Citrus Valley Gastroenterology, A Medical Corp., DAB CR6641 (2025)

DECISION

December 13, 2023, is the effective date of reactivation of the Medicare enrollment and billing privileges of Petitioner, Citrus Valley Gastroenterology, A Medical Corp.

I. Background and Findings of Fact

The Centers for Medicare & Medicaid Services (CMS) has presented evidence that Noridian Healthcare Solutions, a Medicare administrative contractor (MAC), sent Petitioner a letter dated July 10, 2023. The letter informed Petitioner that it was not in compliance with Medicare regulations because Suresht Sharma, MD was deceased and had to be removed from Petitioner’s enrollment. The MAC gave Petitioner 90 days to comply by filing a change of enrollment information or the MAC warned it would deactivate Petitioner’s Medicare billing privileges. CMS Exhibit (Ex.) 1 at 433.

Petitioner has presented the declaration of Madhu Sharma, MD, Petitioner’s Chief Financial Officer (CFO). P. Ex. 1 at 1-3. She testified that she did not become aware of the MAC’s July 10, 2023 notice until August 2024. She also testified that, based on her position as CFO, she knew that Petitioner did not receive the letter until August 2024. P. Ex. 1 at 2-3 ¶ 9. She testified that had Petitioner received the July 10, 2023 notice, Petitioner’s staff would have responded timely. P. Ex. 1 at 3 ¶ 12. I accept as true for

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purposes of summary judgment the assertion that Petitioner did not receive the July 10, 2023 MAC notice until August 2024, and that Petitioner would have responded timely if the notice had been received.

On October 9, 2023, the MAC notified Petitioner that its Medicare billing privileges were deactivated effective October 9, 2023, because Petitioner failed to file a Medicare enrollment application to delete Suresht Sharma, MD, who died June 26, 2023, from its enrollment information as Petitioner’s authorized official, managing employee, and partner. The MAC noted that Petitioner’s Medicare enrollment application signed and certified on September 5, 2023, continued to list Suresht Sharma, MD. CMS Ex. 1 at 430. CFO Sharma admits in her declaration that she learned that Petitioner’s billing privileges were deactivated in October 2023. P. Ex. 1 at 2 ¶ 8.

Petitioner filed a Medicare enrollment application signed and certified on October 16, 2023, to reactivate its Medicare enrollment and billing privileges and effect the change of enrollment information. CMS Ex. 1 at 357, 404-05. The application is marked to remove S. Paul Sharma, physician, from Petitioner’s enrollment as delegated official, director/officer, and contracted managing employee effective June 26, 2023. CMS Ex. 1 at 390. The MAC acknowledged receipt of the application on October 20, 2023. CMS Ex. 1 at 348. CFO Sharma states in her declaration that Petitioner filed a Medicare enrollment application on October 20, 2023. P. Ex. 1 at 2 ¶ 8. On November 10, 2023, the MAC notified Petitioner that changes to the Medicare enrollment application were required in no more than 30 calendar days. CMS Ex. 1 at 344. Petitioner submitted revised information. CMS Ex. 1 at 266-340. The evidence includes a letter dated December 11, 2023, in which the MAC informed Petitioner that its Medicare enrollment application received on October 20, 2023, was rejected. CMS Ex. 1 at 258. Petitioner admits that the letter stated that Petitioner’s October 20, 2023 application was rejected. P. Br. at 7. However, Petitioner argues that the October 20, 2023 application was processed to approval by the MAC. Petitioner asserts that it subsequently amended the October 20, 2023 application by submitting minimal information (20 pages) not already provided prior to December 11, 2023, resulting in the October 20, 2023 application being processed to approval by the MAC. Petitioner’s legal theory is that the MAC had discretion to extend the time granted to Petitioner for correcting the October 20, 2023 application; Petitioner did not file a completely new application on December 13, 2023; and the MAC acquiesced by accepting Petitioner’s corrections to its October 20, 2023 application by not insisting on an entirely new application. P. Br. at 6-8. I am not required to accept as true for purposes of summary judgment or draw a favorable inference for Petitioner based on its legal theory and I do not. Petitioner points to no evidence that the MAC processed Petitioner’s October 20, 2023 application to approval. Rather, Petitioner argues that the MAC had the discretion under CMS policy to treat Petitioner as amending or supplementing its October 20, 2023 application. But the MAC clearly stated in its December 11, 2023 letter that Petitioner’s October 20, 2023 application was rejected. Petitioner cannot create a genuine dispute of material fact and

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defeat summary judgment based solely upon a legal possibility or theory without presenting some evidence that events occurred as Petitioner posits. Fed. R. Civ. P. 56(c)‑(d); Standing Order ¶ G (the federal rule and related cases used as guidance). If Petitioner had evidence that the MAC processed the October 20, 2023 application to approval and not just stacked inferences and a legal theory, Petitioner should have presented the evidence in response to CMS’ motion for summary judgment. It is insufficient for Petitioner to rely upon mere allegations or denials to defeat CMS’ motion for summary judgment and proceed to hearing. Petitioner must, by affidavits or other evidence which set forth specific facts, show that there is a genuine issue for trial. If Petitioner cannot show by some credible evidence that there exists some genuine issue for trial, then summary judgment is appropriate and CMS prevails on the motion as a matter of law. See Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247 (1986). A test for whether an issue of fact is genuinely in dispute is whether “the evidence [as to that issue] is such that a reasonable jury could return a verdict for the nonmoving party.” Id. at 248. In evaluating whether there is a genuine issue as to a material fact, an ALJ must view the facts and the inferences to be drawn from the facts in the light most favorable to the nonmoving party, which I have done. See Pollock v. American Tel. & Tel. Long Lines, 794 F.2d 860, 864 (3rd Cir. 1986). However, no favorable inference may be drawn for Petitioner that the MAC processed Petitioner’s October 20, 2023 application to approval, and no reasonable jury would return a verdict it did so based on the evidence in the record.

Petitioner filed another Medicare enrollment application, or at least part of an application as argued by Petitioner (P. Br. at 7), signed and certified on December 12, 2023 and received by the MAC on December 13, 2023. CMS Ex. 1 at 240, 251-56. The application was to change Petitioner’s Medicare enrollment information and reactivate its Medicare enrollment application and billing privileges. CMS Ex. 1 at 221. The MAC notified Petitioner on December 20, 2023, that corrections were required by January 19, 2024. CMS Ex. 1 at 207. On February 9, 2024, the MAC notified Petitioner that its reactivation application was approved effective December 13, 2023, the date the Medicare enrollment application was received. CMS Ex. 1 at 33; P. Ex. 1 at 22-24.

On March 6, 2024, Petitioner requested a reconsidered determination to reactivate Petitioner’s billing privileges effective October 9, 2023. CMS Ex. 1 at 31. A MAC hearing officer issued a reconsidered determination on June 4, 2024. The hearing officer upheld December 13, 2023, as the effective date of the reactivation of Petitioner’s Medicare enrollment and billing privileges. CMS Ex. 1 at 1-3.

On June 19, 2024, Petitioner filed a request for hearing (RFH) before an administrative law judge (ALJ). On August 15, 2024, CMS filed a combined motion for summary judgment and prehearing brief (CMS Br.) with CMS Exhibits 1 and 2. On September 23, 2024, Petitioner filed a brief in opposition to CMS’ motion for summary judgment (P.

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Br.), objections to CMS’ evidence, and Petitioner’s Exhibit (P. Ex.) 1. CMS filed a reply brief and objections to Petitioner’s evidence on October 7, 2024 (CMS Reply).

Petitioner objects to CMS Ex. 1 on grounds that it has not been authenticated, no foundation has been laid, and the documents are incomplete. Petitioner does not state how CMS Ex. 1 is incomplete or offer evidence to complete the record. Petitioner objects to CMS Ex. 2 on grounds that it has not been authenticated and no foundation has been laid. The Federal Rules of Evidence (Fed. R. Evid.) are not binding in this administrative proceeding but they provide helpful guidance. Fed. R. Evid. 901(a) provides that the requirement to authenticate or identify evidence is satisfied if the offering party produces sufficient evidence to support a finding the evidence is what it is purported to be. Fed. R. Evid. 901(b)(4) recognizes that authentication may be based on appearance, content, substance, internal patterns, or the distinctive characteristics of the item considered with all the circumstances. CMS Exs. 1 and 2 contain more than sufficient indicia that the documents are from Petitioner’s Medicare enrollment records collected or generated by the MAC to support my finding that the documents are what they are purported to be. The content of the documents show that those documents are related to Petitioner’s Medicare enrollment, specifically the deactivation, reactivation, and the effective date of the reactivation of Petitioner’s billing privileges. Therefore, the documents are relevant within the meaning of Fed. R. Evid. 401 for, absent evidence to the contrary, the documents have some tendency to make facts of consequence to deciding the issue before me more or less probable than without the evidence. In this proceeding, authentication and relevance are the two fundamentals of an adequate foundation. Accordingly, Petitioner’s objections to CMS Exhibits 1 and 2 are overruled and they are admitted and considered as evidence.

CMS objects to P. Ex. 1 on grounds that it is new evidence. In provider and supplier enrollment appeals, which this is, an ALJ is required to determine whether the provider or supplier has shown good cause for offering new documentary evidence for the first time at the ALJ level. If not, the evidence must be excluded. 42 C.F.R. § 498.56(e).1 Various documents are included in P. Ex. 1 that need to be analyzed as separate documents.

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P. Ex. 1 at 1 through 3 is a declaration submitted in support of Petitioner’s opposition to CMS’ motion for summary judgment. A declaration like an affidavit is a testimony substitute and is more appropriately treated as testimony subjecting one to a perjury charge if shown to be false, rather than documentary evidence. The plain language of the regulation shows it only applies to documentary evidence. Therefore, 42 C.F.R. § 498.56(e) has no application to a declaration or an affidavit. Good cause can also be found because the declaration executed on September 23, 2024, did not exist at the time of the June 4, 2024 reconsidered determination. Declarations and affidavits are commonly filed in support of a motion for summary judgment or in opposition to such a motion and would typically be dated after the request for hearing is filed. A finding of good cause for not offering a document that did not exist at the time of the reconsidered determination is reasonable. P. Ex. 1 at 1 through 3 is admitted.

P. Ex. 1 at 4 through 21 are letters from the MAC to physicians who are part of Petitioner, which is a practice group. Some of the letters advise that the MAC approved the subject physician’s reactivation and reassignment to Petitioner, others show the MAC approved the subject physician’s change of information application, and others show that the MAC approved an initial enrollment and reassignment application. The MAC letters marked as P. Ex. 1 at 4 through 21 are not relevant to any issue I may decide in this case and not admitted because the cases of those individual practitioners are not before me pursuant to a timely filed request for hearing.

P. Ex. 1 at 22 through 24 is a copy of the February 9, 2024 initial determination of the MAC reactivating Petitioner’s Medicare enrollment and billing privileges effective December 13, 2023. This letter is included in CMS Ex. 1 at 33-35. P. Ex. 1 at 22 through 24 is cumulative but admitted.

P. Ex. 1 at 25 through 26 is an information document from CMS discussing enrollment applications. This document is also not relevant to any issue I may decide, and it is not admitted. However, I accept as true for purposes of summary judgment Petitioner’s assertion that during the pendency of its application, CMS transitioned from requiring the CMS-855R to accepting the CMS-855I as the application for reassigning benefits.

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II. Issues, Conclusions of Law, and Analysis

A. Issues

Whether I have jurisdiction to review the reconsidered determination by CMS or a MAC of the effective date of reactivation of Medicare billing privileges, which are the right to file claims with and to receive payment from Medicare; and

The effective date of reactivation of Petitioner’s billing privileges.

B. Conclusions of Law and Analysis

My conclusions of law are set forth in bold text followed by my analysis applying the law to the undisputed facts.

1. Summary judgment is appropriate.

Petitioner is entitled to a hearing on the record before an ALJ under the Social Security Act (Act). Act §§ 205(b); 1866(h)(1), (j); Crestview Parke Care Ctr. v. Thompson, 373 F.3d 743, 748-51 (6th Cir. 2004). However, when summary judgment is appropriate, no hearing is required. The Departmental Appeals Board (Board) has long accepted that summary judgment is an acceptable procedural device in cases adjudicated pursuant to 42 C.F.R. pt. 498. See, e.g., Crestview Parke, 373 F.3d at 748-51; Ill. Knights Templar Home, DAB No. 2274 at 3-4 (2009); Garden City Med. Clinic, DAB No. 1763 (2001); Everett Rehab. & Med. Ctr., DAB No. 1628 at 3 (1997). The Board has accepted that Fed. R. Civ. P. 56 and related cases provide useful guidance for determining whether summary judgment is appropriate. I advised the parties in the Standing Order ¶¶ D and G that summary judgment is an available procedural device and that the law as it has developed related to Fed. R. Civ. P. 56 will be applied. Summary judgment is appropriate when there is no genuine dispute as to any issue of material fact for adjudication and/or the moving party is entitled to judgment as a matter of law. See Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986); Mission Hosp. Reg’l Med. Ctr., DAB No. 2459 at 5 (2012) (and cases cited therein); Experts Are Us, Inc., DAB No. 2452 at 5 (2012) (and cases cited therein); Senior Rehab. & Skilled Nursing Ctr., DAB No. 2300 at 3 (2010) (and cases cited therein).

The undisputed facts set forth above are the facts necessary to resolve this case. There is no genuine dispute of material fact related to the effective date of the reactivation of Petitioner’s billing privileges. CMS is entitled to judgment as a matter of law and summary judgment is appropriate.

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2. Petitioner has no right to ALJ review of the determination of the MAC to deactivate its billing privileges.
3. Petitioner has no right to ALJ review of the rejection of its Medicare enrollment application.
4. There is authority for ALJ review in this case, but it is limited to the effective date of reactivation of Petitioner’s Medicare enrollment and billing privileges, i.e., the date of reactivation of Petitioner’s right to submit claims to and receive payment from Medicare for care and services delivered to Medicare-eligible beneficiaries.
5. December 13, 2023, is the effective date of reactivation of Petitioner’s billing privileges as that was the date the MAC received the Medicare enrollment application that it could process to approval. 42 C.F.R. § 424.540(d)(2).

This case involves a gap in Petitioner’s billing privileges from October 9 to December 13, 2023. There is no dispute Petitioner’s Medicare enrollment and related billing privileges were deactivated effective October 9, 2023. In its request for a reconsidered determination, Petitioner requested that the effective date of reactivation be changed from December 13, 2023 to October 9, 2023, to eliminate the gap. Petitioner argued in its reconsideration request that the inability to bill for services delivered to Medicare-eligible beneficiaries during the gap period caused financial hardship. CMS Ex. 1 at 31-32. Before me, Petitioner asserts that the effective date of the reactivation of its billing privileges should be October 20, 2023, the date Petitioner submitted the enrollment application Petitioner argues was processed to approval by the MAC. P. Br. at 1-2, 6-8. Petitioner’s grievance is that CMS and the MAC decline to pay for services rendered to Medicare-eligible beneficiaries during the gap period, even though there is no dispute that Petitioner was enrolled in Medicare during the gap period. Petitioner asserts that it was unable to bill over $100,000 of items or services due to the deactivation. P. Br. at 1; CMS Ex. 1 at 31. For purposes of this decision, it is important to understand that there is a difference between deactivation of Medicare enrollment and billing privileges and revocation of Medicare enrollment and billing privileges. Petitioner’s billing privileges were deactivated or temporarily suspended rather than being revoked.

The Secretary of the U.S. Department of Health & Human Services (the Secretary) promulgated regulations at 42 C.F.R. Part 424 that establish a process for enrolling providers and suppliers in Medicare. Pursuant to the regulations, CMS or the MAC may deactivate the billing privileges of an enrolled provider or supplier for any of the eight reasons listed in 42 C.F.R. § 424.540(a). Pursuant to 42 C.F.R. § 424.540(a)(2), Medicare billing privileges may be deactivated if a provider or supplier fails to report a change in enrollment information within the time specified by the regulations.

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Deactivation of billing privileges has no effect on a provider’s or supplier’s “participation agreement or any conditions of participation.” 42 C.F.R. § 424.540(c). But a provider or supplier may receive no payment from Medicare for items or services provided to a Medicare-eligible beneficiary during the period of deactivation. 42 C.F.R. § 424.540(e).

Billing privileges may be reactivated in accordance with 42 C.F.R. § 424.540(b). The provider or supplier must recertify the accuracy of its enrollment information, submit any missing information, and certify it is in compliance with all applicable Medicare enrollment requirements. 42 C.F.R. § 424.540(b)(1). CMS may for any reason require a deactivated provider or supplier to submit a complete Medicare enrollment application (CMS-855) to reactivate billing privileges. 42 C.F.R. § 424.540(b)(2). The regulation clearly gives CMS and the MAC discretion to accept a certification and partial application with missing information provided or required that Petitioner submit a complete Medicare enrollment application.

According to 42 C.F.R. § 424.540(d)(2), the effective date of reactivation of billing privileges is the date the MAC or CMS received the Medicare enrollment application that was processed to approval.

The Secretary has not specifically stated that a provider or supplier has a right to ALJ review of CMS or MAC determinations related to the reactivation of billing privileges. 42 C.F.R. §§ 424.545, 498.3(b), 498.5. However, 42 C.F.R. § 498.3(b)(15) provides that “[t]he effective date of a Medicare provider agreement or supplier approval” is an initial determination subject to review by an ALJ. The Board has given an expansive interpretation to 42 C.F.R. § 498.3(b)(15) and found a right to ALJ review of the effective date of enrollment in Medicare as well as the effective date of the reactivation of billing privileges. See, e.g., Victor Alvarez, M.D., DAB No. 2325 at 3-12 (2010) (determination of effective date of enrollment in Medicare is an initial determination subject to ALJ review and Board appeal); Urology Grp. of NJ, LLC, DAB No. 2860 at 6 (2018) (no right to review of a CMS or MAC determination to deactivate billing privileges but right to review of the determination of the effective date of reactivation).

Applying the reasoning of the Board in Alvarez and Urology, I conclude that a supplier has the right to ALJ review of the CMS or MAC determination of the effective date of reactivation of billing privileges. Furthermore, the only determination of CMS or the MAC that is subject to my review in a provider or supplier enrollment case is the reconsidered determination. 42 C.F.R. § 498.5(l)(1)-(2); Neb Grp. of Ariz. LLC, DAB No. 2573 at 7.

Applying the regulations to the undisputed facts in this case is not complicated.

The MAC deactivated Petitioner’s billing privileges effective October 9, 2023. The deactivation occurred because Petitioner failed to file a change of Medicare enrollment

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information that was necessitated by the death of one of Petitioner’s group who was an owner. CMS Ex. 1 at 31, 433-34; P. Ex. 1 at 2 ¶ 5. Petitioner’s obligation to report such a change in information is imposed by 42 C.F.R. § 424.516(d). A change in ownership, adverse legal action, and a change in practice location must be reported to the MAC within 30 days and other changes in enrollment information must be submitted in 90 days. The obligation to report is not contingent upon the MAC sending notice of the reporting requirement to Petitioner. Deactivation for failure to report changed Medicare enrollment information is authorized by 42 C.F.R. § 424.540(a)(2). The regulations do not require that the MAC provide notice to a provider or supplier prior to deactivation or grant an opportunity for the provider or supplier to correct information prior to deactivation. Rather, the regulations provide that CMS or the MAC sends the notice of deactivation and permits 15 days for the submission of a rebuttal. 42 C.F.R. § 424.546(a)-(b). But the regulation is clear that CMS is not required to delay deactivation pending completion of the review of any rebuttal. 42 C.F.R. § 424.546(e). Therefore, whether Petitioner received the July 10, 2023 MAC notice, which is not required by the regulations, is not material. The deactivation determination is not subject to appeal or review. 42 C.F.R. § 424.546(f). Therefore, any alleged defects in the process followed by the MAC in deactivating Petitioner’s Medicare enrollment and billing privileges are also immaterial to this decision.

By operation of 42 C.F.R. § 424.540(d)(2), the effective date of the reactivation of Petitioner’s Medicare billing privilege must be December 13, 2023, the date the MAC received the application it processed to approval. The regulations grant no discretion to the MAC, CMS, or me to select a different reactivation effective date.

Petitioner’s argument it did not receive the July 10, 2023, notice is without merit. Notice prior to deactivation is not required by the regulations. 42 C.F.R. Part 424, subpart P. CMS or the MAC has discretion to send a notice before or after the deactivation is effective. 42 C.F.R. § 424.546(a)(1). The October 9, 2023 MAC notice was the notice required by 42 C.F.R. § 424.546(a)(1) and it properly advised Petitioner of the right to submit a rebuttal within 15 days. CMS Ex. 1 at 430-31. Petitioner does not dispute it received the October 9, 2023 notice. There is no evidence Petitioner filed a rebuttal. The evidence shows that Petitioner filed a Medicare enrollment application on October 20, 2023, to correct its Medicare enrollment information and reactivate its billing privileges. CMS Ex. 1 at 357, 404-05. A provider or supplier has no right to appeal a CMS or MAC decision to deactivate its billing privileges and I have no authority to review the deactivation determination. 42 C.F.R. § 424.546(f). A provider’s or supplier’s only recourse when billing privileges are deactivated is to file a rebuttal with the MAC or CMS. 42 C.F.R. §§ 424.545(b), 424.546. In the alternative, as here, the deactivated provider or supplier files a Medicare enrollment application to correct its noncompliance so that its billing privileges are reactivated.

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The MAC’s authority to reject a Medicare enrollment application is found in 42 C.F.R. § 424.525. Pursuant to 42 C.F.R. § 424.525(d), the rejection of an application is not subject to appeal or review. Therefore, the MAC’s decision (CMS Ex. 1 at 258) rejecting Petitioner’s October 20, 2023 application to correct its Medicare enrollment application and reactivate its billing privileges is not a decision of the MAC subject to my review as a matter of law.

Petitioner’s arguments that the MAC requested the wrong forms from Petitioner causing delay is also without merit. Petitioner asserts that it filed reassignment applications (CMS-855R) when those forms were still in use. CMS then transitioned from using the CMS-855R to the CMS-855I forms. After the transition, the MAC requested revisions for six items on the CMS-855R forms previously submitted by Petitioner. Petitioner states it complied with the MAC’s request. But, Petitioner asserts, the MAC subsequently requested that a CMS-855I form be filed for each member of Petitioner’s practice group, rather than the previously filed CMS-855R form. P. Br. at 8. I accept Petitioner’s assertions of fact as true for purposes of summary judgment. However, Petitioner does not explain how these facts adversely affected the determination of the reactivation effective date of Petitioner. Petitioner was granted the reactivation effective date of December 13, 2023, the date it filed its enrollment application. Petitioner does not state how subsequent revisions to the reassignment applications of group members delayed the processing of its Medicare enrollment application correcting enrollment information and requesting reactivation. Petitioner argues that the requests for the new applications delayed the processing of the reassignment applications of members of the group, but I have no evidence that hearings were requested for any of the individual practitioners and their cases are not before me for adjudication. My review is limited to the case of Petitioner, more specifically the reconsidered determination issued in Petitioner’s case.

Petitioner’s arguments can be construed to be that the government is estopped from treating December 13, 2023, as Petitioner’s reactivation effective date. But as a matter of law, 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). There is no evidence suggesting fraud on the part of the MAC or CMS. It is not disputed Petitioner received the October 9, 2023 MAC notice that Petitioner’s Medicare billing privileges were deactivated effective October 9, 2023. The notice advised Petitioner of the right to submit a rebuttal within 15 days. CMS Ex. 1 at 430-31. The record before me does not show that Petitioner filed a rebuttal. However, there is evidence that Petitioner submitted an application on October 20, 2023; the MAC requested corrections and Petitioner responded; the MAC notified Petitioner the application was rejected; Petitioner filed another application received by the MAC on December 13, 2023; the MAC notified Petitioner of required corrections; and ultimately, the MAC approved the reactivation of Petitioner’s billing privileges. Petitioner

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complains it did not receive the July 10, 2023 notice (which is not required by the regulations) and that the MAC required Petitioner to file CMS‑855Is, rather than CMS-855Rs for its group members (whose cases are not properly before me). But Petitioner points to no evidence that the MAC was not working with Petitioner to correct its reactivation application.

Petitioner’s argument it was unable to bill Medicare for $100,000 worth of items or services provided to Medicare-eligible beneficiaries (P. Br. at 1, CMS Ex. 1 at 31) may also be viewed as a request for equitable relief. I have no authority to grant equitable relief. US Ultrasound, DAB No. 2302 at 8 (2010). I am bound to follow the Act and regulations, and I have no authority to declare statutes or regulations invalid or ultra vires. 1866ICPayday.com, L.L.C., DAB No. 2289 at 14 (2009) (noting that “[a]n ALJ is bound by applicable laws and regulations and may not invalidate either a law or regulation on any ground”).

III. Conclusion

For the foregoing reasons, I conclude that the effective date of reactivation of Petitioner’s billing privileges is December 13, 2023.