Healthcare providers and suppliers are the targets of a dramatic escalation in regulatory investigations, prosecutions and recoupment demands and are now being held to daunting self disclosure requirements related to noncompliance. Risks include repayment of significant portions of reimbursement, fines and penalties, loss of provider status, governmental regulation of internal compliance matters and even criminal prosecution. Ungaretti & Harris provides experienced counsel to help your organization comply with all applicable rules and regulations, respond appropriately to government investigations, handle internal auditing and self disclosures, including under the Stark Law, and defend your organization in litigation brought by regulatory agencies.
As corporate and regulatory counsel to many not-for-profit and for-profit hospitals, health systems and other provider types, we have gained the insight and discretion necessary to advise management and boards of directors on the most sensitive compliance issues. We review, develop and implement ethics and compliance programs to prevent or detect violations of laws and regulations. We also oversee internal auditing of issues raised and provide self-disclosure guidance as applicable, including as it relates to private inurement prohibitions, physician self-referral laws (e.g., Stark), reimbursement fraud and abuse, compliance with Medicare and Medicaid payment regulations, protected health information privacy requirements, and much more.
An important part of our regulatory guidance relates to our understanding of the specialized requirements of health regulatory enforcement agencies. Our lawyers constantly interact with senior personnel from the Centers for Medicare & Medicaid Services, the Office of the Inspector General, the Department of Justice and various state regulatory agencies, including those overseeing state Medicaid programs.
Reimbursement, Recoupment, and Recovery Audit Contracting (RAC) Disputes
As healthcare costs rise, both governmental and private payors are emphasizing compliance with strict reimbursement procedures and protocols. Payors in both the public and private sectors are contracting with third-party recovery audit contractors (RACs) to identify and report overpayments that have been made to providers state agencies such as the Illinois Department of Health and Family Services and the State Office of Inspector General (OIG) are also involved in audit and recoupment initiatives. RAC and such agencies and OIG audits have resulted in providers being hit with multi-million dollar repayment obligations for failing to comply with stringent reimbursement protocols. Ungaretti & Harris has successfully negotiated and litigated these disputes on behalf of numerous providers. Our experience at state and federal levels enables us to help providers receive and retain appropriate compensation for the services they provide.
Our attorneys have extensive experience in Medicare and Medicaid recoupment and repayment matters. This includes handling Medicaid physician audits, numerous hospital audits (e.g. of physician admission orders) and repayment demands from the state. We implement best practices in internal auditing to better mitigate risk and have experience in numerous Medicare investigations, probe audits and other governmental inquiries. We have handled state grant program recoupment demands related to inpatient admissions, recoupment demands from provider network panel physicians related to upcoding under Medicare Advantage program, and others.
Fraud and Abuse Allegations
Any healthcare provider can face allegations of fraud and abuse, under laws prohibiting kickbacks between or among health care providers, regulating physician self-referral matters, or governing Medicare and Medicaid billing and reimbursement. Such allegations can lead to monetary penalties, exclusion from participation in federal and state healthcare programs, and even criminal prosecution. Because members of our firm have been senior enforcement officials in both the United States Attorney’s and Illinois Attorney General’s offices, we know how to structure internal investigations and litigation defenses that meet the government’s enforcement tactics head-on.
On behalf of providers, we conduct witness interviews and review all documentation, evaluate the results, and help form appropriate responses to government inquiries, search warrants and subpoenas. We often negotiate settlement agreements and corporate integrity agreements with the Department of Justice and the Office of Inspector General and help clients implement their terms.
Overpayment Self-Disclosures and Stark Law Violations
Whether through routine internal auditing practices, compliance hotline complaints, notice of government agency investigations at other organizations, or industry or staff concerns, virtually all healthcare providers have faced the potential of having to repay government agencies for health care services based on noncompliance with one or more rules or regulations.
One area of noncompliance arises out of the Stark Law, a strict liability statute. Virtually all hospitals and health systems have had to address potential Stark Law violations over the past decade. The stakes are particularly high due to more recent changes in the law that apply to both Stark Law violations and noncompliance under reimbursement rules and regulations. The Fraud Enforcement and Recovery Act (FERA 2009) and Patient Protection and Affordable Care Act (PPACA 2010) made significant changes to the law, which now requires providers to self-disclose and repay the government when they become aware of violations of law or noncompliance with reimbursement rules that would have precluded payment at the time claims were submitted. Failure to do so on a timely basis can result in False Claims Act penalties.
Our attorneys are experienced in performing comprehensive audits, or directing internal or external audit functions under attorney-client privilege. This includes focusing on anything from potential Stark issues to medical records documentation issues. Our attorneys have worked with providers on a wide variety of potential liabilities, guiding them through the audit, investigation, disclosure and repayment process. We also work with providers to mitigate exposure through compliance education, structuring Stark compliant contracting processes and procedures, updating service area policy and procedure, etc. We have handled allegations of physician self-referral Stark violations, internal audits of numerous service line coding irregularities and numerous Stark and anti-kickback investigations and audits.
State Health Department Quality of Care Investigations
State health departments frequently use independent third-parties to investigate quality of care issues in provider organizations—particularly mental health and long-term care providers. These third-parties often interview the target organization’s employees and patients to generate reports for the state health departments. These reports become the basis for enforcement actions against the providers. In some instances, the third parties actually publish information about their investigations in the media.
With experience working in state health departments and state government, our attorneys have successfully fended off regulatory efforts that jeopardize facilities' licensure. We work with our clients to plan coordinated responses to investigations and to institute best practices that help minimize their material impact as well as their impact on provider reputation.
State health departments regularly conduct licensure and certification surveys of healthcare facilities. These surveys result in licensure and certification enforcement proceedings that involve physical plant issues pertaining to the Life Safety Code as well as provider services. Our attorneys have successfully defended providers in dozens of such administrative proceedings and have successfully sued state agencies when they have failed to follow legally promulgated rules or have acted without lawful authority.