Gainsharing Arrangements and Bundled Payments: OIG Advisory Opinion and Other Developments

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Presenting a live 90 minute webinar with interactive Q&A Gainsharing Arrangements and Bundled Payments: OIG Advisory Opinion and Other Developments Complying With Legal and Regulatory Requirements, Overcoming Implementation and Operational Challenges THURSDAY, MAY 17, 2018 1pm Eastern 12pm Central 11am Mountain 10am Pacific Today s faculty features: Curtis H. Bernstein, CPA/ABV, ASA, CVA, MBA, Principal, Pinnacle Healthcare Consulting, Denver William T. Mathias, Shareholder, Baker Donelson Bearman Caldwell & Berkowitz, Baltimore Girard F. Senn, RN, MS, Pinnacle Healthcare Consulting, Centennial, CO The audio portion of the conference may be accessed via the telephone or by using your computer's speakers. Please refer to the instructions emailed to registrants for additional information. If you have any questions, please contact Customer Service at 1-800-926-7926 ext. 1.

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Gainsharing Arrangements and Bundled Payments: Latest Developments

Agenda for Today s Webinar Discuss problems that gainsharing and bundled payment are trying to address Identify legal considerations in gainsharing and bundled payment arrangements Discuss recent OIG Advisory Opinion Explore existing gainsharing and bundled payment models and demonstrations Review FMV considerations and structural guidance 6

Changing Reimbursement Paradigm Volume Value Important theme in health care delivery and reimbursement Transitioning toward value based reimbursement models Fee for Service Fee for Service, Linked to Quality Alternative/Bundled Payment Models 7

The Triple Aim Improving the Experience of Care Better care for patients through enhanced care coordination and improved patient outcomes Reducing Per Capita Costs Improving the Health of Populations Smarter spending by holding hospitals accountable for total episode spending, not just inpatient costs Healthier people and communities by improving coordination in health and by connecting care across hospitals, physicians, and other health care providers CONFIDENTIAL Contains proprietary information. Not intended for external distribution. 8

Underlying Motivation Money drives performance Aligning Financial Incentives Hospitals & Physicians Acute & Post acute Providers 9

Big Picture Goals of Gainsharing & Bundled Payments Help bridge the gap between fee for service and valuebased payment methodologies Strategic alignment, collaboration, and integration Improve quality Reduce costs Big Picture 10

Spectrum of Alternative Payment Approaches Traditional Gainsharing Bundled Payments Clinical Co management Arrangements ACOs Clinically Integrated Network Population Health 11

Legal Considerations Bill Mathias, Esq. 410 862 1067 bmathias@bakerdonelson.com 12

Applicable Fraud & Abuse Laws Anti kickback statute Civil money penalty (CMP) against hospital payments to reduce or limit services Stark physician self referral law 13

Fundamental F&A Criteria Additional Cost Over, Under, and Mis Utilization Quality of Care Access to Care Patients Freedom of Choice Competition Exercise of Professional Judgment 14

Anti Kickback Statute Federal anti kickback law generally prohibits the provision of any economic benefit in exchange for the referral of patients or business that will be reimbursed under any Federal health care program 42 U.S.C. 1320a 7b(b) Two way street payment or receipt Intent based statute 15

CMP Reduce or Limit Services Prohibited Conduct Hospital (or critical access hospital) knowingly making payments, directly or indirectly to physician as an inducement to reduce or limit MEDICALLY NECESSARY services to Medicare (Parts A or B) or Medicaid patients under the physician s direct care 42 USC 1320a 7a(b) 16

CMP Reduce or Limit Services Much less of an impediment MACRA Limits CMP to MEDICALLY NECESSARY services OIG previously interpreted CMP to apply to any services (including medically unnecessary services) Don t ignore Need efforts to support 17

Stark Physician Self Referral Law The federal Stark physician self referral law generally prohibits a physician from making referrals to an entity for designated health services if the physician (or an immediate family member) has a financial relationship with the entity 42 U.S.C. 1395nn Ownership or compensation Strict liability 18

Avenues for Addressing Stark Payment not made by hospital or other DHS entity Payment not made to physician Create entity 19

Potentially Relevant Stark Exceptions Indirect compensation arrangement Employment Personal services arrangement Fair market value Risk sharing arrangement 20

OIG Advisory Opinion 17 09 Gainsharing Advisory Opinion Non profit acute care hospital shares cost savings for certain spinal surgeries with neurosurgeons in a multispecialty physician group Elements of gainsharing arrangement Use bone protein on as needed basis Product standardization 31 recommendations for devices and supplies 21

OIG Advisory Opinion 17 09 (cont.) First gainsharing advisory opinion since MACRA added medically necessary language to CMP Despite the change, OIG still found product standardization potentially implicated the CMP Process for developing standardization needs to be done right Need clinical support that standardization is not limiting medically necessary care 22

OIG Advisory Opinion 17 09 (cont.) OIG found sufficient safeguards under Anti Kickback Statute (AKS) Incentive to increase referrals to hospital is mitigated Neurosurgeons are part of multi specialty group which retains a portion of savings, but savings used for administrative expenses, not to reward referrals by non participating physicians Multi year agreement, but with annual re basing Standardization requires new clinical process by neurosurgeons Tie incentives to cost savings, so no phantom savings Physician have access to same selection of device and make patient by patient determination Not intended to attract other physicians to hospital 23

OIG Recognizes Reality [A]ppropriately structured gainsharing arrangements may offer significant benefits. OIG Special Advisory Bulletin on Gainsharing 64 Fed. Reg. 37,985 (July 14, 1999) Properly structured, cost sharing arrangements can serve legitimate business and medical purposes. OIG Advisory Opinion 01 01 24

What Does OIG Consider to be Properly Structured? Commercially reasonable/fmv compensation based on independent appraisal Cost savings tied to specific protocol/cost savings activity. Measured based on existing volume (no incentive to change volume) Ensure quality is measured and maintained Transparency and disclosure to patients Monitor change in case mix (protect against steering away more costly patients) 25

What Does OIG Consider to be Properly Structured? Not limit physician s ability to make medically appropriate patient decisions May condition payment on certain physician choice, but must allow access to same supplies and devices as available previously Not induce physicians from other hospitals to join medical staff must be a member of medical staff at outset of program 26

Helpful Regulatory Guidance Co Management Advisory Opinion OIG Adv. Op. 12 22 (Jan. 7, 2013) Special Advisory Bulletin on Gainsharing 64 Fed. Reg. 37,985 (July 14, 1999) Gainsharing Advisory Opinions OIG Adv. Op. 01 01 (Jan. 11, 2001); OIG Adv. Op 05 01 (Feb. 3, 2005); OIG Adv. Op 05 02 (Feb. 17. 2005); OIG Adv. Op. 05 03 (Feb. 17, 2005); OIG Adv. Op. 05 04 (Feb. 17, 2005); OIG Adv. Op. 05 05 (Feb. 25, 2005); OIG Adv. Op. 05 06 (Feb. 25, 2005); OIG Adv. Op. 06 22 (Nov. 16, 2006); OIG Adv. Op. 07 21 (Jan. 14, 2008); OIG Adv. Op. 07 22 (Jan. 14, 2008); OIG Adv. Op. 08 09 (Aug. 7, 2008); OIG Adv. Op. 08 15 (Oct. 14, 2008); OIG Adv. Op. 08 21 (Dec. 8, 2008); OIG Adv. Op. 09 06 (June 30, 2009); OIG Adv. Op. 15 13 (Oct. 14, 2015); OIG Adv. Op. 17 09 (Dec. 29, 2017) 27

Models and Demonstrations Girard F. Senn, RN, MS Pinnacle Healthcare Consulting (702) 759 4054 GSenn@AskPHC.com 28

Various Models Traditional Gainsharing OIG Opinion Based Arrangements Bundled Payments Medicare prescribed protocols Bundled Payments for Care Improvement (BPCI) program Comprehensive Care for Joint Replacement (CJR) program Bundled Payments for Care Improvement (BPCI) program Advanced 29 IP + 3 OP Episode Payment Models (EPMs) Clinical Co management Arrangements ACOs Clinically Integrated Networks Population Health 29

Gainsharing which one to choose? OIG Opinion Based Arrangements CMS Bundled Payment & Episodes of Care Co Management, PMAs, ACOs 16 approvals same model for different specialties 4 models: Acute & Post Acute Savings Numerous Supplies & drugs General Medical/Surgical and Quality Services: All costs General Medical/Surgical Services and Quality: All costs Gainsharing: Up to 50% of Savings Identified Gainsharing: Up to 50% of Professional Fee Gainsharing: FMV Large savings opportunity and 2 year timeframe Strong inclination to learn where CMS is going 5 year timeframe at a cost of 3% Customized long term working relationship 30

OIG Opinion Gainsharing Opportunities Three Categories of Cost and Utilization Savings with the Monitoring of Quality Use Disposable Products Only As Needed for Each Procedure Change Processes to Utilize Less Quantity of a Product or Substitute a Less Costly Product to Achieve the Identical Result Change Processes to Limit Use of Products to Medically Indicated Clinical Circumstances Shared savings is not derived from quality metrics 31

Steps in Gainsharing 1. Measure current cost and volumes for savings baselines and establish quality metrics. 2. Identify and Quantify Waste Reduction & Maximum Savings Opportunities 3. Prepare Hospital s & MD & Third Party Program Administrator Contracts by Group Rebase Sign 6. Payment to Physicians at the end of the Program Year 5. Provide Quarterly Performance Reviews and Benchmarks know how much has been saved 4. Develop Specific Work Plan with Physicians to Reduce Costs 32

Flow of Funds Savings Opportunities Identified $1,000,000 Opportunities Realized (80%) $800,000 50% 50% $400,000 Hospital $400,000 MD Group 60% MD Group 30% MD Group 10% Payment to Group $ 240,000 Payment to Group $ 120,000 Payment to Group $ 40,000 33

OIG Gainsharing Program CAN NOT: Pay for Future Volume / Value of Referrals Pay a Physician for Individual Performance Pay for Historical Performance Pay a Physician if Quality or Severity Decreases Exclude Qualified Physicians Pay Physicians an Unlimited Amount of Money 34

Opportunity by Physician Group Each group s opportunity is dependent on the cost they control. Case types have different levels of cost. Opportunities for cost reduction are based on the types of cases the group performs and how many cases 35

Example of OIG Submitted List: Knee Replacement ITEM SAVINGS Knee Implants $1989 Suture Routine $11.68 1000 Drape $2.59 Disposable Tourniquet $17.59 Instrument Pouch $4.03 Gown and Hood $73.28 Bone Cement $70.44 Reinfusion Unit $135.53 Foley Catheter $9.16 Proximate $5.77 Plastic Boots $3.47 Freight $19.27 Osteonics Burr $3.73 Saw Blades $20.92 Dressings $22.67 Whitney Curette $20.03 36

Total Joint Implant Expense / Case 37

OIG Opinion Gainsharing Program Tips from a Program Administrator Quality Metrics Define the patient population and initiatives carefully Maximum savings dollar amount is defined per initiative Patient Disclosure Surgeon Invitation to Participate (all that are credentialed and privileged to perform the procedure) Transparency (FAQs & Group Meeting & Reports) Minimum 2 year agreement (100 50=75) Participation is voluntary (conscientious objector) Evidence Folder It only takes one disgruntled person to call the OIG OIG Opinion 17 09 MD overhead allowance or conservative hospital 38

Bundled Payments: Two different opportunities for gainsharing with individual physicians Inpatient Post Acute Based on measured internal cost savings can calculate ongoing Quarterly Reconciliation Report from CMS Can measure each MD s work Enormous Variation in Patient Needs Reward individual effort Reward specialty effort 39

BPCI Advanced https://innovation.cms.gov/files/fact-sheet/bpci-advanced-generalfs.pdf 40

Coexisting Gainsharing Arrangements Annual Perspective Combination Model 470/469 ONLY Volume Hospital Savings Surgeon Annual Share Gain Share Total Average Per Case CJR 500 $1,735,760 $750 $375,000 $ 5,887 ASP Non_Med 460 $1,596,899 $1,736 $798,450 $ 3,472 Savings $3,332,659 $1,173,450 $ 2,415 Target $ 3,472 Savings Per Patient All BPCI Model 470/469 ONLY Volume Hospital Savings Surgeon Annual Share Gain Share Total Average Per Case CJR 500 $750,000 $750 $375,000 $ 5,887 ASP Non_Med 460 $690,000 $750 $345,000 $ 1,500 Savings $1,440,000 $720,000 $ 4,387 Target $ 1,500 Savings Per Patient 41

Review of FMV Considerations Curtis H. Bernstein, CPA/ABV, ASA, CVA, MBA, Pinnacle Healthcare Consulting, (720) 598 1430, cbernstein@askphc.com 42

FMV Definition 1. Fair market value means the value in arm s length transactions, consistent with the general market value. 2. General market value means the price that an asset would bring as the result of bona fide bargaining between wellinformed buyers and sellers who are not otherwise in a position to generate business for the other party, or the compensation that would be included in a service agreement as the result of bona fide bargaining between well informed parties to the agreement who are not otherwise in a position to generate business for the other party, on the date of acquisition of the asset or at the time of the service agreement. 43

FMV Definition Usually, the fair market price is the price at which bona fide sales have been consummated for assets of like type, quality, and quantity in a particular market at the time of acquisition, or the compensation that has been included in bona fide service agreements with comparable terms at the time of the agreement, where the price or compensation has not been determined in any manner that takes into account the volume or value of anticipated or actual referrals. With respect to rentals and leases described in 411.357(a), (b), and (l) (as to equipment leases only), fair market value means the value of rental property for general commercial purposes (not taking into account its intended use). In the case of a lease of space, this value may not be adjusted to reflect the additional value the prospective lessee or lessor would attribute to the proximity or convenience to the lessor when the lessor is a potential source of patient referrals to the lessee. For purposes of this definition, a rental payment does not take into account intended use if it takes into account costs incurred by the lessor in developing or upgrading the property or maintaining the property or its improvements. 44

FMV Considerations Comparison to appropriate base of comparable hospitals Appropriately calculating cost savings per encounter Assigning to a single physicians to avoid double payment 45

Cost Approach Time spent by physicians on various tasks necessary to improve quality of care and reduce cost of care, including but not limited to: Researching medical device and pharmaceutical use, cost, and alternatives Educating patients and staff on medical devices and pharmaceuticals Reviewing with patients procedure and post procedure care (including patient follow up) Developing evidence based protocols / pathways Creating / Reviewing / Approving dashboard quality and strategic benchmarks Reviewing complications and developing strategies to improve 46

FMV Considerations Relationship to all other agreements with a physician: Clinical staffing agreement Call coverage agreements Medical directorship agreements Department/division chair agreements Physician lease/lease back agreements Allocation of value among participating physicians within a medical group Engagement of valuator by counsel to obtain benefit of attorney client privilege to facilitate discussion of preliminary issues without waiving privilege 47

Shared Savings Criteria Cost Incentive Compensation Quality Quality Goals Achieved Shared Savings Cost Target Achieved GI Medical Patient Encounter : DRG 440 Base Compensation: Hospital and Physicians Quality Goals Missed No Shared Savings Geometric Mean Cost Target Missed Review basis for miss No Shared Savings 48

Savings Calculation Report for Dr. John Doe Attending Physician GI Medical Bundle Target LOS < 30 Day Order Set Readmission DRG Encounter Actual Cost Cost Savings GMLOS Used (same MDC) 379 1 $3,755 $5,066 $1,311 Y Y N 379 2 $3,900 $5,066 $1,166 Y Y N 379 3 $3,650 $5,066 $1,416 Y Y N 388 4 $12,993 $14,773 $1,780 Y Y N 388 5 $13,565 $14,773 $1,208 Y Y N 391 6 $7,920 $8,940 $1,020 Y N N 391 7 $7,225 $8,940 $1,715 Y Y N 391 8 $9,579 $8,940 ($639) Y Y N 440 9 $4,000 $5,893 $1,893 Y Y N 440 10 $4,445 $5,893 $1,448 Y Y N 440 11 $4,770 $5,893 $1,123 Y Y N 440 12 $5,050 $5,893 $843 N Y N TOTALS $80,852 $95,136 $14,284 ELIGIBLE SAVINGS $11,644 Indicates a mortality. Even though savings were generated, and this case they will be excluded from distribution. Cost and quality measures must be met for savings to be distributed. These cases are excluded from eligible savings, and any savings generated will go back to Hospital. Gray indicates savings eligibility Attending Physician (30%) $3,493.20 Hospital (50%) $5,822.00 Consultant (20%) $2,328.80 TOTAL PAYOUT: $11,644 49

Benchmarking Compensation ORTHOPEDIC SURGERY Year N 25 th Median 75 th 90 th 2015 841 $445,693 $576,677 $802,244 $1,127,851 2015 1,036 $460,786 $582,056 $733,926 $1,002,336 2015 1,273 $430,000 $525,143 $646,750 $814,257 Problems with this data: Old National Combination of administrative, clinical, call coverage, surgery center profit Not presented on an hourly basis 50

Benchmark Compensation ORTHOPEDIC SURGERY Year N 25 th Median 75 th 90 th 2015 38 $150 $200 $250 $267 2015 24 $219 $261 $330 $394 Problems with this data: Old National Very limited sample size For hourly specific duties and not to incentivize behavior 51

Determining FMV 52

Revenue At Risk Metric Financial Pay for Performance Impact 30 DAY READMISSION Public Reporting Quality / Safety Risk CMS Focus / Improvement Opportunity AMI HRRP Hospital Compare Moderate Moderate THA/TKA HRRP / CJR Hospital Compare Moderate High MORTALITY AMI VBP Hospital Compare Moderate Moderate CABG None Hospital Compare Moderate Low and STS Sepsis None None High High Stroke None Hospital Compare Moderate Moderate 53

Allocating Pool of Funds Metric Volume Average Cost Extended Revenue at Risk 30 DAY READMISSION AMI 28 $10,831 $303,261 Portion of 3% THA/TKA 16 $12,208 $195,325 Portion of 3% MORTALITY AMI 11 $32,126 $353,391 25% of 2% CABG 2 $50,940 $101,879 Sepsis 87 $26,712 $2,323,959 Stroke 5 $19,568 $97,838 54

Allocating Pool of Funds Metric Baseline Target Exceptional Percent of Pool 30 DAY READMISSION AMI 10.62% 9.82% 9.29% 3.7% THA/TKA 3.27% 3.02% 2.86% 5.2% MORTALITY AMI 0.69 0.65 0.52 2.9% CABG 0.85 0.54 0.48 2.2% Sepsis 0.96 0.81 0.76 5.9% Stroke 0.81 0.50 0.39 2.2% 55

Questions & Comments Curtis H. Bernstein, CPA/ABV, ASA, CVA, MBA, Pinnacle Healthcare Consulting (720) 598 1430, cbernstein@askphc.com Girard F. Senn, RN, MS Pinnacle Healthcare Consulting (702) 759 4054, GSenn@AskPHC.com Bill Mathias, Esq. Baker Donelson (410) 862 1067, bmathias@bakerdonelson.com 56

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