IN THE COURT OF APPEALS OF NORTH CAROLINA

2022-NCCOA-199

No. COA21-318

Filed 5 April 2022

Office of Administrative Hearings, Nos. 20 DHR 2366–67

BIO-MEDICAL APPLICATIONS OF NORTH CAROLINA INC d/b/a BMA OF 

SOUTH GREENSBORO and FRESINIUS KIDNEY CARE WEST JOHNSTON,

Petitioner,

v.

NC DEPARTMENT OF HEALTH AND HUMAN SERVICES, DIVISION OF 

HEALTH SERVICE REGULATION, HEALTH CARE PLANNING & CERTIFICATE 

OF NEED SECTION, Respondent, 

and 

TOTAL RENAL CARE OF NORTH CAROLINA, LLC, d/b/a CENTRAL 

GREENSBORO DIALYSIS and CLAYTON DIALYSIS, Respondent-Intervenor.

Appeal by Petitioner from final decision entered 3 November 2020 by 

Administrative Law Judge Stacey Bice Bawtinhimer in the Office of Administrative 

Hearings. Heard in the Court of Appeals 14 December 2021.

Fox Rothschild LLP, by Marcus C. Hewitt and Elizabeth Sims Hedrick, for 

Petitioner-Appellant.

Attorney General Joshua H. Stein, by Assistant Attorney General Derek L.

Hunter and Assistant Attorney General Kimberly M. Randolph, for RespondentAppellee.

Wyrick Robbins Yates & Ponton LLP, by Lee M. Whitman and J. Blakely Kiefer, 

for Respondent-Intervenor-Appellee.

GRIFFIN, Judge.
BIO-MEDICAL APPLICATIONS OF N.C., INC. V. N.C. DEP’T OF HEALTH & HUM. SERVS.

2022-NCCOA-199

Opinion of the Court

¶ 1 Petitioner Bio-Medical Applications of North Carolina, Inc., appeals from a 

final decision granting summary judgment in favor of Respondent North Carolina 

Department of Health and Human Services and Respondent-Intervenor Total Renal 

Care, LLC. BMA argues that the administrative law judge erred by granting 

summary judgment in favor of DHHS and TRC. After review, we affirm the ALJ’s 

decision. 

I. Factual and Procedural Background

¶ 2 BMA and TRC own and operate kidney dialysis clinics across North Carolina. 

N.C. Gen. Stat. § 131E-178(a) provides that any entity seeking to “offer or develop a 

new institutional health service[,]” including dialysis clinics, must first apply for and 

obtain a certificate of need (“CON”) from DHHS. N.C. Gen. Stat. § 131E-178(a) 

(2019). 

¶ 3 In July 2019, a “Semiannual Dialysis Report (‘SDR’) identified a deficit of 20 

dialysis stations in Guilford County” and “a deficit of 12 dialysis stations in Johnston 

County.” Pursuant to the SDR, DHHS could approve no more than the number of 

stations necessary to satisfy the deficit in each county.

¶ 4 On 15 July 2019, BMA and TRC each “submitted competing applications to the 

CON Section[s]” for Guilford and Johnston Counties. In its application for the 

Guilford County service area, “BMA proposed to relocate 12 existing dialysis stations” 

to Guilford County, and “TRC proposed to develop a new 10-station dialysis facility 
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Opinion of the Court

in Guilford County[.]” Because the total number of stations proposed by BMA and 

TRC exceeded the deficit identified in the SDR, BMA’s and TRC’s applications “could 

not both be approved as proposed.” Similarly, BMA’s and TRC’s CON applications 

for the Johnston County service area could not both be approved because, collectively, 

the number of proposed stations in their applications exceeded the deficit identified 

in the SDR.

¶ 5 On 20 December 2019, “the CON Section found both Guilford County 

applications conforming to all applicable statutory and regulatory criteria.” DHHS 

approved TRC’s application in full and partially approved BMA’s application, 

allowing BMA to “develop 10 of the 12 dialysis stations it proposed.” DHHS also 

“found both Johnston County applications conforming to all applicable statutory and 

regulatory criteria.” DHHS again approved TRC’s application in full and partially 

granted BMA’s application, allowing BMA to “relocate 2 of the 4 requested dialysis 

stations” to Johnston County.

¶ 6 On 17 January 2020, BMA appealed DHHS’s decisions as to both its Guilford 

and Johnston County applications by filing petitions for contested case hearings with 

the Office of Administrative Hearings. BMA subsequently filed a motion for 

summary judgment, arguing that its “rights were substantially prejudiced by 

[DHHS’s] decisions” and that DHHS erred by granting TRC’s applications. DHHS 

and TRC, as a party intervenor, jointly filed a cross-motion for summary judgment, 
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Opinion of the Court

contending that BMA could not “show that it was substantially prejudiced by 

[DHHS’s] decision[s.]”

¶ 7 On 6 October 2020, a hearing was held on the parties’ motions for summary 

judgment, after which the ALJ entered a final decision granting DHHS’s and TRC’s 

joint motion for summary judgment because BMA failed to establish that DHHS 

substantially prejudiced BMA by denying its CON applications. BMA timely filed 

notice of appeal from the final decision.

II. Analysis

¶ 8 BMA argues that the ALJ erred by granting DHHS’s and TRC’s motion for 

summary judgment because (1) requiring BMA to demonstrate substantial prejudice 

violated its “unconditional statutory right to administrative review” and (2) even if 

BMA was required to demonstrate substantial prejudice, the ALJ erred in finding 

that BMA did not demonstrate substantial prejudice. We hold that BMA is required 

to demonstrate substantial prejudice pursuant to N.C. Gen. Stat. § 150B-23(a) and 

that BMA has not met its burden. We therefore affirm the ALJ’s final decision.

¶ 9 “As summary judgment is a matter of law, review by this Court in this matter 

is de novo.” Presbyterian Hosp. v. N.C. Dep’t of Health & Hum. Servs., 177 N.C. App. 

780, 782, 630 S.E.2d 213, 214 (citation omitted). 

The burden is upon the moving party to show that no 

genuine issue of material fact exists and that the moving 

party is entitled to judgment as a matter of law. To meet 
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its burden, the movant is required to present a forecast of 

the evidence available at trial that shows there is no 

material issue of fact concerning an essential element of 

the non-movant’s claim and that the element could not be 

proved by the non-movant through the presentation of 

further evidence.

Id. at 782–83, 630 S.E.2d at 215 (citation and internal quotation marks omitted).

A. Substantial Prejudice Requirement

¶ 10 BMA argues that it is not required to demonstrate substantial prejudice “or 

other injury in fact because the legislature has granted it an unconditional right to 

administrative review[.]” We disagree.

¶ 11 “After a decision of the Department to issue, deny or withdraw a certificate of 

need[,] . . . , any affected person . . . shall be entitled to a contested case hearing under 

Article 3 of Chapter 150B of the General Statutes.” N.C. Gen. Stat. § 131E-188(a) 

(2019). Applicants for a certificate of need are considered “affected persons” under 

the CON statutes. Id. § 131E-188(c). “In addition to meeting this prerequisite to 

filing a petition for a contested case hearing regarding CONs, the petitioner must also 

satisfy the actual framework for deciding the contested case as laid out in section 

150B-23(a) of . . . the General Statutes.” Surgical Care Affiliates, LLC v. N.C. Dep’t 

of Health & Hum. Servs., 235 N.C. App. 620, 623, 762 S.E.2d 468, 471 (2014) (internal 

quotation marks and brackets omitted). 

¶ 12 N.C. Gen. Stat. § 150B-23(a) provides in pertinent part:
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A party that files a petition shall . . . state facts tending to 

establish that the agency named as the respondent has 

deprived the petitioner of property, has ordered the 

petitioner to pay a fine or civil penalty, or has otherwise 

substantially prejudiced the petitioner’s rights and that the 

agency did any of the following: 

(1) Exceeded its authority or jurisdiction.

(2) Acted erroneously.

(3) Failed to use proper procedure.

(4) Acted arbitrarily or capriciously.

(5) Failed to act as required by law or rule.

The parties in a contested case shall be given an 

opportunity for a hearing without undue delay. Any person 

aggrieved may commence a contested case under this 

section. 

N.C. Gen. Stat. § 150B-23(a) (2019) (emphasis added). “This Court has interpreted 

subsection (a) to mean that the ALJ in a contested case hearing must determine 

whether the petitioner has met its burden in showing that the agency substantially 

prejudiced the petitioner’s rights.” Surgical Care Affiliates, 235 N.C. App. at 624, 762 

S.E.2d at 471 (internal quotation marks and brackets omitted); see also Parkway 

Urology, P.A. v. N.C. Dep’t of Health & Hum. Servs., 205 N.C. App. 529, 536–37, 696 

S.E.2d 187, 193 (2010) (“Under N.C. Gen. Stat. § 150B-23(a), the ALJ is to determine 

whether the petitioner has met its burden in showing that the agency substantially 

prejudiced petitioner’s rights. . . . [The petitioner’s] contention that it was 
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unnecessary for it to show substantial prejudice to be entitled to relief is contrary to 

our case law and is without merit.” (emphasis in original)). BMA is thus required to 

demonstrate substantial prejudice pursuant to N.C. Gen. Stat. § 150B-23(a) and our 

caselaw construing its requirements. 

¶ 13 BMA likens the substantial prejudice requirement to an “injury in fact” 

requirement for purposes of standing, citing Committee to Elect Dan Forest v. 

Employees Political Action Committee, 376 N.C. 558, 2021-NCSC-6. This contention 

is misguided. Unlike standing, a petitioner has to demonstrate substantial prejudice 

as part of the merits of its case. See Parkway Urology, 205 N.C. App. at 536, 696 

S.E.2d at 193 (describing substantial prejudice as one of “the statutory requirements 

that must be met in order for a petitioner to be entitled to relief” and part of “[t]he 

actual framework of deciding the contested case” (emphasis in original)). BMA’s 

argument is an attempt to avoid proving the merits of its case by asking this Court 

to hold that it is exempt from the substantial prejudice requirement. This argument 

is without merit.

B. Proof of Substantial Prejudice

¶ 14 BMA next argues that the ALJ “erroneously concluded that BMA did not 

forecast evidence of” substantial prejudice. By “limit[ing] the number of its own 

stations that [BMA] could move[,]” BMA contends that DHHS “infringed and 

deprived [BMA] of its liberty and property rights[,] thereby preventing [BMA] from 
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conducting business as it chooses.” We disagree.

¶ 15 “In order to establish substantial prejudice, the petitioner must provide specific 

evidence of harm resulting from the award of the CON . . . that went beyond any 

harm that necessarily resulted from additional . . . competition[.]” Surgical Care 

Affiliates, 235 N.C. App. at 631, 762 S.E.2d at 476 (citation omitted). “The harm 

required to establish substantial prejudice cannot be conjectural or hypothetical” and 

instead must be “concrete, particularized, and actual or imminent.” Id. (internal 

quotation marks omitted).

¶ 16 We hold that BMA did not forecast sufficient evidence of substantial prejudice 

to survive summary judgment. BMA argues that it was substantially prejudiced by 

the partial denial of its CON application because it “limited the number of its own 

stations that [BMA] could move[.]” However, this Court has previously held in 

multiple cases that a petitioner’s “mere status as a denied competitive CON applicant 

alone is insufficient [to establish substantial prejudice] as a matter of law.” Surgical 

Care Affiliates, LLC v. N.C. Dep’t of Health & Hum. Servs., 237 N.C. App. 99, 766 

S.E.2d 699, 2014 WL 5770252, at *3 (2014) (unpublished) (citing CaroMont Health, 

Inc. v. N.C. Dep’t of Health & Hum. Servs., 231 N.C. App. 1, 4–5, 751 S.E.2d 244, 248 

(2013); Parkway Urology, 205 N.C. App. at 536–37, 696 S.E.2d at 193); Bio-Medical 

Apps. Of N. Carolina v. N.C. Dep’t of Health & Hum. Servs., 247 N.C. App. 899, 788 

S.E.2d 684, 2016 WL 3166601, at *3–4 (2016) (unpublished) (holding that the 
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petitioner did not establish substantial prejudice where “the Agency approved [the 

petitioner] to develop seven dialysis stations instead of the 11 it requested” in its CON 

application). Accordingly, BMA’s argument that partial denial of its CON application 

constitutes substantial prejudice is without merit.

¶ 17 We note that “[t]his Court has previously held that, as material questions of 

fact will always exist, summary judgment is never appropriate” where, as here, “two 

or more applicants conform to the majority of the statutory criteria.” Presbyterian 

Hosp., 177 N.C. App. at 783, 630 S.E.2d at 215 (citing Living Centers-Southeast v. 

N.C. Dep’t of Health & Hum. Servs., 138 N.C. App. 572, 580–81, 532 S.E.2d 192, 197 

(2000)). In Living Centers, however, the Court held that summary judgment is never 

appropriate as to the statutory criteria, not as to substantial prejudice. See Living 

Centers, 138 N.C. App. at 580–81, 532 S.E.2d at 197 (“[W]e believe that it is inherent 

that where two or more certificate of need applicants conform to the majority of the 

criteria in N.C. Gen. Stat. § 131E-183, as in the case at bar, and are reviewed 

comparatively, there will always be genuine issues of fact as to who is the superior 

applicant.” (emphasis added)). Substantial prejudice, which was not at issue in 

Living Centers, is a distinct and separate element of a petitioner’s claim; agency error 

as to the statutory criteria is another element. See, e.g., Britthaven, Inc. v. N.C. Dep’t 

of Hum. Res., 118 N.C. App. 379, 382, 455 S.E.2d 455, 459 (1995) (“Under N.C. Gen. 

Stat. § 150B-23(a), the ALJ is to determine whether the petitioner has met its burden 
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in showing that the agency substantially prejudiced petitioner’s rights, and that the 

agency also acted outside its authority, acted erroneously, acted arbitrarily and 

capriciously, used improper procedure, or failed to act as required by law or rule.” 

(emphasis added)). 

¶ 18 Material questions of fact will of course always exist when both applicants for 

a competitive CON meet all of the statutory criteria. Living Centers, 138 N.C. App. 

at 580–81, 532 S.E.2d at 197. However, the same cannot be said as to substantial 

prejudice. The standard for substantial prejudice in our caselaw is clear. The mere 

fact that BMA will face increased competition because of the partial denial of its CON 

application is insufficient to establish substantial prejudice as a matter of law.

Surgical Care Affiliates, 235 N.C. App. at 631, 762 S.E.2d at 476 (“In order to 

establish substantial prejudice, the petitioner must provide specific evidence of harm 

resulting from the award of the CON . . . that went beyond any harm that necessarily 

resulted from additional . . . competition[.]” (citation omitted)).

III. Conclusion

¶ 19 For the reasons stated herein, we affirm the final decision granting summary 

judgment in favor of DHHS and TRC.

AFFIRMED.

Judges ZACHARY and WOOD concur.