CMS Section 111 Penalties Final Rule Released | Verisk

By Mark Popolizio, J.D., Jeremy Farquhar

October 11, 2023 / 24 min read

In a major development on the Section 111 reporting front, the Centers for Medicare and Medicaid Services (CMS) has released its long-awaited Section 111 civil money penalties (CMPs) “final rule” as contained at Fed. Reg. Vol. 88, No. 195, at 70363-70373 (October 11, 2023). CMS has also released an industry alert on this topic.

CMS’s final rule constitutes the agency’s official regulations to enforce Section 111’s “up to a $1,000 per day, per claim” penalty provisions under the Medicare Secondary Payer (MSP) statute.^[1] The final rule adds regulatory provisions codified at 42 CFR Part 402 (Civil Money Penalties, Assessments and Exclusions) and 42 CFR Part 405 (Adjustment of Civil Money Penalties for Inflation). Adjusted annually for inflation, the current Section 111 penalty amount is $1,325.^[2] The final rule applies to both non-group health plans (NGHP) and group health plans (GHPs). This article focuses on the CMPs only from the NGHP context.

Many one dollar bills

Summary

Overall, as outlined below, CMS has made what may be considered significant changes to CMPs in some areas. For instance, CMS is now limiting potential CMPs only to “untimely” TPOC and ORM reporting, has expanded the Section 111 good faith compliance “safe harbor”, and has eliminated all other previously proposed penalty bases. On other fronts, CMS’s final rule also contains information on other topics of likely interest to Section 111 NGHP Responsible Reporting Entities (RREs) such as the rule’s application and scope, how CMS will calculate CMPs, notice and appeals, statute of limitations, and other issues as referenced below.

In terms of what’s next, per the Federal Register CMS’s final rule for Section 111 CMPs is effective as of December 11, 2023, while the provisions of this rule are applicable on or after October 11, 2024.^[3] On this latter point, CMS states that “RREs are expected to be compliant with their Section 111 Mandatory Insurer Reporting requirements no later than October 10, 2024, or they may be eligible for a CMP.”^[4]

Taking it a bit deeper, this article provides the reader with an overview of CMS’s Section 111 CMPs final rule, broken down by topic, and how it impacts Section 111 reporting going forward. Also, please join us on our Section 111 CMPs webinar on October 16^th.

CMPs limited to untimely TPOC and ORM reporting

We start by examining when, per the final rule, CMS may impose CMPs against a NGHP RRE.

In this regard, it is important to first note that CMS has significantly revised and limited the instances in which it may consider imposing CMPs as part of the final rule. Specifically, CMS states, in part, “[i]n this final rule, all other proposed avenues for receiving a CMP have been eliminated and the only method of non-compliance that would be ripe for a CMP would be untimely reporting …”^[5] On this point, CMS further states, “[t]he only basis for the imposition of a CMP will be untimely reporting of required information. The final rule removes all references in the proposed rule to ‘contradictory reporting’ or ‘exceeding error tolerance’ as a reason to impose a CMP. Specifically, any references to an applicable plan providing contradictory reporting, and any CMPs imposed as a result, that were proposed in 42 CFR 402.1(c)(21) and (c)(22), 402.105(b)(2) and (b)(3), or elsewhere, are removed and are not being finalized.”^[6]

Potential CMPs for untimely TPOC and ORM reporting

Accordingly, under the final rule, CMS may impose a CMP in situations where the RRE “[f]ails to report any beneficiary record within 1 year from the date of the settlement, judgment, award, or other payment, or the effective date where on-going payment responsibility for medical care has been assumed by the entity.” See, 42 C.F.R. 402.1(22)(i) (emphasis added).

Echoing the above regulatory language, CMS as part of the final rule states that “[n]oncompliance is defined as any time CMS identifies a new beneficiary record that was not reported to CMS timely. Timeliness is defined as reporting to CMS within 1 year of the date “a settlement, judgment, award, or other payment determination was made (or the funding of a settlement, judgment, award, or other payment, if delayed), or the date when an entity’s Ongoing Responsibility for Medicals (ORM) became effective.”^[7]

Also, it is important to note that while the initial proposed rule had only specifically referenced timeliness regarding TPOC reporting, CMS’s final rule, as noted above, now also includes ORM reporting. Further, the final rule also contains some additional clarification regarding precisely what constitutes a late TPOC report.

Timely submission of TPOC reports

As part of the final rule, CMS provides specific information with respect to determining the timeliness of a TPOC report. For example, CMS indicates that it will compare the date of an RRE’s file submission with one of two potential dates submitted as a part of the RRE’s TPOC report.^[8] The first of those dates is simply the TPOC Date. The second of those dates, when applicable, would be the Funding Delayed Beyond TPOC Start Date (“the funding of a settlement, judgment, award, or other payment, if delayed”).^[9] Per CMS, the latter is only required to be reported in scenarios when full distribution/disbursement of funds from the TPOC are delayed more than 30 days subsequent to the TPOC Date.^[10] In such a scenario, the Funding Delayed Beyond TPOC Start Date should represent the date as of which the TPOC has or will be fully funded.^[11]

From another angle, in scenarios where only a TPOC Date is reported by the RRE, CMS indicates that it will compare the RRE’s file submission date with the TPOC Date and, in the event that the TPOC date is greater than 1 year prior to the file submission date, the TPOC report in question may be subject to the assessment of a penalty due to the RRE’s failure to report in a timely fashion.^[12] In the event that a Funding Delayed Beyond TPOC Start Date is also reported, CMS states that it will utilize that date (“the funding of a settlement, judgment, award, or other payment, if delayed”), as opposed to the TPOC Date, to assess the timeliness of the report. In the event that the Funding Delayed Beyond TPOC Start Date is found to be more than 1 year prior to the RRE’s file submission date, the TPOC report in question may be subject to the assessment of a penalty. ^[13]

Timely submission of ORM reports

Likewise, CMS also provides information regarding what it will consider in determining the timeliness of an ORM report. For example, CMS states that it will look to compare the date of the RRE’s file submission with the date upon which the RRE assumed ORM.^[14] While this may seem relatively straight forward at face value, it is noteworthy that CMS does not presently collect the date of ORM assumption via the Section 111 reporting process. At present, CMS only collects the Date of Incident via the Section 111 process and there may often be a delay between the Date of Incident and the time as of which the determination to assume ORM is established. That being the case, it remains to be seen how CMS will attempt to identify the date as of which an RRE assumed ORM in order to accurately assess potential penalties.

When CMPs will NOT be imposed

The final rule outlines several situations when a CMP will not be imposed. These scenarios are outlined in 42 CFR 402.1(ii) and are as follows:

Good Faith Compliance Safe Harbor -- when the RRE is unable, despite a “good faith” effort, to obtain the claimant’s name, date of birth, Medicare Beneficiary Identifier (MBI), Social Security Number (SSN), or the last 5 digits of the SSN following the specific criteria outlined by CMS per 42 CFR 402.1(c)(ii)(A).
Thresholds/other exclusions apply -- when a NGHP RRE “complies with any reporting thresholds or any other reporting exclusions.” See, 42 CFR 402.1(c)(ii)(B).
Certain CMS policy/procedural changes – when “[t]he incident of noncompliance is associated with a specific reporting policy or procedural change on the part of CMS that has been effective for less than 6 months following the implementation of that policy or procedural change (or for 12 months, should CMS be unable to provide a minimum of 6 months’ notice prior to implementing such changes).” See, 42 CFR 402.1(c)(ii)(C).

In addition to the above bases set-forth in 42 CFR 402.1, as part of the final rule CMS states that “[w]e also wish to convey that time delays caused by CMS or its contractors in the reporting process will not trigger penalties related to timeliness, RREs must adhere to all applicable timelines, but any delay encountered when following CMS’s policies and procedures will not be held against the RRE (for example, time delays related to processing by CMS contractors will not trigger any penalty.)”^[15]

CMS expands its Section 111 “good faith” compliance safe harbor

As noted in the preceding section, CMPs will not be imposed if the criteria of CMS’s “good faith” compliance safe harbor are applicable.

In this regard, as part of the final rule, CMS has expanded its “good faith” compliance safe harbor for circumstances when a RRE “may avoid CMPs for noncompliance caused by failure to obtain identifying information from an individual despite a good faith effort to do so” as follows:

First, CMS notes that under the final rule an RRE’s third attempt to obtain the claimant’s identifying information (e.g., name, gender, date of birth, social security number (or last 5 digits on the SSN), and Medicare beneficiary identifier) may be “via telephone, electronic mail, or some other reasonable method.” On this point, CMS states: “In the proposed rule, we proposed providing NGHPs with the ability to document ‘good faith’ efforts to obtain identifying information of reportable individuals. In the final rule, we are expanding this exemption. Specifically, as proposed in the proposed rule, NGHPs must make a total of three attempts to obtain the required information. At least two attempts to obtain the required information from the individual and his or her attorney must be by mail or electronic mail, but the final rule permits that the third attempt may be via telephone, electronic mail, or some other reasonable method.”^[16]

Second, under the final rule, CMS states that “should an individual or their attorney or representative clearly and unambiguously decline to provide the information requested, no further attempts by the RRE to obtain the required information would be required.” CMS states that “[t]his documented refusal to provide the required information must be maintained for a minimum of 5 years, in accordance with the other requirements of this section of the rule.” Further, CMS states that “[a]ll other parameters related to obtaining identifying information, including records retention requirements, are being finalized as proposed.”^[17]

The full text of CMS’s good faith compliance “safe harbor” as codified at 42 CFR 402.1(c)(ii)(A) can be viewed here.

CMPs will be prospective

As part of the final rule, CMS states that CMPs will be imposed prospectively. On this point, CMS states: “we … will evaluate compliance based only upon files submitted by the RRE on or after the effective date of the final rule. CMPs will only be imposed on instances of noncompliance based on those settlement dates, coverage effective dates, or other operative dates that occur after the effective date of this regulation and as such, there will be no instances of inadvertent or de facto retroactivity of CMPs. The 1-year period to report the required information before CMPs would potentially be imposed would begin on the latter of the rule effective date or the settlement or coverage effective dates which an RRE is required to report in accordance with sections 1862(b)(7) and (b)(8) of the Act.”^[18]

CMS’s audit methodology and scope of analysis

In addition to providing clarification regarding what will and will not constitute a CMP, CMS has also provided details regarding how they intend to perform their analysis and the expected scope of their review. Rather than an automated monitoring of all RRE submissions, CMS will utilize a “process to audit a randomized sample of recently added beneficiary records” which, as outlined below, will apparently limit the volume of claims which CMS intends to review in relation to the CMP process.^[19]

Specifically, CMS indicates that it intends to review a total of 1,000 coverage records per calendar year (250 coverage records per quarter) which will include both GHP and NGHP submissions.^[20]The volume of GHP vs NGHP coverage records reviewed will be dependent on the total volume of GHP and NGHP coverage records reported during the calendar quarter being evaluated at the time.^[21] To illustrate via an example, CMS has provided the following: “For example, if over the calendar quarter being evaluated, CMS received 600,000 GHP records and 400,000 NGHP records for a total of 1,000,000 recently added beneficiary records, then 60 percent of the 250 records audited for that quarter would be GHP records, and 40 percent would be NGHP records.”^[22]

CMS further notes that “[a]t the end of each calendar quarter CMS will randomly select the indicated number of records and analyze each selected record to determine if it is in compliance with the reporting requirements as required by statute defined herein.”^[23]

CMS will use a tiered approach to calculate penalty amounts for NGHP RREs

While CMS notes within the “final rule” that they do not presently have the authority to adjust the amount of a penalty assessed to a GHP entity, they have highlighted the fact that they are permitted discretion in determining the amount of a CMP leveraged against an NGHP entity.^[24] As a result, CMS states that it has settled upon a “tiered approach based upon the length of time for which a submission was untimely to better align the penalty to the severity of the noncompliance” when assessing potential CMPs against NGHP RREs.^[25]

Here, CMS has outlined a three-tiered sliding scale. In essence, the longer an RRE is delayed in successfully submitting a required report, the steeper the penalty amount may become. CMS outline the three tiers as follows:

$250, as adjusted annually under 45 CFR part 102, for each calendar day of noncompliance, where the record was reported 1 year or more, but less than 2 years after, the required reporting date;
$500, as adjusted annually under 45 CFR part 102, for each calendar day of noncompliance, where the record was reported 2 years or more, but less than 3 years after, the required reporting date; or
$1,000, as adjusted annually under 45 CFR part 102, for each calendar day of noncompliance, where the record was reported 3 years or more after the required reporting date.^[26]

In addition, CMS also indicates that the total amount of any penalty leveraged in connection to a single instance of non-compliance will not exceed $365,000 (also adjusted annually for inflation under 45 CFR part 102).^[27] Click here to view the full text of how CMS’s penalty amount will be calculated regarding NGHP RREs per 42 CFR 402.105(b)(3).

CMS will provide RREs with “notice” of potential CMPs

CMS plans on providing RREs with an informal written “pre-notice” before issuing a “formal notice” regarding a potential CMP and will allow RREs to present mitigating evidence for CMS to review prior to the imposition of a CMP. In this regard, RREs “will have 30 calendar days to respond with mitigating information before the issuance of a formal written notice in accordance with 42 CFR 402.7.”^[28] With respect to mitigating evidence, CMS states that “any mitigating factors or circumstances are welcomed, and a dialogue is encouraged in an attempt to find solutions that are short of imposing a CMP. We believe it is in the best interests of all RREs to leave the informal notice process open to any reasonable submission of mitigating factors so that we are free to entertain all such documentation without strict limits on what is, or is not, acceptable.”^[29]

If CMS ultimately determines that a CMP will be imposed, following the informal notice period referenced above, the agency states that it “will provide formal notice to the entity in writing in accordance with 42 CFR 402.7, which will contain information on the event that has triggered the proposed imposition of a CMP, the amount of the proposed CMP, and next steps for the entity, including a right to a hearing in accordance with 42 CFR 402.19 and part 1005.”^[30]

Appealing CMPs

CMS states that its final rule “will be subject to the formal appeals process as prescribed by 42 CFR 402.19 and set forth under 42 CFR part 1005.”^[31] On this point, CMS notes that “[i]n broad terms, parties subject to CMPs will receive formal written notice at the time penalty is proposed. The recipient will have the right to request a hearing with an Administrative Law Judge (ALJ) within 60 calendar days of receipt. Any party may appeal the initial decision of the ALJ to the Departmental Appeals Board (DAB) within 30 calendar days. The DAB’s decision becomes binding 60 calendar days following service of the DAB’s decision, absent petition for judicial review.”^[32]

CMPs will be adjusted annually for inflation

Per 42 CFR Part 102, the Section 111 CMP amount will be adjusted annually for inflation. The current NGHP Section 111 penalty amount, adjusted for inflation, is $1,325.^[33]

Statute of Limitations

As part of the final rule CMS states that it “will apply the 5-year statute of limitations as required by 28 U.S.C. 2462. Under 28 U.S.C. 2462, we may only impose a CMP within 5 years from the date when the noncompliance occurred.”^[34]

Regarding potential application of the five-year limitations period, CMS provides the following example as part of the final rule: “An explanation and example of how this 5-year statute of limitations will apply is as follows: For failure to initially report the date of settlement or effective date of coverage timely (where applicable), noncompliance occurs on every day of non-reporting after the required timeframe for reporting has elapsed. For example, if the date of settlement is January 1, 2025, then the RRE will have 1 year from that date to report the coverage before being potentially subject to a CMP (that is, January 1, 2026). If the settlement date was January 1, 2025, but the RRE did not report it to CMS until October 15, 2026, the RRE will be considered noncompliant for the period of January 2, 2026, through October 15, 2026. If CMS does not act until after October 15, 2031, then the statute of limitations has elapsed and no CMP may be imposed.”^[35]

CMS acknowledged that many commenters argued that the SMART Act’s three-year SOL should apply to CMPs. However, CMS rejected this stating: “Although section 1862(b)(2)(B)(iii) of the Act establishes a 3-year statute of limitations for certain actions, that provision applies only to legal actions CMS may utilize for the recovery of MSP debts. While recovery of conditional payments (overpayments) and the imposition of CMPs may appear, on their face, to be similar actions, they are unique and serve separate, distinct purposes and the statute of limitations applicable to the former does not also apply to the latter.”^[36]

Regulatory Impact

CMS’s final rule contains a lengthy analysis of its estimated economic impact as required under various regulatory requirements, Executive Orders, and other authority. Very generally, CMS projects CMPs to total less than $200 million per year, which is below the threshold for its rule to be considered economically significant under the regulatory rule making process.^[37]On this point, CMS states that assuming its final rule had been in effect in 2022, “the maximum penalties imposed would have been $86.4 million for GHP entities and $42.4 million for NGHP entities, for a total annual CMP amount of $128.8 million, which is below the $200 million threshold to be considered an economically significant rule.”^[38]

Effective Dates

As stated in the Federal Register, CMS’s final rule for Section 111 CMPs is effective as of December 11, 2023, while the provisions of this rule are applicable on or after October 11, 2024.^[39] On this latter point, CMS states that “RREs are expected to be compliant with their Section 111 Mandatory Insurer Reporting requirements no later than October 10, 2024, or they may be eligible for a CMP.”^[40]

Join our Section 111 CMPs webinar – October 16^th!

Learn more about CMS’s Section 111 final rule and how CMPs will impact Section 111 reporting going forward on our upcoming webinar - Section 111 Penalties “Final Rule” Has Been Released - What You Need to Know to Stay Compliant and Avoid Fines

Of course, please do not hesitate to contact the authors if you have any questions.

How Verisk can help!

For those readers who are not Verisk reporting customers, please know that we have the tools and services you need to help improve your Section 111 reporting practices and avoid Section 111 CMPs. For example, MSP Navigator, our best in class S.111 reporting platform, is designed to automate reporting workflows and ensure timely, error free reporting with no gaps. MSP Analyzer, our compliance analytics engine gives clients real time visibility into their reporting trends and metrics through our intuitive analytics dashboard. Also, our popular Section 111 Audit service can quickly and effectively help you identify compliance gaps (and best practices) that may need attention for CMP avoidance.

[1] CMS’s right to impose CMPs stems from 42 U.S.C. § 1395y(b)(8)(E)(i) which states as follows: “An applicable plan that fails to comply with the [Section 111 reporting] requirements … may be subject to a civil money penalty of up to $1,000 for each day of noncompliance with respect to each claimant …A civil money penalty under this clause shall be in addition to any other penalties prescribed by law and in addition to any Medicare secondary payer claim under this subchapter with respect to an individual.” (Emphasis Added) To effectuate this provision, CMS is tasked with "specifying practices for which sanctions will and will not be imposed under subparagraph (E), including not imposing sanctions for good faith efforts to identify a beneficiary pursuant to this paragraph under an applicable entity responsible for reporting information.” 42 U.S.C. § 1395y(b)(8)(I). It is from these provisions upon which CMS’s CMPs are based.

[2] Fed. Reg. Vol. 88, No. 195, at 70373 (October 11, 2023).

[3] Fed. Reg. Vol. 88, No. 195, at 70363 (October 11, 2023).

[4] See, CMS’s alert.

[5] Fed. Reg. Vol. 88, No. 195, at 70366 (October 11, 2023).

[6] Fed. Reg. Vol. 88, No. 195, at 70369 (October 11, 2023).

[7] Fed. Reg. Vol. 88, No. 195, at 70370 (October 11, 2023).

[8] Fed. Reg. Vol. 88, No. 195, at 70370 (October 11, 2023). Of note, CMS defines timeliness of reporting under the final rule as follows: “Timeliness is defined as reporting to CMS within 1 year of the date GHP coverage became effective, the date a settlement, judgment, award, or other payment determination was made (or the funding of a settlement, judgment, award, or other payment, if delayed), or the date when an entity’s Ongoing Responsibility for Medicals (ORM) became effective. Failure to report timely prevents CMS from promptly and accurately determining the proper primary payer and taking the appropriate actions.”(author’s emphasis). In relation to timely reporting of TPOC information (bolded segment above), CMS refers to both “the date a settlement, judgment, award or other payment determination was made” but also include “(or the funding of a settlement, judgment, award, or other payment, if delayed)”. Where the authors of this article note above that “CMS indicates that it will compare the date of an RRE’s file submission with one of two potential dates submitted as a part of the RRE’s TPOC report” it is in order to distinguish that CMS uses two separate and distinct date fields within their Section 111 Claim Input File, as outlined in the agency’s NGHP Section 111 User Guide, in order to identify “the date a settlement, judgment, award, or other payment determination was made” which is CMS’s “TPOC Date” as well as “the funding of a settlement, judgment, award, or other payment, if delayed” which is CMS’s “Funding Delayed Beyond TPOC Start Date" field. Both of these date fields will be utilized by CMS to determine timeliness of reporting; See, CMS’s Section 111 NGHP User Guide, (Version 7.3, August 7, 2023), Chapter III, Section 6.5.1.2.

[9] See n. 8 above.

[10] See, CMS’s Section 111 NGHP User Guide, (Version 7.3, August 7, 2023), Chapter III, Section 6.5.1.2. Of note, within the agency’s NGHP User Guide, CMS outline “Timeliness of Reporting” and the way that the “Funding Delayed Beyond TPOC Start Date” is used to determine timeliness, in conjunction with the “TPOC Date,” as follows:

6.5.1.2 Timeliness of Reporting

NGHP TPOC settlements, judgments, awards, or other payments are reportable once the following criteria are met:

The alleged injured/harmed individual to or on whose behalf payment will be made has been identified.

The TPOC amount (the amount of the settlement, judgement, award, or other payment) for that individual has been determined.

The RRE knows when the TPOC will be funded or disbursed to the individual or their representative(s).

RREs should retain documentation establishing when these criteria were or will be met. RREs should not report the TPOC until the RRE establishes when the TPOC will be funded or disbursed. In some situations, funding or disbursement of the TPOC may not occur until well after the TPOC Date. RREs may submit the date the TPOC will be funded or disbursed in the corresponding Funding Delayed Beyond TPOC Start Date field when they report the TPOC Date and TPOC Amount, but must do so if the TPOC Date and date of the funding of the TPOC are 30 days or more apart. Timeliness of MMSEA Section 111 reporting for a particular Medicare beneficiary will be based upon the latter of the TPOC Date and the Funding Delayed Beyond TPOC Start Date.”

[11] See n. 10 above.

[12] Fed. Reg. Vol. 88, No. 195, at 70372 (October 11, 2023).

[13] Fed. Reg. Vol. 88, No. 195, at 70370 and 70372 (October 11, 2023).

[14] Fed. Reg. Vol. 88, No. 195, at 70372 (October 11, 2023).

[15] Fed. Reg. Vol. 88, No. 195, at 70367 (October 11, 2023).

[16] Fed. Reg. Vol. 88, No. 195, at 70370 (October 11, 2023).

[17] Fed. Reg. Vol. 88, No. 195, at 70370 (October 11, 2023).

[18] Fed. Reg. Vol. 88, No. 195, at 70367 (October 11, 2023).

[19] Fed. Reg. Vol. 88, No. 195, at 70366 (October 11, 2023).

[20] Fed. Reg. Vol. 88, No. 195, at 70369 (October 11, 2023).

[21] Fed. Reg. Vol. 88, No. 195, at 70369 (October 11, 2023).

[22] Fed. Reg. Vol. 88, No. 195, at 70369-70 (October 11, 2023).

[23] Fed. Reg. Vol. 88, No. 195, at 70370 (October 11, 2023).

[24] Fed. Reg. Vol. 88, No. 195, at 70365 (October 11, 2023).

[25] Fed. Reg. Vol. 88, No. 195, at 70365 (October 11, 2023).

[26] Fed. Reg. Vol. 88, No. 195, at 70370 (October 11, 2023).

[27] Fed. Reg. Vol. 88, No. 195, at 70370 (October 11, 2023).

[28] Fed. Reg. Vol. 88, No. 195, at 70367(October 11, 2023).

[29] Fed. Reg. Vol. 88, No. 195, at 70367 (October 11, 2023).

[30] Fed. Reg. Vol. 88, No. 195, at 70367 (October 11, 2023).

[31] Fed. Reg. Vol. 88, No. 195, at 70367 (October 11, 2023).

[32] Fed. Reg. Vol. 88, No. 195, at 70367 (October 11, 2023).

[33] Fed. Reg. Vol. 88, No. 195, at 70373 (October 11, 2023).

[34] Fed. Reg. Vol. 88, No. 195, at 70367-68 (October 11, 2023).

[35] Fed. Reg. Vol. 88, No. 195, at 70367-68 (October 11, 2023).

[36] Fed. Reg. Vol. 88, No. 195, at 70367-68 (October 11, 2023).

[37] Fed. Reg. Vol. 88, No. 195, at 70370-71 (October 11, 2023).

[38] Fed. Reg. Vol. 88, No. 195, at 70370-71 (October 11, 2023).

[39] Fed. Reg. Vol. 88, No. 195, at 70363 (October 11, 2023).

[40] See, CMS’s alert.