1. Attorney-client privileged / confidential / work product
What Every Physician Should Know About Investigations, Audits and Document Requests
Attorney-client privileged / confidential / work product
Presented by:
Guillermo J. Beades, Esq.
Attorney-Client Privileged/Confidential/Work Product.

2. DISCLAIMER
The materials and information provided in this presentation are for informational purposes only and not for the purpose of providing legal advice. The information contained in this presentation is a brief overview and should not be construed as legal advice or exhaustive coverage of the topics. You should contact your attorney to obtain advice with respect to any particular issue or problem. Statements, opinions and descriptions contained herein are based on general experience of Frier Levitt attorneys practicing in pharmacy law, and are not meant to be relied upon by anyone. Use of and access to this presentation or any of the materials or information contained within this presentation do not create an attorney-client relationship between Frier & Levitt, LLC (or any of its attorneys) and the user or viewer. All product and company names are trademarks™ or registered ® trademarks of their respective holders. Any use of such marks is for educational purposes and does not imply any affiliation with or endorsement by them.
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3. 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.
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4. ABOUT GUILLERMO J. BEADES, ESQ.
Guillermo J. Beades, Esq., is Senior Counsel 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
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.
Senior Counsel
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5. Overview: Current Healthcare Climate
CMS estimates that ~$60 billion was lost last year to:
Fraud
Waste
Abuse
Other estimates range to as high as $230 billion per year!
Federal Agencies typically recover ~$2.5 billion per year in judgments and settlements
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6. Overview: Payers’ Responses
Increase in Audits
Post-Payment
Pre-Payment
Civil Litigation (Federal & State)
Criminal Referrals
Restriction of Credentials / Closed Networks
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7. Overview: Agencies Focusing Efforts on Enforcement
Federal Bureau of Investigations (FBI)
Drug Enforcement Agency (DEA)
Office of Inspector General (OIG)
Department of Justice (DOJ)
Office of Civil Rights (OCR)
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8. Overview: 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
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9. Government Investigations
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10. 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
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11. COMMON areas of Investigation
Fraud, Waste and Abuse
False Claims Act
Consultation Services, Teaching Positions, Medical Directorships and Lease Agreements
Anti-Kickback Statute
Referrals
Stark
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12. Common Misconceptions
Investigators have a duty to tell the truth
Power of the Subpoena
Investigators only want a statement
Cooperation means future consideration
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13. 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?
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14. Audits Copyright © 2019. All rights reserved.
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15. Audits: General
Medical record audits target and evaluate procedural and diagnosis code selection as determined by physician documentation.
Reveal weaknesses in coding / documentation
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16. How was the practice notified?
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?
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17. 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
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18. ISSUES Under the Most Scrutiny
High Reimbursable Procedures
Contracts with vendors (e.g., allergy, DNA testing, stem cells, etc.)
Telemedicine
Opioid / TIRF REMS
Beware of specialty specific areas of focus (e.g., pediatricians (developmental testing), ENT (balloon procedures), etc.)
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19. 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!
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20. Audit response plan Determine intent of the audit
Conduct Self Assessment
Beware of deadlines & ask for extensions
Determine if an attorney, coder, statistician, etc. is needed
Most Audited Areas: Consults, High Level E/M, Modifiers 25/59 & high reimbursement codes
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21. Overpayment demands Copyright © 2019. All rights reserved.
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22. 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)
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23. 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
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24. 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?
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25. 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
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26. 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
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27. Adapting to the changes in healthcare
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28. The road ahead
Audits and overpayment demands will continue to dominate
Fee for service will transition to Value Base Medicine
Practices will be asked to take risk
Understanding data (and how it can be manipulated)
Consolidation led by insurance companies
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29. Adapting to the changing landscape
Self-Audit your practice
Billing and coding
HIPAA / HITECH
Compliance Plans
Ensure all providers and staff are trained
Be active in organizations like ANACP and specialty specific
organization (e.g., AAP)
Consider forming / joining a super group or clinically
integrated network
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30. 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
Never give statements without speaking to YOUR attorney first
Use common sense and trust your instincts
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31. Thank You! Guillermo J. Beades, Esq. gbeades@frierlevitt.com
Office:
Direct:
Website: FrierLevitt.com
LinkedIn: LinkedIn.com/company/Frier-Levitt-LLC
Facebook: Facebook.com/FrierLevittAttorneys
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