Regen-X Wound Care, PLLC, DAB CR6987 (2026)

DECISION

The Centers for Medicare & Medicaid Services (CMS), through an administrative contractor, revoked the Medicare enrollment and billing privileges of Regen-X Wound Care, PLLC (Petitioner) because Petitioner’s practice location on file was not operational under 42 C.F.R. § 424.535(a)(5), and it did not timely report a change in practice location under 42 C.F.R. § 424.535(a)(9).  Petitioner requested a hearing to dispute the revocation.  Based on the evidence of record, I find that Petitioner did not provide CMS with the location where it rendered services to Medicare beneficiaries and instead provided an address to what Petitioner now calls an administrative office.  Therefore, I affirm CMS’s determination to revoke Petitioner’s Medicare billing privileges because its practice location on file with CMS was not operational.

I.  Background

Petitioner is a wound care practice that was enrolled in the Medicare program as a supplier.

In a December 9, 2025 initial determination, a CMS administrative contractor revoked Petitioner’s Medicare enrollment and billing privileges.  CMS Ex. 4 at 11-13.  The

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effective date of the revocation was October 2, 2025.  The reasons for revocation were the following:

42 CFR § 424.535(a)(5)(i) – On Site Review

[CMS] has determined that Regen-X Wound Care, PLLC is longer operational . . . to furnish Medicare covered items or services.  Specifically, site visits conducted on October 2, 2025 and October 15, 2025, at 1834 A Jaclif Court, Tallahassee, FL, 32308, revealed a locked facility with no evidence of business activity.

42 CFR § 424.535(a)(9) – Failure to Report

[CMS] has determined that Regen-X Would Care, PLLC is no longer operational . . . to furnish Medicare covered items or services.  Specifically, site visits conducted on October 2, 2025 and October 15, 2025, revealed a locked facility with no business activity.  Regen-X Wound Care, PLLC did not notify [CMS] of this change of practice location as required under 42 [C.F.R.] § 424.516.

CMS Ex. 4.  The initial determination barred Petitioner from reenrollment in the Medicare program for three years.  CMS Ex. 4 at 11.

Subsequently, the CMS administrative contractor received a Corrective Action Plan from Petitioner explaining that its signage was outdated and that the majority of patient care was provided in patient homes.  CMS Ex. 2.  The administrative contractor returned the Corrective Action Plan, advising Petitioner that the Corrective Action Plan process was not available for revocations based on subsections 424.535(a)(5) and (a)(9).  CMS Ex. 1 at 1.

The CMS administrative contractor also received a request from Petitioner to reconsider the revocation.  Petitioner stated that the determination that there was no business activity at Petitioner’s facility was incorrect and had been promptly corrected.  CMS Ex. 1.  Petitioner further stated that it had shifted its operations from providing services at its office location to operating that location as an administrative office and providing the majority of patient care services in patient homes.  Id. at 3.  The request for reconsideration also explained that the signage at the facility reflected these changes and included contact information scheduling an appointment.  Id.

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Petitioner also explained that it started out by providing in-person consultation and treatment at its office location but transitioned to incorporate both facility and home-based services as its primary method of care.  Id.

On February 27, 2026, a hearing officer with the CMS administrative contractor issued an unfavorable reconsidered determination that stated that Petitioner’s Medicare enrollment was properly revoked under § 424.535(a)(5)(i) and § 424.535(a)(9) because it was found to be non-operational at its reported location, and it failed to report this change of location and/or provide all locations where services are rendered.  CMS Ex. 1.

On April 28, 2026, Petitioner timely requested a hearing.  In the hearing request, Petitioner asserts that it was operational at all times and that nothing mandates a permanently open, patient facing office for mobile models.  Hearing Request at 2.

CMS filed a motion for summary judgment and brief in support (CMS Br.), and twelve proposed exhibits (CMS Exs. 1-12).  Petitioner filed a response brief (P. Br.) and seven proposed exhibits (P. Exs. 1-7), including the written declaration of Dr. Catherine Divingian.  CMS filed a reply and objected to Petitioner’s exhibits 1, 2, and 4-7.

CMS did not request to cross-examine Petitioner’s witness.

II.  Decision on the Record and Evidentiary Objections

Petitioner did not object to any of CMS’s proposed exhibits.  Standing Order ¶ 10; Civil Remedies Division Procedures (CRDP) § 14(e).  Therefore, I admit CMS Exs. 1-12 into the record.

CMS objects to Petitioner’s exhibit 1, specifically paragraphs 20-21 and 29-31 because the paragraphs discuss a rejected corrective action plan and make equitable arguments. I overrule CMS’s objections and admit exhibit 1 into evidence in its entirety.  CMS’s arguments go to the weight, if any, I decide to afford the declaration, not its admissibility.

CMS objects to Petitioner’s exhibits 2, 4 and 5 as duplicative.  I agree that Petitioner’s exhibits 4 and 5 are duplicative of CMS’s exhibits and will not admit them.  However, I will admit Petitioner’s exhibit 2 even though it is contained in the hearing request for ease of citing.

Lastly, CMS objected to Petitioner’s exhibits 6 and 7 on the grounds that they constitute new evidence because they were not previously submitted at the reconsideration level.  CMS argues that Petitioner cannot establish good cause for submitting these exhibits for the first time at the administrative law judge (ALJ) level.  As CMS points out, Petitioner did not follow the instructions in my standing order and provide an explanation of good

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cause with its brief explaining why the exhibits are being submitted now for the first time.  Therefore, I will not admit Petitioner’s exhibits 6 and 7 into evidence.

The parties were directed to submit written direct testimony for each proposed witness.  Standing Order ¶ 8.  CMS did not submit any written direct testimony.  Petitioner submitted one declaration; however, CMS did not request to cross-examine Dr. Divingian.  The Standing Order stated that an in-person hearing would only be necessary if the opposing party requested an opportunity to cross-examine a witness.  Standing Order ¶ 10; CRDP § 16(b).  Because CMS did not request to cross-examine Dr. Divingian, I decide this case based on the written record, without considering whether the standard for summary judgment is met.1  CRDP § 19(b), (d).

III.  Issue

Whether CMS had a legitimate basis to revoke Petitioner’s Medicare enrollment and billing privileges.

IV.  Jurisdiction

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

V.  Findings of Fact, Conclusions of Law, and Analysis2

The Secretary of Health and Human Services (Secretary) has the authority to create regulations that establish enrollment standards for providers and suppliers.  42 U.S.C. § 1395cc(j).  The Secretary promulgated regulations that require prospective providers and suppliers to file an enrollment application with CMS and meet certain requirements in order to receive Medicare billing privileges.  42 C.F.R. §§ 424.500, 424.505, 424.510, 424.535.  Further, enrolled providers and suppliers periodically revalidate their enrollment information with CMS and report to CMS changes in information provided on their enrollment applications.  42 C.F.R. §§ 424.515, 424.516.

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The Secretary’s regulations provide that if an enrolled provider or supplier is not in compliance with enrollment requirements or other rules related to providers and suppliers, then CMS may revoke that provider’s or supplier’s Medicare billing privileges.  42 C.F.R. § 424.535.  The Secretary promulgated a regulation that requires providers and suppliers to be operational.  42 C.F.R. § 424.535(a)(5).  In its discretion, CMS or its contractors may conduct a site visit to determine whether a provider or supplier is in compliance with Medicare enrollment requirements.  42 C.F.R. § 424.517.  The Secretary also promulgated regulations requiring physicians to report a change in practice location within 30 days of the change.  42 C.F.R. § 424.516(d)(1)(iii).  A failure to do so may result in revocation of Medicare enrollment and billing privileges.  42 C.F.R. § 424.535(a)(9).

1. CMS attempted to complete two onsite inspections of Petitioner’s practice location at the address provided to CMS: 1834A Jaclif Court, Tallahassee, Florida 32308; however, Petitioner actually rendered the majority of its services to Medicare beneficiaries at their residences, and a site inspection of the address Petitioner provided to CMS as its practice location was not operational.

Petitioner submitted a Medicare enrollment application, on which it indicated that its practice location was “1834A Jaclif Court, Tallahassee, Florida 32308” and indicated that this practice location was its primary location.  CMS Ex. 3 at 1-2; CMS Ex. 5; CMS Ex. 8 at 4.  In signing the enrollment form, Petitioner certified that it had read the contents of the application and that it was “true, correct, and complete.”  CMS Ex. 1 at 8; Centers for Medicare & Medicaid Servs., U.S. Dep’t of Health & Hum. Servs., Medicare Enrollment Application: Clinics/Group Practices and Certain Other Suppliers, Form CMS-855B, https://www.cms.gov/medicare/cms-forms/cms-forms/downloads/cms855b.pdf.

On March 28, 2025, the CMS contractor sent a letter to Petitioner informing it that an unannounced site visit would take place at 1834A Jaclif Court, Tallahassee, Florida 32308.  CMS Ex. 4 at 4.  On October 2, 2025 and again on October 15, 2025, an inspector with a CMS administrative contractor attempted a site visit at Petitioner’s practice location address on file with CMS:  1834A Jaclif Court, Tallahassee, Florida 32308.  CMS Exs. 6, 7.  The site inspector found that the address did not house Petitioner but instead had signage for Operation Phoenix Men’s Health.  Id.  The inspectors approached the address found that the door of the establishment was locked, that there were no people visible inside or outside of the business address, and no evidence that wound care or skin substitute services were performed at the address.  Id.  As a result, the inspectors concluded that Petitioner was non-operational at its listed address.  Id.

Petitioner admits that it does not render services at the 1834A Jaclif Court, Tallahassee, Florida 32308, but rather furnishes mobile care to its patients in their homes and that the address it provided to CMS was its administrative office.  P. Br.; CMS Ex. 3.

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2. CMS had a legitimate basis to revoke Petitioner’s Medicare enrollment and billing privileges under 42 C.F.R. § 424.535(a)(5) because the address that Petitioner identified as its practice location was not operational.

CMS may revoke a supplier if, upon an on-site review, CMS determines that the provider or supplier is no longer operational to furnish Medicare-covered items or services.  42 C.F.R. § 424.535(a)(5)(i).  The term “operational” means:

the provider or supplier has a qualified physical address location, is open to the public for the purpose of providing health care related services, is prepared to submit valid Medicare claims, and is properly staffed, equipped, and stocked (as applicable, based on the type of facility or organization, provider or supplier specialty, or the services or items being rendered), to furnish these items or services.

42 C.F.R. § 424.502 (definition of Operational).  In order “[t]o be ‘operational’ in accordance with the definition in section 424.502, a provider [or supplier], among other things, must have a ‘qualified physical practice location’ that is ‘open to the public for the purpose of providing health care related services.’”  Viora Home Health, Inc., DAB No. 2690 at 7 (2016).  A provider’s or supplier’s qualified physical practice location is the provider’s or supplier’s address that is on file with CMS at the time of a site visit.  Foot Specialists of Northridge, DAB No. 2773 at 8-10 (2017).  CMS has explained, “the primary purpose of an unannounced and unscheduled site visit is to ensure that a provider or supplier is operational at the practice location found on the Medicare enrollment application.”  76 Fed. Reg. 5862, 5870 (Feb. 2, 2011) (emphasis added).

In the present case, Petitioner admits that the 1834A Jaclif Court, Tallahassee, Florida 32308 address listed as its practice location on the Form CMS-855B is not its practice location.  Petitioner nonetheless argues that it “was at all relevant times ‘operational’” because it was a working patient mobile, home-based health service.  P. Br.

The CMS-855B enrollment form requires suppliers disclose each practice location where the supplier renders services to Medicare beneficiaries.  The form permits a provider or supplier to provide a home address if the provider or supplier only renders services in patients’ homes.  Specifically, in Section 4, the form instructs, among other things:

Complete this section for each of your practice locations where you render services to Medicare beneficiaries.

Each practice location must be a specific street address as recorded by the United States Postal Service.

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If you only render services in patients’ homes (house calls), you may supply your home address in this section if you do not have an office.  In Section 4D3, explain that this address is for administrative purposes only and that all services are rendered in patient’s homes.

Centers for Medicare & Medicaid Servs., U.S. Dep’t of Health & Hum. Servs., Medicare Enrollment Application: Clinics/Group Practices and Certain Other Suppliers, Form CMS-855B, https://www.cms.gov/medicare/cms-forms/cms-forms/downloads/cms855b.pdf.  Further down in Subsection D, the enrollment form directs the applicant to “[l]ist the city/town, State, and ZIP code for all locations where health care services are rendered in patients’ homes.”  Id.

The application is clear that the practice locations that must be disclosed are ones where Petitioner actually renders services to Medicare beneficiaries.  It is also explicit that if Petitioner only renders services in patient’s homes, it was to supply a home address or administrative office location along with an explanation and list the city/town, state, and zip code of each location where it rendered services in patient’s homes.  Centers for Medicare & Medicaid Servs., U.S. Dep’t of Health & Hum. Servs., Medicare Enrollment Application: Clinics/Group Practices and Certain Other Suppliers, Form CMS-855B, https://www.cms.gov/medicare/cms-forms/cms-forms/downloads/cms855b.pdf.  However, Petitioner admits that it used to or sometimes did provide services at the 1834A Jaclif Court, Tallahassee, Florida 32308 address and then transitioned to a more mobile centered business.  CMS Exs. 2-3; Hr’g. Req.

There is no dispute that 1834A Jaclif Court, Tallahassee, Florida 32308 was listed on Petitioner’s application as its primary practice location.  There is also no dispute that the location was not open and operational when the inspectors visited.

Petitioner’s assertion that it was operational because it was providing mobile services is not material to the outcome of this case because it was not operational at the practice location on file with the Medicare administrative contractor.  The Departmental Appeals Board (DAB) “has rejected the argument that a physician supplier is operational for purposes of the regulation if, at the time of an on-site review, the supplier is operational at a location other than its practice location on record with the Medicare contractor.”  OC Housecalls, Inc., DAB No. 2893 at 3 (2018) (citing Jason R. Bailey, M.D., P.A., DAB No. 2855 at 9 (2018)).  Just because Petitioner had other practice locations does not mean it did not violate the Medicare requirements.  I conclude that CMS had a legitimate basis to revoke Petitioner’s Medicare enrollment and billing privileges because Petitioner was not operational at the 1834A Jaclif Court address listed as its practice location.

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Additionally, the Board has interpreted the regulations as establishing that a supplier can be operational only at a practice location on file with CMS. OC Housecalls, DAB No. 2893 at 10.  According to the Board, “a Medicare provider or supplier must be operational at its practice location of record upon onsite review, even where the supplier is mobile,” and “[i]t is no defense that a provider or supplier may be operating elsewhere other than at their qualified physical practice location at the time of onsite review . . . .”  Id.  Petitioner attempts to distinguish between its situation and OC Housecalls.  However, that case is on point.  Petitioner provided a business location on its enrollment application and it was not operational at that address, because it argues that it was providing mobile services.  However, as OC Housecalls explains, a provider or supplier must be operational at the address on its enrollment application, even if it is mobile.

I have no authority to review the exercise of discretion by CMS to revoke where there is a basis for revocation.  Dinesh Patel, M.D., DAB No. 2551 at 10 (2013); Fady Fayad, M.D., DAB No. 2266 at 16 (2009) (if CMS establishes the regulatory elements necessary for revocation, an administrative law judge may not substitute his or her “discretion for that of CMS in determining whether revocation is appropriate under all the circumstances.”), aff’d, 803 F. Supp. 2d 699 (E.D. Mich. 2011); Abdul Razzaque Ahmed, M.D., DAB No. 2261 at 16-17, 19 (2009), aff’d, 710 F. Supp. 2d 167 (D. Mass. 2010).

3. I do not need to decide whether Petitioner timely reported a change of practice location under 42 C.F.R. § 424.535(a)(9).

The regulations require that a physician report, within 30 days, a change in his or her practice location.  42 C.F.R. § 424.516(d)(1)(iii).  Failure to timely report is a basis to revoke a physician’s Medicare enrollment and billing privileges.  42 C.F.R. § 424.535(a)(9).  CMS argues that Petitioner failed to timely provide notice of its change in practice location.  CMS Br. at 5-6.  For its part, Petitioner asserts that because its place of employment and correspondence address did not change, there was no new information to report.  P. Br. at 11.

Because I have concluded that Petitioner was not operational, I do not need to decide whether Petitioner also violated 42 C.F.R. § 424.535(a)(9).  If CMS revokes a provider’s or supplier’s billing privileges, the effective date of the revocation is usually 30 days after the date on the notice of revocation.  However, if CMS revokes a provider’s or supplier’s billing privileges because it is not operational, then the effective date of revocation is the date CMS determined that the provider or supplier was not operational.  42 C.F.R. § 424.535(g).  CMS imposed a retroactive effective date of revocation in this case.  CMS Ex. 4 at 1.  Therefore, it was only necessary for me to decide whether to uphold the non-operational finding to affirm CMS’s determination to retroactively revoke Petitioner’s Medicare enrollment and billing privileges.  See also Five Star Healthcare, LLC, DAB No. 3089 at 15 (2023).

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VI.  Conclusion

I affirm CMS’s revocation of Petitioner’s Medicare enrollment and billing privileges effective October 2, 2025.