Category Archives: Hospitals & Health Systems

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California Attorney General Brings Action Against Sutter Health Contending its Contracting Practices Violate the Antitrust Laws

The California Attorney General recently filed a precedent-setting antitrust action against Sutter Health, the largest health system in Northern California (People of the State of California v. Sutter Health, Case No. CGC-18-565398, San Francisco Superior Court), contending that Sutter Health’s contracting practices violate the antitrust laws. The action, filed in the San Francisco Superior Court, seeks to “restore competition … Continue Reading

GDPR: What You Need to Know Now

It is safe to say that there has been much fear and confusion over the European Union (EU) General Data Protection Rule, or GDPR. With an effective date of May 25, 2018, and little guidance as to how the GDPR applies to organizations that do not have a physical presence in the EU or do not target their goods and … Continue Reading

Outpatient Surgery Center Avoids Dismissal of Antitrust Action Through an Assist from the DOJ

In 2012, Marion Healthcare, an outpatient surgery center in southern Illinois, commenced an antitrust action against Southern Illinois Healthcare (“SIH”), a multi-hospital system operating in the same market. Marion alleged that SIH had negotiated exclusive dealing relationships with several area health insurers, and that these agreements made it difficult, if not impossible, for Marion to compete for surgical patients in … Continue Reading

Class III Hospital Permits – Efficient Drug Management May Become a Reality

At the close of the 2018 session, the Florida Legislature passed Senate Bill (SB) 675, which if allowed to become law by the Governor, will help hospitals and their facilities that are under common control manage their patients’ drugs much more efficiently. Under prior law, the hospitals had to obtain a restricted drug distributor-health care entity permit to allow the … Continue Reading

Florida Clinic License Exemptions Subject to Change

Holders of Florida healthcare clinic license exemptions take note. Exemption certificates, which currently bear no expiration date, will expire every two years if a bill recently passed by the Florida Legislature becomes law. Senate Bill 622 will require exemption holders to renew their clinic license exemption biennially.

The bill is silent as to treatment of existing certificate holders, but businesses … Continue Reading

Get your Single IRB lined up for Multi-Site Research

Changes to the federal regulations governing the protection of human subjects participating in research (known as the Common Rule) were amended earlier this year. The changes to the Common Rule impact research conducted, supported, or regulated by the federal government. While many of the Common Rule changes go into effect in 2018, the single IRB requirement has a compliance date … Continue Reading

Hospitals Take Heed: Gradual Evolution of the IRS’ Position on Tax Exemption

There has been much fanfare, but little discussion, among healthcare experts in the United States regarding the Internal Revenue Service recently published PLR 201731014 (the Letter Ruling). The Letter Ruling provides a good opportunity to review where we have come and where we are going in the tax-exempt hospital industry in America.

Let’s focus first on the Internal Revenue … Continue Reading

Uncertainty Surrounds Low Income Pool (LIP) Funding

The Centers for Medicare and Medicaid Services (CMS), in an August 3, 2017 letter to Florida’s Medicaid Director, approved a five-year extension of the State’s 1115 demonstration project, the Managed Medical Assistance Program (MMA). As part of this extension, CMS approved low-income pool (LIP) funding of approximately $1.5 billion annually. The LIP was created in 2005 to support hospitals, county … Continue Reading

Senate Healthcare Bill Released for Public Review

Just over four weeks after the Congressional Budget Office (CBO) released its score of the American Healthcare Act (AHCA), the bill passed by a narrow margin in the U.S. House of Representatives, the U.S. Senate released ‘The Better Care Reconciliation Act of 2017’. Upon initial review, we are providing a quick overview of this proposed legislation. … Continue Reading

Repeal of the Affordable Care Act Will Not Include Changes to Tax Exempt Hospitals’ 501(r) Charitable Care Obligations

While the Senate Budget Committee works to draft legislation to reconcile the American Health Care Act, the repeal and replace bill passed by the House, there is no expectation of a repeal of the charitable care obligations imposed on tax exempt hospitals under Section 501(r) of the Internal Revenue Code as part of the Affordable Care Act.… Continue Reading

ERISA Exemption Upheld for Religious-Affiliated Hospitals

Hospitals that are “church-affiliated” may be breathing easier this week, following the U.S. Supreme Court’s decision on Monday that defined benefit qualified retirement plans (a/k/a pension plans) are not subject to the Employee Retirement Income Security Act (ERISA). The Supreme Court confirmed that ERISA does not require an exempt “church plan” to have actually been established by the church itself.  … Continue Reading

“Sometimes Wrong, Never in Doubt” – A New Perspective?

Two recent studies of medical malpractice claims highlight how patient complaints may identify those surgeons at greater risk for complications, a significant decrease in paid medical malpractice claims since 1992, and the need for greater understanding of the causes of differences in claims experience across medical specialties.… Continue Reading

The American Health Care Act, the Sequel Receives Its CBO Grade

Perhaps the high fives in the Rose Garden of the White House a few weeks ago may have been a bit premature. On Wednesday, May 24, 2017, the non-partisan Congressional Budget Office (CBO) released its analysis of the revised American Health Care Act (AHCA), and the review contained positive budgetary news, but the overall impact of the bill on health … Continue Reading

Global Ransomware Attack Makes Healthcare Organizations Wanna Cry

As has been widely reported, on May 12, 2017, organizations around the world, including Britain’s National Health Service, found their data held hostage by actors using a new variant of ransomware called WannaCry. According to news reports, 200,000 computers in more than 150 countries have been hit by the cyberattack which appears to be spread by phishing emails. There are … Continue Reading

Potential Implications to the ACA Under the Incoming Republican Administration – Part III: Hospitals

President Trump has been clear in his intention to repeal the ACA. In fact, among President Trump’s first executive orders was one seeking to “minimize the economic burden” associated with the Patient Protection and Affordable Care Act (ACA). In addition to calling for its prompt repeal, he calls upon the executive branch to minimize the regulatory burdens of the ACA … Continue Reading

Deciphering Florida’s New Laws on ARNP and PA Controlled Substance Prescribing

During the 2016 legislative session, Florida granted authority to both advanced registered nurse practitioners (ARNPs) and physician assistants (PAs) to prescribe controlled substances, subject to approval by their supervising practitioner. This change brings these professionals’ authority in line with what most other states allow. However, this was not a complete grant of prescribing authority and, as explained below, leaves these … Continue Reading

HIPAA Audits – Phase 2: On-Site Audits Scheduled for First Quarter of 2017

Covered Entities and Business Associates may be ringing in the New Year with the prospect of responding to on-site HIPAA audits by federal regulators. The U.S. Department of Health and Human Services Office for Civil Rights (OCR) has announced that a certain number of comprehensive on-site HIPAA compliance reviews will be done over the first quarter of next year. Details … Continue Reading

HHS Issues Final Non-Discrimination Rules for Healthcare Providers

Healthcare providers and others who receive federal financial assistance are now subject to new non-discrimination rules and notice requirements under the Affordable Care Act. The new regulation prohibits discrimination in healthcare programs and activities on the basis of race, color, national origin, age, disability and sex – including pregnancy, gender identity, and sex stereotyping. The new rule also encompasses the … Continue Reading

Brief Reprieve Before Hospitals Must Provide Medicare Patients with “Observation” Notices

Hospitals now have additional time before they must meet federal requirements to provide written notice to Medicare patients who are receiving observation services. Congress passed the Notice of Observation Treatment and Implication for Care Eligibility Act (NOTICE Act) in 2015, in response to patient confusion and complaints related to hospital observation stays. The rules were expected to be effective in … Continue Reading

Illinois’ Largest Health System Agrees to Stringent HIPAA Breach Settlement

The Department of Health and Human Services Office for Civil Rights (OCR) announced on August 4, 2016, a settlement agreement with Advocate Health Care Network, an integrated healthcare system with ten hospitals and a non-profit medical group of more than 1,500 physicians in Illinois (the System or Advocate). The System agreed to adopt a corrective action plan and to pay … Continue Reading

Attention Employers: Action Required Before Having Employees or Contractors Sign Non-Disclosure Agreements

In May, President Obama signed the federal Defend Trade Secrets Act of 2016 into law, the details of which we reported in a recent Akerman Practice Update. The Act allows companies for the first time to bring trade secret theft claims under federal law. One of the many important provisions of the law that employers should not overlook is … Continue Reading

Accountable Care, Non-Profit Status and the Dangerous Ripple Effect it May Cause

On April 8, 2016, the Internal Revenue Service (IRS) released Private Letter Ruling (PLR) 201615022, which denied tax-exempt 501(c)(3) status to a commercial accountable care organization (ACO). This ruling marks the first time the IRS published any guidance regarding commercial ACOs. The last guidance from the IRS regarding ACOs came in 2011 and was related to ACO participation in … Continue Reading

Lights, Camera, Settlement: OCR says a picture is worth $2.2 million

A New York hospital has settled with the U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) for $2.2 million after allowing a TV crew for the ABC documentary series “NY Med” to film patients receiving medical treatment without obtaining prior authorization from the patients or their representatives. The estate of one those patients is also suing … Continue Reading

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