State and Federal Regulatory Issues

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On July 8, two weeks following the Supreme Court’s ruling in Dobbs v. Jackson that invalidated the constitutional right to abortion, President Biden signed Executive Order 14076 (E.O.). The E.O. directed federal agencies to take various actions to protect access to reproductive health care services,[1] including directing the Secretary of the U.S. Department of Health and Human Services (HHS) to “consider actions” to strengthen the protection of sensitive healthcare information, including data on reproductive healthcare services like abortion, by issuing new guidance under the Health Insurance and Accountability Act of 1996 (HIPAA).[2]
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Continue Reading Biden Administration Seeks to Clarify Patient Privacy Protections Post-Dobbs, Though Questions Remain

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The U.S. Supreme Court is expected to imminently issue its opinion in the case Dobbs v. Jackson Women’s Health Organization (“Dobbs”). If the Court rules in a manner to overturn Roe v. Wade, states will have discretion in determining how to regulate abortion services.[1] Such a ruling would overturn nearly 50 years of precedent, leaving patients, reproductive health providers, health plans, pharmacies, and may other stakeholders to navigate a host of uncharted legal issues. Specifically, stakeholders will likely need to untangle the web of cross-state legal issues that may emerge.
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Continue Reading The Pendulum Swings Both Ways: State Responses to Protect Reproductive Health Data, Post-Roe

On February 23, 2022, in the case captioned Texas Med. Ass’n v. U.S. Dep’t of Health & Human Servs., No. 6:21-cv-00425-JDK (E.D. Tex.), the U.S. District Court for the Eastern District of Texas issued the first major judicial decision addressing implementation of the new federal No Surprises Act, which went into effect nationally on January 1, 2022.  The Court’s decision significantly alters the landscape for claims qualifying for the No Surprises Act’s Federal Independent Dispute Resolution Process (IDRP), an arbitration process designed to resolve certain reimbursement disputes between commercial payors and out-of-network health care providers or emergency facilities.
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Continue Reading Federal District Court Vacates QPA Rebuttable Presumption Provisions of No Surprises Act Regulations

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During a National Stakeholder Call on January 18, 2022, Ellen Montz—Deputy Administrator and Director of the Center for Consumer Information and Insurance Oversight (CCIIO) at the Centers for Medicare and Medicaid Services (CMS)—announced that CMS had begun publishing state-specific letters (the “Enforcement Letters”) detailing anticipated Federal and state responsibilities with respect to enforcement of the No Surprises Act (NSA) on the CCIIO website. Although CCIIO has yet to publish Enforcement Letters for a minority of states,[1] the Enforcement Letters that have been published provide critical details regarding how the NSA intersects with existing state laws and CMS’s expectations regarding NSA enforcement in each state.
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Continue Reading CMS Releases No Surprises Act State Enforcement Letters

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Starting in 2022, Ohio will require owners of tax-exempt real property to notify the county auditor if the exempt property ceases to qualify for exemption.

This is a substantial departure from current law, which had left the role of monitoring changes in exempt properties’ uses to the county auditors or Ohio’s tax commissioner; under the…

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On June 21, 2021, Florida Governor Ron DeSantis signed into law a bill requiring genetic counselors to be licensed by the Florida Department of Health (“FLDOH”).  The new law, known as the Genetic Counseling Workforce Act (“GCWA”), became effective on July 1, 2021.  FLDOH has announced a 90 day enforcement moratorium to allow counselors time to become appropriately licensed in the State.  Florida now joins a growing number of states that regulate the work of genetic counselors.
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Continue Reading Florida Joins a Growing Number of States Requiring Licensure of Genetic Counselors

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At the end of March, Florida joined the roster of states that have erected legal shields for health care providers against COVID-19-oriented liability claims. Concerned about uncertainty surrounding the emergency measures taken in response to COVID-19 and the effects that lawsuits could have on the economic recovery and the ability of health care providers to remain focused on serving the needs of their communities, the Florida Legislature passed CS/SB 72 on March 29, 2021.  Governor Ron DeSantis signed CS/SB 72 into law as Laws of Florida 2021-1.  This law creates two new statutory provisions – section 768.38 and section 768.381, Florida Statutes – effective on passage.

What Are the Liability Protections?

Section 768.381, Florida Statutes provides protection for health care providers regarding COVID-19-related claims, as follows:

  • Complaints alleging claims subject to the law must be pled with particularity, or will be dismissed. This is a higher pleading standard than typically required for a civil complaint, and requires a greater degree of specificity.
  • Plaintiffs must prove gross negligence or intentional misconduct. This is a higher standard than ordinary negligence or professional malpractice.
  • Health care providers are provided with several affirmative defenses which, if proven, preclude liability. These defenses primarily relate to a provider’s substantial compliance with government-issued standards regarding COVID-19, infectious disease generally in the absence of standards specifically applicable to COVID-19 or the inability to comply with applicable standards in light of medical supply shortages.
  • There is a one-year statute of limitations on COVID-19-related claims against health care providers, which is substantially shorter than that for simple and medical negligence claims. When this statute starts to run depends on whether the claim arises out of the transmission, diagnosis, or treatment of COVID-19, or from other circumstances such as a delayed or canceled procedure. Actions for COVID-19 related claims that accrued before the law’s effective date must commence within one year of the effective date.

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Continue Reading Florida Legislature Provides COVID-19 Liability Protection for Health Care Providers

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The regulations for the California Consumer Protection Act (“CCPA”) were approved by the California Office of Administrative Law on August 14, 2020 and went into effect immediately.   Earlier this year, the California Department of Justice proposed these regulations to govern the California Attorney General’s enforcement of CCPA. CCPA was signed into law on June 28,…

Parallel Review – Forcing Manufacturers to Go All In

The Ryan Haight Act Online Pharmacy Consumer Protection Act of 2008 (21 U.S.C. § 802(54)) (the “Ryan Haight Act” or “Act”) expanded the federal Controlled Substances Act to define appropriate internet usage in the dispensing and prescribing of schedule drugs, and in doing so effectively banned the issuance of prescriptions via telemedicine services for any …