Wake Forest Law Review
4Mar

Third Time’s the Charm?: DEA and HHS Proposed Rules for Telemedicine Prescribing

Categories: Current Issues Blog Uncategorized
Comments Off on Third Time’s the Charm?: DEA and HHS Proposed Rules for Telemedicine Prescribing

By Kaitlyn Snyder 

On November 19, 2024, the Drug Enforcement Administration (DEA) and the Department of Health and Human Services (HHS) issued a Third Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications, extending the flexibilities through December 31, 2025.[1] The third—and supposedly final—temporary extension aims to give the DEA and HHS enough time to push through their three newest proposed rules, which were released on January 16, 2025.[2] The proposed rules govern buprenorphine treatment via telemedicine, the establishment of a special registration pathway to allow specialized providers to continue telemedicine prescription of controlled substances, and continuity of care via telemedicine for Veterans Affairs patients.[3]

Background

In 2022, nearly nine million prescriptions for controlled substances had been distributed for human treatment in North Carolina.[4] Controlled substances are medications that have been classified by their potential for abuse or dependency.[5] Controlled substances are divided into five schedules, with Schedule I including illicit drugs with extreme addiction risk, and Schedule V including drugs with lower potential for abuse, but “preparation containing limited quantities of certain narcotics,” like some cough medications.[6] Schedule II drugs include opioids and certain medications for treating ADD/ADHD, such as Ritalin and Adderall.[7] Schedule III drugs have a slightly lower potential for dependency, and include medications used in gender-affirming treatment, like testosterone, and opioid addiction, such as buprenorphine.[8] Schedule IV has a lower dependency risk, and includes medications for treating anxiety and other mental health disorders, such as Xanax, Valium, and Tramadol.[9]

In 2008, as a response to the increasing use of controlled substances illegally dispensed via telemedicine—a trend which greatly contributed to the opioid crisis, especially among adolescents[10]—Congress introduced the Ryan Haight Online Pharmacy Consumer Protection Act (Ryan Haight Act), which required a provider to conduct an in-person examination of a patient before prescribing any controlled substances.[11]

Effects of COVID-19 on Prescription Access

When COVID-19 spread through the United States in 2020, access to prescription medications was impaired, with a two percent drop in prescription dispensation.[12] In response, the DEA and HHS temporarily suspended the requirements for in-person examinations under the Ryan Haight Act, to allow patients to continue getting necessary diagnoses and prescriptions for a variety of conditions for the duration of the public health emergency (PHE).[13] After the announcement of the end of the PHE, effective May 11, 2023, the DEA announced a set of proposed rules for prescribing controlled substances via telemedicine, that would largely return to the requirements under the Ryan Haight Act, reinstituting the requirement for an in-person exam prior to prescription.[14]

The 2023 proposed rules received over 38,000 comments, mostly in opposition to the return to pre-COVID prescribing requirements, raising concerns about access to medication, especially for patients who may be immunocompromised or otherwise unable to see their provider in person to continue receiving medication.[15] The number of comments prompted the agencies to extend the flexibilities a second and third time to allow for the gathering of feedback and implementation of suggestions into a new set of proposed rules.[16]

The 2025 Special Registration Proposed Rule

The 2025 Proposed Rules take a more flexible approach to prescribing controlled substances via telemedicine. Specifically, the Special Registrations for Telemedicine and Limited State Telemedicine Registrations Proposed Rule would introduce three pathways for providers to continue prescribing controlled substances via telemedicine.[17] The Proposed Rule would limit controlled substance prescription via telemedicine to providers with one of three types of Special Registrations: (1) a Telemedicine Prescribing Registration, which would allow clinician practitioners to prescribe Schedule III-V controlled substances; (2) an Advanced Telemedicine Prescribing Registration, allowing specialized practitioners, such as psychiatrists or hospice care providers, to prescribe Schedule II-V controlled substances via telemedicine; and (3) a Telemedicine Platform Registration, which would authorize select telemedicine platforms to dispense Schedule II-V controlled substances.[18] The Proposed Rule has currently received approximately 3500 comments, and comments are due by March 18, 2025.[19]

Effect on North Carolina

With over nine million controlled substance prescriptions per year in North Carolina, a huge number of North Carolina patients and providers stand to be affected by the Proposed Rule.[20] While the Special Registration pathways may allow providers to continue prescribing via telemedicine, registration will take time; the Proposed Rule states that applications shall be approved after consideration of whether the applicant meets the eligibility factors and whether the registration is consistent with the public interest, without a specified timeline.[21] Meanwhile, many North Carolina patients may require a telemedicine prescription option, as effects from Hurricane Helene linger, after the destruction of over 70,000 homes and nearly 7,000 roads and bridges.[22] Thus, patients and providers in North Carolina and across the nation wait with bated breath to see if the third time (or rather, temporary extension), is the charm and whether the Proposed Rule will become final.

[1] 42 C.F.R. § 12 (2024).

[2] DEA Announces Three New Telemedicine Rules that Continue to Open Access to Telehealth Treatment while Protecting Patients, U.S. Drug Enf’t Admin. (Jan. 16, 2025), https://www.dea.gov/press-releases/2025/01/16/dea-announces-three-new-telemedicine-rules-continue-open-access.

[3] Id.

[4] 2023 Controlled Substances Reporting System Annual Report, N.C. Dep’t Health and Hum. Servs. (Jul. 19, 2023), https://www.ncdhhs.gov/ncgs-90-11375b-controlled-substances-reporting-system-1/download?attachment.

[5] Drug Scheduling, U.S. Drug Enf’t Admin, U.S. Drug Enf’t Admin, https://www.dea.gov/drug-information/drug-scheduling (last visited Feb. 28, 2025).

[6] Id.

[7] Id.

[8] Id.

[9] Id.

[10] 21 C.F.R. §§ 1300–1306 (2008).

[11] Pub. L. No. 110-425, 122 Stat. 4280 (2008).

[12] Kyle Grimslid, One Year In: COVID-19 Impact on Prescriptions, Pharmacists, & Providers, covermymeds (Apr. 22, 2021), https://insights.covermymeds.com/healthcare-industry/innovation/one-year-in-covid-19-impact-on-prescriptions-pharmacists-and-providers.

[13] Letter from William T. McDermott, Assistant Administrator, U.S. Drug Enf’t Admin. Diversion Control Div.  (Mar. 25, 2020), https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-018)(DEA067)%20DEA%20state%20reciprocity%20(final)(Signed).pdf.

[14] Nathaniel M. Lacktman, DEA’s Proposed Rules on Telemedicine Controlled Substances Prescribing after the PHE Ends, Foley & Lardner LLP (Feb. 27, 2023), https://www.foley.com/insights/publications/2023/02/deas-telemedicine-controlled-substances-phe-ends/.

[15] Markia Miller & Nathaniel M. Lacktman, New DEA Rule Extends Controlled Substance Telemedicine Prescribing Flexibilities One More Year, Foley & Lardner LLP (Nov. 18, 2024), https://www.foley.com/insights/publications/2024/11/new-dea-rule-extends-controlled-substance-telemedicine-prescribing/.

[16] DEA and HHS Extend Telemedicine Flexibilities Through 2025, U.S. Drug Enf’t Admin. (Nov. 15, 2024), https://www.dea.gov/documents/2024/2024-11/2024-11-15/dea-and-hhs-extend-telemedicine-flexibilities-through-2025.

[17] 90 Fed. Reg. 6541 (proposed Jan. 17, 2025) (to be codified at 21 C.F.R. § 1300).

[18] Id.

[19] Id.

[20] N.C. Dep’t Health and Hum. Servs., supra note 4.

[21] 90 Fed. Reg. 6541 (proposed Jan. 17, 2025) (to be codified at 21 C.F.R. § 1300).

[22] Gov. Roy Cooper, Hurricane Helene Recovery, N.C. Off. of State Budget and Mgmt. (Dec. 13, 2024), https://www.osbm.nc.gov/hurricane-helene-dna/open.

Tags:
15Mar

Substantive and Constitutional Challenge to Use of NCIC Report for Enhanced Sentencing

Categories: 4th Cir. Blog
Comments Off on Substantive and Constitutional Challenge to Use of NCIC Report for Enhanced Sentencing

By Karon Fowler

In 2010, Drug Enforcement Agency (DEA) agents sent an undercover informant to buy fifteen bundles of heroin from a distributor associated with defendant Ernest James McDowell, Jr.  McDowell was eventually busted for dealing and the cops discovered a firearm while searching his apartment. In March 2011, McDowell pled guilty without a plea agreement to one count of possession of heroin with intent to distribute and one count of being a felon in possession of a firearm.

McDowell’s probation officer prepared a presentence report (PSR) with an increased recommended sentence on the ground McDowell as an “armed career criminal” pursuant to the Sentencing Guidelines and defined by the Armed Career Criminal Act (ACCA). Under the ACCA, a felony convicted of unlawfully possessing a firearm after committing three “violent felon[ies]” or “serious drug offense[s]” must be sentenced to a term of fifteen years to life imprisonment.

The probation officer concluded that three of McDowell’s prior convictions qualified as “violent felonies” under the ACCA. The first two convictions were evidenced by formal court judgments, but for the third conviction, the Government relied on a criminal record check obtained from the National Crime Information Center (NCIC) database. The database listed a 1971 conviction in the Bronx for second degree assault.

At McDowell’s sentencing hearing, he objected to the probation officer’s reliance on the NCIC report to establish the existence of the 1971 assault conviction. The Government conceded that a certified court record of the conviction was “no longer available,” but insisted that NCIC reports are sufficiently reliable to evidence McDowell’s commission of the crime.

McDowell’s first argument on appeal was that the NCIC report cannot establish the fact of the 1971 conviction. His specific concerns pertained to the reliability of the NCIC reports in general and his report in particular. However, the Circuit explained that every court of appeals to address a similar argument in a published opinion has rejected it and instead concluded that a district court may use the NCIC report to establish the fact of a prior conviction.

The Circuit stated that McDowell failed to provide any evidence to suggest that the NCIC database is inaccurate with significant frequency. McDowell was only able to provide “anecdotal evidence of a 99.5% accuracy rate,” which obviously failed to establish firm unreliability. In fact, it cuts against his argument and tends to prove the database significantly more reliable than not. Moreover, the NCIC reports are used extensively throughout the criminal justice system. Courts use the system to make bail and pretrial release decisions, while prosecutors rely on the reports at trial to impeach the witnesses.

Even if the reports are generally reliable, McDowell alternatively contends that the specific report at issue in his case is such a blatantly unreliable document that the district court clearly erred it allowing its use. The inaccuracies of his report include his incorrect name and birthday. He also points to the passage of 40 years since the alleged assault conviction, which he suggests increases the unreliability of the information. Nevertheless, the Government provided sufficient explanation of each supposed defect in the report.

The NCIC report includes any names and birthdays provided by the defendant upon arrest, including alias and falsely provided information. More specifically, the Government illustrated that McDowell had been convicted of other crimes in the Bronx under the alias “Michael” within the same time frame of the supposed assault conviction. The Government also stated that if the 1971 conviction were false as McDowell now alleges, he would have sought to challenge it during his 1983 federal crime conviction which would have included a criminal background check.

Although these explanations do not fully resolve the possible unreliability of the NCIC report, they sufficiently substantiated the report’s information for the district court to conclude by a preponderance of the evidence that McDowell committed the 1971 crime. The Circuit refused to hold that a contested NCIC report standing alone would always suffice to establish the fact of a prior conviction. The court, in limited fashion, only held that the district court did not clearly err in finding that McDowell’s NCIC report in conjunction with the corroborative evidence supplied by the Government, established the existence of the 1971 assault by a preponderance of the evidence.

McDowell also challenged the use of the NCIC report on constitutional grounds. He argued that the district court violated his Sixth Amendment right to a jury decision on each element of his offense beyond a reasonable doubt. Under the Sixth Amendment, it is usually required that any fact raising the statutory penalty for a crime “be submitted to a jury, and proved beyond a reasonable doubt.” However, there is an exception to the general rule whereby a jury need not find the “fact of a prior conviction” beyond a reasonable doubt. Instead, a judge may find the fact of a prior conviction by the lower preponderance of the evidence standard, even if it raises the statutory maximum or minimum penalty for the offense. This exception was articulated in the U.S. Supreme Court’s Almendarez-Torres decision. The Fourth Circuit explains that although some recent U.S. Supreme Court jurisprudence has cast doubt on the strength of the Almendarez-Torres exception, it remains good law that the Fourth Circuit will follow.

However, the Circuit acknowledged the distinctions between McDowell’s claim and the defendant’s claim in Almendarez-Torres. Unlike Almendarez-Torres, McDowell did not concede that his prior conviction in fact occurred. Moreover, there was no assurance that the alleged 1971 conviction arose pursuant to proceedings with substantial procedural safeguards of their own that would mitigate McDowell’s constitutional concerns. Thus, McDowell’s claim “untethers the exception from its justifications and lays bare the exception’s incompatibility with constitutional principles that are by now well settled.”

Nevertheless, the court explains that the law as it currently stands provides that the district court may find the fact of a prior conviction by a preponderance of the evidence. Under that standard, the district court did not clearly err in its conclusion that McDowell committed the 1971 crime for purposes of the PSR recommendation.

The NCIC database may be found at http://www.fbi.gov/about-us/cjis/ncic/ncic.

Tags: