Insurance Regulatory

Health Care - Regulatory & Compliance

Anti-Kickback, False Claims, & Stark

Federal and state agencies continue to scrutinize health care providers, particularly with respect to certain referral, compensation, and ownership arrangements and other relationship issues. Additionally, government agencies have sustained an unprecedented level of enforcement directed at the submission of false claims and other fraudulent conduct related to every aspect of the health care delivery system.

Stites & Harbison health care lawyers advise clients on federal and state fraud and abuse, anti-kickback, anti-referral, Stark, and related requirements. Our extensive focus and experience in this area allows our attorneys to effectively monitor ongoing changes in this very fluid situation. It also helps us develop creative approaches to achieve our clients’ goals while maintaining compliance with these complex laws.


Health care is an industry in which antitrust continues to have significant influence. Our lawyers have dealt with health care antitrust issues relating to exclusive contracts with physicians, professional associations and other providers; medical staff membership; volume purchase arrangements and Robinson-Patman Act analysis; Certificate of Need activities; joint ventures and other arrangements between hospitals and physicians; hospital mergers and affiliations, including Hart-Scott-Rodino analysis; physician mergers and affiliations; and managed care contracting arrangements.

Certificate of Need

Our health care lawyers have successfully handled the full range of legal and practical issues relating to state Certificate of Need (CON) laws for hospitals, long term care providers, ambulatory surgical centers, dialysis centers, and other providers. These issues include:

  • Answering threshold questions (such as expenditure minimums, covered health services definitions and whether a proposed project is submitted by or on behalf of a health care facility covered under the law)
  • Permit application and exemption request preparation and processing
  • Proceedings before the applicable state planning boards
  • Obtaining advisory opinions and rulings
  • Cost overrun determinations
  • Compliance/administrative appeals and judicial review proceedings

We also work with architects, contractors, and consultants to develop creative ways to meet our clients’ needs in the CON process.

Clinical Research & Clinical Trials

We understand the unique and complex challenges and protocols of clinical research and clinical trials. Our health care lawyers represent academic medical centers, teaching hospitals, universities and other institutions, as well as principle investigators. We counsel clients on the numerous standard agreements associated with clinical research (master service agreements, confidential disclosure agreements, material transfer agreements, federal and private contracts, grants, clinical and research service agreements, etc.), scientific integrity, scientific misconduct, privacy, human subjects protections and FDA reporting.

Our clients also include biotechnology, life sciences, pharmaceutical, and medical device companies.

Corporate Compliance Programs

Our combination of experience in health care and regulatory matters enables Stites & Harbison health lawyers to develop and review corporate compliance programs for all types and sizes of health care providers and related companies. As part of this process, we have provided clients with tailored documents, policies and procedures for their particular businesses, and appropriate training for their personnel. We also work closely with many of our clients to implement compliance programs, assisting their educational activities and investigating potential compliance program violations. In this regard, we have advised clients on a full array of compliance-related issues. Additionally, we have provided on-site counsel during government and private party investigations and audits, and assisted with the return of overpayments.

HIPAA Privacy & Security

Stites & Harbison's Health Care Service Group regularly counsels clients on federal and state laws related to patient privacy, specifically the privacy and security rules promulgated under the Health Insurance Portability and Accountability Act ("HIPAA"). Our attorneys provide a range of HIPAA compliance policy and procedural counseling to our clients, including HIPAA privacy documents (Authorizations, Notices of Privacy Practices and Business Associate Agreements); implementation checklists and audits; and HIPAA educational seminars.

Medical Staff (Governance, Bylaws, and Peer Review)

Our firm's health care lawyers have represented hospitals and medical staffs in the preparation and/or amendment of medical staff bylaws and association policy manuals. We have substantial experience in representing hospitals and physicians in matters relating to credentialing and peer review hearings and appeals.

We have represented professional associations, hospitals, and medical staffs in all aspects of peer review. As a result, we have a comprehensive view of the legal and practical problems that can arise. We have also represented physicians and hospitals in litigation involving various challenges to the peer review process, and we educate medical staffs on peer review confidentiality and litigation avoidance issues.

Medicare/Medicaid Reimbursement & Audits

  • Reimbursement : Stites & Harbison’s health care lawyers advise clients on a broad spectrum of third-party reimbursement issues, including Medicare and Medicaid reimbursement, relationships with private payors, and arrangements with managed care programs. We have also represented a number of providers in connection with denials of coverage under both insured and self-insured employer-sponsored health benefit plans..
  • Medicare/Medicaid Reimbursement and Appeals: We counsel health care clients on a wide range of issues related to the Medicare and Medicaid payment programs. This counsel includes extensive work on ways to lawfully maximize reimbursement in various situations (such as joint ventures and corporate restructuring) and administrative reviews of judicial appeals. Stites & Harbison health lawyers have dealt with certification, conditions of participation, coverage, reassignment, and other government reimbursement issues for all types of government certified providers. Additionally, we have provided on-site counsel during government and private party investigations and audits, and assisted with the return of overpayments.

Policy and Procedure Development

Institutional health providers rely on their policies and procedures in caring for patients and operating their facilities. Our Health Care Service Group lawyers are experienced in counseling on a wide variety of policy and procedural matters including state licensure and accreditation compliance questions..

Provider Licensure & Accreditation

Our Health Care Service Group attorneys have represented numerous health care providers in handling various regulatory compliance matters including facility licensure and accreditation.

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Louisville Regional Healthcare Compliance Conference

Date: 10/28/22
Time: 7:30 a.m. - 4:30 p.m.

Marriott Louisville East, 1903 Embassy Square Blvd., Louisville, KY 40299

Healthcare attorneys Shea Luna and Ameena Khan will be speakers at this healthcare compliance conference in Louisville, Kentucky on October 28, 2022.

Ameena R. Khan and Stacy Shea Luna (Shea) October 26, 2022
Client Alerts

HHS Releases New Guidance Regarding the Privacy of Reproductive Health Information

In the wake of the recent Supreme Court decision overturning Roe v. Wade, the Department of Health and Human Services (HHS) published guidance on June 29, 2022, regarding an individual’s privacy rights for reproductive health and abortion services under the Health Information Portability and Accountability Act (HIPAA). Shea Luna takes a look at the guidance in this client alert.

by Stacy Shea Luna (Shea) August 10, 2022

Revenue Cycle and Compliance Summit

Date: 6/23/22
Time: 12:00 p.m. - 4:30 p.m.

Online Event

The Revenue Cycle and Compliance Summit is an online half-day workshop to provide convenient education with CEUs and CLE for professionals. Stites attorneys Sarah Spurlock and Michael Denbow will be presenters at this Summit on June. 23, 2022.

Michael Denbow and Sarah Cronan Spurlock May 13, 2022
Press Releases

Stites & Harbison Increases Rank on ABA Health Law Section’s Regional Top 10 List for 2020-21

LOUISVILLE, Ky.—The American Bar Association (ABA) Health Law Section has ranked Stites & Harbison, PLLC in 5th place in its Ninth Annual Regional Top 10 Law Firm Recognition List for the South for 2020-21.

by Stites & Harbison, PLLC April 25, 2022
Client Alerts

Another Surprise! The No Surprises Act Requires Consumer Disclosures

In December 2020, Congress signed into law the No Surprises Act (NSA) addressing surprise medical billing. Specifically, the NSA prohibits out-of-network health care providers and facilities from balance billing certain commercially insured patients in certain circumstances.

by Stacy Shea Luna (Shea) April 12, 2022
Client Alerts

Surprise! The No Surprises Act Applies to All Cash-Pay Medical Services

The federal No Surprises Act (the “NSA”) requires all healthcare service providers to provide accurate and reliable cost estimates (Good Faith Estimates) to patients paying cash for services. The NSA’s Good Faith Estimate requirement has not received the media or industry press enjoyed by the balance billing prohibitions applicable to out-of-network (“OON”) emergency services providers, OON ancillary service providers at in-network facilities, and OON air ambulance providers, but may actually be the biggest surprise in the NSA.

by Dustyn B. Jones April 01, 2022