[Federal Register Volume 88, Number 151 (Tuesday, August 8, 2023)]
[Rules and Regulations]
[Pages 53377-53383]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-16892]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1306

[Docket No. DEA-702]
RIN 1117-AB73


Dispensing of Narcotic Drugs To Relieve Acute Withdrawal Symptoms 
of Opioid Use Disorder

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Drug Enforcement Administration (DEA) is revising existing 
regulations to expand access to medications for the treatment of opioid 
use disorder pursuant to the Easy Medication Access and Treatment for 
Opioid Addiction Act (the Act). The Act directed DEA to revise its 
regulation to allow practitioners to dispense not more than a three-day 
supply of narcotic drugs to one person or for one person's use at one 
time for the purpose of initiating maintenance treatment or 
detoxification treatment (or both).

DATES: This final rule is effective on August 8, 2023.

FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Regulatory Drafting 
and Policy Support Section, Diversion Control Division, Drug 
Enforcement Administration; Telephone: (571) 776-2265.

SUPPLEMENTARY INFORMATION: 

I. Legal Authority and Background

    DEA implements and enforces the Comprehensive Drug Abuse Prevention 
and Control Act of 1970, often referred to as the Controlled Substances 
Act (CSA), and the Controlled Substances Import and Export Act (CSIEA), 
as amended.\1\ DEA publishes the implementing regulations for these 
statutes in 21 CFR parts 1300 to end. These regulations are designed to 
ensure a sufficient supply of controlled substances for medical, 
scientific, and other legitimate purposes, and to deter the diversion 
of controlled substances for illicit purposes.
---------------------------------------------------------------------------

    \1\ 21 U.S.C. 801-971.
---------------------------------------------------------------------------

    As mandated by the CSA, DEA establishes and maintains a closed 
system of control for the manufacturing, distribution, and dispensing 
of controlled substances, and requires any person who manufactures, 
distributes, dispenses, imports, exports, or conducts research or 
chemical analysis with controlled substances to register with DEA.\2\ 
The CSA authorizes the Administrator of DEA (by delegation of authority 
from the Attorney General) to register an applicant to manufacture, 
distribute or dispense controlled substances if the Administrator 
determines such registration is consistent with the public interest.\3\ 
The CSA further authorizes the Administrator to promulgate regulations 
necessary and appropriate to execute the functions of subchapter I 
(Control and Enforcement) and subchapter II (Import and Export) of the 
CSA.\4\
---------------------------------------------------------------------------

    \2\ 21 U.S.C. 822 (all persons must register with DEA unless 
they meet an exception as provided for in 21 U.S.C. 822(c) or 
qualify for a waiver of registration under a regulation promulgated 
pursuant to 21 U.S.C. 822(d)).
    \3\ 21 U.S.C. 823.
    \4\ 21 U.S.C. 871(b) and 958(f).
---------------------------------------------------------------------------

II. Background and Summary of Changes

    To combat substance use disorders and assist individuals in 
receiving proper treatment, DEA published regulations in October 1974 
to implement the Narcotic Addict Treatment Act of 1974 (NATA), allowing 
for practitioners to administer and dispense certain narcotic 
medications for detoxification or maintenance treatment as long as they 
were separately registered as a narcotic treatment program (NTP).\5\ An 
``emergency treatment'' section was added to DEA regulations to allow 
physicians to administer (but not prescribe) one day's worth of 
narcotic drugs, for not more than three continuous days, ``for the 
purpose of relieving acute withdrawal symptoms when necessary while 
arrangements are being made for referral for treatment.'' \6\ This rule 
became known as the ``Three Day Rule,'' and is currently codified at 21 
CFR 1306.07(b). The current regulation allows for ``a physician who is 
not specifically registered to conduct a narcotic treatment program'' 
to administer (but not prescribe) narcotic drugs for not more than one 
day at one time for not more than three days ``for the purpose of 
relieving acute withdrawal symptoms while arrangements are being made 
for referral for treatment.'' \7\
---------------------------------------------------------------------------

    \5\ 39 FR 37986; see also 21 CFR 1306.07(a).
    \6\ 39 FR 37986; see also 21 CFR 1306.07(b).
    \7\ 21 CFR 1306.07(b).
---------------------------------------------------------------------------

    On December 11, 2020, the President signed the Easy Medication 
Access and Treatment for Opioid Addiction Act (the Act) into law as 
Public Law 116-215. One of the provisions of the Act directed DEA to 
revise 21 CFR 1306.07(b) ``so that practitioners . . . are allowed to 
dispense not more than a three-day supply of narcotic drugs to one 
person or for one person's use at one time for the purpose of 
initiating

[[Page 53378]]

maintenance treatment or detoxification treatment (or both).'' \8\ The 
goal of the Act is to significantly expand immediate and emergency 
access to medications for individuals suffering from acute withdrawal 
symptoms while the individual awaits further, long-term treatment. The 
House Report accompanying the Act explains that expanding medication 
dispensing to a three-days' supply at one time alleviates the burden on 
both the patient, specifically transportation issues for those with 
opioid use disorder (OUD), and on the practitioner from having to treat 
the same patient multiple days in a row.\9\ The Report further states 
that appropriate treatment can lead to ``better retention rates in 
treatment and recovery, and lower rates of relapse.'' \10\ Additional 
data underscores this fact--roughly one in twenty patients treated for 
a non-fatal overdose in an emergency department died within one year of 
their visit, many within two days; and two-thirds of these deaths can 
be attributed directly to subsequent opioid-related overdoses.\11\
---------------------------------------------------------------------------

    \8\ Easy Medication Access and Treatment for Opioid Addiction 
Act, Public Law 116-215, Division B, Title III, Section 1302 (Dec. 
11, 2020); see also 21 U.S.C. 829 note.
    \9\ See pg. 2-3 of the House Report of the Committee on Energy 
and Commerce on H.R. 2281 (Report 116-587).
    \10\ Id.
    \11\ Many People Treated for Opioid Overdose in Emergency 
Departments Die Within 1 Year, National Institute on Drug Abuse. 
https://nida.nih.gov/news-events/nida-notes/2020/04/many-people-treated-opioid-overdose-in-emergency-departments-die-within-1-year. 
Published April 2, 2020. Last accessed November 4, 2022.
---------------------------------------------------------------------------

    Allowing a practitioner to supply three days' worth of narcotic 
drugs at one time may help reduce these deaths by providing a short-
term maintenance level of medications while arrangements are made for 
further, more permanent treatment. Therefore, DEA amends the regulatory 
language in 21 CFR 1306.07(b) as directed by Congress.

VI. Regulatory Analyses

Administrative Procedure Act

    An agency may find good cause to exempt a rule from certain 
provisions of the Administrative Procedure Act (APA), including those 
requiring the publication of a prior notice of proposed rulemaking and 
the pre-promulgation opportunity for public comment, if such actions 
are determined to be unnecessary, impracticable, or contrary to the 
public interest.\12\ DEA concludes that ``good cause'' exists to 
promulgate this rule as a final rule rather than a proposed rule for 
the following reasons.
---------------------------------------------------------------------------

    \12\ 5 U.S.C. 553(b)(B).
---------------------------------------------------------------------------

    The Centers for Disease Control and Prevention's (CDC) National 
Center for Health Statistics estimates 108,642 drug overdose deaths 
occurred in the U.S. during the 12-month period ending in February 
2022, an increase of approximately 11,500 more people or nearly 12 
percent more deaths than the previous year.\13\ Specifically, the 
estimated number of overdose deaths from opioids increased from 72,930 
for the 12-month period ending in February 2021 to 81,857 in the 12-
month period ending in February 2022.\14\ Given the increasing number 
of overdose deaths associated with the opioid epidemic, and because 
Congress directed DEA to amend 21 CFR 1306.07(b) in the Easy Medication 
Access and Treatment for Opioid Addiction Act, DEA concludes that it 
would be unnecessary and contrary to the public interest to undertake a 
notice and comment rulemaking prior to the implementation of this rule. 
As such, DEA concludes that ``good cause'' exists within the meaning of 
the APA to promulgate this rule as a final rule rather than a proposed 
rule.
---------------------------------------------------------------------------

    \13\ Provisional Drug Overdose Death Counts, National Center for 
Health Statistics, Centers for Disease Control and Prevention. 
https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm. Updated 
July 13, 2022. Last accessed July 19, 2022.
    \14\ Ibid.
---------------------------------------------------------------------------

    Additionally, under the APA, agencies must generally provide a 30-
day delayed effective date for final rules.\15\ An agency may dispense 
with the 30-day delayed effective date requirement ``for good cause 
found and published with the rule'' or for ``a substantive rule which 
grants or recognizes an exemption or relieves a restriction''.\16\ For 
the reasons just discussed, DEA concludes that such good cause exists 
to justify an immediate effective date. Therefore, DEA makes this rule 
effective immediately.
---------------------------------------------------------------------------

    \15\ 5 U.S.C. 553(d).
    \16\ 5 U.S.C. 553(d)(1), (3).
---------------------------------------------------------------------------

Executive Orders 12866 (Regulatory Planning and Review) and 13563, 
(Improving Regulation and Regulatory Review)

    This final rule was developed in accordance with the principles of 
Executive Orders (E.O.) 12866 and 13563. E.O. 12866 directs agencies to 
assess all costs and benefits of available regulatory alternatives and, 
if regulation is necessary, to select regulatory approaches that 
maximize net benefits (including potential economic, environmental, 
public health, and safety effects; distributive impacts; and equity). 
E.O. 13563 is supplemental to and reaffirms the principles, structures, 
and definitions governing regulatory review as established in E.O. 
12866.
    After consideration of the economic, interagency, budgetary, legal, 
and policy implications of this final rule, DEA has determined that 
this rule is not a significant regulatory action under E.O. 12866, and 
accordingly it has not been reviewed by the Office of Management and 
Budget. While DEA is unable to quantify the benefits of this final 
rule, the potential benefits are anticipated to be disproportionally 
large compared to any cost associated with this rule.
Analysis of Benefits and Costs
    This final rule amends DEA regulations to incorporate the Easy 
Medication Access and Treatment for Opioid Addiction Act (the Act). One 
of the provisions of the Act directed DEA to revise 21 CFR 1306.07(b) 
``so that practitioners . . . are allowed to dispense not more than a 
three-day supply of narcotic drugs to one person or for one person's 
use at one time for the purpose of initiating maintenance treatment or 
detoxification treatment (or both).'' Below is the analysis of the 
revision to 21 CFR 1306.07(b).
    DEA has examined the benefits and costs of this final rule and 
believes it is of net economic benefit. DEA does not have a good 
measure of the number of impacted patients or the number of patient-
practitioner emergency treatment events pursuant to 21 CFR 1306.07(b). 
However, the analysis shows that, even on a per-patient basis, the rule 
will be of net benefit. DEA welcomes any comment on the number of 
affected patients and patient-provider encounters along with references 
and sources for information and data.
Baseline Scenarios--Patient Types
    DEA examined two baseline scenarios based on types of patients 
impacted by the final rule. These two types form the two baselines from 
which the impact of the final rule is analyzed. While emergency 
treatment of acute withdrawal symptoms is not restricted to the 
emergency department (ED) of a hospital, DEA believes that the vast 
majority of the treatment is and will be performed at hospital EDs. 
Therefore, for the purposes of this analysis, DEA refers to ``ED'' as 
the location of emergency treatment.
    Scenario 1--Returning Patients: who would, under current 
regulations, return to the ED for second and third days of medication. 
With the final rule implemented, these patient actions are

[[Page 53379]]

estimated to result in a lower net burden to patient and practitioner.
    Scenario 2--One-time Patients: who would, under current 
regulations, not return to the ED after the first day of medication. 
With the final rule implemented, these patient actions are estimated to 
result in a small increase in costs associated with medication and 
potentially a large benefit from successful treatment.
    DEA does not currently have a basis to estimate the number of each 
patient type. The analysis evaluates the impact of the final rule for a 
single emergency treatment event for both baseline scenarios. 
Additionally, there is a third possible patient type, where the patient 
returns for the second but not the third day of medication. However, 
this third type is not analyzed because the analysis of the two 
baseline scenarios described above is expected to provide the low and 
high estimates, and the impact of the third possible patient type is 
expected to be somewhere between the two baseline scenarios described 
above.
    The analysis below examines the impact of the final rule in three 
general areas:
    (1) Impact on treatment providers.
    (2) Impact on patients.
    (3) Cost and benefit of treatment.
    Bureau of Labor Statistics (BLS) occupational wage data is used to 
calculate labor cost and cost savings for treatment providers and 
patients.\17\ While there are many occupations in the BLS data that may 
represent treatment providers, DEA selected the occupation that best 
corresponds with ED personnel that would provide treatment or other 
service. The occupation and mean hourly wage is:
---------------------------------------------------------------------------

    \17\ BLS, May 2020 National Occupational Employment and Wage 
Estimates United States. https://www.bls.gov/oes/current/oes_nat.htm. (Access 2/27/2022.)
---------------------------------------------------------------------------

     29-1228 Physicians, All Other; and Ophthalmologists, 
Except Pediatric, $85.70.\18\
---------------------------------------------------------------------------

    \18\ Id.
---------------------------------------------------------------------------

    The occupation code that best represents the patient and the 
corresponding mean hourly wage is:
     00-0000 All Occupations, $27.07.\19\
---------------------------------------------------------------------------

    \19\ BLS, May 2020 National Occupational Employment and Wage 
Estimates United States. https://www.bls.gov/oes/current/oes_nat.htm. (Access 2/27/2022.)
---------------------------------------------------------------------------

    Additionally, BLS reports that average benefits for private 
industry is 29.2 percent of total compensation. The 29.2 percent of 
total compensation equates to 41.2 percent (29.2 percent/70.8 percent) 
load on wages and salaries.\20\ The load of 41.2 percent is added to 
each of the hourly rates to estimate the loaded hourly rates.
---------------------------------------------------------------------------

    \20\ BLS, ``Employer Costs for Employee Compensation--September 
2021'' (ECEC).
---------------------------------------------------------------------------

    Table 1 lists the hourly wage, load, and loaded hourly wage for 
physicians ($85.70 + 35.31 = $121.01) and patients ($27.07 + $11.15 = 
$38.22) for each of the occupations.

                                          Table 1--Loaded Hourly Wages
----------------------------------------------------------------------------------------------------------------
                                                                        Load for benefits    Loaded hourly wage
                  Occupation                       Hourly wage ($)             ($)                   ($)
----------------------------------------------------------------------------------------------------------------
Physician.....................................                 85.70                 35.31                121.01
Patient.......................................                 27.07                 11.15                 38.22
----------------------------------------------------------------------------------------------------------------
* Weighted average of Physician, NP, and PA.

Scenario 1: Returning Patients
    Under current regulations, the patient returns for two additional 
visits, where the physician is estimated to spend time to examine and 
administer the narcotic drug for each of the visits. Additionally, the 
patient is expected to incur cost of travel to the ED.
    Under the final rule, the patient is assumed to receive one day's 
dose during the emergency treatment and leave the treatment facility 
with dosages for the second and third days and would not need to return 
to the provider, saving costs for both provider and patient.
    Additionally, DEA anticipates the ED will also save administrative 
cost from not needing to check-in and check-out a patient. However, DEA 
does not have a basis to quantify the administrative cost.
    The economic impact for Returning Patients is detailed below:
    (1) Provider Time Savings: The provider cost savings is estimated 
by applying the estimated time for treatment to the hourly wage rate of 
a provider. Based on Emergency Medicine Provider Productivity by 
American College of Emergency Physicians, a physician is expected to 
spend 20 minutes (or 40 minutes for two visits) to provide emergency 
treatment.\21\ From Table 1, the provider average loaded hourly wage is 
$121.01. As can be seen on Table 2, applying 40 minutes to the loaded 
hourly wage results in an estimated cost savings of $80.67.
---------------------------------------------------------------------------

    \21\ ACEP Emergency Medicine Practice Committee. Emergency 
Medicine Provider Productivity. American College of Emergency 
Physicians. September 2009.
---------------------------------------------------------------------------

    (2) Patient Wait and Treatment Time Savings: The patient wait and 
treatment time cost savings is estimated by applying the estimated 
amount of time a patients is in an ED by the hourly wage of the 
patient. Based on data from the CDC,\22\ patient wait and treatment 
time is three hours. Since two visits are saved, the total times 
savings is six hours. From Table 1, the patient average loaded hourly 
wage is $38.22. As can be seen on Table 3, applying six hours to the 
loaded hourly wage results in an estimated cost savings of $229.32.
---------------------------------------------------------------------------

    \22\ National Hospital Ambulatory Medical Care Survey: 2018 
Emergency Department Summary Tables. CDC.
---------------------------------------------------------------------------

    (3) Patient Travel Time Benefit: The patient travel time cost 
savings is estimated by applying the estimated amount of time a patient 
travels (both to and from the ED) by the hourly wage of the patient. 
Based on research from the Pew Research Center, rural travel time is 
17.0 minutes, suburban is 11.9 minutes, and urban is 10.4 minutes.\23\ 
Most people in the U.S. do not live in rural areas.\24\ While a larger 
population in urban areas is likely to lead to more patients seeking 
emergency treatment at lower travel times, DEA does not have a basis to 
determine the proportion of affected patients that are in rural, urban, 
and suburban areas. As such, DEA does not have a strong basis on which 
to weigh the times, so the middle of the three times was used to 
estimate patient travel time to an ED, or 11.9 minutes. The travel time 
to and from the ED for each visit is then 23.8 minutes, or 47.6 minutes 
for two trips. From Table 1, the patient average loaded hourly wage is

[[Page 53380]]

$38.22. As can be seen on Table 3, applying 47.6 minutes in hours to 
the loaded hourly wage results in an estimated cost savings of $30.32.
---------------------------------------------------------------------------

    \23\ Pew Research Center. How far Americans live from the 
closest hospital differs by community type. www.pewresearch.org/fact-tank/2018/12/12/how-far-americans-live-from-the-closest-hospital-differs-by-community-type/, December 12, 2018.
    \24\ Ratcliff M, Burd C, Holder K, Fields. Defining Rural at the 
U.S. Census Bureau, U.S. Census Bureau. Issued December 2016.
---------------------------------------------------------------------------

    (4) Patient Travel Cost Benefit: The patient travel cost savings is 
estimated by applying the number of miles a patient travels to and from 
the ED by the cost per mile. Based on research from the Pew Research 
Center, rural travel distance to the ED is 10.5 miles, suburban is 5.6 
miles, and urban is 4.4 miles.\25\ Most people in the U.S. do not live 
in rural areas.\26\ While a larger population in urban areas is likely 
to lead to more patients seeking emergency treatment at lower travel 
times, DEA does not have a basis to determine the proportion of 
affected patients that are in rural, urban, and suburban areas. As 
such, DEA does not have a strong basis on which to weigh the distances, 
so the middle of the three distances was used to estimate patient 
travel distance to an ED, or 5.6 miles. Travel mileage cost can be 
estimated using the Internal Revenue Service travel reimbursement rate 
for businesses of 58.5 cents per mile.\27\ The cost of travel for one 
trip is then $3.28. As can be seen on Table 3, the total cost of travel 
to and from the ED for both visits is $13.10 (5.6 x $0.585 x 4).
---------------------------------------------------------------------------

    \25\ Pew Research Center. How far Americans live from the 
closest hospital differs by community type. www.pewresearch.org/fact-tank/2018/12/12/how-far-americans-live-from-the-closest-hospital-differs-by-community-type/, December 12, 2018.
    \26\ Ratcliff M, Burd C, Holder K, Fields. Defining Rural at the 
U.S. Census Bureau, U.S. Census Bureau. Issued December 2016.
    \27\ Internal Revenue Service. Standard Mileage Rates. 
www.irs.gov/tax-professionals/standard-mileage-rates, Accessed March 
9, 2022.
---------------------------------------------------------------------------

    (5) Medication Cost and Patient Outcome: Medication cost and 
patient outcome is expected to be essentially the same. Under current 
regulations, the patient returns to the ED for two additional days of 
medicine. Under the final rule, the patient is dispensed two additional 
days of medicine. Assuming the patient takes the medication as directed 
by the provider, the patient received the same medical and medicine-
assisted treatment. Therefore, patient outcome is expected to be 
essentially the same.

                                                         Table 2--Scenario 1--Impact on Provider
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Current                               DFR
                                                                 ------------------------------------------------------------------------
                                                                    Loaded                              Loaded                               Net cost/
                                                                    hourly      Minutes   Amount ($)    hourly      Minutes   Amount ($)  (cost savings)
                                                                   rate  ($)                           rate  ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Provider time savings (2 visits)................................      121.01          40       80.67  ..........  ..........  ..........         (80.67)
                                                                 ---------------------------------------------------------------------------------------
    Cost (Cost Savings).........................................  ..........  ..........  ..........  ..........  ..........  ..........         (80.67)
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                         Table 3--Scenario 1--Impact on Patient
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Current                               DFR
                                                                 ------------------------------------------------------------------------
                                                                    Loaded                              Loaded                               Net cost/
                                                                    hourly      Minutes   Amount ($)    hourly      Minutes   Amount ($)  (cost savings)
                                                                   rate  ($)                           rate  ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Travel Cost to ER (2 visits)....................................       38.22        47.6       30.32  ..........  ..........  ..........         (30.32)
Wait time plus treatment time (2 visits)........................       38.22         360      229.32  ..........  ..........  ..........        (229.32)
Cost of Travel to ER............................................         N/A         N/A        4.96  ..........  ..........  ..........         (13.10)
Cost of Medication..............................................         N/A         N/A     * 49.29         N/A         N/A     * 49.29  ..............
                                                                 ---------------------------------------------------------------------------------------
    Cost (Cost Savings).........................................  ..........  ..........  ..........  ..........  ..........  ..........        (272.74)
--------------------------------------------------------------------------------------------------------------------------------------------------------
* $49.29 comes from daily medication pricing of $16.43 per day for 3 days. The pricing calculation can be found later under Scenario 2, economic impact
  (3), Medication Cost.

    In summary, for scenario 1, where the patients would have returned 
to the ED for the second- and third-days' medication, the final rule 
will allow for a considerable cost savings for both the patient and 
provider. The reduction in time in the ED for the patient represents 
the bulk of the benefit, or $229.32. Including cost savings for travel 
time and travel cost, the total cost savings per patient is $272.74. 
The provider is expected to have a time savings of $80.67 per patient.
    Therefore, the combined net cost savings is $353.41 ($80.67 + 
$272.74) for each patient under baseline scenario 1.
Scenario 2--One-Time Patients
    Under current regulations, if the patient does not return, the 
patient will only receive one day of medication. The practitioner will 
have examined the patient and dispensed only one day of medication.
    Under the final rule, the patient will be able to receive three 
days of medication with just one visit to the ED. The increased 
medication may lead to an improved patient outcome, resulting in 
benefits associated with lower societal cost of opioid use disorder, 
discussed below. Furthermore, additional physician's time will not be 
needed to dispense medication, resulting in time and cost savings to 
the ED.
    The economic impact for One-time Patients is detailed below:
    (1) Provider Time: There is no change in the required provider time 
and cost because there is only one visit and one examination under both 
the current regulation and the final rule.
    (2) Patient Wait and Treatment Time, Travel Time, and Travel Cost: 
There is no change in patient wait and treatment time, travel time, and 
travel cost because the patient does not return to the ED under both 
current regulations and the final rule.

[[Page 53381]]

    (3) Medication Cost: The increased flexibility from the rule will 
allow a greater amount of medication to be dispensed, adding to the 
cost of medication. Because buprenorphine is predominantly used for 
maintenance, detoxification, or maintenance and detoxification 
treatment of opioid use disorder in EDs, the cost of buprenorphine is 
used to estimate the cost of medication. Based on a 2021 research 
report from the National Institute on Drug Abuse (NIDA), the estimated 
cost of buprenorphine is $115 per week, or $16.43 per day.\28\ As shown 
in Table 5, the two additional days of medication equates to an 
additional medication cost of $32.86 (16.43 x 2).
---------------------------------------------------------------------------

    \28\ NIDA. ``How much does opioid treatment cost?'' National 
Institute on Drug Abuse, 13 Apr. 2021, https://nida.nih.gov/publications/research-reports/medications-to-treat-opioid-addiction/how-much-does-opioid-treatment-cost. Accessed 20 Sep. 2022.
---------------------------------------------------------------------------

    (4) Treatment Benefit: The increased medication dispensed at the ED 
is expected to result in better patient outcomes for some patients. 
Under current regulations, the patient receives only one day of 
medicine and does not return. Under the final rule, the patient is 
dispensed two additional days of medicine. Assuming the patient takes 
the medication as directed by the provider, the patient is more likely 
to have a better outcome.
    In the short term, the benefit is from a lower chance of an 
overdose or death following discharge from an ED. While not everyone 
seeking emergency treatment is an overdose patient, according to a 2020 
study, ``. . . emergency department patients with nonfatal opioid or 
sedative/hypnotic drug overdose have exceptionally high risks of death 
from unintentional overdose, suicide, and other causes. ED-based 
interventions offer potential for reducing these patients' overdose and 
other mortality risks.'' \29\
---------------------------------------------------------------------------

    \29\ Goldman-Mello S, Olfson M, Lidon-Moyano C, Schoenbaum M. 
Mortality following nonfatal opioid and sedative/hypnotic drug 
overdose. Am J Prev Med. 2020.59:59-67.
---------------------------------------------------------------------------

    In the long term, initiating opioid treatment by dispensing up to 
three days' supply may increase the odds for a successful treatment of 
opioid use disorder. In a 2015 study of the efficacy of various 
interventions for opioid dependence, the study concludes that among 
opioid-dependent patients, ED-initiated buprenorphine treatment 
``significantly increased engagement in addiction treatment, reduced 
self-reported illicit opioid use, and decreased use of inpatient 
addiction treatment services.'' \30\
---------------------------------------------------------------------------

    \30\ D'Onofrio G, O'Connor P, Pantalon M, Chawarski M, Et al. 
Emergency Department-Initiated Buprenorphine/Naloxone Treatment for 
Opioid Dependence: A Randomized Clinical Trial. JAMA. 2015 April 28; 
313(16): 1636-1644.
---------------------------------------------------------------------------

    A study published in 2021 of the societal costs for OUD found that 
the ``[C]osts for opioid use disorder and fatal opioid overdose in 2017 
were estimated to be $1.02 trillion. The majority of the economic 
burden is due to reduced quality of life from opioid use disorder and 
the value of life lost due to fatal opioid overdose.'' \31\ According 
to the report, in 2017 total non-fatal costs are $471 billion and total 
fatal costs are $550 billion and there were 2.1 million persons ages 12 
years and older with an OUD, and 47,000 fatal opioid overdoses.\32\ 
Non-fatal costs include costs associated with health care, substance 
use disorder treatment, criminal justice, lost productivity, and the 
value of reduced quality of life. Dividing the total non-fatal cost of 
$471 billion by the number of persons ages 12 and older with an OUD, 
2.1 million, the societal cost of non-fatal OUD is approximately 
$224,000 ($471 billion/2.1 million) per person per year. While DEA is 
unable to quantify how many of the affected patients will be 
successfully treated for OUD or how many fatal opioid overdoses will be 
avoided as a result of this final rule, the potential economic benefit 
is disproportionally large compared to any cost associated with this 
rule.
---------------------------------------------------------------------------

    \31\ Florence C, Luo F, Rice K. The economic burden of opioid 
use disorder and fatal opioid overdose in the United States, 2017. 
Drug Alcohol Depend. 2021;218:108350. doi:10.1016/
j.drugalcdep.2020.108350.
    \32\ Id.

                                                         Table 4--Scenario 2--Impact on Provider
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Current                               DFR
                                                                 ------------------------------------------------------------------------
                                                                    Loaded                              Loaded                               Net cost
                                                                    hourly      Minutes   Amount ($)    hourly      Minutes   Amount ($)
                                                                   rate ($)                            rate ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Provider time savings (2 visits)................................  ..........  ..........  ..........  ..........  ..........  ..........  ..............
                                                                 ---------------------------------------------------------------------------------------
    Cost (Cost Savings).........................................  ..........  ..........  ..........  ..........  ..........  ..........  ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                         Table 5--Scenario 2--Impact on Patient
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Current                               DFR
                                                                 ------------------------------------------------------------------------
                                                                    Loaded                              Loaded                               Net cost
                                                                    hourly      Minutes   Amount ($)    hourly      Minutes   Amount ($)
                                                                   rate ($)                            rate ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Travel Cost to ER (2 visits)....................................  ..........  ..........  ..........  ..........  ..........  ..........  ..............
Wait time plus treatment time (2 visits)........................  ..........  ..........  ..........  ..........  ..........  ..........  ..............
Cost of Travel to ER............................................  ..........  ..........  ..........  ..........  ..........  ..........  ..............
Cost of Medication..............................................         N/A         N/A       16.43         N/A         N/A       49.29           32.86
                                                                 ---------------------------------------------------------------------------------------
    Cost (Cost Savings).........................................  ..........  ..........  ..........  ..........  ..........  ..........           32.86
--------------------------------------------------------------------------------------------------------------------------------------------------------

    In summary, for scenario 2, where patients would not have returned 
to the ED for second- and third-days' medication, the primary economic 
impact of this final rule is from improved patient outcomes. In the 
short

[[Page 53382]]

term, the benefit is from a lower chance of an overdose or death 
following discharge from an ED. In the long term, initiating opioid 
treatment by dispensing up to three days' supply may increase the odds 
for a successful treatment of opioid use disorder, reducing the 
societal cost of opioid use disorder. As discussed above, the societal 
cost of non-fatal cost of opioid use disorder is approximately $224,000 
per person per year.
    As discussed above, in order to obtain the patient outcome benefit, 
the only increased cost will be an increase in medication dispensed 
that will cost the patient an additional $32.86.
Summary of Benefits and Costs
    DEA examined the economic impact of the final rule for two baseline 
scenarios based on anticipated patient actions: (1) Returning Patients 
and (2) One-time Patients. As discussed above, this final rule is 
expected to have net positive benefits and costs.
    For scenario 1, where the patients would have returned to the ED 
for second- and third-days' medication, the final rule is estimated to 
generate a total cost savings of $272.74 to each patient and a net cost 
savings to a provider of $80.67, for a combined net cost savings of 
$353.41 for each patient treated under baseline scenario 1.
    For scenario 2, where patients would not have returned to the ED 
for second- and third-days' medication, the primary economic impact is 
from improved patient outcomes. In the short term, the benefit is a 
lower chance of an overdose or death following discharge from an ED. In 
the long term, initiating opioid treatment by dispensing up to three 
days' supply may increase the odds for a successful treatment of opioid 
use disorder, reducing the societal cost of opioid use disorder. As 
discussed above, the societal cost of non-fatal cost of OUD is 
approximately $224,000 per person per year, while the cost of this rule 
under scenario 2 is $32.86 per patient.
    While DEA is unable to estimate the number of patients under 
scenario 1 or 2, DEA estimates that there is a net benefit for both 
scenarios, and therefore, the economic impact of this final rule will 
be a net benefit.

Executive Order 12988, Civil Justice Reform

    This final rule meets the applicable standards set forth in 
sections 3(a) and 3(b)(2) of E.O. 12988 to eliminate drafting errors 
and ambiguity, minimize litigation, provide a clear legal standard for 
affected conduct, and promote simplification and burden reduction.

Executive Order 13132, Federalism

    This final rule does not have federalism implications warranting 
the application of E.O. 13132. The final rule does not have substantial 
direct effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government.

Executive Order 13175, Consultation and Coordination With Indian Tribal 
Governments

    This final rule does not have tribal implications warranting the 
application of E.O. 13175. It does not have substantial direct effects 
on one or more Indian tribes, on the relationship between the Federal 
government and Indian tribes, or on the distribution of power and 
responsibilities between the Federal government and Indian tribes.

Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) applies to 
rules that are subject to notice and comment under section 553(b) of 
the APA. As explained above, DEA has determined that there is good 
cause to exempt this final rule from pre-publication notice and 
comment. Consequently, the RFA does not apply to this final rule.

Unfunded Mandates Reform Act of 1995

    In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 
2 U.S.C. 1501 et seq., DEA has determined that this action would not 
result in any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100 million or more (adjusted annually for 
inflation) in any one year. Therefore, neither a Small Government 
Agency Plan nor any other action is required under UMRA of 1995.

Paperwork Reduction Act of 1995

    This final rule does not impose a new collection requirement under 
the Paperwork Reduction Act of 1995 (PRA).\33\ This final rule does not 
impose new recordkeeping or reporting requirements on State or local 
governments, individuals, businesses, or organizations. An agency may 
not conduct or sponsor, and a person is not required to respond to, a 
collection of information unless it displays a currently valid OMB 
control number.
---------------------------------------------------------------------------

    \33\ 44 U.S.C. 3501-3521.
---------------------------------------------------------------------------

Congressional Review Act

    This rulemaking is not a ``major rule'' under the Congressional 
Review Act.\34\ DEA will submit a copy of this final rule to both 
Houses of Congress and to the Comptroller General.
---------------------------------------------------------------------------

    \34\ 5 U.S.C. 804(2)(A)-(C).
---------------------------------------------------------------------------

Signing Authority

    This document of the Drug Enforcement Administration was signed on 
August 2, 2023, by Administrator Anne Milgram. That document with the 
original signature and date is maintained by DEA. For administrative 
purposes only, and in compliance with requirements of the Office of the 
Federal Register, the undersigned DEA Federal Register Liaison Officer 
has been authorized to sign and submit the document in electronic 
format for publication, as an official document of DEA. This 
administrative process in no way alters the legal effect of this 
document upon publication in the Federal Register.

Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.

List of Subjects in 21 CFR Part 1306

    Drug traffic control, Prescription drugs.

    For the reasons stated in the preamble, the Drug Enforcement 
Administration amends 21 CFR part 1306 as follows:

PART 1306--PRESCRIPTIONS

0
1. The authority citation for part 1306 continues to read as follows:

    Authority: 21 U.S.C. 821, 823, 829, 829a, 831, 871(b) unless 
otherwise noted.


0
2. In Sec.  1306.07, revise paragraph (b) to read as follows:


Sec.  1306.07  Administering or dispensing of narcotic drugs.

* * * * *
    (b) Nothing in this section shall prohibit a practitioner, who is 
not specifically registered to conduct a narcotic treatment program, 
from dispensing (but not prescribing) narcotic drugs, in accordance 
with applicable Federal, State, and local laws relating to controlled 
substances, to one person or for one person's use at one time for the 
purpose of initiating maintenance treatment or detoxification treatment 
(or both). Not more than a three-day supply of such medication may be 
dispensed to the person or for the person's use at one time while 
arrangements are being made for referral for treatment. Such

[[Page 53383]]

emergency treatment may not be renewed or extended.
* * * * *
[FR Doc. 2023-16892 Filed 8-7-23; 8:45 am]
BILLING CODE 4410-09-P