Date: January 18, 2017 DOJ, OIG & FBI OH MY!!!

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1 Date: January 18, 2017 DOJ, OIG & FBI OH MY!!!

2 CHERYL L. COON For over 20 years, Cheryl L. Coon has advised clients on a broad spectrum of health law, business and environmental issues. In the healthcare arena, Ms. Coon s practice involves advising health care related clients (physician and dental groups, ambulatory surgical centers, imaging centers, medical SPAs, for example) with regard to compliance with federal and state laws. She has experience in evaluating proposed transactions with regard to the federal Affordable Care Act ("Obamacare"), Stark (anti-referral) and Anti-Kickback laws, the related safe harbors, False Claims Act issues, medical wastes, and various state licensing laws, and can assist with HIPAA and HITECH issues. She has experience in professional entities and their formation and governance, e.g., bylaws, buy sell agreements, and can assist with drafting related corporate documents. She also has assisted in certification and licensure issues related to Texas non-profit health organizations. Ms. Coon also can assist with the sale or purchase of health care businesses and related issues such as fair market value evaluations. She can assist with practice related agreements such as employment and independent contractor agreements, non-competition agreements, non-disclosure agreements and business associate agreements. Ms. Coon has substantial experience in multi-million dollar real estate and corporate transactions, and she can assist in drafting and review of related transaction documents and with associated due diligence. Her corporate/business practice includes assisting clients with business issues from forming entities to drafting and negotiating various business documents such as non-competition agreements, consulting agreements, asset and stock purchase agreements, management agreements, marketing agreements, confidentiality agreements, buy sell agreements, non-compete agreements and employment agreements. Ms. Coon has worked on a $450 million dollar major airline purchase, a New York Manhattan REIT and many other substantial projects. She also has experience in certification of minority and women owned businesses. Ms. Coon is licensed in Texas, having graduated from Southern Methodist University School of Law magna cum laude. Prior to going to law school, she worked at several hospitals in Texas, including Baylor University Medical Center Hospital in Dallas and Huguley Hospital in Fort Worth, as an American Society of Clinical Pathologist certified medical technologist. 2

3 SCOPE Health Care Providers Face A Sea Of Laws & Regulators Stark the anti-referral statute (no intent required) Medicare only Anti-Kickback remuneration for referrals Any federal program Requires knowingly / willfully False Claims Act civil and criminal share data; Texas is one of most active states for qui tam HIPAA/HITECH Others Laws: Travel Act 1, RICO, Commercial Bribery, Money Laundering DOJ health care sting divisions; data mining and data sharing Other Players: US Postal Service, US Army Criminal Division, FBI, DOL, New Attorney General Commercial Bribery Taskforce (Jan. 2016) 1 Used in health law cases where more than one state is involved applies to illegal monetary transactions via use of phone, internet or even the mail. 18 USC

4 TRAVEL ACT Use of mail, or any facility, or interstate or foreign travel to distribute proceeds of an unlawful activity, to commit a crime or promote or carry on unlawful activity Unlawful activity includes bribery in violation of any federal or state law (as in commercial bribery) Texas Commercial Bribery 1 defines doctor, lawyers, any person who participates in the direction of an association as a fiduciary. A fiduciary commits an offense if he or she without consent of beneficiary knowingly solicits or accepts any benefit that will influence his or her conduct in relation to beneficiary. 1 Tex. Penal Code

5 STARK/ANTI-KICKBACK Starting Point Federal Or State Health Care Program More than just Medicare!! Other programs: Medicaid Tricare Veterans Administration Indian Health Services OWCP Workers Compensation for Federal Employees Rail Road Retirement Peace Corps Programs covered by maternal and child health grants or social services grants Federal prisoners PLUS others 5

6 REFERRAL and Remuneration Anti- Kickback Request by a provider for any item or service that will be paid for in whole or in part by Medicare or federal or state health care program Request by a physician for a consultation Now: a certification or re-certification for services (Patel case - home health agency as one of several on a list he provided and he was paid $400 per certification any type of approval) Remuneration anything of value CLE, tickets 6

7 WARNING: Two For the Price of One Enforcement HOT AREAS Dr. A violates anti-kickback or Stark Dr. A also violates False Claims Act (the one with treble damages and whistleblower participation) And False Claims qui tam actions are always in the background Also don t forget that overpayments must be reported and returned within 60 days or this too is the basis for a FCA claim. Hot areas: Home health, hospice, DME, therapy (physical, other including infusion therapy 7

8 WARNING: DOJ on Individual Accountability May 2016 Cooperation credit must provide all relevant facts on individual persons involved (cannot have willful ignorance; cannot pick and chose) DOJ will do its own investigation and compare notes Focus on individuals from inception of case Civil and criminal sides will communicate freely Will not provide agreement to protect individuals Will not resolve case without clear plan to resolve related individual cases Credit thoroughness, speed, diligence, proactive, complete disclosure, making witnesses available, assisting with document questions, timeliness of disclosure 8

9 LESSON -Unless you do cash only services, it may be hard to weed out 100% of federal and state programs EXAMPLE: Texas hospital provider accepted no Medicare, which prevented Stark enforcement. Enforcement/Indicted because of kickback issues: problems with management and other agreements with physicians providing improper remuneration in relation to Tricare and federal workers compensation program referrals. Payments for marketing and management RED FLAGS ISSUE: Compensation in any arrangement must be fair market value and commercially reasonable and not take into account the volume or value of any referrals. 9

10 AND DON T IGNORE PRIVATE PAY INSURERS Insurance Fraud submitting claims to private insurers that are incorrect, for services not provided, up coded, unnecessary tests, etc. Recent Dallas example $10M indictment for insurance fraud. It is not just Medicare & Medicaid Blue Cross, United Healthcare were involved in this case. 10

11 RECENT FEDERAL CASE One person 7 years federal prison; $$$ fines; At least 8 providers indicted Referral $$ MRI Center Indicted Chiropractor Indicted Referral $$ Referral Received $$ for referrals Neurologist Indicted $$ $$ Commercial Insurance Fraud Bribery Tax evasion Conspiracy Money Laundering 10 doctors/owners charged Pain Management Indicted Imaging center gave gift cards, money and construction services from sham companies to Drs. Imaging Center also rented spaces from the providers under sham leases and donated to their charities Provided free equipment to Drs. 11

12 Case Analysis Workers Compensation (Private Insurers) Runners referrals Pain Center LLC A Clinic A Clinic Chiropractor A owns Several Clinics Same treatment for everyone to maximize payment Often recommended psychological Pain Free d/b/a Pain Free Management Co. Leased Space at Park Center LLC Management Services Psychologist Clinic Terrence Referrals Lease Space PFMC gets management fee 50% of all money Dr. H. Chiropractor - Largest workers comp in CA - Referred all psychol. to Terrence Chiropractor A owns Performed management & billing Rent and Services provided to physicians really was a kickback payment for referrals Submitting false claims Unnecessary services Kickbacks among participants Services never provided Criminal forfeiture 12

13 Other Recent Cases Watch All Compensation Sources Anesthesia group over $1M settlement - reduced cost/free drugs in exchange for exclusive contract with ASC; also for separate ASC funded part of its construction Home health certification if home health pays the doctor for his certification or recertification = referral/kickback (Patel case) he had no input on choice but did include the home health center on a list provided to patients. 13

14 FMV Value in an arm s length transaction consistent with general market value Value of rental property for general commercial purposes but parties may take into account additional costs incurred by Landlord in developing or upgrading the property. 14

15 COMPENSATION Fair Market Value Hot Areas: Medical Director, Marketing, Consulting Fees Discounted rent for equipment or space ($510,000 fine to hospital for discounted rent to physician group) Marketing fees ex. Payments to home health doctor s spouse for services were held illegal payments Physician bonuses by hospitals ($21.75M fine for payments to cardiologists and ER doctors by Texas hospital (St. Joseph Medical Center) via professional service agreements above FMV or services never provided; another with $237.5M settlement for payments to oncologists and neurologists) Medical director fees is there really work, then document the hours, the tasks, etc. Free anything Just Don t. (food, tickets, CLE, golf, travel) Teaching or consulting fees 2015 criminal conviction for payments by hospital to doctors for teaching. Christ Hospital $108M fine hospital alloted time in procedure room based on referrals. 15

16 CASE ANALYSIS: Tuomey Tuomey Healthcare - $237M kickbacks to specialists via part-time employment contracts above FMV and suspicious productivity bonuses. Stark and False Claims case. (Safe harbor is not just a checklist!) Background Physician group wanted to move procedures to office so hospital employed them part-time. A physician who did not sign brought the False Claims Act claim. Hospital lost money on collections due to high compensation. Physicians agreed to work exclusively at hospital. Employment contracts were only part-time but covered all expenses as for phone, CME, malpractice and full-time benefits Government argued red flags for intent: advisors and board meetings Essentially no duties undefined work requirements. 10 year long term contracts Lesson in part. Getting any FMV will not meet the standard (here report was 3 pages, did not address some issues, glossed over others) Have clear clean record why is contract needed Treat all potential contracts the same way First attorney advised of red flags so Tuomey shopped Could not use employment safe harbor because part-time, not commercially reasonable, not FMV, etc. 16

17 FAIR MARKET VALUE Don t shop around or try to fudge high profile DaVita case where they would pick the number they wanted and back into it with calculations (Tuomey) (disregarded some opinions on FMV and got new reports) Be able to document! Third party evaluation/appraisal but good ones. Do due diligence here! Purchase transactions it will be hard to estimate potential liability Several big cases started during a purchase due diligence 17

18 LEASES FMV is Key Detroit $30M settlement lease below FMV/no written lease discovered during due diligence Free advertising and marketing to Drs.; free tickets and educational seminars Also improper compensation in independent contractor agreements with physicians Self-reported Condell Medical Center $36M settlement leases below FMV Discovered and self-reported in buyer s due diligence 4 Questionable areas: 1. Professional Service Agreements no written contracts with physicians or written agreements that did not meet safe harbor 2. Leases either below FMV or deferred payments 3. Loans/Financial Support write off loans at rates above FMV 4. Recruiting given to doctors already in the area, had exclusive services in physician contracts (no privileges elsewhere). (NOTE: They were also very cooperative imagine the potential fine without this and the self disclosure!) 5. Self Reported Christus Health System (TX) leases below FMV with doctor groups Case against Dr. consulting agreement for $25,000 with no duties; agreed to use only 1 medical device company 18

19 LEASES Need to Audit annually or on a schedule. Same for all agreements. Expired? Failure to enforce operating expense or other pass through. Failure to increase rent as per schedule Providing services/area not covered in written agreement Unsigned Rent not FMV = not based on volume or value of referrals or other business generated between the parties. 19

20 FED SAMPLER TEXAS Imaging center $3.5M improper supervision (on-site physician) (qui tam) Home health Dr. 5 year prison and $913,000 fine improper certifications and kickbacks 3 doctors and imaging center $6M paid marketers, kickbacks to doctor, unnecessary tests, paid patients 10 companies $1.125M Medicaid transportation, false info on drivers and other compliance issues to receive more $$ (qui tam) North Richard Hills Dr. up to 5 yrs. and $250,000 fine false home health certification, i.e., not home bound Dallas Dr. and 3 home health owners $375M paid recruiters/false home health certification-paid homeless, billed unnecessary tests, false certifications DME company kickbacks and false submissions Dr. 42 months and $309,000 fine unnecessary tests, tests not done, done by unlicensed personnel Dallas Nurse and home health owner 10 yr. and $25M improper home health certification, services not provided, services unnecessary. 20

21 TIPS Annual compliance audit including listing all income sources Advise clients to get you involved sooner, even in engaging consultants All arrangements in writing and meet a safe harbor Hot areas now double down on your internal audit, review policies and up training! Home health, hospice, DME, infusion services 21

22 SAFE HARBORS! Equipment and Space Rental Physician Recruitment Do not treat these as checklists and ignore surrounding facts! Do not put in place and not have on-going monitoring Recitals in a contract will not prevent enforcement. 22

23 TAKE AWAYS Due Diligence! On all financial relationships and all parties Have good paper records Monitor billing Annual audits have changes occurred; are you doing what the documents say you are supposed to do? Be informed ex. OIG Fraud Alerts on physician compensation, lab fees and other areas Hot Areas as home health, DME double down on compliance! 23

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