In over 2 decades in healthcare compliance, we ve learned..

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1 Emerging Compliance Risks and Strategies Ed Gaines, JD, CCP Chief Compliance Officer, Emergency Medicine Division Zotec Partners, LLC And Mark Pastin, Ph. D CEO The Compliance Resource Group, Inc. 1 1 In over 2 decades in healthcare compliance, we ve learned.. In theory, there is no difference between theory and practice. But in practice, there is. Yogi Berra, RIP 2015 Denial ain t just a river in Egypt, attributed to Mark Twain Attribution questioned: nial-not-river/ Goals and Objectives: 3 Risk Areas #1: Discuss US DOJ s recent memo for individual accountability for corporate wrongdoing and strategies to address it. #2: Discuss pre-billing EMR risks /pitfalls and strategies #3: Discuss post-billing TCPA and FDCPA risks and strategies. Q&A throughout and available via or phone

2 Key Agencies/Players in compliance and fraud and abuse (F&A) The Centers for Medicare & Medicaid Services (CMS) Secretary of Health and Human Services (HHS) Medicare Administrative Contractors (MACs) Executive Branch HHS Office of The Inspector General (OIG) US Attorney General The US Attorney s Office (USA) F&A recovers $7 for every $1 4 US DOJ Memo to all US Attorneys (USAs) by Sally Q. Yates, Deputy AG, 9/9/2015 Subject: To assess the DOJ s approach to individual accountability for corporate wrongdoing. Several steps were explained to strengthen DOJ s pursuit of individuals. US Attorneys are to review every False Claims case for potential criminal charges. Those criminal charges should specifically include charges against individuals potentially involved in the case. 5 DOJ s New Approach to Individual Accountability: Key concepts for DOJ attorneys to follow: 1. Settlement agreements w/ corporations will include turning over culpable individuals. 2. Focusing on individuals will > likelihood that higher level execs. will be given up. 3. Prosecutorial discretion is more limited if decisions are made not to pursue criminal or civil charges against individuals. 4. Ability to pay for individual should not be overriding consideration to not pursue. 6 2

3 DOJ s New Approach has two overriding goals how does an organization match them?: Gov t Goal #1: recover as much money as possible from corp. and individuals, and Gov t Goal #2: ensure accountability for and deterrence of individual misconduct Can an effective compliance program help protect individuals against criminal charges? The answer is a resounding YES. So how can you do this? What should be the organizational response to the increased compliance threats? Today, a CEO and/or CFO needs to have detailed awareness of what is happening in the compliance program. Reason: to avoid the appearance that the executive is condoning a bad practice that has already been reported to compliance. Strategy: This tool is called Management Certification. This is a process that requires managers to certify periodically (quarterly is best) that they know of no compliance issues that have not been brought forward to the compliance department. Why Management Certifications as a tool? Management certifications have been used in the financial services industry for more than a decade since the days when poor judgment often led to criminal prosecutions. It is time to initiate this practice in healthcare. It enables you to prove that you were not aware of any potential wrong-doing so there is no intent. Bottom line: while a compliance program is designed to protect the corporate entity, it can also protect you

4 #2: Pre-billing risk areas: Electronic medical (health) records (EMR/EHRs), OIG Studies And Strategies to Address Issues. orts/oei pdf The January 2014 OIG Report: Study #2 Report cites two documentation practices that can be used to commit fraud: Copy and paste or cloning, and Over-documentation

5 Tips and Strategies re: EMR risks from our company medical director to his colleagues: CUT AND PASTE: can be considered fraudulent misrepresentation if importing into YOUR medical record information generated by OTHERS without appropriate attribution. MACROS: may be compliant if the information they shortcut into the medical record is tailored to specifically reflect the PATIENT-SPECIFIC findings, and that all the QUESTIONS/FINDINGS that the macro incorporates were, in fact, ASKED/FOUND by the provider. 13 Risk Areas: Teaching Physicians (TP), Residents and Students CMS Transmittal 1780: TP linkage statement and key portion note. CMS Transmittal 811: EMR macro statements may not be sufficient. Students MD, PA or NP not licensed practitioners! Students CANNOT document the Chief Complaint, HPI, perform the Exam or participate in the Decision-Making = NONBILLABLE. 14 Attending physicians Macros: Medicare Transmittal

6 WPS, J8 MAC (MI & IN) : Examples of Unacceptable Documentation for Shared E/M Visits. "I have personally seen and examined the patient independently, reviewed the PA's Hx, exam and MDM and agree with the assessment and plan as written signed by the physician Documentation by the NPP stating The patient was seen and examined by myself and Dr. X., who agrees with the plan with a co-sign of the note by Dr. X. entsplitem.shtml EMR/EHR 5 Strategies for risk mitigation: 1 st : track the problematic functionality, e.g. cut & paste or pre-population of notes w/ default narratives, 2d: Looking for similarities in structured fields, e.g. whether same pain scales were found across diags. (Report on Medicare Compliance 11/17/14) 3d: prohibit pre-population of notes w/ default narratives, e.g. particularly w/ the HPI for Medicare. What to do? Strategies Re: EMR compliance issues from legal perspective. 4 th: Conduct independent coding audits re: cut/paste and overdocumentation: check the actual chart output/printed against Medicare MAC guidance for TP/residents and NPPs. 5 th : Establish & audit clearly defined electronic signatures, for orders at shift change and standing orders w/ hospital and staff: Palmetto GBA Medicare MAC: the physician s name and date appearing in chart w/ log in and password is an electronic signature. (MPIM Chapter 3)

7 #3: Hidden Traps for The Unwary TCPA & FDCPA 19 Medical debt is skyrocketing and shows no signs of lessening: Nearly 4 fold increase in Pts. w/ deductibles of $1K or > since 2006, per the Kaiser Family Foundation Bronze plans (60% of actuarial value [AV]) are high deductible health plans (HDHPs) little to no first dollar coverage for physician services. Some limits to cost sharing up to 250% of federal poverty levels (FPL) Silver plans (70% of AV) may have better 1st $ coverage but similar limits on cost sharing up to 250% of FPL. 20 yrs. ago: 2 Pt statements + pre-collect letter. Today s challenge: software, systems and process in place to repeatedly and lawfully contact the patient regarding payment. Telephone Consumer Protection Act (TCPA) and Fair Debt Collection Practices Act (FDCPA) 20 Strategies for Avoiding Traps and Enhancing Pt. Responsible Balances: Telephone Consumer Protection Act (TCPA) Federal law prohibits automated dialers to cell phones (any # where the called party is charged a fee) w/out the Pt s prior express consent. Purpose: to regulate overly aggressive telemarketing/automated robo-calls & permit consumers to opt out, e.g. Do Not Call List Today: estimated > than 1 of 3 households are mobile-only 21 7

8 FCC s Regulatory Rulings & Guidance: 2008: consumers may provide express consent to be called on mobile phone if he/she knowingly releases his/her number. July 2015: FCC consent is required for calls or text messages for non-emergency purposes using an auto-dialer/artificial or prerecorded message. Consumers may revoke prior express consent. Health related exemption to prior express consent does not apply to pre-collect calls for billing and collections. FCC s Regulatory Rulings & Guidance: Consent to Treatment/Financial Responsibility/Assignment of Benefits Form at the hospital (see Appendix) Limitations on consent via courts: Consent may not be obtained by a 3d party Consent may not be obtained in caller verification July 2015 FCC: Limitations on health-related exemption to prior consent. Hidden Trap #3: be careful w/ language in Pt. statements, pre-collect letters & phone calls: Fair Debt Collection Practices Act (FDCPA) strictly regulates collection agencies when/where/how Pts are contacted. Intent: prohibit abusive debt collection practices, and false, deceptive or misleading representations to collect a debt. Mandatory notification statements to debtors (known as the mini-miranda statements. Strict liability statute w/ Attorney Fees and Class Action potential

9 Be careful in Pt. statement language & phone calls FDCPA: definition of debt collector excludes creditors (physician groups) and those who act for creditors (B/Cs) AND FDCPA applies to only to debts that are in default (15 USC Section 1692a(6)(F)(iii). Strategies: Lawyer up on FDCPA and TCPA. Training and auditing/monitoring phone calls and opt outs by patients to TCPA if any. Summary: #1: New DOJ focus on individuals, higher level executives and limits on prosecutorial discretion. #2: EMRs: understand risks and strategies to address continual audit and monitoring of EMR output. #3: Consult with counsel regarding TCPA and FDCPA issues, compliance for auditing/monitoring communications and risk management re: traditional insurance or risk captives. Ed Gaines, JD, CCP Chief Compliance Officer Zotec Partners, LLC Greensboro, NC Phone: Follow me on Thank You and Presenter Contact information: Mark Pastin, Ph. D President Health Ethics Trust Compliance Resource Group, Inc. Alexandria, VA Phone: mpastin@corporateethics.com

10 Appendix: Gaining Consent for TCPA, used with permission [I/patient/other identifier] acknowledge and agree that [insert company name], or any of [your/its] affiliates, including any bill collection or debt collection companies may contact me by telephone or by text message to any telephone number I provide to you, or at any other telephone number associated with my account, including wireless telephone numbers, which I understand could result in charges. I further agree that you may use any method of contact to any of these telephone numbers, including prerecorded or artificial voice messages, text messages and automatic dialing devices. You may also contact me via electronic mail using any address I have provided to you for use. I acknowledge the contact information provided to you is private to me and I take sole responsibility for maintaining the privacy of any of the information I provide to you. I further understand that in order to revoke my consent to be contacted, I must send a written revocation of my consent to [insert company name] or to the affiliate contacting me on behalfof [insertcompanyname]. (emphasisadded) Frost-Arnett Company, All Rights Reserved Appendix: Additional Physician Compliance Resources OIG Advisory Opinions & training slides: training/files/provider-compliance-training- Presentationv2.pdf Appendix: Resources, References and Links: HHS Office of Inspector General (OIG) loig s compliance guidance to third-party billing agencies (Dec. 1998) OIG s compliance guidance to individual physicians and small group practices (Sept. 2000) ACEP s Fraud, Compliance, and Emergency Medicine (Aug. 2004), on the ACEP Practice Resources Website at Scribe Article:

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