Cardiac Imaging Associates A Medical Corporation, DAB No. 3133 (2024)

FINAL DECISION ON REVIEW OF ADMINISTRATIVE LAW JUDGE DECISION

Cardiac Imaging Associates A Medical Corporation (Petitioner) appeals a February 3, 2020 decision by an administrative law judge (ALJ) affirming the revocation of Petitioner’s Medicare enrollment and billing privileges by the Center for Medicare & Medicaid Services (CMS) pursuant to 42 C.F.R. § 424.535(a)(5).  Cardiac Imaging Associates A Medical Corporation, DAB CR5524 (ALJ Decision).  We affirm the ALJ Decision because it is supported by substantial evidence and free of legal error.

Legal Background

Under the Social Security Act (Act), the Department of Health and Human Services administers the Medicare program, including enrollment of health care “providers” such as hospitals and “suppliers” like Petitioner, through CMS and administrative contractors.  Act §§ 1816(a), 1842(a), 1866(j)(1)(A), 1874A; 42 C.F.R. § 400.202 (defining “Provider” and “Supplier”).¹  Enrollment confers “billing privileges,” meaning the right to claim and receive payment for Medicare-covered items and services provided to program beneficiaries.  42 C.F.R. §§ 424.502 (defining “Enroll/Enrollment”), 424.505.

Regulations at 42 C.F.R. Part 424, Subpart P “contain the requirements for enrollment . . . and timely reporting of updates and changes to enrollment information.”  42 C.F.R. § 424.500.  A supplier must submit a CMS-approved paper enrollment application or complete an approved electronic enrollment process.  Id. §§ 424.502 (defining “Enrollment application”), 424.510(a)(1) (stating suppliers “must submit enrollment information on the applicable enrollment application”).  A supplier must meet other enrollment requirements, including being “operational.”  Id. § 424.510(d)(6).  Information from enrollment applications is stored in the Provider Enrollment, Chain, and Ownership System (PECOS), “an electronic data repository that has existed since

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2003.”  Association of Am. Phys. & Surgeons v. Sebelius, 901 F. Supp. 2d 19, 40 (D.D.C. 2012), aff’d, 746 F.3d 468 (D.C. Cir. 2014), cert. denied, 574 U.S. 1074 (2015). 

CMS reserves the right to perform onsite ² inspections and reviews of suppliers to verify that the information submitted to CMS or its agents is accurate and to determine compliance with Medicare enrollment requirements, including whether a supplier is operational.  42 C.F.R. §§ 424.510(d)(8), 424.515(c), 424.517(a).  “Operational” means that the supplier, among other things, “has a qualified physical practice location, is open to the public for the purpose of providing health care related services,” and “is properly staffed, equipped, and stocked . . . to furnish these items or services.”  Id. § 424.502 (defining “Operational”).  To maintain Medicare billing privileges, a supplier must remain operational.  Id. §§ 424.510(d)(6); 424.515(a).  A physician or physician organization also must report a “change in practice location” within 30 days.  Id. § 424.516(d)(1)(iii). 

CMS may revoke a supplier’s billing privileges for any reason listed in 42 C.F.R. § 424.535(a), including, as relevant to this case, sections 424.535(a)(5) and (a)(9).  Section 424.535(a)(5) authorizes revocation if, “[u]pon on-site review or other reliable evidence, CMS determines that” the supplier is “[n]o longer operational to furnish Medicare-covered items or services,” or “[o]therwise fails to satisfy any Medicare enrollment requirement.”  Section 424.535(a)(9) authorizes revocation if the supplier did not comply with reporting requirements including reporting a change in practice location within 30 days.  If CMS revokes a supplier’s billing privileges, the supplier is “barred from participating in the Medicare program from the date of the revocation until the end of the re-enrollment bar.”  42 C.F.R. § 424.535(c).  Where CMS or its contractor determines a supplier’s practice location is not operational, the revocation takes effect on the date that CMS or its contractor made that determination.  Id. § 424.535(g).  The re-enrollment bar may last “a minimum of 1 year, but not greater than 3 years, depending on the severity of the basis for revocation.”  Id. § 424.535(c)(1).

A supplier may appeal revocation per the procedures in 42 C.F.R. Part 498.  42 C.F.R. §§ 424.545(a), 498.3(b)(17).  A dissatisfied supplier may seek reconsideration of the initial determination by CMS or its contractor, then a hearing on the reconsidered determination before an ALJ, then review of the ALJ’s decision by the Departmental Appeals Board (Board).  Id. §§ 498.5(l); 498.22, 498.40, 498.80. 

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Case Background³

Petitioner was incorporated in California in 2001 and enrolled in Medicare in February 2002.  CMS Ex. 4, at 1; CMS Ex. 5, at 10.  Effective December 8, 2006, Petitioner was enrolled to render services to Medicare beneficiaries in patients’ homes, although “No Historical Records Exist For Rendering Services” in that “Mobile Service(s)” status.  CMS Ex. 4, at 6 (emphasis omitted).  In addition, Petitioner also had enrolled as a Medicare supplier using several correspondence addresses, group practice or clinical locations, and special payment addresses.  Id. at 1-8.  On March 24, 2010, Petitioner sent a letter to Palmetto GBA (“Palmetto”), a Medicare administrative contractor, stating that Petitioner’s office had spoken with Palmetto’s customer service department and learned that, “[a]pparently, our files were not updated correctly,” so Petitioner was submitting “revised documents” for processing.  CMS Ex. 5, at 2.  The letter enclosed a CMS-855B form (an enrollment application for clinics/group practices and certain other suppliers), id. at 3-54, and a CMS-855I form (an enrollment application for physicians, among others) on behalf of Petitioner’s president, Howard C. Lewin, M.D., id. at 55-86.

Petitioner’s March 2010 CMS-855B application requested changes to Petitioner’s “Practice Location Information, Payment Address & Medical Record Storage Information” and its “Billing Agency Information.”  Id. at 8.  Petitioner sought to “add” two “Group practice office/clinic” addresses:  one at 1301 20th St. #590 and one at 8581 Santa Monica Blvd. #471 (the “West Hollywood address”).⁴  Id. at 18-19.  Petitioner also sought to “delete” two other practice locations and to “change” a fifth location.  Id. at 17, 20-21.  Petitioner further asked to “change” to the West Hollywood address the location where Petitioner wanted remittance notices or special payments sent.  Id. at 22.  Petitioner’s requested effective date for each modification was January 15, 2010.  Id. at 17-22, 38.  Petitioner specified the West Hollywood address, together with telephone and fax numbers, as the location for Petitioner’s named contact person.  Id. at 33.  Petitioner’s president, Dr. Lewin, signed the application as Petitioner’s authorized official, certified that its contents were “true, correct, and complete,” and acknowledged “that the supplier may be . . . revoked from the Medicare program if any requirements are not met.”  Id. at 36, 38.  

The simultaneously submitted CMS-855I application for Dr. Lewin, Petitioner’s president, provided somewhat different information, asking to add a 1501 (not 1301) 20th St. #590 address and to “change” instead of “add” the West Hollywood address.  Id. at 60-61, 71-74.  Dr. Lewin signed the CMS-855I, certifying that, like the CMS-855B, it contained “true, correct, and complete” information.  Id. at 83-84.

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A. CMS’s 2016 Initial Determination

On February 5, 2016, a Medicare contractor conducted an onsite inspection of Petitioner’s West Hollywood address.  CMS Exs. 1-3.  The contractor documented that the site was not a medical practice but rather a United Parcel Service (UPS) store.  CMS Ex. 1, at 2; CMS Ex. 2, at 2; CMS Ex. 3, at 2, ¶ 3.  

On November 15, 2016, another Medicare administrative contractor, Noridian Healthcare Solutions (“Noridian”), issued an initial determination revoking Petitioner’s Medicare enrollment and billing privileges as of February 5, 2016 (the onsite inspection date), and barring Petitioner from re-enrolling for two years.  CMS Ex. 7.  Noridian explained:

42 C.F.R. § 424.535(a)(5) – On-site Review/Other Reliable Evidence that Requirements Not Met

You are no longer operational to furnish Medicare covered items or services. A site visit conducted on February 5, 2016 at 8581 Santa Monica Blvd, 471, West Hollywood, CA 90069-4120 confirmed that you are non-operational.

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

You are no longer operational to furnish Medicare covered items or services. A site visit conducted on February 5, 2016 at 8581 Santa Monica Blvd, 471, West Hollywood, CA 90069[-]4120 confirmed that you are non-operational. You did not notify the Centers for Medicare & Medicaid Services of this change of practice location as required under 42 CFR § 424.516.

Id. at 1.

B. Reconsideration by CMS

Petitioner timely requested reconsideration, arguing that CMS had not met its burden of establishing a prima facie case and revocation was not justified under 42 C.F.R. § 424.535(a)(5) or (a)(9).  CMS Ex. 6, at 3-9.  Alternatively, Petitioner argued the revocation effective date was erroneous.  Id. at 10-11.  To show that Petitioner was operational, it submitted a “Medicare ID Report” printout from PECOS, which showed for each of Petitioner’s listed addresses an “Effective Date” of February 13, 2002 (Petitioner’s initial Medicare enrollment date), and a “Termination Date” of February 5, 2016 (the onsite inspection date).  Id. at 35. 

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Noridian upheld the revocation under 42 C.F.R. § 424.535(a)(5) and (a)(9).  CMS Ex. 8.  The reconsidered determination explained that on February 5, 2016, an inspector performed an onsite review at Petitioner’s West Hollywood address and confirmed it “was not open for business,” did not have staff, employees, or customers present, and “did not appear to be operational.”  Id. at 2.  Instead, “the business located at the practice location address was ‘The UPS Store.’”  Id.  The reconsidered determination further explained:

[T]he 855B instructions regarding practice locations state to provide the specific street address as recorded by the United States Postal Service. Do not provide a PO Box. A home address is an acceptable practice location.

The revocation will be upheld due to the on-site confirming that the practice location in the enrollment is not an operational practice location. There are no change of information applications able to be located removing this practice location from the enrollment.

Id.

C. ALJ Proceedings and Decision

Petitioner timely requested an ALJ hearing.  Appeal of Recons. Decision and Req. for Hr’g (RFH) at 1.⁵  Petitioner disputed CMS’s grounds for revocation, contending that CMS and its contractor presented insufficient evidence at the reconsideration stage and violated timely notice provisions in the Medicare Program Integrity Manual (MPIM).  Id. at 2-4.

CMS filed a pre-hearing brief, moved for summary judgment, named as a witness the inspector who performed the February 5, 2016 onsite review, and submitted eight proposed exhibits.  CMS’ Pre-hearing Br. & Mot. for Summ. J. (MSJ); CMS Exs. 1-8.  CMS asserted that, on the onsite visit date, Petitioner was not operational at its sole practice location on file with CMS.  MSJ at 3-6.  CMS argued that Petitioner is not exempt from Medicare requirements to be operational and able to pass a site visit.  Id. at 6-8.  CMS further argued that Petitioner did not provide notice of a change in practice location.  Id. at 8.  CMS asserted Petitioner’s revocation properly took effect on February 5, 2016, denied violating any Medicare hearing regulations, and argued an ALJ cannot address due process arguments or grant equitable relief.  Id. at 8-12.

Petitioner filed a pre-hearing brief, requested denial of CMS’s summary judgment motion and reversal of the revocation, and submitted two proposed exhibits.  P. Pre-Hr’g

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Exchange, Mot. for a Favorable Decision on the Record, & Resp. to CMS’s Mot. for Summ. J. (P. Br. to ALJ); P. Exs. 1-2 (two MPIM excerpts).  Petitioner named no witnesses.  P.’s List of Witnesses (stating, “None”).  Petitioner claimed it complied with the Medicare participation requirement to be operational.  P. Br. to ALJ at 5-12.  Petitioner asserted it had accurate enrollment data in PECOS and objected to admission of CMS’s enrollment record for Petitioner (CMS Ex. 4) as a mere summary that lacked supporting application forms.  Id. at 12-14.  Petitioner contended that CMS failed to perform a valid site verification visit, that CMS’s evidence of the February 5, 2016 site visit (CMS Exs. 1-3) was inadmissible, and that CMS had “failed to meet it[s] prima facie burden.”  Id. at 14-18 (emphasis omitted).  Petitioner further argued that, even if the onsite visit were validly made and documented, the revocation effective date was erroneous due to untimely issuance of the revocation notice.  Id. at 18-20.

The ALJ issued a decision in CMS’s favor on the written record, without holding an in-person hearing (because neither party had requested cross-examination) or granting summary judgment.  ALJ Decision at 3.  The ALJ admitted all proposed exhibits into the record, overruling Petitioner’s objections to CMS Exhibits 1 through 4.  Id. at 3.  The ALJ made four primary findings of fact and conclusions of law.  First, the ALJ determined that, on February 5, 2016, Petitioner’s Medicare enrollment record showed a single practice location at the West Hollywood address.  Id. at 4-6.  Second, the ALJ determined Petitioner’s sole practice location of record was not operational on the onsite inspection date.  Id. at 6.  Third, the ALJ ruled that CMS had a legal basis to revoke Petitioner’s Medicare enrollment and billing privileges as of February 5, 2016, because Petitioner was not operational pursuant to 42 C.F.R. § 424.535(a)(5) at the practice location on file with CMS.  Id. at 6-9.  Finally, the ALJ declined to decide whether Petitioner violated section 424.535(a)(9) as well.  Id. at 9.  Thus, the ALJ affirmed CMS’s revocation of Petitioner’s Medicare enrollment and billing privileges.  Id.

D. Petitioner’s Request for Review

Petitioner timely requested Board review and reversal of the ALJ Decision, raising four primary arguments.  Request for Review (RR) at 1-2, 22.⁶  First, Petitioner contends it had multiple reported practice locations and CMS’s records were inaccurate.  Id. at 2-7.  Second, Petitioner claims CMS failed to meet its prima facie burden of production “by failing to introduce any evidence or identify the legal criteria that justified” revocation.  Id. at 7-8; see generally id. at 7-13.  Third, Petitioner contends no basis existed for “retroactive revocation.”  Id. at 13-19 (emphasis omitted).  Fourth (concerning 42 C.F.R. § 424.535(a)(9)), Petitioner denies that it failed to update its enrollment data.  Id. at 19-22.

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CMS counters that the ALJ Decision “was free from legal and factual error, and CMS properly revoked [Petitioner’s] Medicare billing privileges” because Petitioner’s sole practice location on file with CMS, the West Hollywood address, was not operational as of the February 5, 2016 onsite inspection.  CMS Resp. to P.’s RR (CMS Resp.) at 2-3.  CMS argues Petitioner “has provided no declaration or other persuasive documentary evidence showing that [Petitioner] had any other addresses on file with CMS at the time.”  Id. at 3; see also id. at 7-14.  CMS also maintains that Petitioner is not exempt from Medicare requirements to be operational and able to pass a site visit, and that Petitioner’s MPIM-based arguments about the site inspection report are irrelevant.  Id. at 15-18.

Standard of Review

The standard of review on a disputed factual issue is whether the ALJ decision is supported by substantial evidence in the record as a whole, and the standard of review on a disputed issue of law is whether the ALJ decision is erroneous.  See Guidelines – Appellate Review of Decisions of Administrative Law Judges Affecting a Provider’s or Supplier’s Enrollment in the Medicare Program (Guidelines), “Completion Of The Review Process,” ¶ (c), (last visited March 19, 2024), https://www.hhs.gov/about/agencies/dab/different-appeals-at-dab/appeals-to-board/guidelines/enrollment/index.html.

Analysis

As Petitioner raises several arguments relating to the parties’ evidentiary burdens, we first briefly summarize them.  The Board applies the same burden of proof to supplier enrollment appeals (including revocation appeals) that the Board applies to other cases under 42 C.F.R. Part 498.  Adora Healthcare Svcs., Inc., DAB No. 2714, at 4 (2016).  In revocation appeals, “CMS has the burden of coming forward with evidence that establishes a prima facie case that the cited basis for the revocation exists.”  Id. at 5.  To establish a prima facie case for revocation because Petitioner was not operational, CMS needs to “point to evidence in the record developed before the ALJ that Petitioner no longer ‘had a qualified physical practice location,’ and was not ‘open to the public for the purpose of providing health care related services, . . . prepared to submit valid Medicare claims [or] properly staffed, equipped, and stocked . . . to furnish these items or services.’”  Id. (quoting 42 C.F.R. § 424.502).  If CMS meets that burden, then Petitioner “has the burden to prove its case, that is, to rebut the basis for the revocation, by a preponderance of the evidence.”  Id.

We next list the evidence the ALJ received into the administrative record, beginning with CMS’s exhibits:

• CMS Ex. 1 (Site inspection report by James Neujahr dated February 5, 2016);

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• CMS Ex. 2 (Color photographs from Site Inspection Report);
• CMS Ex. 3 (Declaration of James Neujahr regarding his February 5, 2016 site inspection);
• CMS Ex. 4 (CMS’s Enrollment Record Summary for Petitioner printed May 10, 2017);
• CMS Ex. 5 (Petitioner’s March 24, 2010 CMS-855B enrollment application reflecting changed enrollment information);
• CMS Ex. 6 (Petitioner’s request for reconsideration);
• CMS Ex. 7 (Noridian enrollment revocation notice to Petitioner, dated November 15, 2016); and
• CMS Ex. 8 (Noridian Reconsidered Determination dated March 9, 2017, affirming revocation).

The ALJ also received both of Petitioner’s exhibits:

• Petitioner’s Ex. 1 (MPIM, CMS Pub. 100-08, Transmittal 715 Excerpts); and
• Petitioner’s Ex. 2 (MPIM, CMS Pub. 100-08, Ch. 10 § 4.4 (Rev. 296, Issued: 07-10-09; Effective/Implementation Date: 08-10-09)).

For reasons discussed below, we affirm the ALJ’s determinations that CMS met its evidentiary burden and Petitioner did not, and that CMS had a valid basis for revocation under 42 C.F.R. § 424.535(a)(5).  Therefore, like the ALJ, we need not and do not consider whether CMS had an additional valid basis for revocation under section 424.535(a)(9).

A. The ALJ did not err in determining that CMS had a valid basis for revocation under 42 C.F.R. § 424.535(a)(5).

1. The ALJ’s determination that Petitioner had only one practice location of record, at the West Hollywood address, on the onsite visit date of February 5, 2016, is supported by substantial evidence and free of legal error.

“In March 2010,” the ALJ found, “Petitioner added the West Hollywood address as a practice location in CMS’s PECOS system,” and “[s]ince February 2012, the
 West Hollywood address has been the only location on file with CMS” because “Petitioner’s other practice locations had all been deleted by 2012.”  ALJ Decision at 4.  The ALJ relied in part on CMS Exhibit 4, a May 10, 2017 “Enrollment Record Summary” that showed only Petitioner’s West Hollywood address as active by the onsite inspection date of February 5, 2016.  Id. at 4-5 (citing CMS Ex. 4, at 2-6).  The ALJ found this Enrollment Record Summary “fully consistent with” the Medicare ID Report that Petitioner had submitted and relied on in its reconsideration request.  Id. at 5

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(referencing CMS Ex. 6, at 35).  The ALJ further found and explained that the Medicare ID Report “shows the periods of enrollment for a given Medicare ID, not specific effective start and end dates for a supplier’s individual practice locations.”  Id.  Viewing the entire administrative record, the ALJ stated that “I must conclude in the absence of contrary evidence that CMS’s record-keeping is reliable and trustworthy, and that CMS Ex. 4,” the Enrollment Record Summary, “is accurate.”  Id. at 5.

Petitioner counters that it had multiple reported practice locations and CMS’s records were inaccurate.  RR at 2-7.  Petitioner urges the Board to consider Petitioner’s March 2010 CMS-855B enrollment application as the “only” exhibit “that includes actual Medicare enrollment application forms submitted and certified as accurate,” and denies making any subsequent changes through 2012.  Id. at 3-5 (emphasis omitted).  “The Medicare ID Report on its face,” Petitioner further argues, “contain[s] information for each ‘Practice Location Address’ with the associated ‘Effective Date’ and ‘Termination Date’ for each reported location,” and thus shows other practice locations besides the West Hollywood address as not terminated until February 5, 2016.  RR at 3.  Petitioner disputes the ALJ’s finding that the Medicare ID Report does not “reflect[] accurate effective dates and end dates for each listed practice location.”  Id. at 1.  Petitioner also disputes CMS’s and the ALJ’s reading of the Medicare ID Report as showing the periods of enrollment for a given Medicare ID rather than the effective start and end dates for a supplier’s particular practice locations.  Id. at 3.  Petitioner characterizes CMS’s Enrollment Record Summary as inaccurate and unreliable.  Id. at 2-7.  

To address these arguments, we summarize certain record evidence before the ALJ, beginning with CMS Ex. 5, which is Petitioner’s March 2010 CMS-855B enrollment application, in which Petitioner requested five changes, each effective January 15, 2010:

• 6380 Wilshire Blvd. #1109 was to be deleted;
• 155 N. San Vicente Blvd. was to be changed;
• the West Hollywood address was to be added;
• 1301 20th St. #590 was to be added; and
• 8581 Wilshire Blvd. #471 was to be deleted.

CMS Ex. 5, at 17-22.  The application does not list a 6455 Colgate Street address.  Id.

We next summarize a portion of CMS Ex. 6, consisting of a December 1, 2016 printed form, captioned “Medicare ID Report,” which Petitioner submitted among the 36 pages of letters, forms, Frequently Asked Questions, and other records comprising Petitioner’s Request for Reconsideration dated January 10, 2017.  CMS Ex. 6, at 35.  The Medicare ID Report expressed in chart format the same Medicare ID number associated with the practice locations at issue, together with the practice location names, addresses, effective dates, and termination dates.  Id.  Five practice locations (6380 Wilshire Blvd. #1109, 155 N. San Vicente Blvd., the West Hollywood address, 1301 20th St. #590, and 6455

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Colgate Street) were listed as effective on February 13, 2002 and terminated on February 5, 2016.  Id.  The 8581 Wilshire Blvd. #471 address was not listed.  Id.

We also summarize CMS Exhibit 4, the Enrollment Record Summary for Cardiac Imaging Associates dated May 10, 2017.  CMS Ex. 4.  As listed in this record:

• 6455 Colgate Street has an effective date of June 25, 2004, and an end date of December 8, 2006;
• 6380 Wilshire Blvd. #1109 has an effective date of January 23, 2007, and an end date of January 15, 2010;
• 155 N. San Vicente Blvd. has an effective date of March 9, 2010, and an end date of February 1, 2012;   
• the West Hollywood address has an effective date of March 9, 2010, and an end date of February 5, 2016; and
• 1301 20th St. #590 has an effective date of March 2, 2010, and an end date of February 1, 2012.

CMS Ex. 4, at 3-6.  This record, like the Medicare ID Report, does not list 8581 Wilshire Blvd. #471 as a practice location.  Id.; see CMS Ex. 6, at 35.

We first observe that Petitioner’s simultaneous reliance on its 2010 CMS-855B form and the Medicare ID Report is inconsistent.  Petitioner’s 2010 CMS-855B asked to add two locations (the West Hollywood address and the 1301 20th St. #590 address), yet the Medicare ID Report, by Petitioner’s interpretation, shows both locations as already active since 2002.  The 2010 CMS-855B form sought to delete the 6380 Wilshire Blvd. address, yet the Medicare ID Report, by Petitioner’s reading, shows that address as continuously active until 2016.  If, as Petitioner contends, its 2010 CMS-855B application is accurate, then Petitioner’s view of the Medicare ID Report cannot be.  Thus, we see no error in the ALJ’s adoption of CMS’s interpretation of the Medicare ID Report instead.  See ALJ Decision at 5-6.

We next acknowledge and agree with CMS’s argument that Petitioner failed to raise before the ALJ several of its challenges to the accuracy of CMS’s Enrollment Record Summary, particularly concerning alleged date discrepancies and time gaps when it shows no reported practice location for Petitioner.  See CMS Resp. at 10-12.  The Board need not consider such unpreserved arguments.  See Guidelines, “Completion Of The Review Process,” ¶ (a) (“The Board will not consider issues . . . which could have been presented to the ALJ but were not.”); see also Jason R. Bailey, M.D., P.A., DAB No. 2855, at 12 (2018) (“A party appearing before the Board is not permitted to raise on appeal issues that could have been raised before the ALJ but were not.”).  The requirement to raise issues before the ALJ is not a mere technicality, for it “helps to ensure that the record before the Board is adequate to permit meaningful appellate review of the ALJ’s factual and legal conclusions,” and promotes both “fairness” and “efficient

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adjudication and administration.”  ACT for Health, Inc., DAB No. 1972, at 5 (2005). 

Yet we still would find these claims unpersuasive, even if Petitioner had preserved them by its general contention before the ALJ that CMS’s Enrollment Record Summary “contains inaccurate information.”  See P. Br. to ALJ at 13.  For example, Petitioner claims that the West Hollywood address and the 1301 20th St #590 location in Santa Monica “were added effective January 15, 2010, yet the Enrollment Record Summary notes these two locations have an effective date of March 2, 2010.”⁷  RR at 5-6.  Petitioner also states that its 2010 CMS-855B form changed the 155 N. San Vicente Blvd. location “effective January 15, 2010, yet the Enrollment Record Summary notes this location was not even effective until March 9, 2010, several months after the reported change.”  Id. at 6.  Yet those alleged discrepancies are consistent with a brief administrative delay for the CMS contractor’s verification of enrollment information after receiving it.  See Wendell Foo, M.D., DAB No. 2904, at 19 (2018) (discussing, with approval, ALJ’s finding that application information is not automatically added to final enrollment record until after the applicable administrative contractor has verified the information), aff’d, 420 F. Supp. 3d 1100 (D. Haw. 2019).  The temporal gaps during which CMS’s Enrollment Record Summary shows no practice location for Petitioner are equally explicable.  Regarding the gap from Petitioner’s February 13, 2002 enrollment date through June 24, 2004, Petitioner acknowledges that “its initial enrollment occurred before all Medicare enrollment data was being maintained in the PECOS database.”  RR at 6 n.6; see Association of Am. Phys. at 43 (stating that submission of an enrollment application has automatically generated a record in PECOS only “since 2003”).  The second gap, between the December 8, 2006 end date for the 6455 Colgate Street address and the January 23, 2007 effective date for the 6380 Wilshire Blvd. #1109 address, is consistent with record evidence of a certification by Petitioner’s owner on December 8, 2006, which would explain both events.  See CMS Ex. 4, at 8; Foo, DAB No. 2904, at 19 (discussing verification of supplier-submitted information before its addition to final enrollment record).  Thus, the ALJ did not err in rejecting Petitioner’s contention that CMS’s Enrollment Record Summary was “inaccurate,” or in dismissing Petitioner’s claims that the Medicare ID Report “undermines” the Enrollment Record Summary as “without merit.”  ALJ Decision at 5.   

Considerable record evidence further supports the ALJ’s conclusion that Petitioner’s enrollment records were less accurate and reliable than CMS’s.  For example, Petitioner’s March 24, 2010 letter to Palmetto acknowledged that Petitioner was sending “revised documents” because previously its “files were not updated correctly.”  CMS Ex. 5, at 2.  Petitioner’s 2010 application form deleted locations at 6380 Wilshire Blvd. #1109 and 8581 Wilshire Blvd. #471, yet Petitioner now inconsistently claims it thus deleted “two 6380 Wilshire Blvd locations (#1109 and #471).”  Compare CMS Ex. 5, at 20-21 with

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RR at 6 (emphasis added).  Petitioner’s 2010 application gave telephone and fax numbers for Petitioner’s named contact person at the West Hollywood address, yet the record contains no evidence that Petitioner ever staffed that UPS Store location.  See CMS Ex. 5, at 33; see also CMS Ex. 1, at 1 (describing West Hollywood address as a “commercial mail drop”); ALJ Decision at 8 (describing West Hollywood address as “a commercial mailing address and not an operational practice location”); RR at 20 (acknowledging that Petitioner “obtained a street address” there in lieu of using a “Post Office Box number”).  Other entries in Petitioner’s documentation cast further doubt on its precision.  See, e.g., CMS Ex. 5, at 17 (listing practice location in “Beverly Hill” rather than “Beverly Hills”); id. at 18, 21 (adding 8581 Santa Monica Blvd. #471 address while deleting nearly identical 8581 Wilshire Blvd. #471 address); id. at 19, 72 (adding 1301 20th St. #590 address for Petitioner and 1501 20th St. #590 address for Dr. Lewin); compare id. at 60 (not checking box for change to “Billing Agency Information,”) with id. at 79 (checking box for change to “Billing Agency Information”).

Petitioner’s unsupported arguments and speculation cannot rebut the Enrollment Record Summary’s documentation that all of Petitioner’s listed practice locations except the West Hollywood address were terminated by February 1, 2012, over four years before the 2016 onsite visit that resulted in revocation.  For example, Petitioner argues that “[a]t no time, between 2010 through 2012, did [Petitioner] submit a change of information filing to delete any of its practice locations that were on file after the 2010 update was processed and approved.”  RR at 5.  Yet Petitioner cites no evidence for that assertion and, even if credited, it would not foreclose the possibility that Petitioner made such deletions between 2012 and the 2016 onsite visit.  RR at 5.  Petitioner also does not substantiate through record citations its repeated claims that the 6455 Colgate Street address “was the home address used by the interpreting physician owner” and was “never deleted.”  RR at 4-5, 11 n.7, 12.  Petitioner theorizes that the initial implementation of PECOS or the transition between CMS contractors in 2013 (or both) “could have resulted in” data entry errors and inaccuracies in the Enrollment Record Summary.  RR at 6 & n.6.  However, “arguments by counsel are not evidence.”  Atty’s Parti Expo, Inc., DAB No. 2925, at 8 (2019)).  Speculative inferences also are not evidence.  Wax David Flowers, Ph.D., DAB No. 3039, at 8 (2021) (“Inferences based on speculation are not reasonable.”); accord Sylvie Wamba, DAB No. 3068, at 6 (2022).  Petitioner could have submitted testimony or additional documentation clarifying when Petitioner added and deleted each of its practice locations, but Petitioner chose not to present such evidence.  See Acknowledgment & Pre-Hr’g Order (Pre-Hr’g Order) at 5; P.’s List of Witnesses.   

Sound legal authority, as well as the substantial evidence reviewed above, supports the ALJ’s decision to give greater weight to CMS’s evidence than Petitioner’s concerning practice locations of record on the onsite visit date of February 5, 2016.  As the ALJ appropriately recognized, there is a general presumption of regularity in CMS’s recordkeeping.  See ALJ Decision at 5-6; United States Postal Serv. v. Gregory, 534 U.S. 1, 10 (2001) (“[A] presumption of regularity attaches to the actions of Government

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agencies.”); Brian K. Ellefsen, DO, DAB No. 2626, at 7 (2015) (“The federal courts have held that it is well-established that a presumption of regularity attaches to the actions of government agencies and their agents.”).  “[I]n considering factual findings made by an ALJ after full record review, the Board will defer to the ALJ’s determinations of the credibility to be accorded to witness testimony and the weight to be given to evidence, absent a compelling reason to do otherwise.”  National Seating & Mobility Inc., DAB No. 2984, at 5 (2020).  Petitioner has given us no compelling reason not to defer to the ALJ’s weighing of the evidence.

We find Petitioner’s legal reasoning, rather than the ALJ’s, to be incorrect.  Petitioner’s assertion that “CMS could have easily met its burden” by placing into the record any CMS-855B filing that deleted Petitioner’s other practice locations besides the West Hollywood address, RR at 12, misapplies the burden of proof.  Once CMS established its prima facie case that the West Hollywood address was Petitioner’s only practice location of record on February 5, 2016 (see, e.g., CMS Ex. 3, at 2, ¶ 3; CMS Ex. 4), Petitioner bore the burden of proving the contrary.  See Bailey at 14 (rejecting petitioner’s argument that the “burden is with the CMS to prove that the provider did not provide a change of address”).  Petitioner’s reliance on non-precedential ALJ decisions also is mistaken.  See, e.g.,RR at 5 n.4, 9; see also Bailey at 14 n.11 (“An ALJ’s decision is not precedential and does not bind other ALJs or the Board.”); AR Testing Corp., DAB No. 2679, at 12 (2016) (“ALJ decisions do not bind the Board or other ALJs . . . .”).

Moreover, Petitioner misreads the Board’s decision in Wendell Foo, M.D., DAB No. 2769 (2017).  RR at 7, 12.  Our recognition in that case that a particular PECOS record could be inaccurate was not a determination that every CMS-maintained record is inherently unreliable.  In Foo, a revoked supplier submitted detailed testimony from a witness with first-hand knowledge that “raise[d] a legitimate concern about how PECOS retains data.”  Foo, DAB No. 2769, at 12.  Here, however, Petitioner offered no such evidence.  Furthermore, in Foo, on remand, the ALJ expressly determined that PECOS records are reliable and again upheld revocation after determining that, at the time of onsite review, the petitioner’s reported practice location was a UPS Store location where the petitioner indisputably did not practice and thus was not operational.  Foo, DAB No. 2904, at 5, 11.  As CMS accurately notes, “The Foo case was initially remanded for the ALJ to address arguments related to accuracy of PECOS enrollment records,” but “[u]ltimately, the accuracy of the records was affirmed by the Board and by the District Court.”  CMS Resp. at 11 n.4; see Foo, DAB No. 2904, aff’d, 420 F. Supp. 3d 1100 (D. Haw. 2019)).  Thus, the Foo cases, DAB Nos. 2769 and 2904, weaken rather than strengthen Petitioner’s case.

We uphold the ALJ’s determination that, on February 5, 2016, Petitioner’s Medicare enrollment record showed only the West Hollywood practice location, as that determination is supported by substantial evidence and free of legal error.   

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2. The ALJ’s determination that Petitioner’s only practice location of record was not operational on the site visit date of February 5, 2016, is supported by substantial evidence and free of legal error.

The ALJ found that “the West Hollywood address identified by Petitioner to CMS as a practice location was not operational as a medical office on the date of the site inspection conducted by CMS.”  ALJ Decision at 6.  The ALJ reasoned that CMS may revoke a supplier’s billing privileges per 42 C.F.R. § 424.535(a)(5)(i) when the supplier is no longer operational, and a supplier cannot meet the definition of “operational” in section 424.502 without a “qualified physical practice location.”  Id. at 6-7.  The ALJ found Petitioner’s listing of the West Hollywood address as a practice location to be undisputed, and further found the inspector had “determined that the location was in fact a commercial mailbox location.”  Id. at 6 (citing CMS Exs. 1-3).  The ALJ considered the inspector credible, so concluded that “the site report and photographs that accompany it accurately reflect that the West Hollywood address listed by Petitioner as a practice location is in fact a UPS store.”  Id.  The ALJ concluded that “Petitioner’s claim that Noridian had no basis to determine it was non-operational has no merit, since I have already determined the evidence submitted by CMS provides a factual basis to make that determination.”  Id. at 8.    

Petitioner argues CMS did not meet its burden to establish a prima facie case.  RR at 7-13.  Essentially, Petitioner complains that CMS produced no evidence of the onsite inspection until the ALJ proceedings.  See id. at 8 (complaining CMS revoked “by simply instructing Noridian to send a two-page letter, with no supporting documentation”) (emphasis omitted); P. Br. to ALJ at 4 n.2 (noting “Petitioner was not provided a copy of the site verification visit report, including the photographs, prior to when CMS introduced the documents into evidence” before the ALJ). 

The ALJ did not err in rejecting Petitioner’s arguments concerning CMS’s prima facie case.  Petitioner has not challenged the ALJ’s evidentiary ruling admitting CMS’s site visit documentation (CMS Exhibits 1-3) into evidence over Petitioner’s objections, and we defer to that ruling.  See Shelia Ann Reed, DAB No. 3059, at 6 (2022) (stating it is “well-settled that the Board defers to the evidentiary rulings of ALJs unless there is a compelling reason not to do so”).  Petitioner also cites no authority establishing an entitlement to receive and review CMS’s exhibits before issuance of the reconsidered determination.  See Bailey at 13 (stating that “Petitioner cites no authority . . . in support of its argument that it was entitled to receive the inspection report before the reconsidered determination was rendered”).  The MPIM provisions Petitioner relies on confer no such right.  See Lindsay Zamis, M.D., a Pro. Corp., DAB No. 2802, at 2 n.4 (2017) (stating MPIM is “primarily intended as guidance or instructions for CMS fee-for-service contractors”); Fady Fayad, M.D., DAB No. 2266, at 10 n.6 (2009) (noting, when discussing MPIM, that, “[u]nlike the Medicare statute and regulations, CMS instructions do not have the force and effect of law and are not binding on the Board”), aff’d, 803 F.

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Supp. 2d 699 (E.D. Mich. 2011).  CMS was not precluded from presenting additional evidence before the ALJ.  42 C.F.R. § 498.56(e) (requiring ALJ to “determine whether the provider or supplier,” not CMS, “has good cause for submitting [new documentary] evidence for the first time at the ALJ level”) (emphasis added); Pre-Hr’g Order at 5 (“Petitioner may not offer new documentary evidence in this case absent a showing of good cause for failing to present that evidence previously to CMS.”) (emphasis added). 

Petitioner had adequate notice of CMS’s reasons for revocation, and a reasonable opportunity to respond to them, during the ALJ proceedings.  “The Board has held that a federal agency may clarify its reasons for a challenged determination, or assert new reasons for that determination, during the ALJ proceeding as long as the non-federal party has adequate notice of the reasons and a reasonable opportunity to respond during that proceeding.”  Fayad at 10.  Even where a reconsidered determination “could have been clearer in stating the legal basis for the revocation,” the Board has upheld the revocation when “CMS promptly clarified that matter in the ALJ proceeding.”  Id. at 13.  CMS timely filed its Exhibits 1 to 3, which documented the February 5, 2016 onsite visit, over a month before Petitioner’s responsive pre-hearing filings were due.  ALJ’s Pre-Hr’g Order at 3.  Petitioner could have asked to cross-examine the onsite inspector or put on its own contrary witness testimony, but did neither.  See Fayad at 10-11 (recognizing that opportunity for de novo proceedings before ALJ cured any possible defect in CMS’s notice of revocation).  In short, CMS timely and adequately presented its prima facie case, which Petitioner did not effectively rebut.

Petitioner also argues CMS may not “determine a provider or supplier is not ‘operational’ if [only] one of four currently reported locations is determined to not be a qualified practice location,” but that argument depends on faulty factual and legal premises. See RR at 12-13.  As explained above, Petitioner’s evidence did not establish that any practice location other than the West Hollywood address was on file on the onsite inspection date in 2016.  The Board has consistently held that only a practice location of record is a “qualified” practice location for purposes of determining “operational” status.  See, e.g., OC Housecalls, Inc. DAB No. 2893, at 10 (2018) (rejecting “the flawed premise that a Medicare supplier can be ‘operational,’ as the term is defined in the regulations at 42 C.F.R. § 424.502, at any location other than its qualified physical practice location(s) on file with CMS (or CMS’s contractor) at the time of the site visit”).  Even if Petitioner had proven other practice locations were on file on February 5, 2016, CMS has described revocation under 42 C.F.R. § 424.535(a)(5) as “based on a provider or a supplier no longer being operational at a specific practice location,” in the singular.  Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2009; E-Prescribing Exemption for Computer-Generated Facsimile Transmissions; and Payment for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS), 73 Fed. Reg. 69,726, 69,866 (Nov. 19, 2008) (Final Rule with comment period) (emphasis added).  Where, as here, onsite inspection reveals that a supplier’s only practice location on file is a UPS Store, that

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result is sufficient to support a finding that the supplier is not operational, regardless of its alleged operations at any different address.  See Bailey at 10-13.

Petitioner also incorrectly suggests that its practice location was not properly subject to onsite inspection under the provisions of 42 C.F.R. § 424.517, which “only mandate an on-site review to determine if a Part A provider, not a Part B supplier, is operational.”  RR at 10.  Section 424.517(a) clearly authorizes onsite reviews of suppliers by CMS, stating, “CMS reserves the right, when deemed necessary, to perform onsite review of a provider or supplier to verify that the enrollment information submitted to CMS or its agents is accurate and to determine compliance with Medicare enrollment requirements.”  CMS permissibly exercised that right in this case.

The ALJ properly rejected Petitioner’s argument that it furnished services from its owner’s home and therefore was not subject to onsite review, and correctly concluded that such arguments in this case are “inapt.”  ALJ Decision at 8.  As discussed above, Petitioner cites no evidence substantiating that 6455 Colgate Street was a home address, and the ALJ accurately remarked that “Petitioner did not list a home address” or identify such unique circumstances for any practice location listed in its March 2010 enrollment application.  Id.  Petitioner did not check the available box for “Other health care facility (specify),” but instead certified each location as a “[g]roup practice office/clinic” where Petitioner rendered services to Medicare beneficiaries.  CMS Ex. 5, at 17-21.  Thus, CMS was authorized to conduct an onsite inspection of any of those sites, including the West Hollywood address when it was serving as Petitioner’s sole practice location of record on February 5, 2016.  See 42 C.F.R. § 424.517(a). 

For these reasons, we uphold the ALJ’s determination that Petitioner’s only practice location of record was not operational on the site visit date of February 5, 2016.

3. The ALJ did not err in determining that, because Petitioner’s only practice location of record was not operational on the February 5, 2016, onsite visit date, CMS had a valid basis for revocation under 42 C.F.R. § 424.535(a)(5).

Having found that Petitioner’s only practice location of record was not operational on the onsite visit date in 2016, the ALJ concluded CMS had a legal basis to revoke Petitioner’s enrollment and billing privileges under 42 C.F.R. § 424.535(a)(5).  ALJ Decision at 6-9.  The ALJ explained that, “[o]nce CMS determined that the West Hollywood address was a commercial mailing address and not an operational practice location, it had a legal basis to revoke Petitioner’s enrollment and billing privileges.”  Id. at 8. 

Petitioner has shown no legal error in the ALJ’s determination.  The role of an ALJ and the Board in an appeal from CMS’s revocation of enrollment and billing privileges is limited to determining whether CMS had a “legal basis” for revocation.  Vamet

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Consulting & Med. Servs., DAB No. 2778, at 6 (2017); Letantia Bussell, M.D., DAB No. 2196, at 13 (2008).  If CMS establishes that the regulatory elements necessary for revocation are satisfied, then the ALJ and the Board may not substitute their discretion for CMS’s in determining whether revocation is appropriate under all the circumstances, and must sustain the revocation.  Douglas Bradley, M.D., DAB No. 2663, at 13 (2015).

The ALJ supportably concluded that CMS established the regulatory elements necessary for revocation of Petitioner’s enrollment and billing privileges under 42 C.F.R. § 424.535(a)(5).  That conclusion is consistent with Board precedent that CMS may base its revocation determination on an onsite review of a provider’s or supplier’s practice location of record that reveals it is not operational.  See Foo, DAB No. 2904, at 21-22; Bailey at 9-15; Foot Specialists of Northridge, DAB No. 2773 at 8-12 (2017); Care Pro Home Health, Inc., DAB No. 2723, at 5-11 (2016); Viora Home Health, Inc., DAB No. 2690, at 9-13 (2016).  Where, as here, the supplier’s only practice location of record is a commercial mailbox facility where the supplier does not furnish Medicare-covered services, that supplier does not meet the definition and enrollment requirement of being “operational.”  Foo, DAB No. 2904, at 5, 21-22; Bailey at 10-15. 

Accordingly, we hold that the ALJ correctly concluded that CMS had a valid basis for revocation of Petitioner’s billing privileges under 42 C.F.R. § 424.535(a)(5). 

B. The ALJ’s determination that February 5, 2016, was the correct effective date of revocation is supported by substantial evidence and free of legal error.

Petitioner challenges CMS’s “retroactive” revocation effective date of February 5, 2016, objecting that nine months passed between the onsite inspection on that date and the resulting revocation notice.  RR at 14.  Petitioner claims CMS failed to follow its own MPIM guidance to notify a supplier of revocation within seven days after an onsite review indicating a supplier is not operational.  Id. at 16 (citing MPIM § 15.20.1.E ).⁸ 

The ALJ determined that the CMS contractor’s inaction on Petitioner’s revocation for months after the February 2016 site visit “does not establish ‘affirmative misconduct’” that could estop CMS from revoking Petitioner’s billing privileges.  ALJ Decision at 8.  “Even if this delay amounted to such an offense,” the ALJ concluded, “I do not have the authority to fashion equitable remedies.”  Id. at 9.  The ALJ explained that the alleged delays by CMS in providing requested documents and notice of revocation cannot alter the revocation effective date, which 42 C.F.R. § 424.535(g) makes “clear” is “the date that CMS determined Petitioner was no longer operational.”  Id.

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The ALJ’s upholding of the February 5, 2016 revocation effective date was consistent with applicable regulations.  For any basis of revocation in 42 C.F.R. § 424.535(a), section 424.535(g) determines the effective date.  For revocations under section 424.535(a)(5), revocation takes effect on “the date that CMS or its contractor determined that the . . . supplier was no longer operational.”  42 C.F.R. § 424.535(g).  This regulatory requirement binds both the ALJ and the Board, which may not invalidate or refuse to apply it.  Mark A. Kabat, D.O., DAB No. 2875, at 11 (2018).  Petitioner argues that CMS, “[i]n setting forth its reasoning for adopting the regulations allowing retroactive revocations” in 2008, made “no mention of an onsite visit as a mechanism, much less the sole mechanism, to determine whether a provider or supplier is operational in any of the preamble discussion.”  RR at 15 (discussing 73 Fed. Reg. 69,726, at 69,865-66).  Yet CMS did describe as “important” its “authority to revoke the billing privileges of a Part B supplier . . . if CMS or our contractor determines . . . upon an on-site review or other reliable evidence that the supplier is not operational.”  73 Fed. Reg. at 69,778. 

In upholding the February 5, 2016 revocation date, the ALJ also properly treated the governing regulations, rather than sub-regulatory MPIM guidance, as controlling.  “The MPIM does not have the legal authority of the regulations, which indeed bind the ALJ and constitute the authority an ALJ must follow when deciding whether CMS had a legal basis for denying enrollment” or revoking it.  See Robert J. Tomlinson, M.D., DAB No. 2916, at 6 (2018), aff’d, No. 19-05114, 2020 WL 376657 (W.D. Ark. Jan. 23, 2020).  Moreover, Petitioner’s interpretation of then-current MPIM section 15.20.1.E is questionable in itself, given the Board’s prior rejection of a similar reading.  See Bailey at 19 (rejecting petitioner’s “misreading of sub-regulatory guidance in the MPIM that could not supplant the regulation governing the determination of the effective date of revocation even if the MPIM actually stated what Petitioner asserts it does”).

We reject Petitioner’s charge that the ALJ inconsistently applied CMS’s “interpretive policy” in the MPIM “in a piecemeal fashion to favor the government.”  RR at 18.  The ALJ acknowledged that the inspector’s site report and photographs “were not date- and time-stamped, as required by” the MPIM, but permissibly ruled that the inspector’s credible declaration “cures this deficiency.”  ALJ Decision at 6; see AR Testing at 5, 7 (rejecting petitioner’s “questions about the authenticity, reliability, and sufficiency of CMS’s evidence on the attempted inspection,” including contentions that the inspector’s photograph and report were not properly dated, and upholding revocation under 42 C.F.R. § 424.535(a)(5) on “the undisputed evidence that Petitioner was not operational”); Bailey at 13 (rejecting petitioner’s MPIM-based argument that “the record lacks evidentiary support for revocation” without a valid inspection report and concluding that “none of the alleged ‘irregularities’” raised a genuine factual dispute); Ita Udeobong, DAB No. 2324, at 6 (2010) (rejecting as “without merit” a petitioner’s attempt to invalidate a Medicare contractor’s onsite inspection report for not being contemporaneously signed and dated).  The ALJ acknowledged Petitioner’s reliance “on a provision of the MPIM that states CMS has seven days to issue a revocation notice,”

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but properly applied the controlling regulation instead.  ALJ Decision at 8-9 (applying 42 C.F.R. § 424.535(g)); see Yolanda Hamilton, M.D., DAB No. 3061, at 26-28 (2022) (explaining, when rejecting argument based on MPIM provisions, that, “[i]mportantly, Petitioner’s argument disregards that CMS’s manual provisions are not statutes or regulations”).

Petitioner asserts an inapplicable standard when arguing that “CMS’s failure to follow its own policy . . . made the retroactive revocation determination an arbitrary and capricious agency decision that should be reversed on appeal.”  See RR at 15 (emphasis omitted).  The “arbitrary and capricious” standard of review “does not apply to administrative appeals of Medicare enrollment revocations.”  Blair Allen Nelson, M.D., DAB No. 3024, at 11 (2020); see Lilia Gorovits, M.D., P.C., DAB No. 2985, at 17 (2020) (“Petitioner’s apparent reliance on the Administrative Procedure Act’s (APA’s) ‘arbitrary and capricious’ standard is misplaced in these [revocation] proceedings.”), aff’d, No. 2:20-CV-01850, 2021 WL 1962903 (E.D. Pa. May 17, 2021).

By upholding the February 5, 2016 revocation, the ALJ correctly followed Board precedent rejecting equitable challenges to CMS enrollment determinations, including US Ultrasound, DAB No. 2302 (2010).  ALJ Decision at 8.  Equitable “estoppel against the federal government, if available at all, is presumably unavailable absent ‘affirmative misconduct,’ such as fraud, by the federal government.”  US Ultrasound at 8.  Petitioner attempts to distinguish US Ultrasound on the basis that in this case, “CMS, having published its own interpretive guidance, did not follow that guidance and then attempted to be unjustly enriched for doing so.”  RR at 14.  In other words, Petitioner “is arguing here that CMS should be estopped from prevailing on a nine-month delay in issuing the initial determination, not that CMS should be estopped from revoking Petitioner’s billing privileges altogether.”  RR at 15 (internal quotation marks omitted).  These attempted distinctions are inconsequential.  “The Board has repeatedly confirmed that neither it nor the ALJs have authority to overturn a legally valid agency action on equitable grounds or otherwise grant equitable relief.”  Foot Specialists at 18 (citing cases).  “Whether CMS’s determination here is somehow ‘inequitable’ is not a matter subject to our review as we do not have authority to grant equitable relief from lawful application of the governing regulations.”  Blossomwood Medical, P.C. & Vytautas Pukis, M.D., DAB No. 2914, at 11 (2018), aff’d sub nom. Pukis v. Centers for Medicare & Medicaid Servs., No. 5:19-CV-00232, 2020 WL 5632970 (N.D. Ala. Sept. 21, 2020).

Thus, we affirm the ALJ’s conclusion that the effective date of the revocation of Petitioner’s billing privileges is February 5, 2016.   

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C. The ALJ did not err in declining to determine whether CMS also had a valid legal basis for revocation under 42 C.F.R. § 424.535(a)(9).

The ALJ concluded that “CMS had a legal basis to revoke Petitioner’s enrollment and billing privileges under 42 C.F.R. § 424.535(a)(5),” and therefore found it unnecessary to decide “whether [CMS] had a basis to do so under 42 C.F.R. § 424.535(a)(9) as well.”  ALJ Decision at 9 (citing 1866ICPayday.com, L.L.C., DAB No. 2289 at 13 (2009)). 

Nevertheless, “to avoid a remand,” Petitioner argues that CMS had no basis to revoke under 42 C.F.R. § 424.535(a)(9).  RR at 19.  Petitioner contends that “this issue is entirely an embrace of form over substance” and “[a]ccordingly, CMS’s decision to revoke billing privileges under 42 C.F.R. § 424.535(a)(9) was error.”  Id. at 21-22.

The ALJ appropriately applied the legal principle that “failure to comply with even one supplier standard is a sufficient basis for revoking a supplier’s billing privileges.”  1866ICPayday.com at 13.  See Brenda Lee Jackson, DAB No. 2903, at 11 (2018) (“Concluding that CMS was authorized to act under one of the bases for revocation enumerated in the regulations is all that is necessary to uphold revocation.”); Meadowmere Emergency Physicians, PLLC, DAB No. 2881, at 8 (2018) (confirming that ALJ “need not find noncompliance with more than one of the bases for revocation in section 424.535(a) in order to uphold the revocation”); Bailey at 15 (“Concluding that CMS had one of the bases for revocation enumerated in the regulations is all that is necessary to uphold revocation.”) (underlining replaced with italics). 

Thus, the Board, like the ALJ, declines to consider whether CMS had an additional or alternative basis for revocation under 42 C.F.R. § 424.535(a)(9).  See AR Testing at 4 & n.7 (addressing revocation based on 42 C.F.R. § 424.535(a)(5) alone, despite CMS’s citation of additional ground of “failure to report a change in location,” and noting that “a revocation need only be upheld on one regulatory ground in order to be sustained ”).  “Since the ALJ upheld the revocation under subsection 424.535(a)(5), and we have affirmed the ALJ, the revocation would stand, regardless of whether CMS had an alternative basis to revoke under subsection 424.535(a)(9).”  Bailey at 15.

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Conclusion

We affirm the ALJ Decision.

Endnotes

¹  We apply the enrollment regulations in effect on November 5, 2016, the issuance date of the initial revocation determination.  See Diagnostic Imaging Network Med. Grp., Inc., DAB No. 3100, at 1 n.2 (2023).

²  Pertinent authorities use “onsite” and “on-site” interchangeably.  See, e.g., 42 C.F.R. § 424.517(a) (“onsite”) and 424.517(a)(1) (“on-site”).  We use the unhyphenated spelling unless quoting a source that does not.

³  This section provides context for our decision from the record but does not replace the ALJ’s findings.

⁴  The record documents this street address as being within both Los Angeles and “West Hollywood, California.”  CMS Ex. 4, at 5; CMS Ex. 6, at 35.  Accordingly, the ALJ called this practice location the “West Hollywood address.”  ALJ Decision at 1-2, 4-7.

⁵  We cite to the pages of the RFH itself, omitting the one-page cover letter filed with it.

⁶  We cite to the pages of the RR itself, omitting the six prefatory pages (a two-page cover letter, a copy of the two-page February 3, 2020 Civil Remedies Division letter transmitting the ALJ Decision to the parties, and a two-page Notice of Appearance) that Petitioner filed with it.

⁷  The Enrollment Record Summary actually shows a March 9, 2010 effective date for the West Hollywood address, CMS Ex. 4, at 5, but a March 2, 2010 effective date for the 1301 20th St #590 address, id. at 5-6.

⁸  Effective September 13, 2021, after Petitioner requested Board review, CMS completed the removal of Chapter 15’s provisions to Chapter 10 of the MPIM.  See MPIM, CMS Pub. 100-08, Transmittal 10945 (Aug. 12, 2021), (last visited Mar. 20, 2024), https://www.cms.gov/files/document/r10945pi.pdf.