Rule2021-13519
Registration Requirements for Narcotic Treatment Programs With Mobile Components
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 28, 2021
Effective
July 28, 2021
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
The Drug Enforcement Administration (DEA) is publishing this final rule to revise existing regulations for narcotic treatment programs (NTPs) to allow the operation of a mobile component associated with a DEA-registered NTP to be considered a coincident activity permitted under the NTP's registration. Based on these revisions, NTP registrants that operate or wish to operate mobile components (in the State in which the registrant is registered) to dispense narcotic drugs in schedules II-V at remote location(s) for the purpose of maintenance or detoxification treatment do not need a separate registration for such mobile component. This final rule waives the requirement of a separate registration at each principal place of business or professional practice where controlled substances are dispensed for those NTPs with mobile components that fully comply with the requirements of this rule. These revisions to the regulations are intended to make maintenance or detoxification treatments more widely available, while ensuring that safeguards are in place to reduce the likelihood of diversion.
Full Text
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[Federal Register Volume 86, Number 121 (Monday, June 28, 2021)]
[Rules and Regulations]
[Pages 33861-33885]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-13519]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Parts 1300, 1301, and 1304
[Docket No. DEA-459]
RIN 1117-AB43
Registration Requirements for Narcotic Treatment Programs With
Mobile Components
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final rule.
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SUMMARY: The Drug Enforcement Administration (DEA) is publishing this
final rule to revise existing regulations for narcotic treatment
programs (NTPs) to allow the operation of a mobile
[[Page 33862]]
component associated with a DEA-registered NTP to be considered a
coincident activity permitted under the NTP's registration. Based on
these revisions, NTP registrants that operate or wish to operate mobile
components (in the State in which the registrant is registered) to
dispense narcotic drugs in schedules II-V at remote location(s) for the
purpose of maintenance or detoxification treatment do not need a
separate registration for such mobile component. This final rule waives
the requirement of a separate registration at each principal place of
business or professional practice where controlled substances are
dispensed for those NTPs with mobile components that fully comply with
the requirements of this rule. These revisions to the regulations are
intended to make maintenance or detoxification treatments more widely
available, while ensuring that safeguards are in place to reduce the
likelihood of diversion.
DATES: This final rule is effective July 28, 2021.
FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Drug Enforcement
Administration, Attn: DEA Federal Register Representative/DPW,
Diversion Control Division; Mailing Address: 8701 Morrissette Drive,
Springfield, Virginia 22152; Telephone: (571) 776-2265.
SUPPLEMENTARY INFORMATION:
Legal Authority and Background
The Controlled Substances Act (CSA) generally provides, with
certain exceptions, that all persons who are required to register under
the Act must obtain a separate registration ``at each principal place
of business or professional practice'' where such persons manufacture,
distribute, or dispense a controlled substance. 21 U.S.C. 822(e)(1).
However, the CSA authorizes the Attorney General to issue regulations
waiving the requirement of registration of certain manufacturers,
distributors, or dispensers if he finds it consistent with the public
health and safety. 21 U.S.C. 822(d). The Attorney General has delegated
this authority to the Administrator of the Drug Enforcement
Administration (Administrator of DEA or Administrator). Pursuant to
this authority, DEA is hereby finalizing a regulation that would waive
the requirement of a separate registration for narcotic treatment
programs (NTPs) that utilize mobile components under certain
conditions. Specifically, under this final rule, an NTP is permitted to
dispense narcotic drugs in schedules II-V from a mobile component at
location(s) remote from, but within the same State as, the NTP's
registered location, for the purpose of maintenance or detoxification
treatment. Under this final rule, the NTP does not need to obtain a
separate DEA registration for dispensing from the mobile component at a
separate location as long as it complies with the requirements of the
final rule. Such remote dispensing from an NTP's mobile component is
deemed under the final rule to be a coincident activity permitted under
the NTP's registration. In the interest of helping to alleviate the
ongoing opioid epidemic in the United States, the Acting Administrator
of DEA (Acting Administrator) finds that this waiver of registration is
consistent with the public health and safety.
The final rule also contains additional requirements specified in
the proposed rule to reduce the likelihood of diversion. Certain
aspects of these additional requirements, which were raised by the
commenters, are addressed below in the discussion of the comments. In
addition, a section-by-section analysis of the final rule is provided
following the discussion of the comments.
Notice of Proposed Rulemaking
On February 26, 2020, DEA published a notice of proposed rulemaking
(NPRM) in the Federal Register, which provided an opportunity for
comment on the proposed rule. 85 FR 11008. The comment period closed on
April 27, 2020. Through this final rule, DEA is responding to these
comments and finalizing the proposed rule with certain modifications
discussed below.
Discussion of Comments
DEA received a total of 114 comments on the NPRM, copies of which
are available online at <a href="http://www.regulations.gov">www.regulations.gov</a>. The commenters included:
Researchers, practitioners, universities, non-profit organizations,
addiction treatment programs, State and city boards of behavioral
health and human services, associations, manufacturers, a law
enforcement office, and other individual or anonymous commenters. DEA
thanks all commenters for their thoughtful questions and suggestions,
and appreciates their input during the rulemaking process.
One comment was a general statement of support for the rule, with
no discussion of the proposed regulatory changes. Some commenters
sought clarification of certain provisions in the proposed rule or
recommended additional changes. The majority of commenters expressed
support for various provisions in the proposed rule. That said, some
commenters offered only partial support for the rule, agreeing with its
general purpose but disagreeing with particular provisions; some of
these commenters offered suggestions and proposed amendments to the
rule that they thought would help DEA achieve its purpose. Three
comments were outside of the scope of the rule. One comment--a general
complaint about the government's COVID-19 response, unrelated to DEA--
was outside the scope of the rulemaking and will therefore not be
addressed. Another commenter suggested lengthening the five-year term
for nurse anesthetists to treat patients with substance use disorder,
which is a matter beyond the scope of this rule and will not be
addressed. A third commenter suggested future rule changes DEA should
consider to reduce patient access burdens, including: Reducing
adherence requirements for take-home dosing, allowing community
pharmacies to dispense methadone treatment, and allowing physicians
outside of NTPs to prescribe methadone treatment for patients with
opioid use disorders (OUDs). These issues are outside the scope of the
rule and will not be addressed.
After a review of the comments, DEA noted that there were thirteen
main issues that commenters raised, and many commenters raised multiple
issues in their comments. Each issue is summarized below, along with
DEA's responses. DEA has also summarized the remainder of the comments
that did not fit into one of the thirteen main issues.
Expanding the Rule's Scope Beyond Mobile NTPs
Comment: One commenter recommended that the scope of the proposed
rule be expanded to allow mobile components to carry controlled
substances used for sedation (general anesthesia). The commenter stated
that many specialty doctors (such as oral surgeons) work in multiple
locations each week and are required to obtain separate permits (i.e.,
separate DEA registrations) for each office in which they operate, and
as such, cannot fill in for another doctor in the case of an emergency.
DEA Response: DEA understands that many specialty doctors (such as
oral surgeons) may work in multiple locations each week and are
therefore required under 21 U.S.C. 822(e)(1) and 21 CFR 1301.12(a) to
obtain separate registrations for each office in which they operate,
and as such are unable to fill in for another doctor in the case of an
emergency.
[[Page 33863]]
This CSA requirement of separate registrations for each principal
place of business or professional practice where the practitioner
dispenses controlled substances allows DEA to monitor the dispensing of
controlled substances. This requirement thereby reduces the potential
for diversion of those substances. Accordingly, the CSA only authorizes
the Administrator (by delegation from the Attorney General) to issue
regulations waiving this requirement if he finds doing so to be
consistent with the public health and safety. 21 U.S.C. 822(d).
As explained in the NPRM and above, DEA has concluded that allowing
NTPs to operate mobile NTPs under the conditions specified in this rule
is consistent with the public health and safety. See NPRM, 85 FR 11008,
11010. This conclusion, however, only extends to mobile NTP components
used for maintenance and detoxification treatment; any other use is
beyond the scope of this rule.
In this rulemaking, DEA has not considered whether waiving the
separate registration requirement in any other circumstances would be
consistent with the public health and safety, because such a
determination was not necessary for this rulemaking. It is, in other
words, beyond the scope of this rule. This final rule, therefore, does
not change the requirement for separate registrations at each principal
place of business or professional practice for any other registrants
(including specialty doctors) that dispense controlled substances. To
the degree interested parties believe that the separate registration
requirement should be waived in other circumstances, they may petition
DEA to do so by regulation.
Setting a Mileage Limit for Mobile NTP Dispensing
Comments: One commenter suggested that the proposed rule clarify
the radius outside of the ``dispensary'' (i.e., the NTP's registered
location) within which the ``dispenser'' (i.e., the mobile NTP) can
deliver. Another commenter was concerned that the proposed rule
suggested a mileage limit which might not be realistic, especially when
applied to larger States. The commenter stated that there may be value
in allowing each individual State to set and adjust the mileage limit
that would be most appropriate for mobile NTPs operating in their
State. Several other commenters (discussed in more detail below)
suggested that DEA allow mobile NTPs to operate within a 200-mile
radius of the NTP's registered location, even if that radius included
areas in neighboring states.
DEA Response: DEA will not define an exact distance that the mobile
component can travel from its registered location. As further explained
below, DEA has concluded that mobile NTPs must be required to return to
their registered locations upon the completion of their operations each
day and that such a requirement can be met while still increasing
access to maintenance or detoxification treatment in rural and
underserved areas. A specified mileage limit, however, is not necessary
to ensure that mobile NTPs will return to their registered locations
daily. NTPs are better positioned than DEA to determine how far from
their registered location the mobile components can travel while still
allowing adequate time to return to their registered location at the
end of the day, especially given that this distance is likely to vary
between different geographic regions given differences in roads,
traffic, and other conditions.
Mobile Components Crossing State Lines
Comments: Several organizations, practitioners, and non-profit
organizations; a university policy think tank and researcher; and
members of the general public were opposed to the proposed rule's
requirement that mobile NTP components only operate in the same State
as their registered NTP location. Multiple commenters voiced concern
that this requirement would hinder the effectiveness of the proposed
rule in providing services to underserved communities. One commenter
noted that for many rural communities, the closest NTP may be across
state lines. Five commenters cited studies that provided statistics on
the number of NTP patients that traveled across state lines to access
services, and calculated the mean driving distance to a methadone
clinic in five rural states. These studies noted that many of these
patients lived in areas that have been hit hardest by the opioid
epidemic, and would benefit greatly from mobile medication delivery.
Another commenter provided a citation to an article that showed the
ineffectiveness of limiting mobile NTPs to intrastate in rural and
underserved communities. These commenters urged DEA to allow NTPs
located in one State to provide services to underserved areas in
neighboring States. Commenters suggested that one way of allowing the
mobile components to cross State lines would be to authorize an NTP's
mobile component to operate across State lines so long as it remains
within a 200-mile radius of the NTP's registered location, which would
increase access to remote areas that otherwise might remain
underserved. Commenters went on to say that as long as the NTP abided
by the applicable State laws and secured approval from local DEA field
offices, the mobile component should be allowed to cross State lines.
Finally, one commenter suggested making requirements based on distance
and population, and creating regulations built on collaboration. The
commenter stated this approach would allow an NTP with mobile
capabilities in one state to collaborate with an NTP that seeks to
provide those services in a different state if the two NTPs share a
patient base within a certain geographic area.
Another commenter expressed concern that NTPs would choose to only
operate within their own State if (1) State methadone authorities
hesitated to license a mobile component with a registered location in
another State, or (2) States placed more onerous licensing processes on
mobile components from another State. The commenter suggested that DEA
should not prohibit this at the Federal level. The commenter further
suggested that if States are willing to approve mobile components that
are based in another State to promote access for their own citizens,
DEA should defer to the States and permit mobile NTPs to operate in a
different State than that of the NTP's registered location if the
provider can obtain the requisite license from the State methadone
authority.
Finally, one organization and an anonymous commenter supported the
requirement that a mobile NTP only operate in the same State in which
the NTP is registered with DEA. The organization noted that State
regulations can vary greatly, and the organization was aware of the
immediate regulatory crisis that would exist if DEA promulgated Federal
regulations around mobile NTPs that permitted the mobile NTPs to
dispense controlled substances in States in which they are not
registered. The organization expressed concern that any potential for
conflict within the treatment delivery system could put patient care in
jeopardy and foster confusion that may fuel additional stigma against
an already overly stigmatized medical treatment. The organization also
noted that mobile NTPs are governed by State regulations in addition to
the Federal regulations promulgated by DEA and the Substance Abuse and
Mental Health Services Administration (SAMHSA). The organization
further noted that operating a mobile NTP across State lines would call
into question which
[[Page 33864]]
State has oversight and how the originating State could enforce their
rules on a mobile NTP that is not located within their borders. The
anonymous commenter also supported limiting the mobile NTP to the same
State in which the NTP is registered, stating the restriction would
prevent the mobile NTP from breaking the laws of the surrounding states
it would be operating in, which might be different than the laws of the
State in which the NTP is registered.
DEA Response: DEA appreciates the concerns raised by commenters
that the proposed requirement that mobile NTPs only operate in the same
State as their associated NTP's registered location may hinder the
effectiveness of the rule in providing services to underserved
communities. The intent of the rule is to increase access to these
rural and underserved communities, while ensuring that certain
recordkeeping and security requirements are met to prevent the
diversion of controlled substances.
As stated in the preamble to the proposed rule, however, the CSA
and DEA regulations have always required, with limited exceptions,
practitioners to have separate registrations in each State in which
they dispense controlled substances. See NPRM, 85 FR 11008, 11010. A
practitioner, including an NTP, must maintain a DEA registration in
each State in which it dispenses controlled substances because DEA
registrations are based on State licenses to dispense controlled
substances. See, e.g., Clarification of Registration Requirements for
Individual Practitioners, 71 FR 69478, 69478 (Dec. 1, 2006). DEA relies
on State licensing bodies to determine that NTPs are qualified to
dispense controlled substances for detoxification and maintenance
purposes. State authority to conduct these activities only confers
rights and privileges within the issuing State; consequently, a DEA
registration based on a State license cannot authorize controlled
substance dispensing outside of the State. This aspect of the CSA and
DEA regulations also helps to ensure that each State retains the
primary authority to regulate the practice of medicine within its
borders. Therefore, DEA can only authorize an NTP and, as a coincident
activity, its mobile component, to dispense controlled substances in
the same State in which its brick-and-mortar NTP is registered with DEA
to dispense controlled substances. Restricting a mobile NTP to a 200-
mile radius of the DEA-registered site would not address this
requirement, as the State authority to operate an NTP is limited to the
borders of the State, regardless of distance.
DEA also cannot authorize NTPs to avoid this requirement by
allowing a single mobile NTP to partner with multiple NTPs with
registered locations in different States. This rule authorizes a
registered NTP to operate a mobile component away from its registered
location as a coincident activity of its DEA registration, which, as
stated above, is predicated on state authorization. Moreover, this
arrangement is critical to ensuring that a registered NTP maintains
effective security and recordkeeping oversight of its mobile NTP
operations to safeguard against diversion of the mobile NTP's
controlled substances. Allowing multiple registered NTPs to share the
same mobile component would diminish any individual location's
perceived authority and responsibility for the controlled substances
contained on the mobile NTP. For example, it would complicate the NTP's
task of reconciling the dispensing logs from both the mobile component
and the NTP's registered location to ensure that only the NTP's
enrolled patients are receiving controlled substances. Furthermore, the
task of recording (and investigators' task of tracing) the movement of
controlled substances received at the NTP's registered location and
transferred to the mobile NTP components would also be complicated.
Thus, as reflected in the rule, DEA has concluded that each mobile NTP
component may only operate under the DEA registration of a single NTP
location--and may only operate in the State in which that registered
NTP is licensed.
Comment: One commenter noted that although the proposed rule
limited mobile components to the same State as the existing
registration, it did not enumerate explicit measures for physically
monitoring unauthorized out-of-State dispensations. The commenter
stated that a lack of monitoring requirements in the proposed rule
seemingly undermined effective DEA enforcement of its standards, thus
enabling unauthorized medical practice to go undetected, and,
accordingly, impeding States' rights to authorize practitioners.
DEA Response: The risk of a mobile NTP engaging in unauthorized
out-of-State dispensing is not appreciably greater than any other
practitioner engaging in such dispensing. Thus, DEA has concluded that
the various regulatory requirements and monitoring activities that DEA
uses to combat unauthorized dispensing in general should be adequate to
combat any unauthorized dispensing by mobile NTPs. Moreover, this final
rule already provides for certain measures designed to enhance DEA's
ability to monitor the activities of mobile NTPs, such as the
requirement that NTPs notify their local DEA office before using a
mobile component to dispense controlled substances.
Mobile Components Facilitate Expanded Access in Rural Areas
Comments: A majority of commenters voiced support for the proposed
rule saying that it would expand access to treatment for those who
needed it. Multiple commenters stated that the proposed regulation was
a step in the right direction because it reversed outdated regulations
that have inhibited access to treatment. Several commenters stated that
the proposed rule would greatly improve health outcomes for people with
substance use disorder living in both rural and urban areas. These
commenters noted that rural or geographically remote areas that were
lacking in opioid replacement medication services faced a treatment gap
because of issues like poverty, lack of access to care, and premature
deaths; these mobile components could bridge these gaps, and allow more
individuals to have access to treatment programs, which would help
improve the odds of long-term recovery. Other commenters mentioned that
the use of these mobile components could have positive outcomes outside
of treatment for OUD, stating they could help with human
immunodeficiency virus prevention, overdoses, and relapses. Other
commenters also noted how the mobile components would allow many
underrepresented groups like those suffering from mobility issues,
mental health issues, incarceration, and homelessness to access
treatment. Several commenters also stated that these mobile components,
while expanding access, would reduce costs because there would not be
as great of a need to build more brick-and-mortar NTPs.
Two associations, one representing NTPs and the other representing
the interests of individuals in medication-assisted treatment (MAT),
noted a potential funding source available through the U.S. Department
of Agriculture (USDA). Both associations mentioned that the funding is
available to assist NTPs with the purchase of mobile vans, if the NTPs
meet USDA criteria in serving rural communities as defined by a
population of 50,000 or less. Both associations also stated that they
would advise NTPs to actively pursue this funding, working in
[[Page 33865]]
coordination with State opioid treatment authorities as well as SAMHSA
and DEA, once the proposed rule had been finalized.
Several commenters also pointed out the advantages of allowing
practitioners to dispense controlled substances at multiple locations,
as the rule would facilitate. One commenter provided her personal
experiences that she currently can only treat patients with opioid
addiction at the DEA-registered location, where the injectable
buprenorphine is delivered. The commenter believed that allowing
providers to have more than one location is essential for good health
care, because this would greatly increase access and treatment options
for those suffering from opioid addiction.
Finally, several commenters mentioned how the current COVID-19
public health emergency would have negative effects on individuals who
were suffering from OUD, because of State-mandated stay-at-home orders,
social distancing requirements, and severe limitations on some of the
transportation options on which these individuals rely. Commenters
further noted that these negative consequences of the public health
emergency could cause increases in isolation and an inability to reach
treatment clinics, which could result in an increase in overdoses or
even deaths. These commenters said that the use of mobile components
would ensure that these individuals would be able to continue
treatment.
DEA Response: As stated in the NPRM, DEA concluded that waiving the
requirement for separate registration for mobile NTPs is consistent
with the public health and safety, as it will increase access to
treatment for those suffering from OUD in rural and underserved
communities. See NPRM, 85 FR 11008, 11011. DEA re-affirms that position
in the final rule. Specifically, DEA will waive the requirement of
separate registration only for an NTP operating a mobile component at
location(s) remote from, but within the same State as, the NTP's
registered location for the purpose of maintenance or detoxification
treatment.
The intent of the rule is to ensure that there is greater access to
treatment for those who are suffering from OUD, and who are unable to
access treatment because of rural or geographic limitations, mobility
issues, etc. Furthermore, DEA has no objection to NTPs seeking grants
or funding from government programs, or partnering with other
organizations in order to defray the costs of purchasing and outfitting
a mobile component. Regarding the COVID-19 public health emergency,
this is an unprecedented event that has resulted in many agencies and
organizations changing the way they operate. As a result of the public
health emergency, DEA has worked closely with SAMHSA to provide
guidance and support to opioid treatment programs to ensure that any
individual who relies on MAT is able to continue treatment without
disruption. It is DEA's hope that these mobile NTPs will be able to
ensure greater access in in the future, especially when public health
emergencies like this arise.
The Mobile Component Returning to Its Registered Location on a Daily
Basis
Comments: Multiple commenters expressed concern regarding the
requirement in proposed 21 CFR 1301.72(e) to return the mobile
component and the controlled substances on board to the NTP's
registered location daily. One commenter asserted that the daily return
trip to prevent diversion is unnecessary since the mobile NTPs would be
required to keep a record of all controlled substances removed from the
safe on any given day. Several other commenters were concerned that the
proposal would reduce the effectiveness of the mobile NTPs. Two
commenters specifically stated this requirement would significantly
limit the geographical reach of the mobile component. Multiple
commenters argued that travel times could negatively affect the amount
of time the component could operate, as many of the communities being
served by mobile NTPs were far from the nearest DEA-registered NTP
location. In fact, some commenters contended that many of these
communities were hundreds of miles, with some specifying 100 to 200
miles and some simply stating over one hundred miles, from the NTP's
registered location. One commenter further stated that the time
required to travel such large distances could deter NTPs from offering
regular services in the most remote areas. The commenter indicated that
there are communities with significant rates of OUD located as far as
195 miles from the nearest NTP, which would require the mobile
component to travel six hours round trip daily to reach these
communities. The commenter recommended that DEA allow NTPs to enter
into DEA-approved agreements with local or State law enforcement
entities closer to the remote service area to secure the controlled
substances in their facility while the mobile NTP is not in operation.
The commenter stated that DEA already requires controlled substances in
the possession of law enforcement be stored in a manner consistent with
DEA's standard procedures for storing illicit controlled substances,
and referenced DEA's disposal final rule regulation at 21 CFR
1317.35(c) (Collection by law enforcement).\1\ Accordingly, the
commenter pointed out that, if a law enforcement entity in closer
proximity to the mobile component's service area than the NTP's
registered location has secure storage procedures that meet DEA
standards, the medications could be stored at this location for easier
day-to-day access.
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\1\ 79 FR 53520 (Sept. 9, 2014).
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Another commenter expressed concerns that the security requirements
DEA proposed were administratively burdensome, and specifically
mentioned the requirement that the mobile component return to the NTP's
registered location on a daily basis. The commenter stated that this
requirement would increase the amount of time spent traveling, which
would result in additional wear and tear on the vehicles and less time
to work with patients who need care and rely on the mobile component.
The commenter thus indicated that this requirement would detract from
the increased access to treatment and reduced costs of expanded access
that this regulation aims to achieve.
Likewise, a number of commenters also noted that requiring the
mobile components to return to the NTP's registered location every day
would be costly when factoring in staff time, travel costs, and the
wear and tear on the vehicles. Several commenters postulated that these
expenses could easily rival the cost of opening a new brick-and-mortar
NTP. Two commenters estimated the cost for a mobile NTP, with at least
one nurse and one medical assistant, traveling 100 miles round trip,
six times per week for a year, as approaching $62,000. Both commenters
stated this this amount could be more expensive than renting space for
a new registered NTP location in some areas. Several commenters
suggested that this requirement might hinder the effectiveness of the
rule, particularly in rural areas, due to the extra costs and travel
time associated with traveling back and forth daily. One commenter
further stated that although DEA asserted that the proposed rule would
benefit rural areas, this assertion was incorrect due to the scarcity
of registered NTP locations near rural areas, and the costs that would
be incurred if a mobile NTP attempted to
[[Page 33866]]
travel to a rural area each day from an urban area.
Many commenters suggested that DEA allow these mobile components to
stay in the field for longer periods of time. The commenters indicated
that costs would be reduced significantly and there would be more time
for providing care to patients, thus making the mobile components more
effective, if the components were allowed to return to the registered
location less frequently. The majority of commenters proposed only
requiring the mobile NTPs to return to the registered location once a
week, while another commenter suggested a 72-hour turnaround time, and
another commenter simply requested that the mobile NTP be allowed to
remain in the field for ``multiple days.'' One of the commenters who
suggested returning once a week, alternatively recommended the mobile
NTPs not be required to return more frequently than every other day.
Another commenter stated that DEA should not specify when the mobile
component must return or, as an alternative, suggested that DEA should
consider increasing the intervals between returns and only requiring
weekly returns.
Most commenters believed that requiring the mobile components to
return to the registered location less frequently would increase access
to treatment while still maintaining appropriate safeguards against
potential theft and diversion. Indeed, several commenters asserted that
these longer turnaround times were feasible given that DEA was
proposing to apply existing security protocols to mobile components.
One commenter similarly stated that the security measures required by
the proposed rule were adequate to prevent diversion while the mobile
component is in the field. However, one commenter suggested that if the
mobile components are allowed to stay in the field for longer periods
of time, additional security measures should be taken. The commenter
suggested requiring an armed guard outside the mobile component or
requiring the mobile component to be locked in a secure, fenced-in
location.
Finally, one commenter stated that in the absence of evidence of
abuse, DEA should not require the mobile component to return to the
registered NTP location daily or store the controlled substances in the
registered location at the end of each day. The commenter stated that
the proposed rule includes multiple safety measures and procedures that
are adequate to protect controlled substances, which the commenter felt
acted as a significant check against theft and diversion. The commenter
further contended that it is not clear that moving the mobile component
back to the registered location and removing the controlled substances
daily decreases the risk of diversion. Furthermore, the commenter
asserted that DEA does not provide evidence or reasoning to explain how
these requirements reduce the risk of diversion. The commenter insisted
that pending the development of better information regarding the risks
of diversion, DEA should not specify when the mobile component must
return to the NTP's registered location.
DEA Response: DEA appreciates commenters' concerns over the
proposed requirement that the mobile component and the controlled
substances it carries return to the NTP's registered location daily. As
stated before, the intent of the rule is to ensure that more
individuals have access to treatment despite geographical limitations.
The need to ensure that individuals in these remote locations can
access the care that they need has to be balanced against security and
recordkeeping requirements to ensure that the controlled substances on
board the mobile component are not diverted for illicit use.
Several concerns drive DEA's conclusion that, upon the completion
of their daily operations, mobile NTPs generally must return to their
registered locations and secure all controlled substances within their
registered location.
The first and most important concern is the danger associated with
controlled substances that mobile NTPs will be carrying, should those
substances be diverted. Of course, mobile NTPs will primarily be
storing and distributing methadone, and methadone is an extremely
dangerous drug if abused. More specifically, methadone is a potent
schedule II opioid with a relatively long elimination half-life of 8-59
hours with an average of 24 hours depending on the individual.\2\ As
such, methadone can accumulate in an individual's body if taken more
frequently than prescribed or in doses that exceed an individual's
tolerance for the medication.\3\ Methadone has been associated with
adverse events and opioid overdose deaths in those lacking experience
with the drug as well as in experienced users who overuse the drug or
combine it with other illicit drugs or with other prescribed
medications that have adverse drug-drug interactions with methadone.\4\
---------------------------------------------------------------------------
\2\ Substance Abuse and Mental Health Services Administration,
Medications for Opioid Use Disorder. Treatment Improvement Protocol
(TIP) Series 63, Publication No. PEP20-02-01-006, Rockville, MD:
Substance Abuse and Mental Health Services Administration (2020).
\3\ Roxane Laboratories, Dolophine hydrochloride package insert,
<a href="http://Fda.gov/media/76020/download">Fda.gov/media/76020/download</a> (accessed May 10, 2021).
\4\ Food and Drug Administration, Public health advisory:
Methadone use for pain control may result in death and life-
threatening changes in breathing and heartbeat, Silver Spring, MD:
U.S. Department of Health and Human Services, 2006, <a href="https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm12346.htm">https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm12346.htm</a> (accessed May
10, 2021); Modesto-Lowe V, Brooks D, Petry N., Methadone deaths:
Risk factors in pain and addicted populations, J Gen Intern Med 25:
305-309 (2010); Madden ME, Shapiro SL, The methadone epidemic:
Methadone-related deaths on the rise in Vermont, Am J Forensic Med
Pathol. 32(2): 131-135, 2011.
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Methadone is also a demonstrated diversion risk.\5\ It has
significant street value, and its misuse and abuse has been
documented.\6\ And mobile NTPs, especially if they were allowed to
remain away from their registered locations for multiple days, are
likely to be carrying methadone in substantial quantities, enough to be
of great street value and to impose a significant risk to an entire
community should a fully stocked mobile NTP have its methadone
diverted.\7\
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\5\ McCance-Katz EF. The National Survey on Drug Use and Health:
2019. Slide 14. <a href="http://SAMHSA.gov/data/release/2019-national-survey-on-drug-use-and-health-nsduh-releases">SAMHSA.gov/data/release/2019-national-survey-on-drug-use-and-health-nsduh-releases</a> (accessed May 10, 2021).
\6\ National Drug Intelligence Center. Methadone diversion,
abuse and misuse: Deaths increasing at alarming rate. <a href="http://Justice.gov/archive/ndic/pubs25/25930/index.htm#Diversion">Justice.gov/archive/ndic/pubs25/25930/index.htm#Diversion</a> (2007) (accessed May
10, 2021); Wright N, D'Agnone O, Krajci P, et al. Addressing misuse
and diversion of opioid substitution medication: Guidance based on
systematic evidence review and real-world experience. J Public
Health. 38 (3): e368-e374, 2016.
\7\ For example, an average dose range for an individual on
methadone maintenance is 60-120 mg daily, which would be multiplied
by the number of individuals for whom the mobile NTP conveyance
carries doses. See SAMSHA TIP 63, supra note 2.
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So long as methadone remains in a mobile component, it is at an
elevated risk of theft both because the mobile conveyance itself could
be stolen, and because security measures in a mobile NTP will generally
be less robust than those at the NTP's registered location. This risk
is manageable when the mobile NTP is in operation and thus secured by
staff to guard against theft. However, the risk becomes unwieldy--
especially given that dangers posed by such quantities of methadone--
when the mobile NTP is not in use and is unattended, generally at
night, and the likelihood of theft is greater. Thus, by requiring NTPs
to secure their controlled substances within their registered NTP
location after operation each day, DEA decreases the risk that those
controlled substances will be stolen--and thereby decreases the risk
[[Page 33867]]
that the communities served by mobile NTPs will be harmed by diverted
methadone.
Requiring the mobile NTP and its controlled substances to return to
the registered location of the NTP also reduces the likelihood that
controlled substances will be lost or mishandled. Requiring an NTP's
mobile component to return nightly better enables the NTP to monitor
its mobile component's dispensing, and thus become more readily aware
of any problems--such as the ``double-dipping'' discussed below (under
Recordkeeping Requirements for Mobile Components)--or other
discrepancies that may signal that the mobile NTP's controlled
substances are being diverted or otherwise improperly dispensed.\8\ For
similar reasons, DEA will not allow NTPs to enter into agreements with
local or State law enforcement entities closer to the remote service
area to secure the controlled substances in their facility while the
mobile NTP is not in operation. Even assuming that these law
enforcement entities are equipped to securely store the controlled
substances, the regular transfer of these substances back and forth
between mobile NTPs and the law enforcement entities would inhibit the
NTP's (and ultimately DEA's) ability to monitor the controlled
substances and unnecessarily create opportunities for the substances to
be stolen, mislaid, or otherwise mishandled.
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\8\ DEA appreciates commenters' suggestions that the risk of
theft or diversion of controlled substances left in a mobile NTP
overnight could be mitigated by increasing the security requirements
for mobile NTPs. While such measures could reduce the danger of
theft or diversion somewhat, they would not suffice to overcome the
inherent enhanced dangers of leaving controlled substances in an
unmanned conveyance overnight at an unregistered location. And such
enhanced security measures would do nothing to address the reduction
in the registered NTP's ability to monitor the mobile component's
dispensing that would result if mobile NTPs were not required to
return to their registered NTP location nightly.
---------------------------------------------------------------------------
Additionally, allowing mobile NTPs to remain in operation for
multiple days without returning to their registered locations not only
presents an elevated risk of diversion, there are alternative options
that make it generally unnecessary. For example, nothing in this rule
impacts the ability of an NTP to register at an additional physical
location. Thus, if an NTP wishes to treat patients with methadone at a
remote correctional facility or similar rural location, that NTP could
simply register a physical location in the area to which to return its
mobile component and where to secure its controlled substances. Indeed,
a correctional facility can itself register with DEA as an NTP. While
some correctional facilities have obtained an NTP registration, DEA
wishes to emphasize this option for those who may be unaware of it.
Moreover, many OUD patients may be successfully treated with
alternative medications such as buprenorphine or naltrexone.
Buprenorphine is a schedule III narcotic drug approved by the U.S. Food
and Drug Administration (FDA) for the treatment of OUD, and, as such,
may be dispensed for such purpose without the dispenser being
registered as an NTP.\9\ Naltrexone is a non-controlled substance and,
as such, may be dispensed without a DEA registration. Accordingly, OUD
treatment involving the use of either buprenorphine or naltrexone does
not require the use of a mobile NTP.
---------------------------------------------------------------------------
\9\ The CSA requirements governing the dispensing of
buprenorphine are set forth in 21 U.S.C. 823(g)(2).
---------------------------------------------------------------------------
In sum, DEA has concluded, for the reasons stated above, that it is
necessary and appropriate to maintain in the final rule the requirement
that a mobile NTP return to its registered location each day. However,
in view of the comments DEA received on this issue, DEA wishes to
emphasize that it has decided to add to the text of the final rule a
provision that expressly allows NTPs to apply for an exception to this
requirement. The process for applying for such an exception will be as
set forth in 21 CFR 1307.03, which allows any person to apply for an
exception to any provision of the DEA regulations. As with all
applications for an exception to any provision of the regulations
submitted pursuant to section 1307.03, each application for an
exception to the requirement that a mobile NTP return each day will be
evaluated by DEA on a case-by-case basis in determining whether the
applicant has demonstrated exceptional circumstances that warrant a
waiver of the regulation. In making this determination, DEA will
consider the applicant's security and recordkeeping as well as other
factors relevant to determining whether effective controls against
diversion will be maintained. DEA is revising 21 CFR 1301.72(e) (from
that proposed in the NPRM) to reflect this change to the regulatory
text.
In addition, DEA will continue to evaluate the risk of diversion
that might result from eliminating, in some circumstances, the
requirement that a mobile NTP return to its registered location each
day. DEA will closely monitor applications seeking an exception to that
requirement. One year after this rule is finalized, DEA will review
whether additional rulemaking is necessary to improve access to
treatment via mobile NTPs. In conducting its review, DEA will consult
with the Department of Health and Human Services (HHS) and the Office
of National Drug Control Policy (ONDCP). If the volume and nature of
such applications and an evaluation of the associated risk of diversion
warrant it, DEA will further amend the regulations to allow mobile NTPs
to be excepted from this requirement--without having to apply for an
exception--under certain specified circumstances. If DEA determines
that such additional amendment to the regulations is warranted, it will
initiate a separate rulemaking proceeding to do so in accordance with
the Administrative Procedure Act (APA).
Security Requirements for Mobile Components
Comments: Several commenters addressed the security requirements
that were detailed in the proposed rule. Two commenters, who
recommended a 72-hour return instead of the proposed same day return
requirement for mobile NTPs (see discussion above), suggested that the
final rule add additional security requirements during this 72-hour
time frame. The commenters suggested either utilizing armed security
guards outside the mobile component, or locking the mobile component in
a secure fenced-in location and using, possibly, unarmed (rather than
armed) security guards. One commenter believed such security measures
would not present any additional diversion issues and noted that DEA
acknowledged thefts from mobile NTPs in the past had not been an issue.
One commenter pointed out the known criminal activity risks
associated with having controlled substances on site, such as theft,
and noted that ``brick-and-mortar'' NTPs often protect their employees
and patients through various security measures. The commenter provided
two examples of these measures: (1) A panic button that, when
activated, triggers law enforcement to immediately respond, and (2) the
local law enforcement knows the existence and whereabouts of an NTP
and, therefore, can respond quickly and efficiently to an emergency. In
contrast, the commenter stated that the proposed rule fails to mention
whether mobile NTPs must take any explicit security measures to protect
their employees and patients, including installing panic buttons, or
making local law enforcement aware of the mobile NTPs' exact locations
at any given moment, including during travel. The commenter
[[Page 33868]]
requested that the final rule more fully address how mobile NTPs will
implement such security measures to improve the safety of their
employees and patients.
DEA Response: DEA appreciates the concerns expressed regarding the
security requirements for mobile NTPs. DEA regulations have always
required that all registrants maintain effective security to guard
against theft and diversion of controlled substances. See, e.g., 21 CFR
1301.71(a). The need for such security applies equally to mobile NTPs.
Thus, under this final rule, the security requirements of 21 CFR
1301.72(e) and 1301.74(j)-(n) apply to the mobile components of NTPs to
ensure this need for security is met.
Of course, under certain circumstances, mobile NTPs may need
additional security measures beyond those specifically required by DEA
regulations to effectively protect against theft or diversion of
controlled substances. Because the need for such measures is
circumstance-specific, DEA is not including them in the final rule, but
rather will rely on local DEA personnel, NTPs themselves, and any other
relevant laws and regulations to determine what additional measures, if
any, are necessary. In particular, DEA will leave the decision on
whether armed or unarmed security personnel will be utilized by the
mobile component while it is away from its registered location to the
NTP, as there are many factors that should be considered when making
this decision. For example, the NTP may want to consider the location
to which the mobile components will be traveling, the cost of security
personnel, and whether or not these security personnel would fit in to
any standard operating procedures used by the NTP. Thus, DEA will not
mandate that armed or unarmed security personnel be utilized by these
mobile components.
The proposed rule stated in proposed 21 CFR 1301.72(e) that the
mobile component must be returned to the registered location on a daily
basis. See NPRM, 85 FR 11008, 11011, 11019. DEA appreciates that some
registered NTP locations might not have enough room to park the mobile
component overnight; therefore parking the mobile component in a secure
fenced-in location would be permissible, as long as all DEA security
requirements are met, the controlled substances are removed from the
mobile component at the end of the day, and the local DEA office is
notified of the location where the mobile component will be parked
overnight.
For similar reasons, DEA will leave the decision on what safety
measures the NTP would like to take to ensure the safety of the mobile
component's staff and patients to the NTP and any relevant government
bodies outside of DEA. There are many factors like the location of the
NTP, the number of patients it treats, cost, etc., which would affect
the NTP's decision when deciding which safety measures would ensure
patient and staff safety. Aside from DEA security requirements, there
are other Federal, State, local, and tribal laws these NTPs must take
into consideration when making their decision. Thus, because the
appropriate safety measures for a mobile NTP will vary based on
circumstances and legal requirements, DEA will not attempt to specify
additional safety requirements for NTPs as part of this rule. If such
requirements are necessary, other Federal, State, local, and tribal
authorities can create them.
Comment: One commenter stated that the proposed rule was silent on
what would happen to the medication if the mobile NTP breaks down, and
recommended that DEA include a requirement for a standard operation
procedure or contingency plan if the vehicle breaks down while en route
to the communities where services are provided remotely, and if the
mobile NTP is out of service for an extended period due to repairs. The
commenter suggested that at a minimum, the standard operating procedure
needs to include plans for dosing patients in the following
circumstances: (1) If the mobile NTP breaks down while en route to the
community, and (2) when the mobile NTP is out of service for an
extended period due to repairs. The commenter expressed concern that if
these plans are not in place, patients may encounter barriers to
receiving their medication in an alternative manner (e.g.,
transportation and costs to reach a registered NTP location, waivers by
NTP for patients to have ``take home'' privileges for the medication)
and be put at increased risk for overdose. The commenter also noted
possible limitations in the responsiveness of a mobile NTP's security
system, reliant on Wi-Fi capability, when the mobile NTP has weak or no
access to Wi-Fi while in rural communities and is not near the
registered NTP location.
DEA Response: DEA has concluded that it is unnecessary for this
rule to require NTPs to create a contingency plan for dosing patients
served by the mobile NTP if the mobile NTP breaks down or is placed out
of service. NTPs may well decide that such plans are appropriate, and
other laws, regulations, or governing bodies may require them. The
requirements DEA is imposing in this rule, however, are appropriately
focused on DEA's duty under the CSA to protect against the diversion of
controlled substances. Thus, DEA is requiring a contingency plan for
safeguarding the mobile NTP's controlled substances if it breaks down.
In the proposed rule, DEA stated that if the mobile component was
disabled for any reason (mechanical failure, accident, fire, etc.), the
registrant would be required to have a protocol in place to ensure that
the controlled substances on the conveyance are secure and accounted
for. DEA went on to state that if the conveyance is taken to an
automotive repair shop, all controlled substances would need to be
removed and secured at the registered location. However, other than
those security requirements, DEA will not specify what should be
included in the NTP's standard operating procedures, or what plans NTPs
should implement regarding dosing patients while the mobile component
is out of service. Such matters are beyond the scope of this rule, and
properly within the judgment of the NTP and any relevant regulatory
bodies outside of DEA.
Comment: Another commenter noted that the proposed amendment to DEA
regulations at 21 CFR 1301.74(l) would provide DEA discretion to
require additional security measures for mobile NTPs based on certain
factors. The commenter acknowledged that DEA currently has this
discretion for NTPs but could not locate any DEA guidance on how DEA
utilizes the listed factors to determine if an NTP applying for
registration warrants additional security measures. The commenter
stated that this proposed provision similarly did not provide any
information regarding how DEA would use these factors to evaluate
security measures for mobile components, nor did DEA provide a single
example of the security measures it might require for such a component
if the factors were relevant.
As a result, the commenter believed this provision to not be clear
or transparent and could lead to DEA field offices unevenly or
arbitrarily applying the regulations. The commenter further stated that
a registered NTP considering starting a mobile NTP would likely have to
reach out to the local DEA field office early in the planning phase
which could result in delays getting the mobile component up and
running. Therefore, the commenter recommended that DEA not finalize
this proposed provision, or at the very minimum, that DEA provide
clarity in the final rule preamble regarding the factors and additional
security measures.
[[Page 33869]]
Another commenter noted that current regulations provide DEA
discretion to prescribe security requirements to the NTP based on
certain factors. However, this commenter stated that it would seem
practically impossible for DEA to fully exercise its discretion under
21 CFR 1301.73(l) and effectively set security standards for mobile
components, given the changing locations of mobile components when
contrasted with registered NTP locations.
DEA Response: Under the final rule, DEA will review the security
systems used on these mobile components and make a determination on
which security systems meet DEA requirements on a case-by-case basis
before approving the operation of a mobile NTP. DEA appreciates the
concern that such case-by-case evaluation of mobile NTPs' security
systems may lead to delays and differences in enforcement between local
DEA offices. As it is DEA's intent to ensure that there are no delays
or unfairness in getting mobile components up and running, DEA will
endeavor to prevent such problems from occurring.
DEA, however, cannot forego case-by-case determinations, even if
they inevitably bring some risk of delay or enforcement discrepancies.
As discussed above, although this final rule and DEA regulations more
broadly articulate basic security requirements, they cannot account for
all security situations. Some situations may require additional
security measures for a mobile NTP to be able to adequately guard
against loss through theft or other forms of diversion. Attempting to
account for all such scenarios in advance through regulation is
ineffective and may impose unnecessary restrictions on other mobile
NTPs. DEA can best ensure that mobile NTPs provide adequate security by
enabling local DEA offices to conduct case-by-case evaluations as
appropriate. That said, DEA is slightly modifying the proposed
regulatory language describing how these case-by-case evaluations are
conducted in this final rule to clarify that DEA, not any other entity,
applies the factors.
DEA has concluded that mobile NTPs' changing locations will not
compromise its ability to make such assessments. DEA already evaluates
the security arrangements provided by a wide range of registrants under
many different circumstances. Although mobile NTPs do present some
unique challenges, DEA is confident that it can work with mobile NTPs
to ensure that they operate securely.
Comment: Finally, one commenter stated that DEA's security
requirements in 21 CFR 1301.72 through 1301.76 are extremely outdated
and currently put all registered NTPs, as well all DEA registrants, at
high risk for diversion, and that this risk would extend to mobile
NTPs. In particular, this commenter claimed that, in today's
environment, the controls outlined in 21 CFR 1301.75(a) and (b) are
inconsistent with those in 21 CFR 1301.71(a), and stated that securing
controlled substances consistent with DEA's non-practitioner
requirements in 21 CFR 1301.72(a) can potentially reduce crime by 75-85
percent. This commenter encouraged DEA to strengthen and enhance the
schedule I-V physical security requirements for all registrants
consistent with 21 CFR 1301.72(a), by utilizing currently available
market technologies.
DEA Response: DEA appreciates this comment suggesting in general
terms that it broadly update the security requirements of its
regulations to better reflect currently available security
technologies. DEA recognizes that technologies change, but has
concluded that the security regulations in this rule adequately protect
against theft and diversion in the use of mobile NTPs given current
technologies. The sort of broader changes to DEA security regulations
suggested by the commenter are beyond the scope of this rule.
Recordkeeping Requirements for Mobile Components
Comments: One commenter stated that they did not see a reason why
all of the records mobile components would be required to keep could
not be electronically logged in on a daily basis, while still being in
compliance with the proposed amendment to 21 CFR part 1304. Another
commenter noted that the proposed rule allows mobile NTPs to maintain
electronic dispensing logs; however, the mobile NTP would still need to
print out a hard copy of such log daily with the dispenser of each dose
initialing each relevant entry. The commenter advocated for allowing
these dispensers to use digital signatures in these logs because the
processes for digital signatures are readily available and widely used,
and using digital signatures would reduce unnecessary paperwork for
physicians. In addition, the commenter stated that DEA should not
require pre-approval of the mobile NTP's electronic recordkeeping
system for the dispensing log because this could create unnecessary
delays in the transition to electronic recordkeeping. Further, if DEA
permits digital signatures in the final rule, the commenter requested
that DEA clarify that DEA's approval of an electronic recordkeeping
system for a registered NTP location will be sufficient for the mobile
component.
DEA Response: DEA recognizes the concerns expressed by commenters
regarding the use of electronic dispensing logs. In the proposed rule,
DEA proposed an alternative to maintaining a paper dispensing log,
stating that an NTP or its mobile component may also use an automated/
computerized data processing system for the storage and retrieval of
the program's dispensing records, if a number of conditions were met.
The requirement that the NTP or its mobile component print a hard copy
of each day's dispensing log, which is then initialed appropriately by
each person who dispensed medication to the program's patients, is one
of the conditions that must be met. This requirement, along with the
others specified in section 1304.24(b)(1), is based on recommendations
in the Narcotic Treatment Programs Best Practice Guideline (April
2000).\10\ Furthermore, DEA emphasizes that the rule is not adding
additional recordkeeping requirements to NTPs. The rule is instead
simply applying already-existing recordkeeping requirements of 21 CFR
part 1304 to mobile NTPs, as well as providing NTPs and their mobile
components the option of using a computerized data processing system,
instead of a paper dispensing log. DEA believes the recordkeeping
requirements in this rule are necessary to ensure accountability and
prevent diversion. Thus, DEA generally agrees that electronic logging
of dispensing records is appropriate. These electronic records,
however, will still have to be logged on a daily basis, and must comply
with the requirements in 21 CFR part 1304. Finally, requiring the NTP
employee who dispensed the medication to review and initial the hard
copy of the dispensing log at the end of each day is important for
maintaining accurate records and ensuring accountability.
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\10\ The Narcotic Treatment Programs Best Practices Guideline,
developed by DEA in collaboration with the American Methadone
Treatment Association (now the American Association for the
Treatment of Opioid Dependence), provided assistance in
understanding the provisions of the CSA and in the implementation of
the regulations as they apply to dosage reconciliation practices in
NTPs. DEA rescinded the guideline after publication of the NPRM, but
the recommendations it contained continue to represent best
practices for NTP operation.
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DEA also notes the commenter's concerns about the requirement that
[[Page 33870]]
DEA must pre-approve any electronic recordkeeping system used in lieu
of a paper dispensing log. Prior to granting a registration to an NTP
and its mobile component, under Sec. 1301.13(e)(4) of this rule, the
local DEA field office must evaluate all of the mobile components'
procedures and processes to determine if they provide effective
controls against diversion. If the electronic recordkeeping system
meets all of the recordkeeping and security requirements under the CSA,
DEA will approve the system; this will be done on a case-by-case basis.
If a registered NTP has an electronic recordkeeping system that is
approved by DEA, this does not necessarily mean the same system will be
as useful on the mobile component; this is why the electronic
recordkeeping system on the mobile component must be evaluated
separately.
Comment: One commenter expressed concern that under the proposed
rule, it appeared that patients could engage in ``double-dipping'' by
receiving treatment at a mobile NTP in the morning, and then at a
registered NTP location later in the day, for example. The commenter
stated that under the proposed revisions to 21 CFR 1304.24 there is a
requirement that NTPs must maintain records of patient information
including the dosage consumed, but no requirement that the records be
maintained in real-time, potentially allowing such ``double-dipping''
to occur before an NTP could compare dispensing logs and discover it.
Therefore, to decrease the likelihood of patient overdoses, the
commenter recommended that the final rule require all mobile NTPs to
record doses in real time.
DEA Response: NTPs have protocols in place to ensure that their
patients cannot engage in ``double-dipping'' by receiving treatment at
a mobile component in the morning, and then at a registered NTP
location later in the day; the use of paper or electronic logs should
not have a major impact on these protocols. Moreover, regardless of
whether NTPs have such a protocol in place, ordinary diligence by NTPs,
including periodic comparisons between the dispensing logs of a mobile
NTP and its registered NTP, should readily reveal any individuals who
are engaged in such ``double-dipping'' and enable NTPs to take steps to
prevent them from doing so in the future. Although the use of ``real-
time'' electronic dispensing logs might allow an NTP to uncover such
``double-dipping'' more quickly, DEA has concluded that requiring the
use of technology could be burdensome and is not necessary to prevent
``double-dipping'' from becoming a significant source of diversion or
significant risk of overdose among patients. Thus, DEA has concluded
that NTPs should generally be capable of guarding against ``double-
dipping'' without further regulation. Every NTP has protocols in place
to ensure that their patients receive the correct dose, and to ensure
that the records containing this information are correct and up-to-
date. As stated earlier, DEA has concluded that the use of technology
could be burdensome, which goes against the purpose of this rulemaking.
For these reasons, DEA will not require all mobile components to record
doses in real time; however, if a mobile NTP chooses to do so, that
would be permitted.
Advantages of Serving Multiple Locations
Comments: One commenter stated that the proposed rule was ambiguous
on whether the mobile component could park at a location, dispense
medication, and then move to another location or locations for further
dispensing. The commenter suggested that DEA revise the proposed rule
to explicitly allow mobile treatment components to serve multiple
locations in a single day, because this would enable opioid treatment
providers to help patients residing in skilled nursing/long term
nursing facilities to receive their medication for opioid use disorder.
The commenter did not provide any specific information on how this
would help.
DEA Response: DEA will leave the decision of whether a mobile
component serves multiple locations in a single day to the NTP. For a
mobile component in a more urban area, multiple stops might be more
feasible, in comparison to a mobile component that would be serving a
more remote area. As long as these mobile components follow all
applicable Federal, State, local, and tribal laws, DEA will permit the
mobile component to serve multiple locations. Although the proposed
rule was not intended to limit mobile NTPs to serving a single
location, DEA recognizes that references in the proposed regulatory
text to mobile NTPs serving ``a location'' or ``a dispensing location''
in proposed 21 CFR 1300.01(b) and 1301.72(e) may have been confusing.
Thus, in this final rule, DEA has revised these sections to clarify
that a mobile NTP may serve multiple remote locations.
The Use of Past/Current Mobile Components
Comments: Several commenters noted that mobile components have not
only been used in the past, but some States are currently using them,
and they have had a positive impact on the communities they operate in.
One commenter stated that Minnesota benefited from a mobile methadone
unit that operated approximately 15 years ago, because it increased
compliance with dosing and provided services to geographically remote
patients, allowing for better supervision, and faster stabilization of
both dose and behavior. Another commenter said many NTPs already
operate mobile components and these revisions will allow more
flexibility, allowing even more NTPs to provide treatment via mobile
components. A commenter who worked at a treatment program mentioned
that their organization operated a mobile Suboxone program, and stated
that it benefitted the community because the number of overdoses had
been greatly reduced, and larger numbers of people were able to
initiate treatment who would not otherwise have been able to without
such access.
Finally, two commenters mentioned the use of mobile components in
emergency situations, such as during Hurricanes Katrina and Sandy. One
of these commenters mentioned how mobile methadone components are an
important part of the broad continuum of care for individuals with OUD,
and stated these mobile components provided essential treatment
services during Hurricane Katrina. However, the other commenter noted
that mobile components had been largely unavailable to providers
responding to emergency situations. That commenter mentioned that
during Hurricane Sandy in 2012, affected NTPs employed strategies such
as alternative transportation, take-home dosing, and guest dosing at
nearby programs (i.e., temporary dosing at another NTP) to ensure
continued access to treatment, and stated that these actions had
varying degrees of execution and success. The commenter went on to say
that mobile NTPs were considered as an option for reaching patients
when facilities were destroyed, but one unit was being repaired at the
time and the other was not able to operate because there was not a
functioning registered NTP location to store the methadone.
DEA Response: DEA appreciates the information provided by the
commenters. As stated previously, the intent of this rule is to ensure
that there is greater access to treatment for those who are suffering
from OUD, and are unable to access treatment because of rural or
geographic limitations, mobility issues, etc. The revised regulations
will allow NTPs the option to use mobile
[[Page 33871]]
components during emergency situations such as those described by the
two commenters, as long as all applicable, Federal, State, local, and
tribal laws are followed when operating these mobile components. As
discussed in the NPRM, prior to this rule, DEA only authorized mobile
NTPs on an ad hoc basis and had placed a moratorium on new
authorizations in 2007. See 85 FR 11008, 11009. This rule will allow
the use of mobile NTPs to be expanded more extensively, more
consistently, and with greater protections against theft and diversion
than was possible before.
The Costs and Benefits Associated With Mobile Components
Comments: Many commenters believed that this proposed rule would
give providers a lower cost option for reaching patients where it may
not be otherwise financially feasible to establish a new registered NTP
location. Several commenters stated that the proposed rule would reduce
the costs for NTPs wanting to expand their geographic reach and
increase the treatment they are able to provide. Several commenters
pointed to benefits that would result from the use of these mobile
components that might not be quantifiable. Multiple commenters stated
that the proposed rule would save many lives, as well as improve the
health and well-being of patients receiving treatment, and allow these
patients to live productive and satisfying lives. One commenter
mentioned that the use of mobile NTPs could start saving thousands of
lives and decrease illicit opioid use.
Other commenters mentioned the savings that would be realized by
allowing the mobile components to register only once. One commenter
estimated savings between $1,270,670 and $1,482,272 would be possible
over five years ``simply because operating out of the mobile unit would
allow more treatments to be dispensed and operating over multiple
locations would bring in more revenue.'' However, the commenter did not
explain the basis for this estimate.
Conversely, one State behavioral health agency expressed general
concerns about the startup costs associated with operating a mobile
component, and stated that some NTPs may find this expense to be a
barrier to establishing a mobile component. The commenter further
indicated that as a result, some NTPs may desire to partner with
agencies who already own well-equipped mobile components. The commenter
recommended that DEA explicitly indicate whether it will allow a
registered NTP to partner with an organization who owns a mobile NTP
(e.g., hospital or health center).
As discussed in detail above, many commenters were opposed to
requiring the mobile component to return to the NTP's registered
location on a daily basis; the costs of the daily round trips were
chief among the issues raised when voicing their concerns. These
commenters generally believed that the costs associated with traveling
to and from the communities served by mobile NTPs (e.g., staff time,
travel costs, wear and tear on vehicles, etc.) could easily rival the
cost of opening a new registered NTP location, especially when the
communities are 100 to 200 miles away, as noted by some commenters. Two
commenters gave an example of a mobile NTP with at least one nurse and
one medical assistant traveling 100 miles round trip six times per week
for a year and estimated the yearly cost, based on the proposed rule's
estimated per mile operating cost, would be close to $62,000.
Similarly, another commenter remarked that in the summary and benefits
section of the proposed rule's preamble, the mileage used to estimate
operating costs for a mobile NTP, no more than 5,000 miles per year
(100 miles per week), was rather low, especially for rural areas in
some States.
Three commenters also detailed other expenses that might result
from operating the mobile component. One commenter stated that while
the proposed rule provided potential safeguards addressing security,
theft, and misuse, the rule did not discuss in its cost-benefit
analysis the intangible costs associated with detecting any violation
of either operating the mobile component as a treatment center or any
of the rule's other prohibitions. However, the commenter did not detail
any specific cost numbers for these intangible costs. One commenter
expressed concerns that the costs associated with paying an entire team
of healthcare professionals for their travel time would likely be
expensive and possibly even cost prohibitive, particularly if mobile
NTPs will provide the same interdisciplinary services offered at
registered NTP locations. This commenter further stated that the
proposed rule failed to address these costs. Another commenter also
mentioned the small, extra expense of hiring security personnel to
protect the mobile NTP, which the commenter recommended if the
regulations would no longer require the mobile NTPs to return to the
DEA-registered location at the end of each day.
Finally, a commenter expressed great appreciation that the proposed
rule's economic analysis qualitatively described benefits and cost-
savings that cannot be quantified, including reduced health care costs,
criminal justice costs, and lost productivity costs that will be
reduced as a result of increased access to treatment. However, the
commenter stated that this analysis omitted other important
unquantifiable benefits, such as improved quality of life and improved
dignity for patients who can access treatment. The commenter stated
that the major benefit of this proposed rule is its expected effect on
the cost to treat each patient with OUD and the number of patients who
have access to such treatment (i.e., a decrease in costs and an
increase in patients), noting that this will improve the quality of
life and dignity for patients who can access this critical treatment.
Therefore, the commenter suggested that DEA should revise its economic
analysis and acknowledge these benefits in the final rule. In addition,
this commenter stated that DEA should clarify in the final rule that
the benefit-cost analysis framework applied in the proposed rule shows
that a reduction in the marginal cost of treating patients for OUD
could expand output, which would be a social benefit. The commenter
explained that the analysis conducted by DEA in the proposed rule
assumes that NTPs are currently incurring costs to expand treatment
access by opening additional registered NTP locations. However, the
commenter further noted that if DEA's assumption is not true, and NTPs
are not currently incurring costs to expand registered NTP locations,
then under this rule, NTPs might actually incur more costs, the costs
associated with operating a mobile NTP.
DEA Response: DEA appreciates the support from commenters agreeing
with the agency's assessment that this rule will provide a less costly
avenue for NTP's to expand operations and treat more patients compared
with opening a new registered NTP location. As stated earlier, the
intent of the proposed rule is to ensure that treatment is made more
widely available to those who need it. Although not readily
quantifiable, saving lives, preventing overdoses, and ensuring patients
receiving treatment are able to live productive lives help further the
purpose in the proposed and final rule. Regarding one commenter's view
that DEA has not accounted for a potential increase in costs to the
agency related to monitoring the security and recordkeeping of mobile
components, DEA anticipates that its field offices will conduct any
necessary security reviews
[[Page 33872]]
as a part of their routine NTP inspection workload, thus there will be
no additional costs to DEA.
DEA's estimation of operating costs for a mobile NTP represents the
average costs for an NTP choosing to operate a mobile component. As one
commenter noted, in certain rural locations throughout the United
States, these operating costs may be higher than the average costs
presented in the regulatory analysis because NTPs may choose to travel
further distances on a more frequent basis in order to reach patients
in particularly remote areas. These operating costs may even surpass
the costs associated with opening another registered location.
Delivering treatment to patients in very remote locations will always
carry higher transaction costs than delivering treatment to patients in
readily accessible locations such as urban or suburban centers. Absent
this rule, however, treating patients in these remote areas would
likely require opening not just one more registered location, but many.
DEA is confident that the operating costs of a single mobile NTP
servicing a wide geographic area will always be less than those of
multiple additional registered NTP locations that would be required to
treat the patients dispersed throughout the same area.
Additionally, DEA recognizes that some mobile components may indeed
travel greater distances than the 100 miles per week estimated in the
proposed rule. However, DEA considers this mileage estimate to be a
reasonable average of the weekly distance any particular mobile
component might travel to treat patients, especially when factoring in
mobile components that will operate in more densely-packed urban and
suburban settings. As another commenter noted, operating a mobile
component may also result in higher cost savings than what is presented
in the regulatory analysis due to the possible increased volume of
patients treated by a mobile component. Again, DEA's analysis
represents average cost savings when comparing the operation of a
mobile NTP with a registered location, and therefore, this is factored
into the agency's conclusions below.
Regarding one commenter's challenge that the labor costs for the
healthcare professionals needed to staff a mobile component would
likely be prohibitive, DEA assumes that the labor required to provide
MAT services are the same in a mobile component and a registered NTP
setting. Therefore, any particular NTP would incur those labor costs
when choosing to expand operations, whether via starting a mobile
component or opening an additional registered NTP location.
DEA agrees with the commenter stating that this rule is likely to
result in an increase in quality of life and personal dignity for
previously untreated patients who are able to receive care from a
mobile NTP. DEA believes that these benefits are already discussed in
the regulatory analysis below, and no further expansion is necessary.
DEA also agrees with the commenter's summation that the framework
for the analysis presented in the regulatory impact analysis of this
rule is a marginal cost framework, i.e., a comparison of the
incremental costs incurred by NTPs choosing to expand operations under
the baseline regulatory environment vs. under the rule's regulatory
environment. DEA does not see any benefit to the public in explaining
this fact further in the regulatory impact analysis.
The Ability of the Mobile Component To Operate as an Emergency Medical
Services Vehicle or Hospital
Comments: Several commenters noted that DEA did not address the
specific services the mobile component could and could not provide to
those individuals who utilize it. Many of these commenters also
provided suggestions for the services they believed the mobile
components should provide. One commenter suggested that DEA allow the
mobile component to operate as an emergency medical services (EMS)
vehicle or a hospital. The commenter stated that by not allowing the
vehicles to operate as an EMS vehicle (e.g., to transport patients) or
a hospital, there was a risk to the communities being served by the
mobile component, because many of the rural areas might not have local
hospitals or only have access to hospitals that are overcrowded and
underfunded. The commenter also noted that some community members
utilizing the mobile component may mistakenly assume that the mobile
component is able to treat overdose victims or try to seek emergency
treatment at a mobile component instead of an EMS vehicle or a
hospital.
One commenter suggested that DEA revise the proposed amendment, 21
CFR 1301.13(4)(ii), to state explicitly that mobile NTPs are allowed to
conduct the necessary medical and psychosocial services required to
induct and maintain MAT/medications for opioid use disorder (MOUD); to
utilize a Qualified Service Organization Agreement (QSOA) with an
entity or entities that can provide these services; and to provide
counseling services electronically (e.g., telehealth) by qualified
providers. The commenter also mentioned that allowing these services,
which would have to be consistent with applicable State and Federal
law, would decrease the risk of discontinuity of care, which could
cause the patient to relapse and/overdose.
Another commenter noted that the proposed rule did not include
guidance on ancillary requirements for NTP patients such as toxicology
and serology, and stated that the NTP registrant should be required to
indicate whether physical examinations, toxicology testing, and
serology testing would be conducted in the mobile NTP or at the
registered NTP location. The commenter also asked if the mobile NTP
could conduct these services, and if not, recommended that the rule
include clear guidance as to where these services could be provided or
if these services could be conducted in coordination with a partner,
like a hospital.
Finally, another commenter suggested that the final rule should
expressly state that services such as infectious disease screenings and
harm reduction interventions are available in mobile NTPs just as they
are at the registered NTP locations. As these mobile NTP components are
to operate as ``coincident,'' or equivalent, to the registered NTP
location, the commenter suggested, a mobile NTP should provide most or
all of the same supplemental services that are logistically possible.
The commenter stated further that the exclusion of such language could
be interpreted as prohibiting these critical public health
interventions that are essential to addressing disparate rates of
sexually transmitted and other infectious diseases among persons with
substance use disorder, especially those who inject drugs.
DEA Response: DEA appreciates commenters' concerns about those
individuals in rural communities being served by the mobile component
not having local hospitals or access to hospitals that are overcrowded
or underfunded. However, as stated in the NPRM, the mobile components
will not be configured in a way to allow them to serve as an EMS
vehicle or hospital, and will not have the necessary equipment or
supplies on board to function as such. See NPRM, 85 FR 11008, 11010.
In the preamble of the proposed rule, DEA stated it was proposing
to waive the requirement of a separate registration for NTPs that
utilize mobile components, and that specifically, an NTP would be
permitted to dispense narcotic drugs in schedules II-V at location(s)
remote from, but within the
[[Page 33873]]
same State as, the NTP's registered location, for the purpose of
maintenance or detoxification treatment. See NPRM, 85 FR 11008, 11009.
DEA did not include guidance on ancillary requirements for NTP patients
such as toxicology and serology, infectious disease screenings, and
harm reduction interventions, because if and how such services are
provided is outside the scope of DEA's authority. Although nothing in
the rule prohibits a mobile NTP from providing such services, (if they
can be provided in a manner consistent with the rule and other laws),
it is similarly outside the scope of DEA's authority to explicitly
permit mobile NTPs to conduct the medical and psychosocial services
required to induct and maintain MAT/MOUD, to utilize a QSOA with an
entity or entities that can provide these services, and to provide
counseling services electronically by qualified providers. Further, the
registered NTP should decide whether its mobile component will offer
these services based on the needs of the community they are servicing,
staffing, financial impact to the NTP, etc. As long as the NTP follows
all applicable, Federal, State, local, and tribal laws, DEA knows of no
reason, at this time, why these activities would be prohibited.
The Mobile Component Servicing Correctional Facilities
Comments: Approximately 20 commenters addressed the benefits of
mobile components servicing incarcerated individuals with OUD. All of
these commenters asserted that this rule would help in the treatment of
incarcerated individuals. Commenters posited that the proposed
revisions might allow NTPs to bring their mobile components to
correctional facilities, as these facilities might have logistical
difficulties arranging the transport of inmates to NTPs. One commenter
recommended that DEA collaborate with NTPs and other Federal agencies
to maximize opportunities to increase the use of mobile methadone to
increase treatment access for these vulnerable populations. Several
commenters similarly suggested that NTPs partner with law enforcement
and State opioid treatment authorities to expand access to the services
provided by the mobile component to correctional facilities. An
organization representing individuals in medication-assisted recovery
from OUD declared that it would encourage its members to advocate for
the use of mobile components in these facilities with their State
opioid treatment authorities and local law enforcement agencies.
Some commenters noted that existing mobile NTPs have proven to be
helpful in providing treatment for incarcerated individuals; however,
no specific examples were provided. Another commenter, a non-profit
organization, gave an example where mobile NTPs in Atlantic County, New
Jersey provide medication (methadone, buprenorphine, and naltrexone)
and counseling to inmates onsite, and link those being released from
correctional facilities to community-based NTPs. The non-profit also
stated that one NTP that shared that its mobile NTP had treated more
than 1,000 inmates in more than two years, and that these inmates
subsequently had a lower recidivism rate compared to the general
correctional facility population. Other commenters cited studies that
showed how access to MAT services would decrease the rates of
recidivism and post-release mortality as patients successfully
transition from the correctional environment into an outpatient
treatment setting. Two commenters both referenced data from a study in
Rhode Island; the commenters reported that the data showed that
offering MAT during incarceration and upon release resulted in a 60
percent decrease in overdose mortality among people who were recently
incarcerated. One of the commenters described the study as ``recent,''
but neither provided a specific citation for the study.
Finally, a pharmaceutical manufacturer sought clarity for itself,
and its treatment provider customers, on whether NTPs operating a
mobile component as described in the proposed rule would be allowed to
regularly use the mobile component to transport and provide NTP
services, including methadone treatment, to inmates housed in
correctional facilities. The manufacturer believed the plain language
of the proposed rule's legal authority, as well as the proposed changes
to 21 CFR 1301.13(e)(4), authorize a properly registered NTP operating
a mobile component to dispense narcotic drugs for addiction treatment
to inmates at a correctional facility.
DEA Response: As stated before, the intent of this rule is to
increase access to maintenance or detoxification treatment to those
individuals who need it. As many of the commenters indicated,
incarcerated individuals are a group who would greatly benefit from
mobile NTPs servicing correctional facilities. The current use of
mobile components by some NTPs in states such as New Jersey and Rhode
Island, coupled with research presented by several commenters
demonstrating lower recidivism rates as a result of treatment received
while incarcerated, show that these mobile components are beneficial.
Therefore, to avoid any possible confusion, in this final rule, DEA is
adding an additional provision to 21 CFR 1301.13(e)(4) to clarify that
NTPs may operate mobile components at correctional facilities where
otherwise permitted by law. DEA would like to remind NTP registrants
that they must follow all applicable, Federal, State, local, and tribal
laws when operating these mobile components at correctional facilities.
Promulgation of Telemedicine Special Registration Regulation and
Related Issues
Comments: Several commenters expressed concerns regarding the
status of the telemedicine special registration that Congress mandated
DEA implement by October 2019 in the Substance Use-Disorder Prevention
that Promotes Opioid Recovery and Treatment for Patients and
Communities Act (SUPPORT Act), Public Law 115-271, sec. 3232, 132 Stat.
3894, 3950 (2018). One commenter mentioned that while this proposed
rule was a step in the right direction, it falls short of the special
registration for telemedicine, which would help more people who
struggle to find access to buprenorphine providers. One commenter
similarly noted that the proposed rule was an important step in
expanding access to care for those with OUDs; this commenter, along
with the others, also urged DEA to promulgate regulations implementing
the telemedicine special registration as quickly as possible.
DEA Response: Although these comments regarding telemedicine
special registration are beyond the scope of this rule, DEA understands
commenters' frustration with the delay. DEA intends to promulgate
regulations for the telemedicine special registration in the near
future.
Comment: One commenter suggested that the definition of mobile NTPs
be expanded to include mobile internet-based health applications.
DEA Response: In this final rule, DEA will not expand the
definition of mobile NTPs to include mobile internet health-based
applications. The dispensing of controlled substances through internet
applications raises risks and other issues quite different than those
raised by dispensing through a mobile conveyance. Thus, such internet
dispensing is beyond the scope of this rule, but will be considered in
the context of the aforementioned special telemedicine registration
rulemaking.
[[Page 33874]]
Other Comments
Comments: One commenter discussed how some State treatment agencies
have already experienced staffing shortages or may in the future, and
how it is also possible for an agency to suffer full closure due to the
COVID-19 public health emergency. The commenter stated that both the
lack of treatment facilities and staffing shortages would negatively
impact an agency's ability to admit clients into treatment, and that
this will become more apparent due to the predicted increase in
admissions following the public health emergency. Another commenter
mentioned that DEA, SAMHSA, State regulators, and NTPs have taken steps
to ensure continued access to treatment by changing dosing schedules to
limit face-to-face contact, facilitating access to telehealth, and
allowing home delivery of medications for OUD treatment to quarantined
patients to prevent the spread of COVID-19. Finally, one commenter
stated that due to the ongoing public health crisis, DEA should follow
a tiered approach and immediately begin approving mobile components
while devoting resources to finalizing this rule. The commenter further
stated that DEA used its authority granted by 21 U.S.C. 822(d) to
approve mobile components on an ad hoc basis prior to 2007, and thus
there is no legal constraint on DEA to finalize this rule before
beginning to approve mobile components on an ad hoc basis.
Several commenters expressed concern that SAMHSA's current
requirement of daily dosing at the initiation of methadone treatment
would limit the reach of newly operationalized mobile components to
just one region/one community, given that a mobile component would have
to repeatedly return to the same location(s) each day to provide daily
methadone doses to newly initiated patients. To expand access to
treatment, the commenters urged DEA to work with SAMHSA to revise
regulations restricting take-home medications. Four commenters also
suggested that DEA should work with SAMHSA to allow NTP providers to
prescribe medications to be filled at community pharmacies and to allow
non-NTP providers to prescribe methadone.
DEA Response: DEA has worked closely with SAMHSA during the COVID-
19 public health emergency to provide guidance and support to NTPs to
ensure that any individual who relies on MAT is able to continue
treatment without disruption. It is DEA's intent that mobile NTP
components will be able to help agencies facing lack of treatment
facilities and staffing shortages resulting from COVID-19 or any other
public health or environmental emergency that impacts NTP access. DEA
will continue to work with SAMHSA and its other partners after this
public health emergency has ended to ensure that those suffering from
OUD face fewer barriers to treatment.
DEA is using its discretion to approve mobile components under the
authority granted to it by the CSA. 21 U.S.C. 822(d). Any NTP that
wishes to use a mobile component for maintenance or detoxification
treatment will be able to start the approval process once the final
rule has been published to ensure that all interested NTPs would be
subject to the same requirements.
Comments: Two commenters noted that the proposed rule does not
reference mobile NTPs' need to adhere to Health Insurance Portability
and Accountability Act (HIPAA)/privacy requirements. These commenters
assumed that these same requirements applied to mobile NTPs but advised
DEA to clarify this matter in the final rule to prevent
misinterpretation. One of these commenters advised DEA to include a
reference to ``best practice'' standards as defined by SAMHSA in TIP
63: Medications for Opioid Use Disorder.\11\ The commenter also
recommended that DEA work closely with SAMHSA to develop a companion
document to accompany the new requirements related to the
administration of an NTP.
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\11\ Substance Abuse and Mental Health Services Administration.
(2020). Treatment Improvement Protocol (TIP) 63: Medications for
Opioid Use Disorder (HHS Publication No. PEP20-02-01-006). <a href="https://store.samhsa.gov/SMA18-5063FULLDOC">https://store.samhsa.gov/SMA18-5063FULLDOC</a> (last accessed: 9/2/2020).
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DEA Response: Regarding the commenters seeking clarity regarding
HIPAA/privacy requirements for the mobile NTPs, DEA proposed requiring
the records of the mobile components to be stored at the registered
location of the NTP in a manner that meets all applicable security and
confidentiality requirements. See NPRM, 85 FR 11008, 11010-12 (proposed
21 CFR 1304.24(b)). These same requirements will apply in the final
rule. NTPs already have protocols in place to protect patient
information to ensure that they are in compliance with all Federal,
State, local, or tribal requirements; the final rule is supplementary
to these existing protocols. NTPs also have protocols and procedures in
place to ensure that they are in compliance with all Federal, State,
local, and tribal laws dealing with patient care, and best practices;
therefore, DEA will not include a reference to ``best practice''
standards as defined by SAMHSA in TIP 63: Medications for Opioid Use
Disorder. In sum, DEA does not anticipate any significant differences
in how NTPs protect the privacy of patients served by registered NTPs
and those served by their mobile components.
Comment: One commenter noted that it is also important to be clear
that adding new mobile components does not imply that treatment
standards would be different or less stringent than those of registered
NTPs. The commenter suggested that in order to ensure high quality
treatment, the rule provide additional information about clinical
requirements and the States' role in that area, leaving less room for
problems as new mobile NTPs become operational. Two commenters also
noted that the proposed rule focused exclusively on the operational
aspects of administering a methadone clinic, but did not address any
counseling activities that are required for NTPs. One commenter stated
that DEA should extend the regulations to require mobile components to
have minimum treatment standards and use a multifaceted approach (e.g.,
counseling, recovery network, mandatory number of treatment visits per
month for each patient).
One commenter recommended that the rule acknowledges that States
may have additional requirements for NTPs beyond the Federal
regulations. The commenter also inquired if all requirements that apply
to a registered NTP location apply to a mobile component. The commenter
expressed concern that without explicit guidance, it could lead to a
misinterpretation of NTP requirements. The commenter also recommended
adding language to the proposed regulation to clarify the expectation
that a mobile NTP will provide services beyond the administration of
the medication, such as counseling.
DEA Response: Under the rule, mobile NTPs are part of their DEA-
registered NTP locations: Their dispensing of controlled substances
through their mobile components is now a coincident activity allowed
under their NTP's DEA registration. Thus, except where otherwise
provided for by this rule or other laws or regulations, mobile NTPs are
subject to the same standards as the NTPs of which they are a part.
DEA's NTP regulations seek to minimize diversion or abuse of the
controlled substances dispensed by NTPs, but DEA does not establish
broader treatment standards for NTPs. Thus, to the degree commenters
wish
[[Page 33875]]
the government to clarify treatment standards specific to the mobile
components of NTPs, they should contact the government entities that
establish and enforce those standards.
Comment: One commenter stated that in the final rule DEA should
consider clarifying that the ability of mobile vans to convey
injectable and implantable buprenorphine products that are administered
to patients will not be restricted. The commenter also requested that
DEA consider clarifying in the final rule's preamble section ``the role
of `Hospital/Clinic' as `non-practitioner' registrants to provide
buprenorphine products for the treatment of [OUD] in accordance with 21
CFR 1301.28.''
DEA Response: The purpose of this rule is to waive the requirement
of a separate registration for NTPs that utilize mobile components and
to allow an NTP to dispense narcotic drugs in schedules II-V at
location(s) remote from, but within the same State as, the NTP's
registered location, for the purpose of maintenance or detoxification
treatment. The registered NTP, not DEA, should decide which narcotic
drugs should be dispensed to its patients, both at the registered
location and on the mobile component, in accordance with each
individual patient's medical needs as determined by a medical
professional authorized to make such a determination. Nothing in this
final rule prevents a mobile NTP from providing the same treatment as
would be available at the registered NTP location, as long as the
mobile NTPs follow all applicable Federal, State, local, and tribal
laws.
DEA regulations in 21 CFR 1301.28 include provisions for exemption
from separate registration requirements for individual practitioners
dispensing or prescribing schedule III-V narcotic controlled drugs
approved by FDA for maintenance or detoxification treatment provided
they meet certain conditions, including being a ``qualifying
physician'' or ``qualifying other practitioner,'' as defined in 21
U.S.C. 823(g)(2)(G)(ii) or (g)(2)(G)(iv), respectively. Thus, the
request to clarify the role of Hospital/Clinic in accordance with 21
CFR 1301.28 is beyond the scope of this final rule.
Comment: Another commenter noted that the proposed rule does not
include guidance on parking guidelines for the mobile component, and
suggested that the NTP should be required to establish a standard
operating procedure or obtain linkage agreements with organizations
(e.g., hospitals or programs operating needle exchange programs) where
the vehicle will be parked. The commenter stated the linkage agreements
must include the mobile component's days/date and hours of operation,
and that without these agreements, there may be complaints and issues
for local law enforcement agencies or community leaders.
DEA Response: Regarding the commenter's parking concerns for the
mobile NTP, DEA appreciates the potential issues; however, DEA will not
provide any guidance in this final rule. The NTP is responsible for
establishing a protocol for parking, and to determine the appropriate
organizations that might assist with parking. What constitutes an
appropriate parking location for a mobile NTP will vary significantly
from area to area based on local conditions and laws. Dictating what
must be included in any agreements is thus outside the scope of this
rulemaking and will not be addressed. DEA would like to remind NTP
registrants of their obligations under any applicable Federal, State,
or local laws when it comes to operating these mobile components.
Comment: One commenter suggested that DEA not require NTPs to get
pre-approval from the local DEA field office before operating a mobile
component; rather, DEA should only require registered NTPs to notify
the local DEA field office that they will begin operating a mobile
component. The commenter stated that this will prevent a situation
where a registered NTP seeking to expand access with a mobile component
will be required to wait for approval, missing out on critical days and
weeks that could be spent providing access to patients. The commenter
argued that other conditions in the proposed rule, combined with DEA's
regular inspections, are sufficient to ensure diversion is not
occurring at mobile components, especially since the NTPs that are
already registered will be familiar with DEA diversion regulations and
capable of complying with the conditions for mobile components. The
commenter also suggested that in the preamble to the final rule, DEA
should commit to conducting a retrospective review and collecting data
to assess the impact of the rule on treatment accessibility and the
risk of diversion. The commenter stated that if this final rule
succeeds at expanding treatment for opioid use disorder to patients
while simultaneously minimizing diversion risks, DEA should further
expand the program.
DEA Response: DEA will not change the requirement that NTPs obtain
pre-approval from the local DEA field office before operating a mobile
component. DEA appreciates the commenters' concern about how possible
delays in the approval process could have negative effects on those
individuals who need access to treatment. Pre-approval from the local
DEA field office is part of the registration process for the mobile
component; without it, the NTP will not be permitted to operate the
mobile component under the requirements set forth by this final rule.
DEA continually reviews the programs that fall under its regulatory
authority; if it determines that adjustments are required to ensure
compliance or to ensure that the rule's effect is more successful, the
appropriate action will be taken.
Section-by-Section Analysis of the Final Rule
DEA is finalizing the proposed rule with certain modifications to
21 CFR 1300.01, 1301.13, and 1301.72. In brief, this rule slightly
revises the mobile NTP definition at Sec. 1300.01(b) from that
proposed. The definition is revised to clarify that it is the operation
of the mobile NTP (i.e., administering maintenance and/or
detoxification treatment from the mobile component) that is the
coincident activity, not the vehicle itself. The application fee in
Sec. 1301.13(e)(1)(vii), in the table, is revised to reflect the new
registration fee schedule that became effective on October 1, 2020.\12\
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\12\ 85 FR 44710 (July 24, 2020).
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Also, this rule revises the proposed new Sec. 1301.13(e)(4) by
adding a third subparagraph (iii) to clarify that a mobile NTP may
operate at a location or locations, including correctional facilities,
away from, but within the same State as, the NTP's registered location.
Previously, the proposed rule was silent as to correctional facilities.
Relatedly, in several places, references in the proposed rule to the
remote ``location'' where the mobile NTP operates are replaced with
references to the mobile NTP's ``location or locations'' to clarify
that a mobile NTP can operate at more than one remote location under
appropriate circumstances.
This rule revises the proposed new Sec. 1301.72(e) to allow the
mobile component to be parked at the registered location or any secure,
fenced-in area when the mobile component is not in use. Prior to
parking the conveyance at a secure, fenced-in location, all controlled
substances must be removed from the conveyance and returned to the
registered location and, the local DEA office must be notified of the
location of
[[Page 33876]]
the secure, fenced-in area. The proposed new paragraph did not
previously address this security condition.
This final rule does not change the proposed new requirement in
Sec. 1301.72(e), that upon completion of the operation of the mobile
NTP on a given day, the conveyance must be immediately returned to the
registered location, and all controlled substances must be removed from
the conveyance and secured within the registered location. However,
this rule adds a provision in Sec. 1301.72(e) that expressly allows
NTPs to apply for an exception to this requirement, following the
process set forth in 21 CFR 1307.03, which allows any person to apply
for an exception to any provision of the DEA regulations. In addition,
the revised Sec. 1301.72(e) specifically provides that the application
must include certain other information, and that DEA will evaluate each
application on a case-by-case basis to determine whether the applicant
has demonstrated exceptional circumstances that warrant a waiver of the
daily return requirement.
Finally, this rule makes a variety of minor changes in
capitalization, abbreviation, word choice, and grammar throughout the
regulatory text, but these are not intended as substantive revisions.
For example, whereas the proposed text used both ``narcotic treatment
program'' and ``NTP,'' the revised text more consistently uses ``NTP''
throughout. Similarly, proposed new Sec. 1301.74(j) and (l) referred
to an NTP ``physician,'' whereas the revised text uses the more general
term ``practitioner.''
Below are summaries of provisions contained in the final rule.
Part 1300: Definitions
In section 1300.01, DEA adds a definition for a mobile NTP. This
definition reflects that a mobile NTP is an NTP operating from a motor
vehicle that serves as a mobile component of the NTP. As such, a mobile
NTP engages in maintenance and/or detoxification treatment with
narcotic drugs in schedules II-V, at a location or locations remote
from, but within the same State as, the registered NTP, and operates
under the registration of the NTP. Because the mobile NTP definition
references a motor vehicle, DEA also separately defines ``motor
vehicle'' as a vehicle propelled under its own motive power and
lawfully used on public streets, roads, or highways with more than
three wheels in contact with the ground; a motor vehicle does not
include a trailer in this context. Therefore, a trailer could not serve
as a mobile NTP.
Part 1301: Registration of Manufacturers, Distributors, and Dispensers
of Controlled Substances
DEA regulations have always required that all registrants maintain
effective security to guard against theft and diversion of controlled
substances. See 21 CFR 1301.71-77. The need for such security applies
equally in the mobile NTP context. Thus, this final rule contains
provisions (described below) that require NTPs to secure controlled
substances while operating a mobile component away from the registered
location.
In this final rule, DEA revises section 1301.13 to make operating a
mobile component of an NTP a coincident activity of an existing NTP
registration, provided the NTP has obtained prior approval from the
local DEA office. DEA intends to reduce the regulatory burden on NTPs
by waiving the separate DEA registration requirement, as discussed
above, and allowing them to operate a mobile component of an NTP in the
same State as the registered NTP, under its existing registration. As a
result, the mobile component of a registered NTP will not have to apply
for a separate registration, as its operation is considered coincident
activity. In addition, DEA specifies in the regulations that the
records generated during the operations of a mobile component of an NTP
shall be maintained at the NTP's registered location, rather than
requiring such records to be stored in the mobile component. Section
1301.13 is also revised to explicitly state that registered NTPs may
operate mobile components at correctional facilities where otherwise
permitted by law.
DEA revises section 1301.72 to ensure controlled substances in a
mobile component of an NTP are protected against theft and diversion.
To achieve this end, the security requirements under 21 CFR
1301.72(a)(1) and 21 CFR 1301.72(d) apply to the mobile component of an
NTP. The storage area for controlled substances in a mobile component
of an NTP must not be accessible from outside the vehicle. The
requirement to secure the controlled substances in a securely locked
safe in the conveyance will assist in adequately securing the
controlled substances. Since small quantities of controlled substances
will be present in the mobile component, DEA is requiring that the safe
used by these mobile components have safeguards against forced entry,
lock manipulation, and radiological attacks. The safe must also be
bolted or cemented to the floor or wall in such a way that it cannot be
readily moved. DEA is also requiring that the safe be equipped with an
alarm system that transmits a signal directly to a central protection
company or a local or State police agency which has a legal duty to
respond, or a 24-hour control station operated by the registrant, or
such other protection as the Administrator may approve if there is an
attempted unauthorized entry into the safe.
Upon completion of the operation of the mobile NTP on a given day,
the conveyance will need to immediately return to the registered
location, and all controlled substances removed from the conveyance and
secured within the registered location. After the controlled substances
have been removed, the conveyance may be parked until its next use at
the registered location or any secure, fenced-in area, once the local
DEA office has been notified of the location of this secure, fenced-in
area. If the mobile component is disabled for any reason (mechanical
failure, accident, fire, etc.), the registrant will be required to have
a protocol in place to ensure that the controlled substances on the
conveyance are secure and accounted for. If the conveyance is taken to
an automotive repair shop, all controlled substances will need to be
removed and secured at the registered location.
NTPs will not be required to obtain a separate registration for
conveyances (mobile components) utilized by the registrant to transport
controlled substances away from registered locations for dispensing
within the same State at unregistered locations. Vehicles must possess
valid county/city and State information (e.g., a vehicle information
number (VIN) or license plate number) on file at the NTP's registered
location. NTPs are also required to provide State and local licensing
and registration documentation to DEA at the time of inspection and
prior to transporting controlled substances away from their registered
location.
Regarding the requirement for the mobile NTP to return daily to the
registered location, and to store its controlled substances at the
registered location, DEA revises 21 CFR 1301.72(e) to expressly allow
the NTP to apply for an exception to this requirement, following the
process set forth in 21 CFR 1307.03. In addition, the revised Sec.
1301.72(e) specifically provides that the application must include the
proposed alternate return period, enhanced security measures, and any
other factors the applicant wishes the Administrator to consider. DEA
will evaluate each application on a case-by-case basis to determine
whether the
[[Page 33877]]
applicant has demonstrated exceptional circumstances that warrant a
waiver of the daily return requirement. DEA will consider the
applicant's security and recordkeeping as well as other factors
relevant to determining whether effective controls against diversion
will be maintained.
DEA revises 21 CFR 1301.74 to include mobile components of DEA-
registered NTPs, since the existing regulations do not contain such a
provision. As described in the revisions to section 1301.74, personnel
who are authorized to dispense controlled substances for narcotic
treatment must ensure proper security measures and patient dosage. For
example, DEA is now requiring that persons enrolled in any NTP,
including those who receive treatment at a mobile NTP, wait in an area
that is physically separated from the narcotic storage and dispensing
area by a physical entrance such as a door or other entryway.
Mobile NTPs may only be stocked with narcotic drugs in schedules
II-V from the registered NTP location. Personnel designated to transfer
narcotic drugs in schedules II-V from the registered location to mobile
NTPs are not able to: Receive narcotic drugs in schedules II-V from
other mobile NTPs or any other entity; deliver narcotic drugs in
schedules II-V to other mobile NTPs or any other entity; or conduct
reverse distribution of controlled substances on a mobile NTP. Any
controlled substances being transported to the registered NTP location
for disposal from the dispensing location(s) of the mobile component
shall be secured and disposed of in compliance with 21 CFR part 1317
and all other applicable Federal, State, tribal, and local laws and
regulations.
Finally, the physical security controls of mobile components will
need to be implemented by the NTP pursuant to 21 CFR 1301.72 and
1301.74. In the event of a security breach in which controlled
substances are lost or stolen, the registrant must determine the
significance of the loss and comply with the theft and significant loss
reporting requirements in 21 CFR 1301.74(c).
Part 1304: Records and Reports of Registrants
Under the final rule, the recordkeeping requirements of 21 CFR part
1304 apply to mobile components of NTPs. DEA revises sections 1304.04
and 1304.24 to include mobile components. As with registered NTP
locations, the records of the mobile components will be stored at the
registered location of the NTP in a manner that meets all applicable
security and confidentiality requirements, and must be readily
retrievable.
21 CFR 1304.24(b) requires that an NTP maintain the records,
required by 21 CFR 1304.24(a), in a dispensing log at the registered
location. It is understood that this log is in paper form. As an
alternative to maintaining a paper dispensing log, DEA is permitting an
NTP or its mobile component to also use an automated/computerized data
processing system for the storage and retrieval of its dispensing
records, if a number of conditions are met: The automated system
maintains the same information required in 21 CFR 1304.24(a) for paper
records; the automated system has the capability of producing a hard
copy printout of the program's dispensing records; the NTP or its
mobile component prints a hard copy of each daily dispensing log, which
is then initialed appropriately by each practitioner who dispensed
medication to the NTP's patients; and the automated system is approved
by DEA.
The NTP's computer software program must be capable of producing
accurate summary dispensing reports for the registered NTP location and
its mobile component, for any time-frame selected by DEA personnel
during an investigation. Further, if summary reports are maintained in
hard copy form, they should be stored in a systematically organized
file at the registered location of the NTP. Additionally, a back-up of
all computer generated records of dispensing by the NTP and its mobile
component is required to be maintained off-site.
Finally, NTPs are required to retain all records for the registered
NTP location as well as any mobile components for two years from the
date of execution. This time period is the same period as that required
by 21 CFR 1304.04(a). However, because some States require that records
be retained for longer than two years, the NTP should contact its State
opioid treatment authority for information about State requirements.
Regulatory Analyses
Summary of Costs and Benefits
DEA examined each of the provisions of the final rule to estimate
its economic impact. DEA's analytic approach focuses on comparing the
costs and/or cost-savings of a ``no action'' baseline regulatory
environment with the costs and/or cost-savings of the regulatory
environment that would result from the promulgation of this final rule.
This is the standard analytic framework codified in the Office of
Management and Budget (OMB) Circular A-4, published on September 17,
2003. This final rule is an enabling rule designed to expand access to
MAT offered by NTPs in underserved communities. Previously, DEA had
only authorized mobile NTPs on an ad hoc basis, and had placed a
moratorium on further such authorizations in 2007. Thus, DEA compared
the costs of delivering MAT services in a baseline regulatory
environment, in which no new mobile NTPs are authorized, to the costs
of delivering an equivalent level of MAT services in the final rule's
regulatory environment, in which a registered NTP may begin to operate
a mobile component as a coincident activity, if authorized by DEA. This
analysis, detailed below, finds that this final rule will result in a
cost savings for DEA-registered NTPs in the form of reduced startup,
labor, and operating costs of MAT services delivered via a mobile
component. DEA also recognizes that this final rule is likely to result
in benefits in the form of economic burden reductions (healthcare
costs, criminal justice costs, and lost productivity costs) as access
to treatment for underserved communities is expected to expand.
However, DEA does not have a basis to estimate the totality of this
benefit with any accuracy since data on the number of patients treated
via existing mobile components are not available. Thus, while these
benefits are not quantified, DEA expects that this final rule will
result in a net benefit to society.
MAT has been shown to be an effective opioid treatment option--a
2014 meta-analysis concluded that MAT has significantly increased
treatment retention and decreased illicit opioid use.\13\ While SAMHSA
estimated that 2 million Americans have an OUD involving medications,
and another 526,000 had an OUD involving heroin, in 2018, only 19.7
percent of Americans with an OUD received any specialty treatment.\14\
A review of private insurance data collected from 2010 to 2014 found
that, following an opioid-related hospitalization, fewer than 11
percent of covered patients received
[[Page 33878]]
MAT in combination with psychosocial services. An additional 6 percent
received MAT without psychosocial services, and 43 percent received
psychosocial services only.\15\ As of 2016, over 90 percent of NTPs
were located in urban areas, forcing rural patients to travel great
distances to receive their doses of medication.\16\ According to
research published in 2014, some rural patients reported that the
burden of traveling daily to receive their medication effectively
prevents them from working,\17\ further increasing the risk that they
will discontinue treatment.\18\
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\13\ Thomas CP, Fullerton CA, Kim M, et al. Medication-Assisted
Treatment with Buprenorphine: Assessing the Evidence. Psychiatry
Serv. 2014; 65(2):158-170. doi:10.1176/appi.ps.201300256.
\14\ Substance Abuse and Mental Health Services Administration.
(2019). Key substance use and mental health indicators in the United
States: Results from the 2018 National Survey on Drug Use and Health
(HHS Publication No. PEP19-5068, NSDUH Series H-54). Rockville, MD:
Center for Behavioral Health Statistics and Quality, Substance Abuse
and Mental Health Services Administration.
\15\ Ali, M. M., Mutter, R. (2016). The CBHSQ Report: Patients
Who Are Privately Insured Receive Limited Follow-up Services After
Opioid-Related Hospitalizations. Rockville, MD: Substance Abuse and
Mental Health Services Administration, Center for Behavioral Health
Statistics and Quality. Retrieved by ONDCP on August 18, 2017 at
<a href="http://www.samhsa.gov/data/sites/default/files/report_2117/ShortReport-2117.pdf">http://www.samhsa.gov/data/sites/default/files/report_2117/ShortReport-2117.pdf</a>.
\16\ Leonardson J, Gale JA. Distribution of Substance Abuse
Treatment Facilities Across the Rural--Urban Continuum. 2016.
<a href="https://muskie.usm.maine.edu/Publications/rural/pb35bSubstAbuseTreatmentFacilities.pdf">https://muskie.usm.maine.edu/Publications/rural/pb35bSubstAbuseTreatmentFacilities.pdf</a>.
\17\ Sigmon SC. Access to Treatment for Opioid Dependence in
Rural America: Challenges and Future Directions. JAMA Psychiatry.
2014; 71(4):359-360. doi:10.1001/jamapsychiatry.2013.4450.
\18\ Leonardson J, Gale JA. Distribution of Substance Abuse
Treatment Facilities Across the Rural--Urban Continuum. 2016.
<a href="https://muskie.usm.maine.edu/Publications/rural/pb35bSubstAbuseTreatmentFacilities.pdf">https://muskie.usm.maine.edu/Publications/rural/pb35bSubstAbuseTreatmentFacilities.pdf</a>.
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Without this rule permitting registered NTPs to operate mobile
components as coincident activity, an NTP wishing to provide MAT
services to patient populations with little or no access to an NTP
would be required to register and open another NTP location in the
underserved geographic area. The many fixed capital and operating
expenses associated with the startup and ongoing operation of a new
facility discourage providers from doing this. For example, registrants
would be required to obtain another NTP registration at $296 per year
and incur the cost of renting additional office space, and ensuring
that the new location meets DEA requirements, that it is appropriately
licensed by the State, and that it is accredited by an accrediting
organization approved by SAMHSA. Additionally, opening a new location
would entail additional staffing and facilities costs. Under the final
rule's regulatory provisions, registrants are able to operate a mobile
component as a coincident activity of their existing registered
location, foregoing the expenses of opening and operating a new
registered location, in favor of the comparatively lower cost of
operating a mobile component.
DEA believes it is reasonable to assume that in any given
geographic region, the fixed capital expenses of opening a new
registered location (most significantly office rent) will always exceed
the capital expenses of operating a mobile component (most
significantly the purchase price of a conveyance to be converted to a
mobile NTP). These major capital expenses are discussed and compared in
detail in the following paragraph; however, it is important to first
set boundaries for this analysis by discussing what costs will not be
included and why. DEA assumes that two significant expenses are the
same for both activities, and therefore, are excluded from the
analysis: The labor required to dispense narcotic drugs in schedules
II-V, and the cost to outfit an NTP office or mobile conveyance with
sufficient medical and office equipment. Labor costs are considered to
be equal for both activities as the final rule does not change the
requirements for the personnel that are authorized to dispense
controlled substances. Whether an NTP expands via a new registered
location or a mobile component, DEA assumes that the registrant would
need to expand the quantity and type of labor required to dispense
narcotic drugs in schedules II-V, at the same rate for both. However,
it is likely that registered locations would be required to employ a
medical administrative assistant to handle records management, billing,
and reception; functions that a mobile component of an existing NTP
would outsource to the labor provided by the associated registered NTP.
DEA assumes that a new registered NTP location requires one medical
assistant, and calculates the total annual compensation for this
medical assistant to be $48,994.\19\
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\19\ The total annual cost of compensation is based on the
median annual wage for Occupation Code 31-9092 Medical Assistants
($33,610). May 2018 National Occupational Employment and Wage
Estimates, United States, Bureau of Labor Statistics, <a href="https://www.bls.gov/oes/current/oes_nat.htm#31-9092">https://www.bls.gov/oes/current/oes_nat.htm#31-9092</a> (last visited November
11, 2019). Average benefits for employees in private industry is
31.4% of total compensation. Employer Costs for Employee
Compensation--June, 2019, Bureau of Labor Statistics, <a href="https://www.bls.gov/news.release/pdf/ecec.pdf">https://www.bls.gov/news.release/pdf/ecec.pdf</a> (last visited November 11,
2019). The 31.4% of total compensation equates to 45.8% (31.4%/
68.6%) load on wages and salaries. $33,610 x (1 + 0.4577) =
$48,994.17.
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DEA also recognizes that there are startup costs that will be the
same for both activities. This includes the purchase of medical
equipment and basic office supplies, and the installation of an alarm
system compliant with 21 CFR 1301.72(a)(iii). Such startup costs are
accordingly also omitted from this analysis. Whether MAT services are
being rendered via a mobile NTP or the traditional office environment,
the same type and quantity of labor, medical equipment, and security
equipment is assumed necessary to deliver the same amount of treatment
while adhering to DEA regulations.
According to the National Association of Realtors, the average
annual price per square foot for office space throughout the United
States was $46 in the first quarter of 2017 (the most recent year in
which this figure was updated).\20\ Based on DEA's knowledge of
registrant operations, NTPs require a minimum of 1,000 square feet of
office space, which equates to a conservative estimate of yearly rent
for NTPs of $46,000. Assuming the NTP agrees to a five-year lease, the
present value of the cost of five years of office rent is $188,609.08
at a 7 percent discount rate and $210,666.53 at a 3 percent discount
rate. In comparison, commercial vehicles suitable for service as a
mobile NTP range in price from $30,000 to $40,000.\21\ Furthermore, the
final rule does not require an NTP to obtain a separate registration
for the mobile component at a cost of $296 per year, which is a cost
that a new registered NTP location would incur. The present value of
registration costs per registrant over a five-year period is $1,213.66
at a 7 percent discount rate and $1,355.59 at a 3 percent discount
rate.
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\20\ ``2017 Q1 Commercial Real Estate Market Survey.''
www.nar.realtor, 2017, www.nar.realtor/research-and-statistics/
research-reports/commercial-real-estate-market-survey/2017-q1-
commercial-real-estate-market-survey.
\21\ Price range gathered by searching <a href="http://commercialtrucktrader.com">commercialtrucktrader.com</a>
for class 1, 2, and 3 light duty box trucks and class 4, 5, and 6
medium duty box trucks. These vehicle classes were used based on
DEA's knowledge of the types of vehicles currently used by NTP
registrants for mobile components.
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There are also several operating expenses that are unique to a
mobile component that should be factored into this analysis. The first
is the cost of the narcotic safe and associated installation costs. DEA
recognizes that while both a mobile component and a traditional NTP
office require a safe, the confined space of a mobile component likely
requires some amount of customization in the installation process in
order to meet the requirements of 21 CFR 1301.72(a)(1). To account for
this unique installation cost, DEA doubled the highest quoted price of
the safe \22\ and attributed that full amount to the
[[Page 33879]]
mobile component, while attributing only the purchase price of the safe
to the cost of a stationary NTP. The second set of costs unique to the
operation of a mobile component are maintenance and transportation
expenses such as fuel, repair, insurance, permits, licenses, tires,
tolls, and driver wages and benefits. The American Transportation
Research Institute estimates that the average marginal cost per mile of
operating a straight truck in 2016 (the most recent year in which this
figure was updated) was $1.63. This figure is inclusive of all
previously listed expenses.\23\ Based on DEA's knowledge of the
operations of existing mobile NTPs, DEA estimates that a mobile NTP
operating under the final rule will travel an average of 5,000 miles
per year (roughly 100 miles per week). This equates to an annual
transportation and maintenance expense of $8,150.00 per year.\24\
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\22\ Quotes for safes meeting DEA's regulatory specifications
were sourced online from three leading manufacturers: Healthcare
Logistics, Medicus Health and Harloff. The highest price quoted was
$899.00. Doubling the price to account for installation yields a
total cost of $1,798.00.
\23\ Hooper, Alan, and Dan Murray. An Analysis of the
Operational Costs of Trucking: 2017 Update. ATRI, American
Transportation Research Institute, 2017, <a href="http://atri-online.org/wp-content/uploads/2017/10/ATRI-Operational-Costs-of-Trucking-2017-10-2017.pdf">atri-online.org/wp-content/uploads/2017/10/ATRI-Operational-Costs-of-Trucking-2017-10-2017.pdf</a>.
\24\ $1.63 per mile x 5,000 miles per year = $8,150.
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Comparing the present value of the costs associated with operating
a mobile NTP over a five-year period with the present value of the
costs associated with opening an additional NTP location over a five-
year period yields a net present value of cost savings between $319,069
(at a 7 percent discount rate) and $359,369 (at a 3 percent discount
rate) for the operation of a mobile NTP. The comparison of costs
between the baseline and proposed regulatory environment are summarized
in the tables below:
Baseline Regulatory Environment--Total Costs for Additional NTP Locations *
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
Office rent per year........ $46,000.00
Cost of safe \25\........... 899.00
Labor Cost.................. 48,994.00
Registration fee............ 296.00
----------------------------------------------------------------------------------------------------------------
NPV 3% Year 1 Year 2 Year 3 Year 4 Year 5
----------------------------------------------------------------------------------------------------------------
$437,274.................... $96,189.00 $95,290.00 $95,290.00 $95,290.00 $95,290.00
----------------------------------------------------------------------------------------------------------------
NPV 7% Year 1 Year 2 Year 3 Year 4 Year 5
----------------------------------------------------------------------------------------------------------------
$391,549.................... $96,189.00 $95,290.00 $95,290.00 $95,290.00 $95,290.00
----------------------------------------------------------------------------------------------------------------
* All figures rounded to the nearest whole dollar.
Final Rule's Regulatory Environment--Total Mobile NTP Costs *
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
Vehicle purchase price...... $40,000.00
Cost to install DEA 1,798.00
compliant safe.............
Maintenance cost per year... 8,150.00
----------------------------------------------------------------------------------------------------------------
NPV 3% Year 1 Year 2 Year 3 Year 4 Year 5
----------------------------------------------------------------------------------------------------------------
$77,905..................... $49,948.00 $8,150.00 $8,150.00 $8,150.00 $8,150.00
----------------------------------------------------------------------------------------------------------------
NPV 7% Year 1 Year 2 Year 3 Year 4 Year 5
----------------------------------------------------------------------------------------------------------------
$72,480..................... $49,948.00 $8,150.00 $8,150.00 $8,150.00 $8,150.00
----------------------------------------------------------------------------------------------------------------
* All figures rounded to the nearest whole dollar.
DEA does not have a systematic method for estimating how many NTP
registrants that are currently deterred or prevented from opening
additional NTP locations due to costs might take advantage of this
enabling rule to begin operating a mobile NTP. DEA also recognizes
that, because of their fixed locations, registered NTPs are more
limited in their geographic service area than a mobile NTP would be.
DEA conservatively estimates, however, that this number would at least
equal the number of NTP registrants that operated mobile components at
some point in the previous five years under ad hoc agreements with DEA
field offices. There have been nineteen such NTP registrants, and there
are currently eight with mobile components still in operation.
Therefore, DEA considers it a reasonable assumption that at least
eleven additional NTP registrants will begin operating a mobile NTP
after this final rule is published, bringing the total number of mobile
NTPs to at least the previous total of nineteen. This yields a total
cost savings for all of those NTPs over a five-year period of
$3,509,759 \26\ (at a 7 percent discount rate) to $3,953,059 \27\ (at a
3 percent discount rate).
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\25\ The cost of a safe is a one-time expense incurred in the
first year of operation.
\26\ The final rule's regulatory environment yields a five-year
cost savings (discounted at 7%) of $318,855 over the current
regulatory environment. $319,069 x 11 = $3,509,759.
\27\ The final rule's regulatory environment yields a five-year
cost savings (discounted at 3%) of $359,131 over the current
regulatory environment. $359,369 x 11 = $3,953,059.
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For the reasons outlined in the comparative analysis discussed
above, DEA concludes that moving from the baseline regulatory
environment to the regulatory environment of the final rule results in
a cost reduction for NTP registrants that wish to expand their services
to new geographic areas, and will spur an increase in the number of
mobile NTPs. Therefore, this final rule is a deregulatory action that
will result in a net cost savings between $3,509,759 and $3,953,059.
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
[[Page 33880]]
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 established in E.O. 12866.
DEA expects that this final rule will not have an annual effect on the
economy of $100 million or more in at least one year and therefore is
not an economically significant regulatory action. DEA examined each of
the provisions of the final rule to estimate its economic impact,
comparing the costs and/or cost-savings of a ``no action'' baseline
regulatory environment with the costs and/or cost-savings of the
regulatory environment that will result from this final rule. This
final rule is an enabling rule designed to expand the supply of MAT
providers, and DEA currently has only authorized mobile NTPs on an ad
hoc basis, with a present moratorium on further such authorizations.
Thus, DEA compared the costs of delivering MAT services in a baseline
regulatory environment in which no new mobile NTPs are authorized, to
the costs of delivering an equivalent level of MAT services in the
final rule's regulatory environment in which a registered NTP may begin
to operate a mobile component as a coincident activity, subject to the
provisions of this final rule. DEA's analysis, summarized in the
preceding section, finds that this final rule will result in a net
cost-savings between $3,509,759 and $3,953,059, and is therefore below
the $100 million threshold.
For a number of years, DEA has allowed registered NTPs to utilize
mobile components as part of their programs through special
arrangements with local DEA field offices. The use of these mobile
components was in response to the opioid epidemic that is currently
affecting the nation. With the number of deaths attributed to overdoses
increasing, the demand for access to medication-assisted treatment
increased. In many areas, this has resulted in long wait lists and high
service fees for services provided by NTPs. Alternative guidelines and
methods were sought to increase accessibility to treatment for people
with substance use disorder, including OUD, especially in rural areas
or areas where NTPs are not accessible, or to allow those who have
health conditions that prevent them from traveling long distances to
receive maintenance or detoxification treatment. Mobile components
associated with the registered NTP were seen as an alternative because
they increased accessibility to treatment in the areas that needed it.
This final rule builds on the existing experience and provides
additional flexibility for NTPs in operating mobile components, subject
to regulatory restrictions put into place to prevent the diversion of
controlled substances. DEA is revising 21 CFR 1301.13 to make operating
a mobile component of an NTP a coincident activity of an existing NTP
registration, and this provision will reduce the regulatory burden on
NTPs by waiving the separate DEA registration requirement. These mobile
NTPs are required to maintain effective security to guard against theft
and diversion of controlled substances in accordance with 21 CFR
1301.72. The mobile NTPs are also subject to the recordkeeping
requirements in 21 CFR 1304.04 and 1304.24. Many of the current mobile
NTPs are already following these regulatory requirements. This final
rule ensures that these regulatory requirements can be enforced
consistently over any current or future NTP wishing to operate a mobile
NTP.
Thus, this final rule will enable any NTP registered with DEA to
engage in an activity that was previously authorized through special
arrangements with DEA field offices. Furthermore, DEA's purpose for
allowing registered NTPs to operate a mobile component as a coincident
activity is to expand the availability of MAT in accordance with the
priorities outlined in the President's Commission on Combating Drug
Addiction and The Opioid Crisis, published on November 1, 2017.
While the findings of the regulatory impact analysis of this final
rule support the conclusion that this rulemaking is not economically
significant, the Office of Information and Regulatory Affairs (OIRA)
has nonetheless determined that the final rule is a ``significant
regulatory action'' under E.O. 12866, section 3(f). Accordingly, this
rule has been reviewed by OIRA.
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, Civil Justice Reform, to
eliminate ambiguity, minimize litigation, establish clear legal
standards, and reduce burden.
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
In accordance with the Regulatory Flexibility Act (RFA), DEA
evaluated the impact of this final rule on small entities. DEA's
evaluation of economic impact by size category indicates that the final
rule will not have a significant economic impact on a substantial
number of these small entities.
The RFA requires agencies to analyze options for regulatory relief
of small entities unless it can certify that the rule will not have a
significant impact on a substantial number of small entities. For
purposes of the RFA, small entities include small businesses, nonprofit
organizations, and small governmental jurisdictions. DEA evaluated the
impact of this rule on small entities and discussions of its findings
are below.
Description and Estimate of the Number of Small Entities
To determine the final rule's effect on small entities, DEA must
first calculate the total number of affected entities. To do this, DEA
must determine the total number of NTP entities in the United States,
as those are the entities that are able to take advantage of this
enabling rule.
DEA begins with the number of relevant DEA registrations--that is,
NTP registrations. The number of NTP entities differs from the number
of NTP registrations, however, because NTP entities often hold more
than one DEA registration, such as where a registrant handles
controlled substances at multiple locations, requiring the entity to
hold registrations for each of these locations. DEA does not, in the
general course of business, collect or otherwise maintain information
regarding associated or parent organizations holding multiple
registrations. Therefore, to derive the total number of NTP entities
from the number of NTP
[[Page 33881]]
registrations, DEA needs to develop a relationship, or ratio, between
the total number of NTP registrations and the number of entities
possessing those registrations.
To do so, DEA first determined the North American Industry
Classification System (NAICS) \28\ classification codes that most
closely represent the affected business activity--namely, NTP activity.
The business activity and its corresponding representative NAICS codes
are listed in the table below.
---------------------------------------------------------------------------
\28\ The North American Industry Classification System (NAICS)
is the standard used by the Federal statistical agencies in
classifying business establishments for the purpose of collecting,
analyzing, and publishing statistical data related to the U.S.
business economy. <a href="https://www.census.gov/eos/www/naics/">https://www.census.gov/eos/www/naics/</a> (last
accessed: September 1, 2020).
Business Activity and Representative NAICS Codes
------------------------------------------------------------------------
Business activity NAICS codes
------------------------------------------------------------------------
Narcotic Treatment Program........ 622210--Psychiatric and Substance
Abuse Hospitals.
621420--Outpatient Mental Health and
Substance Abuse Centers.
------------------------------------------------------------------------
DEA then gathered economic data for those codes using the U.S.
Census Bureau, Statistics of U.S. Businesses (SUSB). Specifically, DEA
used the SUSB data to determine the number of ``firms'' and the number
of ``establishments'' in the United States that correspond to each
relevant NAICS code. (For the purposes of this analysis, the term
``firm'' as defined in the SUSB is used interchangeably with ``entity''
as defined in the RFA.) From this, DEA calculated a firm-to-
establishment ratio--i.e., the average number of organizations for each
establishment engaged in these activities. DEA calculated this ratio to
be 0.56, as listed in the table below. In other words, each
organization engaged in activities covered by these NAICS codes
operated, on average, slightly fewer than two establishments.
Firm-to-Establishment Ratio by NAICS Code
----------------------------------------------------------------------------------------------------------------
Firm to
NAICS code Number of firms Number of establishment
establishments ratio
----------------------------------------------------------------------------------------------------------------
Total Narcotic Treatment Program....................... 6,919 12,449 0.56
--------------------------------------------------------
622210--Psychiatric and Substance Abuse Hospitals...... 396 623 .64
621420--Outpatient Mental Health and Substance Abuse 6,523 11,826 .55
Centers...............................................
----------------------------------------------------------------------------------------------------------------
Source: SUSB.\29\ (Accessed 9/8/2020).
Because an entity generally must obtain a separate registration
``at each principal place of business or professional practice'' where
it manufactures, distributes, or dispenses a controlled substance, see
21 U.S.C. 822(e)(1), the number of NTP establishments should be roughly
equivalent to the number of DEA registrations for NTPs. Thus, DEA
applied the calculated firm-to-establishment ratio of 0.56 to the 1,832
NTP registrations in DEA's database to estimate the number of NTP
entities, resulting in an estimate of 1,026 NTP entities in the United
States. The table below summarizes this calculation.
---------------------------------------------------------------------------
\29\ Data for NAICS codes related to NTPs are based on the 2017
SUSB Annual Datasets by Establishment Industry, last revised on July
16, 2020. SUSB annual or static data includes: Number of firms,
number of establishments, employment, and annual payroll for most
U.S. business establishments. The data are tabulated by geographic
area, industry, and employment size of the enterprise. The industry
classification is based on 2012 NAICS codes.
Number of Entities by Business Activity
----------------------------------------------------------------------------------------------------------------
Number of Entity to
Business activity NAICS code registrations/ establishment Number of
establishment ratio entities
----------------------------------------------------------------------------------------------------------------
Narcotic Treatment Program................ 622210 1,832 0.56 1,026
621420
---------------------------------------------------------------------
Grand Total........................... .............. 1,832 ................. 1,026
----------------------------------------------------------------------------------------------------------------
Thus, based on these calculations, DEA estimates that 1,026
entities could currently operate a mobile NTP, including the eight NTP
entities that currently operate mobile NTP components. Of these, DEA
estimates that at least an additional eleven entities will choose to
operate a mobile NTP as a coincident activity in response to the final
rule, matching the previous total of nineteen mobile NTPs that were in
operation over the previous five years. Because the final rule is an
enabling rule and thus does not affect entities that choose not to
change their behavior in response to it, only NTP entities that choose
to establish mobile NTP units will be affected by the rule. Therefore,
DEA estimates that 1.07 percent (11 of 1,026) of total NTP entities in
the United States will be affected by this final rule.
To estimate the number of NTP entities that are small entities for
RFA purposes, DEA used a process similar to that used to estimate the
total number of NTP entities. As described above,
[[Page 33882]]
U.S. Small Business Administration (SBA) \30\ size standards--based on
the number of employees or annual receipts, depending on the industry--
determine what constitutes a ``small entity'' under the RFA. The SBA
has established these size standards for business activities
corresponding to each NAICS code. The SBA size standards for each of
the NAICS codes that best correspond to NTPs are listed below: Firms
below this SBA size standard (based on annual receipts for these codes)
are small firms--and thus small entities under the RFA.
---------------------------------------------------------------------------
\30\ The SBA is an independent agency of the Federal Government
to aid, counsel, assist, and protect the interests of small business
concerns, to preserve free competitive enterprise, and to maintain
and strengthen the overall economy of the nation. <a href="https://www.sba.gov/about-sba">https://www.sba.gov/about-sba</a> (last accessed: 9/8/2020).
SBA Size Standards
----------------------------------------------------------------------------------------------------------------
Size standards
($ million in Size standards
NAICS codes Description annual (number of
receipts) employees)
----------------------------------------------------------------------------------------------------------------
622210..................................... Psychiatric and Substance Abuse 41.5 ..............
Hospitals.
621420..................................... Outpatient Mental Health and 16.5 ..............
Substance Abuse Centers.
----------------------------------------------------------------------------------------------------------------
Source: SBA, August 19, 2019. (Accessed 9/8/20120).
DEA used SUSB data to estimate the number of small firms for each
of these NAICS codes. In 2012, the last year for which the SUSB has
published the necessary receipts data,\31\ 180 of 411 (43.78%) firms
within code 622210 fell below the SBA size standard and thus were small
firms.\32\ 4,369 of 4,987 (87.61 percent) firms within code 621420 fell
below the standard. DEA assumes that these percentages of small firms
for each code have remained constant in recent years. DEA then applied
these percentages to the updated totals found in the 2017 SUSB Annual
Datasets by Establishment Industry, resulting in approximately 173
firms (43.78 percent of the total 396) within code 622210 and 5,714
firms (87.61 percent of the total 6,523) within code 621420 classified
as small firms. Combining these values indicates that, for these codes,
5,887 of 6,919 firms, or 85.1 percent, are small firms. Thus, since
these are the NAICS codes that most closely correspond to NTP entities,
DEA estimates that 85.1 percent of NTP entities are small firms. As
described above, DEA has concluded that there are roughly 1,026 total
NTP entities in the United States. Accordingly, DEA estimates that 873
(85.1 percent) of the total 1,026 NTP entities are small entities. The
analysis is summarized in the table below.
---------------------------------------------------------------------------
\31\ SUSB receipts data are available only for Economic Census
years (years ending in 2 and 7). Thus, DEA used SUSB data from 2012,
the most recent available annual receipt data.
\32\ SUSB data gives the number of firms for each NAICS code
within a series of ranges of annual receipts. Thus, to determine the
number of firms falling below the SBA size standard, DEA added
together the number of firms in each range falling completely below
the SBA standard. Because the SBA size standard for code 622210
falls within the middle of a range, DEA's calculations may slightly
underestimate the number of small firms for this code.
Summary of Registration, Establishment, Entity, and Small Entity
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Entity to
Business activity registrations/ establishment Number of Percent small Number of
establishments ratio entities entities small entities
--------------------------------------------------------------------------------------------------------------------------------------------------------
Narcotic Treatment Program........................................ 1,832 0.56 1,026 85.1 873
Percent Small Entity.............................................. ................. ................. .............. .............. 85.1%
--------------------------------------------------------------------------------------------------------------------------------------------------------
In consultation with the SBA's Office of Advocacy, DEA has adopted
the SBA standard that the amount of small entities affected by a final
rule is ``substantial'' if 30% or more of the relevant group of small
entities will be affected by the rule. As described in the Summary of
Costs and Benefits section, this final rule is an enabling rule and a
deregulatory action resulting in a total cost savings of at least
$3,509,759 over a five-year period. The final rule allows NTP
registrants another option for expanding the reach of their services,
if they so choose, without requiring that current or future NTP
registrants change their business practices or incur any costs. DEA
estimates that only an additional eleven entities will choose to
operate a mobile NTP as a coincident activity in response to the final
rule. Because the final rule is an enabling rule and thus does not
affect entities that do not change their behavior in response to it,
only these 11 NTP entities and the 8 NTPs currently operating units
under ad hoc agreements are affected by the rule. Therefore, DEA
estimates that 1.85 percent (19 of 1,026) of total NTP entities in the
United States are affected by this final rule. DEA estimates that 11
NTPs not already operating a mobile NTP (or 1.07 percent of all NTPs)
will choose to operate a mobile NTP. DEA has no reason to conclude that
the percentage of small NTP entities that begin operating mobile
components in response to the rule will differ from the percentage of
total NTPs (11 of 1,026, or 1.07 percent), especially since most NTP
entities are small. Thus, DEA estimates that 1.07 percent (9 of the 873
\33\) of small NTP entities will choose to begin operating a mobile NTP
as a coincident activity in response to the rule.
---------------------------------------------------------------------------
\33\ 0.0107 x 873 = 9.3411. Rounding down to the nearest whole
number yields 9.
---------------------------------------------------------------------------
Estimating Impact on Small Entities
The nine affected small entities are estimated to realize the same
cost savings as other affected entities, as calculated above: Between
$319,069 (at a 7 percent discount rate) and $359,369 (at a 3 percent
discount rate) per entity over a five-year period. DEA generally
considers impacts that are greater than 3% of yearly revenue to be a
``significant economic impact'' on an entity, and recognizes that this
amount of cost savings rises above that threshold for those small
entities.
[[Page 33883]]
However, since the percentage of affected small entities is less than
30 percent (1.07 percent), this final rule does not impact a
substantial number of small entities. Therefore, this final rule does
not rise to the level of certification as economically significant.
The table below summarizes the analysis.
Summary of Analysis
----------------------------------------------------------------------------------------------------------------
Estimated number Estimated number Percentage of
Business activity of small entities of affected small small entities Economic impact of
(Establishments) entities affected compliance
----------------------------------------------------------------------------------------------------------------
Narcotic Treatment Program... 873 9 1.07% (Not Not significant.
Substantial).
----------------------------------------------------------------------------------------------------------------
DEA examined the economic impact of the final rule for each
affected industry for various size ranges. Based on the analysis above,
and because of these facts, DEA certifies this final rule will not have
a significant economic impact on a substantial number of small
entities.
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 will 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 1 year. Therefore, neither a Small Government Agency
Plan nor any other action is required under UMRA of 1995.
Paperwork Reduction Act of 1995
This action does not impose a new collection of information
requirement under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-
3521. This action will not impose new recordkeeping or reporting
requirements on State or local governments, individuals, businesses, or
organizations. Although the final rule revises certain recordkeeping
and reporting provisions to explicitly apply them to mobile NTPs, these
provisions already apply to NTPs in general and thus do not impose any
new collection of information requirement.
Congressional Review Act
This final rule is not a major rule as defined by the Congressional
Review Act (CRA), 5 U.S.C. 804. This final rule will not result in an
annual effect on the economy of $100 million or more; a major increase
in costs or prices; or significant adverse effects on competition,
employment, investment, productivity, innovation, or on the ability of
United States-based companies to compete with foreign-based companies
in domestic and export markets. Accordingly, this final rule is not
subject to the reporting requirements under the CRA.
List of Subjects
21 CFR Part 1300
Chemicals, traffic control.
21 CFR Part 1301
Administrative practice and procedure, Drug traffic control,
Security measures.
21 CFR Part 1304
Drug traffic control, Reporting and recordkeeping requirements.
For the reasons stated in the preamble, DEA amends 21 CFR parts
1300, 1301, and 1304 as follows:
PART 1300--DEFINITIONS
0
1. The authority citation for part 1300 continues to read as follows:
Authority: 21 U.S.C. 802, 821, 822, 829, 871(b), 951, 958(f).
0
2. In Sec. 1300.01(b), add in alphabetical order the definitions of
``Mobile Narcotic Treatment Program'' and ``Motor vehicle'' to read as
follows:
Sec. 1300.01 Definitions relating to controlled substances.
* * * * *
(b) * * *
Mobile Narcotic Treatment Program means a narcotic treatment
program (NTP) operating from a motor vehicle, as defined in this
section, that serves as a mobile component (conveyance) and is
operating under the registration of the NTP, and engages in maintenance
and/or detoxification treatment with narcotic drugs in schedules II-V,
at a location or locations remote from, but within the same State as,
its registered location. Operating a mobile NTP is a coincident
activity of an existing NTP, as listed in Sec. 1301.13(e) of this
chapter.
Motor vehicle means a vehicle propelled under its own motive power
and lawfully used on public streets, roads, or highways with more than
three wheels in contact with the ground. This term does not include a
trailer.
* * * * *
PART 1301--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND
DISPENSERS OF CONTROLLED SUBSTANCES
0
3. The authority citation for part 1301 continues to read as follows:
Authority: 21 U.S.C. 821, 822, 823, 824, 831, 871(b), 875, 877,
886a, 951, 952, 956, 957, 958, 965 unless otherwise noted.
0
4. In Sec. 1301.13, revise paragraph (e)(1)(vii), and add paragraph
(e)(4) to read as follows:
Sec. 1301.13 Application for registration; time for application;
expiration date; registration for independent activities; application
forms, fees, contents and signature; coincident activities.
* * * * *
(e) * * *
(1) * * *
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
(vii) Narcotic Treatment Narcotic Drugs New-363........ 296 1 May operate one or
Program (including in Schedules Renewal-363a... more mobile
compounder). II-V. narcotic treatment
programs as defined
under Sec.
1300.01(b),
provided approval
has been obtained
under Sec.
1301.13(e)(4).
----------------------------------------------------------------------------------------------------------------
* * * * *
(4) For any narcotic treatment program (NTP) intending to operate a
mobile NTP, the registrant must notify the local DEA office, in
writing, of its intent to do so, and the NTP must receive explicit
written approval from the local DEA office prior to operating the
mobile NTP. The mobile NTP may only operate in the same State in which
the NTP is registered.
[[Page 33884]]
(i) Registrants are not required to obtain a separate registration
for conveyances (mobile components) utilized by the registrant to
transport controlled substances away from registered locations for
dispensing at unregistered locations as part of a mobile NTP. Vehicles
must possess valid county/city and State information (e.g., a vehicle
information number (license plate number) on file at the registered
location of the NTP. Registrants are also required to provide proper
city/county and State licensing and registration to DEA at the time of
inspection, and prior to transporting controlled substances away from
their registered location.
(ii) A mobile NTP is not permitted to reverse distribute, share, or
transfer controlled substances from one mobile component to another
mobile component while deployed away from the registered location. NTPs
with mobile components are not allowed to modify their registrations to
authorize their mobile components to act as collectors under 21 CFR
1301.51 and 1317.40. Mobile components of NTPs may not function as
hospitals, long-term care facilities, or emergency medical service
vehicles, and will not transport patients.
(iii) A mobile NTP may operate at any remote location or locations
within the same State as its registered location, including
correctional facilities, so long as doing so is otherwise consistent
with applicable Federal, State, tribal, and local laws and regulations,
and so long as the local DEA office, when notified pursuant to this
section, does not otherwise direct.
* * * * *
0
5. In Sec. 1301.72, revise the section heading and add paragraph (e)
to read as follows:
Sec. 1301.72 Physical security controls for non-practitioners;
narcotic treatment programs and compounders for narcotic treatment
programs; mobile narcotic treatment programs; storage areas.
* * * * *
(e) Mobile Narcotic Treatment Programs. (1) For any conveyance
operated as a mobile narcotic treatment program (NTP), a safe must be
installed and used to store narcotic drugs in schedules II-V for the
purpose of maintenance or detoxification treatment, when not located at
the registrant's registered location. The safe must conform to the
requirements set forth in paragraph (a)(1) of this section. The mobile
component must also be equipped with an alarm system that conforms to
the requirements set forth in paragraph (a)(1)(iii) of this section.
The storage area of the mobile component must conform to the
accessibility requirements in paragraph (d) of this section. The
storage area for controlled substances in a mobile component of an NTP
must not be accessible from outside of the vehicle. Personnel
transporting the controlled substances on behalf of the mobile NTP are
required to retain control over all controlled substances when
transferring them between the registered location and the conveyance,
while en route to and from the dispensing location or locations, and
when dispensing at the dispensing location or locations. At all other
times during transportation, all controlled substances must be properly
secured in the safe. Upon completion of the operation of the mobile NTP
on a given day, the conveyance must be immediately returned to the
registered location, and all controlled substances must be removed from
the conveyance and secured within the registered location. After the
conveyance has returned to the registered location and the controlled
substances have been removed, the conveyance may be parked until its
next use at the registered location or any secure, fenced-in area, once
the local DEA office has been notified of the location of this secure,
fenced-in area. All NTPs with mobile components shall be required to
establish a standard operating procedure to ensure, if the mobile
component becomes inoperable (mechanical failure, accidents, fire,
etc.), that all controlled substances on the inoperable conveyance are
accounted for, removed from the inoperable conveyance, and secured at
the registered location.
(2) With regard to the requirement of paragraph (e)(1) of this
section, that upon completion of the operation of the mobile NTP on a
given day, the conveyance must be immediately returned to the
registered location, and all controlled substances must be removed from
the conveyance and secured within the registered location, an NTP may
apply for an exception to this requirement as provided in this
paragraph. The application for such an exception must be submitted in
accordance with Sec. 1307.03 of this chapter and must include the
proposed alternate return period, enhanced security measures, and any
other factors the applicant wishes the Administrator to consider. The
Administrator may grant such an exception in his discretion and will
evaluate each application on a case-by-case basis in determining
whether the applicant has demonstrated exceptional circumstances that
warrant the exception. In making this determination, the Administrator
will consider the applicant's security and recordkeeping as well as any
other factors he deems relevant to determining whether effective
controls against diversion will be maintained.
0
6. In Sec. 1301.74:
0
a. Revise the section heading;
0
b. Revise paragraphs (j) through (l);
0
c. Redesignate paragraph (m) as paragraph (o); and
0
d. Add new paragraphs (m) and (n).
The revisions and additions read as follows:
Sec. 1301.74 Other security controls for non-practitioners; narcotic
treatment programs and compounders for narcotic treatment programs;
mobile narcotic treatment programs.
* * * * *
(j) Persons enrolled in any narcotic treatment program (NTP),
including those receiving treatment at a mobile NTP, will be required
to wait in an area that is physically separated from the narcotic
storage and dispensing area by a physical entrance such as a door or
other entryway. Patients must wait outside of a mobile NTP component if
that conveyance does not have seating or a reception area that is
separated from the narcotic storage and dispensing area. This
requirement will be enforced by the program practitioner and NTP
employees.
(k) All NTPs, including mobile NTPs, must comply with standards
established by the Secretary of Health and Human Services (after
consultation with the Administration) respecting the quantities of
narcotic drugs which may be provided to persons enrolled in a NTP or
mobile NTP for unsupervised use (e.g., take home or non-directly
observed therapy).
(l) DEA may exercise discretion regarding the degree of security
required in NTPs, including mobile NTPs, based on such factors as the
location of a program, the number of patients enrolled in a program,
and the number of practitioners, staff members, and security guards.
Personnel that are authorized to dispense controlled substances for
narcotic treatment must ensure proper security measures and patient
dosage. Similarly, DEA will consider such factors when evaluating
existing security or requiring new security at a narcotic treatment
program or mobile NTP.
(m) Any controlled substances being transported for disposal from
the dispensing location of a mobile NTP shall be secured and disposed
of in compliance with part 1317, and all other applicable Federal,
State, tribal, and local laws and regulations.
[[Page 33885]]
(n) A conveyance used as part of a mobile NTP may only be supplied
with narcotic drugs by the registered NTP that operates such
conveyance. Persons permitted to dispense controlled substances to
mobile NTPs shall not:
(1) Receive controlled substances from other mobile NTPs or any
other entity;
(2) Deliver controlled substances to other mobile NTPs or any other
entity; or
(3) Conduct reverse distribution of controlled substances on a
mobile NTP.
* * * * *
PART 1304--RECORDS AND REPORTS OF REGISTRANTS
0
7. The authority citation for part 1304 continues to read as follows:
Authority: 21 U.S.C. 821, 827, 831, 871(b), 958(e)-(g), and
965, unless otherwise noted.
Sec. 1304.04 [Amended]
0
8. In Sec. 1304.04, amend paragraph (f) introductory text by adding
``mobile narcotic treatment program,'' after ``exporter''.
0
9. In Sec. 1304.24, revise the section heading and paragraphs (a) and
(b) to read as follows:
Sec. 1304.24 Records for maintenance treatment programs, mobile
narcotic treatment programs, and detoxification treatment programs.
(a) Each person registered or authorized (by Sec. 1301.22 of this
chapter) to maintain and/or detoxify controlled substance users in a
narcotic treatment program (NTP), including a mobile NTP, shall
maintain records with the following information for each narcotic
controlled substance:
(1) Name of substance;
(2) Strength of substance;
(3) Dosage form;
(4) Date dispensed;
(5) Adequate identification of patient (consumer);
(6) Amount consumed;
(7) Amount and dosage form taken home by patient; and
(8) Dispenser's initials.
(b) The records required by paragraph (a) of this section will be
maintained in a dispensing log at the NTP site, or in the case of a
mobile NTP, at the registered site of the NTP, and will be maintained
in compliance with Sec. 1304.22 without reference to Sec. 1304.03.
(1) As an alternative to maintaining a paper dispensing log, an NTP
or its mobile component may also use an automated/computerized data
processing system for the storage and retrieval of the program's
dispensing records, if the following conditions are met:
(i) The automated system maintains the information required in
paragraph (a);
(ii) The automated system has the capability of producing a hard
copy printout of the program's dispensing records;
(iii) The NTP or its mobile component prints a hard copy of each
day's dispensing log, which is then initialed appropriately by each
person who dispensed medication to the program's patients;
(iv) The automated system is approved by DEA;
(v) The NTP or its mobile component maintains an off-site back-up
of all computer generated program information; and
(vi) The automated system is capable of producing accurate summary
reports for both the registered site of the NTP and any mobile
component, for any time-frame selected by DEA personnel during an
investigation. If these summary reports are maintained in hard copy
form, they must be kept in a systematically organized file located at
the registered site of the NTP.
(2) The NTP must retain all records for the NTP as well as any
mobile component two years from the date of execution, in accordance
with Sec. 1304.04(a). However, if the State in which the NTP is
located requires that records be retained longer than two years, the
NTP should contact its State opioid treatment authority for information
about State requirements.
* * * * *
D. Christopher Evans,
Acting Administrator.
[FR Doc. 2021-13519 Filed 6-25-21; 8:45 am]
BILLING CODE 4410-09-P
</pre></body>
</html>Indexed from Federal Register on June 28, 2021.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.