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We help our clients navigate the many challenges and opportunities created by the constantly changing regulatory landscape of the health care industry.
Aging & Disability Providers
Artificial Intelligence
Data Protection & Cybersecurity
Food, Drug & Medical Device Regulation
Government Contracts & Grants
Health Care Fraud & Compliance
Health Care Innovation & IT
Health Licensing Defense
Internal Investigations
Life Sciences
Medical Practices Defense
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:
Our expertise:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
May 16, 2022
By Erin M. Edgerton Hall and Brian T. Benkstein
On April 29, 2022, Gov. Tim Walz signed Frontline Worker Payments into law, enabling certain Minnesotans who worked on the frontlines during the COVID-19 emergency to apply for bonus pay. While details of the program, including the online application process and timeline, are still being finalized, below we offer a summary of the salient points of the bill.
April 20, 2022
Our May Health Law Webinar presented a basic overview of the regulatory framework governing coding and billing for governmental and private payors. It began with a basic introduction of the issues and concluded with common questions.
March 22, 2022
Our April Health Law Webinar will open with an overview of regulations with a focus on the requirements involving Good Faith Estimates. We will then address your most common questions.
February 17, 2022
After a lengthy COVID-19 lull, audits and investigations have returned with a vengeance. Our March Health Law Webinar will focus on what you should know to prepare for and respond to audits and investigations by Medicare, Medicaid, private payers and some government agencies.
January 20, 2022
Join a conversation with two of our healthcare and technology attorneys as they provide an overview of the issues and offer some best practices for taking advantage of AI and Big Data in healthcare.
January 4, 2022
By Katherine B. Ilten, Sean M. Nagle and Marielos S. Cabrera
This article provides an update on the status of the CMS Vaccine Mandate, the litigation surrounding its implementation and CMS’s intent to begin enforcement on January 27, 2022.
December 22, 2021
The HIPAA Security Rule requires covered entities to have appropriate administrative, physical and technical safeguards, but the rule does not explain what to do when your organization is hit with a ransomware attack or other security incident.
December 1, 2021
By Katherine B. Ilten, Sean M. Nagle and Marielos S. Cabrera
These FAQs provide information about the CMS Vaccine Mandate and clarity around the overlap between it and the various OSHA Emergency Temporary Standards.
Update: As of November 30, 2021, implementation and enforcement of the CMS COVID-19 Vaccine Mandate has been temporarily halted in all 50 states.
November 18, 2021
Every year, our December Health Law Webinar is devoted to new regulatory developments, including topics like the Medicare Physician Fee Schedule, Outpatient Prospective Payment System and Inpatient Prospective Payment System rules.
October 20, 2021
We will explain how the very complicated provisions impact health care facilities and professionals in a simple, straightforward way.
September 22, 2021
Our October Health Law Webinar covered common challenging patient scenarios and the legal consequences that flow from them, as well as providing tips for preventing and minimizing risk.
July 22, 2021
Don’t miss what is usually the most popular webinar of the year!
May 20, 2021
Ambulatory Surgical Centers (ASCs) can be a great way to reduce costs and generate profit. They can also become a huge albatross. Our June Health Law Webinar explores common legal and practical issues, including ideas for structuring ownership and dividing income, the benefits and risks of joint ventures, common misperceptions about the antikickback safe harbors and the perils of management contracts.
April 22, 2021
In both hospital systems and physician-owned clinics, there are rules that limit the options for compensating physicians for their work. In addition, there are practical considerations that should influence compensation formula design. Our May Health Law Webinar will discuss both scenarios, including how changes to Stark will require changes to some compensation arrangements.
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.
February 19, 2021
The Biden Administration has announced changes to immigration policy, regulations and enforcement. Through executive orders and new bills proposed in Congress, the administration seeks to reform and reverse prior changes to U.S. immigration.
January 21, 2021
On February 10, 2021, our attorneys discussed attorney/client and work/product privileges, as well as the protections that are unique to health care, including peer review and patient/physician privilege.
December 22, 2020
This Health Law Webinar details new information blocking requirements, the CARES Act Provider Relief Fund and new Stark and antikickback regulations.
November 12, 2020
During the December Health Law Webinar, members of our Health Law team discussed the Medicare physician fee schedule, inpatient prospective payment rule and the other new regulations affecting hospitals, clinics and others in the healthcare industry.
October 21, 2020
During the Health Law Webinar on November 11, two experienced employment law counselors and litigators discussed ongoing challenges health care employers are facing during the pandemic and highlight emerging issues on the horizon.
September 16, 2020
This webinar, presented on October 14, 2020, discussed practical tips for addressing a problem that every lawyer and compliance professional has struggled with, including several specific examples.
August 20, 2020
This telehealth webinar on September 16 covered payment rules and policies, complex issues of providing care across state lines, deals and transactions, and more.
July 22, 2020
On August 12, 2020, attorneys from our Health Law Group discussed the most common questions we received about COVID-19, as well as more traditional health law care questions.
May 15, 2020
This June 10, 2020, webinar offered basic HIPAA training for a health care workforce. It may be used as a direct training session for employees or as a “train-the-trainer” session.
May 1, 2020
On May 6, 2020, attorneys David Glaser and Katie Ilten presented the Health Law Webinar “COVID-19 Interim Final Rule: The Sequel.”
April 22, 2020
Our Health Law Webinar on May 13, 2020, covered the basic legal theories that apply to health care reimbursement and addressed the most common questions we receive about fees and discounts.
April 7, 2020
In this Health Law Webinar on April 15, 2020, attorneys Ryan Johnson and Briar Andresen discussed the new final rule on interoperability, how it empowers patients and what it will require of health care providers.
April 1, 2020
We provided an update on COVID-19 developments, including how organizations with fewer than 500 employees can obtain financial relief and an examination of the many waivers that were issued on Monday. We also discussed the state of telehealth, licensure, EMTALA and other issues.
March 18, 2020
In this webinar, we discussed CMS and OIG’s actions and updates regarding COVID-19 as of March 20, 2020 and addressed some of the most common questions from our clients.
March 10, 2020
Our Health Law Webinar on March 11 covered the legal issues for potential stakeholders to consider in designing, implementing and participating in programs and arrangements that compensate physicians for their work improving quality and reducing cost.
January 29, 2020
Our special 90-minute Health Law Webinar on February 20, 2020, briefed viewers on the substance every health lawyer and compliance officer should know about the response to the opioid crisis
January 13, 2020
Minnesota’s Medical Alley is a leading health care center anchored by world-class providers, technology companies and payors near Rochester, Minnesota.
December 31, 2019
During the Health Law Webinar on January 15, attorneys Steven Beck and Ryan Johnson walked through an array of recent models of hospital-physician deals, each of which is based on an innovative idea or useful legal complexity.
December 2, 2019
We focused on highlights from the 2020 Medicare Physician Fee Schedule and the Inpatient and Outpatient Prospective Payment Rules. We also addressed the recently-issued hospital price transparency final rule, recent proposals to add exceptions/safe harbors to the Stark law and Antikickback Statute, as well as a few other significant regulatory developments for 2020.
November 6, 2019
On November 20, 2019, our Health Law Webinar featured a soup to nuts discussion on the current state of telemedicine from a licensure, reimbursement and compliance perspective.
September 26, 2019
At our October 2019 Health Law Webinar, we hosted an hour of questions and answers from our daily practice in a fast-paced Q&A format.
August 22, 2019
Our September 2019 webinar educated hospital and clinics on their rights with respect to ICE searches and inquiries and as well as responsibilities with respect to patient rights and patient privacy.
July 9, 2019
Our August 2019 Health Law Webinar explored questions around Medicare Manuals and discussed trends and recent case law dealing with the use of Manuals, FAQs, memos and other program guidance.
June 20, 2019
Our July 2019 Health Law Webinar explored your rights and obligations when interacting with a variety of governmental and private organizations, including what you should do if government agents visit your facility.
May 22, 2019
Our June 2019 Health Law Webinar offered an in-depth analysis of the draft guidance issued by CMS and the practical implications for hospitals struggling to reconfigure and/or plan medical campuses for future growth.
May 1, 2019
On May 15, 2019, attorney Kevin Riach presented the Health Law Webinar “Medical Marijuana and Health Care Providers.”
April 4, 2019
On April 24, 2019, attorney Steve Helland presented the Health Law Webinar “Health Industry Website Accessibility: 2019 Lawsuit Trends and Practical Steps to Reduce Risk and Promote Compliance for Websites, Apps, Portals and Connected Devices.”
March 5, 2019
On March 13, 2019, attorneys Debra Schneider and Jennifer Bouta Mojica presented the Health Law Webinar “Immigration Options for Health Care Practitioners.”
February 1, 2019
On February 13, 2019, attorney David Glaser presented the Health Law Webinar “Tips for Conducting Employee Interviews During Internal Investigations.”
January 9, 2019
On January 16, 2019, attorneys Ryan Johnson and Nikola Datzov presented the Health Law Webinar “Digital Health: Emerging Legal, Regulatory and Ethical Issues.”
November 27, 2018
Join us on December 12, 2018, for our next Health Law Webinar.
October 18, 2018
Please join us for our next Health Law Webinar on November 14, 2018.
September 20, 2018
Please join us for our next Health Law Webinar on October 10, 2018.
August 23, 2018
Please join us for our next Health Law Webinar on September 12, 2018.
July 25, 2018
Please join us for our next Health Law Webinar on August 8, 2018, when we will focus on questions of general applicability to our listeners.
June 21, 2018
Please join us for our next Health Law Webinar on July 11, 2018, that will provide an in-depth tutorial for in-house attorneys, compliance professionals, coders, human resources personnel and anyone else involved in internal investigations.
April 23, 2018
On May 9, 2018, please join us for our next Health Law Webinar that will offer an easy-to-understand explanation of the CMS policies related to “incident to” billing and shared visits.
March 22, 2018
On April 11, 2018, please join us for our next Health Law Webinar that will cover key legal issues for healthcare investors and business development teams.
March 6, 2018
Join us on March 14, 2018, for our next Health Law Webinar: Almost Everything You Want To Know About Ancillaries. Imaging, Therapy, Lab, DMEPOS, and ASCs play a core role in the delivery of health care. We will cover as many of the key regulatory and practical issues associated with providing them as possible.
January 12, 2018
Join us on February 14, 2018, for our next Health Law Webinar – Love Letters to and from CMS: Responding to Audits and Overpayments and Making Voluntary Refunds.
December 29, 2017
Join us for our next Health Law Webinar – Electronic Health Record: Contracting and Data Security on January 10, 2018.
November 27, 2017
Join us for our next Health Law Webinar – 2018 Medicare Regulatory Update on December 13, 2017.
October 30, 2017
Please join us on November 8, 2017, for our next Health Law Webinar. We will discuss the current government enforcement focus and compliance updates and much more.
September 19, 2017
Please join us on October 18, 2017, for our next Health Law Webinar.
August 28, 2017
Please join us on September 13, 2017, for our next Health Law Webinar.
June 26, 2017
Please join us on July 12, 2017, for our next Health Law Webinar in which our Health Care attorneys will update you on the most common questions from our hospital and clinic clients.
June 1, 2017
Join us on June 14, 2017, for our next Health Law Webinar on Measuring the Aftershocks from the Landmark Supreme Court Decision in United Health Services, Inc. v. Escobar.
April 17, 2017
Please join us on May 10, 2017, for our next Health Law Webinar. This session will discuss key compensation related issues, describe common mistakes and misconceptions and describe shortcomings in many fair market value analyses.
March 22, 2017
Join us on April 12 for our next Health Law Webinar as we discuss recent updates affecting health record privacy and confidentiality.
February 21, 2017
Please join us on March 8, 2017, for our next Health Law Webinar: Nondiscrimination Update: Website Accessibility, Recent ADA Litigation and Section 1557 of the ACA.
January 25, 2017
Please join us on February 8 for our next Health Law Webinar: Turning Immigration into a Powerful Physician Recruitment Tool. Presenters will provide an understanding of the basic immigration legal provisions affecting IMG recruitment, insights on how to incorporate immigration into a physician recruitment and retention program, suggestions on how to provide the employing institution a competitive advantage in employing IMGs and more.
January 9, 2017
Please join us on January 18, 2017, for our next Health Law Webinar: Preparing Your Practice for Sale.
November 18, 2016
Please join us on December 14, 2016, for our next Health Law Webinar: New Rules: MIPS, Physician Fee Schedule, Outpatient Rule and More!
September 20, 2016
Please join us on Thursday, October 13, 2016, for our next Health Law Webinar: Health Law 101. This session will provide a plain language summary of the basic health laws that affect hospitals and clinics, including the Medicare antikickback statute, Stark, the 2 midnight rule, and more.
August 25, 2016
Please join us on September 14, 2016, for our next Health Law Webinar: Social Media and the Health Care Worker: Questions and Practical Solutions.
July 29, 2016
Please join us on August 10 for our next Health Law Webinar. This webinar will provide short summaries of many important topics.
June 21, 2016
Please join us on July 13 for our next Health Law Webinar. This webinar will provide an overview of some of the issues already apparent in the Merit-Based Incentive Payment System (MIPS), CJR and other value and bundled payments.
May 17, 2016
Please join us on June 8, 2016, for our next Health Law Webinar: Voluntary Refunds: The 60 Day Rule and More.
April 27, 2016
Please join us on May 11, 2016, for our next Health Law Webinar: Digital, Mobile and Virtual Medicine: Legal Challenges. Ryan Johnson and Catherine London will discuss the key legal and regulatory issues associated with virtual medicine.
March 17, 2016
On April 13, 2016, please join us for our next Health Law Webinar on Government Enforcement and Pitfalls in Provider-Based Billing.
January 25, 2016
Please join us for our next Health Law Webinar on February 10, 2016. David Glaser will discuss the issues associated with establishing fees, including what information you can gather from and share with competitors and how you can set prices in a manner that will appeal to patients with high deductible plans.
