Rule2023-16892
Dispensing of Narcotic Drugs To Relieve Acute Withdrawal Symptoms of Opioid Use Disorder
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Published
August 8, 2023
Effective
August 8, 2023
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
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).
Full Text
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<title>Federal Register, Volume 88 Issue 151 (Tuesday, August 8, 2023)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-16892]
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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.
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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.
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\1\ 21 U.S.C. 801-971.
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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\
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\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).
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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\
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\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).
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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\
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\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.
<a href="https://nida.nih.gov/news-events/nida-notes/2020/04/many-people-treated-opioid-overdose-in-emergency-departments-die-within-1-year">https://nida.nih.gov/news-events/nida-notes/2020/04/many-people-treated-opioid-overdose-in-emergency-departments-die-within-1-year</a>.
Published April 2, 2020. Last accessed November 4, 2022.
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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.
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\12\ 5 U.S.C. 553(b)(B).
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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.
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\13\ Provisional Drug Overdose Death Counts, National Center for
Health Statistics, Centers for Disease Control and Prevention.
<a href="https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm">https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm</a>. Updated
July 13, 2022. Last accessed July 19, 2022.
\14\ Ibid.
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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.
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\15\ 5 U.S.C. 553(d).
\16\ 5 U.S.C. 553(d)(1), (3).
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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:
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\17\ BLS, May 2020 National Occupational Employment and Wage
Estimates United States. <a href="https://www.bls.gov/oes/current/oes_nat.htm">https://www.bls.gov/oes/current/oes_nat.htm</a>. (Access 2/27/2022.)
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<bullet> 29-1228 Physicians, All Other; and Ophthalmologists,
Except Pediatric, $85.70.\18\
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\18\ Id.
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The occupation code that best represents the patient and the
corresponding mean hourly wage is:
<bullet> 00-0000 All Occupations, $27.07.\19\
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\19\ BLS, May 2020 National Occupational Employment and Wage
Estimates United States. <a href="https://www.bls.gov/oes/current/oes_nat.htm">https://www.bls.gov/oes/current/oes_nat.htm</a>. (Access 2/27/2022.)
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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.
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\20\ BLS, ``Employer Costs for Employee Compensation--September
2021'' (ECEC).
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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 =
$38.22) for each of the occupations.
Table 1--Loaded Hourly Wages
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Load for benefits Loaded hourly wage
Occupation Hourly wage ($) ($) ($)
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Physician..................................... 85.70 35.31 121.01
Patient....................................... 27.07 11.15 38.22
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* 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.
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\21\ ACEP Emergency Medicine Practice Committee. Emergency
Medicine Provider Productivity. American College of Emergency
Physicians. September 2009.
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(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.
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\22\ National Hospital Ambulatory Medical Care Survey: 2018
Emergency Department Summary Tables. CDC.
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(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.
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\23\ Pew Research Center. How far Americans live from the
closest hospital differs by community type. <a href="http://www.pewresearch.org/fact-tank/2018/12/12/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/</a>, 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.
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(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 $0.585 x 4).
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\25\ Pew Research Center. How far Americans live from the
closest hospital differs by community type. <a href="http://www.pewresearch.org/fact-tank/2018/12/12/how-far-americans-live-from-the-closest-hospital-differs-by-community-type/">www.pewresearch.org/fact-tank/2018/12/12/how-far-americans-live-from-the-closest-hospital-differs-by-community-type/</a>, December 12, 2018.
\26\ Ratcliff M, Burd C, Holder K, Fields. Defining Rural at the
U.S. Census Bureau, U.S. Census Bureau. Issued December 2016.
\27\ Internal Revenue Service. Standard Mileage Rates.
<a href="http://www.irs.gov/tax-professionals/standard-mileage-rates">www.irs.gov/tax-professionals/standard-mileage-rates</a>, Accessed March
9, 2022.
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(5) Medication Cost and Patient Outcome: Medication cost and
patient outcome is expected to be essentially the same. Under current
regulations, the patient returns to the ED for two additional days of
medicine. Under the final rule, the patient is dispensed two additional
days of medicine. Assuming the patient takes the medication as directed
by the provider, the patient received the same medical and medicine-
assisted treatment. Therefore, patient outcome is expected to be
essentially the same.
Table 2--Scenario 1--Impact on Provider
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Current DFR
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Loaded Loaded Net cost/
hourly Minutes Amount ($) hourly Minutes Amount ($) (cost savings)
rate ($) rate ($)
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Provider time savings (2 visits)................................ 121.01 40 80.67 .......... .......... .......... (80.67)
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Cost (Cost Savings)......................................... .......... .......... .......... .......... .......... .......... (80.67)
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Table 3--Scenario 1--Impact on Patient
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Current DFR
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Loaded Loaded Net cost/
hourly Minutes Amount ($) hourly Minutes Amount ($) (cost savings)
rate ($) rate ($)
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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 ..............
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Cost (Cost Savings)......................................... .......... .......... .......... .......... .......... .......... (272.74)
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* $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).
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\28\ NIDA. ``How much does opioid treatment cost?'' National
Institute on Drug Abuse, 13 Apr. 2021, <a href="https://nida.nih.gov/publications/research-reports/medications-to-treat-opioid-addiction/how-much-does-opioid-treatment-cost">https://nida.nih.gov/publications/research-reports/medications-to-treat-opioid-addiction/how-much-does-opioid-treatment-cost</a>. Accessed 20 Sep. 2022.
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(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\
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\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.
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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\
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\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.
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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 ($471 billion/2.1 million) per person per year. While DEA is
unable to quantify how many of the affected patients will be
successfully treated for OUD or how many fatal opioid overdoses will be
avoided as a result of this final rule, the potential economic benefit
is disproportionally large compared to any cost associated with this
rule.
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\31\ Florence C, Luo F, Rice K. The economic burden of opioid
use disorder and fatal opioid overdose in the United States, 2017.
Drug Alcohol Depend. 2021;218:108350. doi:10.1016/
j.drugalcdep.2020.108350.
\32\ Id.
Table 4--Scenario 2--Impact on Provider
--------------------------------------------------------------------------------------------------------------------------------------------------------
Current DFR
------------------------------------------------------------------------
Loaded Loaded Net cost
hourly Minutes Amount ($) 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
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</html>Indexed from Federal Register on August 8, 2023.
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