Regulatory Solutions | FTI Consulting
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Regulatory Solutions

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When dealing with regulatory and compliance matters, healthcare and life science organizations continually engage the senior experts at FTI Consulting for our integrated approach that best addresses their organization’s unique needs. Our multidisciplinary group of industry-experienced compliance and investigative professionals works collaboratively to bring the right mix of experience and skills to your particular issues. This approach combines the skills of industry specialists with those of compliance and strategic communications experts, investigative professionals, forensic accountants, computer forensic specialists, and electronic evidence and technology consultants. These are supplemented, as necessary, with experts in healthcare provider and payer matters.

How We Help

Investigations & Disputes

When facing investigations or litigation, healthcare organizations and their legal counsel engage our experts to help them strengthen operations and protect assets and reputations. Our integrated team includes seasoned healthcare professionals with expert credentials in economics, accounting, finance, valuation, complex data analysis, computer forensics and fraud investigations.

Over the past several years, we have played a significant role in many of the best-known and most substantial healthcare investigation and litigation matters, including False Claims Act cases, Stark Law and Anti-Kickback Statute investigations, business disputes and other issues. We’ve testified as expert witnesses at trial and deposition in federal and state proceedings, before administrative bodies, and in bankruptcy and tax court. Clients rely on our proven and cost-effective solutions based on benchmarking, advanced statistical sampling, development of complex industry and company-specific databases, and sophisticated risk assessment techniques.

Engage us for our advisory and support on:

  • Government healthcare program investigations. A wide variety of healthcare clients rely on our assistance, including hospital systems, pharmaceutical companies, electronic health record (EHR) software vendors, inpatient rehabilitation facilities, skilled nursing facilities, home health companies, device manufacturers, and payers. These clients engage us to help conduct internal investigations related to government healthcare programs, including Medicare and Medicaid false claims and fraud and abuse issues. As part of these investigations, we regularly assist clients and their counsel in discussions with the DOJ, OIG, state Medicaid and regulatory agencies, and the SEC.
  • Litigation and commercial disputes. Clients and their outside counsel call on us to serve as expert witnesses and privileged consultants in nationwide class-action matters, federal and state court litigation, international arbitration, and arbitration and mediation matters.
  • Data analysis and benchmarking. We leverage your organization’s data and relevant industry data to develop analytics that drive insights in investigations and litigation, proactively identify and contextualize compliance issues, and foster organizational improvement.
  • Clinical insights and analysis. Our multidisciplinary team includes nurses, clinicians, physicians, coders and other experienced healthcare professionals. Clients rely on our clinical experience in matters involving medical necessity of care; analysis of billing, coding, and reimbursement issues; and other federal and state healthcare program coverage and healthcare compliance issues.

Regulatory Compliance

In today’s regulatory climate, healthcare providers need targeted compliance programs to prevent and detect violations and to respond effectively when issues arise. Public and private healthcare clients rely on our expertise to evaluate the effectiveness of compliance and ethics programs and to develop a proactive approach to mitigating risks. Our experts can assist in developing and implementing auditing and monitoring regimens that identify potential risk areas. We have performed this work on a proactive basis and also as an Independent Review Organization under corporate integrity agreements.

Engage for our expert services that include:

  • Development and implementation of compliance programs. Across the healthcare industry, clients engage us to develop and assess the effectiveness of comprehensive compliance programs. This involves strengthening internal monitoring and auditing processes; advising on policies, procedures, and standards of conduct; building effective training programs and lines of communication; and performing detailed reviews of healthcare claims using statistical samples, benchmarking of client and industry data, and sophisticated electronic models.
  • Corporate integrity agreements and other independent review activities. We have performed independent review and monitoring activities for a wide variety of healthcare clients, including serving as Independent Review Organization (IRO) and Compliance Expert as part of corporate integrity agreements. Government agencies also regularly engage us to help them develop analytical methodologies and reporting formats.
  • Risk adjustment operational improvement and compliance assessments. Health plans and providers seek our assistance to assess and redesign work flows, policies and procedures, controls, reporting and forecasting related to Medicare Advantage and risk-adjusted populations.

Valuation Services

Valuation is a complex process that requires a skillful blend of fundamental analysis, industry experience and sound judgment. Our team draws upon extensive expertise to provide conclusions that are both reasonable and supportable. Many of the largest for-profit and non-profit healthcare systems, as well as some of the largest pharmaceutical and medical device companies, rely on our valuation services. In addition, we work with many of the world’s top law firms on regulatory, transaction advisory and litigation matters.

Our professionals bring a combination of education, training and industry expertise to every healthcare valuation engagement. Clients lean on our assistance through the often confusing and convoluted regulatory landscape related to fair market value and commercially reasonable compensation. To ensure that we provide you with the highest level of expertise, we stay abreast of legal and regulatory issues affecting healthcare valuations, including but not limited to: Stark Law, Anti-Kickback Statute, Office of Inspector General Advisory Opinions, and Physician Payments Sunshine Act.

Our seasoned team offers a broad range of services designed to assist you on issues related to regulatory compliance, transaction planning, strategic planning, tax compliance, financial reporting and litigation or arbitration support. Whether you are contemplating new physician-related agreements, a joint venture, acquisition or divestiture, or responding to a regulatory or compliance investigation, we are equipped to provide the valuation services your organization needs. These include:

Compensation valuation assessments. The increase in False Claims Act judgments and settlements over the past several years, as well as the increase in Qui Tam allegations related to potential Stark Law and Anti-Kickback Statute violations, has elevated the need for compliant arrangements. Our team provides fair market value and commercial reasonableness assessments related to the following arrangement types between healthcare entities (e.g., health systems, hospitals, academic medical centers, ambulatory surgery centers, diagnostic imaging centers, clinically-integrated networks, etc.) and providers:

  • Employment agreements
  • Administrative services agreements
  • Medical directorship agreements
  • Call coverage agreements
  • Telemedicine services agreements
  • Professional services agreements
  • Management services agreements
  • Co-management agreements
  • Value-based compensation agreements
  • IT services agreements

We have experience producing fair market value assessments related to the following arrangement types between life sciences entities (e.g., pharmaceutical and medical device companies) and providers:

  • Consulting services agreements
  • Key opinion leader agreements
  • Speaking engagement agreements
  • Medical device supplier agreements
  • Data warehousing agreements

Business enterprise valuation assessments. As healthcare entities continue to search for strategic acquisitions and mergers to grow their footprint in the regional or national market, or to assist in the delivery of quality coordinated patient care, the need for experience and expertise in the valuation of healthcare entities is paramount. Our team has significant experience and expertise valuing a wide variety of entities, ownership interests, tangible assets, and intangible assets. In all valuation engagements, we rely on one or more of the three widely accepted approaches: income, market and cost.

We have provided valuation opinions related to the following healthcare entities:

  • Hospitals (for-profit and non-profit)
  • Physician practices (all specialties)
  • Accountable care organizations (ACOs)
  • Ambulatory surgery centers
  • Diagnostic imaging centers and laboratories
  • Dialysis centers
  • Fertility clinics
  • Home health companies

We have developed valuation opinions related to the following life sciences entities:

  • Pharmaceutical
  • Specialty pharmacy
  • Medical device
  • Biotechnology
  • Durable medical equipment
  • Hospice companies
  • Physician hospital organizations
  • Urgent care centers
  • Managed care organizations
  • Clinical and anatomic laboratories
  • Skilled nursing and long-term care
  • Physical therapy centers
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