Universal Key Solutions, DAB CR6755 (2025)

DECISION

The Medicare enrollment application of Petitioner, Universal Key Solutions, is denied pursuant to 42 C.F.R. § 424.530(a)(1).1

I. Procedural History and Undisputed Facts

The material facts are undisputed.  Any reasonable inferences are drawn in favor of Petitioner.

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On November 5, 2024, Novitas Solutions DME, a durable medical equipment Medicare administrative contractor (MAC), received an application from Tyrone DeVore, Petitioner’s owner and operations manager, to enroll Petitioner for the first time in Medicare as a supplier of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS).  Centers for Medicare and Medicaid Services (CMS) Exhibit (Ex.) 1 at 53-61.  The application listed Petitioner’s physical address as 1086 Cameron Road, Baltimore, Maryland (1086 Cameron Road).  CMS Ex. 1 at 54.

The MAC notified Petitioner by letter dated March 4, 2025, that an unannounced site visit of Petitioner’s business location was required as part of the enrollment process.  CMS Ex. 1 at 51-52.

A site visit was conducted on March 6, 2025.  CMS Ex. 1 at 35-50.  The inspector noted that 1086 Cameron Road is a private residence.  Petitioner’s owner was not present.  Petitioner operates through e-commerce and no inventory was at the site.  CMS Ex. 1 at 19, 47.  The inspector noted that Petitioner was a home-based business; Medicare beneficiaries do not normally visit; Petitioner was not open to visitors; and hours of operation were posted.  CMS Ex. 1 at 36.  A second site visit was conducted on March 11, 2025.  CMS Ex. 1 at 13-34.  Findings of the second visit were consistent with those of the first visit, but during this visit, the owner was present.  CMS Ex. 1 at 19.

The MAC notified Petitioner by letter dated April 17, 2025, that its application to enroll in Medicare was denied.  The MAC cited 42 C.F.R. § 424.530(a)(1) as the basis for the denial of enrollment and stated that Petitioner was not in compliance with Medicare requirements.  The MAC stated that Petitioner’s facility did not meet the following Supplier Standards established by 42 C.F.R. § 424.57(c):  Petitioner was not accessible to the disabled as required by 42 C.F.R. § 424.57(c)(1)(i); Petitioner did not have permanent signage listing the business name as required by 42 C.F.R. § 424.57(c)(7)(i)(D); and Petitioner did not provide its contact information to beneficiaries when DMEPOS was delivered as required by 42 C.F.R. § 424.57(c)(12).  The MAC advised Petitioner that for a denial of enrollment under 42 C.F.R. § 424.530(a)(1), Petitioner could submit within 35 days a corrective action plan (CAP) to show it corrected the deficiencies in Medicare compliance.  The MAC informed Petitioner that a denial of a CAP could not be appealed.  The MAC informed Petitioner it could also request a reconsidered determination within 65 days.  CMS Ex. 1 at 10-12.

Petitioner requested a reconsidered determination by letter dated April 21, 2025.  Petitioner explained that its business is conducted online with fulfillment of DMEPOS orders through a partnership with suppliers, such as McKesson and Henry Schein.  Therefore, customers do not visit Petitioner’s physical location at 1086 Cameron Road and the accessibility requirement for disabled individuals established by 42 C.F.R. § 424.57(c)(1)(i) should not be applicable.  Petitioner did not specifically address the other Supplier Standards listed in the MAC’s initial determination, that is, Petitioner did

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not have permanent signage listing the business name as required by 42 C.F.R. § 424.57(c)(7)(i)(D) (Supplier Standard 7); and Petitioner did not provide its contact information to beneficiaries when DMEPOS was delivered as required by 42 C.F.R. § 424.57(c)(12) (Supplier Standard 12).  CMS Ex. 1 at 8-9.

On May 28, 2025, a reconsidered determination was issued by Chags Health Information Technology, LLC (C-HIT).  C-HIT upheld the denial of Petitioner’s Medicare enrollment pursuant to 42 C.F.R. § 424.530(a)(1).  CMS Ex. 1 at 1-6.  C-HIT concluded that the requirement of 42 C.F.R. § 424.57(c)(1)(i) requiring access for disabled individuals does not apply to Petitioner and “overturned” denial of enrollment on that basis.  However, C-HIT concluded Petitioner failed to address its noncompliance with 42 C.F.R. § 424.57(c)(7)(i)(D) and (c)(12) and upheld denial for noncompliance with those requirements.  C-HIT noted that the site visits determined that Petitioner did not have permanent signage listing the business name and Petitioner did not ensure that beneficiaries were provided Petitioner’s contact information when DMEPOS was delivered.  CMS Ex. 1 at 3, 13, 17, 36, 45.  The reconsidered determination does not indicate that Petitioner submitted a CAP, and if so, its disposition.

On June 5, 2025, Petitioner requested a hearing (RFH) before an administrative law judge (ALJ).  The case was assigned to me for hearing and decision on June 9, 2025, and my Standing Order was issued.  On June 9, 2025, Petitioner filed a brief (P. Br.) and Petitioner’s exhibits (P. Exs.) 1 through 9, an exhibit list, and other documents.  On July 9, 2025, CMS filed a motion for summary judgment (CMS Br.) with CMS Ex. 1.  Petitioner filed a response on July 9, 2025 (P. Reply).  CMS declined to file a further reply on July 16, 2025.

CMS Ex. 1 is admitted as evidence.  P. Ex. 1 is a copy of the MAC’s initial determination.  P. Ex. 2 is a copy of the reconsidered determination.  Both documents are also included in CMS Ex. 1.  Both are admitted as evidence even though they are cumulative evidence.  P. Ex. 8 is a copy of Petitioner’s non-expiring license issued by the Maryland Department of Health Office of Health Care Quality effective October 22, 2024.  P. Ex. 9 is a copy of an email from McKesson to Petitioner’s owner dated September 24, 2024, showing that Petitioner had an account with McKesson.  There are no issues regarding Petitioner’s licensure in Maryland or its relationship with McKesson.  Relevant evidence is evidence that has any tendency to make a fact of consequence in determining a case more or less probable than it would be without the evidence.  Fed. R. Evid. 401.  Therefore, P. Exs. 8 and 9 are not admitted as evidence as neither document is relevant to the issues before me.  P. Exs. 3 through 7 are copies of the documents submitted by Petitioner as its CAP.  CMS or MAC action or failure to act upon a CAP is not subject to my review.  42 C.F.R. §§ 424.545, 498.3(b), 498.5; Marcia M. Snodgrass, APRN, DAB No. 2646 at 18-19 (2015).  Accordingly, P. Exs. 3 through 7 are not relevant and not admitted as evidence.  However, the following facts that are accepted as true for purposes of summary judgement are gleaned from P. Exs. 3 through 7.

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The following additional facts are accepted as true for purposes of summary judgment:

On May 21, 2025, seven days before the reconsidered determination was issued, Petitioner submitted a CAP to the MAC.  Departmental Appeals Board Electronic Filing System (DAB E-File) #1d-f; P. Exs. 3-7.

There is no evidence before me that the MAC, C-HIT, or CMS took any action on Petitioner’s CAP.

On May 12, 2025, Petitioner entered a lease for a new office space at 22 W. Pennsylvania Avenue, Towson, Maryland.  The lease began June 1, 2025.  P. Exs. 3, 7.  Petitioner’s lease beginning June 1, 2025, was not in effect at the time of the reconsidered determination issued on May 28, 2025.

Petitioner had new signage at its new office location on its office door (including hours of operation) and the building main directory.  P. Ex. 5.

Petitioner’s new office location is accessible to those with accessibility challenges such as the use of wheelchairs or walkers, including an elevator.  P. Ex. 4.

As part of its CAP, Petitioner devised a procedure to ensure Medicare beneficiaries were notified of Petitioner’s contact information upon delivery of DMEPOS.  P. Ex. 6.

II. Discussion

A. Applicable Law

Section 1831 of the Social Security Act (Act) (42 U.S.C. § 1395j) establishes the supplementary medical insurance benefits program for the aged and disabled known as Medicare Part B.  Administration of the Part B program is through the MACs.  Act § 1842(a) (42 U.S.C. § 1395u(a)).  Payment under the program for services rendered to Medicare-eligible beneficiaries may only be made to eligible providers of services and suppliers.2  Act §§ 1835(a) (42 U.S.C. § 1395n(a)), 1842(h)(1) (42 U.S.C. § 1395u(h)(1)).

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Petitioner filed an application to initially enroll in Medicare as a DMEPOS supplier.  CMS Ex. 1 at 53-61.

The Act requires the Secretary of Health and Human Services (Secretary) to issue regulations that establish a process for the enrollment in Medicare of providers and suppliers, including the right to a hearing and judicial review of certain enrollment determinations, such as denial of enrollment and revocation of enrollment and billing privileges.  Act § 1866(j) (42 U.S.C. § 1395cc(j)).

Pursuant to 42 C.F.R. § 424.505, a provider or supplier must be enrolled in the Medicare program and be issued a billing number to have billing privileges and to be eligible to receive payment for services rendered to a Medicare-eligible beneficiary.  Pursuant to 42 C.F.R. §§ 424.57(b) and 424.505, a DMEPOS supplier such as Petitioner must be enrolled in the Medicare program to be reimbursed for DMEPOS sold or rented to Medicare beneficiaries.  The regulations establish detailed requirements that suppliers must meet and maintain to enroll in Medicare and to receive and maintain Medicare billing privileges.  42 C.F.R. pt. 424, subpt. P.  DMEPOS suppliers have additional requirements imposed by 42 C.F.R. § 424.57(b) and (c).  To receive direct-billing privileges, a DMEPOS supplier must meet and maintain the Medicare application certification standards set forth in 42 C.F.R. § 424.57(c), the Supplier Standards.

The Secretary has delegated the authority to accept or deny enrollment applications to CMS.  Pursuant to the Secretary’s regulations, CMS may deny a provider’s or supplier’s enrollment application for any of the reasons set out in 42 C.F.R. § 424.530(a).  In this case, CMS has denied Petitioner’s application under 42 C.F.R. § 424.530(a)(1) because CMS determined that Petitioner did not meet the requirements to enroll in Medicare as a supplier of DMEPOS.  The MAC concluded that Petitioner did not meet three Supplier Standards in its April 17, 2025 initial determination – 42 C.F.R. § 424.57(c)(1)(i), (c)(7)(i)(D), and (c)(12).  CMS Ex. 1 at 10.  The reconsidered determination concluded that Petitioner did not satisfy only two applicable Supplier Standards – 42 C.F.R. § 424.57(c)(7)(i)(D) and (c)(12).  CMS Ex. 1 at 3.  The reconsidered determination is the determination subject to my review.  Neb Grp. of Ariz. LLC, DAB No. 2573 at 7.

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A prospective supplier whose enrollment application has been denied may request reconsideration and review as provided by 42 C.F.R. pt. 498.  42 C.F.R. § 424.545(a).  A prospective supplier submits a written request for reconsideration to CMS or its contractor.  42 C.F.R. § 498.22(a), (b).  CMS or its contractor must give notice of its reconsidered determination to the prospective supplier, giving the reasons for its determination, specifying the conditions or requirements the prospective supplier failed to meet, and advising of the right to an ALJ hearing.  42 C.F.R. § 498.25.  If the decision on reconsideration is unfavorable to the prospective supplier, the prospective supplier has the right to request a hearing by an ALJ and further review by the Board.  Act § 1866(j)(8) (42 U.S.C. § 1395cc(j)(8)); 42 C.F.R. §§ 424.545, 498.3(b)(17), 498.5.  A hearing on the record, also known as an oral hearing, is required under the Act.  Crestview Parke Care Ctr. v. Thompson, 373 F.3d 743, 748-51 (6th Cir. 2004).  The prospective supplier bears the burden to demonstrate that the supplier meets enrollment requirements with documents and records.  42 C.F.R. § 424.545(c).

B. Issue

Whether there was a basis for the denial of Petitioner’s application to enroll in the Medicare program.

C. Findings of Fact, Conclusions of Law, and Analysis

My conclusions of law are set forth in bold text followed by my findings of undisputed fact and analysis.

1. Summary judgment is appropriate.

A supplier, such as Petitioner, denied enrollment in Medicare and billing privileges, has a right to a hearing and judicial review.  A hearing on the record before an ALJ is required under the Act.  Act §§ 205(b), 1866(h)(1), (j); 42 C.F.R. §§ 498.3(b)(17), 498.5(l); Crestview, 373 F.3d at 748-51.  A party may waive appearance at an oral hearing but must do so affirmatively in writing.  42 C.F.R. § 498.66.  Petitioner has not waived an oral hearing.

CMS filed a motion for summary judgment.  I read Petitioner’s pleadings as opposing summary judgment for CMS.  Summary judgment is not automatic but is limited to certain specific conditions.  The procedures applicable to the adjudication of this case are at 42 C.F.R. pt. 498.  The regulations do not establish or recognize a summary judgment procedure.  However, the Board has long accepted that summary judgment is an acceptable procedural device in cases adjudicated pursuant to 42 C.F.R. pt. 498.  See, e.g., Ill. Knights Templar Home, DAB No. 2274 at 3-4 (2009); Garden City Med. Clinic, DAB No. 1763 (2001); Everett Rehab. & Med. Ctr., DAB No. 1628 at 3 (1997).  The Board has also recognized that the Federal Rules of Civil Procedure do not apply in

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administrative adjudications such as this, but the Board has accepted that Fed. R. Civ. P. 56 and related cases provide useful guidance for determining whether summary judgment is appropriate.  Furthermore, a summary judgment procedure was adopted as a matter of judicial economy within my authority to regulate the course of proceedings and made available to the parties in the litigation of this case by my Standing Order.  The parties were given notice by the Standing Order that summary judgment is an available procedural device and that the law as it has developed related to Fed. R. Civ. P. 56 will be applied.  Standing Order ¶¶ II.D. & G.

Summary judgment is appropriate when there is no genuine dispute as to any issue of material fact for adjudication and/or the moving party is entitled to judgment as a matter of law.  In determining whether there are genuine issues of material fact for trial, the reviewer must view the evidence in the light most favorable to the non-moving party, drawing all reasonable inferences in that party’s favor.  The party requesting summary judgment bears the burden of showing that there are no genuine issues of material fact for trial and/or that it is entitled to judgment as a matter of law.  Generally, the non-movant may not defeat an adequately supported summary judgment motion by relying upon the denials in its pleadings or briefs but must furnish evidence of a dispute concerning a material fact, i.e., a fact that would affect the outcome of the case if proven.  Mission Hosp. Reg’l Med. Ctr., DAB No. 2459 at 5 (2012) (and cases cited therein); Experts Are Us, Inc., DAB No. 2452 at 5 (2012) (and cases cited therein); Senior Rehab. & Skilled Nursing Ctr., DAB No. 2300 at 3 (2010) (and cases cited therein); see also Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986).

The standard for deciding a case on summary judgment and an ALJ’s decision-making in deciding a summary judgment motion differs from that used in resolving a case after a hearing or a waiver of oral hearing.  On summary judgment, the ALJ does not make credibility determinations, weigh the evidence, or decide which inferences to draw from the evidence, as would be done when finding facts after a hearing or on the documentary record.  Rather, on summary judgment, the ALJ construes the evidence in a light most favorable to the non-movant and avoids deciding which version of the facts is more likely true.  Holy Cross Vill. at Notre Dame, Inc., DAB No. 2291 at 5 (2009).  The Board also has recognized that on summary judgment it is appropriate for the ALJ to consider whether a rational trier of fact could find that the party’s evidence would be sufficient to meet that party’s evidentiary burden.  Dumas Nursing & Rehab., L.P., DAB No. 2347 at 5 (2010).  The Secretary has not provided in 42 C.F.R. pt. 498 for the allocation of the burden of persuasion or the quantum of evidence required to satisfy the burden.  However, the Board has provided some persuasive analysis regarding the allocation of the burden of persuasion in cases subject to 42 C.F.R. pt. 498.  Batavia Nursing & Convalescent Ctr., DAB No. 1904 (2004), aff’d, Batavia Nursing & Convalescent Ctr. v. Thompson, 129 F. App’x 181 (6th Cir. 2005).

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In this case, viewing the evidence before me in a light most favorable to Petitioner and drawing all inference in its favor, I conclude that there are no genuine disputes as to any material fact pertinent to denial of enrollment under 42 C.F.R. § 424.530(a)(1) that requires a trial.  Petitioner did not dispute in its request for a reconsidered determination that it was in violation of Supplier Standard 7 (42 C.F.R. § 424.57(c)(7)(i)(D)) because it did not have a permanent sign.  Therefore, the reconsidered determination upheld denial pursuant to 42 C.F.R. § 424.530(a)(1) because Petitioner did not dispute the violation of Supplier Standard 7.  Whether there was a basis for denial of enrollment at the time of the reconsidered determination must be resolved against Petitioner as a matter of law.  The issues Petitioner raises before me regarding its CAP are without merit in this forum as CMS or MAC action on a CAP is not subject to my review under 42 C.F.R. §§ 424.545, 498.3(b), or 498.5.  Marcia M. Snodgrass, APRN, DAB No. 2646 at 18-19.  The undisputed material facts establish a basis for the denial of Petitioner’s enrollment in Medicare under 42 C.F.R. § 424.530(a)(1) as a matter of law.  Accordingly, I conclude that summary judgment is appropriate.

2. Petitioner did not dispute in its request for a reconsidered determination that it was not in compliance with 42 C.F.R. § 424.57(c)(7)(i)(D) (Supplier Standard 7).

3. There is a basis for denial of Petitioner’s enrollment in Medicare pursuant to 42 C.F.R. § 424.530(a)(1) because Petitioner did not meet the requirements of 42 C.F.R. § 424.57(c)(7)(i)(D) (Supplier Standard 7) at the time of the reconsidered determination.

4. There is no right to review of MAC or CMS action or inaction on Petitioner’s CAP.

5. No equitable relief is available in this forum.

In its April 17, 2025 initial determination, the MAC found that Petitioner did not meet three Supplier Standards:  Petitioner was not accessible to the disabled as required by 42 C.F.R. § 424.57(c)(1)(i); Petitioner did not have permanent signage listing its business name as required by 42 C.F.R. § 424.57(c)(7)(i)(D); and Petitioner did not provide its contact information to beneficiaries when DMEPOS was delivered as required by 42 C.F.R. § 424.57(c)(12).  CMS Ex. 1 at 10-12.  In its May 28, 2025 reconsidered determination, C-HIT concluded that the requirement of 42 C.F.R. § 424.57(c)(1)(i) (Supplier Standard 1) related to access for disabled individuals did not apply to Petitioner and “overturned” denial of enrollment on that basis.  But C-HIT found that the site visits determined that Petitioner did not have permanent signage listing the business name and Petitioner did not ensure that beneficiaries were provided Petitioner’s contact information when DMEPOS was delivered.  CMS Ex. 1 at 3, 13, 17, 36, 45.  C-HIT concluded Petitioner failed to address in its request for reconsideration its alleged noncompliance

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with 42 C.F.R. § 424.57(c)(7)(i)(D) (Supplier Standard 7) and (c)(12) (Supplier Standard 12).  Therefore, C-HIT upheld denial of enrollment pursuant to 42 C.F.R. § 424.530(a)(1), based on Petitioner undisputed noncompliance with Supplier Standards 7 and 12.

There is no dispute that in its April 21, 2025 request for a reconsidered determination Petitioner requested a reconsidered determination that 42 C.F.R. § 424.57(c)(1)(i) was not applicable to it because no Medicare beneficiaries visited its office as Petitioner was a web-based DMEPOS supplier.  But Petitioner did not specifically challenge the denial of enrollment based on the findings that Petitioner did not have permanent signage listing the business name as required by 42 C.F.R. § 424.57(c)(7)(i)(D); and Petitioner did not provide its contact information to beneficiaries when DMEPOS was delivered as required by 42 C.F.R. § 424.57(c)(12).  CMS Ex. 1 at 8-9; P. Br.; RFH; P. Reply.

I conclude that Supplier Standard 12 was not violated based on C-HIT’s findings in the reconsidered determination.  Pursuant to 42 C.F.R. § 424.57(c)(12), the DMEPOS supplier:

Must be responsible for the delivery of Medicare covered items to beneficiaries and maintain proof of delivery.  (The supplier must document that it or another qualified party has at an appropriate time, provided beneficiaries with necessary information and instructions on how to use Medicare-covered items safely and effectively).

The reconsidered determination states that the site inspector’s report indicates Petitioner did not furnish contact information to beneficiaries at the time of delivery of DMEPOS.  The reconsidered determination upheld the initial determination that Petitioner was noncompliant with Supplier Standard 12 (42 C.F.R. § 424.57(c)(12)) based on the finding that Petitioner failed to provide its contact information on delivery.  CMS Ex. 1 at 3.  However, providing contact information is not the requirement established by Supplier Standard 12.  Supplier Standard 12 requires that a DMEPOS supplier is: (1) responsible for delivery of DMEPOS supplies; (2) the DMEPOS supplier must maintain evidence of or proof that the DMEPOS supplies were delivered; and (3) the DMEPOS supplier must maintain evidence that it provided beneficiaries with information and instructions for how to safely and effectively use Medicare covered DMEPOS supplies that were delivered.  Supplier Standard 12 is far more substantive than simply requiring that a DMEPOS supplier provide its contact information on delivery of DMEPOS.  The site investigator’s report does not include findings that Petitioner failed to be responsible for delivery, or to maintain proof of delivery.  CMS Ex. 1 at 13-50.  The site inspector’s report does state that Petitioner’s records included proof that beneficiaries were provided written information/instructions for safe and effective use of DMEPOS supplies that Petitioner delivered or caused to be delivered.  CMS Ex. 1 at 40.  I conclude that C-HIT

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committed an error of law when concluding that Petitioner violated Supplier Standard 12 by not having evidence it provided contact information on delivery of DMEPOS supplies.  I further conclude that denial of enrollment under 42 C.F.R. § 424.530(a)(1) may not be upheld based on violation of Supplier Standard 12.

I conclude that only Supplier Standard 7 is at issue before me, that is, whether Petitioner had a permanent visible sign as required by 42 C.F.R. § 424.57(c)(7)(i)(D) (Supplier Standard 7).  Only the reconsidered determination is subject to my review.  Neb Grp. of Ariz. LLC, DAB No. 2573 at 7.  Therefore, resolution of the issue turns on whether the evidence considered on reconsideration showed that Petitioner had a permanent visible sign.

Supplier Standard 7 requires that a DMEPOS supplier maintain a physical facility that meets listed requirements, including:

Maintains a permanent visible sign in plain view and posts hours of operation.  If the supplier’s place of business is located within a building complex, the sign must be visible at the main entrance of the building or the hours can be posted at the entrance of the supplier.

42 C.F.R. § 424.57(c)(7)(i)(D).  The CMS, MAC, and C-HIT interpretation of the regulation seems to be that a DMEPOS supplier’s name must be on the permanent sign and Petitioner has not argued the contrary.  No exception to the sign requirement is provided in the regulation for a web-based DMEPOS supplier such as Petitioner to ensure that CMS or the MAC can identify the business property for inspections.  75 Fed. Reg. 52,629, 52,635-636 (Aug. 27, 2010).

Petitioner did not challenge in its request for reconsideration the initial determination that it was noncompliant with Supplier Standard 7.  Petitioner did not present evidence in requesting a reconsidered determination that it had the required sign.  CMS Ex. 1 at 3, 8-9; RFH.  Petitioner offered evidence that it had the required sign when it submitted its CAP, even though the CAP was filed on May 21, 2025, several days before the effective date of Petitioner’s lease for its new office.  P. Ex. 5.  But Petitioner does not dispute that the content of P. Ex. 5 was not presented as part of the request for reconsideration (P. Br.; P. Reply; RFH).  Because the content of P. Ex. 5 was not present as part of Petitioner’s request for reconsideration, it is not subject to my consideration in reviewing the reconsidered determination.  Neb Grp. of Ariz. LLC, DAB No. 2573 at 7.  Further, pursuant to 42 C.F.R. § 498.56(e), I must consider whether Petitioner had good cause for offering evidence from its CAP to me and not the official who rendered the reconsidered determination.  Petitioner does not allege it had good cause for not presenting evidence from its CAP as part of its request for reconsideration.  Further, I have accepted as true for purposes of summary judgment Petitioner’s evidence that on May 12, 2025, Petitioner

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entered a lease for a new office space at 22 W. Pennsylvania Avenue, Towson, Maryland.  But Petitioner’s evidence shows that the lease did not begin until June 1, 2025.  P. Exs. 3, 7.  Because Petitioner’s lease began June 1, 2025, it was not in effect at the time of the reconsidered determination issued on May 28, 2025.  Petitioner’s evidence shows that the permanent sign was for the new leased space and not the office subject to the site inspections.  P. Ex. 5; CMS Ex. 1 at 13-50.  I do not have evidence from which I can draw a favorable inference for Petitioner that it had the required sign at the office where it operated at the time of the reconsidered determination or before.3

Even a violation of a single Supplier Standard is an adequate basis for revocation of billing privileges and enrollment.  1866ICPayday.com, L.L.C., DAB No. 2289 at 13 (2009).  I conclude that there was a basis for denial of Petitioner’s enrollment in Medicare pursuant to 42 C.F.R. § 424.530(a)(1) for noncompliance with 42 C.F.R. § 424.57(c)(7)(i)(D) (Supplier Standard 7).

Petitioner argues that its CAP was not considered when the reconsidered determination was made and that was an error because its CAP shows Petitioner achieved compliance with the three Supplier Standards cited in the initial determination.  The reconsidered determination does not mention Petitioner’s CAP and the record considered on reconsideration presented by CMS does not include the evidence Petitioner submitted to me related to its CAP.  CMS Ex. 1; P. Exs. 3-7.  Under 42 C.F.R. § 424.530(a)(1), CMS or the MAC may deny a provider’s or supplier’s Medicare enrollment application based on noncompliance with enrollment requirements if the provider or supplier has not submitted a plan of corrective action.  As previously noted, CMS or MAC action or failure to act upon a CAP is not subject to my review.  42 C.F.R. §§ 424.545, 498.3(b), 498.5; Marcia M. Snodgrass, APRN, DAB No. 2646 at 18-19.  In this case, it is undisputed that Petitioner submitted its CAP on May 21, 2025, before the reconsidered determination on May 28, 2025.  P. Br.; P. Reply; RFH; P. Ex. 3; CMS Ex. 1 at 1.  The initial denial instructed that the CAP and a reconsidered request be submitted to the same address.  CMS Ex. 1 at 11-12.  I do not infer, based on the fact that Petitioner’s CAP is not mentioned in the reconsidered determination, that the C-HIT or the MAC considered and rejected the CAP.  The evidence shows that Petitioner was advised by the initial determination that it could submit a CAP and Petitioner did so.  There is no evidence that the MAC or C-HIT took any favorable action based on the CAP.  And I conclude that no inquiry as to any action or inaction of the MAC, C-HIT, or CMS related to Petitioner’s CAP is necessary or appropriate given my lack of authority to review such action.  My review is limited to the record of the reconsidered determination.

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I have concluded that there is a basis for CMS to deny Petitioner Medicare enrollment and billing privileges pursuant to 42 C.F.R. § 424.530(a)(1).  I have no authority to review the exercise of discretion by CMS or its contractor to deny Petitioner enrollment where there is a basis for denial.  See Abdul Razzaque Ahmed, M.D., DAB No. 2261 at 19 (2009), aff’d, Ahmed v. Sebelius, 710 F. Supp. 2d 167 (D. Mass. 2010); Letantia Bussell, M.D., DAB No. 2196 at 12-13 (2008).  The scope of my authority is limited to determining whether there is a legal basis for denial of Petitioner’s Medicare enrollment and billing privileges.

Petitioner states in an April 22, 2025 email submitting its request for a reconsidered determination that a MAC representative advised Petitioner that its business model was eligible for Medicare enrollment.  Petitioner’s assertion, which is accepted as true for purposes of summary judgment, may be construed to be an argument that CMS and the MAC should be estopped from denying Petitioner’s Medicare enrollment application.  But estoppel against the federal government, if available at all, is presumably unavailable absent “affirmative misconduct,” such as fraud.  See, e.g., Pac. Islander Council of Leaders, DAB No. 2091 at 12 (2007); Off. of Pers. Mgmt. v. Richmond, 496 U.S. 414, 421 (1990).  There is no evidence suggesting fraud or other affirmative misconduct on the part of CMS, the MAC, or a staff member.

Petitioner’s arguments may be construed as requests for equitable relief.  But I have no authority to grant such relief.  US Ultrasound, DAB No. 2302 at 8 (2010).  I am bound to follow the Act and regulations, and I have no authority to declare statutes or regulations invalid or ultra vires.  1866ICPayday.com, L.L.C., DAB No. 2289 at 14.

III. Conclusion

For the foregoing reasons, I conclude that there was a basis to deny Petitioner’s application to enroll in Medicare pursuant to 42 C.F.R. § 424.530(a)(1).