Advanced Gastroenterology of Northern NJ LLC, DAB CR6770 (2025)

DECISION

Advanced Gastroenterology of Northern NJ LLC (Petitioner) challenges the Centers for Medicare & Medicaid Services’ (CMS’s) determination of its effective date of reactivation as a biller to the Medicare program following a period of deactivation due to its failure to revalidate.  As explained below, I find CMS properly determined October 15, 2024 as the reactivation effective date of Petitioner’s Medicare enrollment and billing privileges, as that is the date the Medicare administrative contractor received Petitioner’s revalidation/reactivation application that was processed to approval. 

I. Background

On March 28, 2024, CMS contractor Novitas Solutions, Inc. (Novitas) advised Petitioner that it was obligated to revalidate its Medicare enrollment by June 30, 2024.  CMS Ex. 8.  The letter informed Petitioner that it could submit its revalidation application either online through the Medicare Provider Enrollment, Chain, and Ownership System (PECOS) or by mail.  Id. at 1-2.  The letter, which was mailed to Petitioner, further warned that “[i]f we don’t receive your response by then, we may stop your Medicare billing privileges.”  Id. at 1. 

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On July 10, 2024, Novitas sent notice to Petitioner advising it was “placing a stay on your Medicare enrollment record effective July 10, 2024 because you have not responded to our revalidation request of March 28, 2024.”  CMS Ex. 7 at 1.  The letter further warned that “[f]ailure to submit a revalidation application within 30 days of this notice may result in a deactivation of your Medicare enrollment.”  Id.  Lastly, Petitioner was informed of its right to file a rebuttal if it believed the stay determination was incorrect.  Id. at 2.  

On October 7, 2024, Novitas deactivated Petitioner’s Medicare billing privileges effective July 1, 2024.  CMS Ex. 6 at 1.  Novitas stated that Petitioner’s deactivation was due to its failure to submit a timely revalidation application.  Id. (citing 42 C.F.R. § 424.540(a)(3)).  Novitas advised Petitioner of its right to file a rebuttal if Petitioner believed the deactivation was incorrect.  Id. at 1-2.  

On October 15, 2024, Novitas received a revalidation/reactivation application from Petitioner.  See CMS Ex. 5.  Petitioner also submitted corrections to its application on December 10, 2024.  CMS Ex. 4.  Novitas subsequently approved Petitioner’s application with an effective date of October 15, 2024.  CMS Ex. 3.  Novitas also advised Petitioner that there would be a gap in billing privileges from July 1, 2024 to October 14, 2024 for failing to revalidate.  Id. at 1.  

Petitioner thereafter filed a request for reconsideration of the deactivation and the gap in billing privileges.  CMS Ex. 2.  On March 12, 2025, Novitas issued a reconsidered determination and found no error in reactivating Petitioner’s Medicare billing privileges as of October 15, 2024, and with a gap in billing from July 1, 2024 to October 14, 2024.  CMS Ex. 1 at 3-4. 

On May 5, 2025, Petitioner timely requested a hearing to dispute the reconsidered determination.  DAB E-File Doc. Nos. 1-1_a.  That same day, the undersigned Administrative Law Judge (ALJ) was designated to hear and decide this case and the Civil Remedies Division (CRD) acknowledged the hearing request and issued my Standing Order.  Id. at Doc. Nos. 2-2_c.  Among other things, the Standing Order instructed the parties to file pre-hearing exchanges by specified dates.  Id. at Doc. No. 2_a.  

On June 9, 2025, CMS timely filed a motion for summary judgment and pre-hearing brief (CMS Br.) and eight proposed exhibits (CMS Exs. 1-8).  Id. at Doc. Nos. 4-4_i.  Petitioner did not file a timely pre-hearing exchange; therefore, I issued an order to show cause on July 21, 2025.  Id. at Doc. No. 5.  On July 31, 2025, Petitioner submitted an explanation for its untimely submissions, and I discharged the order to show cause that same day.  Id. at Doc. Nos. 6, 7.  Petitioner also submitted a brief (P. Br.) and copies of documents already in the record and did not submit any proposed exhibits.  Id. at Doc. Nos. 6_a-6_b.  On August 19, 2025, CMS filed notice that it would not submit a reply brief.  Id. at Doc. No. 8.  

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II. Admission of Exhibits and Decision on the Record

Petitioner did not object to CMS Exs. 1 through 8.  In the absence of objections, I admit CMS Exs. 1 through 8 into the record. 

The Standing Order advised the parties that an in-person hearing would only be necessary if a party submitted the written direct testimony of a proposed witness, and the opposing party requested an opportunity to cross-examine the witness.  Standing Order ¶¶ 11-13; see Vandalia Park, DAB No. 1940 (2004); Pac. Regency Arvin, DAB No. 1823 at 8 (2002) (holding that the use of written direct testimony for witnesses is permissible so long as the opposing party has the opportunity to cross-examine those witnesses).  

Neither party has submitted any proposed witnesses.  As such, a hearing in this case is unnecessary, and I decide this case based on the written record.  CRDP §§ 16(b), 19(b), (d).  CMS’s motion for summary judgment is therefore moot. 

III. Issue

Whether CMS had a legitimate basis to establish October 15, 2024, as the effective date of Petitioner’s reactivated Medicare billing privileges.  

IV. Jurisdiction

I have jurisdiction to decide this case.  42 C.F.R. §§ 498.3(b)(15), 498.5(l)(2).  

V. Findings of Fact, Conclusions of Law, and Analysis1

1. A. Applicable Law
   1. 1. Enrollment

Petitioner participates in the Medicare program as a “supplier” of services.  Social Security Act (Act) § 1861(d); 42 C.F.R. § 498.2.  To receive Medicare payments for the services it furnishes to program beneficiaries, a prospective supplier must enroll in the program.  42 C.F.R. § 424.505.  “Enrollment” is the process by which CMS and its contractors: (1) identify the prospective supplier; (2) validate the supplier’s eligibility to provide items or services to Medicare beneficiaries; (3) identify and confirm a supplier’s owners and practice location; and (4) grant the supplier Medicare billing privileges.  42 C.F.R. § 424.502. 

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To enroll, a prospective supplier must complete and submit an enrollment application.  42 C.F.R. §§ 424.510(d)(1), 424.515(a).  An enrollment application is either a CMS‑approved paper application or an electronic process approved by the Office of Management and Budget.  42 C.F.R. § 424.502.  When CMS determines a prospective supplier meets the applicable enrollment requirements, it grants Medicare billing privileges, which means that the supplier can submit claims and receive payments from Medicare for covered services provided to program beneficiaries.  42 C.F.R. § 424.505. 

The effective date for its billing privileges “is the later of the date of filing” a subsequently approved enrollment application or “[t]he date that the . . . supplier first began furnishing services at a new practice location.”  42 C.F.R. § 424.520(d)(1) (emphasis added).  The “date of filing” is the date that the Medicare contractor “receives” a signed enrollment application that the Medicare contractor is able to process to approval.  73 Fed. Reg. 69,726, 69,769 (Nov. 19, 2008); Donald Dolce, M.D., DAB No. 2685 at 7-8 (2016).  If a supplier satisfies certain requirements, CMS may allow a supplier to bill retrospectively for up to 30 days prior to the effective date.  42 C.F.R. § 424.521(a)(1). 

2. 2. Revalidation

To maintain billing privileges, a supplier must resubmit and recertify the accuracy of its enrollment information at least every five years, a process referred to as “revalidation.”  42 C.F.R. § 424.515.  Beyond these periodic revalidations, CMS may, at other times and for its own reasons, ask a supplier to recertify the accuracy of its enrollment information.  42 C.F.R. § 424.515(d).  Within 60 days of receiving CMS’s notice to recertify, the supplier must submit an appropriate enrollment application with complete and accurate information and supporting documentation.  42 C.F.R. § 424.515(a)(2). 

3. 3. Deactivation

The regulation authorizing deactivation explains that “deactivation [of Medicare billing privileges] is intended to protect the provider or supplier from the misuse of its billing number and to protect the Medicare Trust Funds from unnecessary overpayments.” 86 Fed. Reg. 62,240, 62,359 (Nov. 9, 2021).  CMS is authorized to deactivate an enrolled supplier’s Medicare billing privileges if the enrollee does not “furnish complete and accurate information and all supporting documentation within 90 calendar days of receipt of notification from CMS to submit an enrollment application and supporting documentation, or resubmit and certify to the accuracy of its enrollment information.”  42 C.F.R. § 424.540(a)(3).  If CMS deactivates a supplier’s Medicare billing privileges, “[n]o payment may be made for otherwise Medicare covered items or services furnished to a Medicare beneficiary.”  42 C.F.R. § 424.555(b); see also 42 C.F.R. § 424.540(e). 

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4. 4. Reactivation

The reactivation of an enrolled supplier’s Medicare billing privileges is governed by 42 C.F.R. § 424.540(b).  The process for reactivation is contingent on the reason for deactivation.  If CMS deactivates a supplier’s billing privileges due to a reason other than nonsubmission of a claim, the supplier must apply for CMS to reactivate its Medicare billing privileges by completing and submitting the appropriate enrollment application(s) or recertifying its enrollment information, if deemed appropriate.  42 C.F.R. § 424.540(a)(3), (b)(1); 71 Fed. Reg. 20,754, 20,762 (Apr. 21, 2006).  The effective date of a reactivation of billing privileges, following a period of deactivation, is the date on which the Medicare contractor received the supplier’s reactivation submission that was processed to approval.  42 C.F.R. § 424.540(d)(2). 

1. B. Analysis
   1. 1. Novitas received Petitioner’s revalidation/reactivation enrollment application on October 15, 2024 that was processed to approval and that date is the effective date of its Medicare reactivated enrollment.

As discussed above, the effective date of a reactivation of Medicare billing privileges is the date on which the Medicare contractor received the supplier’s reactivation submission that was subsequently processed to approval.  Id. 

In this case, Novitas received a revalidation/reactivation enrollment application from Petitioner on October 15, 2024, and this application was processed to approval.  CMS Exs. 3, 5.  Novitas thus appropriately found the effective date of Medicare billing privileges for Petitioner to be October 15, 2024, the date of receipt of the Medicare application that was subsequently approved by the Medicare contractor with a gap in billing privileges from July 1, 2024 through October 14, 2024.  CMS Exs. 3, 5.  Moreover, Petitioner does not claim that it submitted an earlier application than the one submitted on October 15, 2024, that Novitas received and subsequently approved. 

Therefore, pursuant to 42 C.F.R. § 424.540(d)(2), the date Novitas received Petitioner’s subsequently-approved enrollment application – October 15, 2024, – is the correct reactivation effective date of enrollment.  Michael B. Zafrani, M.D., DAB No. 3075 at 2 n.1 (2022).  

2. 2. I have no authority to review the deactivation of Petitioner’s billing privileges and cannot afford it equitable relief.

In its brief, Petitioner generally contends that Novitas erred in deactivating its Medicare billing privileges, which resulted in a gap of billing privileges from July 1, 2024 through 

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October 14, 2024.  P. Br. at 1.  Petitioner also states that the deactivation has caused a financial hardship.  Id.  Petitioner specifically states: 

• Our practice was not aware of any revalidation notifications or correspondence sent by Medicare because all communications were erroneously directed at an incorrect address. We have submitted a reconsideration letter explaining the circumstances that prevented us to quickly respond to the revalidation process. 

Id. 

I acknowledge Petitioner’s argument, but I have no authority to review Novitas’ deactivation of its Medicare billing privileges.  CMS Ex. 6; Howard M. Sokoloff, DPM, MS, Inc., DAB No. 2972 at 6 (2019); Ark. Health Grp., DAB No. 2929 at 7-9 (2019).  Here, the lack of notice is only relevant, if at all, to whether Novitas acted properly in deactivating Petitioner’s billing privileges.  Deactivation decisions in fact have an altogether separate review process that requires a provider or supplier dissatisfied with deactivation to file a rebuttal with CMS’s administrative contractor.  42 C.F.R. §§ 424.545(b), 424.546.  It does not appear that Petitioner filed a rebuttal and my jurisdiction in this case is limited to reviewing the effective date of the approval of Petitioner’s reactivation enrollment application.  42 C.F.R. § 498.3(b)(15). 

Further, even if Petitioner never received notice, this would not be a basis to grant an earlier effective date.  As the Departmental Appeals Board (Board) observed in James Shepard, M.D., DAB No. 2793 (2017), providers and suppliers may not challenge indirectly an action for which the regulations prohibit direct administrative review.  Shepard, DAB No. 2793 at 8.  In Shepard, the Board held that the supplier could not obtain review of a CMS contractor’s rejection of a previous enrollment application by challenging the effective date of enrollment based on a later approved application.  Id.  For the same reasons articulated by the panel in Shepard, Petitioner’s arguments in the present case amount to a backdoor challenge to a contractor determination—here, deactivation—for which there are no administrative appeal rights.  See id. 

Nor may I direct the contractor to allow for retrospective reimbursement during the gap in billing privileges.  A supplier may not receive payment for services or items furnished while deactivated.  42 C.F.R. §§ 424.540(e), 424.555(b).  This represents a departure; CMS previously permitted retrospective billing after reactivation.  In promulgating the new regulation, the Secretary explained the change:  

• After careful reflection . . . the most sensible approach from a program integrity perspective is to prohibit such payments altogether.  In our view, a provider or supplier should not be 

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• effectively rewarded for its non-adherence to enrollment requirements (for example, failing to respond to a revalidation request or failing to timely report enrollment information changes) by receiving payment for services or items furnished while out of compliance. 

86 Fed. Reg. 62,240, 62,359-60 (Nov. 9, 2021); see Michael B. Zafrani, M.D., DAB No. 3075 at 2 n.1. 

Lastly, I have no authority to review CMS’s revalidation process or otherwise grant Petitioner any form of equitable relief.  See, e.g., US Ultrasound, DAB No. 2302 at 8 (2010) (“Neither the ALJ nor the Board is authorized to provide equitable relief by reimbursing or enrolling a supplier who does not meet statutory or regulatory requirements.”); Pepper Hill Nursing & Rehab. Ctr., LLC, DAB No. 2395 at 10-11 (2011) (holding that the ALJ and Board were not authorized to provide equitable relief by reimbursing or enrolling a supplier who does not meet statutory or regulatory requirements); UpturnCare Co., DAB No. 2632 at 19 (2015) (providing the Board may not overturn the denial of provider enrollment in Medicare on equitable grounds).  I am sympathetic to the fact that the practice has suffered a significant loss of income while rendering services to the Medicare program, however, I have no authority under the law to revise the effective date of reactivation determined by CMS. 

VI. Conclusion

Because Novitas received the revalidation/reactivation application that was processed to approval on October 15, 2024, that same date is the earliest possible reactivation effective date.  See 42 C.F.R. § 424.540(d)(2).  

I may not review the deactivation.  

Retrospective reimbursement is not available for those whose enrollment has been deactivated.  42 C.F.R. § 424.540(e).