Ohio Wound Care Network, et. al., DAB, CR6911 (2026)

DECISION

This decision affirms the Centers for Medicare & Medicaid Services (CMS’s) determination to revoke the Medicare enrollment and billing privileges of 31 suppliers (Otiko Suppliers or Petitioners), to impose a five-year reenrollment bar, and to place them on the CMS preclusion list. 

I. Background and Procedural History

Dr. Christopher Otiko is a Doctor of Podiatric Medicine (D.P.M.) licensed to practice in California.  P. Exhibit (Ex.) 1 at 1; CMS Ex. 1 at 206.  Dr. Otiko had dual enrollment in the Medicare program, one as an individual supplier of Part B services and a separate enrollment as a supplier of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS).  On February 24, 2023, CMS, through its contractor, Noridian Healthcare Solutions (Noridian), informed Dr. Otiko that his Medicare Part B billing privileges were revoked effective March 26, 2023, due to an affiliation that poses an undue risk.  CMS Ex. 6 at 14.  The notice also states: 

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“Within the last 5 years, Christopher Otiko was listed as being an individual with ownership interest and/or managerial control of Biogenx Medical 855S and 855B enrollments, previously enrolled Medicare Entities that had disclosable events.  Biogenx Medical 855S’ and 855B’s Medicare billing privileges were revoked effective January 6, 2022 and January 9, 2022 respectively, under 42 CFR § 424.535(a)(4) False or Misleading information.  A revocation is considered a disclosable event as defined in 42 CFR § 424.502.”

Id.

Due to the revocation, CMS imposed a five-year re-enrollment bar and placed Dr. Otiko on the CMS preclusion list pursuant to 42 C.F.R. §§ 422.2 and 422.222.  Id. at 14-16. 

Similarly, on February 28, 2023, Palmetto GBA (Palmetto), a Medicare contractor, informed Dr. Otiko that his DMEPOS Medicare supplier number was being revoked, effective 30 days after the postmark date of the letter pursuant to 42 C.F.R. § 424.535(a)(19).  CMS Ex. 16 at 18.  Again, CMS imposed a five-year reenrollment bar and placed Dr. Otiko on its preclusion list.  CMS Ex. 16 at 19-21. 

By letter dated April 28, 2023, Dr. Otiko filed a request for reconsideration of the revocation of both of his enrollments and placement on the preclusion list, and CMS issued unfavorable determinations on August 11, 2023.  CMS Ex. 16 at 1; CMS Ex. 16 at 1 n.1; CMS Ex. 6 at 1, 18. 

Dr. Otiko has relationships with approximately 30 suppliers, collectively referred to as the “Otiko Suppliers”, that are Petitioners in this matter because they are subject to revocation, re-enrollment bar, and placement on CMS’s preclusion list due to Dr. Otiko’s affiliation with Biogenx Medical (Biogenx) d/b/a Coast to Coast Medical.  The Otiko Suppliers are comprised of the following entities: 

• Ohio Wound Care Network;
• Ohio Wound Care Physicians;
• Wound Pros Texas;
• Coast to Coast Podiatry (DMEPOS);
• Wound Pros Arizona;
• Dr. Christopher Otiko (individual capacity);
• Wound Pros Ohio;
• Wound Pros Tennessee (DMEPOS);
• Coast to Coast DME (Part B Enrollment)
• Wound Pros Utah
• Wound Pros Michigan (DMEPOS)
• Ohio Wound Care Specialists, Inc.

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• DPMOtikoNrCa, LLC
• Wound Care Medical Group
• Texas Wound Care Management
• Dr. Otiko (DMEPOS Supplier Revocation)
• Wound Pros Illinois
• Wound Pros Washington
• Coast to Coast Podiatry
• Wound Pros Georgia (Part B Revocation)
• Wound Pros Tennessee (Part B Revocation)
• Wound Pros Michigan (Part B Revocation)
• Wound Pros Georgia (DMEPOS)
• Wound Pros Nevada
• Wound Pros Louisiana
• PLS Podiatry Group
• Wound Pros Texas Medical Group
• Coast to Coast DME (DMEPOS Supplier Revocation)
• Wound Pros New York
• Wound Pros Doctors
• Wound Pros Florida. 

The Otiko Suppliers all requested reconsideration of the initial determinations of their revocations.  CMS issued unfavorable reconsideration determinations for each of the Otiko Suppliers.  The hearing officers upheld CMS’s determinations and found that no error was made in the revocation of Petitioners billing privileges, in imposing a reenrollment bar, or in placing Petitioners on the preclusion list. 

On October 10, 2023, Petitioners timely requested a hearing before an administrative law judge.  This case was assigned to me for hearing and decision, and the Civil Remedies Division issued my Standing Order. 

On January 16, 2024, CMS filed a prehearing brief and a Motion for Summary Judgment (CMS Br.) with 31 exhibits (CMS Exs. 1-31).  On March 7, 2024, Petitioner filed a Prehearing Brief and Opposition to Respondent’s Motion for Summary Judgment (P. Br.), a Statement of Disputed Facts (P. Statement), and three exhibits (P. Exs. 1-3). 

II. Admission of Evidence

Petitioners object to CMS Exs. 1-31, the reconsideration documents for each petitioner, based on authentication and hearsay.  This is an administrative proceeding, and evidence may be admitted even though typically inadmissible under the rules of evidence.  The ALJ rules on the admissibility of evidence and receives testimony and documents that are “relevant and material.”  42 C.F.R. §§ 498.60-.61.  The reconsideration documents

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submitted as CMS Exs. 1-31, including the determinations and evidence considered by the hearing officer, are unquestionably “relevant and material.”  Therefore, CMS Exs. 1-31 are admitted into evidence. 

CMS objected to Petitioner’s expert witness, Michael N. Wakshull, and his declaration which is labeled as P. Ex. 3.  CMS argues that federal courts have excluded the testimony of  handwriting experts when there was not sufficient detail regarding methodology beyond merely “comparing” the handwriting on several documents and when the work has not been subject to peer review.  CMS Objections at 3.  While I note CMS’s objections, I find Mr. Wakshull’s declaration to be relevant and material; therefore, CMS’s objection is overruled and P. Ex. 3 is admitted into evidence.  CMS’s objection is more suited to address the credibility and weight afforded to the evidence not admissibility. 

All evidence will be given proper weight and consideration. 

Because neither party requested to cross-examine witnesses it is not necessary to hold a hearing.  Standing Order ¶ 12.  Therefore, CMS’s motion for summary judgment is moot and this matter will be decided on the written record. 

III. Issues

1. Whether CMS has a legitimate basis to revoke Petitioners’ Medicare enrollment and billing privileges under 42 C.F.R. § 424.535(a)(19); and
2. Whether CMS has a legal basis to place Petitioners on the CMS Preclusion List, as defined at 42 C.F.R. §§ 422.2 and 422.222. 

IV. Jurisdiction

I have jurisdiction to hear and decide the issues in this case.  42 C.F.R. §§ 498.3(b)(17), (20); 498.5(l)(2), (n)(2); see also 42 U.S.C. § 1395cc(j)(8); 42 C.F.R. §§ 405.803(a); 424.545(a); 498.1(g). 

V. Findings of Fact

The basis for the revocation of the Otiko Suppliers centers around Dr. Otiko’s affiliation with Biogenx .  Biogenx, located in Glendora, California, was enrolled in the Medicare program as both a Part B clinic/group practice and DMEPOS supplier.  CMS Ex. 1 at 30, 89; P. Binder 1 at 4.  On December 7, 2021, Palmetto, a Medicare administrative contractor, informed Biogenx that its DMEPOS Medicare enrollment was revoked effective 30 days from the date of the letter, pursuant to 42 C.F.R. § 424.535(a)(4).  P. Binder 1 at 4; CMS Ex. 1 at 30.  On December 10, 2021, Noridian, also a Medicare

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contractor, informed Biogenx that its Part B Medicare enrollment was revoked, effective January 9, 2022.  CMS Ex. 1 at 89.  Both revocations were imposed under 42 C.F.R. § 424.535(a)(4) due to Biogenx providing False or Misleading Information.  CMS Ex. 1 at 30, 89.  CMS determined that Biogenx failed to report Don Swearingen as a managing employee and an authorized official on its Medicare 855S enrollment application, which constituted false or misleading information. Id.  The enrollment application only listed Dr. Otiko, Carla Ethier, and Allyson Berkey as people with ownership interests and/or managing control in Biogenx.  CMS Ex. 1 at 30, 83.  As a result, Biogenx was subject to a five-year reenrollment bar and placement on the CMS preclusion list.  CMS Ex. 1 at 30-33, 90-91.  Biogenx requested reconsideration for both revocations.  On March 16, 2022, CMS issued unfavorable decisions, upholding the revocation of Biogenx’s DMEPOS and Medicare Part B enrollments, the re-enrollment bars, and placement on the CMS preclusion list.  CMS Ex. 1 at 5-11. 

Subsequently, based on Dr. Otiko’s affiliation with Biogenx, CMS contractors revoked the enrollment of the Otiko suppliers.  At the reconsideration level, Dr. Otiko argued that he was never an owner or officer of Biogenx.  CMS Ex. 6 at 18.  Petitioners argue that Dr. Otiko has not been affiliated with Biogenx since August 2020.  CMS Ex. 2 at 17; P. Br. at 2.  Dr. Otiko admits to having an affiliation with Biogenx from 2017-2020 but stops short of defining the nature of the affiliation.  P. Br. at 2, 19. 

The evidence shows that Dr. Otiko has been listed on several Biogenx documents since 2017.  On November 22, 2016, the Internal Revenue Service (IRS) issued an Employer Identification Number to Biogenx Medical in care of Dr. Otiko.  CMS Ex. 1 at 163.  Dr. Otiko’s ownership and managerial relationship to Biogenx dates back to April 24, 2017, when a filing with the California Secretary of State lists Dr. Otiko as a director and officer of Biogenx.  CMS Ex. 1 at 166.  On a Medicare Enrollment Application signed by Dr. Otiko on July 17, 2018, Dr. Otiko is listed as having ownership/managing control in Biogenx, effective July 1, 2018, while Carla Ethier is listed as the contact person on that document.  CMS. Ex. 1 at 197, 198.  Additionally, Dr. Otiko signed a surety bond for suppliers of DMEPOS as the Principal of Biogenx on November 16, 2017.  CMS Ex. 1 at 209-10.  Dr. Otiko signed a Medicare Participating Physician or Supplier Agreement as Chief Executive Officer (CEO) of Biogenx with a NPI number of 1962912246 on July 17, 2018.  CMS Ex. 1 at 229.  The February 26, 2020 Corporation, Statement of Information for Biogenx bears Dr. Otiko’s electronic signature and includes Dr. Otiko as the CEO and Don Swearingen as the Secretary, Chief Financial Officer, Director, and Agent for Service of Process.  CMS Ex. 1 at 263, 264.  An Application Data Report of a change of information application shows Dr. Otiko listed as an authorized signer and CEO of Biogenx as recently as October 12, 2021.  CMS Ex. 1 at 237, 241. 

Two letters were submitted to the National Supplier Clearinghouse on January 18 and 21, 2022 on Biogenx letterhead, and purportedly signed by Dr. Otiko.  CMS Ex. 1 at 28, 37. Dr. Otiko claims that these letters, in addition to other documents were forged.  To

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support his assertion, Dr. Otiko hired a handwriting expert to analyze the signatures of the January 2022 letters, other documents that the reconsidered determinations relied on in establishing the affiliation with Biogenx, and previous documents that he signed.  CMS Ex. 1 at 37-40. 

VI. Legal Analysis and Conclusions

1. Revocation of Billing Privileges

CMS may revoke a currently enrolled provider or supplier’s Medicare enrollment and any corresponding provider or supplier agreement if CMS determines that a provider or supplier has or has had an affiliation under section 424.519 that poses an undue risk for fraud, waste, or abuse to the Medicare program.  42 C.F.R. § 424.535(a)(19).  CMS may request a revalidating provider or supplier to disclose any and all affiliations that it or any of its owning or managing employees or organizations has or, within the previous five years, had with a currently or formerly enrolled Medicare, Medicaid, or CHIP (Children’s Health Insurance Program) provider or supplier that has a disclosable event (as defined in § 424.502).  CMS will request such disclosures when it is determined that the initially enrolling or revalidating provider or supplier may have at least one such affiliation.  42 C.F.R. § 424.519.  A disclosable event occurs if Medicare, Medicaid, or CHIP enrollment has been denied, revoked, or terminated, regardless of—

(i) The reason for the denial, revocation, or termination;

(ii) Whether the denial, revocation, or termination is currently being appealed; or

(iii) When the denial, revocation, or termination occurred or was imposed. 

42 C.F.R. § 424.502.  It is undisputed that Biogenx had a disclosable event when its Medicare Part B and DMEPOS enrollment privileges were revoked.  CMS Ex. 1 at 4, 74, 89. 

Dr. Otiko’s relationship with Biogenx

In order to determine whether revocation is proper, I must examine Dr. Otiko’s relationship and affiliation with Biogenx.  Despite the plethora of documents which show his connection to Biogenx, Dr. Otiko focuses on the authenticity of two letters and six documents, arguing that his signatures on those documents were forged.  P. Exs. 1, 3.  The first letter, dated January 18, 2022, written on Biogenx Medical Group letterhead, was addressed to the National Supplier Clearinghouse and stated, “Please find attached all the information correcting the issue of the reference number listed above,” and was allegedly signed by Dr. Otiko.  P. Ex. 1 at 4.  The second letter, also on Biogenx letterhead and allegedly signed by Dr. Otiko, dated January 21, 2022, was also addressed to the National Supplier Clearinghouse, stated in pertinent part, “[p]lease understand that not everyone is a Fraud[.]  We try very hard to follow all the guidelines for Medicare and

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all insurances.  We are trying to help the geriatric industry.  We have done what we said and would like to continue to do so.”  CMS Ex. 6 at 49. 

In support of his argument, Dr. Otiko submitted a declaration from Mr. Michael Wakshull, a handwriting expert.  Mr. Wakshull examined several PDF documents chosen and submitted by Dr. Otiko with “normal course of business signatures” and compared them to eight “questioned” documents related to Biogenx that Dr. Otiko claims to be forged.  CMS Ex. 6 at 41-45; P. Ex. 3.  The eight questioned documents include two letters to the National Supplier Clearinghouse, three Section 15 Authorized Official Certification and Signatures, a California Secretary of State Statement of Information, a letter from Biogenx Medical, and an authorization signature line.  P. Ex. 3 at 3.  In order to make a determination, Mr. Wakshull assumed that the signatures attributed to Dr. Otiko were written by Dr. Otiko, as Mr. Wakshull was not present when the documents were signed.  Id. at 5; CMS Ex. 6 at 43.  Mr. Wakshull noted a limitation due to the copies being PDF documents; however, he noted that examining PDF documents is a generally accepted practice for document examiners.  P. Ex. 3 at 6; CMS Ex. 6 at 43.  To examine the signatures, Mr. Wakshull compared common and unusual attributes in the known signatures and in the ones questioned by Dr. Otiko.  There were many similarities in the known and questioned signatures; however, Mr. Wakshull noted differences such as the “C” being taller than the “O” in the known signatures (beginning in 2021), and the direction of the final stroke.  CMS Ex. 6 at 44-47.  After examining the documents, Mr. Wakshull determined that there was a “strong probability” that Dr. Otiko did not write the signatures on the questioned documents.  CMS Ex. 6 at 42; P. Ex. 3 at 5, 6. 

Mr. Wakshull explains that, according to industry standard definitions (Scientific Working Group for Forensic Document Examination), “strong probability did not” means that “the evidence is very persuasive, yet some crucial feature or quality is missing so that an identification is not in order.”  CMS Ex. 6 at 61; P. Ex. 3 at 5, 56.  “Strong Probability Did Not” is not as persuasive as an “elimination” or “identification,” but indicates that the examiner is “virtually certain” that the questioned and known writings were not written by the “same individual.”  P. Ex. 3 at 56. 

Though I have no reason to doubt Mr. Wakshull’s credibility, I am greatly concerned about the limitations mentioned in his report.  Notably, the lack of exemplars from within one year of the questioned document, the documents that were provided in PDF or photocopy format, and the lack of an identification.  I am also concerned with the assumption that the known signatures provided by Dr. Otiko were actually written by Dr. Otiko.  Giving Mr. Wakshull’s report adequate weight and consideration, it is not enough to convince me that Dr. Otiko did not sign, or permit someone to sign on his behalf, the documents in question.  Nor am I convinced that Dr. Otiko did not have an affiliation with Biogenx. 

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However, even if the documents in question were forged, there are still numerous documents in the record that show Dr. Otiko’s affiliation with Biogenx.  As CMS notes, the documented ownership and managerial relationship between Biogenx and Dr. Otiko dates back to 2017.  CMS Br. at 48; CMS Ex. 1 at 274-77. 

First, Medicare enrollment records show that Dr. Otiko reassigned his billing privileges to Biogenx effective January 2018 through January 2022 for PTAN CA2950569 and effective December 2017 through January 2022 for PTAN CB294436.  CMS Ex. 1 at 294-95.  The reassignments are undisputed and are dispositive of Dr. Otiko’s affiliation with Biogenx.  42 C.F.R. § 424.502 (defining affiliation to include “(5) Any reassignment relationship under § 424.80”).  The record also includes the following documents showing Dr. Otiko’s affiliation with Biogenx: 

• A CMS-855S application for Biogenx Medical Corporation, was signed by Dr. Otiko on July 17, 2018, to enroll a new business location as a DMEPOS supplier.  CMS Ex. 1 at 178, 180, 184, 203.  The application lists Dr. Otiko as 5% or greater direct/indirect owner and officer.  CMS Ex. 1 at 197.
• The Biogenx Corporation Statement of Information filed with the California Secretary of State on January 4, 2022, lists Dr. Otiko as the Chief Executive Officer, Secretary, Chief Financial Officer, and Director of Biogenx.  CMS Ex. 1 at 28, 29.  An earlier Biogenx Statement of Information filed with the California Secretary of State on February 26, 2020, listed Dr. Otiko as the Chief Executive Officer.  CMS Ex. 1 at 263.
• On November 16, 2017, Dr. Otiko signed a surety bond for suppliers of DMEPOS as the principle of Biogenx Medical.  CMS Ex. 1 at 209. Dr. Otiko also signed a Medicare Participating Physician or Supplier Agreement as the CEO on July 17, 2018.  CMS Ex. 1 at 229.
• Lastly, Dr. Otiko’s email address is listed throughout the enrollment documents. 

Despite initially denying any relationship with Biogenx, Dr. Otiko admits to having an affiliation with Biogenx from 2017-2020 and later notes that he ended his relationship with Biogenx prior to August 2020.  P. Br. at 4, 19; P. Ex. 1; CMS Ex. 1 at 22.  However, Dr. Otiko never states what his relationship was with Biogenx prior to “ending the relationship.”  The inconsistency and the differing accounts of his relationship with Biogenx cause me to question Dr. Otiko’s credibility.  Additionally, I find it quite concerning that Dr. Otiko has not provided any proof of his alleged attempt to end his relationship with Biogenx. 

Based on the evidence before me, CMS has proven that Dr. Otiko had an affiliation with Biogenx, as defined in 42 C.F.R. § 424.519, within five years of the revocation.  Dr. Otiko admits to ending his relationship with Biogenx sometime in 2020, which would still be within the five-year period.  Additionally, Dr. Otiko is listed as a director and officer on numerous documents regarding Biogenx. 

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Dr. Otiko’s affiliation with Biogenx poses an undue risk of fraud, waste, or abuse. 

In determining whether an affiliation poses an undue risk of fraud, waste, or abuse, CMS considers: 

(1) The duration of the affiliation. 

(2) Whether the affiliation still exists and, if not, how long ago it ended. 

(3) The degree and extent of the affiliation. 

(4) If applicable, the reason for the termination of the affiliation. 

(5) Regarding the affiliated provider’s or supplier’s disclosable event under paragraph (b) of this section: 

1. The type of disclosable event.
2. When the disclosable event occurred or was imposed.
3. Whether the affiliation existed when the disclosable event occurred or was imposed.
4. If the disclosable event is an uncollected debt:
   1. The amount of the debt.
   2. Whether the affiliated provider or supplier is repaying the debt.
   3. To whom the debt is owed.
5. If a denial, revocation, termination, exclusion, or payment suspension is involved, the reason for the disclosable event. 

(6) Any other evidence that CMS deems relevant to its determination. 

Regarding these factors, CMS determined, and the evidence shows that Dr. Otiko had an extensive affiliation with Biogenx dating back to April 24, 2017, when he was first identified as the director with the California Secretary of State.  CMS Ex. 6 at 8, 150.  Documents show that Dr. Otiko has served as the authorized official or director/officer of Biogenx.  CMS Ex. 1 at 209-10, 229.  Though Dr. Otiko argues that the affiliation ended in August 2020, he has not provided any evidence to support this claim.  P. Br. at 4, 19.  The filing with the California Secretary of statement shows Dr. Otiko remained an officer and director of Biogenx as of January 6, 2022.  CMS Ex. 1 at 28-29.  Based on the evidence presented, Dr. Otiko’s affiliation with Biogenx existed when the disclosable event occurred.  It is undisputed that Biogenx’s DMEPOS and Part B Medicare privileges were revoked because Biogenx “affirmatively reported false and misleading information on its Medicare applications.”  CMS Ex. 1 at 9, 30-33, 74-77.  CMS explained that the “submission of false information or the withholding of information relevant to the provider’s or supplier’s enrollment eligibility represents a significant program integrity risk.”  CMS Ex. 1 at 9 (citing 84 Fed. Reg. 47,794, 47,826 (Sep. 10, 2019)). 

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In relation to factor 6, CMS notes concern with Dr. Otiko denying his affiliation with Biogenx stating, “Dr. Otiko’s misrepresentation of his relationship to the corporation exemplifies the risk posed to the program.”  CMS Ex. 6 at 9. 

I find that CMS considered the regulatory factors in determining that Dr. Otiko’s affiliation with Biogenx poses an undue risk of fraud, waste, or abuse and find that the determination is supported by evidence in the record.  Therefore, I conclude that CMS had a basis to revoke Dr. Otiko’s enrollments pursuant to 42 C.F.R. § 424.535(a)(19). 

Revocation of the Otiko Suppliers

CMS argues that the Otiko Suppliers are subject to revocation due to Dr. Otiko’s affiliation with Biogenx.  Because I have ruled that Dr. Otiko is subject to revocation, I will now discuss the Otiko Suppliers, their relationship with Dr. Otiko, and the revocation actions imposed by CMS.  The evidence shows, and Dr. Otiko does not dispute, that he was a 5% or greater indirect owner, authorized official, and/or managing employee, of the following Otiko Suppliers at the time of the revocations.  Because I have ruled that CMS correctly determined Dr. Otiko’s affiliation with Biogenx poses an undue risk, the same analysis applies to the following Otiko Suppliers.  As a result, I find that the following Otiko Suppliers are also subject to revocation under 42 C.F.R. § 424.535(a)(19). 

Ohio Wound Care Network (OWCN)

On February 27, 2023, CMS, through its contractor CGS Administrators, LLC (CGS), informed OWCN that its Medicare billing privileges were revoked effective March 29, 2023.  CMS Ex. 1 at 19.  OWCN submitted a timely request for reconsideration on April 28, 2023.  CMS Ex. 1 at 18.  By notice letter dated August 11, 2023, CMS informed OWCN that its reconsideration request resulted in an unfavorable decision.  CMS Ex. 1 at 1.  The Medicare enrollment application for OWCN lists Dr. Otiko as the president, and he is also listed as a 5% or greater direct/indirect owner, authorized official, and managing employee effective May 1, 2022.  CMS Ex. 1 at 103.  Therefore, CMS has proven that OWCN is subject to revocation pursuant to 42 C.F.R. § 424.535(a)(19). 

Ohio Wound Care Physicians (OWCP)

By letter dated February 21, 2023, CMS, through its contractor, CGS, informed OWCP that its Medicare billing privileges were revoked effective March 23, 2023.  CMS Ex. 2 at 18.  The letter also informed that OWCP was subject to a five-year re-enrollment bar and placement on the CMS’s preclusion list.  Id. at 18-20.  OWCP timely requested a reconsideration on April 27, 2023.  On August 11, 2023, CMS issued an unfavorable reconsideration determination upholding OWCP’s revocation, re-enrollment bar, and placement on the preclusion list.   CMS Ex. 2 at 11.  A Medicare enrollment application

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indicates that Dr. Otiko established managing control of OWCP on November 22, 2016.  CMS Ex. 2 at 137.  Dr. Otiko’s role with OWCP continued as recently as April 2, 2022.  CMS Ex. 2 at 104.  Therefore, CMS has proven that OWCP is subject to revocation pursuant to 42 C.F.R. § 424.535(a)(19). 

Wound Pros Texas (WPTX)

By letter dated February 24, 2023, CMS, through its contractor Novitas Solutions (Novitas), informed WPTX that its Medicare billing privileges were revoked effective March 26, 2023 due to an affiliation that poses an undue risk.  CMS Ex. 3 at 19.  WPTX was also placed on the CMS preclusion list. Id. at 14.  Petitioner requested reconsideration and CMS issued an unfavorable reconsideration determination on August 11, 2023.  CMS Ex. 3 at 1.  Effective December 20, 2019, Dr. Otiko is listed as being a 5% or greater direct/indirect owner, authorized official, and managing employee of WPTX.  CMS Ex. 3 at 105.  Dr. Otiko has not disputed his role with WPTX.  Dr. Otiko is listed as an authorized official on a Medicare enrollment application for WPTX.  CMS Ex. 3 at 150.  Therefore, CMS has proven that WPTX is subject to revocation pursuant to 42 C.F.R. § 424.535(a)(19). 

Coast to Coast Podiatry (C2C Podiatry)

C2C Podiatry is a DMEPOS supplier in the Medicare program.  On February 28, 2023, CMS, through its contractor Palmetto, issued a revised notice revoking the DMEPOS Medicare supplier number for C2C Podiatry.  CMS Ex. 4 at 16.  A five-year reenrollment bar was imposed, and C2C Podiatry was placed on the CMS preclusion list.  Petitioner requested reconsideration and CMS issued an unfavorable determination on August 11, 2023.  CMS Ex. 4 at 1.  On a Medicare enrollment revalidation application dated April 24, 2020, Dr. Otiko is listed as the authorized signer for C2C Podiatry, in addition to being a 5% or greater direct/indirect owner, director/officer, authorized official, and managing employee, effective March 1, 2012.  CMS Ex. 4 at 109, 115.  Therefore, CMS has proven that C2C Podiatry is subject to revocation pursuant to 42 C.F.R. § 424.535(a)(19). 

Wound Pros Arizona (WPAZ)

By notice dated February 28, 2023, Noridian notified WPAZ that its Medicare privileges were being revoked effective March 30, 2023, because Dr. Otiko, the owner, managing employee, and authorized official was found to have an affiliation that posed an undue risk.  CMS Ex. 5 at 14.  WPAZ was also placed on the CMS preclusion list and subjected to a five-year reenrollment bar.  Id. at 15, 16.  Petitioner requested reconsideration and CMS issued an unfavorable determination on August 11, 2023.  CMS Ex. 5 at 1.  The evidence shows, and Dr. Otiko does not dispute, that he was a 5% or greater direct/indirect owner, authorized official, and managing employee of WPAZ, effective

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September 1, 2020.  CMS Ex. 5 at 105.  Therefore, CMS has proven that WPAZ is subject to revocation pursuant to 42 C.F.R. § 424.535(a)(19). 

Wound Pros Ohio (WPO)

On February 21, 2023, CGS issued an initial determination informing WPO that its Medicare privileges were revoked effective March 23, 2023, because Dr. Otiko, the owner, managing employee, and authorized official was found to have an affiliation with Biogenx that posed an undue risk.  CMS Ex. 7 at 14.  Petitioner was also placed on the CMS preclusion list and subjected to a five-year re-enrollment bar.  Id. at 15, 16.  Petitioner requested reconsideration and CMS issued an unfavorable reconsideration determination on August 11, 2023.  CMS Ex. 7 at 1.  On a Medicare enrollment application, Dr. Otiko is listed as a 5% or greater direct/indirect owner, authorized official, and a director/officer of WPO, effective November 22, 2016.  CMS Ex. 7 at 138.  Therefore, CMS has proven that WPO is subject to revocation pursuant to 42 C.F.R. § 424.535(a)(19). 

Wound Pros Tennessee (WPTN)

On February 24, 2023, Novitas issued an initial determination informing DMEPOS supplier, WPTN, that its Medicare supplier number was revoked effective 30 days from the date of the notice, that it was subject to a five-year re-enrollment bar, and that it was added to CMS’s preclusion list.  CMS Ex. 8 at 14, 15.  The revocation was due to Dr. Otiko, the owner, managing employee, and authorized official was found to have an affiliation with Biogenx that posed an undue risk.  CMS Ex. 8 at 14.  Petitioner requested reconsideration and CMS issued an unfavorable reconsideration determination on August 11, 2023.  CMS Ex. 8 at 1.  A Medicare enrollment application shows that Dr. Otiko is listed as a 5% or greater direct/indirect owner, authorized official, and a managing employee of WPTN, effective September 1, 2020.  CMS Ex. 8 at 50.  Therefore, CMS has proven that WPTN is subject to revocation and pursuant to 42 C.F.R. § 424.535(a)(19). 

Coast to Coast DME (Part B Enrollment) (Coast to Coast)

Coast to Coast has two enrollments in the Medicare program, one as a DMEPOS supplier and one as a supplier of Part B services.  CMS Ex. 9 at 1 n.1.  This portion of my decision only involves revocation of the Part B enrollment.  Id.  Noridian informed Coast to Coast that effective March 26, 2023, its Medicare privileges were being revoked due to Dr. Otiko and Dr. Berkley, and Carla Ethier’s affiliation with Biogenx that posed an undue risk of fraud, waste, or abuse to the Medicare Program.  CMS Ex. 9 at 16.  Coast to Coast was also added to the CMS preclusion list and a five-year reenrollment bar was imposed.  CMS Ex. 9 at 16-19.  Coast to Coast requested reconsideration and CMS issued an unfavorable decision on August 11, 2023.  It is undisputed that Dr. Otiko

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served as the chief executive officer, secretary, and chief financial officer of Coast to Coast.  CMS Ex. 9 at 298, 299.  Therefore, I find that CMS has proven that Coast to Coast is subject to revocation pursuant to 42 C.F.R. § 424.535(a)(19). 

Wound Pros Utah (WPUT)

On February 24, 2023, Noridian notified WPUT that its Medicare privileges were revoked effective March 26, 2023 pursuant to 42 C.F.R. § 424.535(a)(19) due to Dr. Otiko’s affiliation with Biogenx that posed an undue risk of fraud, waste, or abuse to the Medicare Program.  CMS Ex. 10 at 14.  WPUT was also added to the CMS preclusion list and subject to a five-year reenrollment bar.  Id. at 15, 16.  WPUT requested reconsideration and CMS issued an unfavorable determination on August 11, 2023.  CMS Ex. 10 at 1.  It is undisputed that Dr. Otiko was a managing employee of WPUT.  CMS Ex. 10 at 293.  Therefore, I find that CMS has proven that WPUT is subject to revocation pursuant to 42 C.F.R. § 424.535(a)(19). 

Wound Pros Michigan (WPMI)

Wisconsin Physicians Service (WPS), a Medicare contractor, informed WPMI that its Medicare privileges were being revoked effective March 23, 2023 pursuant to 42 C.F.R. § 424.535(a)(19) and 42 C.F.R. § 424.535(a)(5).  CMS Ex. 11 at 16; see CMS Ex. 11 at 1, 6-7 (addressing DMEPOS revocation from inspection finding supplier non-operational).  WPMI requested reconsideration and CMS issued an unfavorable determination on August 11, 2023.  CMS Ex. 11 at 1; CMS Ex. 22 at 1. 

The articles of incorporation and the Medicare enrollment record summary both show Dr. Otiko served as the managing employee, 5% or greater direct/indirect owner, and president of WPMI.  CMS Ex. 11 at 295, 307-09; CMS Ex. 22 at 105, 305-06. 

A surveyor visited WPMI on November 22, 2021 at 10:02 am and found that the office was not open for business. CMS Ex. 11 at 322.  No staff were present and there were no signs of activity.  Id.  The surveyor revisited WPMI on November 30, 2021, and noted that it was non-operational and there was no business at the location.  Id.  The surveyor called the out-of-state telephone number listed for the business and did not receive a return call.  Id.  CMS may revoke a supplier’s Medicare privileges if it determines that the provider or supplier is no longer operational to furnish Medicare covered items or services or otherwise fails to satisfy any Medicare enrollment requirement.  42 C.F.R. § 424.535(a)(5).  Petitioner has not refuted CMS’s claims of it being non-operational. 

Based on the evidence provided, I find that CMS has proven that WPMI is subject to revocation under both 42 C.F.R. § 424.535(a)(19) and 42 C.F.R. § 424.535(a)(5). 

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Ohio Wound Care Specialists, Inc. (OWCS)

CGS informed OWCS that its Medicare privileges were being revoked effective March 23, 2023, because Dr. Otiko, the owner, managing employee and authorized official, had an affiliation with Biogenx that created an undue risk of fraud, waste, or abuse to the Medicare program.  CMS Ex. 12 at 14.  OWCS was also subject to inclusion on the CMS preclusion list and a five-year reenrollment bar.  CMS Ex. 12 at 15, 16.  OWCS appealed and CMS issued an unfavorable determination on August 11, 2023.  The evidence shows that Dr. Otiko served as a 5% or greater direct/indirect owner, authorized official, and managing employee of OWCS effective April 2, 2022.  CMS Ex. 12 at 103-04, 309.  Dr. Otiko has not disputed his relationship with OWCS.  Therefore, I find that CMS has proven that OWCS is subject to revocation pursuant to 42 C.F.R. § 424.535(a)(19). 

DPMOtikoNrCa LLC d/b/a Plasmagenix Foot and Ankle Institute (Plasmagenix)

Noridian informed Plasmagenix that its Medicare privileges were being revoked effective March 26, 2023, because Dr. Otiko, the owner, managing employee and authorized official, had an affiliation with Biogenx that created an undue risk of fraud, waste, or abuse to the Medicare program.  CMS Ex. 13 at 20.  Plasmagenix was also subject to inclusion on the CMS preclusion list and a five-year reenrollment bar.  CMS Ex. 12 at 21, 22.  The evidence shows that Dr. Otiko served as a 5% or greater direct/indirect owner, authorized official, and managing employee of Plasmagenix effective May 27, 2010.  CMS Ex. 13 at 115-16.  Dr. Otiko has not disputed his relationship with Plasmagenix.  Therefore, I find that CMS has proven that Plasmagenix is subject to revocation pursuant to 42 C.F.R. § 424.535(a)(19). 

Wound Care Medical Group (WCMG)

Noridian informed WCMG that its Medicare privileges were being revoked effective March 30, 2023, because Dr. Otiko, the owner, managing employee and authorized official, had an affiliation with Biogenx that created an undue risk of fraud, waste, or abuse to the Medicare program.  CMS Ex. 14 at 14.  WCMG was also subject to inclusion on the CMS preclusion list and a five-year reenrollment bar. CMS Ex. 14 at 14, 16.  The evidence shows that Dr. Otiko served as a 5% or greater direct/indirect owner, authorized official, and managing employee of WCMG effective April 2, 2022.  CMS Ex. 14 at 108.  Dr. Otiko has not disputed his relationship with WCMG.  Therefore, I find that CMS has proven that WCMG is subject to revocation pursuant to 42 C.F.R. § 424.535(a)(19). 

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Texas Wound Care Management (TWCM)

Novitas informed TWCM that its Medicare privileges were being revoked effective March 26, 2023, because Dr. Otiko, the owner, managing employee and authorized official, had an affiliation with Biogenx that created an undue risk of fraud, waste, or abuse to the Medicare program.  CMS Ex. 15 at 14.  TWCM was also subject to inclusion on the CMS preclusion list and a five-year reenrollment bar.  CMS Ex. 15 at 15, 17.  The evidence shows that Dr. Otiko served as a 5% or greater direct/indirect owner, authorized official, and managing employee of TWCM effective May 1, 2022.  CMS Ex. 15 at 49.  Dr. Otiko has not disputed his relationship with TWCM.  Therefore, I find that CMS has proven that TWCM is subject to revocation pursuant to 42 C.F.R. § 424.535(a)(19). 

Wound Pros Illinois (WPIL)

National Government Services (NGS) informed WPIL that its Medicare privileges were being revoked effective March 31, 2023, because Dr. Otiko, the owner, managing employee and authorized official, had an affiliation with Biogenx that created an undue risk of fraud, waste, or abuse to the Medicare program.  CMS Ex. 17 at 14.  WPIL was also subject to inclusion on the CMS preclusion list and a five-year reenrollment bar.  CMS Ex. 17 at 15, 17.  The evidence shows that Dr. Otiko served as a 5% or greater direct/indirect owner, authorized official, and managing employee of WPIL effective September 1, 2020.  CMS Ex. 17 at 105.  Dr. Otiko has not disputed his relationship with WPIL.  Therefore, I find that CMS has proven that WPIL is subject to revocation pursuant to 42 C.F.R. § 424.535(a)(19). 

Wound Pros Washington (WPWA)

Noridian informed WPWA that its Medicare privileges were being revoked effective March 26, 2023, because Dr. Otiko, the owner, managing employee and authorized official, had an affiliation with Biogenx that created an undue risk of fraud, waste, or abuse to the Medicare program.  CMS Ex. 18 at 14.  WPWA was also subject to inclusion on the CMS preclusion list and a five-year reenrollment bar.  CMS Ex. 18 at 14, 16.  The evidence shows that Dr. Otiko served as a 5% or greater direct/indirect owner, authorized official, and managing employee of WPIL effective September 1, 2020.  CMS Ex. 18 at 103, 104.  Dr. Otiko has not disputed his relationship with WPWA.  Therefore, I find that CMS has proven that WPWA is subject to revocation pursuant to 42 C.F.R. § 424.535(a)(19). 

Coast to Coast Podiatry d/b/a Neurogenx NerveCenter Newport Beach (Neurogenx)

Noridian informed Neurogenx that its Medicare Part B enrollment privileges were being revoked effective March 29, 2023, because Dr. Otiko, the owner, managing employee

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and authorized official, had an affiliation with Biogenx that created an undue risk of fraud, waste, or abuse to the Medicare program.  CMS Ex. 19 at 15.  Neurogenx was also subject to inclusion on the CMS preclusion list and a five-year reenrollment bar. CMS Ex. 19 at 15, 17.  The evidence shows that Dr. Otiko served as a 5% or greater direct/indirect owner, authorized official, and managing employee of Neurogenx effective January 25, 2012.  CMS Ex. 19 at 108.  Dr. Otiko has not disputed his relationship with Neurogenx.  Therefore, I find that CMS has proven that Neurogenx is subject to revocation pursuant to 42 C.F.R. § 424.535(a)(19). 

Wound Pros Georgia (WPGA)

Palmetto informed WPGA that its Medicare Part B privileges were being revoked effective March 29, 2023, because Dr. Otiko, the owner, managing employee and authorized official, had an affiliation with Biogenx that created an undue risk of fraud, waste, or abuse to the Medicare program.  CMS Ex. 20 at 14.  WPGA was also subject to inclusion on the CMS preclusion list and a five-year reenrollment bar.  CMS Ex. 20 at 14, 16. 

On February 28, 2023, Novitas informed WPGA that its Medicare supplier number for DMEOPS was revoked effective 30 days after the date of the notice.  CMS Ex. 23 at 15.  The revocation was due to Dr. Otiko, the owner, managing employee and authorized official for WPGA, having an affiliation with Biogenx that created an undue risk of fraud, waste, or abuse to the Medicare program.  Id.  WPGA-DMEPOS was also subject to a five-year re-enrollment bar and inclusion on the CMS inclusion list.  Id. at 15-16. 

The evidence shows that Dr. Otiko served as a 5% or greater direct/indirect owner, authorized official, and managing employee of WPGA effective September 1, 2020 for the clinic/group practice and effective August 3, 2020 for the DMEPOS supplier.  CMS Ex. 20 at 104; CMS Ex. 23 at 113.  Dr. Otiko has not disputed his relationship with WPGA.  Therefore, I find that CMS has proven that WPGA is subject to revocation pursuant to 42 C.F.R. § 424.535(a)(19). 

Wound Pros Tennessee (WPTN)

Palmetto informed WPTN that its Medicare privileges were being revoked effective March 29, 2023, because Dr. Otiko, the owner, managing employee and authorized official, had an affiliation with Biogenx that created an undue risk of fraud, waste, or abuse to the Medicare program.  CMS Ex. 21 at 14.  WPTN was also subject to inclusion on the CMS preclusion list and a five-year reenrollment bar.  CMS Ex. 20 at 14, 16.   The evidence shows that Dr. Otiko served as a 5% or greater direct/indirect owner, authorized official, and managing employee of WPTN effective September 1, 2020.  CMS Ex. 21 at 50.  Dr. Otiko has not disputed his relationship with WPTN.  Therefore, I find that CMS has proven that WPTN is subject to revocation pursuant to 42 C.F.R. § 424.535(a)(19). 

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Wound Pros Michigan (WPMI)

WPS informed WPMI that its Medicare Part B privileges were being revoked effective March 23, 2023, because Dr. Otiko, the owner, managing employee and authorized official, had an affiliation with Biogenx that created an undue risk of fraud, waste, or abuse to the Medicare program.  CMS Ex. 22 at 14.  WPMI was also subject to inclusion on the CMS preclusion list and a five-year reenrollment bar.  CMS Ex. 20 at 14, 16.  The evidence shows that Dr. Otiko served as a 5% or greater direct/indirect owner, authorized official, and managing employee of WPMI effective September 1, 2020.  CMS Ex. 22 at 105.  Dr. Otiko has not disputed his relationship with WPMI.  Therefore, I find that CMS has proven that WPMI is subject to revocation pursuant to 42 C.F.R. § 424.535(a)(19). 

Wound Pros Nevada (WPNV)1

Noridian informed WPNV that its Medicare Part B privileges were revoked effective March 30, 2023, because Dr. Otiko, the owner, managing employee and authorized official, had an affiliation with Biogenx that created an undue risk of fraud, waste, or abuse to the Medicare program.  CMS Ex. 24 at 14.  WPNV was also subject to inclusion on the CMS preclusion list and a five-year reenrollment bar.  CMS Ex. 24 at 15, 16.  The evidence shows that Dr. Otiko served as a 5% or greater direct/indirect owner, authorized official, and managing employee of WPNV effective March 1, 2020.  CMS Ex. 22 at 105.  Dr. Otiko has not disputed his relationship with WPNV.  Therefore, I find that CMS has proven that WPNV is subject to revocation pursuant to 42 C.F.R. § 424.535(a)(19). 

Wound Pros Louisiana (WPLA)

Noridian informed WPLA that its Medicare Part B privileges were revoked effective March 26, 2023, because Dr. Otiko, the owner, managing employee and authorized official, had an affiliation with Biogenx that created an undue risk of fraud, waste, or abuse to the Medicare program.  CMS Ex. 25 at 14.  WPNV was also subject to inclusion on the CMS preclusion list and a five-year reenrollment bar.  CMS Ex. 25 at 15, 17.  The evidence shows that Dr. Otiko served as a 5% or greater direct/indirect owner, authorized official, and managing employee of WPLA effective March 1, 2022.  CMS Ex. 22 at 104.  Dr. Otiko has not disputed his relationship with WPLA.  Therefore, I find that CMS has proven that WPLA is subject to revocation pursuant to 42 C.F.R. § 424.535(a)(19). 

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PLS Podiatry Group (PLSPG)

Noridian informed PLSPG that its Medicare privileges were revoked effective March 30, 2023, because Dr. Otiko, the owner, managing employee and authorized official, had an affiliation with Biogenx that created an undue risk of fraud, waste, or abuse to the Medicare program.  CMS Ex. 26 at 14.  PLSPG was also subject to inclusion on the CMS preclusion list and a five-year reenrollment bar.  Id. at 14, 16.  The evidence shows that Dr. Otiko served as a 5% or greater direct/indirect owner, authorized official, and managing employee of PLSPG effective July 2, 2015.  CMS Ex. 26 at 107-108, 302.  Dr. Otiko has not disputed his relationship with PLSPG.  Therefore, I find that CMS has proven that PLSPG is subject to revocation pursuant to 42 C.F.R. § 424.535(a)(19). 

WP Texas Medical Group (WPTX)

Novitas informed WPTX that its Medicare privileges were revoked effective March 26, 2023, because Dr. Otiko, the owner, managing employee and authorized official, had an affiliation with Biogenx that created an undue risk of fraud, waste, or abuse to the Medicare program.  CMS Ex. 27 at 14.  WPTX was also subject to inclusion on the CMS preclusion list and a five-year reenrollment bar.  Id. at 15, 17.  The evidence shows that Dr. Otiko served as a 5% or greater direct/indirect owner, authorized official, and managing employee of WPTX effective April 2, 2022.  CMS Ex. 27 at 104-05, 301.  Dr. Otiko has not disputed his relationship with WPTX.  Therefore, I find that CMS has proven that WPTX is subject to revocation pursuant to 42 C.F.R. § 424.535(a)(19). 

Coast to Coast DME

On February 28, 2023, Palmetto informed Coast to Coast that its Medicare supplier number for DMEPOS was revoked effective 30 days after the notice date, because Dr. Otiko, the owner, managing employee and authorized official, had an affiliation with Biogenx that created an undue risk of fraud, waste, or abuse to the Medicare program.  CMS Ex. 28 at 16.  Coast to Coast was also subject to inclusion on the CMS preclusion list and a five-year reenrollment bar.  Id. at 17-19.  The evidence shows that Dr. Otiko served as a 5% or greater direct/indirect owner and authorized official of Coast to Coast effective March 1, 2021.  CMS Ex. 28 at 110.  Dr. Otiko has not disputed his relationship with Coast to Coast.  Therefore, I find that CMS has proven that Coast to Coast is subject to revocation pursuant to 42 C.F.R. § 424.535(a)(19). 

Wound Pros New York (WPNY)

NGS informed WPNY that its Medicare privileges were revoked effective March 31, 2023, because Dr. Otiko, the owner, managing employee and authorized official, had an affiliation with Biogenx that created an undue risk of fraud, waste, or abuse to the Medicare program.  CMS Ex. 29 at 2, 322.  WPNY was also subject to inclusion on the

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CMS preclusion list and a five-year reenrollment bar.  Id. at 2.  The evidence shows that Dr. Otiko served as a 5% or greater direct/indirect owner, authorized official, and managing employee of WPNY effective December 9, 2019.  CMS Ex. 29 at 315.  Dr. Otiko has not disputed his relationship with WPNY.  Therefore, I find that CMS has proven that WPNY is subject to revocation pursuant to 42 C.F.R. § 424.535(a)(19). 

Wound Pros Doctors (WPDR)

Noridian informed WPDR that its Medicare privileges were revoked effective March 26, 2023, because Dr. Otiko, the owner, managing employee and authorized official, had an affiliation with Biogenx that created an undue risk of fraud, waste, or abuse to the Medicare program.  CMS Ex. 30 at 14.  WPDR was also subject to inclusion on the CMS preclusion list and a five-year reenrollment bar.  Id. at 14-16.  The evidence shows that Dr. Otiko served as a 5% or greater direct/indirect owner, authorized official, and managing employee of WPDR effective January 15, 2022.  CMS Ex. 30 at 104.  Dr. Otiko has not disputed his relationship with WPDR.  Therefore, I find that CMS has proven that WPDR is subject to revocation pursuant to 42 C.F.R. § 424.535(a)(19). 

Wound Pros Florida (WPFL)

First Coast Service Options, a Medicare contractor, informed WPFL that its Medicare privileges were revoked effective March 24, 2023, because Dr. Otiko, the owner, managing employee and authorized official, had an affiliation with Biogenx that created an undue risk of fraud, waste, or abuse to the Medicare program.  CMS Ex. 31 at 14.  WPFL was also subject to inclusion on the CMS preclusion list and a five-year reenrollment bar.  Id. at 15, 17.  The evidence shows that Dr. Otiko served as a 5% or greater direct/indirect owner, director/officer, authorized official, and managing employee of WPFL effective September 5, 2020.  CMS Ex. 31 at 105.  Dr. Otiko has not disputed his relationship with WPFL.  Therefore, I find that CMS has proven that WPFL is subject to revocation pursuant to 42 C.F.R. § 424.535(a)(19). 

2. Re-enrollment Bar

When CMS revokes the Medicare enrollment of a supplier, it must also impose a re-enrollment bar from one to ten years in length depending on the severity of the basis for revocation.  42 C.F.R. § 424.535(c)(1)(i).  Here, CMS has imposed a five-year re-enrollment bar for each of the Otiko Suppliers.  See, e.g., CMS Ex. 2 at 16.  Petitioners have not challenged, nor do I have the authority to review the re-enrollment bar imposed by CMS. 

An ALJ is authorized to review CMS’s initial determination to “revoke a . . . supplier’s Medicare enrollment.”  42 C.F.R § 498.3(b)(17).  However, the determination of the reenrollment bar is not considered an initial determination and is not subject to review by

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an ALJ.  42 C.F.R. § 498.3(b), (d).  “An appealable determination to revoke a supplier’s enrollment, and a decision about how long the revoked supplier must wait before being allowed to apply for reentry to the program, are factually distinct matters governed by different legal requirements.”  Vijendra Dave, M.D., DAB No. 2672 at 10 (2016).   Board decisions have interpreted the regulations as indicating the re-enrollment bar is not subject to ALJ review.  E.g., Lilia Gorovits, M.D., P.C., DAB No. 2985 at 15-16 (2020); Vijendra Dave, M.D., DAB No. 2672 at 9 (2016); see also Shah v. Azar, 920 F.3d 987, 998-99 (5th Cir. 2019) (indicating that CMS’s decision as to the length of the re-enrollment bar is accorded significant deference).  Therefore, I cannot review whether a five-year re-enrollment bar is appropriate in this case. 

3. Preclusion List

CMS placed each of the Otiko Suppliers on the preclusion list. 

The CMS preclusion list is comprised of individuals and entities who are precluded from receiving payment for Medicare Advantage items and services or Medicare Part D drugs furnished or prescribed to Medicare beneficiaries.  42 C.F.R. §§ 422.222, 423.120(c).  CMS may place an individual or entity on the preclusion list if: 

1. The individual or entity is currently revoked from Medicare for a reason other than that stated in [42 C.F.R.] § 424.535(a)(3) of this chapter.
2. The individual or entity is currently under a reenrollment bar under [42 C.F.R.] § 424.535(c).
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 (defining Preclusion list).  In determining whether conduct is detrimental to the best interests of the Medicare program, CMS considers: 

1. the seriousness of the conduct underlying the revocation,
2. the degree to which that conduct could affect the integrity of the Medicare program, and
3. any other evidence that CMS deems relevant to its determination. 

42 C.F.R. §§ 422.2, 423.100 (defining Preclusion list). 

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When CMS made the decision to add the Otiko Suppliers to the preclusion list, they were all  “revoked from Medicare” pursuant to 42 C.F.R. § 424.535(a)(19) and were all subject to reenrollment bar pursuant to 42 C.F.R. § 424.535(c).  See CMS Exs. 1-31. 

In determining whether the conduct that led to the revocation is detrimental to the best interests of the Medicare program CMS considered: 

1. The seriousness of the conduct underlying the individual’s or entity’s revocation;
2. The degree to which the individual’s or entity's conduct could affect the integrity of the Medicare program; and
3. Any other evidence that CMS deems relevant to its determination

Here, CMS met its regulatory obligation to consider whether the conduct underlying Petitioners’ revocations were detrimental to the best interests of the Medicare program by assessing the seriousness of that conduct, the degree to which that conduct could affect the integrity of the Medicare program, and any other information CMS deemed relevant to its determination.  42 C.F.R. § 422.2 (defining Preclusion list).  CMS found that the revocations, based on Dr. Otiko’s affiliation to Biogenx and Biogenx’s “affirmative reporting of false and misleading information,” involved a risk to the Medicare program that was “plainly very serious.”  See, e.g., CMS Ex. 1 at 10.  CMS added that such an affiliation necessarily poses a threat to the integrity of the Medicare program.  Finally, CMS also observed that Dr. Otiko’s “continued and fervent” denial of his affiliation to Biogenx demonstrates a propensity to mislead Medicare and misrepresent relevant enrollment information, and the integrity of the Medicare program depends on the integrity of its partners.  CMS Ex. 1 at 11. 

Where the regulations have granted CMS discretion to determine whether a provider or supplier’s underlying conduct is detrimental to the Medicare program, the ALJ may not substitute their own judgment as to whether CMS properly exercised that discretion.  Brian K. Ellefsen, DO, DAB No. 2626 at 7 (2015); see also Pa. Physicians, P.C., DAB No. 2980 at 13 (2019). 

Petitioners argue that the record does not support revocation or placement on the preclusion list because CMS has not proven that that there was an “undue risk of fraud, waste or abuse”.   P. Br. at 20-21.  Because these arguments have been addressed, Petitioners’ arguments are unpersuasive as to their placement on CMS’s preclusion list. 

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VII. Conclusion

For the foregoing reasons, I affirm CMS’s revocation of Petitioners’ Medicare enrollment and billing privileges under 42 C.F.R. § 424.535(a)(19) (and under § 424.535(a)(5) for WPMI) and uphold the five-year reenrollment bar and inclusion of Petitioners on the CMS preclusion list.