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Health Law

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Health Law

We help our clients navigate the many challenges and opportunities created by the constantly changing regulatory landscape of the health care industry.

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Katie Ilten

Email: kilten@fredlaw.com
Office: 612.492.7428

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What We Do

Deep expertise. Creative approach. Critical thinking. Practical advice.

For over 60 years, Fredrikson and Byron’s Health Law team has advised health care organizations and navigated regulatory issues in the health care industry. We have witnessed the evolution of “health law,” and we will be here to anticipate its future. From professional practices to multi-state health systems, our clients turn to us to interpret the law—beyond the conventional wisdom—explain the risk and recommend a unique approach. Our clients describe us as their “gut check” and “backstop” as they navigate the regulatory landscape and grow their businesses. Because of this approach, we have gained the trust of some of the top hospitals and life science companies in the world.

We are supporting our clients through the COVID-19 pandemic. Since February 2020, we have been working with our clients on issues of telehealth, professional licensing, disaster credentialing, CMS waivers, surge staffing, the Payment Protection Program, HHS provider relief funds, employee and visitor safety, and unique liability matters.

Our lawyers regularly speak at national conferences, such as the American Health Lawyers Association (AHLA), Health Care Compliance Association (HCCA), American Academy of Orthopedic Executives (AAOE), Medical Group Management Association (MGMA), as well as many state medical group and hospital associations. We are frequent contributors to industry and trade group publications and broadcasts such as RAC Monitor’s Monitor Monday, Medicare Compliance Report, and Orthopedics Today.

2020 marks the 15th year of Fredrikson & Byron’s free monthly health law webinar series. We reach hundreds of health lawyers and compliance and operations executives each month from all 50 states. You can view previous presentations and sign up for our upcoming webinars on our Health Law Webinar Page.

Our clients:

Hospitals and Health Systems
Physician and Professional Organizations
Behavioral Health Providers
Dental Service Organizations
Medical Device Manufacturers
Management Service Organizations
Health Insurers
Lab and Imaging Facilities
Long-term Care and Assisted Living Providers
Disability Service Providers
Digital Health Companies

Our expertise:

Telehealth and Virtual Care
Anti-kickback and Fraud and Abuse
Physician Self-referral (Stark)
Compliance Advice and Risk Management
HIPAA Privacy and Security
Multi-state Regulatory Expansion
Strategic M&A, Joint Ventures, and Affiliations
Internal Investigations
Overpayments and Voluntary Refunds
Private Equity Transactions
Government Audits
Medical Staff Governance and Disputes
Licensing and Accreditation
Nonprofit Governance and Tax Exemption
Health Litigation
Medicare and Medicaid Reimbursement
False Claims Act Defense
Value-based Payment Models

Experience

REPRESENTATIVE EXPERIENCE

Hospitals and Health Systems

We counsel hospitals and health systems across the United States, from critical access and sole community hospitals to two of the Top 5 health systems in the world. We structure transactions, defend against allegations of non-compliance, and navigate the complex web of reimbursement regulations. We have an outside general counsel program with alternative fee arrangement opportunities for health systems needing outside counsel support. Our deep expertise in the industry allows our team to provide creative yet practical advice to our hospital clients.

Physician Organizations

For over 60 years our lawyers have represented physician groups, growing our practice and expertise as legal issues for physicians and other health care professionals became increasingly complex. Now our physician group practice team represents some of the largest physician organizations in the country. We advise on strategic affiliations, joint ventures, divisional mergers, acquisitions, and co-management arrangements with hospitals. Our bread and butter expertise includes Stark, Anti-kickback, state medical practice laws, non-compete and employment counseling, tax planning, compliance planning, research and innovation, and reimbursement advice.

Dental and Management Service Organizations

We represent dental service organizations (DSOs) and management service organizations (MSOs) across the country. We guide clients through strategic transactions and assist private equity groups, other investors, and their portfolio companies in dental and professional practice acquisitions. We routinely advise on the corporate practice doctrine, multi-state expansion matters, fee splitting laws, professional advertising regulations, patient finance and billing rules, and credentialing and licensing matters affecting dental and other professional practices.

Aging and Disability Service Providers

We help aging and disability service providers fulfill their mission—not just by explaining the complex laws governing their services, but also by challenging unwarranted licensing, maltreatment and certification sanctions or penalties imposed by federal and state departments, agencies, and professional boards. We formulate and implement operational and compliance policies that not only comply with state and federal regulatory requirements, but also make common sense.

Digital Health and Telemedicine

We advise digital health companies and telehealth leaders as the virtual care industry evolves and expands—accelerating with the COVID-19 pandemic. We guide clients through all aspects of digital health, including the formation, financing and governance of business entities, joint venture arrangements, mergers and acquisitions, and regulatory compliance. Since the beginning of the COVID-19 pandemic, we have advised several national health systems and behavior health providers in launching their digital health platforms.

Regulatory Compliance and Advice

From Stark and Anti-kickback to Open Payments reporting and billing rules, our team advises clinics, hospitals, life science companies, health insurers, behavioral health providers, and long-term care facilities on the web of regulations governing the health care industry. Many firms will repeat the conventional wisdom—even when it is not correct. Our team is careful and analytical about the source of the rule, its interpretation, and how it applies to each unique situation. We apply this regulatory expertise to our litigation and transactional matters as well as clients’ day-to-day operations. Our clients describe us as experts who are practical and business savvy.

Mergers and Acquisitions, Joint Ventures, and Affiliations

Our team has closed hundreds of sales, mergers, joint ventures, acquisitions, and strategic affiliations in the health care space. We represent for-profit, non-profit, professional, and private equity health care providers and life science companies in transactions across the country. Our transactional lawyers are also experienced health care regulatory advisors. We identify critical issues, help our clients evaluate risk, and implement common sense solutions when problems arise.

Reimbursement, Overpayments, and Refunds

The government’s rules for reimbursement are constantly changing, and they are rarely intuitive. We help clients interpret and apply the regulations, but we also scrutinize the authority and save our clients money when the billing rules do not require a refund. We have a fixed-fee program in which our health lawyers review all proposed refunds. One client in the program was prepared to refund $9 million dollars before the $900 fixed-fee review found a strong legal basis for concluding that the error in question did not create an overpayment. That return on investment is very difficult to beat.

Health Litigation

Our deep health law expertise puts clients facing health care litigation at a distinct advantage. We use creative approaches for resolving disputes in efficient and cost-effective ways. Whether inside the courtroom or negotiating with the government, we are fierce advocates for favorable results that minimize disruption and expense to our clients.

Medical Staff Governance and Disputes

Our expertise and experience representing both physicians and health systems put us at a unique advantage to represent hospitals with respect to medical staff matters as well as professionals facing medical staff actions. We routinely advise on medical staff issues such as bylaws, rules and regulations, peer review, corrective actions, fair hearings, and National Practitioner Data Bank reporting. We partner with hospital medical staff leaders to develop and implement medical staff governance structures and practices that maximize patient safety and collaboration with medical professionals.

Internal and Government Investigations

Investigations of health care providers can lead to complex parallel civil, criminal, and administrative proceedings under the False Claims Act, the Stark law on self-referrals, the federal Anti-kickback statute and state laws. Our lawyers have experience advising clients on how to control the scope of an investigation and can help them understand the government’s strategy and goals. We have defended health care fraud allegations at all stages of an investigation, from internal allegations of non-compliance and Civil Investigative Demands (CIDs) to settlement negotiations and trial. In many cases, we convinced the government to close the investigation or drop the case without bringing a suit or demanding a settlement.

Health Privacy and Security

We navigate the web of state and federal privacy laws, advising clients on the HIPAA Privacy, Security, and Breach Notification Rules and responding to Office of Civil Rights investigations regarding HIPAA compliance. We have negotiated settlements and convinced the government to dismiss complaints against our covered entity and business associate clients. Our health privacy and security compliance services include developing and implementing HIPAA compliance plans, responding to breaches of unsecured PHI, and structuring clinical care models and transactions to maximize the sharing of information while minimizing exposure under privacy and security laws.

Value-based Payment Arrangements

Our team counsels health and life science companies across the treatment continuum on the regulatory sprint to value-based care. We have watched the evolution and transition of payment models from fee-for-service to capitation to accountable care organizations to bundled payments. We have established clinically integrated networks, negotiated gainsharing arrangements, structured value-based incentive arrangements, and designed provider-payer models with outcomes-focused metrics. Our experience representing many types of health care providers uniquely positions us to advise clients on their strategy for the future of health care.

News & Articles

Health Law Webinar—Health Care Transactions: Key Issues and Strategic Considerations

March 24, 2021

The April 2021 Health Law Webinar addresses the key issues and strategic considerations in structuring and negotiating health care transactions. Topics include innovative deal structures, due diligence essentials, negotiation strategies, regulatory considerations and more.

Health Law

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