[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