Has the DOJ Signaled a More Critical Approach to FCA Cases?

Posted in Fraud & Abuse & False Claims Act, Healthcare Law, Healthcare Litigation

Defendants have faced an ever increasing number of qui tam actions, yet the government has historically declined to seek dismissal of those actions where it declined to intervene. On January 10, 2018, the Director of the DOJ Civil Division Commercial Litigation Branch’s Fraud Section issued a memorandum to all DOJ attorneys, including AUSAs, advising them that when declining to intervene in a qui tam action, they should also consider whether to seek dismissal under 31 U.S.C. § 3730(c)(2)(A), which provides that “…[T]he government may dismiss the action notwithstanding the objections of the person initiating the action if the person has been notified by the Government of the filing of the motion and the court has provided the person with an opportunity for a hearing on the motion.” (“Memorandum”). Continue Reading

DEA Implements CARA, Enlisting Mid-Level Practitioners in the War on Opioid Addiction

Posted in Government Affairs, Licensure & Regulatory, Healthcare Law, Pharmacy, Drugs, Medical Devices & Equipment

Prior to the Comprehensive Addiction and Recovery Act of 2016 (CARA) only “physicians” could dispense and prescribe narcotic drugs for maintenance and detoxification treatment. CARA expanded who may prescribe for maintenance and detoxification treatment to “qualifying practitioners” (temporarily through October 1, 2021), a broader term than “physicians” that allows for a wider array of practitioners to prescribe. This change opened the door for advanced registered nurse practitioners (ARNPs) and physician assistants (PAs) to provide these needed services to patients battling opioid addiction, once they obtain a Drug Enforcement Administration (DEA) mid-level practitioner registration and meet the CARA requirements below.

The DEA adopted its Final Rule, effective January 22, 2018, that recognizes ARNPs and PAs to be “other qualifying practitioners” if they meet the CARA criteria which generally provides: Continue Reading

Florida Federal Court: Escobar Requires Reversal of $348 Million False Claims Act Jury Verdict

Posted in Fraud & Abuse & False Claims Act, Healthcare Litigation

The United States District Court for the Middle District of Florida vacated a large jury verdict in a False Claims Act case against the owners and operators of nursing homes because the evidence did not satisfy the materiality standards articulated in the U.S Supreme Court’s 2016 opinion in Universal Health Services v. Escobar.

The court’s thorough and well-written opinion in United States ex rel. Ruckh v. Salus Rehabilitation Services, LLC concluded the nearly $350 million verdict could not survive because the relator failed to present evidence that the federal and state governments would not have paid the claims if they were aware of the alleged violations.  Indeed, as the court noted, both governments were aware of the disputed practices and the litigation, but both continued to pay the claims despite this knowledge. Continue Reading

2018 Legislative Session –A Sampling of Health Related Bills Filed

Posted in Government Affairs, Licensure & Regulatory, Health Insurers & Managed Care Organizations, Healthcare Law, Healthcare Reform Legislation, Medicare & Medicaid

The 2018 Florida Legislative Session began its 60 day trek to completion on Tuesday, January 9, 2018.  Both House and Senate will be debating various health related bills which may be of interest to healthcare providers in the State.  The following is a sample of those bills which we feel are pertinent to our clients’ practices and the patients/customers that they serve.  We encourage you to review these bills, and contact us with specific questions about them.  The listing of these bills should not be interpreted as an indication that their passage into law is likely.  In fact, many bills are never picked up in Committee and will not pass into law. Many more will be debated, but fail when voted on.  The likelihood of passage is dependent upon any number of factors and is difficult to predict with any certainty.

Some 2018 bills of interest include:

2018 FLORIDA LEGISLATIVE SESSION

(HEALTH CARE BILLS)

Akerman is pleased to be able to offer this timely update to you. Please note that the bills listed above may be or may have been revised in subsequent committee meetings.  Our team stands ready to assist you should you have specific questions and issues regarding these pieces of proposed legislation.

AHCA Sees the Light on Nursing Home Generator Rule, Unplugging Challenge

Posted in Government Affairs, Licensure & Regulatory, Healthcare Law, Healthcare Litigation

After Hurricane Irma made landfall in Florida, a nursing home in South Florida lost power, and several residents of that nursing home died allegedly as the result of increased temperatures caused by the loss of air conditioning. In the immediate aftermath of this tragic accident, the Agency for Health Care Administration (AHCA) (for nursing homes) and the Department of Elder Affairs (DOEA) (for assisted living facilities (ALFs)) adopted nearly identical emergency rules requiring these facilities to develop and implement emergency management plans addressing the provision of emergency power during power outages.

The emergency rules required the facilities to have the ability to maintain the facilities at 80 degrees or cooler for 96 hours during power outages. As a result, most of the affected nursing homes and ALFs were required to quickly purchase and install large, expensive generators and ensure fuel storage capacity to operate the generators for at least 96 hours. Several parties challenged the emergency rules and an administrative law judge ultimately determined the rules were invalid. The agencies appealed that decision, and the appeal is currently pending. The agencies have since renewed the invalid rules through mid-March 2018. Continue Reading

Medicare Providers Face December 1 Deadline to Request Review of Medicare Payment Adjustments

Posted in Medicare & Medicaid, Physicians

Providers have just a couple more days to challenge Medicare’s proposed 2018 value modifier payment adjustments. On September 18, 2017, Medicare released quality reports and measures used to calculate quality-based payment adjustments affecting providers’ 2018 Medicare fees. Physicians, physicians assistants, nurse practitioners, clinical nurse specialists, and nurse anesthetists who believe such proposed payment adjustments are in error have until 8 p.m. Eastern Time on December 1, 2017 to request an informal review. Providers may request a review by logging in to the CMS Enterprise Secure Portal and selecting the option for Value Modifier Informal Review.  Continue Reading

Get your Single IRB lined up for Multi-Site Research

Posted in Healthcare Law, Hospitals & Health Systems, Pharmacy, Drugs, Medical Devices & Equipment

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 of January 20, 2020. Institutions engaged in National Institutes of Health (NIH) funded research must comply much earlier, however. The NIH has adopted a single Institutional Review Board (IRB) policy, which will apply to all NIH grant applications for multi-site research received on or after January 25, 2018 (NIH Policy).  Continue Reading

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

Posted in Healthcare Law, Hospitals & Health Systems

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 Service. For years, the IRS was flummoxed by the tax-exempt hospital industry that, at one time, made up more than 80% of the hospital providers in the United States. The Service simply had no method of regulating tax-exempt hospitals short of rescinding the tax-exempt status of hospitals and, therefore, the survivability of the hospital. Tax-exemption was the essential pre-condition to the access of tax-exempt financing that is the best reliable source of capital for rejuvenation and expansion of hospital facilities. The only other pool of funds for capital available to tax-exempt hospitals is donations that, while sometimes significant, are not, on balance, a reliable source of capital for a functioning hospital. Continue Reading

Florida Nursing Home Deaths Have Ripple Effects for Facilities Statewide

Posted in Healthcare Law

Hurricane Irma’s wrath knocked out power to much of Florida. At one South Florida senior rehabilitation center left in the dark, the generator was not powerful enough to sustain the air conditioning system, and a portable cooling system malfunctioned. Indoor temperatures swelled, leading to the deaths of eight patients before the facility was evacuated. An additional three patients passed away subsequent to the evacuation.   Continue Reading

Florida Supreme Court: Referral Sources Can Be Protected By A Non-Compete

Posted in Healthcare Law, Healthcare Litigation

Big news for home health agencies and others whose business comes from referral sources: the Florida Supreme Court just held that referral sources are the kind of protectable business interest that will support a non-compete agreement. Home health agencies, like other health care businesses, routinely use non-compete agreements to prevent marketing employees from leaving and going to work for direct competitors. But there have been conflicting rulings in Florida appellate courts as to whether those agreements can be used to prevent home health employees soliciting the physician practices and other referral sources of their previous employers when they go to work for a competitor. Under Florida Statute, 542.335, non-compete agreements can only be enforced if necessary to protect legitimate business interests, such as trade secrets and customer lists. Florida appellate courts had reached different conclusions as to whether referral sources could be protected interests, as they were not specifically listed in the statute. The Florida Supreme Court, in a decision published this week, has ruled that home health referrals sources can be a legitimate business interest worthy of protection under the statute. Continue Reading

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