Guardian Biologics LLC, DAB CR6581 (2024)

Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division

Guardian Biologics LLC,
(NPI: 1033890876 / PTAN: 6E0308),
Petitioner,

v.

Centers for Medicare & Medicaid Services.

Docket No. C-24-545
Decision No. CR6581

DECISION

I affirm the determination of the Centers for Medicare & Medicaid Services (CMS) that the effective date for the reactivation of the Medicare billing privileges for Petitioner, Guardian Biologics LLC, is November 14, 2023. 

I. Procedural History

On June 27, 2024, Petitioner requested a hearing before an administrative law judge to dispute the deactivation of its Medicare billing privileges based on the deactivation of Petitioner’s National Provider Identifier (NPI). 

On July 8, 2024, the Civil Remedies Division (CRD) acknowledged receipt of Petitioner’s hearing request, provided the parties with a prehearing submission schedule, and issued copies of my Standing Order and the Civil Remedies Division Procedures (CRDP).  Consistent with the Standing Order, on August 8, 2024, CMS filed a brief/motion for summary judgment and seven proposed exhibits (CMS Exs. 1-7).  On September 13, 2024, Petitioner filed a letter brief (P. Br.), which Petitioner labeled as 

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Exhibit 3 (i.e., E-Filing System (E-File) Doc. No. 8) and two proposed exhibits (i.e., P. Ex. 1 (E-File Doc. No. 6) and P. Ex. 2 (E-File Doc. No. 7).  CMS filed a notice that it would not submit a reply brief. 

II. Admission of Evidence

I admit all of CMS’s proposed exhibits into the record without objection.  See Standing Order ¶ 10; CRDP § 14(e). 

Of Petitioner’s proposed exhibits, I only admit Petitioner Exhibit 1 into the record.  Petitioner Exhibit 2 duplicates page 11 of CMS Exhibit 5, so Petitioner should not have submitted it.  Standing Order ¶ 7 (“Petitioner must not submit documents that CMS has already submitted as proposed exhibits.”); CRDP § 14(a).  Further, Petitioner Exhibit 3 is an unsigned letter from Petitioner’s representative, which I treat as a letter brief.  

III. Decision on the Written Record

I directed the parties to submit written direct testimony for any witnesses they wanted to offer.  Standing Order ¶ 11; see also CRDP § 16(b).  I also informed the parties as follows: 

If the parties either do not file any written direct testimony or the parties do not request to cross-examine any of the witnesses from whom written direct testimony has been submitted, I will consider such actions by the parties to serve as a constructive request for a decision on the written record because there will be no reason to hold an in-person hearing.  

Standing Order ¶ 7(g)(iii) see also CRDP § 19(d).  I further advised:  “Unless a hearing is required for cross-examination of a witness or witnesses, the record will be closed and the case will be ready for a decision after all the submission deadlines have passed.”  Standing Order ¶ 14. 

Neither party submitted written direct testimony from any witnesses and all submission deadlines have passed.  Therefore, I decide this case on the written record.  See Anil Hanuman, D.O., DAB No. 3080 at 11-12 (2022); CRDP § 19(d). 

IV. Issue

Whether November 14, 2023, is the correct effective date for the reactivation of Petitioner’s Medicare billing privileges. 

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V. Jurisdiction

I have jurisdiction to decide the issues in this case.  42 C.F.R. § 498.3(b)(15). 

VI. Findings of Fact

  1. Petitioner is a clinic/group practice that is enrolled in the Medicare program as a supplier. See CMS Ex. 3 at 1.
  2. On October 14, 2023, the National Plan and Provider Enumeration System (NPPES) deactivated Petitioner’s NPI because Petitioner’s Taxpayer ID was entered incorrectly. CMS Ex. 2.
  3. In an October 26, 2023 letter, the CMS contractor advised Petitioner that it was deactivating Petitioner’s Medicare billing privileges under 42 C.F.R. § 424.540(a)(4) as of October 14, 2023, because the CMS contractor “has been made aware that your National Provider Identifier (NPI) 1033890876 has been deactivated as of October 14, 2023.” CMS Ex. 1 at 1.  The CMS contractor advised Petitioner of the right to appeal the deactivation through filing a “rebuttal.”  CMS Ex. 1 at 1-2.  
  4. The CMS contractor never received a rebuttal from Petitioner concerning the deactivation of Medicare billing privileges. CMS Ex. 7 at 2.
  5. On November 14, 2023, CMS received a Medicare enrollment application that Petitioner filed in order to reactivate its Medicare billing privileges. CMS Ex. 3.  
  6. On November 28, 2023, the CMS contractor approved Petitioner’s application for reactivation with a reactivation effective date of November 14, 2023. CMS Ex. 4 at 1.
  7. On February 6, 2024, Petitioner requested that CMS reconsider the effective date for the reactivation of billing privileges. CMS Ex. 5.  Petitioner argued that the deactivation of billing privileges was based on the accidental deletion of Petitioner’s NPI, but NPPES corrected this situation.  CMS Ex. 5 at 10.  Petitioner requested that CMS change the reactivation effective date to October 14, 2023, because NPPES now shows that Petitioner’s NPI was effective during the period of deactivation.  CMS Ex. 5 at 10-11.  
  8. On February 15, 2024, CMS found that there was good cause for Petitioner to file an untimely request for reconsideration. CMS Ex. 6.  

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  1. On April 26, 2024, the CMS contractor issued a reconsidered determination upholding November 14, 2023, as the effective date for the reactivation of billing privileges. The CMS contractor did not consider whether Petitioner’s Medicare billing privileges had been properly deactivated.  CMS Ex. 7. 

VII. Conclusions of Law and Analysis

The Social Security Act (Act) authorizes the Secretary of Health and Human Services (Secretary) to promulgate regulations governing the enrollment process for providers and suppliers.  42 U.S.C. §§ 1302, 1395cc(j).  A “supplier” includes “a physician or other practitioner, a facility, or other entity (other than a provider of services) that furnishes items or services” under the Medicare provisions of the Act.  42 U.S.C. § 1395x(d).  A supplier must enroll in the Medicare program to receive payment for covered items or services.  42 U.S.C. §§ 1395n(a),1395u(h)(1); 42 C.F.R. § 424.505.  To enroll, the supplier must submit an enrollment application and provide all required information.  42 C.F.R. § 424.510(a). 

One enrollment requirement is that each supplier must have an NPI.  The Act requires the Secretary to adopt standards for providing a unique health identifier for each individual, employer, health plan, or health care provider for use in the health care system.  42 U.S.C. § 1320d-2(b)(1).  The Secretary established the NPI.  45 C.F.R. § 162.406.  The Secretary also established the National Provider System, which assigns “a single, unique NPI” to health care providers.  45 C.F.R. § 162.408(a).  When a supplier files an enrollment application with the Medicare program, the supplier must report the supplier’s NPI.  42 C.F.R. § 424.506(b)(1)(i).  When a supplier files a Medicare claim, the supplier must include the supplier’s NPI or else a Medicare contractor will deny the claim.  42 C.F.R. § 424.506(c). 

  1. 1. I have no jurisdiction to review or reverse CMS’s decision to deactivate Petitioner’s Medicare billing privileges. Petitioner needed to file a rebuttal with CMS to appeal CMS’s decision to deactivate Medicare billing privileges. 

The CMS contractor deactivated Petitioner’s Medicare billing privileges because Petitioner’s NPI was deactivated.  CMS Ex. 1 at 1.  As a result, CMS deactivated Petitioner’s Medicare billing privileges because Petitioner failed to meet enrollment requirements.  See 42 C.F.R. §§ 424.506(b)(1)(i), 424.540(a)(4).  The deactivation notice provided Petitioner with detailed information as to how to appeal the deactivation by filing a rebuttal.  CMS Ex. 1 at 1-2; see 42 C.F.R. §§ 424.545(b), 424.546.  In the reconsidered determination, the CMS contractor stated that it did not receive a rebuttal from Petitioner.  CMS Ex. 7 at 2.  In this proceeding, Petitioner has not alleged that it submitted a rebuttal to CMS. 

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Petitioner argues in this case that in October 2023, NPPES accidentally deactivated Petitioner’s NPI.  When this happened, Petitioner contacted NPPES to seek reactivation of the NPI and submitted the necessary form.  As a result, “[t]he issue was corrected.”  P. Br.; see also CMS Ex. 5 at 10 (“This was corrected and our NPI was reactivated and does not show a lapse.”); 45 C.F.R. § 162.408(d) (NPPES may, “[i]f appropriate, reactivate a deactivated NPI upon receipt of appropriate information.”).  An NPPES document that Petitioner submitted with its reconsideration request shows that Petitioner’s NPI enumeration date was July 25, 2023, and Petitioner’s NPI certification date was November 14, 2023.  CMS Ex. 5 at 11.  However, despite this, it is unclear whether there was or was not a lapse in Petitioner’s NPI.  

Although the record is not clear whether or not Petitioner’s NPI was correctly deactivated, this is not an issue before me to decide.  Rather, Petitioner could have raised this issue with CMS if Petitioner had filed a rebuttal to the deactivation notice.  See 42 C.F.R. § 424.546(d).  I have no jurisdiction to consider whether CMS rightly or wrongly deactivated Petitioner’s Medicare billing privileges because the deactivation is not an initial determination appealable to an administrative law judge.  See 42 C.F.R. § 424.546(f).  Petitioner’s appeal before me is limited to the question as to whether CMS provided Petitioner with the correct date of reactivation for its billing privileges. 

  1. The effective date for the reactivation of Petitioner’s Medicare billing privileges is November 14, 2023.

Once CMS deactivated Petitioner’s Medicare billing privileges, Petitioner needed to submit relevant information to reactivate its Medicare billing privileges.  42 C.F.R. § 424.540(b).  If a supplier seeks reactivation, “[t]he effective date of a reactivation of billing privileges under this section is the date on which the Medicare contractor received the . . . supplier’s reactivation submission that was processed to approval by the Medicare contractor.”  42 C.F.R. § 424.540(d)(2). 

In this case, CMS received Petitioner’s enrollment application to reactivate Medicare billing privileges on November 14, 2023, and the CMS contractor approved that application.  CMS Exs. 3-4.  Therefore, the effective date of reactivation is November 14, 2023. 

Petitioner is primarily concerned with the fact that the deactivation of Medicare billing privileges on October 14, 2023, and the reactivation on November 14, 2023, caused a gap in its billing privileges.  This is problematic to Petitioner because, as Petitioner wrote:  “[W]e have claims for multiple patients that we need to file and get reimbursement on.”  CMS Ex. 5 at 10; P. Ex. 1 (listing claims affected by the deactivation). 

Although I am sympathetic to Petitioner’s situation, I cannot ignore the regulations and change the effective date for reactivation so that Petitioner may bill for the services it 

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provided to patients while Petitioner’s Medicare billing privileges were deactivated.  Further, I cannot direct CMS to pay Petitioner’s claims because the regulations expressly prohibit CMS from paying Petitioner for any health care items or services provided during the period of deactivate.  42 C.F.R. §§ 424.540(e), 424.555(b); 86 Fed. Reg. 62,240, 62,359-60 (Nov. 9, 2021); see also Goffney v. Becerra, 995 F.3d 737, 743 (9th Cir. 2021).  I only have authority to determine if CMS properly set the date reactivation.  See 42 C.F.R. § 498.3(b)(15).  In this case, CMS has done so. 

VIII.   Conclusion

The effective date for the reactivation of Petitioner’s Medicare billing privileges is November 14, 2023. 

                                                                                               

                                                                                                /s/ Scott Anderson

                                                                                                Scott Anderson

                                                                                                Administrative Law Judge

                                                                                                         

/s/

Scott Anderson Administrative Law Judge