A Samuel's Christian Home Care, DAB No. 3043 (2021)

FINAL DECISION ON REVIEW OF ADMINISTRATIVE LAW JUDGE DECISION

Petitioner A Samuel's Christian Home Care, which participated in the Medicare program as a home health agency (HHA), appeals the July 25, 2018 decision of an Administrative Law Judge (ALJ), which sustained a determination of the Centers for Medicare & Medicaid Services (CMS) to terminate Petitioner's Medicare provider agreement effective November 14, 2017.  A Samuel's Christian Home Care, DAB CR5146 (2018) (ALJ Decision).  The ALJ granted summary judgment for CMS on the ground that the undisputed facts established that Petitioner did not satisfy the legal definition of an HHA because it was not "primarily engaged in providing skilled nursing services and other therapeutic services" consistent with section 1861(o)(1) of the Social Security Act (Act).

For the reasons set out below, we determine that summary judgment for CMS was appropriate.  Accordingly, we affirm the ALJ Decision.

Legal authorities

Title XVIII of the Act establishes the Medicare program, which reimburses health care providers and suppliers for the medical care and services they furnish to Medicare beneficiaries.  Act §§ 1811, 1812, 1831, 1832.  An HHA is a Medicare "provider of services."  Act § 1861(u); see also id. § 1861(m) (defining "home health services").

To participate in the Medicare program, an HHA must have in place a provider agreement and undergo surveys – performed by a state agency (such as the Pennsylvania Department of Health (PDH), as discussed below) under agreement with CMS – to certify its compliance with program requirements.  Consol. Home Health, DAB No.

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2878, at 2 (2018); 42 C.F.R. §§ 488.10-488.12, 488.18-488.26; subpart I; 489.11.1   To have a Medicare provider agreement as an HHA, an agency must, among other things, meet the requirements of section 1861(o) of the Act, the institutional planning requirements of section 1861(z) of the Act, and the other conditions of participation in section 1891(a) of the Act and the implementing regulations in 42 C.F.R. Part 484.  The provider agreement contains assurances that the provider meets, and will continue to meet, applicable conditions for Medicare participation and reflects CMS's acceptance of the provider's eligibility to participate in Medicare.  Id. §§ 489.11(a), 489.20.

"[U]pon such reasonable notice to [the HHA] and the public as may be specified in [the] regulations, [the Secretary of Health and Human Services (Secretary)] . . . may terminate" a provider agreement with an HHA "after the Secretary . . . has determined that the [HHA] fails substantially to meet the applicable provisions of section 1861 [of the Act]."  Act § 1866(b)(2)(B); see also 42 C.F.R. § 489.53(a)(1) (CMS may terminate a provider agreement if the provider "is not complying with the provisions of title XVIII and the applicable regulations . . . or with the provisions of the agreement").  In this case, the "applicable provision" of section 1861 is section 1861(o), which defines a "home health agency."  Of the enumerated criteria in section 1861(o), the first criterion is at issue here.  Section 1861(o)(1) provides:

The term "home health agency" means a public agency or private organization, or a subdivision of such an agency or organization, which — (1)  is primarily engaged in providing skilled nursing services and other therapeutic services[.]

Act § 1861(o)(1).

The termination of an HHA's provider agreement is an "initial determination" by CMS that an HHA may appeal in accordance with the procedures in 42 C.F.R. Part 498.  See 42 C.F.R. §§ 489.53(e), 498.3(b)(8), 498.5(b), 498.40, 498.82(a).

Case background

The following background facts are drawn from the record of the ALJ proceedings and the ALJ Decision.  These facts are undisputed unless otherwise indicated.

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Petitioner, established in 2003 in Pennsylvania, participated in the Medicare program as an HHA.  CMS Exs. 1, at 1; 16, at 1.  On August 16, 2017, PDH completed a survey of Petitioner.  The survey found numerous instances of noncompliance with Medicare participation requirements.2   The state agency determined that Petitioner was not in substantial compliance with three conditions of participation, set out in 42 C.F.R. §§ 484.14 (Organization, Services & Administration), 484.18 (Acceptance of Patients, Plans of Care, Medical Supervision), and 484.30 (Skilled Nursing Services).  CMS Exs. 1, 4, 6.  The state agency performed a revisit survey on September 29, 2017.  It found that Petitioner had not corrected the deficiencies found on August 16, 2017, and thus remained out of compliance with the same three conditions of participation.  CMS Exs. 5, at 1; 7; 14, at 2.

By notice dated October 17, 2017, CMS informed Petitioner of its determination that it agreed with the state agency's survey findings, including, specifically, that on the revisit survey, Petitioner remained out of compliance with 42 C.F.R. §§ 484.14, 484.18 and 484.30.  CMS Ex. 14, at 1-2.  In that notice, CMS wrote, "Because of your failure to comply with the Medicare Conditions of Participation as evidenced by the August 16, 2017 and September 29, 2017 surveys, we are terminating your Medicare agreement effective November 14, 2017. . . ."  Id. at 2 (citing Act § 1866(b)(2)(B); 42 C.F.R. §§ 488.865(b)(1), 489.53(a)(1)) (emphasis in original removed).  The notice informed Petitioner of his right to appeal the termination by filing a request for a hearing before an ALJ in the Civil Remedies Division (CRD).  Id. at 3.

Petitioner filed a request for hearing.  Shortly after the appeal was docketed with CRD, CMS notified Petitioner and the ALJ that CMS had issued a Notice of Reopening and Revised Determination.  Jan. 7, 2018 CMS letter addressed to ALJ (CRD Dkt. C-18-351); CMS Ex. 22 (CMS's Jan. 3, 2018 notice).  CMS's January 3, 2018 notice informed Petitioner that it had reopened and revised its October 17, 2017 determination3 to "delete[] the Condition-level and Standard-level deficiencies cited under 42 C.F.R. § 484.14" (CMS Ex. 22, at 1), but that it had "made no change to [its prior] determination" that Petitioner was "out of compliance with the Condition-level and Standard-level deficiencies cited under" 42 C.F.R. §§ 484.18 and 484.30.  Id. at 1-2.  CMS added that its determination to terminate the provider agreement was also based on

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Petitioner's "failure to meet the [statutory] definition of a Medicare home health agency."  Id. at 2 (citing Act §§ 1861(o)(1), 1866(b)(2)(B); 42 C.F.R. § 489.53(a)(1)).  CMS stated that Petitioner no longer met the first of eight "elements or criteria" in section 1861(o) of the Act, that is, to be considered a Medicare HHA, the entity must be "primarily engaged in providing skilled nursing services and other therapeutic services."  Id. (citing Act § 1861(o)(1)).  CMS wrote, "The provision of services is a prerequisite to certification (an[d] therefore to continued program participation) as a Medicare [HHA] because the entity must provide services in order to demonstrate that it is in compliance with the Medicare Conditions of Participation."  Id.  CMS explained why it determined Petitioner was not "'primarily engaged' in providing skilled nursing services and other therapeutic services" as follows:

The survey findings from the August 16, 2017 recertification survey indicate that, while the state survey agency was able to review ten (10) clinical records, none of those clinical records involved patients for whom [Petitioner] provided home visits.  Additionally, the survey findings from the September 29, 2017 revisit survey document that, at the time of the revisit survey, [Petitioner] had no active patients and had not admitted any new patients since the exit date of the previous survey (August 16, 2017).  Moreover, [Petitioner] provided information to the State survey agency for purposes of [Petitioner's] state licensure and that information indicated [Petitioner] had only two (2) patients and no active services provided during the period from September 1, 2015 through August 31, 2016.  Similarly, [Petitioner] provided information to the State survey agency for purposes of [Petitioner's] state licensure and that information indicated [Petitioner] had only three (3) patients and no active services provided during the period from September 1, 2016 through August 31, 2017.

Id.

By order issued March 19, 2018, the ALJ directed Petitioner to file an amended request for hearing in light of CMS's assertion in its January 3, 2018 notice that Petitioner did not meet the statutory definition of an HHA.  A Samuel's Christian Home Care, Order Directing Petitioner to File Amended Hearing Request, Docket No. C-18-351.  Petitioner filed an amended request for hearing.

CMS moved for summary judgment in its favor, asserting there is no genuine dispute of material fact that Petitioner was not primarily engaged in providing skilled nursing services and other therapeutic services and therefore Petitioner failed substantially to meet a part of the legal definition of a Medicare "home health agency."  CMS Motion for Summary Judgment, Docket No. C-18-351.  The failure to meet the definition, CMS asserted, constitutes "a legally sufficient ground upon which to terminate the provider agreement."  CMS's Motion at 1 n.1, 2 (citing 42 C.F.R. § 489.53(a)(1)); see CMS

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Motion at 4 n.2, 11-12.4  CMS submitted 22 exhibits.  ALJ Decision at 2.5   Petitioner filed a brief opposing CMS's motion and asserting that it is entitled to judgment in its favor.  Id.  Petitioner did not submit any exhibits.

The ALJ granted summary judgment for CMS.  ALJ Decision at 1.  The ALJ first determined the undisputed facts established that Petitioner was "not actively providing" services.  Id. at 3; id. at 2 ("An entity that exists on paper but that does not actively treat patients is not [an HHA] within the Act's definition.").  The ALJ stated:

On June 2, 2017, Petitioner's owner admitted that Petitioner was not, as of that date, providing services to any patients and that it had provided services to only two patients within the previous year.  CMS Ex. 8 at 2; CMS Ex. 11 at 1.  The [state agency] surveyed Petitioner in August 2017.  Petitioner had no active patients at that time.  CMS Ex. 8 at 5.  Petitioner remained without patients as of a revisit survey on September 29, 2017.  CMS Ex. 5 at 2-3; CMS Ex. 7 at 1; CMS Ex. 8 at 6-7; P. Br. at 8.  Petitioner, in fact, indicates it was operating without a Pennsylvania state home health license during September 2017,^[6 ^] and therefore could not have admitted new patients.  P. Br. at 8.  Petitioner did not dispute the absence of patients nor has it offered any evidence to show that it provided care to patients after September 29, 2017.

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Id. at 3 (footnote omitted).7   The ALJ reasoned that since "Petitioner failed actively to provide services to patients for a period of at least five months" and "[i]n the year prior to that five-month period it provided almost no patient services," Petitioner did not "actively" provide services.  Id.  The ALJ concluded that an entity that fails actively to provide services to patients, such as Petitioner, does not satisfy the first element of section 1861(o)(1) of the Act (i.e., the entity must be "primarily engaged" in providing services) and, accordingly, may be terminated from participation in Medicare.  Id. (citing A.M. Home Health Servs., Inc., DAB No. 2354 (2010); United Med. Home Care, Inc., DAB No. 2194 (2008)).

The ALJ also determined that Petitioner did not meet the second element of section 1861(o)(1) because Petitioner "provided only skilled nursing services" and "did not provide therapeutic services in addition to skilled nursing services."  ALJ Decision at 2, 4 (citing CMS Exs. 2, at 2; 3, at 2; 8, at 5; 11, at 1).  The ALJ reasoned that Petitioner "provided no facts and no supporting evidence" to substantiate its claim that it provided home health aide services as a therapeutic service in addition to skilled nursing services.  Id. at 4.  Petitioner, the ALJ noted, "does not refute any of the facts that [he, the ALJ] . . . discussed" and "provides no facts to show that it provided services to patients on or after June 2, 2017."  Id.  "Moreover," the ALJ also stated, "CMS would have a basis to terminate Petitioner's participation even if in the past it had provided some therapeutic services other than skilled nursing services, because, as of September 2017, there is no dispute that Petitioner was providing no services of any kind to patients, and had not done so for quite some time."  Id. (citing CMS Exs. 5, at 2-3; 7, at 1; 8, at 2-3, 5; 11, at 1; and P. Br. at 8).

Disputing CMS's position that Petitioner did not met section 1861(o)(1) criteria, Petitioner asserted that CMS wrongly opted to rely on an interpretation of section 1861(o) that is interpreted differently by PDH, the state licensing authority.  ALJ Decision at 4 (citing P. Br. at 2, 7-8).  Petitioner asserted that, unlike CMS, PDH found Petitioner met the statutory definition of an HHA because PDH had previously renewed Petitioner's state license.  Id. (citing P. Br. at 2, 9, 16-18).  The ALJ explained that whether Petitioner was asserting that PDH had considered the facts relied on by CMS or that PDH had interpreted section 1861(o) differently than had CMS was immaterial because CMS, as the federal agency charged with applying the Act, interprets the Act to require Petitioner to "actively" treat patients and to provide services other than skilled nursing services in order to meet the Act's requirements.  ALJ Decision at 4.  CMS's

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interpretation, the ALJ stated, "takes precedence over any possibly conflicting interpretation that a State agency might make."  Id.

The ALJ also considered arguments that CMS's actions against Petitioner were "tinged by bias, by inconsistency, and by misfeasance," and that Petitioner had complied with the conditions of participation.  ALJ Decision at 5.  The ALJ determined that those arguments were irrelevant and raised no dispute of material fact.  Id.  Because his decision "hinge[d] on Petitioner's failure to satisfy the Act's definition" of an HHA and Petitioner did not satisfy that definition, the ALJ stated, whether or not Petitioner had complied with the conditions of participation was, ultimately, inconsequential.  Id.

Standard of review

Our standard of review on a disputed conclusion of law is whether the ALJ's decision is erroneous.  Guidelines – Appellate Review of Decisions of Administrative Law Judges Affecting a Provider's Participation in the Medicare and Medicaid Programs (Guidelines), accessible at https://www.hhs.gov/about/agencies/dab/different-appeals-at-dab/appeals-to-board/guidelines/participation/index.html?language=en.

We review whether summary judgment is appropriate de novo.  A.M. Home Health Servs., DAB No. 2354, at 3.  "Summary judgment is appropriate when the record shows there is no genuine issue as to any material fact, and the moving party is entitled to judgment as a matter of law."  Southpark Meadows Nursing & Rehab. Ctr., DAB No. 2703, at 5 (2016) (internal quotation marks and citation omitted).  A dispute of fact is "material" if its resolution might affect the case's outcome under the governing law.  Id. (citing Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986)).  In evaluating a party's motion for summary judgment, we view the record in the light most favorable to the non-moving party and giving that party the benefit of all reasonable inferences.  Pearsall Nursing & Rehab. Ctr., DAB No. 2692, at 5 (2016); Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986); U.S. v. Diebold, Inc., 369 U.S. 654, 655 (1962).  Drawing factual inferences in the light most favorable to the non-moving party does not, however, require that a reviewer draw unreasonable inferences or accept the non-moving party's legal conclusions.  See Brightview Care Ctr., DAB No. 2132, at 2, 9-10 (2007); Cedar Lake Nursing Home, DAB No. 2344, at 7 (2010).  Inferences based on speculation are not reasonable.  Dumas Nursing & Rehab., L.P., DAB No. 2347, at 18 (2010) (internal quotation marks and citation omitted).  Nor may the adjudicator make credibility determinations or weigh the evidence when deciding a summary judgment motion.  See Anderson, 477 U.S. at 249, 255.

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Analysis

Petitioner8 filed a brief in support of its request for review of the ALJ Decision (RR).  CMS filed a response brief.  Petitioner filed a reply brief (Reply Br.), along with documents.  As stated earlier, Petitioner offered no evidence to the ALJ; only CMS submitted evidence below.  The ALJ granted summary judgment for CMS because he found no genuine dispute of material fact on the dispositive issue of whether Petitioner was "primarily engaged in providing skilled nursing services and other therapeutic services" consistent with section 1861(o)(1) of the Act.  ALJ Decision at 1, 5.

In urging the Board to reverse the ALJ's decision, Petitioner raises arguments concerning, among other things, the 2017 survey findings on which CMS cited Petitioner for violations of multiple conditions of participation.  Request for Review (RR).  Petitioner also states the ALJ did not provide Petitioner sufficient opportunity to submit a full prehearing exchange that included evidence.  Id. at 3, 11

In section I below, we explain why we conclude that the undisputed facts, established by the evidence that was before the ALJ, support a conclusion that Petitioner was not primarily engaged in providing skilled nursing services and other therapeutic services.  Accordingly, Petitioner did not meet section 1861(o)(1) criteria and was ineligible to continue participating in Medicare as an HHA.

In section II, we address the documents Petitioner submitted to the Board and the argument that Petitioner did not have sufficient opportunity to submit a complete prehearing exchange to the ALJ.  We have considered the argument as an explanation of good cause for now submitting evidence for the first time in the appeal process.  We explain why good cause is not established.  We nevertheless discuss the documents in some detail and explain why we determine that, at bottom, no document, even when viewed in the light most favorable to Petitioner, raises any dispute of material fact that could affect the outcome in Petitioner's favor.  We therefore need not determine whether to admit new evidence into the record of the Board proceedings.

In section III, we address Petitioner's remaining arguments about CMS wrongdoing and ALJ bias.  They amount to nothing more than bare allegations and, ultimately, are immaterial to the dispositive issue before us.

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I.  Summary judgment is appropriate because the undisputed facts show that Petitioner was not primarily engaged in providing skilled nursing services and other therapeutic services.

For purposes of participation in Medicare as a "home health agency," the entity in question must be "a public agency or private organization . . . which is primarily engaged in providing skilled nursing services and other therapeutic services."  Act § 1861(o)(1).  CMS's State Operations Manual (SOM), CMS Pub. 100-07, includes guidance on the statutory requirements.  As relevant here, the guidance provides in part:

All HHAs must provide skilled nursing services and at least one of the following other therapeutic services:  physical therapy, speech language pathology, or occupational therapy, medical social services, or home health aide services in a place of residence used as a patient's home.  The HHA must provide at least one of these services (i.e., skilled nursing, physical therapy, speech language pathology, occupational therapy, medical social services, or home health aide services) directly and in its entirety by employees of the HHA.  The other therapeutic services and any additional services may be provided either directly or under arrangement.

SOM, Ch. 2, "The Certification Process," § 2180D (Services Provided) (emphasis added).

Before we turn to the facts, we further discuss section 1861(o)(1) of the Act and the above-quoted SOM language because Petitioner's arguments reveal a fundamental misunderstanding of both.  Petitioner repeatedly asserts that:  (1) CMS wrongly terminated its provider agreement based on alleged failure to meet section 1861(o)(1) of the Act because section 1861(o)(1) is not enforceable authority; (2) SOM, section 2180D is an enforceable law or regulation (and that Petitioner complied with SOM, section 2180D); and (3) the ALJ erred in applying section 1861(o)(1) of the Act in upholding the termination.  Petitioner emphasizes the bolded sentence in the above-quoted SOM language as setting out the requirements an HHA must meet.  See, e.g., RR at 1-2, 8-9, 10, 11; Reply Br. at 2.

Section 1861(o)(1) is a statutory provision.  The Board (and the ALJ) are bound to follow statutes.  The ALJ correctly applied section 1861(o)(1) of the Act, the failure to meet the criteria of which authorizes termination of an HHA's provider agreement pursuant to section 1866(b)(2)(B) of the Act.  See United Med. Home Care, DAB No. 2194, at 10, 14.  Section 2180D of the SOM is not a regulation or statute with the force and effect of law.  The ALJ correctly explained what SOM, section 2180D is and why he was applying it to determine whether Petitioner provided "other therapeutic services."  The ALJ stated:

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CMS interprets the Act's requirement that a home health agency provide other therapeutic services in addition to skilled nursing services to mean that a home health agency must also provide at least one of the following:  physical therapy, speech language pathology, occupational therapy, medical social services, or home health aide services. . . .

The SOM is not a published regulation but it is an influential agency interpretation of the Act.  Here, CMS has reasonably defined the minimum services that a home health agency must provide in addition to providing skilled nursing services.

ALJ Decision at 3.

Petitioner's argument that SOM, section 2180D is controlling law or regulation, like other arguments in its briefs, is repetitive and not clearly articulated.  As far as we are able to discern the argument, Petitioner appears to assert that the SOM language controls, or should control, because it reads the bolded sentence in the above-quoted SOM language as imposing a less onerous burden in terms of proof.  Unlike section 1861(o)(1) of the Act, the SOM language does not include the words "primarily engaged."  Also, the SOM language states that an HHA need provide only one of the listed services as a therapeutic service in addition to skilled nursing services, whereas the statute requires the HHA to provide "other therapeutic services" in addition to skilled nursing services.

Petitioner must be "primarily engaged" in providing the services consistent with section 1861(o)(1).  As for the types of services an HHA must provide, the SOM states that an HHA must provide skilled nursing services, as section 1861(o)(1) requires.  SOM, section 2180D.  As for the "other therapeutic services" requirement in the statute, as the ALJ explained, CMS interpreted that language to mean that the HHA must provide at least one, not all, of the listed therapeutic services – physical therapy, speech language pathology, occupational therapy, medical social services, home health aide services – in addition to the skilled nursing services.  ALJ Decision at 3; SOM, section 2180D.

To determine whether Petitioner was primarily engaged in providing skilled nursing services and other therapeutic services, we ask what information would help us make that determination.  Information about professional staffing plainly would be relevant, since an HHA must have qualified professionals to provide the required services.  For instance, evidence that an HHA had no one qualified to provide skilled nursing services, whether employed or under arrangement (see above-quoted SOM, section 2180D language), could support an inference that an HHA could not have met the requirement since an HHA must provide skilled nursing services.  Also relevant would be information about an HHA's patient population and the level of staffing.  It is reasonable to expect to see a correlation between the number of patients the HHA serves and the types and number of professionals an HHA employs or has available to provide services.  The larger the

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patient population an HHA serves, the more likely the HHA would need qualified staffing at a level sufficient to meet patient needs.  Information that an HHA served few patients and had few staff could inform a determination about how, as the ALJ stated, "actively" the HHA was engaged in providing the required services.  Data on the number of visits made, the types of services provided (e.g., skilled nursing, occupational therapy), and the dates of the visits made also would be relevant.

We note that in prior decisions, the Board has considered evidence on the duration of time an HHA was not engaged in providing required services in determining whether the HHA met the section 1861(o)(1) criteria.  See United Med. Home Care, DAB No. 2194, at 11 (evidence that the HHA provided no skilled nursing or other therapeutic services for a six-month period supported a finding of "manifestly 'substantial' failure to meet the statutory definition of an HHA") and 12 n.3 (ALJ reasonably concluded that a six-month failure to meet the statutory requirements was too long); A.M. Home Health Servs., DAB No. 2354, at 4 (an HHA that had not provided services for ten months preceding a survey was not primarily engaged in providing skilled nursing or other therapeutic services).

We now turn to the question of whether the evidence shows Petitioner met the criteria in section 1861(o)(1) of the Act.  In connection with its state licensure, Petitioner is required to give PDH annual reports about its census and the number and range of skilled staff employed.  CMS Ex. 8 (Decl. of W.A., a registered nurse and Health Facility Quality Examiner at the PDH), at 2 (¶ 8).  PDH also performs periodic certification and licensing surveys of providers participating in Medicare, such as Petitioner.  Id. at 1-2 (¶ 5).  As noted earlier, PDH performed surveys of Petitioner in August and September 2017.  The evidence that was before the ALJ documents communication between Petitioner (by its owner and administrator) and PDH in writing and through telephone calls in connection with Petitioner's licensure and/or recertification dating back a few years before termination of Petitioner's provider agreement.  To the extent that evidence includes information about, among other things, the level of Petitioner's staffing and patients served, the evidence is relevant to determining whether Petitioner was primarily engaged in providing skilled nursing services and other therapeutic services.  That evidence reveals that Petitioner was not "primarily engaged" in providing services consistent with the statutory requirements for at least a few years preceding termination.  We summarize that evidence below:

• September 2015 - August 2016:  In mid-2017, PDH communicated with Petitioner as part of its preparation to conduct an upcoming Medicare certification and license renewal survey.  CMS Ex. 8, at 2 (¶ 7), 3 (¶ 10); CMS Ex. 11, at 1.  In the course of those communications, Petitioner informed PDH that it had only provided services to two patients during the period from September 1, 2015 through August 31, 2016; it employed two nurses during that period; it had no home health aides or therapists employed or under contract to provide "other therapeutic services"; and the only services it provided during that period were skilled nursing services.  CMS Ex. 2, at 1-

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2; 8, at 2-3 (¶¶ 7, 8).

• Mid-2016 - mid-2017:  During a call with W.A. on June 2, 2017, Petitioner reported it had no active patients at the time and that it had two patients in the past year (which we understand to mean the period from around mid-2016 through mid-2017).  CMS Ex. 11, at 1; CMS Ex. 8, at 3 (¶ 10).  Petitioner reportedly indicated it was "hopeful for patients soon, but [was] unsure if it will happen or not[.]"  CMS Ex. 11, at 1.9
• September 2016 - August 2017:  In connection with its reporting obligations for the period from September 1, 2016 through August 31, 2017, Petitioner informed PDH that it had provided services to three patients and that it employed two nurses.  Since Petitioner had no clinical professionals on staff other than the two nurses, Petitioner was unable to provide services (that is, at least one therapeutic service) in addition to skilled nursing services.  CMS Ex. 8, at 3 (¶ 9); CMS Ex. 3, at 1-2.
• August 2017:  From August 9 through August 16, 2017, PDH performed a Medicare recertification and state licensure survey of Petitioner.  CMS Ex. 4, at 1.  During the survey, W.A.10 determined that Petitioner had no active patients.  CMS Ex. 8, at 5 (¶ 15); CMS Ex. 6, at 2 (plan of correction associated with the August 2017 survey, in which Petitioner reported that it "did not have active patients at the time of survey").  W.A. reviewed ten clinical records for patients who had received services between 2014 and 2017.  Those records were the only clinical records Petitioner was able to provide for surveyor review, given the few patients Petitioner had served between August 2014 and August 2017.  Five records were from 2014; four were from 2015; and one was from 2016.  There was one additional record related to a referral for physical therapy services, but, since Petitioner was unable to provide and did not provide physical therapy services, W.A. determined it would not be appropriate to include a review of that referral record in the survey.  CMS Ex. 8, at 5 (¶ 15).  W.A. was unable to choose an appropriate sample of patients for clinical record review consistent with survey guidelines because Petitioner provided only skilled services, had served very few patients, and did not have any active patients.  CMS Ex. 8, at 5 (¶ 16).11

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• September 2017:  Petitioner reported it did not have active patients at the time of the revisit survey and had not admitted any new patients since the exit date of the August 2017 survey.  CMS Ex. 5, at 2 and 3; CMS Ex. 7, at 1 (W.A.'s September 29, 2017 notes, stating Petitioner confirmed it "has no current patients and has admitted no patients since the exit date of the previous survey"; noting Petitioner's statement, "[w]ith no patients coming in, [it is] difficult to find staff and even agree to an interview")); CMS Ex. 8, at 6-7 (¶¶ 18, 19, 20).

The evidence as discussed above supports a finding that for at least a few years before January 2018, when CMS decided to terminate Petitioner's provider agreement, Petitioner was not primarily engaged in providing the required services.  During the year preceding the August 2017 survey, Petitioner served only a few patients and could not provide the required therapeutic services (in addition to skilled nursing services) since it did not have the professionals to provide those services.  As the ALJ stated, and we agree on our de novo review, Petitioner had no active patients at the time of the survey in early August 2017 and still had none on revisit survey at the end of September 2017 (ALJ Decision at 3).  Petitioner did not show to the ALJ and does not show to the Board that it had any active patients during the five-month period from August 2017 through early January 2018, when CMS issued its revised notice of termination.  Petitioner did not have a sufficient patient base to serve to sustain itself as a viable entity compliant with Medicare participation requirements at least for several months before termination.

Throughout its briefs submitted to the Board, Petitioner asserts the ALJ was wrong to grant summary judgment for CMS.  But Petitioner does not raise any specific dispute as to the factual findings the ALJ made on the evidence that was put before the ALJ, by CMS.  See 42 C.F.R. § 498.82(b) ("A request for review of an ALJ decision . . . must specify the issues, the findings of fact or conclusions of law with which the party disagrees, and the basis for contending that the findings and conclusions are incorrect.").  Having conducted a de novo review of the evidence that was before the ALJ, we too determine that the evidence shows Petitioner was not primarily engaged in providing skilled nursing services and other therapeutic services.  The ALJ appropriately granted summary judgment for CMS because there is no genuine dispute of material fact on the question of whether Petitioner met the criteria in section 1861(o)(1) of the Act.  To overcome CMS's sufficiently supported motion for summary judgment, Petitioner cannot simply argue that CMS did not show it was entitled to judgment in its favor and that the ALJ was wrong to grant summary judgment for CMS.  It must come forward with evidence showing a genuine dispute concerning a material fact that, if proven, would affect the outcome.  See Kingsville Nursing & Rehab. Ctr., DAB No. 2234, at 3 (2009).  Petitioner attempts to establish the existence of a genuine dispute of material fact late in the process by submitting evidence with its reply brief on appeal to the Board.  However, as we discuss below, none of the documents Petitioner submitted raises a genuine dispute of material fact.

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II.  Petitioner had a full opportunity to substantiate its arguments disputing the termination; the documents Petitioner submitted to the Board raise no dispute of material fact that could defeat summary judgment for CMS.

Petitioner asserts the ALJ deprived it of a full opportunity to submit a complete prehearing exchange because the ALJ issued his decision on July 25, 2018, before the date on which his prehearing exchange was due.  See RR at 3 and 9 (alleging the ALJ denied Petitioner "due process of law").

We discuss the procedural history as necessary to fully respond to Petitioner's assertion that the ALJ violated its due process rights.  By order issued March 19, 2018, the ALJ directed Petitioner to file an amended hearing request (by April 9, 2018) since, by revised determination dated January 3, 2018, CMS notified Petitioner that it was terminating Petitioner's provider agreement for failure to meet the legal definition of a Medicare HHA.  A Samuel's Christian Home Care, Order Directing Petitioner to File Amended Hearing Request, Docket No. C-18-351.  By that order, the ALJ informed the parties that the prehearing exchange deadlines he had set in his January 2, 2018 Acknowledgment and Pre-hearing Order (Pre-hearing Order) were suspended.  On April 4, 2018, Petitioner filed an amended request for hearing.  By email on April 9, 2018, the CRD attorney assigned to assist the ALJ in this case informed the parties that the ALJ had set new exchange deadlines – the due date for CMS's prehearing exchange would be July 5, 2018; the due date for Petitioner's prehearing exchange would be August 9, 2018.  Id.

CMS timely filed its motion for summary judgment, 22 exhibits, and an exhibit list on June 11, 2018, weeks before the due date.  On July 7, 2018, Petitioner timely filed its brief, opposing CMS's motion and urging the ALJ to issue a summary judgment decision in Petitioner's favor, but not any exhibits or exhibit list.  In the last page of its brief to the ALJ Petitioner wrote:

"Additionally, the petitioner brings this to the ALJ attention that CMS has not submitted its prehearing exchange that was due on July 5^th 2018.  We plead that the ALJ should not tolerate such delaying tactics of CMS.  CMS is clearly in default and the ALJ should take due action against CMS.  CMS has not requested for extension of time to submit its prehearing exchange in a timely manner.  Therefore, any request by CMS for extension of time should be denied.  The petitioner will meet its deadline in submitting his prehearing exchange response, along with the lists of exhibits on or before August 9^th 2018 if CMS is allowed to submit its prehearing exchange."

Pet. Response to CMS Motion at 20.  The record reveals no communication between the parties and CRD after July 7, 2018, the date on which Petitioner filed its brief, through July 25, 2018, the date on which the ALJ issued his decision.

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Petitioner was plainly mistaken when it stated in its brief that CMS failed to submit its prehearing exchange.  The record shows that, on June 11, 2018, CMS timely filed its complete prehearing exchange (motion, 22 exhibits, exhibit list) consistent with the ALJ's Pre-hearing Order, page 3, paragraph 3c, which put both parties on notice that a complete exchange "shall consist of" a brief of all issues of law and fact, including any motion for summary judgment; a list of proposed exhibits; a copy of each proposed exhibit; and a list of proposed witnesses (if any).  A Samuel's Christian Home Care, Pre-hearing Order, Docket No. C-18-351 (Jan. 2, 2018).  Contrary to Petitioner's allegations, CMS fully complied with the ALJ's instructions on submitting a prehearing exchange.  CMS's prehearing exchange was available to Petitioner on July 7, 2018, when it filed its brief.  Petitioner does not state that it was unable to access the electronic DAB E-File record that included CMS's prehearing exchange.

Petitioner was given an opportunity to submit its complete prehearing exchange after reviewing CMS's prehearing exchange.  Pre-hearing Order; March 19, 2018 Order Directing Petitioner to File Amended Hearing Request (suspending prehearing exchange deadlines in the Pre-hearing Order); April 9, 2018 CRD attorney email informing Petitioner about the new deadlines.  Petitioner was obliged to file any exhibits it wanted the ALJ to admit and consider, along with an exhibit list, at the same time it filed its (timely) brief, but did not do so.12   In any case, we discern no prejudice to Petitioner resulting from the ALJ's proceeding to decision about two weeks before the date on which Petitioner's prehearing exchange was due.  Petitioner has submitted documents directly to the Board and we have considered every one of those documents.  As we discuss below, none of those documents raise a genuine dispute of material fact.

We now discuss the documents Petitioner submitted with its reply brief.  The documents include affidavits of four individuals executed after the date on which Petitioner filed its appeal to the Board and apparently were obtained for the purpose of supporting the appeal.  Also included are multiple records related to Petitioner's state licensure; most of them appear to have been in existence before the ALJ issued his decision and available for submission earlier.  One item (Social Security Act provisions) is not evidence.  One

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item duplicates CMS's exhibit 4 (SOD from the August 2017 survey).  Petitioner included multiple copies of certain items.  Also submitted were documents related to the 2017 surveys and Petitioner's communication with the Small Business Administration concerning the 2017 surveys and CMS's termination.

In general, the Board issues a decision based on a review of the record of the ALJ proceedings.  However, with exceptions not applicable here, 42 C.F.R. § 498.86 permits the Board to admit and consider evidence that was not included in the record of the ALJ proceedings if the evidence is relevant and material to an issue before the Board.  The Board has stated that the regulation does not obligate the Board to admit additional evidence not presented to the ALJ; it has discretion to refuse to admit such evidence.  See N. Las Vegas Care Ctr., DAB No. 2946, at 16 (2019) (citing Cmty. Nursing Home, DAB No. 1807, at 28 (2002)).  In determining whether to admit evidence in accordance with section 498.86, the Board considers whether its proponent has shown "good cause" for not producing it earlier.  See id.; see also Guidelines, "Development of the Record on Appeal," ¶ (g).13   If the Board decides to admit evidence into the record, the Board must first give the parties notice (unless notice is waived) of the proposed admission of the evidence and give them a reasonable opportunity to comment and present other evidence pertinent to the specified issues.  42 C.F.R. § 498.86(c).

To the extent Petitioner's argument about the ALJ's depriving it of a full opportunity to submit a complete prehearing exchange could be viewed as an explanation of good cause,14 we are not inclined to accept the argument as establishing good cause.  Petitioner was mistaken in asserting that CMS did not file its prehearing exchange in compliance with the ALJ's instructions and suggesting that Petitioner was not obliged to submit its complete prehearing exchange unless and until the ALJ issued an order directing CMS to file its prehearing exchange.  It is Petitioner who failed to comply with the ALJ's instructions to submit a complete prehearing exchange.  Petitioner should have submitted any evidence it believed would establish a genuine dispute of material fact earlier, to the ALJ.

Under these circumstances and in the absence of good cause, it would be well within the Board's discretionary authority to decline to further consider the documents submitted very late in the appeal process.  Nevertheless, we have considered every document.  Some of the documents are not relevant to the extent they appear to relate only to

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Petitioner's complaints that Petitioner did not violate the conditions of participation.  We need not further discuss those documents.  We discuss certain documents below to explain why they do not raise a genuine dispute of material fact on the dispositive issue:  whether Petitioner was primarily engaged in providing skilled nursing services and other therapeutic services consistent with section 1861(o)(1) of the Act.  We need not decide whether to admit any of those documents because they do not raise a genuine dispute of material fact.15

Petitioner submitted several items related to its Pennsylvania licensure.  They include evidence of payment of a fee to renew the license for one year and a copy of a Certificate of Licensure for the period from September 1, 2017 through August 31, 2018, issued by PDH.16  Also included are a summary of licensing history going back to the early 2000s, shortly after Petitioner established itself as an HHA, as well as data Petitioner submitted online to respond to information PDH asked for in connection with annual state licensure requirements.  See Dkt. A-18-129.  The fact that Petitioner has a licensing history in Pennsylvania does not prove that Petitioner was primarily engaged in providing skilled nursing services and other therapeutic services consistent with section 1861(o)(1) of the Act.17   See United Med. Home Care, DAB No. 2194, at 11 ("The mere possession of a [state] license, in the absence of a demonstrated capacity to actually provide services, cannot overcome evidence of substantial failure to meet the statutory definition of an HHA.").  However, the evidence related to state licensing history, particularly during the time period immediately preceding termination, could be relevant to the section 1861(o)(1) issue to the extent the evidence includes information such as the number of patients served, as we discussed in section I.  But, the licensing-related evidence Petitioner submitted to the Board does not raise any dispute of material fact.  Data for a full one-year period ending August 31, 2018 (which includes the September-December 2017 period preceding the termination) indicate that, other than an administrator (who is also Petitioner's owner), Petitioner employed a registered nurse and a supervising registered nurse, served three patients, and provided no therapeutic service in addition to skilled nursing services.  See Dkt. A-18-129.  This evidence essentially reaffirms what we know based on the record that was before the ALJ.

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Petitioner submitted the affidavits of four individuals, K.A., A.G., L. F.-C., and M.M.  See Dkt. A-18-129.  The affiants indicate that they have been a part of Petitioner's professional staff in prior years, but they either do not specify whether they have direct personal knowledge of information relevant to determining whether Petitioner met section 1861(o)(1) criteria or do not explain in any detail the circumstances of their personal involvement in providing care to Petitioner's patients.  The affidavits are not relevant and material to the dispositive issue before us to the extent they discuss the 2017 surveys or the SODs from those surveys and apparently are offered in part as support for repeated assertions that:  (1) CMS has not met its burden to prove the deficiency allegations in the survey findings18 ; (2) Petitioner is not in violation of the conditions of participation; and (3) CMS therefore had no legal basis to terminate Petitioner's participation19 based on allegations of violation of the conditions of participation; (4) nevertheless, CMS wrongly continued to pursue termination on a new, different basis (failure to meet section 1861(o)(1) of the Act).  See, e.g., RR at 1-2.  Since Petitioner did not meet section 1861(o)(1) criteria, it was not eligible to continue participating in Medicare as an HHA.  Even were we to assume Petitioner was not in violation of the conditions of participation as alleged in the 2017 survey findings (and we need not and do not make any such determination), CMS could terminate Petitioner's provider agreement, as it did here, for failure to meet the criteria in section 1861(o)(1) of the Act.

To the limited extent the affiants address the issue before us, they assert without elaboration that Petitioner has provided the required services.  For instance, K.A. states that Petitioner "has provided and is equipped to provide skilled nursing services and/or

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home health aide services only if ordered by the patient's physician.  I affirm [Petitioner] is equipped to provide 'now' and in the 'future' skilled Nursing and/or Home Health aide services to patients if ordered by the patient's physician.  Medicare regulations strictly require that only those services be provided to patients that are ordered by the physician."  K.A. affidavit, pages 2-3 (affiant's emphasis) (Dkt. A-18-129).20   K.A. does not state whether she herself provided the services and, if so, the type of services she provided, and when and to whom she provided them.  K.A.'s use of the words "and/or" is also equivocal; it is not clear to us whether K.A. is stating that Petitioner provided both skilled nursing and home health aide services.  Viewing the statements such as that made by K.A. in the light most favorable to Petitioner, the statements at best address something that is not actually in dispute – that Petitioner provided some services, such as skilled nursing services.  But the issue is whether Petitioner was primarily engaged in providing both skilled nursing services and other therapeutic services.  The affiants' statements, viewed in the light most favorable to Petitioner, do not raise a genuine dispute of material fact on this issue.

We also note that A.G., a registered nurse, indicated that in the past she worked for Petitioner as a "home health nurse" and "Nurse Supervisor."  A.G. affidavit, page 1 (Dkt. A-18-129).  She also wrote:  "An aide has never worked with me, instead I have always provided all the nursing needs including home health aide services to my patients from basic bathing to complex life assistive devices. . . . It is convenient and therapeutic to visit the patient and perform the necessary nursing duties and skills; but also to then stay with the patient and provide home health aide services to patients if ordered by the physician."  Id.  A.G. does not specify when she worked for Petitioner as a nurse or specifically state that she provided skilled nursing services and aide services together to Petitioner's patients and when she did so.  Nevertheless, even were we to read A.G.'s statements as suggesting that A.G. provided skilled nursing services to a patient at the patient's home but also provided home health aide services during the home visit, A.G.'s affidavit ultimately would not change the outcome.  A.G.'s statements suggesting she provided both services together, alone, do not overcome undisputed evidence that

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Petitioner provided very few services to very few patients over a lengthy period of time, that is, Petitioner was not primarily engaged in providing the required services.  A.G.'s affidavit does not raise a genuine dispute of material fact.

III.  We reject Petitioner's allegations of CMS wrongdoing and ALJ bias.

The ALJ stated that Petitioner's allegations of CMS malfeasance and misfeasance are not relevant to the dispositive issue of whether Petitioner was primarily engaged in providing skilled nursing and other therapeutic services.  ALJ Decision at 5.  Before the Board, Petitioner reprises its allegations of CMS wrongdoing and does so repeatedly.  It also alleges discrimination.  See, e.g., RR at 5 (CMS engaged in an "illegal maneuver" by not submitting to the ALJ clinical evidence that it already had, which Petitioner asserts proved that it actively provided services); 12 (alleging CMS's "tampering" with material evidence by withholding PDH licensing records); 31 (alleging "prosecutory misconduct" and intent to harm a "small minority owned HHA" in using "invalid evidence" to pursue termination); 36 (CMS personnel "conspir[ed] to "protect" the surveyor's "deliberate misconduct"); Reply Br. at 9 (implying that CMS staff are prejudiced against Petitioner, a "minority based small business owned by an elderly disabled person").  We agree with the ALJ that allegations such as these are not relevant unless they somehow raise a genuine dispute of material fact on the dispositive question.  ALJ Decision at 5.  Bare allegations of bad motives and intention, and discriminatory conduct do not raise any dispute of material fact.21

Petitioner also alleges ALJ bias and prejudice (see, e.g., RR at 13, 37), stating that the ALJ "openly condon[ed]" the acts of "'Administrative Malpractice[]'" by CMS employees (RR at 35) in granting summary judgment to CMS.  However disappointed Petitioner might be with the outcome of the appeal, and however Petitioner might disagree with the ALJ's reasoning and his fact-finding and conclusions, an ALJ is responsible for independently assessing the evidence, applying the facts as he finds them to the governing law, and reaching a conclusion of law.  See Meadow Wood Nursing Home, DAB No. 1841, at 10 (2002) (Assessment of the evidence "is the essential task of an ALJ and can hardly be viewed as a demonstration of bias toward the party that does not prevail on the merits, however disappointed."), aff'd, 364 F.3d 786 (6th Cir. 2004).  That the ALJ determined summary judgment for CMS was appropriate is not proof of bias against Petitioner or bias in favor of CMS.  Petitioner has done nothing more than

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raise bare allegations of bias on the part of the ALJ who issued the decision before us.  We flatly reject the baseless allegations.

We also note that, in prior cases the Board has stated that, to be disqualifying, alleged bias or prejudice must have stemmed from an extrajudicial source and must have resulted in an opinion on the merits on a basis other than what the ALJ learned through presiding over the case.  See Adel Kallini, M.D., DAB No. 3021, at 17-18 (2020); Avalon Place Trinity, DAB No. 2819, at 42-43 (2017), aff'd, 761 F. App'x 407 (5th Cir. 2019); Zahid Imran, M.D., DAB No. 2680, at 14 (2016).  Petitioner has not shown that the ALJ's decision was based on something other than what was before the ALJ and what he learned about the case in the course of his presiding over it.

Conclusion

CMS lawfully terminated Petitioner's participation in Medicare as an HHA effective November 14, 2017.22   We affirm the ALJ Decision.

1. Effective July 13, 2017, CMS revised the regulations governing the participation of HHAs, including a number of conditions of participation in Part 484.  See Final Rule, Medicare and Medicaid Program:  Conditions of Participation for Home Health Agencies, 82 Fed. Reg. 4504 (Jan. 13, 2017).  The 2017 regulatory revisions are not at issue in this case.
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2. Survey findings are described in CMS Form 2567, Statement of Deficiencies (SOD), which identifies noncompliance findings using "Tag" designations that correspond to the regulations allegedly violated and CMS's guidance on the regulatory requirements.  See generally CMS Pub. 100-07, State Operations Manual (SOM), Chapter 10, Survey and Enforcement Process for Home Health Agencies, and Appendix B, Guidance to Surveyors:  Home Health Agencies.  The Manual and Appendices are available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs-Items/CMS1201984.
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3. With exceptions not applicable here, CMS may reopen an initial determination or reconsidered determination "within 12 months after the date of the notice of the initial determination."  42 C.F.R. § 498.30.
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4. Although CMS indicated that it was moving for summary judgment in the absence of any material factual question as to whether Petitioner met the statutory definition of a "home health agency," CMS also indicated that it had not abandoned the other two bases for termination (violation of two conditions of participation as alleged in its revised notice of termination).  CMS's motion at 1 n.1 (citing CMS Ex. 22).  CMS stated that, should the ALJ deny its motion, it reserved the right to later rely on either one (or both) of the other two bases for termination cited in its revised notice.  Id.; id. at 9 n.4 (citing Act § 1866(b)(2)(B); 42 C.F.R. §§ 488.865(b)(1), 489.53(a)(1)) and 25.
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5. The ALJ stated, "It is unnecessary that I receive CMS's proposed exhibits into the record inasmuch as I grant summary judgment based on undisputed material facts.  I cite to some of the exhibits in this decision, but only for the purpose of illustrating facts that are undisputed."  ALJ Decision at 2.  The Board has held that an ALJ need not rule on the admission of exhibits to resolve a motion for summary judgment, but, in that situation, the proposed exhibits are "properly treated as an offer of proof" and that they "may be evaluated if necessary to determine whether a genuine issue of material fact exists."  Illinois Knights Templar Home, DAB No. 2274, at 6-7 (2009) (citation omitted).  We presume the ALJ considered all of the proffered exhibits in determining whether to grant summary judgment.  In any case, we have reviewed the summary judgment question de novo and have considered every exhibit.
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6. In January 2018, PDH informed Petitioner that it was "rescinding" Petitioner's "regular license dated September 1, 2017-August 31, 2018" and "revoking . . . [the] home health agency effective February 23, 2018."  CMS Ex. 17, at 1 (emphasis in original omitted).
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7. The ALJ rejected Petitioner's argument that it should be excused from the requirement to actively treat patients because it could not have admitted patients, noting that Petitioner offered no justification for the claim.  Moreover, the ALJ observed that the failure to maintain the state license indicated potential violation of the condition of participation in 42 C.F.R. § 484.12(a), though in this instance the failure to maintain the license only served to illustrate that Petitioner was not providing services to patients during the suspension.  ALJ Decision at 3 n.1.
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8. Petitioner appears pro se before the Board, as it did before the ALJ.  Petitioner's owner and administrator (see CMS Ex. 13, at 1) submitted the briefs and documents discussed herein.
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9. We note that, in an email to PDH on May 31, 2017, Petitioner's owner and administrator informed PDH that Petitioner wanted to renew its license and remain Medicare-certified and that it had "seen 12 patients in the last three years" (which we assume covered a period from approximately mid-2014 through mid-2017); and stated that "at this time" (which we understand to mean at the time of the email communication), Petitioner was "just providing Skilled nursing services plus aide service."  CMS Ex. 11, at 1.
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10. W.A. appears to have erroneously referred to "2018" in referring to the survey dates.  CMS Ex. 8, at 4 (¶ 12), 5 (¶ 16).  The surveys took place in 2017, in August and September.  CMS Exs. 4, 5.
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11. A surveyor needs to be able to review records to determine whether an HHA is compliant with program requirements.  An HHA that serves few patients would have few records of services provided, which could impede a surveyor's ability to adequately assess compliance.  See United Med. Home Care, DAB No. 2194, at 11-12.
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12. Before the Board, Petitioner acknowledges receipt of the April 9, 2018 email from the CRD attorney.  Petitioner also acknowledges that, later, the same attorney confirmed over the phone that CMS had submitted its prehearing exchange early and that Petitioner's prehearing exchange was due August 9, 2018.  RR at 3.  Petitioner was thus aware of when its prehearing exchange was due; it was responsible for following the ALJ's instructions to submit a complete prehearing change by the due date.  Petitioner complains its due process rights were violated solely because the ALJ proceeded to decision two weeks before August 9.  Id.  But Petitioner does not state how it was harmed by the ALJ's proceeding to decision earlier.  We see no indication in the record that Petitioner had evidence ready to submit to the ALJ by August 9, or that it communicated to the CRD attorney assisting the ALJ that it wanted to submit evidence by August 9, to be considered together with the brief it had filed earlier.  Had Petitioner informed the CRD that it wanted to submit evidence after it filed its brief, the ALJ could have considered whether to permit Petitioner to deviate from his earlier instructions to submit all parts of a prehearing exchange together.
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13. The Guidelines were provided to the parties on July 25, 2018.
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14. In page 2 of its September 24, 2018 letter acknowledging Petitioner's appeal of the ALJ Decision, the Board notified the parties that they "should identify the specific issues to which any additional evidence submitted relates and explain why the evidence was not produced in the proceedings before the ALJ."  Although we are able to glean from the Petitioner's briefs why Petitioner might believe the documents submitted to the Board support its arguments, however irrelevant, Petitioner did not explain why it failed to submit any evidence to the ALJ.
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15. Had we determined that any document raised a genuine dispute of material fact, we would have given CMS an opportunity to respond to Petitioner's reply brief.  We note that CMS did not ask for an opportunity to respond to Petitioner's reply brief and/or submit additional evidence.
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16. As we noted earlier, the evidence indicates that PDH later rescinded the license.  See note 6 supra.
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17. Section 1861(o)(4) of the Act requires that HHAs be licensed as required by state authorities.  It is one element of several elements in section 1861(o) that HHAs must meet.  See also SOM, Ch. 2, § 2180C.  But Petitioner's Pennsylvania licensure itself is not at issue here.  The evidence supports a conclusion that Petitioner did not meet the criteria in section 1861(o)(1) of the Act.  CMS therefore had a lawful basis to terminate Petitioner's provider agreement.
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18. Petitioner repeatedly takes issue with CMS's alleged failure to issue a final SOD following the September 2017 revisit survey, asserting that the ALJ therefore wrongly issued a decision based on an "unripe record."  See, e.g., RR at 12.  The survey findings concerning allegations of violation of conditions of participation are not at issue here.  The survey-related documents are discussed only to the extent that they include information relevant to determining whether Petitioner met section 1861(o)(1) criteria.  For instance, as noted earlier, the plan of correction associated with the August 2017 survey includes a notation that Petitioner's owner and administrator himself reported that Petitioner did not have any active patients at that time.  See CMS Ex. 6, at 2.
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19. Petitioner repeatedly raises an argument relying on 42 C.F.R. § 424.540.  The argument is not clearly articulated, but as far as we are able to discern it, Petitioner asserts that CMS wrongfully terminated its provider agreement because, under section 424.540, "not having a patient for 12 consecutive months" "is not a violation" (for termination purposes); rather, the provider would only be subject to deactivation.  Referring to CMS's brief to the ALJ (but not citing any evidence), Petitioner maintains that it had a patient in December 2016, around eight months before the August 2017 survey (that is, within the 12-month period before the survey), apparently meaning that it did not even violate section 424.540 for deactivation purposes and should not be subject to termination.  See RR at 7-8.  As Petitioner is aware (see id. at 8), section 424.540 concerns deactivation of billing privileges.  See Arkansas Health Group, DAB No. 2929, at 2 (2019) (discussing deactivation).  Termination of an HHA's provider agreement should not be confused with deactivation of billing privileges.  The former action is authorized by different authority.  See "Legal authorities" section supra.  An assertion that Petitioner had a patient on a particular month (December 2016) does not raise a genuine dispute of material fact.  Even were we to assume for the moment that the assertion is supported with evidence, Petitioner does not address how that would overcome evidence, which remains undisputed, that supports a conclusion that Petitioner was not primarily engaged in providing the required services.
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20. Petitioner suggests it should be excused from meeting the section 1861(o)(1) criteria since Petitioner's ability to provide services like aide services and the extent to which Petitioner can provide them are not entirely within its control; Petitioner can provide these services only if a physician orders them.  RR at 16.  The affiants echo that suggestion.  Also, K.A. suggests that Petitioner should be deemed to have been engaged in providing services since it was "equipped" to provide services "now" and "in the future."  See, e.g., K.A. affidavit, pages 2-3; see also M.M. affidavit, page 1 (Petitioner "has been equipped to provide Skilled Nursing and/or Home health aide services when and if they were ordered by the patient's physician."); RR at 9, 10.  The question is whether Petitioner was primarily engaged in skilled nursing services and other therapeutic services; it is not excused from that requirement because a physician must first order the services.  Petitioner also must have actually provided the services.  See A.M. Home Health, DAB No. 2354, at 5-6 (rejecting argument that petitioner was in "ready mode" to provide services and not "dormant" as taking the word "engaged" out of context); United Med. Home Care, DAB No. 2194, at 10 (citing Ariz. Surgical Hosp., LLC, DAB No. 1890 (2003) and stating that "[t]he Board held in Arizona that in order to be 'primarily engaged' in providing inpatient services" to meet the definition of a "hospital" in section 1861(e)(1) of the Act, "the hospital had to be actually 'engaged' in that activity").
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21. The allegations of CMS wrongdoing indicate a fundamental misconception:  that CMS, as the governmental entity, was obliged to produce all evidence in existence, even evidence that concerns allegations of compliance with the conditions of participation that are not at issue here, throughout the appeal process.  CMS was obliged to put before the ALJ evidence that supported its position that there is no dispute of material fact on the issue of whether Petitioner met section 1861(o)(1) criteria and that CMS is entitled to judgment in its favor as a matter of law.  CMS made its case for summary judgment in its favor.  It is Petitioner who did not and still does not establish the existence of a genuine dispute of material fact.
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22. We have not addressed the effective date of termination since Petitioner has not raised any argument about it.
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