Today's federal and state regulators are highly aggressive in their approach to enforcement of complicated, far-reaching laws and rules. Health care providers are expected to monitor their compliance with Medicare and Medicaid billing requirements as well as other fraud and abuse laws, including the anti-kickback statute and prohibitions against physician self-referrals.

Developing and implementing a health care compliance plan need not be a daunting task. Our compliance group has worked with a wide variety of health care providers on compliance issues, including hospitals, pharmacies, medical equipment suppliers and physician groups.

We offer each client the approach to compliance services that best suits its needs. Our attorneys are available to perform internal compliance audits, identify risk areas, prepare policies and procedures and assist with internal training and monitoring. We also work with clients as an external resource, "coaching" internal personnel through the compliance process.

We believe that compliance is ideally an everyday activity, ingrained in an organization's culture; therefore, compliance activities must be reasonable, realistic and business-friendly while promoting compliance with all applicable law.

Our health care compliance activities commonly include analysis and application of the following:

• Organizational, professional, and technical licensing, operations, and accreditation standards;
• Referral relationships (e.g., joint ventures between physicians and hospitals, transport arrangements or professional services arrangements) between healthcare providers and suppliers;
• Billing arrangements involving healthcare providers, suppliers, and third-party billing companies;
• Payor relationships involving private insurance and public payment sources including Medicare and Medicaid;
• Clinical and practice-related laws such as the Emergency Treatment and Active Labor Act ("EMTALA"); and
• Privacy and confidentiality laws, including the Health Insurance and Portability Act of 1996 ("HIPAA") and state privacy laws.

In applying these and other laws, our attorneys' compliance experience includes the following:

• Counseled more than 20 physician groups, hospitals, health plans, and suppliers nationwide on implementing and improving their internal compliance programs, including the following activities:

  • Audit current compliance program and activities to identify areas of potential or actual noncompliance with the following:

    • Medicare, Medicaid, and private payor billing requirements;
    • Federal and state government and accredited associational standards for coding and claims submission;
    • State and federal organizational standards;
    • State professional and technical licensing and certification standards;
    • Applicable equipment certification standards;
    • Laws governing referral relationships, including physician self-referral, anti-kickback laws, fee-splitting laws, and corporate practice of medicine laws; and
    • Laws governing clinical performance requirements and standards, including EMTALA and state organizational survey requirements.

• Develop alternative strategies to address areas of potential or actual noncompliance;
• As requested, develop policies and procedures to address specific compliance needs; and
• As requested, develop education and training systems to disseminate updated compliance information and policies and procedures to organization employees.

• Conducted Medicare billing compliance reviews, on both the Part A and Part B sides. In this context, we have addressed compliance with cost reporting principles, billing requirements for teaching physicians, medical necessity reviews, compliance with conditions of participation and internal claims processing standards.   

• Represented a large public hospital system (including an 800-bed tertiary care teaching hospital and its affiliated community hospitals, long-term care centers and physician clinics) in the context of a federal criminal investigation. This representation involved extensive counseling on the current function and restructuring of the hospital's corporate compliance program, and included the following activities:

  • Perform a governance compliance and function assessment and assist the system in moving toward optimal governance-directed corporate compliance.
  • Perform a full audit of the system's compliance program, including both operational and clinical compliance with legal and accreditation standards.
  • Perform a full audit of agreements between the system and its referral sources, including employment agreements, physician services agreements, management services and personal services agreements, and technical services provision agreements.
  • Identify and prioritize a list of potential and actual compliance issues, including a variety of suggested possible actions to minimize or eliminate risk associated with identified areas needing improvement.
  • Based on information obtained during the compliance audit and associated activities, develop and recommend alternative structures for an organizational compliance program implementing a system-wide, multi-disciplinary cooperative approach to continuous quality improvement.

• Following government investigations that pre-dated our representation, we successfully negotiated Corporate Integrity Agreements with the U.S. Health and Human Services Office of Inspector General ("OIG") on behalf of (i) the largest public hospital system in the third most-populous state in the country, and (ii) one of the largest nationwide pharmacy retail chains. With respect to compliance activities, both these negotiations required us to:

  • Audit the client's current compliance activities, including its governance function and oversight, licensing and accreditation compliance, clinical compliance, relationships with referral sources, and affiliated or associated supplier compliance;
  • Develop alternative strategies to address outstanding issues and assist in implementation as required;
  • Zealously and professionally advocate on the organization's behalf with representatives from the United States Attorney's Office and representatives of the OIG; and
  • Monitor and document ongoing compliance activities under the CIA.  

• Developed compliance programs and trained staff for durable medical equipment suppliers and physician offices across the country. More specifically, we provide these organizations with model compliance plans, assist them in adjusting those plans to their own internal operations, conduct staff training regarding the compliance process and how to respond to government investigations. Further, we guide them through resolving compliance concerns identified by staff.

• Served as outside compliance counsel for one of the largest suppliers of power wheelchairs in the country and one of the largest suppliers of enteral and parenteral nutrition. In this capacity, we are in daily communication with internal compliance officers as day-to-day operational issues arise. Typical questions include how to interpret Medicare Conditions of Participation, billing issues, addressing recalcitrant or problematic employees and system reengineering to improve compliance outcomes.

• Assisted a number of major academic medical centers in developing and revising their compliance policies and procedures and served as their regular compliance counsel. In one instance we were heavily involved in negotiating the hospital's corporate integrity agreement ("CIA") as part of a settlement with the Office of the Inspector General, assisted the hospital in developing policies and procedures to meet the terms of the CIA and helped monitor compliance with the terms of the CIA.

• Assisted clients in making voluntary disclosures as appropriate through the OIG's Voluntary Disclosure Protocols. This has involved not only making the initial disclosure, but also negotiating with the OIG to limit organizational liability and financial penalties. We also regularly advise clients on how to address overpayment situations and help them negotiate resolutions with Medicare carriers and intermediaries.

• We regularly speak and publish in the area of compliance. We have made presentations to the following organizations:

  • American Health Lawyers Association
  • American Bar Association, Health Law Section
  • National Association of Public Hospitals
  • University Health Consortium
  • Association of Community Cancer Centers
  • American Association of Medical Colleges
  • District of Columbia Bar Association Community Development Project
  • American College of Cardiology
  • American Academy of Pediatrics  

Moreover, our experience with providers and suppliers that operate in multiple jurisdictions brings with it the need to assist with multi-jurisdictional compliance obligations. Our experience with multi-state compliance analysis, then, is also relevant, as follows:

• Multi-state survey for national retail pharmacy chain regarding application of state anti-kickback, self-referral and other regulatory laws to proposed joint venture.

• Multi-state survey of state laws relating to facility licensure, applicable professional licensure, applicable technical licensure or certification, materials certification, anti-kickback laws, fee splitting and anti-markup laws, state self-referral laws, and corporate practice of medicine laws for provider joint ventures in the provision of the following services:

  • lithotripsy (24 states)
  • lasik eye surgery (21 states)
  • barometric wound treatment (16 states)

• Multi-state survey of application of state blood shield laws in connection with a proposed acquisition of a blood fractionating company that operated in every jurisdiction in the union.
• Multi-state surveys of laws governing change of ownership and other licensure issues in connection with mergers and acquisitions in the health care industry.
• National survey of state pharmaceutical assistance programs.
• 50-state survey of wire-tapping laws as they pertain to customer assistance lines.

We excel at assisting our clients to comply with the law because we understand that compliance is more than a single program, and more than a book of policies and procedures. Compliance is "day-to-day operational," and requires living our clients' businesses and understanding the everyday challenges they face. Accordingly, our goal in compliance counseling is to help our clients to optimize their businesses and minimize their risk through reasonable and realistic compliance activities.