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

Uncertainty Surrounds Low Income Pool (LIP) Funding

Posted in Government Affairs, Licensure & Regulatory, Healthcare Reform Legislation, Hospitals & Health Systems, Medicare & Medicaid

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 health departments (CHD), and federally qualified health centers (FQHC) that provide charity care for the uninsured or underinsured. LIP has both state and federal funding sources. State funding is provided almost entirely through Intergovernmental Transfers (IGT) between counties, taxing districts, municipalities, and qualified institutions on behalf of those providers that receive funds from the LIP. Continue Reading

Issues and Analysis of the State’s Medicaid Managed Assistance ITN

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

The recently released Invitations to Negotiate (ITN) for Florida’s Statewide Medicaid Managed Care program (SMMC) parallels in large part the State’s initial procurements that were released in 2012 and 2013. Where the current ITN differs, however, should be of interest to all applicants and associated parties. This blog post addresses several of the more significant changes for consideration and may serve as a platform for questions to be addressed to the Agency for Health Care Administration (AHCA). Any such questions should be forwarded to the Agency, per the ITN requirements, no later than 2:00 pm on August 14, 2017. Specifics on this may be found in Attachment A, Instructions and Special Conditions, Section A.10 of the ITN. Given that no specification challenge was raised with the Agency during the 72-hour window after release of the ITN, the Agency’s question period will be the first opportunity for prospective respondents to raise concerns and request feedback on issues that may impact their responses. Continue Reading

Medicare Fraud Strike Force Strikes Again – in a Big Way

Posted in Fraud & Abuse & False Claims Act, Healthcare Law, Medicare & Medicaid

The Medicare Fraud Strike Force initiated its largest ever healthcare enforcement action, charging 412 defendants in July 2017 with approximately $1.3 billion in fraudulent claims. The Strike Force consists of teams that include the Office of Inspector General, the Department of Justice, Offices of the United States Attorneys, the Federal Bureau of Investigation, and local law enforcement, with efforts concentrated in South Florida, Illinois, New York, Texas, Michigan, California, and Louisiana. Continue Reading

State Releases Medicaid Managed Care Invitation to Negotiate

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

Last Friday, July 14, 2017, the Florida Agency for Health Care Administration (AHCA) released its long awaited Invitation to Negotiate (ITN) for State Wide Medicaid Managed Care services. The ITN, one for each of the 11 regions within the state, may be found on the state Vendor Bid System (VBS), the link for which is provided here. This ITN is a reprocurement of the five year program presently in effect for Medicaid beneficiaries in the 11 designated regions of the State and is open to all managed care plans with an interest in providing care and services in these areas. The opening for review of all ITN responses will be done at AHCA on or about November 1, 2017. Award decisions by the State are anticipated to be announced on April 19, 2018. AHCA reserves the right to reject any and all responses or waive minor irregularities when determined to be in the best interest of the State. Continue Reading

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