Health Law Advisor

On February 24, 2023, the Drug Enforcement Agency (“DEA”) announced proposed permanent rules around prescribing controlled substances via telemedicine that expand the circumstances under which practitioners can prescribe controlled substances without first conducting an in-person medical evaluation of the patient outside of the COVID-19 public health emergency (“PHE”). The proposed rules are more restrictive than the DEA emergency waivers under which providers conducted telemedicine prescribing for the last three years, but are less restrictive in comparison to the pre-PHE regulations applicable to telemedicine prescribing of controlled substances under the federal Controlled Substances Act (“CSA”).

Both the proposed rules related to telemedicine prescribing of Schedule III-V non-narcotic controlled substances, and the separate proposed rules related to telemedicine prescribing of buprenorphine, were published in the Federal Register on March 1, 2023. The public has been given until March 31, 2023 to review and provide comments regarding the proposed rules, which the DEA will consider before promulgating final regulations.

On February 22, 2023, the U.S. Food and Drug Administration (“FDA”) announced a much-anticipated draft guidance regarding the naming and labeling of plant-based milk alternatives.[1] Significantly, under the draft guidance, FDA will not prohibit the use of the identifier “milk” in plant-based milk alternatives but does recommend the product be labeled with “voluntary nutrient statements” to help consumers understand the nutritional differences in the products.

Over the past decade, plant-based milk alternatives have dramatically increased in both availability and consumption. During this time, industry stakeholders have disagreed over the use of the term “milk” for plant-based alternatives that do not contain milk from cows. The dairy industry has lobbied both federal and state governments to restrict the use of “milk” to only fluid “obtained by the complete milking of one or more healthy cows.”[2] To address this debate and to acknowledge the exponential increase in the sale of plant-based milk products, FDA issued a notice for public comment in September 2018 on the “Use of Name of Dairy Foods in the Labeling of Plant-Based Products” that amassed over 13,000 comments. The recently issued draft guidance indicates that the agency did in fact rely on the findings from this notice in developing its recommendations.

In the era of abortion regulation and the wind-down of the COVID-19 public health emergency (“PHE”), new legislation in states such as Utah may be a sign of what is to come for online and telehealth prescribing. On February 14, 2023, the Utah Senate passed a bill that would repeal the State’s “Online Prescribing, Dispensing, and Facilitation Licensing Act” (“Online Prescribing Act”). Utah H.B. 152. The bill currently awaits Governor Spencer Cox’s signature and would take effect sixty (60) days after its signing.[1] Originally enacted in 2010, the Online Prescribing Act has allowed health care providers to register with the State to prescribe and dispense certain FDA-approved drugs via online pharmacies and utilization of telehealth visits. Utah Code § 58-83-306. While providers have been required under the Online Prescribing Act to obtain a comprehensive patient history and assessment prior to issuing a prescription, at present, this may be done via telehealth. Utah Code § 58-83-305. Once signed into law, the effect of H.B. 152 would be to make asynchronous telehealth-only prescribing unlawful in the state, with Utah’s law on the scope of telehealth practice amended to prohibit “diagnos[ing] a patient, provid[ing] treatment, or prescribe[ing] a prescription drug based solely on . . . an online questionnaire; []an email message; or []a patient-generated medical history. Utah H.B. 152, amending Utah Code § 26-60-103.

Federal agencies in health care publish large amounts of data, and my posts typically analyze that data.  To provide more value to readers, I’ve started submitting FOIA requests for unpublished data to produce additional insights into how FDA works.  And what better first topic than data on FDA responses to FOIA requests.

Information is important, and thus so is access to it.  Our democracy needs to know what’s going on in our government, and businesses trying to navigate the FDA regulatory process likewise need to understand the regulatory process.  For both purposes, the FOIA process should be fair and efficient.

FDA has been releasing data on its FOIA process, specifically its FOIA logs, for a few years.  For data analysis purposes, those data are missing some important fields such as the date of the final decision.  Further, when it comes to looking at the data on the closed cases, the data only go back four years.  In my experience, the pandemic years were anomalous in so many ways that we can’t treat any data from the last three years as typical.  As a result, I wanted to go back 10 years.

On February 17, 2023, the Federal Trade Commission (“FTC”) announced the creation of the Office of Technology (the “OT”), which will be headed by Stephanie T. Nguyen as Chief Technology Officer. This development comes on the heels of increasing FTC scrutiny of technology companies. The OT will provide technical expertise and strengthen the FTC’s ability to enforce competition and consumer protection laws across a wide variety of technology-related topics, such as artificial intelligence (“AI”), automated decision systems, digital advertising, and the collection and sale of data. In addition to assisting with enforcement matters, the OT will be responsible for, among other things, policy and research initiatives, and advising the FTC’s Office of Congressional Relations and its Office of International Affairs. 

In this episode of the Diagnosing Health Care Podcast:  What are the various factors impacting stakeholders in the direct access testing industry?

By the end of this four-part series on direct access laboratory testing, listeners will have gained insight into how to navigate the complex regulatory and legal regimes that govern the process of making lab tests available directly to patients and understand the aspects that will dictate how their operations should be structured.

• Lowest Total Recoveries Since 2008
• Record-Shattering Number of New Cases Filed
• Health Care and Life Sciences Cases Continue to Dominate

On February 7, 2023, the U.S. Department of Justice (DOJ) released its annual False Claims Act (FCA) enforcement statistics for fiscal year (FY) 2022, which ended on September 30, 2022.[1] While total recoveries exceeded $2.2 billion, this is a drop of more than 50 percent from the $5.7 billion recovered in FY 2021, marking the lowest annual reported recovery in 14 years. The total recoveries in fraud cases brought with respect to the health care and life sciences industries fell to the lowest level since 2009.

In this episode of the Diagnosing Health Care Podcast:   The U.S. Food and Drug Administration (FDA) recently issued a final guidance document clarifying how the agency intends to regulate clinical decision support (CDS) software.

How has this document caused confusion for industry? How can companies respond?

In a quiet yet shocking announcement on February 3, 2023, the Antitrust Division of the U.S. Department of Justice (DOJ) withdrew three major antitrust policy statements (collectively, the “Statements”) that have served for years as mainstays of health care antitrust enforcement guidance. Specifically, DOJ withdrew the following statements: Department of Justice and FTC Antitrust Enforcement Policy Statements in the Health Care Area (September 15, 1993); Statements of Antitrust Enforcement Policy in Health Care (August 1, 1996); and Statement of Antitrust Enforcement Policy Regarding Accountable Care Organizations Participating in Medicare Shared Savings Program (October 20, 2011).

The California Privacy Protection Agency Board (the “Board”) held a public meeting on February 3, 2023, adopting and approving the current set of draft rules (the “Draft Rules”), which implement and clarify the California Consumer Privacy Act of 2018 (“CCPA”) as amended by the California Privacy Rights Act of 2020 (“CPRA”). The Draft Rules cover many CCPA requirements, including restrictions on the collection and use of personal information, transparency obligations, consumer rights and responding to consumer requests, and service provider contract requirements. At the meeting, the Board also addressed additional proposed rulemaking processes concerning cybersecurity audits, risk assessments, and automated decision-making.