Bogies: Federal Anti- Kickback Law & EMS Contracting - Emerging Issues Pamela L. Johnston Foley & Lardner LLP Partner, Los Angeles.

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1 Bogies: Federal Anti- Kickback Law & EMS Contracting - Emerging Issues Pamela L. Johnston Foley & Lardner LLP Partner, Los Angeles May 2018

2 Agenda Big Picture Quick Refresher on the AKS Emerging Issues Criminal Enforcement False Claims Act Enforcement Prevention through Smart Contracting Some Do s and Don ts Questions 2

3 Big Picture Ambulance transports are still in the HHS-OIG work plan HEAT task forces are doing ambulance cases Linkage of ambulance and hospitals DOJ has started looking Kickback and medical necessity cases continue on Contracts under scrutiny 3

4 Quick Refresher: Statutory and Regulatory Requirements

5 Anti-Kickback Statute 42 U.S.C. 1320a-7b(b) 5

6 AKS Federal criminal statute, can also result in civil and administrative penalties and exclusion Intent-based statute Covers all types of arrangements and individuals Statutory exceptions and regulatory safe harbors available, if all conditions met and followed 6

7 AKS (cont.) A violation requires three elements: Remuneration anything of value, in cash or in kind The remuneration must be made knowingly and willfully The remuneration must be made with intent to induce referrals or business 7

8 AKS: Need Only Be A Purpose Violation if only one purpose of the remuneration is to induce Medicare referrals Violation even if there are also other legitimate reasons for the payment Mixed motive cases can lead to a violation 8

9 Criminal Enforcement

10 Enforcement Agencies United States Department of Justice (DOJ) Federal Bureau of Investigation (FBI) United States Department of Health and Human Services (HHS) Office of Inspector General (OIG) Cal MediCal Unit 10

11 Criminal Main Focus Three main types of cases Unnecessary dialysis transports Main focus in CA Over-the-top non medical necessity transports Provable kickbacks 11

12 Example -- Alpha Criminal Conviction Manager received a sentence of 78 months in federal prison $5.5 million in fraudulent billings for unnecessary transports, mostly dialysis trips Faked patient files ahead of audit and shredded real files Brought by HEAT strike force in Los Angeles Just the kind of case that the HEAT task force criminal prosecutors like to do Straightforward Good for young prosecutors 12

13 Example Mauran Criminal conviction Manager received a sentence of 36 months in federal prison $1.1 million in fraudulent billings for unnecessary transports, mostly dialysis Crews instructed to alter the PCRs Again, brought by the HEAT strike force in Los Angeles 13

14 Take Aways / Emerging Issues for Criminal Some cases are brought, but not as many as FCA cases Tends to involve strong facts Dialysis runs are tempting for DOJ Note: young lawyers from DOJ cannot always tell the difference between a strong case and no case Be concerned if: Search warrant Subpoena Hear about a criminal agent or prosecutor Witness interviews by the agent Get help from counsel 14

15 False Claims Act Enforcement

16 False Claims Act Main Focus Unfortunately common Started usually by employees or former employees when they file the case under seal FCA Sections lawyers at USAO or DOJ not the HEAT task force lawyers More experienced but not trial lawyers Trends: Medical necessity, particularly dialysis Kickbacks and swapping Number of cases continues to rise 16

17 Example 1 San Diego Swapping Cases USAO in SD here investigated 10+ EMS providers about possible swapping arrangements with hospitals All had to spend money to respond to subpoenas and interact with USAO Just a few had to settle Issue was the under market rates for facility transports

18 Example 2 Paramedics Plus Case USAO in East Texas brought a case against Paramedics Plus and the public entity in this PUM, EMSA Undisclosed profit cap used to return money to the public entity big number returned to EMSA Entities spent more than a $1.0 million defending the case Paramedics Plus was up for sale and USAO got a court order setting aside the sales proceeds forced a settlement that is still in the final stages

19 Take Aways / Emerging Issues for FCA Cases Bread and butter medical necessity cases churn on, usually without DOJ s intervention Profit cap provisions are a new target of DOJ Some scrutiny of EMS /hospital arrangements Dialysis continues to be under the microscope DOJ often does not intervene, but Relators counsel will bring the case

20 Prevention Through Careful Contracting

21 Signed, Written Agreement Before any items or services are provided No back-dating Do not begin to perform in anticipation of obtaining signatures Process to get to signed, written agreement takes time and must be followed before services and payment commences Not just a technicality 21

22 Enforcement Example (Signed, Written Agreement): Dignity Health November 18, 2016 $368, Self disclosure resolved by OIG under Civil Monetary Penalties Law, including beneficiary inducements, physician self-referrals and kickbacks Alleged illegal remuneration to induce referrals from physician specialists at a community physician practice included medical equipment provided without charge and without a written agreement 22

23 Dignity Health (cont.) Alleged illegal remuneration also included: Payments made to the physician practice for teaching physician supervision services that were not provided as claimed Payments to a physician for services that were not provided as claimed Payment for medical waste disposal services provided to the physician practice by a third party 23

24 Dignity Health (cont.) Free medical supplies provided to the physician practice Free taxi vouchers provided to patients of the physician practice Food, drinks and baby shower gifts provided to patients of the physician practice Payments to two physicians for liaison marketing services that were not provided 24

25 Fair Market Value and Commercial Reasonableness Fair market value for services provided to a hospital or other referral source Should also make good business sense be commercially reasonable 25

26 Commercial Reasonableness vs. Fair Market Value Commercial reasonableness is different than fair market value: Does the agreement make cents (fair market value) / sense (commercial reasonableness)? Fair market value: -What is the range of dollars you are going to pay for the services? Commercial reasonableness: -Is this a good business arrangement to enter into? -Is it commercially reasonable even if there are no referrals between the parties? -Do the underlying economics of the transaction make sense? 26

27 Commercial Reasonableness vs. Fair Market Value (cont.) Key distinction: Fair market value assesses the reasonableness of the range of dollars Commercial reasonableness looks to the reasonableness of the business arrangement generally Because of this differentiation, an arrangement may be at fair market value but not be commercially reasonable 27

28 Volume/Value of Referrals Referral is used in a very broad sense in statutes, regulations, and enforcement Compensating based on the volume or potential volume of health care business or referrals is prohibited Compensating based on the value or potential value of health care business or referrals is prohibited 28

29 Tracking Referrals Huge Red Flag If provider tracks referrals, government will infer intent to compensate based on volume or value of referrals There is typically a better way to obtain necessary information without tracking referrals from an entity Not tracking referrals (and making other referral sources aware that the provider does not track referrals) is important compliance safeguard 29

30 Lessons about Contracts Communications are scrutinized years later through the lens of subsequent events Communications can be misinterpreted Communications may seem innocuous at the time they are written Humor never works Keep your records usually the defense is found in your documents 30

31 Do s and Don ts in General Do comply with company policies and code of conduct Do bring concerns to supervisor, compliance, or lawyers Do extra work regarding repetitive patients to be sure the trips are medically necessary Do more than just rely on a doctor s PCS Understand your dialysis profile Keep all communications inside the system avoid side paper systems that cannot be traced later 31

32 Do s and Don ts (cont.) Don t make informal commitments about money Don t make handshake deals Don t overlook failure by others to pay amounts due chase your AR Don t overlook failure by other parties to perform contracted duties Don t overlook other parties failure to follow policies or contractual requirements 32

33 Do s and Don ts (cont.) Don t drop off goodies or TVs at hospitals Don t provide gifts, payments, or anything of value in exchange for referrals or business (and don t offer them) Don t forget to analyze and document for posterity the FMV Don t follow the Paramedics Plus path by paying money without a written provision. 33

34 Questions? Pamela L. Johnston Foley & Lardner LLP 555 S. Flower Street, Suite 3500 Los Angeles, CA ATTORNEY ADVERTISEMENT. The contents of this document, current at the date of publication, are for reference purposes only and do not constitute legal advice. Where previous cases are included, prior results do not guarantee a similar outcome. Images of people may not be Foley personnel Foley & Lardner LLP 34

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