[Federal Register Volume 86, Number 221 (Friday, November 19, 2021)]
[Rules and Regulations]
[Pages 66031-66036]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23973]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 410
[CMS-1751-IFC]
RIN 0938-AU95
Medicare Program; Opioid Treatment Programs: CY 2022 Methadone
Payment Exception
AGENCY: Centers for Medicare & Medicaid Services (CMS), Health and
Human Services (HHS).
ACTION: Interim final rule with comment period.
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SUMMARY: This interim final rule with comment period (IFC) freezes the
payment to Opioid Treatment Programs for methadone in CY 2022 at the CY
2021 rate because it would not be appropriate to implement a decrease
to the rate when substance use and overdoses have been exacerbated by
the Coronavirus Disease 2019 (COVID-19) pandemic.
DATES: Effective date: These regulations are effective on January 1,
2022.
Comment date: To be assured consideration, comments on CMS-1751-IFC
must be received at one of the addresses provided below, no later than
5 p.m. January 3, 2022.
ADDRESSES: Please refer to file code CMS-1751-IFC when commenting on
issues in the interim final rule with comment period.
Comments, including mass comment submissions, must be submitted in
one of the following three ways (please choose only one of the ways
listed):
1. Electronically. You may submit electronic comments on this
regulation to http://www.regulations.gov. Follow the ``Submit a
comment'' instructions.
2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-1751-IFC, P.O. Box 8016,
Baltimore, MD 21244-8016.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address ONLY: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-1751-IFC, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
FOR FURTHER INFORMATION CONTACT: Lindsey Baldwin, (410) 786-1694, and
Michele Franklin, (410) 786-9226.
SUPPLEMENTARY INFORMATION:
I. Background
A. Methadone
The Food and Drug Administration (FDA) has approved three
medications for the treatment of opioid use disorder (OUD): Methadone,
buprenorphine, and naltrexone. These are referred to as medications for
opioid use disorder (MOUD). The combination of MOUD with counseling and
behavioral therapies to provide a ``whole-patient'' approach to OUD
care is referred to as medication-assisted treatment (MAT). Opioid
treatment programs (OTPs) are clinically driven and tailored to meet
each patient's needs.\1\ MOUD are also used to prevent or reduce opioid
overdose. These medications are safe to use for months, years, or even
a lifetime.\2\
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\1\ https://www.samhsa.gov/medication-assisted-treatment.
\2\ https://www.samhsa.gov/medication-assisted-treatment.
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As discussed in the CY 2020 PFS final rule (84 FR 62630), when used
to treat those with a confirmed diagnosis of OUD, methadone cannot be
dispensed by a pharmacy like certain other MOUD treatments (that is
buprenorphine, buprenorphine-naloxone combination
[[Page 66032]]
products, or naltrexone products) and therefore is not covered under
Medicare Part D. Methadone is a schedule II controlled substance that
is highly regulated because it has a potential for misuse and serious
adverse effects if taken by opioid-na[iuml]ve individuals. Methadone is
also used as an analgesic to treat chronic pain. When used for the
treatment of OUD, methadone is taken daily and is available in tablet,
tablet for suspension, and solution forms and can only be dispensed and
administered by an OTP as provided under section 303(g)(1) of the
Controlled Substances Act (21 U.S.C. 823(g)(1)) and 42 CFR part 8. In
the CY 2020 PFS final rule, we noted that approximately 74 percent of
patients receiving services from OTPs receive methadone for OUD
treatment, with the vast majority of the remaining patients receiving
buprenorphine (84 FR 62631).\3\ In monitoring utilization of OTP
services furnished under the new Medicare benefit, we have observed the
percentage of Medicare beneficiaries receiving methadone to be closer
to 95 percent.
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\3\ https://www.cdc.gov/drugoverdose/deaths/index.html.
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According to SAMHSA's website, MAT has been shown to improve
patient survival and increase retention in treatment.\4\ Several
studies indicate that retention in MAT is associated with lower
mortality rates. One study stated that ``Retention in MAT of over one
year was associated with a lower mortality rate than that with
retention of less than one year. Improved coverage and adherence to MAT
and post-treatment follow-up are crucial to reduce the mortality.'' \5\
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\4\ https://www.samhsa.gov/medication-assisted-treatment.
\5\ Ma, J., Bao, YP., Wang, RJ. et al. Effects of medication-
assisted treatment on mortality among opioids users: a systematic
review and meta-analysis. Mol Psychiatry 24, 1868-1883 (2019).
https://doi.org/10.1038/s41380-018-0094-5.
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B. Effects of the COVID-19 pandemic on the Opioid Crisis
The United States is now facing a fourth wave of the overdose
crisis as a result of rising polysubstance use, such as the co-use of
opioids and psychostimulants (for example, methamphetamine, cocaine).
Recent CDC estimates of overdose deaths now exceed 96,000 for the 12-
month period to March 2021,\6\ with overdose death rates surging among
Black and Latino Americans.\7\ While overdose deaths were already
increasing in the months preceding the COVID-19 pandemic, the latest
numbers suggest an acceleration of overdose deaths during the pandemic.
Public comments received in response to the CY 2022 PFS proposed rule
described the recent increases in overdose deaths. One commenter stated
that drug overdose deaths have reached historic highs in this country.
According to the commenter, these spikes in substance use and overdose
deaths reflect a combination of increasingly deadly illicit drug
supplies, as well as treatment disruptions, social isolation, and other
hardships imposed by the COVID-19 pandemic, but they also reflect the
longstanding inadequacy of our medical infrastructure when it comes to
preventing and treating substance use disorders (SUD) (for example,
alcohol, tobacco, cannabis, opioids). Even before the COVID-19 pandemic
began, more than 21 million Americans aged 12 or over in 2019 needed
treatment for a SUD in the past year, but only about 4.2 million of
them received any treatment or ancillary services for it.\8\
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\6\ https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm.
\7\ Drake, J., Charles, C., Bourgeois, J.W., Daniel, E.S., &
Kwende, M. (January 2020). Exploring the impact of the opioid
epidemic in Black and Hispanic communities in the United States.
Drug Science, Policy and Law. doi:10.1177/2050324520940428.
\8\ Substance Abuse and Mental Health Services Administration.
(2020). Key substance use and mental health indicators in the United
States: Results from the 2019 National Survey on Drug Use and Health
(HHS Publication No. PEP20-07-01-001, NSDUH Series H-55). Rockville,
MD: Center for Behavioral Health Statistics and Quality, Substance
Abuse and Mental Health Services Administration. Retrieved from
https://www.samhsa.gov/data/.
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C. Opioid Use Disorders (OUDs) in the Medicare Population
Nearly one million adults aged 65 and older live with a SUD, as
reported in 2018 data.\9\ According to a Data Highlight published by
CMS' Office of Minority Health, Medicare beneficiaries represent a
growing proportion of individuals with OUD. Overall, 2.8 percent of
Medicare Fee-for-Service (FFS) beneficiaries had an opioid use disorder
(OUD) in 2018 out of a total of 38,665,082 Medicare FFS
beneficiaries.\10\ The problems associated with OUD in the Medicare
population are compounded by chronic pain-associated conditions more
common in later life, as well as the increased prevalence of multiple
comorbidities and polypharmacy risks that exist among older adults.\11\
A public comment received in response to the CY 2022 PFS proposed rule
referred to increases in overdose deaths in individuals over age 65,
stating that data from the CDC indicates that drug overdose deaths are
increasing across all age groups, including those over age 65.
Additionally, a recent Office of Inspector General (OIG) analysis of
Medicare data reported that opioid overdoses have resulted in more than
200,000 deaths among Medicare beneficiaries nationwide since 2015. From
2016 to 2019, Medicare Part D saw a steady decline in opioid use, along
with an increased use of drugs for treatment of OUD. OIG also noted
that COVID-19 poses specific dangers for people using opioids, as
respiratory diseases like COVID-19 can increase the risk of fatal
overdose among those taking opioids and those with OUD are more likely
to contract COVID-19 and suffer complications. With the onset of COVID-
19 and the new dangers it poses for beneficiaries taking opioids, the
OIG report states that it is imperative that the HHS closely monitor
opioid use during this unprecedented time. During the first 8 months of
2020, about 5,000 Medicare Part D beneficiaries per month had an opioid
overdose.\12\
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\9\ https://www.drugabuse.gov/publications/substance-use-in-older-adults-drugfacts.
\10\ https://www.cms.gov/research-statistics-data-systems/cms-program-statistics/2018-medicare-enrollment-section.
\11\ https://www.cms.gov/files/document/oud-disparities-prevalence-2018-medicare-ffs-dh-002.pdf.
\12\ Opioid Use in Medicare Part D During the Onset of the
COVID-19 Pandemic. U.S. Department of Health and Human Services
Office of Inspector General. Data Snapshot, OEI-02-20-00400.
Published February 2021.
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II. Methadone Pricing
In the CY 2020 PFS final rule (84 FR 62667), we finalized a policy
in Sec. 410.67(d)(2)(i) under which the payment for the drug component
of episodes of care will be updated annually using the most recent data
available from the applicable pricing mechanism at the time of
ratesetting for the applicable calendar year. Under the policy
finalized at Sec. 410.67(d)(2)(i)(B), for oral medications, if ASP
data are available, the payment amount is 100 percent of ASP, which
will be determined based on ASP data that have been calculated
consistent with the provisions in 42 CFR part 414, subpart J and
voluntarily submitted by drug manufacturers. If ASP data are not
available, the payment amount for methadone will be based on the
TRICARE rate. The payment amount for methadone furnished by OTPs during
an episode of care in CY 2021 is $37.38,\13\ which is 100 percent of
ASP, as determined based on voluntarily submitted ASP data for the
methadone.
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\13\ https://www.cms.gov/files/document/otp-billing-and-payment-fact-sheet.pdf.
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Quarterly ASP pricing files are typically posted on the CMS website
[[Page 66033]]
prior to the beginning of the quarter in which Medicare payments will
be effective, which allows drug manufacturers that are required to
submit their sales data to review and identify any issues. Due to the
timing of CY PFS rulemaking and because ASP drug pricing file data is
updated on a quarterly basis, the most recent ASP drug pricing file
data available for this CY 2022 PFS final rule is the October 2021
update. For payment limits effective October 1, 2021, CMS posted the
ASP drug pricing file on September 9, 2021.
In early September 2021, while gathering available manufacturer-
reported ASP data for the annual update to the OTP drug pricing for CY
2022, we found that the volume-weighted ASP for oral methadone had
decreased by just over 50 percent compared to last year's rate, from
$37.38 to $17.64.\14\ This reduction is due to inclusion of newly
reported ASP data for methadone tablets, whereas previously the
manufacturer-reported ASP data reflected only sales of the methadone
oral concentrate. The ASP is volume-weighted; however, ASP reporting is
not required for oral methadone and only a small subset of methadone
manufacturers voluntarily submit ASP data. Of the nearly 50 available
NDCs for oral methadone preparations with available pricing in the Red
Book[supreg] compendia, voluntarily submitted ASP data is available for
only three of these NDCs. Pricing for oral methadone is distinct from
most other drug pricing based on ASP because oral methadone is not
separately payable as a drug or biological under Medicare Part B, and
manufacturers are not subject to ASP reporting requirements under
section 1927(b)(3)(A)(iii) of the Act for those NDCs. Additionally, we
do not currently have utilization data on the different forms of
methadone that can be dispensed or administered at the OTPs. That is,
at this time we do not have data showing whether OTPs utilize oral
methadone concentrate or tablets more often, or if the two formulations
are utilized equally. When we researched OTP practice patterns as we
were preparing to implement this new benefit, we received anecdotal
reports that several OTPs used the oral concentrate exclusively.
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\14\ The TRICARE rate for the drug portion of its weekly bundled
payment for methadone treatment is $24.04 for 2022, which would also
be a decrease from the CY 2021 payment rate under Medicare and
cannot be used to set the Medicare payment rate for methadone in CY
2022 under Sec. 410.67(d)(2)(i)(B) because ASP data is available
for methadone.
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For these reasons, we have questions as to whether the current ASP
data, which reflects voluntarily reported data from only a very small
subset of methadone manufacturers, is representative of utilization of
the two forms of oral methadone by the Medicare beneficiaries receiving
OUD treatment services in OTPs.
Given recent reports regarding the effects of the public health
emergency (PHE) for COVID-19 on individuals with SUD, including OUD,
and the questions we have related to whether the ASP data we have for
methadone is reflective of OTP utilization due to the distinct nature
of methadone pricing, as described above, we believe it is in the
public's best interest not to implement a significant decrease in the
payment rate for methadone furnished by OTPs as part of OUD treatment
services without first having an opportunity to review the issue, seek
input from the OTP stakeholder community regarding utilization of
methadone oral concentrate compared to utilization of methadone
tablets, and consider how this information should factor into the
determination of the payment rate for methadone furnished by OTPs. We
note that section 1834(w)(2) of the Act allows for flexibility to
consider the scope of services furnished, the characteristics of the
individuals receiving services, and such other factors as the Secretary
determines appropriate, in determining the rates paid to OTPs under
Medicare.
Therefore, in this interim final rule with comment period (IFC), we
are establishing a limited exception to the current methodology for
determining the payment amount for the drug component of an episode of
care in order to freeze the payment amount for methadone furnished
during an episode of care in CY 2022 at the payment amount that was
determined for CY 2021. We are also revising the regulation at Sec.
410.67(d)(2)(i)(B), which governs the determination of the payment
amount for oral medications, to reflect this exception and to make a
conforming change to the reference to 42 CFR part 414, subpart J.
Under this exception, the payment amount for the drug component of
the methadone bundle described by HCPCS code G2067 (Medication assisted
treatment, methadone; weekly bundle including dispensing and/or
administration, substance use counseling, individual and group therapy,
and toxicology testing, if performed (provision of the services by a
Medicare-enrolled Opioid Treatment Program)) and the methadone add-on
code described by HCPCS code G2078 (Take-home supply of methadone; up
to 7 additional day supply (provision of the services by a Medicare-
enrolled Opioid Treatment Program); List separately in addition to code
for primary procedure) will be maintained at the CY 2021 rate of $37.38
for the duration of CY 2022. We will apply the annual update to the
non-drug component of HCPCS G2067 for CY 2022 as required under Sec.
410.67(d)(4)(iii). We believe that maintaining the payment amount for
methadone at the CY 2021 rate during CY 2022 will allow time for CMS to
study the issue further and, if appropriate, to develop an alternative
payment methodology for methadone that could be proposed through
notice-and-comment rulemaking for CY 2023.
We seek comment on the exception to the payment methodology for the
drug component of an episode of care that we are adopting in this IFC
in order to maintain the payment rate for methadone at the CY 2021
payment amount during CY 2022. Additionally, we are seeking comment on
OTP utilization patterns for methadone, particularly, the frequency
with which methadone oral concentrate is used compared to methadone
tablets in the OTP setting, including any applicable data on this
topic. As the OTP benefit is still new under Medicare, we have not had
the opportunity to fully understand how changes in the payment rates
may affect OTP operations and beneficiary access to treatment. However,
it is our intent to continue to refine our payment policies in order to
best meet the needs of Medicare beneficiaries. We will consider the
comments received in determining how best to determine the payment rate
for methadone in CY 2023, including whether we should propose changes
in future rulemaking to the structure of OTP coding and payment in
order to account for differences in pricing and utilization for the
different formulations of methadone.
III. Waiver of Proposed Rulemaking
We ordinarily publish a notice of proposed rulemaking in the
Federal Register and consider public comment on the proposed rule
before the provisions of the rule are finalized and take effect, either
as proposed or as amended, in accordance with the Administrative
Procedure Act (APA) (Pub. L. 79-404), 5 U.S.C. 553 and, where
applicable, section 1871 of the Act. Specifically, 5 U.S.C. 553
requires the agency to publish a notice of proposed rulemaking in the
Federal Register that includes a reference to the legal authority under
which the rule is proposed, and the terms and substance of the proposed
rule or a description of the subjects and issues involved.
[[Page 66034]]
Section 553(c) of the APA further requires the agency to give
interested parties the opportunity to participate in the rulemaking
through public comment before the provisions of the rule take effect.
Similarly, section 1871(b)(1) of the Act requires the Secretary to
provide for notice of the proposed rule in the Federal Register and a
period of not less than 60 days for public comment for rulemaking
carrying out the administration of the insurance programs under Title
XVIII of the Act. Section 553(b)(B) of the APA and section
1871(b)(2)(C) of the Act authorize the agency to waive these
procedures, however, if the agency finds good cause that notice and
comment procedures are impracticable, unnecessary, or contrary to the
public interest and incorporates a statement of the finding and its
reasons in the rule issued.
According to the National Quality Forum (NQF) September 2021
Report, Addressing Opioid-Related Outcomes Among Individuals With Co-
occurring Behavioral Health Conditions, ``the ongoing opioid and SUDs
crisis has been amplified by COVID-19 pandemic. The convergence of
these two public health emergencies has led to an acceleration in
overdose deaths. As information continues to emerge related to the
long-term impacts of the pandemic, it has become increasingly clear
that individuals with SUDs have been disproportionately affected by the
disruption to daily life. Not only are individuals with a recent
diagnosis of SUDs--particularly OUD and tobacco use disorder--at a
significantly increased risk for COVID-19, but individuals with SUDs
and COVID-19 had significantly worse outcomes than other COVID-19
individuals (for example, death and hospitalization). The mental health
ramifications of social distancing and isolation also have far reaching
impacts, especially for individuals with SUDs. In particular, younger
adults and racial/ethnic minorities experienced disproportionally worse
mental health outcomes during the pandemic, including increased
substance use and suicidal ideation.'' \15\
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\15\ https://www.qualityforum.org/ProjectMaterials.aspx?projectID=93434.
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Additionally, the NQF September 2021 Report states, ``OUD is often
associated with a high risk for morbidity, mortality, and other adverse
health and social conditions. Adverse events include, but are not
limited to, overdose, infection, injury, hospitalization, and suicide.
Individuals with OUD and/or other SUDs may face challenges across
multiple facets of their lives, such as unemployment or
underemployment, fractured family structures, and involvement with the
criminal justice system.'' It goes on to say that ``with over 255
individuals dying each day from a drug overdose--and with just over 70
percent of all drug overdose deaths involving an opioid--it is
essential for stakeholders to take action to address overdose and
mortality related to the ongoing SUD crisis.10 16
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\16\ Ahmad F, Rossen L, Sutton P. Provisional drug overdose
death counts. National Center for Health Statistics. Centers for
Disease Control and Prevention. https://www.cdc.gov/nchs/nvss/vsrr/drugoverdose-data.htm. Published August 5, 2021. Last accessed
August 2021.
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We believe that it would be contrary to the public interest to
allow the payment rate for methadone furnished by OTPs to decrease to
$17.64, a decrease of over 50 percent from the current payment rate of
$37.38, on January 1, 2022, as required under the current regulation.
As described in section I. of this IFC, the PHE for COVID-19 has had a
significant impact on individuals with SUD, including OUD. We believe
it is essential to ensure that Medicare beneficiaries retain access to
treatment for OUD at OTPs at a time when overdose deaths are
increasing. As we previously discussed, this is the second year we have
updated the payment rates for OTPs. This benefit was established by the
SUPPORT Act as part of the strategy to fight the opioid crisis. This
benefit is still building the trust and confidence of OTPs to enroll in
Medicare and furnish OUD treatment services and we have heard
stakeholder feedback regarding the shortage of available behavioral
health specialists for treatment of SUDs. According to a report by the
National Academies of Sciences, Engineering, and Medicine Committee on
Medication-Assisted Treatment for Opioid Use Disorder, ``the barriers
preventing broader access to life-saving medications for OUD include
stigma, inadequate professional education and training related to the
evidence base for using medication, and challenges in connecting
individuals with medication-based treatment due to delivery system
fragmentation, regulatory and legal barriers, barriers related to
public and private health insurance coverage, and reimbursement and
payment policies that do not incentivize the provision of high-value
care for OUD'' \17\. From 2010 through 2019, we have seen that the
Medicare population has a growing need for OUD treatment. Specifically,
analyzing Medicare data regarding chronic condition counts, we found
that in 2010 there were approximately 311,000 beneficiaries with OUD
and this number has grown to approximately 983,000 beneficiaries as of
2019.\18\ We anticipate that this data will continue to trend upward
and that the number of Medicare beneficiaries with OUD will increase as
well as the need for access to these lifesaving services. We are still
studying the payment system implemented in CY 2020 and the implications
of the payment methodologies put into place. We had not contemplated
that there could be such a significant fluctuation in payment at this
point especially for one of the most commonly used medications for OUD
treatment.
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\17\ National Academies of Sciences, Engineering, and Medicine;
Health and Medicine Division; Board on Health Sciences Policy;
Committee on Medication-Assisted Treatment for Opioid Use Disorder;
Mancher M, Leshner AI, editors. Washington (DC): National Academies
Press (US); 2019 Mar 30. https://www.ncbi.nlm.nih.gov/books/NBK541389/.
\18\ https://www2.ccwdata.org/web/guest/medicare-tables-reports.
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In addition, as discussed in section II. of this IFC, we have
questions with respect to whether the ASP data we have for methadone is
reflective of OTP utilization due to the distinct nature of methadone
pricing and anecdotal reports that the more expensive methadone oral
concentrate is more commonly used by OTPs. We note that public comments
received in response to the CY 2020 PFS proposed rule described that
OTPs incur costs associated with rigorous storage and inventory
tracking systems required by the DEA and suggested a cautious approach
to pricing the drugs to ensure the success of these programs (84 FR
62656). Regarding the annual update to the rates, commenters also
indicated that if the OTP rates were not adequately updated, this would
create access to care issues as federal and state mandated OTP costs
grow faster than Medicare reimbursements (84 FR 62668). Additionally,
in the CY 2017 PFS final rule, we referred to the shortage of available
psychiatric and other mental health professionals in many parts of the
country, and stated we believe it is important to identify and make
accurate payment for models of care that facilitate access to
psychiatric and other behavioral health specialty care (81 FR 80233).
As a result, we believe it is in the public's best interest not to
decrease the payment rate for methadone furnished by OTPs as part of
OUD treatment services and risk restricting access to OUD treatment
services without first having an opportunity to review the issue, seek
[[Page 66035]]
input from the OTP stakeholder community regarding utilization of
methadone oral concentrate compared to utilization of methadone
tablets, and consider how this information should factor into the
determination of the payment rate for methadone furnished by OTPs.
As explained in section II. of this IFC, we identified the
reduction in the payment rate for methadone in September as part of
determining the annual update to the drug component of the OTP payment
rates under Sec. 410.67(d)(2)(i) in conjunction with the development
of the CY 2022 PFS final rule. Because we did not propose any change to
the payment methodology for methadone in the CY 2022 PFS proposed rule,
it was not possible for us to address the payment decrease in the CY
2022 PFS final rule. In addition, we have determined that it would be
impracticable to undertake a new notice-and-comment rulemaking process
in order to freeze the payment rate for methadone before the payment
rate decrease required under the current regulations takes effect on
January 1, 2022.
If we were to proceed with notice-and-comment rulemaking procedures
to propose a change to the payment methodology for methadone, we
estimate the process would take at least 6 months to complete, which
would require that the decreased rate take effect on January 1, 2022,
and remain in effect for several months before we would be able to
issue a final rule to modify the payment rate. For the reasons
explained previously, we believe that allowing the payment decrease to
take effect could cause harm to the Medicare beneficiaries who rely on
OTP services during a time where stable and predictable access to OUD
treatment services is needed the most. We believe that implementing a
sudden and significant decrease in the rate for methadone could affect
the ability of OTPs to continue to offer services to Medicare
beneficiaries, thereby impeding access to treatment for OUD, at a time
when overdose deaths are at an all-time high. As noted in section I. of
this IFC, estimates of total drug overdose deaths now exceed 96,000 for
the 12-month period to March 2021. Therefore, we believe that
maintaining the payment amount for methadone at the CY 2021 rate while
we seek information about OTP utilization patterns and explore other
alternatives for addressing our payment methodology is of life-saving
importance. Thus, in light of the timing constraints and the potential
consequences of allowing the payment reduction to take effect, we have
determined that it would be impracticable and contrary to the public
interest to undertake notice-and-comment rulemaking before freezing the
payment rate for methadone during CY 2022.
Therefore, we find good cause to waive notice-and-comment
procedures and to issue this IFC. We are providing a 60-day public
comment period as specified in the DATES section of this document. The
agency will carefully consider any comments received before taking any
future action with respect to this policy.
IV. Collection of Information Requirements
This document does not impose information collection requirements,
that is, reporting, recordkeeping, or third-party disclosure
requirements. Consequently, there is no need for review by the Office
of Management and Budget under the authority of the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.).
V. Response to Comments
Because of the large number of public comments we normally receive
on Federal Register documents, we are not able to acknowledge or
respond to them individually. We will consider all comments we receive
by the date and time specified in the DATES section of this preamble,
and, when we proceed with a subsequent document, we will respond to the
comments in the preamble to that document.
VI. Regulatory Impact Statement
This IFC is necessary to make policy changes under Medicare fee-
for-service. Specifically, this IFC freezes payment to Opioid Treatment
Programs for methadone in CY 2022 at the CY 2021 rate because it would
not be appropriate to implement a decrease to the payment rate when
substance use and overdoses have been exacerbated by the COVID-19
pandemic.
We are unaware of any relevant federal rules that duplicate,
overlap, or conflict with this IFC. The relevant sections of this IFC
contain a description of significant alternatives, if applicable.
In the CY 2020 PFS final rule (84 FR 62667), we finalized a policy
under which the payment to opioid treatment programs (OTPs) for the
drug component of episodes of care will be updated annually using the
most recent data available from the applicable pricing mechanism at the
time of ratesetting for the applicable calendar year. However, in
gathering available manufacturer-reported ASP data for the annual
update to the OTP drug pricing for CY 2022, we found that the volume-
weighted ASP for oral methadone had decreased by just over 50 percent
compared to last year's rate because it now includes newly reported ASP
data for methadone tablets, whereas previously only manufacturer-
reported data for methadone oral concentrate had been included. The ASP
is volume-weighted; however, because ASP reporting is not required for
oral methadone, we have questions as to whether this data is
representative of utilization of the two types of oral methadone in
OTPs. Given the recent reports on the effects of the PHE for COVID-19
on individuals with substance use disorders, including opioid use
disorder, and the questions we have related to whether the ASP data we
have for methadone is reflective of OTP utilization, we believe it is
in the public's best interest not to implement a significant decrease
in the payment rate for methadone furnished by OTPs without first
having an opportunity to review the issue, seek input from the OTP
stakeholder community regarding utilization of methadone oral
concentrate compared to utilization of methadone tablets in the OTP
setting, and consider how this information should factor into the
determination of the payment rate for methadone furnished by OTPs.
Therefore, in this IFC we are modifying our payment methodology in
order to maintain the price for the drug component of the methadone
bundle described by HCPCS code G2067 (Medication assisted treatment,
methadone; weekly bundle including dispensing and/or administration,
substance use counseling, individual and group therapy, and toxicology
testing, if performed (provision of the services by a Medicare-enrolled
Opioid Treatment Program) and the methadone add-on code described by
HCPCS code G2078 (Take-home supply of methadone; up to 7 additional day
supply (provision of the services by a Medicare-enrolled Opioid
Treatment Program); List separately in addition to code for primary
procedure) at the CY 2021 rate of $37.38 on an interim final basis for
the duration of CY 2022.
Based on an analysis of the 2020 and 2021 utilization of the OTP
benefit, we estimate that the Part B cost impact of maintaining the CY
2021 price for the drug component of the methadone bundle and the
methadone add-on code for take-home supplies of methadone on an interim
final basis for the duration of CY 2022 rather than implementing the
[[Page 66036]]
decrease in the available manufacturer-reported ASP data will be
approximately $25 million. Additionally, we believe that not
implementing the decrease based on the available manufacturer-reported
ASP data is in the public's best interest given the recent reports on
the effects of the PHE for COVID-19 on individuals with OUD, especially
as it pertains to overdose deaths. We note that we are also seeking
public comment on patterns of utilization of oral methadone by OTPs in
order to inform future rulemaking on this topic.
We have examined the impact of this rule as required by Executive
Order 12866 on Regulatory Planning and Review (September 30, 1993),
Executive Order 13563 on Improving Regulation and Regulatory Review
(January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19,
1980, Pub. L. 96-354), section 1102(b) of the Act, section 202 of the
Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4),
Executive Order 13132 on Federalism (August 4, 1999), and the
Congressional Review Act (5 U.S.C. 804(2)).
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). A
Regulatory Impact Analysis (RIA) must be prepared for major rules with
economically significant effects ($100 million or more in any 1 year).
This rule does not reach the economic threshold and thus is not
considered a major rule.
The RFA requires agencies to analyze options for regulatory relief
of small entities. For purposes of the RFA, small entities include
small businesses, nonprofit organizations, and small governmental
jurisdictions. Most hospitals and most other providers and suppliers
are small entities, either by nonprofit status or by having revenues of
less than $8.0 million to $41.5 million in any 1 year. Individuals and
states are not included in the definition of a small entity. We are not
preparing an analysis for the RFA because we have determined, and the
Secretary certifies, that this IFC will not have a significant economic
impact on a substantial number of small entities.
In addition, section 1102(b) of the Act requires us to prepare an
RIA if a rule may have a significant impact on the operations of a
substantial number of small rural hospitals. This analysis must conform
to the provisions of section 604 of the RFA. For purposes of section
1102(b) of the Act, we define a small rural hospital as a hospital that
is located outside of a Metropolitan Statistical Area for Medicare
payment regulations and has fewer than 100 beds. We are not preparing
an analysis for section 1102(b) of the Act because we have determined,
and the Secretary certifies, that this IFC will not have a significant
impact on the operations of a substantial number of small rural
hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 also
requires that agencies assess anticipated costs and benefits before
issuing any rule whose mandates require spending in any 1 year of $100
million in 1995 dollars, updated annually for inflation. In 2021, that
threshold is approximately $158 million. This rule will have no
consequential effect on state, local, or tribal governments or on the
private sector.
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule) that imposes substantial direct requirement costs on state
and local governments, preempts state law, or otherwise has Federalism
implications. Since this regulation does not impose any costs on state
or local governments, the requirements of Executive Order 13132 are not
applicable.
In accordance with the provisions of Executive Order 12866, this
regulation was reviewed by the Office of Management and Budget.
Chiquita Brooks-LaSure, Administrator of the Centers for Medicare &
Medicaid Services, approved this document on October 27, 2021.
List of Subjects in 42 CFR Part 410
Diseases, Health facilities, Health professions, Laboratories,
Medicare, Reporting and recordkeeping requirements, Rural areas, X-
rays.
For the reasons set forth in the preamble, the Centers for Medicare
& Medicaid Services amends 42 CFR chapter IV as set forth below:
PART 410--SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS
0
1. The authority citation for part 410 continues to read as follows:
Authority: 42 U.S.C. 1302, 1395m, 1395hh, 1395rr, and 1395ddd.
0
2. Amend Sec. 410.67 by revising paragraph (d)(2)(i)(B) to read as
follows:
Sec. 410.67 Medicare coverage and payment of Opioid use disorder
treatment services furnished by Opioid treatment programs.
* * * * *
(d) * * *
(2) * * *
(i) * * *
(B) For oral medications. (1) Except as provided under paragraph
(d)(2)(i)(B)(2) of this section, if ASP data are available, the payment
amount is 100 percent of ASP, which will be determined based on ASP
data that have been calculated consistent with the provisions in part
414, subpart J of this chapter and voluntarily submitted by drug
manufacturers. If ASP data are not available, the payment amount for
methadone will be based on the TRICARE rate and for buprenorphine will
be calculated using the National Average Drug Acquisition Cost.
(2) For CY 2022, the payment amount for methadone is the payment
amount determined under paragraph (d)(i)(B)(1) of this section for
methadone in CY 2021.
* * * * *
Dated: October 29, 2021.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2021-23973 Filed 11-2-21; 4:15 pm]
BILLING CODE 4120-01-P