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HIPAA   FDA    HHS

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Healthcare Blog

Holland & Knight's Healthcare Blog provides insights and analysis on important issues and new developments in healthcare law. We cover a wide variety of topics including fraud and abuse, technology, health plans, facility operations, long-term care, life sciences and public policy.

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In December 2018, the U.S. Department of Justice (DOJ) released its annual statistics for its civil False Claims Act (FCA) and fraud cases from the fiscal year ending Sept. 30, 2018 (fiscal year 2018). The DOJ reports it recovered $2.8 billion in settlements and judgements for Fiscal Year 2018.
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Cybersecurity risks to the healthcare sector have been growing exponentially in the last five years and, over time, have come to include not only data security and privacy risks but also operational and systemic risks that could affect the health and safety of patients.
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With the enactment of the Agriculture Improvement Act of 2018 (Farm Bill) on Dec. 20, 2018, hemp and cannabis derivatives with extremely low concentrations of Tetrahydrocannabinol (THC)—less than 0.3 percent on a dry weight basis—are no longer illegal substances under the Controlled Substances Act. While this means that these products can be legally produced and marketed in the United States, it does not mean that marijuana is legal or that the U.S. Food and Drug Administration (FDA) no longer has regulatory authority over hemp and other cannabis-derived products.
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January 4, 2019
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On Dec. 28, 2018, the U.S. Department of Health and Human Services (HHS) announced the release of voluntary cybersecurity practices and tools for the healthcare industry. The documents were the result of Section 405(d) of the Cybersecurity Act of 2015 and developed by a task group of 103 members and tested by more than 120 stakeholders, including clinicians and IT professionals.
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The U.S. Food and Drug Administration (FDA) issued a statement on Dec. 20, 2018, once again putting stem cell companies on notice about its intention to crack down on the marketing of unapproved stem cell products, and reminding manufacturers about the parameters of its current compliance and enforcement policy for certain human cell, tissue, or cellular or tissue based products (HCT/Ps).
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The HHS Office of Inspector General issued OIG Advisory Opinion No. 18-11, addressing the breadth of the Eligible Managed Care Organization (EMCO) safe harbor.
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On Dec. 12, 2018, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced tougher compliance and enforcement policies for drug manufacturers, dietary supplement manufacturers, stem cell clinics and others. He made these remarks at the Food and Drug Law Institute's Enforcement, Litigation and Compliance Conference.
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December 14, 2018
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The Department of Health and Human Services' Office for Civil Rights (OCR) has issued a Request for Information, which is scheduled for publication in the Federal Register on Dec. 14, 2018. OCR is asking the public to provide input on ways that the HIPAA privacy and security rules could be modified to improve coordinated care.
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December 12, 2018
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By Jan. 1, 2019, all healthcare facilities that meet the statutory definition of "pain-management clinic" under Fla Stat. §§ 458.3265 and/or 459.0137 must be registered with the Department of Health (DOH) or hold a certificate of exemption. Under these statutes, public or private facilities that (i) advertise in any medium any type of pain management services, or (ii) have in any month a majority of the patients who are prescribed opioids, benzodiazepines, barbiturates, or carisoprodol for the treatment of chronic malignant pain, are required register with the DOH unless that facility meets one of the many enumerated exemptions.
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December 6, 2018
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Another government settlement demonstrates that not having a HIPAA compliance program can be costly. HHS's Office for Civil Rights (OCR) announced, on Dec. 4, 2018, that Advanced Care Hospitalists PL (ACH) agreed to pay a whopping $500,000 to settle allegations that it violated HIPAA. ACH, based in Florida, provides physician contractors to hospitals and nursing homes.
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December 5, 2018
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Partner Jeffrey Mittleman and Associate Jenna Schapiro co-authored an article for The PE Hub Network on "Why Regulatory Due Diligence is Essential in Healthcare PE Transactions" in which they discuss the risks that a private equity buyer could be liable for if due diligence is not properly done especially if the buyer is new to the healthcare market. One such liability would be in making sure that the healthcare practice is never without a license (as state licensure requirements often include a change of ownership provision). Mr. Mittleman and Ms. Schapiro reviewed that such a violation could be severe and can result in steep fines, criminal charges and license revocation.
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Allergy Associates of Hartford, P.C., entered into a Resolution Agreement and agreed to pay $125,000 to the U.S. Department of Health and Human Services, Office for Civil Rights (HHS) in order to settle certain Health Insurance Portability and Accountability (HIPAA) violations relating to the impermissible disclosure of a patient's protected health information.
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November 29, 2018
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On Sept. 9, 2015, then-Deputy Attorney General Sally Yates issued a memo requiring federal prosecutors to investigate any individuals responsible for illegal corporate conduct before settling a case. This applied to both criminal pleas and civil settlements. Today at the American Conference Institute's International Conference on the Foreign Corrupt Practices Act, current Deputy Attorney General Rod Rosenstein announced a number of revisions to the U.S. Department of Justice's (DOJ) policies concerning individual accountability in corporate cases.
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November 29, 2018
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In remarkable fashion, the U.S. Department of Health and Human Services Office of the Inspector General (OIG) posted Advisory Opinion 18-14 on Nov. 16, 2018, an unfavorable opinion on a proposal to provide a free specialty drug to hospitals for use in the inpatient setting. Specifically, the requestor is a marketer of a particular drug that is one of two currently FDA-approved drugs that can treat a particular form of infantile epilepsy syndrome.
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On Nov. 16, 2018, the Florida Department of Revenue renewed Emergency Rule 12AER18-02, which implemented Section 56, Chapter 2018-118, Laws of Florida, providing for a sales tax exemption for equipment purchased to generate emergency electric energy at nursing homes and assisted living facilities. Nursing homes and assisted living facilities across the state have been working to acquire and install the necessary generators, fuel and associated equipment in order to come into compliance with the Generator Rules (Rule 58A-5.036 and Rule 59A-4.1265) adopted by the Agency for Health Care Administration (AHCA) and the Department of Elder Affairs (DOEA).
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November 20, 2018
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HIPAA and several other privacy laws do not include a private right of action. This is cold comfort for healthcare providers, health plans and other members of the healthcare industry if a patient is able to demonstrate that the statutory violation caused actual harm. In an opinion filed on Nov. 9, 2018, Florida's Fifth District Court of Appeal held that a patient could bring a claim for breach of fiduciary duty and negligence relating to a physician's disclosure of medical records.
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November 15, 2018
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The Centers for Medicare & Medicaid Services (CMS), part of the U.S. Department of Health and Human Services (HHS), announced a new proposed reimbursement model for certain Medicare Part B drugs and biologicals (together, "drugs") on Oct. 25, 2018. The proposed structure, called the International Pricing Index (IPI) Model, is premised on the idea that Medicare spending for Part B drugs is increasing and exceeds that of 16 other developed countries by 1.8 times.
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The Centers for Medicare & Medicaid Services (CMS) on Nov. 2, 2018, issued the Calendar Year (CY) 2019 Final Rule that updates payment rates and policy changes in the Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System. It is scheduled to be published in the Nov. 21, 2018, issue of the Federal Register and will become effective on Jan. 1, 2019.
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November 13, 2018
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Healthcare was a top voter priority in the 2018 midterm elections, with 41 percent of national voters stating that healthcare was their "most important" issue. Accordingly, the Democratic strategy to focus on healthcare opened opportunities in states the party likely wouldn't have dreamed of winning two years ago when the future of the Affordable Care Act (ACA) was in serious doubt. Ultimately, healthcare helped Democrats win control of the House, adding a nurse, dermatologist and a former U.S. Department of Health and Human Services (HHS) secretary as freshman representatives.
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November 12, 2018
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The Centers for Medicare & Medicaid Services (CMS) on Nov. 1, 2018, published the Calendar Year (CY) 2019 Final Rule for the Medicare Physician Fee Schedule (PFS). Although in previous years regulations for the Quality Payment Program (QPP) were released independently, the 2019 Medicare PFS Final Rule includes provisions related to Medicare physician payments as well as the QPP.
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November 7, 2018
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