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

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

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?

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

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?

Many health insurers and the federal government are waiting for the U.S. Supreme Court’s decision involving risk corridors. The issue is whether the federal government is required to pay health insurers money under the risk corridors statute.
This case has implications far beyond even the $12 billion in dispute. At stake is whether the government can be a trusted business partner to pay private entities when that entity already performed its statutory obligations and is entitled to payment.
This…
Continue Reading Risk Corridors and Promised Payments: Massive Government Bait and Switch?

The Centers for Medicare & Medicaid Services (CMS) recently published its Proposed Rule, 84 Fed. Reg. 55766 (Oct. 17, 2019), for modernizing the Physician Self-Referral Regulations (Stark).In this article, we focus on the portion of the Proposed Rule in which CMS addresses attacks on compensation practices that until recently have been considered to be perfectly permissible.
CMS provides guidance on fundamental terminology regarding compensation arrangements, specifically the definition of “commercial reasonableness,” the “volume or value” standard pertaining to physician…
Continue Reading Modernizing Stark: Centers for Medicare & Medicaid Service’s Proposal

Demographics in the U.S. are changing, as 10,000 baby boomers turn 65 each day through the year 2030, says the Pew Research Center. According to the 2015 National Council on Aging’s United States of Aging Survey, 75% of older adults prefer to continue living in their own home as they age.

Long-term care services are thus vital to assisting these individuals live in their home for as long as possible. Family Care, a Medicaid long-term care program…
Continue Reading Family Care: Supporting the Independence of Wisconsin's Aging Residents