The U.S. Department of Justice (DOJ) recently announced that it recouped over $2.2 billion through the enforcement of False Claims Act (FCA) settlements and judgments in fiscal year (FY) 2022. This is less than half of the prior year’s recoupment of more than $5.6 billion from civil FCA claims.However, the DOJ noted “the government and whistleblowers were party to 351 settlements and judgments,” which made FY 2022 the second highest for the number of settlements and judgments in one
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The Future of Affirmative Action in Medical School Admissions
This article was originally published in the Healthcare Law Insights blog on the Husch Blackwell website, and is published here with the author’s permission. Blog has been edited for publication on WisBar, with author approval.
A medical school applicant recently filed suit, alleging that several Texas medical schools improperly rejected him by basing their admissions decisions on race and gender. The complaint asserts that these schools (along with “nearly every school and university in the United States”) participate
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Wisconsin Post-Dobbs: Challenges for Health Care Providers (and their Lawyers)
As every licensed attorney in Wisconsin is likely aware, on June 24, 2022, the U.S. Supreme Court ruled on the case Dobbs v. Jackson Women’s Health Organization and overturned the constitutional right to an abortion. As such, a woman’s ability to obtain an abortion now falls in the hands of each individual state. Abortion law currently varies from state to state, as does the enforcement (or lack thereof) of abortion-related statutes. While the scope and sophistication of state abortion
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Price Transparency Laws Reveal Negotiated Prices between Providers and Health Plans
Have you ever paid the price for a hotel room that is listed on the back of the door? Me neither. It’s common knowledge that the market price of a room is typically less than what is posted.
Similarly, most patients and payers don’t pay the price listed on a hospital’s chargemaster. Accordingly, when hospitals were first required to disclose their chargemasters publicly, the data just didn’t mean much.1
The actual cost of health care services is most
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Two Strikes for DOJ: Health Care Executives Not Guilty of Antitrust Conspiracies
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
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Medicare Exclusion: A Guide for Health Care Providers
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
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False Claims Act: Department of Justice Recoups Second Highest Total in Claims in 2021
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
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Yes and No: U.S. Supreme Court Rules on COVID Vaccine Mandates
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
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Three Licensure Changes to Watch in 2022
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
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Three Recent Non-COVID Legal Health Law Updates
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
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District Courts Add to Drug Pricing Upheaval: 340B Pricing and Enforcement Litigation
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
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Vaccine Mandate for Health Care Providers: The Deadline is Right around the Corner
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
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Speaker Programs Now on the Office of the Inspector General’s Radar
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
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Information Blocking Rule Has Arrived … for Real This Time
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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PREP Act Provider Immunity and COVID-related Litigation
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,
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State Regulation of Centers of Excellence Programs: Where a National Trend Meets Local Law
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
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