Health Law Section | State Bar of Wisconsin

The Health Law Section addresses areas of interest to health law practitioners including issues such as regulation and operation of health care organizations, bioethics, managed care, accountable care, privacy, and risk management.

The State Bar of Wisconsin offers its members the opportunity to network with other lawyers who share a common interest through its 24 sections. Learn more at http://www.wisbar.org/groups.

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

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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 MogdenHeather Mogden, Marquette 2012, is an associate with Hall Render Killian Heath

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Continue Reading HHS’s Proposed Rule on Guidance Documents Would Clarify Agency Expectations

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Health care providers who qualify for preferential pricing through the Health Resources and Services Administration 340B Drug Pricing Program are bracing themselves for further reductions in the drugs they can dispense through their contract pharmacy networks.

Many manufacturers have announced changes in their policies effective Oct. 1, 2020, (or sooner) that will limit 340B drug discounts to in-house pharmacies or a single contract pharmacy for each qualifying provider.

The change comes as drug manufacturers react to statements by the…
Continue Reading Drug Manufacturers Cut Off 340B Pricing for Contract Pharmacies

It is a situation that can happen: a licensed health care professional is arrested for a first-offense operating while intoxicated (OWI), and they immediately hire a criminal defense attorney.

A first-offense OWI is not a criminal offense in Wisconsin, but rather a traffic violation. Depending on the county, the case may not even show up in CCAP (the Wisconsin Circuit Court Access Program).

The health care professional wants to resolve the case quickly, so they stipulate to a…
Continue Reading When Health Care Workers Are Arrested: Health, Criminal, and Employment Law Issues

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The federal and state responses to COVID-19 have resulted in a dizzying and ever-evolving array of executive orders, waivers, flexibilities, emergency declarations and enforcement discretion (collectively referred to as “regulatory flexibilities”) that significantly change the rules governing health care providers. Although regulatory flexibilities and relief funds are in part intended to shield front-line responders from liability and mitigate financial losses, taking advantage of these accommodations comes with independent risks. While not exhaustive, health care providers should be aware of…
Continue Reading Providers Beware: Avoiding the Pitfalls in Regulatory Flexibilities and Relief Funds

The president signed the Coronavirus Aid, Relief, and Economic Security (CARES) Act into law on March 27, 2020.
Among its many provisions are significant modifications to the Public Health Services (PHS) Act,1 which contains the federal confidentiality protections currently afforded to substance use disorder (SUD) records.
The Substance Abuse and Mental Health Services Administration (SAMHSA) will need to incorporate these changes into its regulations contained at 42 C.F.R. Part 2 (Part 2) through the standard rulemaking process, so

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Continue Reading Top 10 Takeaways from CARES Act Revisions to Substance Use Disorder Record Protections

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By now, the novel coronavirus and COVID-19 has impacted everyone’s jobs, families, and daily lives as we learn how to operate in the new environment and timeline set by COVID-19.Health care supply chains are vital in supporting the daily operations of any health care organization. With the global COVID-19 pandemic, supply chains are being disrupted, resulting in shortages of personal protective equipment (PPE), ventilators, and other medical equipment. As health care systems, providers, and workers (collectively, Providers) are flooded…
Continue Reading Hello COVID-19, You Broke My Supply Chain – Now What?

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Individuals accustomed to working with surrogate decision makers such as activated power of attorney agents and guardians should prepare for an additional – and different – individual at the table: a supporter.
The Supporter’s Role
Enacted in April 2018, 2017 Wisconsin ACT 345 provided for supported decision-making agreements.

com ruedinger uwalumni Leah Ruedinger, Mitchell Hamline 2013, has worked on the payor and provider side of health care for the past six years.

As a party to the supported decision-making…
Continue Reading What You Need to Know about Supported Decision-Making Agreements

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Journey with me back to your 1L contracts law class, to discussions of carbolic smoke balls, offers, acceptance, and the “meeting of the minds.” My contracts law professor had a habit of referencing horses in nearly every hypothetical, which is a topic for another time. She also had a habit of using the language of the Restatement to describe deals between parties as a “bargain.”
More on that later.
These days, in health care, it seems a bargain is…
Continue Reading Health Plan Reference-based Pricing: Is It Really a Bargain?