3/22/2016 THE STARK TRIFECTA. How Legal, Compliance, and Outside Counsel Work Together on Stark Compliance

Size: px

Start display at page:

Download "3/22/2016 THE STARK TRIFECTA. How Legal, Compliance, and Outside Counsel Work Together on Stark Compliance"

William Miles
5 years ago
Views:

1 3/22/2016 THE STARK TRIFECTA How Legal, Compliance, and Outside Counsel Work Together on Stark Compliance 1

2 1. Understand the risks posed by any financial relationship between a hospital and a physician group, and how even well intentioned arrangements can cost you millions. 2

Be prepared to take action once Stark issues are identified, including

3 2. Learn how to develop and implement a comprehensive, multi disciplinary program to prevent and detect Stark violations at your facilities. 3. Be prepared to take action once Stark issues are identified, including conducting an internal investigation and making repayment or disclosing to CMS via the SRDP process. 3

4 IDENTIFYING THE RISK Leverage in house counsel s knowledge of the company with outside counsel s multi client experience to help frame the risk. 4

5 Have you heard of these? U.S. ex rel. Drakeford v. Tuomey (Oct. 16, 2015) $72.4 million settlement before sale following protracted litigation related to improper 10-year employment contracts to 19 specialists in exchange for performing all outpatient procedures at the Hospital or its other facilities U.S. ex rel. Baklid-Kunz v. Halifax Hosp. Med. Ctr. (M.D. Fla.) $85 million settlement to resolve FCA allegations that the hospital violated the Stark Law by entering into employment contracts with six oncologists above FMC and containing improper incentive bonus 5

Hospital Whistleblowers SOME RECENT HOSPITAL TARGETS: Whistleblower: consultant hired by hospital Integris Baptist Medical Center ($12.

of operations Raritan Bay Medical Center ($7.5 million) Whistleblowers: former CEO and billing manager Northside Hospital (Atlanta) ($6.

know you don t want to hear this, but Recoupment of Medicare reimbursements for all referred DHS during period of non-compliance $15,000 CMPs per referral

6 Hospital Whistleblowers SOME RECENT HOSPITAL TARGETS: Whistleblower: consultant hired by hospital Integris Baptist Medical Center ($12.2 million) Whistleblower: co-chair of cardiothoracic surgery University Hospital s Health System ($14 million) Whistleblowers: compliance specialist and head of operations Raritan Bay Medical Center ($7.5 million) Whistleblowers: former CEO and billing manager Northside Hospital (Atlanta) ($6.9 million) Whistleblowers: supervisor of home health services Colquitt County Hospital Authority ($475,000 plus outstanding employment retaliation lawsuit) I know you don t want to hear this, but Recoupment of Medicare reimbursements for all referred DHS during period of non-compliance $15,000 CMPs per referral False Claims Act damages, fines (whistleblower and government) $11,000 fine per claim Treble damages Attorneys fees New CMPs under PPACA (similar to FCA damages, fines) 5 years prison Public relations nightmare 6

7 DEVELOPING OUR PROGRAM In house counsel serves as an expert and conduit for translating legal risk for an organization based on its operations. But an effective risk mitigation strategy requires an effective process to guide success. 7

8 Leverage Compliance s operational expertise to identify areas for process improvement to minimize risk. Compliance is an organization s first line of defense, and offence, for creating a best practice organization. 8

9 Developing our Program: March 2010: Patient Protection and Affordable Care Act Passed March 2012: Revised Provider Arrangements Policy approved by Allina Health governance April 2012: First Provider Arrangements Policy and Process Training July 2014: System wide follow up training; revised process documents released June 2015: Second Revised Provider Arrangements Policy approved by Allina Health governance; separate process created for employed physicians : Legal performs comprehensive review and rewriting of Policy. Allina Health stakeholders begin meeting to develop a comprehensive Provider Arrangements Process : Ongoing training, monitoring, data gathering, and process improvement Provider Arrangement Process Oversight & Administration Allina Health Audit and Compliance Committee (ACC) Executive Compliance Oversight Committee (ECOC) Provider Arrangements Executive Steering Committee (PAESC) VP Audit; General Counsel; Chief Compliance Officer; President Hospital Business Unit; VP Medical Affairs; SVP Clinical Service Lines; VP Finance and Business Development Allina Health Group Provider Arrangements Process Owners SO VP Audit; SO Provider Arrangements Manager System Office (SO) Contract Coordinator Provider Arrangements Core Team Vice President Audit; Manager Provider Arrangements; Director Financial Reporting; Manager Accounts Receivable; Legal; Director Organizational Integrity; Business Associate Compliance 360 Support; VP Finance Hospital Business Unit Contract Admin Designee (CAD) Workgroup Hospital, Clinic, Specialty, and System Office CADs PA Core Team 9

10 Business Unit Role in Provider Contracting Authorized Signatory (per Policy) Senior Accountable Executive (SAE) Finance Lead (Finance VP Metro/SO, Fin Dir Regional/Specialty) Transaction Owner President, SVP, VPMA, VP Ops, Chief Medical Officer, Site Director) Contract Admin Designee (CAD) (Dir, Mgr, or Sr) Transaction Owner (President, SVP, VPMA, VP Ops, Chief Medical Officer, Site Director) SO Contract Manager/SO Contract Coordinator Contracting Process 1. Identify contract need and perform initial due diligence 2. Internal stakeholders discuss concept terms and receive initial approval 3. Determine appropriate contract; engage Legal if appropriate 6. Finalize contract terms; obtain final fair market value opinion 7. Complete Certificate of Compliance obtain Legal sign off if not a standard template 5. Finalize business plan and obtain all necessary committee and capital approvals 8. Obtain authorized signatures on checklist; attest to compliance with the Policy 11. Perform ongoing monitoring of arrangement 4. Initiate Fair Market Value process 9. Execute Agreement 10. Submit contract and all supporting documents to contract database 10

Contracting Process 1. Identify contract need and perform initial due diligence 2. Internal stakeholders discuss concept terms and receive initial approval 3.

11 Contracting Process 1. Identify contract need and perform initial due diligence 2. Internal stakeholders discuss concept terms and receive initial approval 3. Determine appropriate contract; engage Legal if appropriate 6. Finalize contract terms; obtain final fair market value opinion 7. Complete Certificate of Compliance obtain Legal sign off if not a standard template 5. Finalize business plan and obtain all necessary committee and capital approvals 8. Obtain authorized signatures on checklist; attest to compliance with the Policy 11. Perform ongoing monitoring of arrangement 4. Initiate Fair Market Value process 9. Execute Agreement 10. Submit contract and all supporting documents to contract database Contracting Process 1. Identify contract need and perform initial due diligence 2. Internal stakeholders discuss concept terms and receive initial approval 3. Determine appropriate contract; engage Legal if appropriate 6. Finalize contract terms; obtain final fair market value opinion 7. Complete Certificate of Compliance obtain Legal sign off if not a standard template 5. Finalize business plan and obtain all necessary committee and capital approvals 8. Obtain authorized signatures on checklist; attest to compliance with the Policy 11. Perform ongoing monitoring of arrangement 4. Initiate Fair Market Value process 9. Execute Agreement 10. Submit contract and all supporting documents to contract database 11

12 Contracting Process 1. Identify contract need and perform initial due diligence 2. Internal stakeholders discuss concept terms and receive initial approval 3. Determine appropriate contract; engage Legal if appropriate 6. Finalize contract terms; obtain final fair market value opinion 7. Complete Certificate of Compliance obtain Legal sign off if not a standard template 5. Finalize business plan and obtain all necessary committee and capital approvals 8. Obtain authorized signatures on checklist; attest to compliance with the Policy 11. Perform ongoing monitoring of arrangement 4. Initiate Fair Market Value process 9. Execute Agreement 10. Submit contract and all supporting documents to contract database Contracting Process 1. Identify contract need and perform initial due diligence 2. Internal stakeholders discuss concept terms and receive initial approval 3. Determine appropriate contract; engage Legal if appropriate 6. Finalize contract terms; obtain final fair market value opinion 7. Complete Certificate of Compliance obtain Legal sign off if not a standard template 5. Finalize business plan and obtain all necessary committee and capital approvals 8. Obtain authorized signatures on checklist; attest to compliance with the Policy 11. Perform ongoing monitoring of arrangement 4. Initiate Fair Market Value process 9. Execute Agreement 10. Submit contract and all supporting documents to contract database 12

13 Contracting Process 1. Identify contract need and perform initial due diligence 2. Internal stakeholders discuss concept terms and receive initial approval 3. Determine appropriate contract; engage Legal if appropriate 6. Finalize contract terms; obtain final fair market value opinion 7. Complete Certificate of Compliance obtain Legal sign off if not a standard template 5. Finalize business plan and obtain all necessary committee and capital approvals 8. Obtain authorized signatures on checklist; attest to compliance with the Policy 11. Perform ongoing monitoring of arrangement 4. Initiate Fair Market Value process 9. Execute Agreement 10. Submit contract and all supporting documents to contract database Contracting Process 1. Identify contract need and perform initial due diligence 2. Internal stakeholders discuss concept terms and receive initial approval 3. Determine appropriate contract; engage Legal if appropriate 6. Finalize contract terms; obtain final fair market value opinion 7. Complete Certificate of Compliance obtain Legal sign off if not a standard template 5. Finalize business plan and obtain all necessary committee and capital approvals 8. Obtain authorized signatures on checklist; attest to compliance with the Policy 11. Perform ongoing monitoring of arrangement 4. Initiate Fair Market Value process 9. Execute Agreement 10. Submit contract and all supporting documents to contract database 13

14 Contracting Process 1. Identify contract need and perform initial due diligence 2. Internal stakeholders discuss concept terms and receive initial approval 3. Determine appropriate contract; engage Legal if appropriate 6. Finalize contract terms; obtain final fair market value opinion 7. Complete Certificate of Compliance obtain Legal sign off if not a standard template 5. Finalize business plan and obtain all necessary committee and capital approvals 8. Obtain authorized signatures on checklist; attest to compliance with the Policy 11. Perform ongoing monitoring of arrangement 4. Initiate Fair Market Value process 9. Execute Agreement 10. Submit contract and all supporting documents to contract database Contracting Process 1. Identify contract need and perform initial due diligence 2. Internal stakeholders discuss concept terms and receive initial approval 3. Determine appropriate contract; engage Legal if appropriate 6. Finalize contract terms; obtain final fair market value opinion 7. Complete Certificate of Compliance obtain Legal sign off if not a standard template 5. Finalize business plan and obtain all necessary committee and capital approvals 8. Obtain authorized signatures on checklist; attest to compliance with the Policy 11. Perform ongoing monitoring of arrangement 4. Initiate Fair Market Value process 9. Execute Agreement 10. Submit contract and all supporting documents to contract database 14

15 Contracting Process 1. Identify contract need and perform initial due diligence 2. Internal stakeholders discuss concept terms and receive initial approval 3. Determine appropriate contract; engage Legal if appropriate 6. Finalize contract terms; obtain final fair market value opinion 7. Complete Certificate of Compliance obtain Legal sign off if not a standard template 5. Finalize business plan and obtain all necessary committee and capital approvals 8. Obtain authorized signatures on checklist; attest to compliance with the Policy 11. Perform ongoing monitoring of arrangement 4. Initiate Fair Market Value process 9. Execute Agreement 10. Submit contract and all supporting documents to contract database Contracting Process 1. Identify contract need and perform initial due diligence 2. Internal stakeholders discuss concept terms and receive initial approval 3. Determine appropriate contract; engage Legal if appropriate 6. Finalize contract terms; obtain final fair market value opinion 7. Complete Certificate of Compliance obtain Legal sign off if not a standard template 5. Finalize business plan and obtain all necessary committee and capital approvals 8. Obtain authorized signatures on checklist; attest to compliance with the Policy 11. Perform ongoing monitoring of arrangement 4. Initiate Fair Market Value process 9. Execute Agreement 10. Submit contract and all supporting documents to contract database 15

How do you promote reporting of old issues while

Complete Policy Training Compliant with Provider

16 How do you promote reporting of old issues while also ensuring compliance in new arrangements? It s a balancing act The completion of the following were tied to Leaders merit increases: Complete Policy Training Compliant with Provider Arrangements Policy Compliant with Stark and anti kickback laws 16

17 TAKING ACTION WHEN AN ISSUE ARISES An effective process doesn t end when the contract is signed. Compliance is integral for helping assess ongoing compliance and identifying risks that require Legal involvement. 17

Provider Arrangement (PA) Policy Violation Reporting Workflow Where a potential provider contract issue may be surfaced: BU Department BU CAD/Finance Lead SO Contract Manager/Contract Coordinator

analysis: Determine if regulatory impact Determine if PA Policy Violation BU CAD/Finance Lead provides Legal any requested additional information Legal Department sends determination o PA Policy

18 Provider Arrangement (PA) Policy Violation Reporting Workflow Where a potential provider contract issue may be surfaced: BU Department BU CAD/Finance Lead SO Contract Manager/Contract Coordinator Legal Department A/P, A/R, or other Finance Department Audit or Compliance Department Notification should include: Legal Department BU CAD/Finance Lead SO Contract Manager Legal Department conducts analysis: Determine if regulatory impact Determine if PA Policy Violation BU CAD/Finance Lead provides Legal any requested additional information Legal Department sends determination o PA Policy Violation to: Reporter BU CAD/Finance Lead SO Contract Manager If Policy violation, SO Contract Manager contracts BU Senior Accountable Executive to report PA Policy Violation SO Contract Manager determines if reportable on PA KPIs If KPI Reportable and/or Process Violation only, SO Contact manager notifies: Reporter BU CAD/Finance Lead Abbreviation Key BU = Business Unit CAD = Contract Admin Designee SO = System Office KPI = Key Performance Indicator 18

performed 4 months ago. The business unit completed a check request and submitted it for payment.

Compliance called Legal and, at Legal's request, reached back out to the business unit to see if

They found an email to the group (dated 5 months ago) asking for the services and including a job

19 It s Not Complicated! Hello, Legal? I think we have a problem Physicians Group, PA submitted an invoice for medical director services performed 4 months ago. The business unit completed a check request and submitted it for payment. Accounts Payable did not see a C360 number on the form so returned it to the business unit, called Compliance, and did not issue payment. The business unit believed an agreement was signed but no one can find it. Compliance called Legal and, at Legal's request, reached back out to the business unit to see if they could find any s or other writings. They found an to the group (dated 5 months ago) asking for the services and including a job description for the medical director role. They also found the draft agreement with the terms on Hospital VP's desk, including the compensation amount, but it wasn't signed by either party and no one can confirm whether it was sent to the group The invoice was for the amount that was reflected in the draft agreement. 19

20 CMS SRDP 20

SRDP settlement experience to-date Settlements posted at: http://www.cms.

html 740 submissions to-date 69 settlements: High = $584,000 19 violations by hospital/hospice in NC

21 SRDP settlement experience to-date Settlements posted at: Settlements.html 740 submissions to-date 69 settlements: High = $584, violations by hospital/hospice in NC (Oct. 2012) Low = $60 Single IOAS violation by physician practice in OH (Sept. 2012) Average = $110,000 The Lady or the Tiger? 21

Stark II, Phase Never mind. Recent amendments and clarifications to the Stark regs provide new flexibility CY 2016 PPS Final Rule, 80 Fed. Reg. 7086 (Nov.

22 Stark II, Phase Never mind. Recent amendments and clarifications to the Stark regs provide new flexibility CY 2016 PPS Final Rule, 80 Fed. Reg (Nov. 16, 2015) Arrangement rather than agreement Expired agreements may not be expired arrangements Writings rather than a [single] writing 90 days for signature which can relate to other (earlier?) writings 52 SRDP submissions withdrawn as of 12/31/

The Rye Ambulatory Surgery Center, LLC Compliance Plan

The Rye Ambulatory Surgery Center, LLC Compliance Plan Approved By Board of Managers October 27, 2010 INTRODUCTION The Rye Ambulatory Surgery Center ( Rye ASC ) is committed to conducting its operations