Larisa N. Likver Medical PC, DAB CR6638 (2025)

DECISION

National Government Services (NGS), an administrative contractor acting on behalf of the Centers for Medicare & Medicaid Services (CMS), revoked the Medicare enrollment and billing privileges of Petitioner, Larisa N. Likver Medical PC, pursuant to 42 C.F.R. § 424.535(a)(8)(ii). NGS also added Petitioner to CMS’s Preclusion List. CMS subsequently issued a reconsidered determination that upheld NGS’s determinations. I affirm the revocation of Petitioner’s Medicare enrollment and billing privileges and its placement on the Preclusion List.

I. Factual Background and Procedural History

Petitioner is a medical practice solely owned by Larisa N. Likver (owner). CMS Ex. 2 at 1. Petitioner specializes in pain management. P. Ex. 3 at 1.

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2018 Claims Review

In a letter dated August 27, 2018, SafeGuard Services LLC (SafeGuard), a Unified Program Integrity Contractor for CMS, informed Petitioner that it had requested records from Petitioner for dates of service from January 2, 2017, to December 14, 2017, for 14 Medicare beneficiaries. CMS Ex. 4 at 2. The investigation was predicated on data analysis showing Petitioner submitted claims and received payment for billing Evaluation and Management (E/M) services using modifier 25. Id.

Based on a medical review of the claims, 114 out of 145, or 79%, lines of service were denied. CMS Ex. 4 at 3. The medical review resulted in general findings of “Service Not Supported,” and “Not Medically Necessary.” Id. at 3-5. For example, E/M services were denied because “[t]he records submitted were insufficient to support that a significant, separately identifiable service was provided above and beyond the pre and post service work inherent in the procedure . . . .” Id. at 4. Other E/M services were recoded because the documentation did not support the level of E/M services billed. Id. Also, ultrasound services billed on the same day as ultrasound guided procedures were also denied as not medically necessary. Id. The notice letter explained that “evaluation of an anatomic region and guidance for needle placement in that anatomic region by the same radiologic modality at the same or different patient encounter(s) on the same date of service are not separately reportable.” Id. Additional review comments noted that documents were electronically signed and dated months after the billed date of service and after receiving the request for records. Id. at 5. Petitioner was instructed that all services provided to beneficiaries are expected to be documented in the medical record at the time services are rendered and late signatures should not be added to the medical record. Id.

SafeGuard also provided an encrypted CD to Petitioner containing a spreadsheet of claims that were allowed and denied. CMS Ex. 4 at 6. CMS provided a condensed, redacted version of the spreadsheet. CMS’s Pre-Hearing Brief (Br.) at 9 n.3. The spreadsheet addressed, in detail, multiple reasons supporting the denied services. CMS Ex. 5.

SafeGuard reported that its review determined that Petitioner had been overpaid $5,405.02. CMS Ex. 4 at 6. To conclude its letter, SafeGuard stated that the purpose of its letter was to educate Petitioner about the appropriate submission of Medicare claims. Id. at 8. SafeGuard further cautioned that “we remind you that the regulation at 42 [C.F.R.] § 424.535 authorizes us to revoke Medicare billing privileges under certain circumstances,” including “if CMS determines that the provider or suppler has a pattern or practice of submitting claims that fail to meet Medicare requirements.” Id.

In separate letters dated September 20, 2018, and September 21, 2018, NGS informed Petitioner of overpayments that totaled $5,474.85. CMS Ex. 6. The letters included appended lists of claims that were the basis for the overpayment determination. Id. at

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7‑15, 22-23. NGS informed Petitioner that it could file a rebuttal within 15 days, which is “the opportunity, before the . . . recoupment takes effect, to submit any statement (to include any pertinent information) as to why it should not be put into effect . . . .” Id. at 2. NGS also informed Petitioner that it could appeal the overpayment decision and provided instructions on how to do so. Id. at 4. Petitioner declined to file a rebuttal or appeal. Petitioner’s (P.’s) Pre-Hearing Br. at 6 n.2. Petitioner explains that it did not appeal the overpayment because the owner was caring for her father. Id.

2020 Claims Review

SafeGuard conducted another investigation in 2020, predicated on data analysis that revealed billing of potentially medically unnecessary ultrasound services. CMS. Ex. 7 at 2. The billing history for 19 Medicare beneficiaries for dates of service from February 17, 2019, to December 16, 2019, were reviewed. Id. In a letter dated October 22, 2020, SafeGuard informed Petitioner of the results of its investigation identified billing discrepancies and provided educational information to assist with future claims for Medicare reimbursement. Id.

Based on the medical review, 61 of the 140, or 43%, lines of service were denied. CMS Ex. 7 at 3. A summary of the review findings state documentation did not support the medical necessity of services billed, including for nerve conduction studies and E/M services. Id. Regarding E/M services, the letter stated that the “medical records were insufficient to support that a significant, separately identifiable service was provided above and beyond the pre and post service inherent to the procedure.” Id. The letter further explained that documentation was insufficient to show the medical necessity of nerve conduction studies and ultrasound services, among others. Id. at 4-5. Additional review comments acknowledged that billed joint injections generally met Medicare criteria and were allowed. Id. at 4.

SafeGuard included an encrypted CD containing a spreadsheet of claims that were allowed and denied. CMS Ex. 7 at 6. CMS provided a condensed, redacted version of the spreadsheet. CMS’s Pre-Hearing Br. at 9 n.3. Like the spreadsheet provided in the 2018 investigation, Petitioner was provided, in detail, the multiple reasons supporting the denied services. CMS Ex. 8.

SafeGuard reported that its review determined that Petitioner had been overpaid $6,919.88. CMS Ex. 7 at 5. At the conclusion of its letter, SafeGuard reiterated that the purpose of its letter was to educate Petitioner about the appropriate submission of Medicare claims and again cautioned Petitioner that it was authorized to revoke Medicare billing privileges under certain circumstances, including “if CMS determines that the provider or suppler has a pattern or practice of submitting claims that fail to meet Medicare requirements.” Id. at 7.

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In separate letters dated November 3, 5 and 16, 2020, NGS informed Petitioner of overpayments that totaled $6,921.33. CMS Ex. 9. The letters included appended lists of claims that were the basis for the overpayment determination. See, e.g., id. at 7. NGS informed Petitioner of its rebuttal and appeal rights if it disagreed with the overpayment determinations, but “Petitioner declined to appeal the findings of this review, as [the owner] was recovering from the long-term effects of the Covid 19 virus and running her practice.” P. Pre-Hearing Br. at 7.

2022 Claims Review

In December 2021 and January 2022, SafeGuard requested medical records for 29 beneficiaries for dates of service between January 25, 2021, to July 15, 2021. CMS Ex. 10 at 3. This investigation was based on data analysis that “revealed continued questionable billing of services denied as medically unnecessary in a previous medical review in which [Petitioner was] educated.” Id. at 2.

In a letter dated March 11, 2022, Petitioner was informed of the results of the review, resulting in an overpayment amount of $15,230.22. CMS Ex. 10 at 2 and 6. Based on medical review, 654 of 674, or 97%, of services were denied. Id. at 3. Notable findings included “[d]ocumentation was insufficient to support medical necessity” and “[m]edical progress notes and/or test results not received.” Id. A summary of review findings provided additional detail. For example, regarding E/M services, after a detailed explanation of appropriate billing for services with modifier 25 with an injection code, the medical review found “[d]ocumentation did not support a significant and separately identifiable service . . . .” Id. at 4-5. Other findings included the denial of ultrasound services billed at the same time as the injection code with ultrasonic guidance, billed with modifier 59. Id. The letter explained that the purpose of the modifier is to indicate two or more procedures are performed at different anatomic sites or different patients encounters, but the review of the documentation demonstrated that the services were performed at the same anatomic site on the same date of service. Id. at 4. SafeGuard again provided an encrypted CD containing a spreadsheet of the allowed and denied claims. Id. at 6. CMS provided an excerpt of the spreadsheet, which provides the detailed reasons for the claim denials. CMS. Ex. 11.

At the conclusion of its letter, SafeGuard stated that the letter was intended to be educational regarding the appropriate submission of Medicare claims. CMS Ex. 10 at 8. Petitioner was again reminded of CMS’s authority to revoke Medicare billing privileges under certain circumstances, including “if CMS determines that the provider or suppler has a pattern or practice of submitting claims that fail to meet Medicare requirements.” Id.

Petitioner appealed the overpayment determinations and received partially favorable findings throughout the claims appeals process. P. Pre-Hearing Br. at 7. At the third

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level of review, an administrative law judge (ALJ) issued a partially favorable decision, overturning the denial of 24 services. Id.; see also CMS Pre-Hearing Br. at 13.

2022 Pre-Payment Review

In a letter dated November 14, 2022, SafeGuard notified Petitioner that it was selected for prepayment review based on “analysis of [Petitioner’s] billing data indicat[ing] that there may be aberrancies in . . . billing.” CMS Ex. 13 at 2. Based on a review of 25 claims, for a total of 216 service units, between November 14, 2022, and November 23, 2022, SafeGuard informed Petitioner that 84% of the claims were denied and 93% of service units were denied. CMS Ex. 14 at 2. SafeGuard informed Petitioner that “[m]edical review determined that the allegations of possibly rendering medically unnecessary ultrasound services and injection CPT codes were partially substantiated.” Id. Further, SafeGuard informed Petitioner that for E/M services billed, “[d]ocumentation did not support that there was a significant, separately identifiable service rendered which involved taking a history, performing an exam, and making medical decisions that were distinct from the procedure that was performed.” Id. Petitioner did not challenge the prepayment review findings. P. Pre-Hearing Br. at 7.

Like the post-payment reviews, SafeGuard advised Petitioner that its letter was intended to be educational regarding the appropriate submission of Medicare claims and warned Petitioner that CMS had the authority to revoke if it determined a pattern or practice of submitting claims that fail to meet Medicare requirements. CMS Ex. 14 at 5.

The Revocation

In a July 7, 2023 initial determination, NGS revoked Petitioner’s Medicare enrollment and billing privileges, effective August 6, 2023, pursuant to 42 C.F.R. § 424.535(a)(8)(ii). CMS Ex. 17. NGS explained that CMS determined Petitioner had engaged in a pattern or practice of submitting claims that fail to meet Medicare requirements despite “repeated instances of specific and targeted education . . . .” Id. at 1.

NGS provided the following explanation supporting its revocation:

A review of [Petitioner’s] submitted claims was conducted. This review consisted of 20 claims with dates of service from April 1, 2019 through December 16, 2019. Of the 20 claims reviewed, 18 were denied as the documentation did not supporting medical necessity of the therapeutic joint injections services billed. A sample of the noncompliant billing is reflected on the attachment titled Enclosure A. In a letter dated October 22, 2020, [Petitioner] was educated regarding the submission of these noncompliant billings.

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An additional review of [Petitioner’s] submitted claims was conducted. This review consisted of 30 claims with dates of service from January 25, 2021 through July 15, 2021. Of the 30 claims reviewed, 30 were denied as the documentation did not supporting medical necessity of the therapeutic joint injections services billed. A sample of the noncompliant billing is reflected on the attachment titled Enclosure B. In a letter dated March 11, 2022, [Petitioner] was educated regarding the submission of these noncompliant billings.

An additional review of [Petitioner’s] submitted claims was conducted. This review consisted of 25 claims with dates of service from November 14, 2022 through November 23, 2022. Of the 25 claims reviewed, 21 claims were denied as the documentation did not supporting medical necessity of the therapeutic Joint Injections services billed. A sample of the noncompliant billing is reflected on the attachment titled Enclosure C.

Despite several instances of specific education, which detailed the correct billing procedures for medical necessity, [Petitioner] has continued to submit claims that fail to meet Medicare requirements. Evidenced by the continued high percentage of submitted claims that were denied and the specific facts surrounding said non-compliance over which the pattern has continued, [Petitioner’s] above billing behavior constitutes a violation of 42 CFR 424.535(a)(8)(ii), and therefore, CMS has determined that the provider, “has a pattern or practice of submitting claims that fail to meet Medicare requirements [ . . . .”]

CMS Ex. 17 at 1-2.

NGS also barred Petitioner from re-enrolling in the Medicare program for a period of 10 years. CMS Ex. 17 at 4. Finally, NGS informed Petitioner that, pursuant to 42 C.F.R. §§ 422.2, 422.222, 423.100, and 423.120(c)(6), it would be added to CMS’s Preclusion List. Id. at 2.

Petitioner, through its counsel, submitted a request for reconsideration dated July 27, 2023. CMS Ex. 18. Petitioner stated that it was awaiting a post-hearing decision from an ALJ “who heard arguments regarding allegations similar to those set forth in the Revocation Letter.” Id. at 2. Petitioner thus argued that any revocation was premature while it was awaiting the ALJ’s decision and requested that CMS cease and desist in effectuating the revocation until the decision issued. Id.

CMS, through its Provider Enrollment & Oversight Group, issued a reconsidered determination on January 3, 2024, in which it upheld the revocation of Petitioner’s Medicare enrollment and billing privileges pursuant to 42 C.F.R. § 424.535(a)(8)(ii) and

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upheld its placement on the Preclusion List. DAB E-File Dkt. No. 1a (Reconsidered Determination).

On February 6, 2024, Petitioner, through counsel, filed a request for an ALJ hearing. DAB E-File Dkt. No. 1. The matter was initially assigned to ALJ Bill Thomas but reassigned to me on January 30, 2025. ALJ Thomas acknowledged receipt of Petitioner’s request for hearing and issued his Standing Pre-Hearing Order (Standing Order) directing the parties to file pre-hearing exchanges in accordance with specific requirements and deadlines.

CMS filed a motion for summary judgment and pre-hearing brief, along with 19 proposed exhibits (CMS Exs. 1-19), including the written direct testimony of one witness (CMS Ex. 1). Petitioner filed its pre-hearing brief and memorandum in opposition of CMS’s motion for summary judgment, along with eight proposed exhibits (P. Exs. 1-8), including the written direct testimony of one witness (P. Ex. 8).

II. Admissions to the Record and Decision on the Written Record

Petitioner did not object to any of CMS’s proposed exhibits; therefore, I admit CMS’s Exhibits 1 through 19 into the record. Standing Order ¶ 10; Civ. Remedies Div. P. § 14(e).

Petitioner submitted new documentary evidence with its request for hearing but did not offer any explanation for failing to present the evidence previously to CMS. Standing Order ¶ 9. Absent objection from CMS, I nevertheless examine whether good cause exists for the new evidence submission for the first time at the ALJ level of review. If I find that good cause does not exist, I must exclude the evidence and may not consider it in reaching a decision. 42 C.F.R. § 498.56(e).

Petitioner’s proposed Exhibit 3 is a letter from the owner to a Program Integrity Contractor, dated June 30, 2023, and titled “Rebuttal Statement.” The statement is in response to a Notice of Suspension of Medicare payments. Upon review, the statement is not evidence but instead raises factual arguments (many of which are set forth in Petitioner’s brief). Compare P. Ex. 3, with P. Pre-Hearing Br. While the statement was certainly available at the time Petitioner requested reconsideration and could have been submitted, I admit the statement into the record. Petitioner’s proposed Exhibits 4 through 6 were not available at the time it filed its reconsideration request; therefore, despite Petitioner failing to follow the instructions set forth in ALJ Thomas’s Standing Order, I find good cause for Petitioner not submitting the documents earlier. Petitioner’s proposed Exhibits 7 and 8 are also not new evidence, but the declaration of Petitioner’s proposed witness and his curriculum vitae and, therefore, are admitted. Petitioner’s Exhibits 3 through 8 are admitted into the record.

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Petitioner’s proposed Exhibits 1 and 2 are comprised of Petitioner’s license and corporation information. Petitioner has not explained why it did not submit these exhibits at the reconsideration level. They were certainly available. Because no good cause justifies Petitioner’s failing to submit the documents at the reconsideration stage, I must exclude the evidence and may not consider it in conjunction with Petitioner’s challenge to the revocation of its enrollment.1 42 C.F.R. § 498.56(e). However, there is no prohibition on submitting evidence to an ALJ when challenging the placement of an entity on the CMS Preclusion List. Therefore, Petitioner’s Exhibits 1 and 2 are submitted for the sole purpose of Petitioner’s placement on CMS’s Preclusion List.

Neither party requested an opportunity to cross-examine the other party’s witness; therefore, a hearing is not necessary. See P. Pre-Hearing Br. I decide this case on the written record, meaning the parties’ written submissions and arguments, and without considering whether the standard for summary judgment is met. Pre-hearing Order ¶ 13; Civ. Remedies Div. P. § 19(d). I deny CMS’s Motion for Summary Judgment as moot. I consider the record to be closed and the matter ready for a decision on the merits.

III. Issues

Whether CMS had a legitimate basis to uphold the revocation of Petitioner’s Medicare enrollment and billing privileges pursuant to 42 C.F.R. § 424.535(a)(8)(ii).

Whether CMS had a legitimate basis to uphold Petitioner’s placement on its Preclusion List pursuant to 42 C.F.R. §§ 422.2 and 423.100.

IV. Jurisdiction

I have jurisdiction to hear and decide this case. 42 U.S.C. § 1395cc(j)(8); see also 42 C.F.R. §§ 498.1(g), 498.3(b)(17), 498.5(l)(2).

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V. Discussion

A. Statutory and regulatory authority

Pursuant to 42 U.S.C. § 1395cc(j)(1)(A), CMS has promulgated enrollment regulations. 42 C.F.R. § 424.500 et seq. These regulations give CMS the authority to revoke the billing privileges of an enrolled supplier if CMS determines that certain circumstances exist. 42 C.F.R. § 424.535(a). Relevant to this case, CMS may revoke a supplier’s billing privileges when it determines that the supplier has abused its billing privileges. 42 C.F.R. § 424.535(a)(8).

In November 2021, the Secretary substantially revised section 424.535(a)(8). 86 Fed. Reg. 64,996 (Nov. 19, 2021). Addressing comments received from the public, the Secretary stated that “providers and suppliers have a responsibility to always submit correct claims.” 86 Fed. Reg. at 65,335. The Secretary further explained that “the core consideration is the incorrect claim submission itself rather than the reason it occurred[,]” and that “[e]ven if a series of non-compliant claims did not involve any deceit by the provider or supplier, the fact remains that the latter did not adhere to Medicare claim submission requirements.” Id. Finally, the Secretary, in response to a comment requesting that a provider or supplier first be given an opportunity to correct its errors or that CMS be required to provide advance notice of its concerns, stated, “[i]f the provider or supplier is submitting non-compliant claims, it is the provider’s or supplier’s responsibility to remedy the matter on its own initiative; respectfully, it is not CMS’s obligation to delay a crucial program integrity measure, such as revocation, to enable a provider or supplier to execute steps that it should have taken previously.” 86 Fed. Reg. at 65,336.

The version of 42 C.F.R. § 424.535(a)(8) applicable to the instant case allows CMS to revoke enrollment and billing privileges where it “determines that the provider or supplier has a pattern or practice of submitting claims that fail to meet Medicare requirements.” 42 C.F.R. § 424.535(a)(8)(ii). In making this determination, CMS considers, as appropriate or applicable, the following:

(A) The percentage of submitted claims that were denied during the period under consideration.

(B) Whether the provider or supplier has any history of final adverse actions and the nature of any such actions.

(C) The type of billing non-compliance and the specific facts surrounding said non-compliance (to the extent this can be determined).

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(D) Any other information regarding the provider or supplier’s specific circumstances that CMS deems relevant to its determination.

42 C.F.R. § 424.535(a)(8)(ii).

When a provider or supplier’s enrollment has been revoked, CMS is authorized to impose a bar on reenrollment for a minimum of one year, but no more than 10 years. 42 C.F.R. § 424.535(c)(1)(i).

B. CMS had a legitimate basis to revoke Petitioner’s Medicare enrollment and billing privileges under 42 C.F.R. § 424.535(a)(8)(ii) because CMS reasonably concluded, based on thorough consideration of relevant regulatory factors, that Petitioner had a pattern or practice of filing claims that did not meet Medicare requirements.

I find the evidence establishes that CMS appropriately considered the regulatory factors set forth above and found sufficient support to justify a determination to revoke Petitioner’s Medicare enrollment based on Petitioner’s pattern or practice of improper claims submissions. Indeed, “Petitioner does not deny that there is a well-documented history of failure to submit claims that meet CMS documentation guidelines prior to 2023.” P. Pre-hearing Br. at 9. However, Petitioner argues that close examination of the factors makes it clear that there is an insufficient basis to establish a pattern or practice. Id. More specifically, Petitioner argues that CMS’s decision was overly broad, not entirely reflective of the initiatives Petitioner undertook to correct its non-compliant billing and documentation, and prejudicial. Id.

As discussed below, I find Petitioner’s arguments unpersuasive and find that CMS lawfully could revoke and had ample basis to do so. Below, I discuss each factor individually and address Petitioner’s arguments.

In doing so, I emphasize that my role as the ALJ “is limited to determining whether CMS’s action is legally authorized and does not extend to second-guessing whether CMS properly exercised its discretion . . . .” Acute Care Homenursing Servs., Inc., DAB No. 2837, at 9 (2017). “ALJs . . . may review only whether CMS had a valid legal basis to revoke billing privileges, and, if it did, may not address whether it properly exercised its discretion to do so.” Wendell Foo, M.D., DAB No. 2904 at 25 (2018), aff’d, 420 F. Supp. 3d 1100 (D. Haw. 2019). In other words, I must determine whether CMS could revoke, not whether it should revoke.

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1. The percentages of the claims denied during the periods under consideration were high and support the finding of a pattern or practice of filing claims that do not meet Medicare requirements.

As detailed above, SafeGuard conducted three reviews that formed the basis of Petitioner’s revocation. CMS Ex. 17 at 1. The results of each review demonstrate Petitioner submitted multiple non-compliant claims. First, the 2020 Claims Review reviewed the claims for 19 beneficiaries from February 17, 2019, to December 16, 2019. CMS Ex. 7 at 2. The medical review resulted in 61 of the 140 lines of services, or 43%, being denied. Id. NGS further explained in its Revocation Notice that 18 of the 20 claims, or 90%, reviewed were denied, a percentage with which Petitioner agrees. Compare CMS Ex. 17 at 1, with P. Pre-Hearing Br. at 10. These findings were not appealed; therefore, the findings are final and binding. 42 C.F.R. § 405.928(b).

SafeGuard later conducted an audit of 29 beneficiaries, involving billing for 674 services, provided from January 25, 2021, to July 15, 2021. CMS Ex. 10 at 3. The medical review of these claims resulted in 654 of the 674, or 97%, of the services being denied, and 100% of the claims being denied. Id.; CMS Ex. 17 at 1. However, Petitioner appealed the overpayment determination, received partially favorable decisions, and the denial rate of claims was reduced to 83%. P. Pre-Hearing Br. at 10; CMS Ex. 19; see also CMS’s Pre-Hearing Br. at 13. Petitioner did not request review of the ALJ’s decision; therefore, the ALJ’s findings are binding. 42 C.F.R. § 405.1048.

Finally, Safeguard initiated a pre-payment review in 2022. Twenty-five claims were reviewed for a total of 216 services for dates of service between November 14, 2022, to November 23, 2022. CMS Ex. 14 at 2. The review resulted in an “84% denial rate for the claims and a 93% denial rate for service units.” Id.

Petitioner does not dispute the percentage of denied claims.2 Rather, Petitioner argues that they do not establish a pattern or practice, considering improvements it made over time. P. Pre-Hearing Br. at 10. In addition, Petitioner argues that CMS “failed to give adequate time and education for Petitioner to demonstrate substantial compliance.” P. Pre-Hearing Br. at 10. In support of its contention, Petitioner cites to Dhulmar Health Care Services LLC, DAB No. CR6357 (2023), which I note is currently on appeal with the Board.

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CMS considered the percentage of claims denied over the three reviews and considered them to be “exceedingly high denial rates, across three distinct periods for dates of service over nearly four years.” Id. at 7. CMS then concluded that the high denial rates indicate that Petitioner “ha[d] engaged in a pattern or practice of submitting claims that fail to meet Medicare requirements.” Id. As such, CMS appropriately considered the percentage of denied claims as a factor as required by 42 C.F.R. § 424.535(a)(8)(ii)(A).

While CMS provided ample discussion supporting its consideration of this factor, and my review is limited to whether CMS had a legitimate basis for its action, I note the record evidence supports CMS’s conclusions. The first review supporting the revocation yielded a rate of claims denial of 90%. Despite the warnings and information provided to Petitioner, the next review conducted less than two years later resulted in an 83% denial rate, and another review conducted two years later resulted in an 84% denial rate. These rates of denial for the periods under review are not in dispute.3 Although the record supports Petitioner’s contention that the denial rates showed somewhat of a downward trend over the successive post-payment reviews (88%, 90%, and 83%), the percentages remained extremely high and do not diminish Petitioner’s practice of submitting non-compliant claims.

Similarly, I find Petitioner’s contentions that it was given insufficient time and education to demonstrate substantial compliance are belied by the evidence. I remind Petitioner that it is its responsibility to submit medical documentation supporting the medical necessity and reasonableness of its claims. 42 U.S.C. § 1395l(e); 42 C.F.R. § 424.5(a)(6); see also 86 Fed. Reg. at 65,336 (“If the provider or supplier is submitting non-compliant claims, it is the provider’s or supplier’s responsibility to remedy the matter on its own initiative; it is not CMS’ obligation to delay a crucial program integrity measure, such as revocation, to enable the provider or supplier to execute steps that should have been taken previously.”).

Moreover, the record demonstrates that SafeGuard furnished, for each review, a detailed discussion of the reasons for denying Petitioner’s claims. For example, regarding E/M services reviewed in 2018, among others, Petitioner was advised its claims were denied because “[t]he records are insufficient to support that a significant, separately identifiable service was provided above and beyond the pre and post service work inherent in the procedure.” CMS Ex. 5 at 8.

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Despite the benefit of the specific and targeted, beginning in 2018, Petitioner continued to submit E/M claims that failed to document separate and distinctive services beyond the underlying procedure. CMS Ex. 8 at 6; CMS Ex. 11 at 6. The record demonstrates Petitioner’s deficient billing practices continued through November 2022, when a prepayment review resulted in a 84% denial rate for claims submitted for review. CMS Ex. 14 at 2. Moreover, each of CMS’s notices included an unambiguous warning that it was authorized to revoke enrollment when a provider or supplier has a pattern or practice of submitting claims that fail to meet Medicare requirements, Petitioner continued to submit claims that failed to meet Medicare requirements. See, e.g., CMS Ex. 4 at 8; CMS Ex. 7 at 5; CMS Ex. 10 at 8.

In sum, CMS’s use of this factor to support its conclusion that Petitioner engaged in a pattern or practice of filing claims that do not meet Medicare requirements was thoroughly considered and well-supported.

2. Petitioner does not have a history of final adverse actions. Therefore, this factor does not support the finding of a pattern or practice of filing claims that do not meet Medicare requirements.

3. The billing non-compliance in this case generally involves Petitioner’s failure to provide documentation that supported the medical necessity of the services billed. Because providers and suppliers have the duty to submit accurate and supported claims, this billing non-compliance supports the finding of a pattern or practice of filing claims that do not meet Medicare requirements.

Another factor involves the type of billing non-compliance. 42 C.F.R. § 424.535(a)(8)(ii)(C). Petitioner argues that the claim types for each review were not identical and did not provide an opportunity for education. P. Pre-Hearing Br. at 12. Therefore, Petitioner contends this factor does not support a finding of a pattern or practice. As an example, Petitioner states that nerve conduction studies were reviewed in the 2018 and 2020 post-payment reviews, but not the 2022 post-payment review. Id.

Petitioner cites to no authority stating that the same types of services must be reviewed to establish a pattern or practice of submitting non-compliant claims, and I am aware of none. Notwithstanding, as stated in CMS’s reconsidered determination, the record demonstrates that similar services were in fact reviewed across the reviews. For example, E/M services were reviewed in each of the reviews and CMS found Petitioner “repeatedly billed for [E/M] services, that did not meet Medicare requirements . . . [m]ore specifically, the medical records were insufficient to support that a significant, separately identifiable service was provided above and beyond the pre- and post-service inherent to other procedures billed.” Reconsidered Determination at 8. Similarly, CMS noted in its reconsideration that “claims in Round 3 were denied for the same reasons that the ALJ

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found that the claims in Round 2 did not meet Medicare requirements[,]” and concluded that “repeated claim denials for the same reasons, despite specific education indicates that [Petitioner] engaged in a pattern or practice of submitting non-compliance claims.” Id. at 9.

CMS’s findings are well-supported. Based on my review of the evidence, the reviews at issue found, among others, a lack of documentation to show that billed tests were performed, incorrect CPT codes were provided on the billing, and that claimed services failed to have documentation showing medical necessity. While Petitioner is correct that some of the services reviewed vary from review to review, the non-compliance is essentially the same or similar – lack of documentation that supported the medical necessity of services provided. Filing many claims with insufficient documentation demonstrating medical necessity supports CMS’s finding that a pattern or practice existed of filing claims that do not meet Medicare requirements.

4. CMS considered the owner’s previous license suspension as relevant to its determination, which I find was appropriate and supported by the record.

The CMS hearing officer also found the disciplinary actions imposed on the owner of Petitioner by the state licensing board relevant to its determination. Reconsidered Determination at 9. CMS noted that the underlying allegations of the state disciplinary action included that the owner “knowingly submitted to insurance companies reports of diagnostic studies for two or more patients were identical . . . .” Id. (emphasis in original). The licensing Board alleged the owner knew the reports were fabricated and she intended to deceive by submitting the false reports. Id.

Petitioner argues that the owner’s previous disciplinary action is stale and unrelated to this Medicare-related matter. P. Pre-Hearing Br. at 14. Petitioner explains that it was not formed until after its owner was sanctioned and, therefore, it has no history of final adverse actions. Id. I agree, as does CMS, that there is no history of adverse actions against Petitioner. Reconsidered Determination at 8.

Rather, CMS found the “disciplinary action shows that the [owner] has a history of disregarding insurance billing requirements and has been willing to fabricate documentation to obtain reimbursement . . . .” Id. at 9. As she was Petitioner’s sole owner, I find no error in CMS’s determination to consider her billing and documentation history as it is highly relevant to the basis of the instant revocation.

Petitioner also contends that CMS failed to consider the measures it took, at its own personal cost, to improve its billing practices. P. Pre-Hearing Br. at 13. Petitioner points to the 2023 Pre-Payment reviews to demonstrate that it “understand[s] CMS standards

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and the importance of submitting complete and accurate records and have brought themselves into compliance.” Id.

Again, I find no error in CMS’s exercise of its discretion in failing to consider this information because Petitioner never put forth the argument before CMS. CMS Ex. 18 at 2. Petitioner’s entire argument in its reconsideration request was that any revocation was premature considering the pending ALJ review. Id. While the record supports that Petitioner hired a consultant in “2023” it is unclear that it ever notified CMS of its action to overturn the revocation.

While my review is limited to whether CMS had a legitimate basis for its action, which I find it did based on the ample evidence in the record, I note that I am at a loss as to why Petitioner failed to take any proactive measures to educate itself of proper claim submission after three distinct reviews that spanned over four years. Petitioner states that it was by the time of the pre-payment review denials it recognized the need to seek outside help to fix its billing and coding issues. P. Pre-Hearing Br. at 10-11. However, the three previous reviews had already yielded very high denial rates. In sum, CMS gave Petitioner the opportunity, over four years, to change its ways to ensure that it filed compliant claims; however, Petitioner failed to take advantage of this opportunity by the time it was revoked from the Medicare program.

Moreover, as I indicated before, my role in this review is limited. I am “limited to determining whether CMS’s action is legally authorized and does not extend to second-guessing whether CMS properly exercised its discretion.” Acute Care Home nursing Servs., Inc. at 9. “[I]t is not for the ALJ . . . to look behind that exercise of discretion to ask whether [the ALJ] . . . , standing in CMS’s shoes, would reach the same decision to revoke.” George M. Young, M.D., DAB No. 2750 at 11 (2016).

CMS plainly considered the sole owner of Petitioner’s similar history as another factor to be considered pursuant to subpart (D) of the regulation in deciding whether a pattern or practice of improper billing is present. And despite Petitioner’s belated affirmative actions, it was only after three reviews covering a span of more than four years, which unearthed numerous improper claims, CMS concluded that Petitioner should not be allowed to continue to participate in Medicare. I find CMS properly considered this factor in determining a pattern or practice of submitting non-compliant claims existed.

C. Petitioner’s 10-year re-enrollment bar is sustained.

I sustain CMS’s determination to impose a re-enrollment bar of 10 years against Petitioner. A bar against re-enrollment is a mandatory remedy where a supplier engages in a pattern or practice of filing improper claims. 42 C.F.R. § 424.535(c)(1)(i). In this case CMS imposed a re-enrollment bar against Petitioner of 10 years, the maximum that the regulation permits, except in circumstances not applicable here. Id.

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Petitioner does not raise any arguments regarding the re-enrollment bar. However, even if it had, I do not have the authority to review CMS’s decision “about how long to bar a revoked supplier from re-enrolling in Medicare” because “it is not an appealable ‘initial determination’ under 42 C.F.R. Part 498.” Linda Silva, P.A., DAB No. 2966 at 11 (2020) (internal citations omitted); see also 42 C.F.R. § 498.3(b) (listing initial determinations that are reviewable).

D. Petitioner does not present any legal or factual arguments disputing its inclusion on the Preclusion List.

CMS has established a single list of individuals and entities for whom Medicare Advantage plans cannot provide reimbursement for items and services they provide, and for prescribers to whom Medicare Part D plans cannot provide reimbursement for any prescriptions the individuals write. 42 C.F.R. §§ 422.222, 423.120(c)(6). As relevant here, for CMS to include an individual, entity, or prescriber on its Preclusion List, the following three requirements must be met:

1. The individual or entity is currently revoked from Medicare under § 424.535;

2. The individual or entity is currently under a reenrollment bar under § 424.535(c); and

3. CMS determines that the underlying conduct that led to the revocation is detrimental to the best interests of the Medicare program.

42 C.F.R. §§ 422.2; 423.100.

Petitioner opposes its inclusion on the Preclusion List. P. Pre-Hearing Br. at 2.

Petitioner’s request for hearing stated that it intended to argue that its conduct is not detrimental to the best interests of the Medicare program, but Petitioner does not present any legal or factual arguments disputing its inclusion on the Preclusion List. Compare RFH, with P. Pre-Hearing Br. However, in arguing against its revocation, I acknowledge Petitioner’s arguments that the overpayment demands were relatively small and satisfied in full. P. Pre-Hearing Br. at 3. Accordingly, Petitioner proffers that it is “not a threat to the integrity of the Medicare trust.” Id.

Because I have upheld Petitioner’s revocation pursuant to 42 C.F.R. § 424.535(a)(8)(ii), and Petitioner is currently subject to a bar to re-enrollment, the first two requirements for inclusion on the preclusion list are met. 42 C.F.R. §§ 422.2, 423.100. As for the third requirement listed in 42 C.F.R. §§ 422.2 and 423.100, CMS determined that Petitioner’s

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conduct underlying its revocation was detrimental to the best interests of the Medicare program. Reconsidered Determination at 10.

At the outset I note that where the regulations have granted CMS discretion to determine whether a provider or supplier’s underlying conduct is detrimental to the Medicare program, I may not substitute my own judgment as to whether CMS properly exercised that discretion. Brian K. Ellefsen, D.O., DAB No. 2626 at 7 (2015).

CMS stated that it considers a pattern or practice of non-compliant billing to be very serious and that, “[s]ince at least 2018, [Petitioner] has been submitting claims for services that are not reasonable or necessary.” Id. CMS explained that considering the “protracted period of non-compliance, despite targeted and specific education,” it found Petitioner’s conduct to be very serious. Id. CMS stated that Petitioner’s conduct “calls into question [its] ability and willingness to be a trustworthy Medicare partner” and that the “integrity of the Medicare program is dependent on the integrity of its partners.” Id. at 10-11.

CMS also explained that Petitioner’s non-compliant billing had a “clear and measurable impact on the integrity of the Medicare program.” Id. at 11. Contrary to Petitioner’s contentions, CMS found the overpayment determinations that resulted in overpayment determinations totaling over $26,000 a threat to the integrity of the program. Id. Again, I have no authority to question CMS’s discretion in considering this factor but agree with CMS that any payment of noncompliant claims puts the Medicare Trust Fund at risk and is detrimental to the best interest of the program.

Finally, CMS found that Petitioner’s abusive billing negatively affects the program because Petitioner’s actions reflect poorly on the Medicare program as a whole and jeopardizes public confidence in Medicare providers and suppliers. Id. CMS explained Medicare is a public program and the public’s confidence in the program is vital to its success. Id.

The evidence demonstrates that CMS, after considering the requisite factors, had a legitimate basis to uphold Petitioner’s placement on the Preclusion List. Therefore, I conclude that CMS reasonably found that the basis for the revocation was detrimental to the Medicare program and that CMS legitimately added Petitioner’s name to the Preclusion List.

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VI. Conclusion

I affirm the determinations revoking Petitioner’s Medicare enrollment and billing privileges, imposing a 10-year enrollment bar, and placing Petitioner on CMS’s Preclusion List.