Health Law Advisor

On Friday, February 14, 2025, the Drug Enforcement Administration (“DEA”) and the U.S. Department of Health and Human Services (“HHS”) announced that the effective dates for two recently published final rules involving telemedicine prescribing of controlled substances – the final rule titled “Expansion of Buprenorphine Treatment via Telemedicine Encounter” and the final rule titled “Continuity of Care via Telemedicine for Veterans Affairs Patients” (collectively referred to herein as the “Buprenorphine and VA Telemedicine Prescribing Rules”) – are delayed from February 18, 2025, until at least March 21, 2025 (see our previous post on the Buprenorphine and VA Telemedicine Prescribing Rules).

The final rule delaying the effective dates of these final rules is scheduled for publication to the Federal Register on Wednesday, February 19, 2025.

The delays stem from the Presidential Memorandum titled “Regulatory Freeze Pending Review,” (the “Freeze Memo”) issued on January 20, 2025. The Freeze Memo orders all executive departments and agencies to “consider postponing” the effective dates of all rules published to the Federal Register that have not yet taken effect, such as the Buprenorphine and VA Telemedicine Prescribing Rules, until at least March 21, 2025 (sixty days from the issuance of the Freeze Memo), to allow review of any questions of fact, law, and/or policy raised by the rule, and to “consider opening” a comment period for stakeholders to comment on those questions. Accordingly, the DEA is also soliciting comments on: 1) the extension of the effective dates, 2) whether the effective dates should be further extended, and 3) questions of fact, law, and policy raised by these rules, for consideration by officials of the two agencies. Comments are due by February 28, 2025.

Remote prescribing via telemedicine continues to be a huge area of interest among prescribers and other health care providers.

After publishing a Notice of Proposed Rulemaking (“NPRM”) in March 2023 on the prescribing of controlled substances via telemedicine that was widely criticized for being far more restrictive than temporary waivers then in place under the COVID-19 public health emergency, the Drug Enforcement Administration (“DEA”) went back to the drawing board.

Additional time and a new year has brought renewed focus. Published January 17 in the Federal Register as one NPRM and two final rules (collectively referred to herein as the “DEA’s 2025 Rules”), the DEA’s 2025 Rules seek, as DEA indicates in its press release, to “focus[] on the patient to ensure telemedicine is accessible for medical care.”

On Friday, November 15, 2024, the Drug Enforcement Administration (“DEA”) and Department of Health and Human Services (“HHS”) filed a Third Temporary Extension of the COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications (“Third Temporary Extension”), extending the full set of telemedicine flexibilities adopted during the COVID-19 public health emergency (“PHE”) through December 31, 2025. The Third Temporary Extension is scheduled for publication in the Federal Register on November 19, 2024.

This means the DEA will continue to allow DEA registered practitioners (“Practitioners”) to prescribe controlled substances via telemedicine without having previously conducted an in-person patient examination. Likewise, and of particular interest to telemedicine providers that practice in multiple states, Practitioners may continue prescribing via telemedicine to patients physically located in any state in which the Practitioners are licensed to practice medicine, without needing to have a separate DEA registration in each such state, subject to compliance with state prescribing requirements.

State courts continue to debate whether a state’s constitution recognizes a right to “liberty of privacy” or personal autonomy that would encompass the right to make personal health care decisions, including abortion.

In the post-Dobbs era, state supreme courts have been divided over whether state constitutions offer protections for abortion. Supreme courts in Florida and Iowa have rejected state constitutional protections for abortions, while those in Oklahoma and Montana have found or upheld certain constitutional protections for abortion. Recently, district court judges in Georgia and North Dakota have issued injunctions against their respective state’s abortion bans, finding that each state’s constitution protects a right to abortion.

On September 14, 2024, a district court judge in North Dakota enjoined North Dakota’s total prohibition on abortion, and on September 30, 2024, a superior court judge in Fulton County, Georgia, issued an injunction blocking the state’s six-week abortion ban. While the fate of the North Dakota injunction remains pending, on October 7, the Georgia Supreme Court stayed the lower court’s injunction, allowing Georgia’s six-week ban on abortion to once again take effect. One Georgia Supreme Court justice—Justice John J. Ellington—dissented in part from the decision, opining that “[t]he ‘status quo’ that should be maintained is the state of the law before the challenged law took effect.”

On Friday, June 14, the Texas Supreme Court declined to consider a case that asked the Court to determine whether frozen embryos are persons or property under Texas law.

On June 13, 2024, a unanimous Supreme Court held that physicians and medical associations opposed to abortion lacked standing to challenge the U.S. Food and Drug Administration’s (FDA’s) approval of the drug mifepristone, which is primarily used in terminating pregnancy. The Court’s decision in FDA v. Alliance for Hippocratic Medicine affirms the status quo—mifepristone will remain available to patients without in-person dispensing requirements and for pregnancies up to 10 weeks.

In April 2023, the U.S. District Court for the Northern District of Texas ruled that the physicians and medical associations in this case did have standing to sue the FDA for approving mifepristone in 2000. Based on that standing, the District Court determined that the FDA’s approval of mifepristone was invalid under the Administrative Procedure Act and enjoined the FDA’s original approval. The District Court delayed its decision for seven days and, as we have previously discussed on this blog, set off a flurry of filings before the Fifth Circuit and Supreme Court, ultimately leading the latter to issue a stay on the District Court’s injunction of the FDA’s original approval of mifepristone. The stay allowed mifepristone to remain on the market under its current approval and remained in effect through the June 13, 2024 decision by the Court.

On May 25, 2024, Louisiana Governor Jeff Landry signed a bill, SB 276, into law that will classify medications commonly used in pregnancy and to treat stomach ulcers (mifepristone and misoprostol) as controlled substances. The provision classifying mifepristone and misoprostol as controlled substances was added in an amendment to SB 276 to make “coerced” abortions unlawful in the state. The new law is scheduled to take effect on October 1, 2024.

SB 276 represents the first attempt by a state to categorically restrict certain types of medication because they can be used for abortion. Many states have laws restricting the prescription and dispensing of drugs determined to be “abortion-inducing drugs,” but such drugs are only restricted if they are intended to be used to produce an abortion.[1] The laws restricting “abortion-inducing drugs” left open the ability of medical professionals to prescribe these drugs without restriction for non-abortion purposes, such as managing the effects of miscarriage or, in the case of misoprostol, preventing stomach ulcers. Now, due to these drugs’ association with abortion, they will be subject to new restrictions in the state and may impact the treatment of conditions unrelated to abortion.

In response to the recent turmoil caused by the Alabama Supreme Court’s February 16th ruling in LePage et al., v. The Center for Reproductive Medicine et al. and Burdick-Aysenne et al., v. The Center for Reproductive Medicine et al.  that pre-embryos are human children for the purposes of advancing a wrongful death claim, the Alabama legislature enacted a law intended to shield those who “provide or receive goods or services related to in vitro fertilization [(“IVF”)]” from any “action, suit, or criminal prosecution for the damage to or death of an embryo[.]” AL SB ...

Background

On February 16, 2024, the Alabama Supreme Court issued an opinion in the consolidated cases LePage et al., v. The Center for Reproductive Medicine et al. and Burdick-Aysenne et al., v. The Center for Reproductive Medicine et al., SC-2022-0579, in which the Court reversed a trial court’s dismissal of the plaintiffs’ civil wrongful-death claims and allowed the plaintiffs to move forward with a cause of action under the Alabama Wrongful Death of a Minor Act (the “Act”).[1] In so holding, the Alabama Supreme Court found that fertilized pre-embryos stored outside of ...

On November 7, 2023, the citizens of the state of Ohio voted to codify reproductive rights, including the right to abortion, in the state constitution.

In 2019, Ohio banned nearly all abortions once fetal cardiac activity was detected (typically around six weeks’ gestation) through its “Heartbeat Law.” Challenges to Ohio’s Heartbeat Law  under Roe v. Wade and Planned Parenthood v. Casey prevented it from taking effect until the U.S. Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization repealed those cases. After Dobbs, Ohio’s “Heartbeat ...

On Friday, October 6, 2023, the Drug Enforcement Administration (“DEA”) and Department of Health and Human Services (“HHS”) filed a Second Temporary Extension of the COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications (“Second Temporary Rule”), extending the full set of telemedicine flexibilities adopted during the COVID-19 public health emergency (“PHE”) through December 31, 2024. The Second Temporary Rule is scheduled for publication in the Federal Register today (October 10, 2023) and scheduled to take effect on November ...

As health care entities around the country face staffing shortages, hospitals have started to turn to apps to fill nursing shifts. New apps allow hospitals to engage nurses as independent contractors to fill open shifts, allowing nurses to bid on shifts and select hours that match their schedule. Apps allow nurses to work as independent contractors and engage directly with the hospital as opposed to employees of the hospital or a nursing staffing agency that then engages on their behalf to staff the hospital. The Wall Street Journal recently reported on these apps, crediting their rise to nurses retiring or leaving the field after burn out from the COVID-19 pandemic, from which hospitals are still struggling to recover. But, these apps have existed for several years, and employment issues such as correct calculation of wages and tracking work time are something Epstein Becker Green has previously spotted.

During the past several turbulent weeks for the U.S. health care system, rulings in the case Alliance for Hippocratic Medicine v. FDA have called into question the U.S. Food and Drug Administration’s (“FDA’s”) scientific review process to approve new drug applications. While the U.S. Supreme Court acted on the afternoon of Friday, April 21, 2023 to preserve access to the drug mifepristone while the case continues in the United States Court of Appeals for the  Fifth Circuit, the future of mifepristone—and the FDA’s authority to approve new drugs—will continue to be debated on appeal.

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.

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.

On April 14, 2022, the Centers for Medicare & Medicaid Services (CMS) issued new guidance on the Independent Dispute Resolution (IDR) process, created under the No Surprises Act (NSA) to provide a mechanism for payers and providers to resolve disputes as to appropriate payment amounts for certain out-of-network claims. In addition, the Departments of Health and Human Services, Labor and the Treasury launched two online portals– one to host the IDR process for providers and payers and one to host the patient-provider dispute resolution process for self-pay and uninsured patients.

This new guidance replaces earlier instruction from the agency on how the IDR process would operate and what the independent arbitrator was required to consider. The prior guidance was withdrawn after a successful legal challenge to the interim final rule implementing the No Surprises Act provisions on the IDR process, specifically with respect to the weight to be given to the Qualifying Payment Amount (QPA). The QPA is essentially the payer’s median contracted rate for similar services. The QPA is used to calculate patient cost sharing and must be considered by the independent arbitrator in resolving a payment dispute between a payer and an out-of-network provider. Initially, regulators directed arbitrators to use the QPA as a baseline, and when choosing between the parties’ proposed payment offers to choose the amount closest to the QPA unless one of the parties submitted credible information demonstrating that the appropriate payment amount was materially different from QPA.