Advanced Medical Transport of Springfield, Inc., DAB CR6067 (2022)

DECISION

National Government Services, Inc. (NGS), an administrative contractor for the Centers for Medicare & Medicaid Services (CMS), determined that the effective date of Medicare enrollment and billing privileges for Advanced Medical Transport of Springfield, Inc., (Petitioner) was November 6, 2019.  NGS also determined that Petitioner could submit claims for payment for services performed or delivered beginning October 7, 2019.  NGS affirmed the effective date on reconsideration, and Petitioner appealed.  Because November 6, 2019, is the date NGS received an application from Petitioner that it processed to approval, NGS correctly determined that Petitioner’s Medicare billing privileges became effective November 6, 2019.  Therefore, I affirm NGS’s effective date determination.

I.  Background

Petitioner is an ambulance service supplier incorporated in the State of Illinois.  CMS Exhibit (Ex.) 1 at 1-2.  On September 24, 2019, Petitioner submitted an internet-based Provider Enrollment, Chain and Ownership System (PECOS) Medicare enrollment application, Form CMS-855B, to enroll in the Medicare program.  Petitioner’s Exhibit (P. Ex.) 7 at ¶ 15.  NGS received the application on the same day, September 24, 2019.

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CMS Ex. 1 at 1; see also P. Ex. 4.  Petitioner’s application requested an effective date of August 1, 2019, which was the date Petitioner began servicing the Springfield, Illinois area.  CMS Ex. 1 at 3-4; see also P. Ex. 7 at ¶¶ 9, 10.

In an October 4, 2019 letter (development request), NGS acknowledged receipt of Petitioner’s enrollment application, but requested that Petitioner submit additional supporting documentation within “30 days from the postmarked date of this letter [11/03/2019].”  CMS Ex. 2 at 1.  The letter warned that if Petitioner failed to respond by the deadline, NGS may reject or deny the application.1   Id.

NGS rejected Petitioner’s September 24, 2019 Medicare enrollment application by letter dated November 5, 2019.2   CMS Ex. 6 at 1.  NGS’s November 5 letter stated that Petitioner’s application had been rejected because Petitioner failed to respond to the October 4 development request.  Id.  The November 5 letter further informed Petitioner that if it wanted to resubmit an application, it must complete a new Medicare enrollment application.  Id.

The next day, November 6, 2019, Petitioner submitted a new PECOS Medicare application, Form CMS-855B.  CMS Ex. 7; P. Ex. 7 at ¶ 29.  NGS received the application and supporting documentation on November 6, 2019.  CMS Ex. 7 at 1.  Petitioner’s second application again requested an effective date of August 1, 2019.  Id. at 4.

In an e-mail sent to Petitioner on November 12, 2019, NGS acknowledged receipt of Petitioner’s November 6, 2019 enrollment application and requested additional information needed to complete processing the application.  CMS Ex. 9.  Petitioner submitted the requested information.  CMS’s Prehearing Brief in Support of Summary Judgment (CMS Br.) at 3-4; see also CMS Ex. 10.  NGS approved Petitioner’s enrollment application by letter dated November 15, 2019.  CMS Ex. 11.  NGS assigned an effective date of Medicare billing privileges to begin on October 7, 2019.3   CMS Ex. 11.

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Petitioner requested reconsideration.  CMS Ex. 12.  By letter dated January 13, 2020, NGS issued an unfavorable reconsidered determination and affirmed November 6, 2019 as the effective date of Petitioner’s enrollment of Medicare billing privileges, with retrospective billing privileges effective October 7, 2019.  CMS Ex. 13.  On March 6, 2020, Petitioner timely requested a hearing before an administrative law judge to challenge NGS’s unfavorable reconsidered determination.  I was designated to hear and decide this case.

On March 11, 2020, my office acknowledged receipt of Petitioner’s hearing request and provided a copy of my Standing Prehearing Order (Prehearing Order).  The Prehearing Order required the parties to file a prehearing exchange consisting of a brief and any supporting documents, including any Motion to Dismiss or Motion for Summary Judgment.  Prehearing Order ¶ 4.  CMS filed its brief and thirteen proposed exhibits (CMS Exs. 1‑13).  Petitioner filed its brief and seven proposed exhibits (P. Exs. 1-7), including the written direct testimony of Petitioner’s Vice-President of Finance, Timothy Beccue.

Objections to Exhibits

CMS objects to attachments 2, 3, 5, and 6 filed with Petitioner’s hearing request on the grounds that they consist of new evidence offered for the first time at the administrative law judge level of review without a showing of good cause.4   CMS Br. at 8-9 (citing 42 C.F.R. § 498.56(e)(2)).  Petitioner argues that good cause exists to present its exhibits for the first time in the present proceeding because at the reconsideration level Petitioner was not represented by counsel and its Vice-President of Finance, Mr. Beccue, served as Petitioner’s non-attorney representative.  P. Br. at 17-18 (citing Arkady B. Stern, M.D., DAB No. CR2246 (2010)).  Petitioner suggests that Mr. Beccue “did not understand the need to present all exhibits when making [Petitioner’s] initial argument.”  Id. at 17.  Petitioner further argues that the exhibits to which CMS objects are exhibits that CMS or NGS drafted and sent to Petitioner.  Id. at 18.  Petitioner argues that no prejudice exists for the admission of its exhibits.  Id.

I do not find Petitioner’s situation analogous to that described in the Stern decision.  In that case, the administrative law judge remanded the matter to CMS and its contractor with instructions to diligently search their files for evidence, if any, that might support Dr. Stern’s contention that he had filed a Medicare enrollment application that was received prior to the application on which CMS based Dr. Stern’s effective date of

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enrollment.  Stern, DAB No. CR2246 at 2.  Thus, the Stern decision concerned evidence that may have been in CMS’s possession to which the petitioner may not have had access or known how to access.  By contrast, in the present case, the issue is whether Petitioner, though not represented by an attorney, understood that it was required to present all of the documentary evidence in its possession with its reconsideration request.  Importantly, this requirement is publicly available in the Code of Federal Regulations and was described explicitly in NGS’s letter to Petitioner informing it of the right to request reconsideration.5

In addition, Petitioner’s non-attorney representative, Mr. Beccue, testified on written direct that he consulted an attorney regarding Petitioner’s application for a Medicare provider number “on or about September 24, 2019.”  P. Ex. 7 at ¶ 12.  Thus, by his own testimony, prior to filing Petitioner’s reconsideration request, Mr. Beccue was aware that there were legal requirements associated with the Medicare enrollment process and knew how to ask for legal advice concerning those requirements.  I therefore infer that Mr. Beccue made a business decision to proceed with the application (and reconsideration) process without retaining an attorney to represent Petitioner.  I do not find credible the suggestion that he was so unsophisticated regarding legal matters that he could not understand the instructions in the NGS letter or make an informed decision whether to proceed without legal representation.  I therefore do not find that Petitioner’s explanation establishes that it had good cause to submit P. Exs. 2, 3, 5, and 6 for the first time at the

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administrative law judge level of review.  I therefore exclude them as required by 42 C.F.R. § 498.56(e)(2).6   I admit P. Exs. 1, 4, and 7.

Petitioner did not object to CMS Exs. 1, 2, 4, 5, and 7-13.  In the absence of objection and because I find them relevant to the issue before me, I admit CMS Exs. 1, 2, 4, 5, and 7-13 into the record.

Petitioner objects to CMS Exs. 3 and 6.  P. Br. at 17.  CMS identifies Ex. 3 as “NGS Discussion Notes.”  See CMS Exhibit List (Docket Entry #5a in the Departmental Appeals Board (DAB) Electronic Filing System (E-File)).  Petitioner acknowledges that “CMS Ex. 3 shows that emails were drafted [by NGS] on October 4, 2019 and November 5, 2019.”  P. Br. at 17.  However, Petitioner objects that the exhibit is “inadequate to demonstrate that the emails on October 4, 2019 and November 5, 2019 actually left the servers on which they were drafted.”  Id.  CMS provided no witness statement establishing a foundation for CMS Ex. 3.  Nevertheless, Petitioner concedes that the exhibit is an NGS business file and objects only to my drawing any inference regarding Petitioner’s receipt of the emails described in the exhibit.  I therefore find that the objection goes to the weight of the evidence, not its admissibility.  Accordingly, I admit CMS Ex. 3.

Petitioner also objects to CMS Ex. 6, NGS’s November 5, 2019 rejection letter.  Id.  Petitioner argues that it never received the letter and only saw it for the first time as part of CMS’s prehearing exchange.  Id.  Petitioner’s objection to CMS Ex. 6 appears to be the same as to CMS Ex. 3, namely, that I should not infer from the existence of the November 5 letter that Petitioner actually received it.  Therefore, for the same reason I have already articulated, I admit CMS Ex. 6, but consider Petitioner’s objection in determining what weight, if any, to give to the exhibit.

Petitioner listed Mr. Beccue as a witness and offered his written direct testimony as part of its pre-hearing exchange, but CMS did not request to cross-examine him.  As I informed the parties in my Prehearing Order, “[a]n in-person hearing to cross-examine witnesses will be necessary only if a party files admissible, written direct testimony, and the opposing party asks to cross-examine.”  Prehearing Order ¶ 10.  Consequently, an in‑person hearing is not required, and I issue this decision based on the written record, without regard to whether the standards for summary judgment are met.  Prehearing

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Order ¶¶ 8-11; CRDP § 19(d).  I therefore deny CMS’s motion for summary judgment as moot.

II.  Issue

Whether NGS, acting on behalf of CMS, properly established that Petitioner’s effective date of Medicare enrollment and billing privileges was November 6, 2019.

III.  Jurisdiction

I have jurisdiction to hear and decide this case.  42 C.F.R. §§ 498.3(b)(15), 498.5(l)(2); see also Social Security Act (Act) § 1866(j)(8) (codified at 42 U.S.C. § 1395cc(j)(8)).

IV.  Discussion

1. Applicable Legal Authority

The Act authorizes the Secretary of Health and Human Services to promulgate regulations governing the enrollment process for providers and suppliers.  Act §§ 1102, 1866(j) (42 U.S.C. §§ 1302, 1395cc(j)).  A “supplier” is “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.  Act § 1861(d) (42 U.S.C. § 1395x(d)); see also Act § 1861(u) (42 U.S.C. § 1395x(u)).

A supplier must enroll in the Medicare program to receive payment for covered Medicare items or services.  42 C.F.R. § 424.505.  The regulations define “Enroll/Enrollment” as “the process that Medicare uses to establish eligibility to submit claims for Medicare covered items and services.”  42 C.F.R. § 424.502.  A provider or supplier seeking billing privileges under the Medicare program must “submit enrollment information on the applicable enrollment application.  Once the provider or supplier successfully completes the enrollment process . . . CMS enrolls the provider or supplier into the Medicare program.”  42 C.F.R. § 424.510(a).  CMS then establishes an effective date for billing privileges consistent with 42 C.F.R. § 424.520(d), which provides:

The effective date for billing privileges for physicians, non‑physician practitioners, physician and non-physician practitioner organizations, and ambulance suppliers is the later of—

(1) The date of filing of a Medicare enrollment application that was subsequently approved by a Medicare contractor; or

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(2) The date that the supplier first began furnishing services at a new practice location.

CMS or its contractor may permit retrospective billing as provided in 42 C.F.R. § 424.521.  Suppliers have the right to appeal an initial determination regarding the effective date.  42 C.F.R. §§ 498.3(b)(15), 498.5(l)(1); see also 42 C.F.R. § 498.22(a).  However, “[e]nrollment applications that are rejected are not afforded appeal rights.”  42 C.F.R. § 424.525(d).

2. Findings of Fact and Conclusions of Law7

1. On November 6, 2019, NGS received Petitioner’s Medicare enrollment application and subsequently approved that application.
2. The effective date for Petitioner’s Medicare billing privileges is November 6, 2019, with retrospective billing privileges effective October 7, 2019.

The effective date for Medicare billing privileges for Medicare suppliers, including suppliers of ambulance services, such as Petitioner, is either:  1) the date of filing of a Medicare enrollment application that was subsequently approved by a Medicare contractor; or 2) the date the supplier first began furnishing services at a new practice location, whichever is later.  42 C.F.R. § 424.520(d).  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); see also Alexander C. Gatzimos, MD, JD, LLC, DAB No. 2730 at 17 (2016) (it is CMS policy that the “date of filing” is the date a contractor receives an enrollment application from a supplier).

NGS received a Medicare enrollment application from Petitioner on November 6, 2019, via PECOS.  CMS Ex. 7 at 1.  NGS subsequently approved that application.  CMS Ex. 11.  Petitioner does not contend that NGS received its second filed enrollment application at any time prior to November 6, 2019, and in fact, confirms that it sent the second application on this date.  P. Ex. 7 at ¶ 29.  Accordingly, as required by regulation, the effective date of Petitioner’s Medicare enrollment is November 6, 2019, the date NGS received the application that was processed to approval.  As permitted by 42 C.F.R. § 424.521(a)(1), NGS authorized Petitioner to retrospectively bill for services from October 7, 2019, 30 days prior to the effective date of enrollment.  See CMS Ex. 13 at 2.

In support of its position that I should grant it an earlier effective date of enrollment, Petitioner argues that it never received the October 4 development request from NGS.

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P. Br. at 3. Petitioner argues that the defective notice makes NGS’s rejection of the September 24 enrollment application arbitrary and capricious.  Id.  Petitioner further argues that, to the extent the regulations permit NGS to reject Petitioner’s application in the circumstances presented, I should decline to apply the regulations as inconsistent with the Act.  Id. at 4-5.  As I explain in the following sections of this decision, Petitioner’s arguments raise issues that are beyond my jurisdiction to hear and decide.

3. I have no authority to review NGS’s rejection of Petitioner’s September 24, 2019 enrollment application.

Petitioner argues that it never received NGS’s October 4 development request and hypothesizes that “the e-mail containing the development letter was drafted by NGS, but . . . the e-mail was never actually sent to [Petitioner].”  P. Br. at 2; see also id. at 8 n.3.8  Petitioner suggests that because it did not receive actual notice of the corrections needed to make its September 24 enrollment application acceptable, NGS may not “deny” that application.9  P. Br. at 16.  Petitioner additionally argues that it was “actively working with [NGS] to resolve any outstanding issues” within the meaning of 42 C.F.R. § 424.525(b).

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P. Br. at 3-4.10 For these reasons, Petitioner contends that NGS improperly rejected its September 24 enrollment application.

Even if I were to accept as true that Petitioner never received NGS’s October 4 development request and that Petitioner was actively working with NGS to process the application, I could not change the effective date of Petitioner’s Medicare enrollment based on these factors.  That is because administrative law judges are not authorized to review a contractor’s decision to reject an enrollment application.  42 C.F.R. § 424.525(d); see also George Yaplee Med. Ctr., DAB No. 3003 at 6 (2020) (“the regulations do not allow suppliers to appeal the rejection of an enrollment application”); James Shepard, M.D., DAB No. 2793 at 8 (2017).  Therefore, even if NGS should not have rejected Petitioner’s September 24 enrollment application, I am without authority to overturn the rejection.

As the Shepard decision explained, a supplier’s argument that the Medicare contractor was to blame for the supplier’s failing to submit an approvable application “is an implicit request that we assess the reasonableness or legality of [the contractor’s] decision to reject the . . . application.  However, section 424.525(d) plainly prohibits [administrative law judge] or [Departmental Appeals] Board review of that decision . . . .”  DAB No. 2793 at 8.  As was the case in Shepard, Petitioner’s arguments in the present case amount to a backdoor challenge to the contractor’s rejection of its enrollment application – a determination for which there is no right to administrative appeal.Id.

Therefore, whether Petitioner characterizes the relief it seeks as review of NGS’s “denial” of its September 24 enrollment application (P. Br. at 14) or as the opportunity to request reopening of that application (Id. at 16-17), I cannot grant Petitioner relief without exercising authority over NGS’s rejection of Petitioner’s September 24 enrollment application.  As the decisions discussed above hold, the regulations do not permit me to exercise such authority.

Petitioner appears to concede that 42 C.F.R. § 424.525(d) forbids administrative review of the determination to reject an enrollment application.  P. Br. at 11, 15.  However, Petitioner argues that I should “overrule” the regulation.  Id. at 15-16.  I next explain why I may not do so.

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4. An administrative law judge is bound by applicable regulations and may not refuse to apply them.

Petitioner asserts that the regulation which deprives suppliers of the right to appeal their rejected enrollment applications “should be overruled by the [DAB] as being superseded by a federal statute, 42 U.S.C. § 1395cc(j)(8) [Act § 1866(j)(8)], as CMS does not have the legal ability to attempt to overrule a federal law by passing a Regulation.”  P. Br. at 11.  Additionally, Petitioner asserts that “[s]ince 42 U.S.C. § 1395cc(j)(8) directly, clearly and unambiguously guarantees hearing rights for suppliers who have been denied the renewal of enrollment under this title, and since revalidations are discussed earlier not just in the same title but in the same section of the title, by statute, revalidation actions, such as a decision to deactivate, have hearing rights.”11   P. Br. at 15.  Petitioner cites to the Supreme Court’s decision in Chevron U.S.A., Inc. v. Nat. Resources Def. Council, Inc., 467 U.S. 837, 843 (1984), in support of the proposition that CMS “must give effect to the unambiguously expressed intent of Congress.”  P. Br. at 12.  Even if Petitioner’s argument had merit – a finding I do not make – I could not entertain it.

Petitioner’s argument that I, as an administrative law judge, or the DAB in its appellate capacity, should invalidate a properly promulgated regulation, fundamentally misunderstands the DAB’s role in the administrative process.  Many appellate decisions of the DAB have held that its adjudicators may not “ignore an unambiguous . . . regulation.”  See Cmty. Home Health Care of W. Mich., Inc., DAB No. 2867 at 10 (2018) (and cases cited therein); see also 1866ICPayday.com, L.L.C., DAB No. 2289 at 14

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(2009) (administrative law judge “may not invalidate . . . a . . . regulation on any ground, even a constitutional one.”).  Therefore, while Petitioner is free to argue to a federal court in some future appeal that 42 C.F.R. § 424.525(d) is invalid because it is inconsistent with section 1866(j)(8) of the Act, an administrative adjudicator, whether an administrative law judge or the DAB, cannot invalidate a regulation.  Cent. Kan. Cancer Inst., DAB No. 2749 at 10 (2016).

5. I cannot change the effective date of Petitioner’s Medicare enrollment based on what are, in essence, equitable arguments.

At bottom, Petitioner’s argument that NGS should not be permitted to reject Petitioner’s enrollment application amounts to a request for equitable relief.  That is, Petitioner contends it is fundamentally unfair to reject Petitioner’s application for failing to respond to a development request that it did not receive.  I understand Petitioner’s frustration that the effective date of its Medicare enrollment was delayed and that the delay was, arguably, not of Petitioner’s making.  Nevertheless, I may not set aside the lawful exercise of discretion by CMS or its contractor based on principles of equity.  See US Ultrasound, DAB No. 2302 at 8 (2010); Cent. Kan. Cancer Inst., DAB No. 2749 at 10; see also Shepard, DAB No. 2793 at 9.

V.  Conclusion

I affirm CMS’s decision that the effective date of Petitioner’s Medicare enrollment and billing privileges is November 6, 2019, with retrospective billing permitted as of October 7, 2019.

1. As I discuss in greater detail below, Petitioner denies that it ever received the October 4 development request.  Petitioner’s Prehearing Brief and Memorandum of Law in Opposition to Summary Judgment (P. Br.) at 3; see also P. Ex. 7 at ¶ 17.
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2. Petitioner also denies receiving a copy of NGS’s rejection letter.  P. Br. at 3; see also P. Ex. 7 at ¶ 18.
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3. NGS erroneously characterized Petitioner’s effective date of enrollment and billing privileges as October 7, 2019.  CMS Ex. 11 at 2.  In fact, October 7, 2019 is Petitioner’s retrospective billing date.  NGS clarified in its reconsidered determination that Petitioner’s effective date of enrollment was November 6, 2019.  CMS Ex. 13 at 2.
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4. Because CMS filed the opening brief, Petitioner had not yet filed its proposed exhibits.  Petitioner offered its attachments, properly marked as proposed exhibits, with its brief.  I therefore construe CMS’s objections to attachments 2, 3, 5, and 6 as objections to P. Exs. 2, 3, 5, and 6, which appear to be duplicates of the attachments to Petitioner’s hearing request.
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5. The NGS letter included the following statement:



[I]f you have additional information that you would like a hearing officer to consider during the reconsideration or, if necessary, an administrative law judge to consider during a hearing, you must submit that information with your request for reconsideration.  This is your only opportunity to submit information during the administrative appeals process; you will not have another opportunity to do so unless an administrative law judge specifically allows you to do so under 42 CFR § 498.56(e).

CMS Ex. 11 at 3 (emphasis added).  Further, even if the letter had not provided Petitioner with actual notice of the requirement, “Medicare suppliers are presumed to have constructive notice of the statutes and regulations that govern their participation as a matter of law.”  Pepper Hill Nursing & Rehab. Ctr., LLC, DAB No. 2395 at 8 (2011).
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6. Even if I were to find that Petitioner had good cause to offer P. Exs. 2, 3, 5, and 6 for the first time before me, I would find that they are not material to any issue that I have authority to hear and decide.  I discuss my reasons for reaching this conclusion in more detail below.  See infra n.8.  This is a separate and independent basis to exclude the exhibits.
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7. My findings of fact and conclusions of law appear as numbered headings in bold italic type.
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8. For support, Petitioner points to the written direct testimony of its witness, Mr. Beccue (P. Ex. 7).  Mr. Beccue testified that, at his direction, Petitioner’s computer personnel checked Petitioner’s servers (including Petitioner’s spam filter) for any and all e-mails to Mr. Beccue that may have been sent from CMS or NGS.  P. Ex. 7 at ¶¶ 17, 18.  Mr. Beccue testified that “the computer personnel informed me that no e-mails from any of these sources entered [Petitioner’s] servers [from September 26, 2019 through November 4, 2019], except the one [offered as] P. Ex. 5.”  Id. at ¶ 18.  Mr. Beccue’s testimony on this point, as well as the email offered as P. Ex. 5, is not material to any issue I may hear and decide.  This evidence is only relevant to whether NGS properly rejected Petitioner’s September 24 enrollment application, which is an issue foreclosed from administrative review for the reasons explained in this section of my decision.  This is an additional basis for my sustaining CMS’s objection to P. Ex. 5.
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9. Petitioner cites to the administrative law judge’s decision in Rushita Patel, M.D., DAB CR2129 (2010) in support of its argument.  P. Br. at 16.  However, in the Patel decision, the contractor denied Dr. Patel’s enrollment application, rather than rejecting it.  DAB CR2129 at 8 n.10.  As I discuss infra at n.11, denial of an enrollment application is not equivalent to rejection of an enrollment application.
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10. I have no authority to review NGS’s decision not to extend the 30-day deadline for Petitioner to submit a response to the development request in accordance with 42 C.F.R. § 424.525(b).  As the decision in Lindsey Zamis, M.D., DAB No. 2802 (2017), explained, “[t]he regulation is permissive in that it allows, but does not require, CMS to first consider whether (in its judgment) the application is ‘actively working with CMS,’ and then to decide whether to extend the response deadline . . . a determination by CMS not to extend the 30-day period of responses to requests for information is not an initial determination subject to appeal.”  Id. at 12.
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11. Although not necessary to my decision, I disagree with Petitioner’s contention that “rejection” of an application is synonymous with “denial” of an application.  The regulations define “Deny/Denial” as a determination that “the enrolling provider or supplier [is] ineligible to receive Medicare billing privileges for Medicare covered items or services provided to Medicare beneficiaries.”  42 C.F.R. § 424.502.  By contrast, “Reject/Rejected” means that “the provider or supplier’s enrollment application was not processed due to incomplete information, or that additional information or corrected information was not received from the provider or supplier in a timely manner.”  Id.  In the present case, there is no indication in the record that NGS ever determined that Petitioner was ineligible to be enrolled as a Medicare supplier.  Thus, NGS did not “deny” Petitioner’s enrollment application.  To the contrary, NGS did ultimately approve Petitioner’s enrollment application.  Accordingly, section 1866(j)(8) of the Act (42 U.S.C. § 1395cc(j)(8)), on which Petitioner relies, does not apply to NGS’s “rejection” of Petitioner’s enrollment application, because the statute, by its terms, applies to “denial” of enrollment.  Further, Petitioner’s attempt to equate “rejection” of an application with “deactivation” of Medicare billing privileges (P. Br. at 15) is similarly mistaken, as deactivation is itself a separate administrative action.  See 42 C.F.R. § 424.502 (definition of “Deactivate”); see also 42 C.F.R. § 424.540.
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