Health Care Regulatory

No industry is regulated more closely, or changes faster, than health care. Federal regulators, state agencies, licensing boards, and commercial and federal payors all have a say in how you bill, who you partner with, how you pay your physicians, and how you structure your organization. A single misstep—a compensation clause drafting error, an unintentional failure to recognize a designated health service, a billing pattern that draws an audit or a management agreement that crosses a state line it shouldn't—can trigger repayment demands, licensure risk, significant civil monetary penalties, and, in the most serious cases, criminal exposure.  In today’s health care ecosystem, there is no credit for almost or near misses.

Phelps helps clients anticipate and manage regulatory risk without slowing the business drivers behind care delivery, growth and investment. We provide clear, practical and actionable guidance on what the law requires, where the meaningful exposure lies, and how to move forward with confidence. Our health care regulatory team works alongside our transactional, litigation and government enforcement defense colleagues so that the advice you get is grounded in how these issues play out in practice—in deals, in audits and in front of the government.

How We Help

We counsel clients across the full range of federal and state regulatory issues that shape operations, transactions, reimbursement, physician relationships and long-term strategy.

Federal Stark and Anti-Kickback Counseling

We advise health care providers, physician groups, investors and management companies on federal Stark Law and Anti-Kickback Statute issues that arise in physician compensation, referral relationships, joint ventures, investment structures, management arrangements, value based arrangements and other commercial relationships. Our focus is practical. We identify the regulatory constraints early, structure arrangements to fit available exceptions or safe harbors where possible, and help clients move forward with a clear understanding of the risk.

State Corporate Practice of Medicine, Scope of Practice and Fee-Splitting Laws

State law often adds another layer of complexity, particularly for physician practices, MSOs, DSOs, private equity-backed platforms and providers operating across multiple states. Corporate-practice-of-medicine restrictions are often the starting point for evaluating state-law risk, and a growing number of states are sharpening their corporate-practice-of-medicine rules and taking a hard look at management and "friendly PC" structures.

We help clients structure ownership, management and professional services arrangements around those restrictions, while also addressing related fee-splitting rules and state laws governing self-referrals, kickbacks and state scope-of-practice rules for allied health providers.

Reimbursement, Audits and Overpayments

Payor audits, RAC and UPIC reviews, prepayment edits and overpayment demands can disrupt cash flow and signal larger problems. We help you respond to audits, appeal denials, manage repayment obligations and tighten the documentation and coding practices that keep you off the radar in the first place.

Licensing, Certification and Certificate of Need

Whether you are opening a new facility, adding a service line or engaging in a transaction, changes of ownership and information filings often drive the licensing and Certificate-of-Need (CON) timeline. We help clients identify those requirements early and manage the related licensing, Medicare and Medicaid enrollment, accreditation, CON and agency applications and approval processes needed to keep transactions on track.

HIPAA and Data Privacy

Patient data sits at the center of nearly every regulatory and enforcement trend. We advise on HIPAA and HITECH compliance, business associate arrangements, website and tracking-technology exposure, breach prevention and response and the privacy questions raised by new technology, including AI tools used in clinical and administrative settings.

Managed Care and Payor Contracting

The terms in your payor agreements determine how you get paid and how disputes get resolved. We negotiate and review managed care contracts, advise on network and credentialing issues and step in when reimbursement disputes escalate.

Compliance Programs and Government Investigations

An effective compliance program is your best protection and your strongest argument if the government ever calls. We build and stress-test compliance programs, run internal investigations and defend providers in audits, investigations and enforcement actions before the OIG, DOJ, CMS and state authorities.

Specialized Programs or Alternative Care Delivery

We counsel clients on the specific rules that govern their corner of the industry, including the 340B drug pricing program, EMTALA obligations, telehealth and remote-care requirements, medical marijuana licensure and related state program regulatory compliance, controlled-substance and DEA matters and Affordable Care Act compliance.

Who We Help

We provide regulatory and compliance counsel to clients across the care continuum:

• Physician practices and specialty groups
• Dental practices
• Ambulatory surgery centers and outpatient providers
• Management services organizations (MSOs) and practice platforms
• Hospitals and health systems
• Private equity investors and their portfolio companies
• Behavioral health, home health and hospice providers
• Diagnostic imaging centers and clinical laboratories
• Pharmacies and 340B covered entities
• Telehealth and digital health companies
• Medical spas and physician-owned ancillary businesses
• Medical marijuana providers and dispensaries.

Why Clients Choose Phelps

• We understand how health care businesses operate. Clients are caring for patients, building practices, integrating platforms, negotiating with payors, recruiting clinicians and deploying capital. Our regulatory team includes lawyers with meaningful in-house experience at major national health systems, giving us firsthand perspective on the operational, financial and clinical realities behind the legal question. We provide practical counsel that supports  strategic objectives while protecting the enterprise from avoidable regulatory exposure.
• We focus on the question that matters. Clients need to know whether they can close the transaction, employ or contract with a physician, launch a service line or implement a new business model. We translate complex regulatory requirements into clear guidance about what is permissible, where the meaningful risk lies, and how to move forward.
• We take an integrated view. Regulatory issues rarely stay in one lane. A Stark, Anti-Kickback, reimbursement or licensure question may affect deal structure, employment terms, tax treatment, privacy obligations, antitrust exposure or litigation strategy. Our health care regulatory lawyers work closely with colleagues in our corporate, data privacy, labor and employment and litigation practices, so clients receive coordinated advice grounded in the full commercial, operational and legal context.
• We look ahead. Federal enforcement priorities continue to shift, and states are taking a more active role in regulating private investment, professional ownership, management arrangements and transaction review. We help clients assess not only whether a structure works today, but whether it is built to withstand future scrutiny.