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1 Pennsylvania Bar Institute 24 th Annual Health Law Institute Physician Year In Review MARCH 13, 2018 Charles I. Artz, Esq. Artz McCarrie Health Law

2 I. STARK/FALSE CLAIMS ACT VIOLATION $20.75 MILLION RECOVERY UNSIGNED/BACK-DATED CONTRACTS U.S. ex rel. Emanuele v. Medicor Associates, 242 F.Supp.3d 409 (W.D. Pa. 2017) (2017 WL /25/17) Disgruntled physician in a medical practice filed a whistleblower case under the False Claims Act contending that medical director and other contracts were shams created for the purpose of inducing unlawful patient referrals in violation of the Stark Self- Referral law and the Anti-Kickback statute.

3 II. INFORMED CONSENT REQUIREMENTS PHYSICIAN DUTY NON-DELEGABLE Shinal v. Toms, 162 A.3d 429 (Pa. 2017) (2017 WL ) Informed Consent Requirements under the MCARE Act (40 P.S ): The Pennsylvania Supreme Court issued a landmark ruling detailing a physician s duty to provide information to a patient sufficient to obtain legally valid informed consent. Duty of physicians Description of procedure Expert testimony Liability

4 III. PHYSICIAN OPIOID OVER-PRESCRIPTION $16.7 MILLION JURY VERDICT UPHELD Koon v. Walden, S.W.3d (2017) (2017 WL ) A state appeals court upheld a jury verdict imposing negligence liability on a physician for overprescribing opioids and a $16.7 Million compensatory and punitive damages award.

5 IV. PHYSICIAN/MEDICAL GROUP LIABILITY STARK/ANTI-KICKBACK VIOLATION The government alleged the improperly structured transaction, the excessive compensation and the co-management contracts violated the Stark Self-Referral law and the Anti- Kickback statute. U.S. ex rel. Miller v. Health Management Associates, Physicians Alliance, Ltd., et al., No. 10-CV-3007 (E.D. Pa. 2017) $4 Million Settlement

6 V. ILLEGAL PRODUCTIVITY BONUSES STARK/FALSE CLAIMS ACT VIOLATION $26 MILLION RECOVERY U.S. ex rel. Moore v. 21 st Century Oncology, No. 2:16-CV-99 (M.D. Fla. 2017) The whistleblower alleged the provider entered into agreements with employed physicians that included compensation based on the volume or value of physician referrals in violation of the Stark Self-Referral law.

7 VI. STARK PHYSICIAN PRODUCTIVITY BONUS VIOLATION $2 MILLION RECOVERY U.S. ex rel. Schaefer v. Family Medicine Centers of South Carolina, (D.S.C. 2016) 2016 WL A physician formerly employed by the medical group practice filed a whistleblower case under the False Claims Act alleging violations of the Stark Self-Referral law based upon an illegal internal productivity bonus structure.

8 VII. STARK PRODUCTIVITY BONUS/ CODING VIOLATIONS U.S. ex rel. Salters v. American Family Care, 262 F.Supp.3d 1266 (N.D. Ala. 2017) 2017 WL Stark Violations Locum Tenens Claims Global Surgery Period Violations No Harm/No Foul Defense Effective Date of 60-day Refund Rule A whistleblower sued her former medical group practice employer under the False Claims Act, alleging that the group practice engaged in illegal physician referrals in violation of Stark and several coding, documentation and Medicare Manual violations.

9 VIII. PHYSICIAN-OWNED SPINAL IMPLANT DISTRIBUTORSHIP/ANTI-KICKBACK VIOLATION/$1.6 MILLION JURY VERDICT A whistleblower sued a neurosurgeon, medical practice and spinal implant distributorship under the False Claims Act for alleged violations of the Anti-Kickback statute in the context of a physician-owned distributorship. U.S. ex rel. Cairns v. D.S. Medical, LLC, (2017 WL ) (E.D. Mo. 2017)

10 IX. PENNSYLVANIA ANTI-KICKBACK STATUTE APPLICABLE TO LICENSED HEALTH CARE PROVIDERS ONLY CO-INSURANCE WAIVER FRAUD Aetna v. Huntingdon Valley Surgery Center, 703 Fed. Appx. 126 (3 rd Cir. 2017) (2017 WL ) The Third Circuit U.S. Court of Appeals addressed whether co-insurance waivers or reductions constitute fraud and whether the state Anti-Kickback statute applies to nonlicensed persons.

11 X. ANTI-KICKBACK STATUTE CONSTITUTIONALITY MEDICAL DIRECTOR/SPACE LEASE ARRANGEMENTS U.S. v. Nagelvoort, 856 F.3d 1117 (7 th Cir. 2017) (2017 WL ) The Seventh Circuit U.S. Court of Appeals upheld a criminal conviction against hospital executives for violating the Anti-Kickback statute, and rejected a constitutional challenge to the Anti-Kickback statute.

12 XI. FAILURE TO REFUND OVERPAYMENTS $449,000 FCA LIABILITY U.S. ex rel. Malie v. First Coast Cardiovascular Institute, No. 3:16-cv (M.D. Fla. 2017) The government recovered $448,829 because the provider knowingly delayed repayment of more than $175,000 in overpayments owed to Medicare, Medicaid, TRICARE and the Department of Veterans Affairs.

13 XII. OUT-OF-NETWORK PHYSICIAN PRACTICE PROMISSORY ESTOPPEL/ ERISA NON-PREEMPTION McCulloch Orthopaedic Surgical Services v. Aetna, 857 F.3d 141 (2d Cir. 2017) (2017 WL ) Aetna representative told surgeon reimbursement at 70% UCR but paid only 23%. Insurer misstatement can be litigated in state court under promissory estoppel, not preempted by ERISA.

14 XIII. MEDICAL NECESSITY CRIMINAL FRAUD DIFFERENCE OF OPINION/ACQUITTAL U.S. v. Paulus, F.Supp.3d (E.D. Ky. 2017) (2017 WL ) Physician was indicted for one count of health care fraud under 18 U.S and 26 counts of false statements relating to health care matters under 18 U.S

15 XIV. MEDICAL NECESSITY DIFFERENCE OF OPINION U.S. ex rel. Polukoff v. St. Mark s/intermountain Medical Center, F.Supp.3d (D. Utah 2017) (2017 WL ) A whistleblower filed suit against a hospital and medical practice contending that the procedures performed were not medically necessary and constituted false claims. The providers filed a motion to dismiss, which the Court granted.

16 XV. MEDICAL NECESSITY FCA LIABILITY CLINICAL LABORATORY RELIANCE ON ORDERING PHYSICIAN PERMISSIBLE U.S. ex rel. Groat v. Boston Heart Diagnostics, F.Supp.3d (D.D.C. 2017) (2017 WL ) Initial decision published at 255 F.Supp.3d (D.D.C. 2017) This was the first decision holding a clinical laboratory responsible for traditional claims of medical necessity, other than billing for laboratory panels or other tests that were not ordered.

17 XVI. INCIDENT TO VIOLATION $7 MILLION RECOVERY U.S. ex rel. Jainniney v. AnMed Health/ Blue Ridge Radiation Oncology, No. 1:12-cv-2942 (N.D. Ga. 2017) A whistleblower filed a lawsuit under the False Claims Act contending that the provider, including a physician group practice and several individual physicians, recklessly violated the incident to supervision requirements because the physician under whose name and NPI the services were billed were not in the same office suite and not immediately available to provide assistance and direction throughout the service being billed, as required by Medicare regulations.

18 XVII. PHYSICIAN RECRUITMENT CONTRACT EARLY TERMINATION REPAYMENT OBLIGATIONS U.S. Court of Appeals upheld trial court s decision requiring physician to repay hospital almost $65,000 to pay amount owed on unforgiven Promissory Note plus court costs and attorneys fees. Johnson Regional Medical Center v. Halterman, 867 F.3d 1013 (8 th Cir. 2017) (2017 WL )

19 XVIII. PROFESSIONAL COMPONENT COMPENSATION FAIR MARKET VALUE ANALYSIS U.S. ex rel. Lutz v. Berkeley Heartlab, F.Supp.3d (S.D.C. 2017) (2017 WL ) Defendants were sued in a whistleblower case alleging False Claims Act violations because physicians were paid for certain services above fair market value.

20 XIX. STARK/ANTI-KICKBACK DEFENSE WIN INDIRECT COMPENSATION ARRANGEMENT U.S. ex rel. Bingham v. BayCare Health System, F.Supp.3d (M.D. Fla. 2017) (2017 WL ) A whistleblower filed a False Claims Act lawsuit against a health system alleging violations of Stark and the Anti-Kickback statute. Although the allegations focused on office space and parking, the only way to establish FCA liability based upon a Stark violation was to prove non-compliance with the Stark Indirect Compensation Arrangement exception.

21 XX. ANESTHESIA MEDICAL DIRECTION/ MEDICAL SUPERVISION The Middle District of Pennsylvania issued a decision involving a whistleblower alleging an anesthesiology company engaged in a scheme to defraud Medicare to receive higher reimbursement by knowingly and falsely billing Medicare for anesthesiology services provided as medical direction services when they should have been properly billed as medical supervision services. U.S. ex rel. Lord v. NAPA Management Services Corporation, North American Partners and Anesthesia PA, LLC, F.Supp.3d (M.D. PA 2017) (2017 WL )

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