How to respond to Document Requests, audits & overpayment demands Attorney-client privileged / confidential / work product Presented by: Guillermo J. Beades, Esq. Attorney-Client Privileged/Confidential/Work Product.

About Frier Levitt, LLC Frier Levitt is a national boutique healthcare law firm located in Pine Brook, New Jersey. Our over 30 attorneys bring collective experience and backgrounds in pharmacy, hospital administration, professional licensing, Attorney General actions, clinical practice, and medical billing. Through our experience in representing thousands of pharmacies across the country, we have developed strong relationships with key decision-makers at each pharmacy benefits manager and have successfully fought on behalf of pharmacies and healthcare providers in conducting Medicare appeals. Frier Levitt provides directed and uniquely-tailored legal services to specialty pharmacies including network issues, State and Federal Any Willing Provider laws, regulations limiting specialty drug co- payments and limited distribution drug concerns. Moreover, Frier Levitt also provides comprehensive legal services to our healthcare clients, including corporate and transactional services, regulatory advice, and litigation support. Copyright © 2017. All rights reserved. Confidential and Proprietary. Not for distribution.

About Frier Levitt, LLC Guillermo J. Beades, Esq. Attorney Guillermo J. Beades, Esq., is an associate practicing in Frier Levitt’s Healthcare Litigation Department. Guillermo represents healthcare professionals in a broad range of administrative, civil and criminal healthcare matters. Guillermo has extensive litigation experience before state licensing authorities and Medical Boards (e.g., NJ BME, OPMC), federal healthcare agencies (e.g., OIG, CMS, DEA) and state healthcare agencies (e.g., NJ Medicaid Fraud Division, NY OMIG). Guillermo has represented practices and healthcare professionals in matters concerning credentialing and denial of privileges, administrative discipline, Medicare audits, post-payment demands and pre-payment audits. Guillermo also represents healthcare professionals in criminal and civil white collar defense matters, including matters alleging Medicare / Medicaid Fraud and violations of the Anti-Kickback Statute, False Claims Act, Codey Law and Stark. Guillermo has been selected to the New Jersey Super Lawyers Rising Stars list in 2015 - 2017. Education Villanova University School of Law Pennsylvania State University, Bachelor of Science, Crime, Law and Justice Bar Admissions State of New Jersey U.S. District Court, New Jersey State of New York Commonwealth of Pennsylvania Guillermo J. Beades, Esq. Attorney Copyright © 2017. All rights reserved. Confidential and Proprietary. Not for distribution.

Not all investigations are created equal

Investigations: healthcare scrutiny Healthcare is one of the most highly regulated industries in the country Current areas of particular concern to federal and state investigations include, but are not limited to: Fraud, waste and abuse Diversion / Indiscriminate Prescribing Anti-Kickback Act violations Allergy Testing (NJ) Copyright © 2017. All rights reserved. Confidential and Proprietary. Not for distribution.

Investigations: LICENSING BOARDS State Investigators conduct all Board investigations Failure to comply can lead to Board discipline Subpoena power Copyright © 2017. All rights reserved. Confidential and Proprietary. Not for distribution.

Investigations: State Agencies State Agencies – like the DOH – have more power than Board investigators DOH may conduct unannounced inspections May be working in tandem with other agencies or State Attorney General’s Office Copyright © 2017. All rights reserved. Confidential and Proprietary. Not for distribution.

Investigations: Federal Agencies Typically involve more serious allegations Usually more than one agency involved Parallel criminal and civil investigations Higher fines and penalties than Board or State Investigators Copyright © 2017. All rights reserved. Confidential and Proprietary. Not for distribution.

Common Misconceptions Investigators have a duty to tell the truth Power of the Subpoena Investigators only want a statement Cooperation means future consideration Copyright © 2017. All rights reserved. Confidential and Proprietary. Not for distribution.

When is an investigation problematic? Pay attention to: Tone Who is the investigator? How many agencies are present? Specific v. Broad Investigation Length of document request / subpoena What type of records are being requested? Copyright © 2017. All rights reserved. Confidential and Proprietary. Not for distribution.

Audits Copyright © 2017. All rights reserved. Confidential and Proprietary. Not for distribution.

Audits: General Medical record audits target and evaluate procedural and diagnosis code selection as determined by physician documentation. Reveal weaknesses in coding / documentation Copyright © 2017. All rights reserved. Confidential and Proprietary. Not for distribution.

Audits: Routine How was the practice notified? Who addressed the letter to the practice? How many charts are being requested? Pursuant to provider agreement terms? Copyright © 2017. All rights reserved. Confidential and Proprietary. Not for distribution.

Audits: Red Flags Audits from recovery audit contractors (RACs) or zone program integrity contractors (ZPICs) Audits buzzwords: billing irregularities, outlier, etc. Large number of documents requested Specific procedure (e.g., balloon sinuplasty) or code (e.g., consultations) In-office copying of records Copyright © 2017. All rights reserved. Confidential and Proprietary. Not for distribution.

Audits: Dos and Don’ts DO comply with the audit! DO copy all records, intakes, diagnostic testing, operative reports, etc. that support the DOS at issue! DON’T give statements or hand over control of your work station! DON’T send illegible records, sparse records and/or fail to keep a copy of what was produced! Copyright © 2017. All rights reserved. Confidential and Proprietary. Not for distribution.

Audit trends in 2019 Allergy Testing / Immunotherapy Injections Pediatrics Developmental Testing (CPT 96110) Vaccines for Children (“VFC”) Program High Reimbursement Procedures (e.g., balloon sinuplasty) The Classics: Consultations, High Level E/M & Modifiers 25/59

Overpayment demands

Overpayment demands: General Demand for Overpayment are secondary to audits and document demands They can be based on documentation, failure to credential, the services being performed by an unauthorized provider or a litany of other reasons Overpayment demands can also come after a request for records targeting potential kickbacks (e.g., contract with vendors) Copyright © 2017. All rights reserved. Confidential and Proprietary. Not for distribution.

Impact of on Site copying vs. Production On-site document inspections expose a practice If an on-site inspection cannot be avoided, instruct staff accordingly Anything said to the investigator can and will be misinterpreted against you Production allows your attorney and expert(s) to give context Copyright © 2017. All rights reserved. Confidential and Proprietary. Not for distribution.

Is an overpayment demand looming? How many documents are being requested? Who is requesting the documents? Does it relate to a “hot topic” area? (e.g., prescribing, contract with an allergy company, etc.) Is the request general or specific? Copyright © 2017. All rights reserved. Confidential and Proprietary. Not for distribution.

Overpayment Demand: Common Mistakes Not keeping a copy of what was sent out / copied Giving statements to investigators without first speaking to an attorney Producing incomplete or illegible records Treating all requests as routine Not reviewing what is being sent out Copyright © 2017. All rights reserved. Confidential and Proprietary. Not for distribution.

How to respond to an Overpayment Demand Fight Every Overpayment Demand! Determine Potential Insurance Coverage Coverage for Legal Fees & Expert Costs Do not give insurance auditors the benefit of the doubt Coding Medical Necessity Statistical Sampling Lookback period Copyright © 2017. All rights reserved. Confidential and Proprietary. Not for distribution.

The healthcare industry is highly regulated and full of pitfalls Final Thoughts The healthcare industry is highly regulated and full of pitfalls Handling a matter “in-house” can cost a practice far more than getting experts involved from the beginning (particularly if there is insurance!) Take time to determine if something is routine or not Use common sense and trust your instincts Copyright © 2017. All rights reserved. Confidential and Proprietary. Not for distribution.

Thank You! Guillermo J. Beades, Esq. gbeades@frierlevitt.com Office: 973.618.1660 Direct: 973.852.8354 Website: FrierLevitt.com LinkedIn: LinkedIn.com/company/Frier-Levitt-LLC Twitter: @FrierLevitt Facebook: Facebook.com/FrierLevittAttorneys Copyright © 2017. All rights reserved. Confidential and Proprietary. Not for distribution.