Regulatory Compliance, Fraud and Abuse

Health Care

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Stevens & Lee works with health care organizations to ensure regulatory compliance to prevent violations under fraud and abuse laws and other violations applicable to federal health care programs. Our familiarity with the enforcement and litigation processes, our understanding of the health care industry and our knowledge of the regulations governing the industry make Stevens & Lee the right choice for counsel.

We have represented health care clients in a variety of investigations and enforcement matters, including:

  • Preliminary inquiries and formal government investigations
  • Litigation related to fraud and abuse laws, such as the Anti-Kickback Statute, Ethics in Patient Referral Act (Stark Law), False Claims Act, Civil Monetary Penalties Law, qui tam suits and other enforcement activities, Emergency Medical Treatment and Active Labor Act (EMTALA), and matters pertaining to the Sarbanes-Oxley Act
  • Suspension, exclusion and collateral proceedings, including immediate jeopardy actions that arise in connection with alleged EMTALA violations
  • Grand jury investigations
  • Federal and state criminal prosecutions affecting corporations and individuals
  • Compliance and counseling

Stevens & Lee lawyers have significant experience investigating allegations and negotiating settlements of various compliance matters on behalf of our clients with the United States Attorneys Office, the United States Department of Justice and the Office of the Inspector General (OIG) in the U.S Department of Health and Human Services. We have negotiated corporate integrity agreements (CIAs) with the OIG and have prepared required reports to the OIG as part of our clients’ ongoing CIA obligations. In addition to voluntary disclosures, we have prepared requests for OIG Advisory Opinions on behalf of our clients.

A key part of our compliance practice is counseling clients on how to operate in accordance with regulations to avoid entanglements and demonstrate compliance under government scrutiny. Stevens & Lee can assist in developing a corporate compliance program to suit your needs and provide ongoing support as issues arise and regulations change.

Stevens & Lee offers complete corporate compliance legal services for our health care clients:

  • Compliance program design and implementation
  • Corporate Integrity Agreement negotiation, design and implementation
  • Legal risk assessment/audit to identify potential issues
  • Regulatory and reimbursement counsel
  • Anti-Kickback Statute and Safe Harbor regulations, and federal and state self-referral law interpretation and counsel
  • Billing system policy and procedure review
  • Transactional analysis

Specifically, we provide our clients with clarification and interpretation of health care laws and regulations, as needed, including obtaining guidance on behalf of our clients from state and federal government agencies and Medicare Assistance Contractors (MACs) concerning interpretations of statutes, regulations, Medicare manual provisions, or any other directives affecting documentation, coverage determinations, or other activities related to billing and claims for Medicare or Medicaid.

We monitor developments and changes in reimbursement policies, relevant state and federal law, regulations and government agency guidance and governmental enforcement initiatives to determine whether our clients’ compliance programs should be modified to address any identified risk areas.

We perform regulatory compliance assessments of our clients in specific risk areas, including reviewing and revising, as appropriate, our clients’ policies and procedures to meet specific regulatory requirements.

In addition, Stevens & Lee’s health care team provides training and consultation for boards, senior management and compliance committees on compliance matters, including general fraud and abuse laws, reimbursement and billing matters and tax-exempt compliance matters (conflict of interests, excess benefits, etc.).

Compliance with federal and state regulations can be a deal maker or a deal breaker. Health care clients considering mergers, acquisitions, joint ventures, affiliations and reorganizations or engaging in health care contracting look to Stevens & Lee for assistance with compliance matters, including:

  • Strategic legal plans for acquisitions of facilities and practices
  • Legal analyses of new financial relationships
  • Regulatory review of investment documents, leases, service contracts, employment arrangements and similar formal documents
  • Due diligence review for buyers and sellers of health care companies and for parties involved in joint ventures and affiliations
  • Analysis and review of new financial offerings

We have extensive experience and good working relationships with the state and federal regulators and MACs in obtaining guidance on compliance questions and submitting voluntary repayments in accordance with applicable voluntary disclosure protocols. We have similar experience seeking compliance guidance from our Medical Assistance contacts and have been involved with Medical Assistance fraud investigations and negotiated settlements on our clients’ behalf.

In addition to general corporate compliance, Stevens & Lee assists health care organizations and other providers with compliance and contracting activities related to clinical research, including review and negotiation of clinical research agreements, confidentiality agreements, informed consents, HIPAA authorizations and investigator agreements. We also assist with development of research participation network arrangements and research collaborations, development of standard operating procedures and research compliance plans and review of clinical research billing and compliance matters.

Franklin_Harriett

Harriet Franklin

Shareholder

hf@stevenslee.com

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Valley Forge: 610.205.6014

Gritz_Clayton

Clayton Gritz

Associate

cg@stevenslee.com

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Valley Forge: 610.205.6359

Henefer_Tom

E. Thomas Henefer

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eth@stevenslee.com

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Reading: 610.478.2223

Hennessey_Daniel

Daniel J. Hennessey

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djh@stevenslee.com

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Valley Forge: 610.205.6011

Reading: 610.478.2093

Hogan_John

John M. Hogan

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jho@stevenslee.com

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Valley Forge: 610.205.6013

Honart_Charles

Charles M. Honart

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cmh@stevenslee.com

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Valley Forge: 610.205.6017

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Joanne M. Judge

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jmj@stevenslee.com

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Lancaster: 717.209.5866

Reading: 610.478.2226

King_Richard

Richard J. King

Shareholder

rjk@stevenslee.com

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Wilmington: 302.425.3303

Marshall_Chip

Joseph W. “Chip” Marshall, III

Vice Chairman

chip.marshall@stevenslee.com

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Philadelphia: 215.751.1240

McEvilly_Walt

Walter P. McEvilly, Jr.

Of Counsel

wpm@stevenslee.com

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Wilmington: 302.425.3300

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Douglas L. Moak

Associate

dm@stevenslee.com

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Valley Forge: 610-205-6005

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Kirsten McAuliffe Raleigh

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kmr@stevenslee.com

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Valley Forge: 610.205.6015

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Thomas M. Tammany

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tmt@stevenslee.com

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Princeton: 609.987.5339

Valley Forge: 610.205.6342

Urban_Cathy

Catherine Reese Urban

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cru@stevenslee.com

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Valley Forge: 610.205.6021

Wilhelm_Stephanie

Stephanie A. Wilhelm

Associate

sawi@stevenslee.com

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Valley Forge: 610.205.6022

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