Hospital-Acquired Condition Reduction Program Lowest performing 25% of hospitals are penalized Penalty of -1% for all Medicare MSDRG payments HAC Score comprised of two domains DOMAIN 2 (CDC NHSN) 65% Central line-associated bloodstream infection (CLABSI) standardized infection ratio (SIR) Catheter-associated urinary tract infection (CAUTI) standardized infection ratio (SIR) Surgical site infection (SSI) for colon surgery or abdominal hysterectomy Methicillin-resistant Staphylococcus aureus (MRSA) standardized infection ratio (SIR) Clostridium difficile (CDI) standardized infection ratio (SIR) DOMAIN 1 (AHRQ PSI 90) 35% PSI 3. Pressure ulcer rate PSI 6. Iatrogenic pneumothorax rate PSI 7. Central venous catheter-related bloodstream infection rate PSI 8. Postoperative hip fracture rate PSI 12. Postoperative PE or DVT rate PSI 13. Postoperative sepsis rate PSI 14. Wound dehiscence rate PSI 15. Accidental puncture and laceration rate NHSN: National health safety network PSI 90: Patient safety indicator composite measure 90

Hospital Readmissions Reduction Program Patients readmitted to hospital within 30 days of previous hospitalization Scores rate of Excess Admissions Risk adjustment for patient age, sex, diagnosis, and comorbidities. Current maximum penalty of 3% (since 2015) DIAGNOSTIC GROUPS REPORTED Acute myocardial infarction (AMI) Chronic obstructive pulmonary disease (COPD) Heart Failure (HF) Pneumonia (PN) Stroke Total hip arthroplasty/total knee arthroplasty (THA/TKA) Coronary artery bypass graft (CABG) Roberson B ( Oct 2015). The Hospital Readmissions Reduction Program: Four Years of Data. Essential Hospitals Institute

MEAN PCT REDUCTION Hospital Readmissions Reduction Program 1.0% 0.9% 0.8% 0.7% 0.6% 0.5% 0.4% 0.3% 0.2% 0.1% 0.0% Average Penalty by Hospital Quartile Score Quartile 1 2012 2013 2014 2015 YEAR Quartile 2 Quartile 3 Quartile 4 Roberson B ( Oct 2015). The Hospital Readmissions Reduction Program: Four Years of Data. Essential Hospitals Institute

Medicare Access & CHIP Reauthorization Act MACRA 1.Medicare rewards to providers for value over volume 2.Streamlines multiple quality programs 3.Provides bonus payments for participation in eligible alternate payment models (APMs) 4.First measurement year is 2017 (applies to 2019)

MACRA: Physician Fee Schedule Example Year Increase Allowed HCPCS 88305-26 2015 Base year $33.90 2016 0.5% $34.07 2017 0.5% $34.24 2018 0.5% $34.41 2019 0.5% $34.58 2020 0% $34.58 2021 0% $34.58 2022 0% $34.58 2023 0% $34.58 2024 0% $34.58 2025 0% $34.58 2026 onward 0.25% - 0.75% $34.67-34.84

MACRA: Payment Adjustments 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 Alternate Payment Models (APM) 5% 5% 5% 5% 5% 5% Merit-Based Incentive Payment System (MIPS) MIPS Range Development ±4% ±5% ±7% ±9% Up to $500M/yr for exceptional performers

Merit-Based Incentive Payment System (MIPS) Physician Quality Reporting Program (PQRS) Value-Based Payment (VBP) Modifier Merit-Based Incentive Payment System (MIPS) Medicare EHR Incentive Program (Meaningful Use)

Component Weight MIPS*: Component Weights 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% Clinical Practice Improvement Activities Advancing Care Information Resource Use Quality 0% 2019 2020 2021 *Merit-based incentive payment system Year

How Medicare Pays for Care Fee For Service Physician fee schedule (PFS) Clinical laboratory (CLFS) Ambulance fee schedule (AFS) Durable medical equipment, prosthetics/orthotic & supplies fee schedule (DMEPOSFS) New Payment Models Medicare shared savings models Accountable care organization (ACO) Alternate payment models (APM) Prospective Payment Acute inpatient Home health Inpatient psychiatric facility Inpatient rehabilitation facility Long-term care hospital Skilled nursing facility Hospice center

Implications for the Lab If payers no longer paid for laboratory testing, would healthcare systems still laboratory tests? What opportunities will emerge for the laboratory as new payment models are enacted? How important will it become for laboratories to accurately understand their underlying cost structure?

Value Propositions 1. Improve patient outcomes (quantifiable) 2. Improve patient satisfaction (quantifiable) Value = Benefit Cost 3. Decrease cost 4. Simplify operational tasks/improve efficiency (quantifiable 5. Increase net revenue *Profit = Revenue Expenses

Questions? Thank you!