Mary Olszewski and Associates, PC, DAB CR6650 (2025)

DECISION

Petitioner, Mary Olszewski and Associates, PC, is a supplier of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS), located in Palatine, Illinois, that participated in the Medicare program.  On April 24, 2023, the Centers for Medicare & Medicaid Services (CMS), through its Medicare administrative contractor, notified Petitioner of the revocation of its Medicare enrollment and billing privileges.  For the reasons explained below, I find that there was a legitimate basis for CMS to revoke Petitioner's Medicare enrollment and billing privileges because it was not in compliance with 42 C.F.R. § 424.57(c)(7)(i)(D).  I also affirm CMS's determination to impose upon Petitioner a one-year reenrollment bar.

I.  Background

On November 14, 2022, Petitioner sought to reactivate its Medicare enrollment following a period of deactivation.  CMS Ex. 1.  In its application, Petitioner provided the following hours of operation:  Monday – Friday, 10:00am – 7:00pm, Saturday, 9:00am – 5:00pm, and closed on Sunday.  Id. at 3.  In a letter dated December 1, 2022, the Medicare contractor, Novitas Solutions (Novitas), notified Petitioner that its application was

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received on November 14, 2022, and that an unannounced site visit would take place at Petitioner's place of business during the hours of operation provided in the application.  CMS Ex. 2 at 1.  The letter advised that Petitioner's "hours of operation posted on location must match the information in the Provider Enrollment Chain and Ownership System (PECOS)."  Id.

An inspection was conducted at Petitioner's place of business on January 17, 2023.  CMS Ex. 3.  In relevant part, the inspector observed that the hours of operation sign taped to the front door posted different hours of operation than that in Petitioner's Medicare reactivation application.  Compare CMS Ex. 3 at 1, 5, with CMS Ex. 1 at 3.  The inspector noted that the sign posted on the door indicated operating hours of Monday – Wednesday, 10:00am – 7:00pm, Thursday – Saturday, 9:00am – 5:00pm, and closed on Sunday.  CMS Ex. 3 at 1, 5.

On February 22, 2023, Novitas sent two letters to Petitioner.  CMS Exs. 4, 5.  The first letter advised Petitioner that its Medicare reactivation application had been approved with a Provider Transaction Access Number (PTAN) effective date of November 7, 2022.  CMS Ex. 4 at 1.  The second letter advised Petitioner that following an on-site visit to its location, it was still required to meet the DMEPOS supplier standards in 42 C.F.R. § 424.57, and that the hours of operation sign posted on the facility did not match the hours provided in its application.  CMS Ex. 5 at 1.  The letter informed Petitioner that it could update its hours of operation in PECOS or update the sign at its place of business.  Id. at 1-2.  The letter further stated that the "information is provided as education and to give notice that you must come into compliance and meet all supplier standards."  Id. at 2.

On March 29, 2023, another site inspection was conducted at Petitioner's place of business.  CMS Ex. 6.  During this inspection, the inspector noted that Petitioner's facility no longer posted any hours of operation.  See id. at 1.  Based on the inspector's findings, Novitas, in a letter dated April 24, 2023, advised Petitioner that it was revoking its Medicare enrollment based on its failure to comply with 42 C.F.R. § 424.57(c)(7)(i)(D).  CMS Ex. 7 at 1-2.  Novitas also imposed a one-year reenrollment bar upon Petitioner.  Id.

On May 30, 2023, Petitioner filed a request for reconsideration of its Medicare enrollment revocation.  CMS Ex. 8.  In support of its request, Petitioner submitted photographs, including two images of signs displaying its hours of operation at its place of business.  Id. at 7-8.  Notably, the posted hours of operation on these signs are Monday – Wednesday, 10:00am – 7:00pm, and Thursday – Saturday, 9:00am – 5:00pm.  Id.

On July 7, 2023, the Medicare Contractor Palmetto GBA (Palmetto) issued a reconsidered determination.  CMS Ex. 9.  Palmetto issued an unfavorable decision finding that there was no error in the revocation of Petitioner's Medicare billing

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privileges.  Id. at 2-3.  Palmetto noted that Petitioner failed to comply with the requirement of 42 C.F.R. § 424.57(c)(7), did not provide an explanation for its noncompliance, and that the submitted evidence continued to reveal different hours of operation from those provided within Petitioner's Medicare reactivation application.  Id.

On September 5, 2023, Petitioner timely requested a hearing to dispute the reconsidered determination.  Departmental Appeals Board (DAB) Electronic Filing System (E-File) Doc. No. 1.  As discussed further below, Petitioner also filed a number of documents with its hearing request.   DAB E-File Doc. No. 1b.  On September 12, 2023, Administrative Law Judge (ALJ) Tannisha D. Bell was designated to hear and decide this case.  DAB E-File Doc. No. 2.  That same day, the Civil Remedies Division (CRD) acknowledged the hearing request and issued ALJ Bell's Standing Pre-hearing Order (Standing Order).  DAB E-File Doc. No. 2a.  Among other things, the Standing Order instructed the parties to file prehearing exchanges by specified dates.  Id.

On September 21, 2023, Petitioner filed additional documents.  DAB E-File Doc. No. 5. On October 17, 2023, CMS filed a motion for summary judgement and prehearing brief (CMS Br.), along with nine proposed exhibits (CMS Exs. 1-9).1 DAB E-File Doc. Nos. 8-9.  On November 20, 2023, Petitioner timely filed a motion for summary response.  DAB E-File Doc. No. 10.

On November 1, 2024, this case was transferred to the undersigned for adjudication.  DAB E-File Doc. No. 11.

II.  Admission of Exhibits

Petitioner did not object to CMS Exhibits 1 through 9, which consist of documents from the proceedings below.  DAB E-File Doc. Nos. 8-9.  In the absence of objection, I admit CMS Exhibits 1 through 9 into the record.

In its filings of September 5, 2023, and September 21, 2023, Petitioner submitted documents, which I will mark collectively as Petitioner's Exhibit 1.  DAB E‑File Doc. Nos. 1b, 5.  These documents include an undated and unsigned timeline of events, a commercial lease agreement, photographs, e-mails between Petitioner and Novitas, and other documents from the proceedings below.  See id.

CMS objects to some of these documents to the extent Petitioner submitted them for the first time in the request for hearing.  CMS Br. at 8 n.2.  However, CMS does not specify which documents Petitioner submitted for the first time in these proceedings.  See id.

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I "must exclude 'new documentary evidence' – that is, documentary evidence that a provider did not previously submit to CMS at the reconsideration stage (or earlier) – unless [I] determine[] that 'the provider or supplier has good cause for submitting the evidence for the first time at the ALJ level.'"  Care Pro Home Health, Inc., DAB No. 2723 at 11 (2016) (citing 42 C.F.R. § 498.56(e)(1)).

To the extent these documents were submitted in the proceedings below, they are admitted.  However, to the extent Petitioner's exhibits also include additional new documentary evidence (e.g., DAB E-File Doc. Nos. 1b at 13, 26), I am required to exclude these documents from evidence pursuant to 42 C.F.R. § 498.56(e)(1)-(2).  Petitioner has not shown good cause for submitting new documents for the first time at the ALJ level.  Thus, I decline to admit any new documents into the record and will not consider them here.  The new documents are retained in the administrative record, but this new evidence is not admitted to the record for decision.

III.  Decision on the Written Record

Petitioner now appeals the reconsidered determination, and CMS has moved for summary judgment.  Although CMS has moved for summary judgment, I find that this matter may be decided on the written record, without considering whether the standards for summary judgment are satisfied.

In the Standing Order, the parties were instructed to list all proposed witnesses and to submit their written direct testimony.  Standing Order ¶ 10.  The Standing Order further advised that each party has the right to cross-examine any witness for whom the opposing party offers written direct testimony; however, the party must affirmatively indicate that it wishes to do so.  Id. ¶ 11.  The Standing Order also specified that a hearing would be necessary only if a party files admissible, written direct testimony, and, in compliance with the order, the opposing party asks to cross-examine.  Id. ¶ 12.

Neither party lists any witnesses.  Because there are no witnesses to be examined or cross-examined, an in-person hearing would serve no purpose.  This matter may therefore be decided based on the written record.

IV.  Jurisdiction

This tribunal has the authority to hear and decide this matter.  42 U.S.C. § 1395cc(j)(8); 42 C.F.R. §§ 424.545(a), 498.1(g), 498.3(b)(17), 498.5(l)(2).

V.  Issue

The issue to be decided is whether CMS had a legitimate basis to revoke Petitioner's Medicare enrollment and billing privileges.

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VI.  Discussion

1. There was a legitimate basis to revoke Petitioner's Medicare enrollment and billing privileges pursuant to 42 C.F.R. § 424.57(c)(7)(i)(D) (Supplier Standard 7).2

To receive Medicare payments for items furnished to a Medicare-eligible beneficiary, a supplier of medical equipment and supplies must be enrolled in the Medicare program and must have a supplier number issued by the Secretary of Health and Human Services.  Social Security Act § 1834(j)(1)(A); 42 C.F.R. § 424.505.  To keep that number, the supplier must be operational and must meet the standards set forth in 42 C.F.R. § 424.57(c).  CMS may revoke its billing privileges if it fails to do so.  42 C.F.R. §§ 424.57(c)(1), (e), 424.535(a)(1), (5).

Following enrollment into the Medicare program, the DMEPOS supplier must continue to remain in compliance with the standards set forth in 42 C.F.R. § 424.57(c).  Under section 424.57(c)(7) (commonly known as Supplier Standard 7), a DMEPOS supplier is required to maintain "a physical facility on an appropriate site."  An "appropriate site" must be "accessible and staffed during posted hours of operation."  Id. § 424.57(c)(7)(i)(C).  The supplier's place of business also must have posted hours of operation.  Id. § 424.57(c)(7)(i)(D).

In order to verify a supplier's compliance with the supplier standards and other Medicare requirements, CMS, through its contractors, performs on-site inspections.  42 C.F.R. §§ 424.57(c)(8), 424.517.  CMS is authorized to revoke a DMEPOS supplier's billing privileges for the failure to meet the supplier standards.  Id. § 424.57(e)(1).  The effective date of revocation for noncompliance with any of the section 424.57(c) standards is thirty (30) days after the supplier is sent notice of the revocation.  Id.

The facts in this case indicate that in its application for Medicare reactivation, Petitioner advised that its hours of operation were: Monday – Friday, 10:00am – 7:00pm, Saturday 9:00am – 5:00pm, and closed on Sunday.  CMS Ex. 1. at 3.  During an initial inspection of Petitioner's place of business on January 17, 2023, an inspector observed that the hours of operation sign affixed to Petitioner's place of business provided different hours of operation than those listed in Petitioner's Medicare reactivation application.  CMS Ex. 3 at 1, 5.  See CMS Ex.1 at 3.

While Novitas subsequently approved Petitioner's Medicare reactivation application on February 22, 2023, it also informed Petitioner of its obligations to meet the DMEPOS supplier standards and post hours of operation that matched those provided in the

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application.3 CMS Exs. 4, 5.  Specifically, Petitioner was sent an "education letter" which advised that it could either update its hours of operation in PECOS or update the sign posted outside the facility.  CMS Ex. 5 at 1-2.  Thereafter, a follow-up site inspection took place on March 29, 2023.  CMS Ex. 6.  At this inspection, Petitioner's place of business had no posted hours of operation.  See id. at 1.

The facts in this case clearly show that Petitioner violated 42 C.F.R. § 424.57(c)(7)(i)(D) (Supplier Standard 7).  This standard requires that a DMEPOS supplier "[m]aintains 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."  Id.  As Petitioner had no visible sign at its facility with posted hours of operation, it did not comply with 42 C.F.R. § 424.57(c)(7)(i)(D).

In its brief, Petitioner disputes that its hours of operation were not posted at its business location during the March 29, 2023 inspection.  See P. Br. at 3-4.  Petitioner claims that it had a "wooden sign" in operation at the time of the inspection.  Id.  In support of this assertion, Petitioner has submitted two different sets of photographs.  First, in its request for reconsideration, Petitioner submitted photographs showing two hours of operation signs posted near the front door and another taped to a window.  See CMS Ex. 8 at 7-8.  Significantly, these photos are undated and fail to establish that they were posted at the time of the inspection.  Moreover, these photos also show different hours of operation than those in the Medicare reactivation application.  See CMS Ex. 1 at 3.  Second, with its request for hearing, Petitioner, for the first time, includes photographs of hours of operation signs permanently affixed to its business.  See DAB E-File Doc. No. 1b at 13, 26.  As detailed above, however, this new evidence is not admitted into the record.  In any event, there is nothing in these images to suggest that they were taken prior to the inspection.  I further note that the inspector's photographs of the same exact locations of the building do not show any evidence that these permanent signs were affixed to Petitioner's place of business at the time of the inspection.  See CMS Ex. 6 at 3-8.

Petitioner also contends that it was not out of compliance with Supplier Standard 7, because as a physician it was exempt from this requirement.  P. Br. at 4-5.  However, the Board has determined that, "[n]othing in the text of Supplier Standard 7 provides for an exception to the requirement that suppliers must post their hours of operation . . . .

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Nor would such an exception be consistent with the purpose of the requirement."  Marcus Singel, D.P.M., DAB No. 2609 at 6 (2014).  As the Board has further stated, the rationale behind requiring suppliers to post their hours of operation is "to facilitate both on-site inspections and transactions with beneficiaries in need of items or services."  Id. (quoting Ita Udeobong, DAB No. 2324 at 7 (2010)).

Moreover, even as a supplier of prosthetics or orthotics, Petitioner would only be relieved of the requirement of 42 C.F.R. § 424.57(c)(7)(i)(A)(1), which is the requirement to have a facility of 200 square feet.  Contrary to Petitioner's argument, there is no exception for the requirements to have a location accessible to the public and CMS or its agents; staffed and accessible during posted hours of operation; with signage identifying the location as Petitioner's and posted hours of operation; and with space for retaining required records.  42 C.F.R. § 424.57(c)(7)(i)(B)-(F).  Petitioner seems to be conflating the exception provided in Supplier Standard 30, which is not applicable here.  See P. Br. at 4-5.  That exception provides that a physician who furnishes "items to his or her own patient(s) as part of his or her professional services" is exempt from the requirement of being open to the public for a minimum of 30 hours per week.  42 C.F.R. § 424.57(c)(30)(ii)(A).  However, this exception only applies to the requirement of being open to the public for a minimum of 30 hours per week.  The exception does not apply here where Petitioner's hours indicate that it was open for more than 30 hours per week and the sole basis for revocation was the failure to post hours of operation pursuant to 42 C.F.R. § 424.57(c)(7)(i)(D).

Thus, given that Petitioner failed to post its facility's hours of operation, Petitioner was not in compliance with Supplier Standard 7, and CMS justifiably revoked its billing privileges under section 424.57(e).  Ortho Rehab Designs Prosthetics and Orthotics, Inc., DAB No. 2591 at 6 (2014).  The failure to comply with even one supplier standard is a sufficient basis for revoking a supplier's billing privileges under section 424.57(e).  See 1866ICPayday.com, DAB No. 2289 at 13 (2009).  The revocation is effective "30 days after the entity is sent notice of the revocation . . . ."  42 C.F.R. § 424.57(e)(1).

2. Petitioner was not entitled to submit a Corrective Action Plan (CAP) before having its billing privileges revoked and cannot obtain equitable relief in this forum.

Petitioner also states that it corrected the deficiency by altering its posted hours of operation and submitting a new enrollment application containing the revised hours.  See P. Br. at 9.  Even if true, corrections made after revocation are immaterial to whether the revocation was authorized in the first place.  See Neb Grp. of Ariz. LLC, DAB No. 2573 at 6 (2014); A to Z DME, LLC, DAB No. 2303 at 6-7 (2010) (citing 73 Fed. Reg. 36,448, 36,452 (June 27, 2008)).

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Petitioner also appears to argue that it was entitled to submit a CAP prior to its revocation.  See P. Br. at 9.  However, there is no merit to this argument because section 424.57(e) does not contain any requirement to provide a supplier an opportunity to submit a CAP or correct any deficiencies before the revocation decision is made.  Neb Grp. of Ariz., DAB No. 2573 at 6 n.4.  While Petitioner did submit a CAP that was rejected (DAB E-File Doc. No. 1b at 38), CMS's decision to reject a proposed CAP is not an initial determination subject to appeal under 42 C.F.R. Part 498, so neither the ALJ nor the Board has jurisdiction to review such a decision.  42 C.F.R. § 405.809; see 42 C.F.R. § 498.3(b) (itemizing all reviewable "initial determinations"); see also DMS Imaging, Inc., DAB No. 2313 at 7-10 (2010) (in appeal of section 424.535(a)(1) revocation, Board agreed ALJ was not authorized to hear CMS contractor's rejection of supplier's CAP and consequent refusal to reinstate billing privileges).

Petitioner likewise states that CMS "failed in its duties to provide the Petitioner with [its] revalidation" based on the findings of a "poorly trained inspector."  P. Br at 4, 9.  Petitioner's argument may be construed to be that the government should be estopped from revoking its Medicare billing privileges based on the inspector's findings.  However, 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); Office of Pers. Mgmt. v. Richmond, 496 U.S. 414, 421 (1990).  Petitioner has not provided any evidentiary support for these allegations and there is no evidence suggesting fraud on the part of CMS or the inspector.

Petitioner further avers that its:

patients rely on her for acutely needed medical services, not limited to DMEPOS materials including ambulatory assistive devices, to immobilize fractures and dislocations.  These urgently needed items if not provided for by the Petitioner, can cause undue harm to the Petitioner's patients by causing the Petitioner the need to prescribe these devices and refer them to another health care provider.

P. Br. at 8.  I cannot provide the relief Petitioner seeks because I lack the authority to restore its billing privileges on equitable grounds.  See Letantia Bussell, M.D., DAB No. 2196 at 12-13 (2008) (explaining that ALJs and the Board are authorized to review only whether CMS has a legal basis to revoke a provider's or supplier's billing privileges).  See also US Ultrasound, DAB No. 2302 at 8 (2010).

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3. I have no authority to review CMS's determination to impose a one-year reenrollment bar.

When a supplier's billing privileges are revoked, it may not participate in the Medicare program until the end of its reenrollment bar, which must be for a minimum of one year but no more than ten years (except under circumstance that do not apply here), depending on the severity of the underlying offense.  42 C.F.R. § 424.535(c)(1).  Here, CMS imposed a one-year reenrollment bar.

I have no authority to review the length of a reenrollment bar.  42 C.F.R. § 498.3(b); Linda Silva, P.A., DAB No. 2966 at 11 (2019); Vijendra Dave, M.D., DAB No. 2672 at 9-12 (2016); accord William Garner, M.D., DAB No. 3026 at 16 (2020); Lilia Gorovits, M.D., P.C., DAB No. 2985 at 15-16 (2020).  I am authorized to review initial determinations "to deny or revoke a provider's or supplier's Medicare enrollment in accordance with [section] 424.530 or [section] 424.535 . . . ."  42 C.F.R. § 498.3(b)(17).  As the Board observed in Vijendra Dave, the regulations confer no such right to appeal CMS's determination concerning the duration of a post-revocation reenrollment bar.  DAB No. 2672 at 10.

VII.  Conclusion

For the reasons explained above, because Petitioner did not comply with the requirements specified in 42 C.F.R. § 424.57(c)(7)(i)(D), I affirm the revocation of Petitioner's Medicare enrollment and billing privileges.