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Imported Drugs: (Possibly) Coming Soon to a State Near You

In recent years, states have been exploring innovative avenues to address rising healthcare costs and ensure access to affordable medication for their residents. One idea gaining traction involves pursuing authorization from the US Food and Drug Administration (FDA) for importation programs under Section 804 of the Federal Food, Drug, and Cosmetic Act (FDCA) to import prescription drugs from Canada. These “Section 804 Importation Programs” (SIPs), if approved, would enable states to import prescription drugs from Canada, often at significantly lower prices than those available in the United States.

After years of legal and other challenges to the rule, on January 5, 2024, the FDA authorized Florida’s SIP proposal. While eight other states have laws that permit drug importation, and six of them are seeking FDA approval, this is the first time that the FDA has approved a state entity to import drugs from another country. Following Florida’s example, Colorado and other states are moving forward with their own SIP plans.

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States Advance Telehealth Legislation and Rulemaking

Numerous states—including Alaska, Florida, Texas, Utah and Washington—have been busy finalizing and proposing rulemaking and legislation impacting telehealth-related care. Washington’s Department of Health, for example, published a proposed rule focused on implementing the multistate nurse licensure compact.

What else have these states been up to over the last month?

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States Move to Advance Telehealth Objectives

Numerous states—including Florida, Texas and Michigan—have been busy finalizing telehealth-related rulemaking and legislation. Michigan’s proposed bills, for example, push for coverage parity across insurers and payment parity.

What else have these states been up to over the last month?

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States Move to Regulate Telehealth-Related Youth Services

Numerous states—including Louisiana, Ohio, California, Tennessee and New Jersey—have been finalizing rulemaking and legislation that create or amend professional practice standards to incorporate telehealth. Several of these states have also proposed regulations or laws related to the provision of care to youths.

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Guarding the Gateway: Florida Tightens Grip on Electronic Health Records Storage

In May 2023, the Florida Legislature amended the Florida Electronic Health Records Exchange Act to add a provision regarding the security and storage of patient information. It took effect on July 1, 2023. To ensure compliance, Florida healthcare providers should review where their electronic patient information is physically maintained.

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Fla. Class Actions Show Why Correct COBRA Notices Matter

In Florida’s federal courts, there has been an epidemic of class actions alleging that employers failed to provide technically proper notice of the right to continued healthcare coverage under the Consolidated Omnibus Budget Reconciliation Act. A dozen such lawsuits have been filed (each by the same law firm) with mirror image allegations.

These cases illustrate why it is necessary to sweat the details in issuing COBRA notices, which McDermott’s Megan Mardy and Julie McConnell walk through in a recent analysis for Law360.

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Originally published by Law360, October 2019




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DOJ’s Enforcement Activity Against Individuals: Acute Focus on Telemedicine

DOJ’s focus on individual accountability is particularly important with respect to telemedicine. Telemedicine is a burgeoning field, with a projected market increase of 18% annually over the next six years, reaching $103 billion in 2024. In light of this recent surge in profitability, DOJ has begun paying extra attention to telemedicine, with at least one recent HHS-OIG report asserting that more than one-third of all telemedicine claims are improper.

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Enhanced Nurse Licensure Compact Eases the Practice of Nursing across State Lines

The Enhanced Nurse Licensure Compact (Compact) has now been adopted by 26 states, which means the Compact will be taking effect on January 19, 2018. Nurses who seek to practice telemedicine and deliver in-person care across state lines and who meet the Compact’s licensure requirements in these states will have one less obstacle to overcome going forward.

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View From McDermott: Hurricane Survival Guide for Employee Benefit Plans and Employers

According to U.S. News & World Report, estimates for the cost of Hurricane Harvey’s damage have come in as high as $190 billion, and damage estimates for Hurricane Irma are still rolling in but range up to $100 billion. To assist taxpayers affected by these devastating storms, the Internal Revenue Service, Department of Labor, and Pension Benefit Guaranty Corporation have granted multiple forms of relief to taxpayers impacted by Hurricane Harvey, Hurricane Irma, and other disasters enumerated by the Federal Emergency Management Agency.

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