Examining PAMA s Preliminary 2018 Payment Rates: Bottom Line For Your Lab?

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1 Examining PAMA s Preliminary 2018 Payment Rates: Bottom Line For Your Lab? Annual CCLA Conference November 1, 2017 Lale White, Executive Chairman and CEO, XIFIN, Inc.

2 PAMA Releases Proposed 2018 Pricing Cuts After years of rule-making and private payer data collection/submission in accord with the 2014 Protecting Access to Medicare Act (PAMA), CMS finally released on Sept. 22 preliminary payment amounts for laboratory tests to be paid under a new market-based Clinical Laboratory Fee Schedule (CLFS). Following a 30-day comment period, CMS intends to publish final payment rates this November for implementation starting January 1, Here s the bottom line: for about three quarters of all codes on the CLFS, the weighted median of the private-payer rates show a decrease over current payment rates whereas only 10% would result in an increase. Significantly, CMS claims that its proposed changes in lab prices would save Medicare Part B a whopping $670 million in calendar-year 2018 alone. 2

3 How Did We Get Here and What s Next? In 2014 CMS Across the board reductions to pay for SGR Across the board reductions for Technical Adjustments PAMA No cuts % reduction CAP from Repeal CMS authority for Technical Adjustment cuts No indication by CMS that they intend to delay implementation Industry impact NH Labs Rural Labs Routine Clinical Labs AP Labs Genetic Labs 3

4 PAMA Impact by Sector (Cumulative) Segment Medicare/caid % of Revenue 2018 Impact 2019 Impact 2020 Impact No Cap Pathology 35% -1.50% -2.88% -4.07% -5.32% Molecular 26% 0.03% -0.16% -0.31% -0.61% Clinical 31% -2.00% -3.77% -5.33% -7.04% Pain/PGx 40% -2.15% -4.08% -5.63% -8.38% Hospital 12% -0.82% -1.55% -2.18% -2.81% Nursing Home 51%* -3.59% -6.75% -9.44% %. *Excludes Part A 4

5 Medicare Payments for Lab Tests in 2016: Year 3 of Baseline Data - Summary Medicare Part B paid $6.8 billion for lab tests in 2016 (~$0.2B less than 2015) The top 25 lab tests totaled $4.3 billion in 2016 (60% of total MCare) 50% of reimbursement for the top 25 tests went to 1% of labs Medicare paid 26% less for drug tests & 37% less for molecular tests in 2016 vs Payment for MAAAs increased by 665% OIG estimated savings of $390M in 2018 vs. draft 2018 CLFS estimate of $670M Source: September 2016 HHS OIG DATA BRIEF: Second set of annual baseline analysis of payment for the top 25 lab tests 5

6 Four Key Issues to Challenge Definition of "applicable lab" Retrospective data collection period resulted in inaccuracies in reporting Clear and Transparent Mechanism for Aggregation of Data Calculation of a "weighted median" vs. a "weighted average" 6

7 #1 Definition of Applicable Lab" CMS definition of "applicable lab" resulted in the exclusion of the majority of hospital labs and POLs Hospitals and physician office labs comprise half of Medicare CLFS volume But represented only 8.5% of the reported data used by CMS to calculate rates Leaving the exercise to just 34% of the lab market, where the two major labs represent 80% of the volume PAMA reporting exercise was far from a market-based analysis 7

8 PAMA Test Volume by Facility Type POL, 7% Other, 5% Hospital Inpatient, 26% Big Labs, 17% Hospital Outreach, 27% Rest of Independent Labs, 17% Big Labs, 28% Rest of Independent Labs, 28% Hospital Outreach Labs, 44% Lab Type Percent of Total Weighted Average Impact % Big Labs 28% (44.8%)* Rest of Independent Labs 28% 8.0%* Hospital Outreach Labs 44% 32.1%* Total 100% 3.8% Source: XIFIN analysis based on XIFIN PAMA data set *Top 20 OIG Codes 8

9 CMS Simulation Shows No Change to Outcome With Full Hospital Lab Participation CMS data check is fundamentally flawed. CMS took the 21 submitting hospitals and multiplied data by 10x A 210 hospital lab simulation with no data correlation used to represent 7000 hospital labs would produce an invalid analysis Our analysis demonstrated that hospital labs not categorized as "applicable labs" and that did not report, had higher private payor reimbursement rates than hospital labs that qualified as "applicable labs" A simulation would not be accurate without considering the (higher) fee schedule data from nonreporting entities 9

10 Hospital Labs: Limited Sampling of Reporting vs. Non Reporting 10

11 #2 Calculation of a Weighted Median" vs. a Weighted Average" The legislation mandates calculation of "weighted median" vs. "weighted average" Because the "applicable lab" definition has skewed the submitting labs to be primarily the two major labs A weighted median resulted in high volume tests skewing to private payor pricing to only the top volume labs without the benefit of weighting payments made to the greater majority of the lab industry 11

12 Calculation of Average and Median Row # Reimbursement Units Sum Average / 34 = 8.71 Median ( )/2 = 7.75 (there are 2 middle values ) Source: Briggs Henan University

13 Overall Data Skewed A cursory review of the data indicates that: Pricing on the top volume tests was driven by the large labs Skewed further downward by using a weighted median instead of weighted average Pricing for lower volume tests was distorted by reporting errors that were further exacerbated by the weighted median exercise 13

14 #3 Retrospective Data Collection Period Prior administration's decision Imposed a retrospective data collection period through rulemaking Does not allow labs to make arrangements to collect data accurately or in totality 14

15 Inaccurate Data Submitted Clear evidence that submitted data was flawed in its own right Labs have inadvertently submitted inaccurate data because they lacked: Source data from which to audit their billing system An adequate understanding of payor errors, such as miss reported units, that can greatly alter the unit allowable A key driver of these errors is CMS' delay in publishing reporting criteria and guidelines for data collection until after the data collection period had closed, making it impossible for labs to retrieve source data from payors 15

16 Tests With Largest Reductions (by % change) HCPCS Code HCPCS Code Description 2017 NLA Weighted Median Weighted Median vs NLA Payment Difference Pct. Change in Payment Trb@ gene rearrange dirprobe $68.02 $0.01 -$ % Hereditary colon ca dsordrs $ $ $ % Brca1 full seq & com dup/del $1, $ $1, % N.gonorrhoeae dna quant $58.76 $3.89 -$ % Hrdtry brst ca-rlatd dsordrs $ $ $ % Albumin ischemia modified $46.56 $7.08 -$ % Heredtry nurondcrn tum dsrdr $ $ $ % 0008M Onc breast risk score $3, $ $2, % Lymphocytotoxicity assay $65.28 $ $ % Chemotaxis assay $21.93 $7.05 -$ % G9143 Warfarin respon genetic test $ $ $ % Retrograde ejaculation anal $26.87 $9.58 -$ % Legion pneumo dna dir prob $27.51 $ $ % Hla class ii semiquant panel $ $ $ % Rbc mechanical fragility $11.80 $4.50 -$ % Hla class i semiquant panel $ $ $ % Cytomegalovirus ag ia $16.44 $6.53 -$ % Resp virus targets $ $ $ % Legionella micdadei ag if $16.44 $6.67 -$ % G0480 Drug test def 1-7 classes $ $ $ % Average % Change for 20 Largest Reduction Codes $9, $2, $7, % 16

17 Tests With Largest Increases (by % change) HCPCS Code HCPCS Code Description 2017 NLA Weighted Median Weighted Median vs NLA Payment Difference Pct. Change in Payment Column Column Urine screen for bacteria $3.52 $29.98 $ % Fibrinogen test $11.82 $80.46 $ % Cytopath c/v select $14.49 $86.80 $ % M.pneumon dna quant $57.28 $ $ % Counterimmunoelectrophoresis $12.28 $56.15 $ % Ashkenazi jewish assoc dis $ $2, $1, % Brca1 gene known fam variant $93.75 $ $ % Brca2 gene known fam variant $93.75 $ $ % Rubeola ag if $16.44 $60.80 $ % Noonan spectrum disorders $ $2, $1, % Pten gene dup/delet variant $88.08 $ $ % Blood clot lysis time $6.25 $20.37 $ % Cytopath c/v automated $15.61 $50.56 $ % Cytopath tbs c/v redo $14.49 $42.22 $ % Lyme dis dna quant $58.76 $ $ % Microbe susceptible mlc $14.22 $40.17 $ % Lymphocytotoxicity assay $71.73 $ $ % Assay of procainamide $22.98 $60.00 $ % Msh2 gene known variants $ $ $ % Growth stimulation gene 2 $30.17 $75.60 $ % Average % Change for 20 Largest Increase Codes $1, $7, $5, % 17

18 G-Code Data Looks to be Most Flawed CMS indicates market-based data submitted for the definitive G- codes was 23%-59% lower than the Medicare rates CMS issued the preliminary G-codes and pricing for 2016 on September 25, 2015, cutting rates by ~75% Private payors began adopting in H had much lower adoption than 2H Many payors were paying G codes in addition to paying for the 8**** codes discontinued by Medicare, making it an apples to oranges comparison The 75% reimbursement cut to G Codes put many pain labs out of business prior to the data submission deadline CMS increased G-Code pricing in 2017 XIFIN data shows private payor average pricing to be 14% higher, while XIFIN medians were similar to CMS medians indicating that median pricing defaulted to high volume/low price providers fees Private payor pricing of G-Codes fluctuated significantly across payors Private payor pricing ticked down through out 2016 influenced by Medicare fees 18

19 CMS Medians Highlight Flawed Process TRB Gene Rearrangement with Direct Probe CMS Median price of $.01! and Hereditary Breast and Oncology Testing CMS Median price ranges from 80-95% lower than the current NLA and true weighted averages and medians Sequencing of just BRCA1 CMS median is 95% lower than the NLA 19

20 Some Proprietary Tests Fare Well While Others Fall Victim to Reporting Challenges One CPT code resulting in a fee schedule update was based solely on one unit for a single payor that was grossly under paid Many labs included the sequestration adjustment that Medicare/Medicaid Advantage plans included in their contractual allowance calculation falsely reducing the reimbursement Some of the reimbursement rates submitted for codes commonly provided with multiple units grossly understated the allowable due to payor errors in under-reporting units paid Many providers reported under payments made by payors because they did not challenge the incorrect payment The establishment of Definitive G codes for drug panels in 2016 resulted in slow private payor adoption in 1H with large payment variation, while the majority of drug panels were paid at much higher, but unreportable, rates under the 8xxxx codes 20

21 Examples In Genetic Testing Prices Test CPT Old Fee New Fee Myriad s myrisk Hereditary Cancer Test $2781 $2949 Vectra DA Rheumatoid Arthritis Test $591 $841 Invitae s Hereditary Cancer Panel $931 $838 Exact Sciences Cologuard $512 $509 Noninvasive Prenatal Testing $802 $759 GSP-Ashkenazi Gene Panel $602 $2449 GSP-Lynch Syndrome Gene Panel $802 $722 (Median $38) NGS Panel of 50 genes or less $598 $602 NGS Panel of greater than 50 genes $2920 Genomic Health s Oncotype Breast Cancer Recurrence $3443 $3873 Genomic Health s Oncotype Colon Cancer Test $3126 $3116 Nanostring s Prosigna Breast Cancer Recurrence 0008M $3443 $3099 (Median $900) Veracyte s Afirma Gene Expression Classifier $3222 $3600 CareDx s AlloMap Cardiac Transplant Reject Risk $2841 $

22 Challenges to Fair Pricing ADLT pricing fared better since sole source labs have better ability to establish market based pricing and negotiate rates The GSP pricing for the Ashkenazi vs. Lynch Syndrome Gene Panels demonstrate no relation between reimbursement and cost of testing In 2016 many labs were billing individual genes The raw data files provided by CMS show wide ranges in pricing for some non sole sourced tests BRCA (81211) with a median price at $2395, showed payments of up to $30,000 Prosigna also showed wide variance in reimbursement for various labs submitting data CMS received no private payor rates for 58 codes CMS posted preliminary pricing for these codes using gapfill & crosswalk methods Added value and purpose of algorithms not understood well enough in gapfill exercise Focus on what CMS perceives to be similar methodologies for crosswalk Number of markers included impacts cost - interpretation costs not understood CMS proposing removing some of these from CLFS, but no provision in PAMA for them to do so 22

23 Market Based Reimbursement Strategy Appropriate for the introduction of a newer sole sourced assay Dependent on Procedure Codes Used by Payors NOC codes excluded from analysis but assigned by MolDx G Codes lack private payor adoption but established by Medicare Timing of private payor adoption of new CPT coding not always aligned with Medicare BUT NOT reflective of true market value for test pricing that has been exploited through coding and coverage sophistry and nonmarket based reimbursement manipulation over decades by both public and private payors 23

24 #4 Clear and Transparent Mechanism for Aggregation of Data Current regulation does not provide: Clear and transparent mechanism for aggregation of each clinical test's payment data A means for stakeholders to validate the accuracy of the reported data and the final payment amount 24

25 Circumvention of Legislative Intent Far away from a market based analysis Legislative intent of market based pricing was artfully crafted to optimize a price cutting exercise Serious ramifications for many laboratories and healthcare industry Clear intent of Congress under PAMA was to insure payments on the CLFS reflected private market rates Congress did not expect the agency to develop methodology that would result in: Reporting of incomplete and inaccurate data Extremely costly Burdensome to produce data Not reflect market prices 25

26 Everyone Should Speak Up Even labs not servicing Medicare should be concerned about the impact on private payors CMS stated 75% of tests surveyed had median rates below the CLFS All labs including those with more limited menus will be affected CMS public comment period ended Oct 23 rd : CLFS_Annual_Public_Meeting@cms.hhs.gov. for-service- Payment/ClinicalLabFeeSched/PAMA- Regulations.html Letters can be sent to CMS & Members of Congress via ACLA s PAMA grassroots advocacy platform: Review Economic Impact to Labs at: