Health Law Blog | Health Law Section

This blog delivers the latest news, practical advice, and valuable resources for those who practice in the health law field. Topics cover issues such as regulation and operation of health care organizations, bioethics, managed care, accountable care, privacy, and risk management. Published by the State Bar of Wisconsin's Health Law Section.

This section has an email list, sponsors CLE seminars including a joint institute with the Labor & Employment Law Section, publishes a newsletter, and monitors legislation and administrative rules.

Members of the State Bar of Wisconsin may join the section by visiting https://www.wisbar.org/formembers/groups/pages/join-a-group.aspx (login required).

Section website: https://www.wisbar.org/forMembers/Groups/Sections/HealthLawSection/pages/home.aspx

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By: Health Law Section | State Bar of Wisconsin

Blog Authors

Kristin A. Degeneffe
Richelle A. Ladwig
John A. Rubin
Richard B. Davis
Daniel J. Balk III
Jessica Biondo
Heather D. Mogden
Aaron Dumas
Stacy Gerber Ward
Jonathan H. Klock
David J. Edquist
Leah J. Ruedinger
Stephen J. Veit
Barbara J. Zabawa
James Junger
Wendy K. Arends
Peggy L. Barlett
Amy L. Bradshaw
Julianne M. Cox
Angela M. Rust
Robin M. Sheridan
Diane M. Welsh
Kristen N. Nelson
Stephane P. Fabus
Madeline Schmid

Latest from Health Law Blog | Health Law Section

In mid-April, juries in Texas and Colorado found health care company executives not guilty of criminal antitrust charges brought by the U.S. Department of Justice Antitrust Division (DOJ).

Despite the two losses, DOJ continues to move forward with similar charges brought against other health care companies. Employers in the health care industry (and beyond) should be aware that human resources (HR) practices that restrain competition in the labor market may be investigated or prosecuted by antitrust enforcers.
DOJ Prosecutes…
Continue Reading Two Strikes for DOJ: Health Care Executives Not Guilty of Antitrust Conspiracies

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Licensed health care professionals are required to comply with both state and federal rules regulations within their practice. In Wisconsin, health care providers are aware they need to renew their license through the Department of Safety and Professional Services. Many providers realize employment termination or a criminal conviction can impact their professional licenses. What a large majority of these licensed health care professionals don’t know is the consequence an adverse legal action may have on their ability to…
Continue Reading Medicare Exclusion: A Guide for Health Care Providers

What a past year for the Department of Justice (DOJ) and its False Claims Act (FCA) settlements and judgments.

In February 2022, the DOJ released a statement detailing the efforts by the agency for fiscal year 2021 (FY 2021), including the recoupment of more than $5.6 billion from civil FCA claims – making this the second largest annual total to date and the largest since fiscal year 2014.

Out of the $5.6 billion, over $5 billion related to…
Continue Reading False Claims Act: Department of Justice Recoups Second Highest Total in Claims in 2021

On Jan. 13, 2022, the U.S. Supreme Court issued two decisions, both with respect to the various vaccine mandates issued by the Biden administration.In the first opinion, the Court held that Centers for Medicare & Medicaid Services (CMS) may implement its vaccine mandate through its Interim Final Rule (IFR).1However, in its second opinion, the Court held that Occupational Safety and Health Administration (OSHA) is prohibited from enforcing its vaccine-or-test Emergency Temporary Standard (ETS), which would have affected…
Continue Reading Yes and No: U.S. Supreme Court Rules on COVID Vaccine Mandates

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Stresses on Wisconsin’s medical systems have prompted re-evaluation of provider licensing requirements. Three recent pieces of legislation seek to remove barriers to practice and expand access to medical care. This article discusses recent changes and highlights considerations for health insurers, physician clinics, and hospitals in response to these new credentialing standards.Wisconsin Act 23 Regarding Physicians AssistantsThe passage of Wisconsin Act 23 updated and expanded the licensure of physicians assistants (PAs) practicing in Wisconsin.Prior to the Act’s publication on…
Continue Reading Three Licensure Changes to Watch in 2022

For health lawyers, COVID issues remain relentless. Recently, speculation about the impact about the Omicron variant has spiked. And on the eve of a key December deadline, a flurry of judicial activity has delayed and created uncertainty about the fate of the Centers for Medicare & Medicaid Services (CMS) vaccine mandate for health care workers.Although COVID issues can feel all-consuming, we know that other legal issues – including new lawmaking – hasn’t gone away. Here are a few other…
Continue Reading Three Recent Non-COVID Legal Health Law Updates

Over the last year, the federal 340B Drug Pricing Program has seen an immense amount of change and upheaval.Many manufacturers have begun to limit 340B pricing available through contract pharmacy relationships, significantly limiting available 340B savings to participating entities and, in some cases, exacerbating financial difficulties caused by the COVID-19 pandemic.To add to the uncertainty, the Health Resources and Services Administration Office of Pharmacy Affairs’ (HRSA OPA) enforcement authority to levy penalties or otherwise obligate manufacturers to change their…
Continue Reading District Courts Add to Drug Pricing Upheaval: 340B Pricing and Enforcement Litigation

On Nov. 5, 2021, the Centers for Medicare & Medicaid Services (CMS) issued an
interim final rule with comment period (IFC), requiring Medicare and Medicaid-certified providers and suppliers to establish COVID-19 vaccination requirements for all covered staff.

Part of the Biden-Harris Administration’s path out of the pandemic, the IFC applies to more than 17 million workers at approximately 76,000 health care facilities, including hospitals and long-term care facilities.

This article provides an overview of the IFC’s provisions, including…
Continue Reading Vaccine Mandate for Health Care Providers: The Deadline is Right around the Corner

The Office of the Inspector General (OIG) issued its first Special Fraud Alert in over six years Nov. 16, 2020. The Alert highlights growing concerns with pharmaceutical and medical device companies’ speaker programs.

The OIG considers speaker programs as “company-sponsored events at which a physician or other health care professional (collectively, HCP) makes a speech or presentation to other HCPs about a drug or device product or a disease state on behalf of the company.”

These HCPs are not…
Continue Reading Speaker Programs Now on the Office of the Inspector General’s Radar

As of April 5, 2021, health care providers, health information exchanges, health information networks, and certified health IT developers are subject to the 21st Century Cures Act Information Blocking Rule.

The changes necessitated by the Information Blocking Rule are daunting.

A diverse team of stakeholders within the health care space spent the better part of last summer and fall working to develop policies, plans, educational materials, workflows, software adjustments, and patient materials as part of a comprehensive Information Blocking…
Continue Reading Information Blocking Rule Has Arrived … for Real This Time

Although passed into law 15 years ago, the Public Readiness and Emergency Preparedness Act (PREP Act) resulted in fairly limited litigation – that is, until this past year.

The PREP Act was enacted to shield drug makers from liability when bringing vaccines to market during a public health emergency.

With the recent focus on the rapid development of COVID-19 testing, mitigation, and vaccine strategies, the PREP Act has taken on new relevance since the onset of the COVID-19 pandemic,…
Continue Reading PREP Act Provider Immunity and COVID-related Litigation

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One in four large employers sought to expand their Centers of Excellence (COE) offerings last year.

Although the format of Centers of Excellence programs vary, the term is generally used to describe the efforts of an employer or other payer to steer patients to high quality, cost efficient providers. These programs frequently target specialty and surgical care, in part because of their high financial and clinical impact, and in part because of the likelihood that such care can be…
Continue Reading State Regulation of Centers of Excellence Programs: Where a National Trend Meets Local Law

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Long-term care services and supports are important to assist older adults in achieving their wishes to remain living in their own home as long as possible.1

One long-term care option in Wisconsin is IRIS (Include, Respect, I Self-Direct), a Medicaid self-directed program created in 2008 for eligible individuals, including older adults. IRIS allows individuals the freedom to decide what goods, support, and services will meet their needs to help them lead a meaningful life.

According to the Wisconisn …
Continue Reading IRIS: Self-directed Care for Wisconsin’s Aging Residents

In 1996, the Journal of the American Medical Association published a study on nuns and their unique writing styles. Before joining a nunnery, the School Sisters of Notre Dame, young women were asked to write brief autobiographies. Many decades later, their medical information, autobiographies, and other personal attributes were studied.

Researchers noticed that distinctions in the nuns’ writing styles “predicted with uncanny accuracy” which of them would become severely afflicted with Alzheimer’s disease 60 years later.1

Results like…
Continue Reading Legal Considerations for Adopting Predictive AI

On July 9, 2020, the Wisconsin Supreme Court handed a landmark victory to Medicaid providers who were subject to an exacting payment recoupment standard imposed on them by the Wisconsin Department of Health Services (the department).

In Papa v. Wisconsin Dep’t of Health Servs.,1 the Court unanimously agreed with the Waukesha County Circuit Court that the department lacked statutory authority for what courts have termed its “perfection policy,” by which it had recouped Medicaid reimbursement payments made to…
Continue Reading Post Papa: What’s Next for Medicaid Recoupment in Wisconsin

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The federal government relies heavily on nonbinding, subregulatory guidance when regulating health care entities, which can cause confusion.
In response to an Executive Order1 that sought to address this problem across all federal agencies, the Department of Health and Human Services (HHS) proposed a rule2 that requires HHS components to inform the public when issuing a “guidance document” and to clarify the document’s legal impact.

Heather Mogden, Marquette 2012, is an associate with Hall Render Killian Heath …
Continue Reading HHS’s Proposed Rule on Guidance Documents Would Clarify Agency Expectations