Clock 9 minute read

State governments are increasingly entering the field of health care market oversight and enforcement. In what was once an issue typically left to the federal government, state governments are looking for ways to regulate market activity in the health care industry as a way to stem increases in health care costs. Late May brought yet another example of what the future may offer in this regard.

Clock 4 minute read

Think you’re being healthy when you reach for that KIND bar in the middle of your workday? We won’t say yes or no—since the U.S. Court of Appeals for the Second Circuit has recently declined to opine on what “all natural” means—or to hear from experts on the matter.

On May 2, the Second Circuit held that the U.S. District Court for the Southern District of New York did not err in throwing out a class action suit against KIND, LLC based on the use of the term “all natural.”[1] The company, of course, markets, advertises, and distributes snack foods including that Caramel Almond & Sea Salt bar that got you through the afternoon.

The district court granted KIND’s motion for summary judgment in September 2022, holding that the plaintiffs (consumers) had failed to establish how a reasonable consumer would understand the term “all natural.”

Clock 9 minute read

The Supreme Court’s 2022 decision in Dobbs v. Jackson Women’s Health Organization to eliminate the federal constitutional right to abortion continues to alter the legal landscape across the country. On April 26, 2024, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) published the “HIPAA Privacy Rule to Support Reproductive Health Care Privacy” (the “Final Rule”).

The Final Rule—amending the Standards for Privacy of Individually Identifiable Health Information (“Privacy Rule”) under the Health Insurance ...

Clock 14 minute read

On May 17, 2024, Colorado Governor Jared Polis signed into law SB 24-205—concerning consumer protections in interactions with artificial intelligence systems—after the Senate passed the bill on May 3. The law adds a new part 17, “Artificial Intelligence,” to Article I, Title 6 of the Colorado Consumer Protection Act, to take effect on February 1, 2026. This makes Colorado “among the first in the country to attempt to regulate the burgeoning artificial intelligence industry on such a scale,” Polis said in a letter to the Colorado General Assembly.

The new law will ...

Clock less than a minute

In this episode of the Diagnosing Health Care Podcast: Gender-affirming care has become the latest flashpoint in state legislatures and state and federal courts across the nation.

States are divided, with some passing laws that seek to restrict access to gender-affirming care and others aiming to protect access.

What is gender-affirming care? What risks does it pose to providers and patients? On this episode, Epstein Becker Green attorneys Jenny Nelson CarneyLisa Pierce Reisz, and Erin Sutton dissect gender-affirming care: what it is, what it isn't, and what is at stake for everyone involved.

Clock 5 minute read

In our ongoing series of blog posts, we have been examining several key negotiating points for tenants in triple net health care leases. We also have offered suggestions for certain lease provisions that will protect tenants from overreaching and unfair expenses, overly burdensome obligations, and ambiguous terms with respect to the rights and responsibilities of the parties. These suggestions are intended to result in efficient lease negotiations and favorable lease terms from a tenant’s perspective. In our previous blog posts, we considered the importance of negotiating ...

Clock 10 minute read

At the end of 2022, FDA published a draft guidance on Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers. The draft guidance explains several aspects of the VMSR Program, including FDA’s approach to determining the eligibility of product codes for the program.  Consistent with the goals outlined in the Medical Device User Fee Amendments of 2017 (MDUFA IV) Commitment Letter, the VMSR Program streamlines reporting of device malfunctions. The program began in 2018 when FDA issued an order granting an alternative reporting approach under 21 CFR 803.19.  The ...

Clock 6 minute read

A major update in cannabis law was announced by the Drug Enforcement Administration (DEA) and Attorney General (AG) this past Tuesday, April 30, 2024 regarding their intent to ease restrictions on cannabis. The DEA plans to recommend that cannabis be rescheduled as a Schedule III substance under the Controlled Substances Act (CSA). This announcement follows mounting federal support over the course of the last few years to reschedule cannabis, which has been listed as a Schedule I substance since 1970.

Although it is possible to change the schedule status of a substance per the CSA via ...

Clock 15 minute read

Turns out, ignorance really is bliss, at least according to the Office of Civil Rights (“OCR”) within the Department of Health and Human Services (“HHS”), in publishing its final rule on algorithmic discrimination by payers and providers. Our concern is that the final rule,  based on section 1557 of the Affordable Care Act, creates a double standard where more sophisticated organizations are held to a higher level of compliance.  Set to become effective 300 days after publication, health care providers and payers will have a lot of work to do in that time.

In this post, we will lay ...

Clock 7 minute read

Today, on April 29, 2024, following more than a decade of discourse, the U.S. Food and Drug Administration (“FDA” or the “Agency”) released its long-awaited “Medical Devices; Laboratory Developed Tests” Final Rule (the “Final Rule”) formalizing the Agency’s authority to regulate laboratory developed tests (“LDTs”) as medical devices.

Since FDA issued its Proposed Rule (the “Proposed Rule”) in the Fall of 2023, Epstein Becker Green (EBG) and other industry stakeholders have eagerly awaited FDA’s issuance of the Final Rule and have speculated as to the provisions the Agency would choose to finalize.

Now, with the wait finally over, EBG joins the rest of industry in our review of the Final Rule, and we will be preparing a more in-depth analysis of the Final Rule and its potential impact on laboratories and the nationwide healthcare system. For now, here are important preliminary takeaways from the Final Rule.

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