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Technology, Bioscience & Health Care Industry Services Section
Section Head: Robert J. Crump
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Regulatory Compliance Group |
Practice Group Chair: Amy S. Leopard
Walter & Haverfield attorneys have served as compliance counsel for a variety of business entities and provider types in a variety of settings. The attorneys in the Regulatory Compliance Group have worked extensively with health care organizations to conduct internal investigations and design compliance strategies. We structure contracts, negotiate transactions and develop corporate compliance programs for providers desiring to manage risks associated with the use and disclosure of health information, billing and referral relationships. Our clients include: hospitals, eye care facilities, rehabilitation centers, mental health practices, physicians, medical imaging and surgery centers, manufacturers, DME suppliers, intensive and primary care, cardiology, anesthesiology, radiology, general surgery, emergency medicine, and HIV clinic settings. Representative projects include:
- Structured dozens of fraud and abuse compliance plans and policies for health care providers, suppliers, and third party billing companies.
- Resolved technology issues, telemedicine licensure, regulatory, reimbursement and contractual issues for high technology manufacturers, distributors, and providers.
- Developed programs to meet the rigors of HIPAA medical privacy and security rules, including training materials, compliance policies, and related forms.
- Successfully handled self-reporting and designed corrective action plans for providers.
- Regularly structure arrangements designed to comply with the antikickback statute and the Stark laws and submitting advisory opinion requests under both statutes.
- Successfully coached numerous health care clients in governmental investigations of compliance and voluntary disclosures.
- Successfully defended several health care providers in Medicare and Medicaid billing fraud audits.
- Counseled dozens of physician groups on development of ancillary services in compliance with Stark and other regulatory requirements.
- Assisted numerous clients with state law issues regarding medical records, licensing, self-referrals, and kickbacks.
- Assisted various clients to comply with group purchasing organization and discount safe harbor issues related to discounts and rebates in supply chain and between referral sources.
- Strategized compliance initiatives with numerous business attorneys, in-house counsel, and hospital executives on Medicare, Medicaid, IRS, Federal Trade Commission, Department of Health, Department of Insurance and other agency regulations.
- Counseled hospitals and physicians on National Practitioner Data Bank and reporting issues.
- Prepared comments for associations on Medicare rules.
- Drafted antitrust compliance plan for independent practice association and negotiated “messenger model” with FTC for single-specialty physician IPA.
- Handled labels and advertising claims for FDA regulated products to comply with regulations.
Attorneys Practicing In This Area
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