Disclaimer This presentation is intended only for use by Tulane University faculty, staff, and students. No copy or use of this presentation should occur without the permission of Tulane University. Tulane University retains all intellectual property interests associated with the presentation. Tulane University makes no claim, promise, or guarantee of any kind about the accuracy, completeness, or adequacy of the content of the presentation and expressly disclaims liability for errors and omissions in such content. 11/24/2018

Overview of Health Care Laws TUMG Compliance Training Anti-Kickback False Claims Act Stark Laws Sarbanes-Oxley Print the Overview of Health Care Laws Quiz before viewing presentation Overview of Health Care Laws 11/24/2018

Read Before Proceeding Physicians and Staff may earn one compliance credit by viewing this presentation, completing the assessment, and faxing the assessment to the University Privacy and Contracting Office: 504-988-7777 This presentation may be viewed for compliance credit only once in a fiscal year (July 1 - June 30). To check how many compliance credits you have and to see which training sessions you have completed, contact the University Privacy and Contracting Office at 504-988-7739 11/24/2018

It is the policy of TUMG to provide healthcare services that are in compliance with all state and federal laws governing its operations and consistent with the highest standards of business and professional ethics. Education for all TUMG physicians is an essential step in ensuring the ongoing success of compliance efforts. 11/24/2018

The other general compliance education presentations are: This education is a General Compliance Education Presentations available on the Tulane University Privacy and Contracting website: http://tulane.edu/counsel/upco/billing-ed The other general compliance education presentations are: Fraud and Abuse TUMG Documentation Top 10 11/24/2018

Purpose of Presentation Health Care law is expanding. Health care entities and providers must keep abreast of the latest regulations. This presentation will provide a brief overview of four laws that pertain to healthcare practices Anti-Kickback Statute False Claims Act Stark Laws Sarbanes-Oxley 11/24/2018

The Federal Health Care Anti-Kickback Statute (Social Security Act §1128B(b), 42 U.S.C. § 1320a-7(b)) 11/24/2018

What is the scope of the Statute? The Anti-kickback Statute is an “extremely broad criminal statute which provides penalties for individuals or entities that knowingly and willfully offer, pay, solicit or received remuneration in order to induce business for which payment may be made, in whole or in part, by a Federal health care program, including the Medicare and Medicaid programs.” 11/24/2018

Remuneration includes but is not limited to: Kickbacks, bribes, and rebates made directly or indirectly, overtly or covertly, in cash or in kind 11/24/2018

Examples of Anti-Kickback Violations Cash for patients: giving cash in exchange for the referral of patients covered by a Federal Health Care program 11/24/2018

Examples of Anti-Kickback Violations Waivers of co-pays and deductibles: The routine waiver of Medicare Part B co-payments and deductibles violates the Anti-Kickback Statute. Nah…we don’t need your co-pay 11/24/2018

OIG position on Waivers of Co-pays and/or Deductibles In addition to the Anti-Kickback Statute, the OIG (Office of the Inspector General) says that a provider, practitioner or supplier who routinely waives Medicare co-payments or deductibles is misstating its actual charge. 11/24/2018

Waivers of Co-pays and Deductibles have consequences For example, if a supplier claims that its charge for a piece of equipment is $100, but routinely waives the $20 co-payment, the OIG considers that the actual charge is $80. 11/24/2018

Waivers of Co-pays and Deductibles Medicare should be paying 80% of $80 ($64) rather than 80% of $100 ($80). As a result of the supplier’s misrepresentation of the charge, the Medicare program is paying $16 more than it should for this item In addition, the Medicare recipient should be paying a lower co-pay. 11/24/2018

Examples of Anti-Kickback Violations Medical Director agreements: If compensation is paid, even in part, for referrals covered by a Federal health care program, the Anti-Kickback statute may be violated. 11/24/2018

Anti-Kickback Indictments Source: “This Week in Corporate Compliance” Vol. VI, No. 28 – August 11 2004 Published by the Health Care Compliance Association Anti-Kickback Indictments On August 4, [2004] US Attorney for the Southern District of Florida, Marcos Daniel Jiménez, announced the unsealing of a 324 count Indictment in Fort Lauderdale, Florida. Fourteen defendants... are charged with participating in a scheme to defraud Medicare of over $8 million. If convicted, the defendants face various statutory maximum sentences ranging from five (5) years’ imprisonment to twenty (20) years’ imprisonment per count, and face fines of up to $16 million. The Indictment alleges that three therapy companies …paid kickbacks to assisted living facilities and to patient recruiters for access to patients. 11/24/2018

Penalties for Anti-Kickback Violations Violation of the anti-kickback laws is a felony, punishable by a $50,000 fine plus three times the amount of remuneration paid, or imprisonment up to five years, or both. Violation of the law could also mean the TUMG and/or a TUMG physician or other clinician is excluded from participating in the Medicare and Medicaid programs for up to five years. Source: Tulane University Health Care Compliance Policy Manual 11/24/2018

The False Claims or Qui Tam Act Signed into law in 1863 during Abraham Lincoln’s term of office, the False Claims Act was significantly changed in 1986 to make it a more effective tool for prosecuting and obtaining judgments for filing false or fraudulent claims. 11/24/2018

The False Claims Act applies when a person or company: Conspires with others to get a false or fraudulent claim paid by the Federal Government Knowingly uses (or causes to be used) a false record or statement to conceal, avoid, or decrease an obligation to pay or transmit money or property to the Federal Government. 11/24/2018

The False Claims Act applies when a person or company: Knowingly uses (or causes to be used) a false record or statement to get a claim paid by the Federal Government Knowingly presents (or causes to be presented) to the Federal Government a false or fraudulent claim for payment. 11/24/2018

Lawsuits filed under the False Claims Act are often referred to as “Whistleblower” lawsuits. 11/24/2018

The False Claims Act allows everyday people to bring suits against groups or individuals that are defrauding the government through programs, agencies or contracts 11/24/2018

Statute of Limitations for False Claims Suits under the False Claims Act can be brought (whichever is the later date): Within six years from the date of the illegal conduct, or Within three years after the Government knows or should have known about the illegal conduct, but in no event later than ten years after the illegal activity. 11/24/2018

What Money Can Be Recovered? A person who initiates a False Claims Act lawsuit is entitled to a proportional share of the funds recovered for the government. 11/24/2018

Protections for People Who Bring False Claims Act Cases The False Claims Act protects anyone who lawfully acts in investigation of, initiation of, testimony for, or assistance in a False Claim. The individual is protected against discharge, demotion, suspension, threats, harassment, and discrimination. 11/24/2018

What Kinds of False Claims Cases Are Filed? Originally, most claims were against companies involved in the Military or Defense Industry. Over time, the focus shifted to health care companies. Now the source of claims is becoming more and more diverse. 11/24/2018

False Claims Settlements Downey Regional Medical Center Settlement Announced On August 18, (2004) US Attorney for the Central District of California Debra W. Yang announced that Downey Regional Medical Center (DRMC), a 200-bed hospital located in Downey, California, has paid the United States more than $2.2 million to resolve allegations that the hospital submitted false claims to Medicare, the taxpayer-funded health care insurance program for many of the nation’s elderly and disabled. The settlement amount - which totaled $2,220,060 - is two times the loss suffered by the Medicare program. Source: “This Week in Corporate Compliance,” Vol. VI, No. 30 – August 24, 2004, Health Care Compliance Association Publication 11/24/2018

False Claims Conviction On March 3, [2005] US Attorney for the Southern District of Florida Marcos Daniel Jiménez announced that two defendants were convicted by a federal jury, after a three-week trial… in Miami, Florida, bringing the total number of convictions to twelve (12), in a multi-million dollar Medicare fraud and money laundering scheme involving local durable medical equipment (DME) companies that fraudulently submitted false claims to Medicare with respect to expensive custom-made orthotic devices such as knee, shoulder, and hip braces. Source: “This Week in Corporate Compliance,” Vol. VII, No.8–March 10, 2005 Health Care Compliance Association Publication 11/24/2018

False Claims Settlements Source: “This Week in Corporate Compliance, Vol. VI, No. 35 – October 4, 2004, Health Care Compliance Association Publication False Claims Settlements On September 29 [2004] the Seattle Post-Intelligencer reported that the “University of Washington has lifted its objection to unsealing federal records compiled during a nearly five-year investigation into medical school billing practices.” ”The records have been sealed since 1999, when a whistle-blower lawsuit sparked the Justice Department investigation. In the suit, former UW employee Mark Erickson accused the medical school of intentionally over billing Medicare and Medicaid.” ”In April, the university paid $35 million to settle the suit and some records were unsealed.” 11/24/2018

Stark Laws Stark Laws, Phases I and II, pertain to physicians’ referrals to health care entities with which they have financial relationships. 11/24/2018

Stark Laws The Stark Laws incorporate provisions of the Social Security Act into Medicare regulations 11/24/2018

Section 1877 of the Social Security Act prohibits physicians from referring Medicare patients for certain designated health services (DHS) to an entity with which the physician or a member of the physician’s immediate family has a financial relationship unless an exception applies. 11/24/2018

Section 1877 also prohibits an entity from presenting, or causing to be presented, a bill or claim to anyone for a DHS furnished as a result of a prohibited referral. 11/24/2018

Phase I of the Stark Laws Addresses section 1877 of the Social Security Act, paragraphs (a) and (b) regarding the general prohibition and the exceptions applicable to both ownership and compensation arrangements. 11/24/2018

Phase II of the Stark Laws Addresses statutory exceptions related to ownership and investment interests, the statutory exceptions for certain compensation arrangements, and the reporting requirements. 11/24/2018

Source: “This Week in Corporate Compliance,” Vol. VI, No Source: “This Week in Corporate Compliance,” Vol. VI, No. 28 – August 11 2004 , Health Care Compliance Association Publication Recent Stark Case On August 6, [2004] US Attorney for the Eastern District of Pennsylvania Patrick Meehan announced a civil settlement between the United States of America and Leonard Ginsburg, M.D., Moore Eye Care, Retina and Diabetic Eye Specialists, ….that resolves alleged violations of the Stark law and the anti-kickback statute. This civil settlement arose out of a qui tam suit filed by a former office administrator for the Moore Eye Institute. 11/24/2018

Sarbanes-Oxley (SOX) Act of 2002 The purpose of the Sarbanes-Oxley Act is “To protect investors by improving the accuracy and reliability of corporate disclosures made pursuant to the securities laws, and for other purposes.” 11/24/2018

Sarbanes-Oxley Act of 2002 Of the four laws discussed in this presentation, Sarbanes-Oxley is the newest. It was enacted in response to recent financial disasters such as ENRON. 11/24/2018

Health Care Company the first to test the new law The Founder and Chief Executive of Health South Corp., Richard Scrushy, was the first individual indicted under the Sarbanes-Oxley law. Scrushy was found not-guilty on all indictments against him. 11/24/2018

Overview of SOX Signed into law July 30, 2002. The most dramatic change to federal securities laws since the 1930’s. 11/24/2018

Sarbanes-Oxley: Radically redesigns federal regulations of public company corporate governance and reporting obligations. 11/24/2018

Sarbanes-Oxley: Significantly tightens accountability standards for directors and officers, auditors, securities analysts and legal counsel. 11/24/2018

Key Change As of April 26, 2003, the SEC has directed the NYSE and NASDAQ to prohibit listing any public company whose audit committee does not comply with new requirements regarding auditor appointment, compensation and oversight. 11/24/2018

Sarbanes-Oxley will have direct impact on any public health care company 11/24/2018

Summary 11/24/2018

Anti-Kickback Statute Three areas of direct risk for providers Cash for patient referrals (either giving or receiving remuneration) Waiver of co-pays and deductibles Medical Director Agreements 11/24/2018

False Claims Act Often referred to as Whistleblower or “Qui Tam” lawsuits 11/24/2018

False Claims Act Violations involve: Knowingly filing fraud claims Knowingly submitting a fraudulent record or statement to receive payment for a claim Knowingly conspiring with others to get a fraudulent claim paid by the government Knowingly using (or causing to be used) a false record or statement to conceal, avoid, or decrease an obligation to pay or transmit money or property to the Federal Government 11/24/2018

Stark Laws, Phases I and II pertain to physicians’ referrals to health care entities with which they have financial relationships. 11/24/2018

Sarbanes-Oxley: New Law (2002) which addresses issues regarding financial reporting and responsibilities of boards of public companies. 11/24/2018

Go to the Source The following sources were consulted for this presentation: http://www.wmolaw.com/dischistory.html History of Federal Anti-Kickback Statute http://hippo.findlaw.com/title2.html Health Insurance Portability and Accountability Act of 1996 11/24/2018

Go to the Source http://www.cpeonline.com/cpenew/sarox.asp Sarbanes-Oxley Act of 2002 11/24/2018

Go to the Source http://www.cms.hhs.gov/MLNProducts/40_PhysSelfReferral.asp Physician’s Referrals to Health Care Entities With Which They Have Financial Relationships www.consumerlaw.com/false.html The False Claims or Qui Tam Act 11/24/2018

Go to the Source http://www.ssa.gov/OP_Home/ssact/title11/1128B.htm Criminal Penalties For Acts Involving Federal Health Care Programs 11/24/2018

TUMG Business Services Compliance Reporting Hotline: 504-988-5142 Know who to contact: TUMG Business Services Compliance Reporting Hotline: 504-988-5142 11/24/2018

Complete and Sign the “Overview of Health Care Laws” Quiz End of Presentation To Earn Compliance Credit: Complete and Sign the “Overview of Health Care Laws” Quiz Fax to: 504-988-7777 11/24/2018