Baylor Scott & White Medical Center – Brenham, DAB CR6780 (2025)

DECISION

Petitioner, Baylor Scott & White Medical Center – Brenham, was ineligible for designation as a critical access hospital (CAH) pursuant to section 1820(c)(2)(B)(i)(1) of the Social Security Act (Act) (42 U.S.C. § 1395i-4(c)(2)(B)(i)(I)) and 42 C.F.R. pt. 485, subpt. F,1 because it does not meet the proximity requirement for a CAH under 42 C.F.R. § 485.610(c). 

The hearing scheduled for February 11, 2026, is cancelled. 

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I. Procedural History and Undisputed Facts

The parties have stipulated that: 

• On June 1, 2021, Petitioner filed its initial application for CAH designation.  The application stated that Petitioner was 16.7 miles from Bellville Medical Center traveling on Texas state numbered highway TX-36S.  The application stated that 4.11 miles of the road was divided by median or other division of the roadway.  
• On July 5, 2022, the Centers for Medicare & Medicaid Services (CMS) approved Petitioner for CAH designation effective April 21, 2022.  
• On October 1, 2024, CMS notified Petitioner that it rescinded Petitioner’s CAH designation because Petitioner’s proximity to Bellville Medical Center did not satisfy the distance (also referred to as proximity) requirement of 42 C.F.R. § 485.610(c).  The distance or proximity requirement was not met because there were fewer than 15 miles of secondary road between Petitioner and Bellville Medical Center using TX-36S.   

Joint Statement of Issues Presented for Hearing, Joint Stipulation of Undisputed Facts and Joint Settlement Status Report (Jt. Stip.) ¶¶ 1-3. 

The parties also stipulated: 

• [Petitioner] is located 16.7 miles from Bellville Medical Center, with such distance being wholly on TX-36 S, a numbered state highway, and of the 16.7 miles on such roadway, 12.59 miles consist of either two or three lanes and one stretch of 4.11 miles includes two or more lanes in each direction. 

Jt. Stip. ¶ 7. 

Petitioner stated in its initial application for designation as a CAH that Bellville Medical Center in Bellville, Texas was the nearest hospital at 16.7 miles traveling on TX-36S (a numbered state highway).  Petitioner stated that more than half the distance to Bellville Hospital on TX-36S was two or three-lane roadway with only 4.11 miles of road divided by a median or other division.  Petitioner’s Exhibit (P. Ex.) 1 at 2; CMS Exhibit (Ex.) 8 at 2. 

In its October 30, 2024 request for a reconsidered determination, Petitioner described TX-36S between Petitioner and Bellville Medical Center as a numbered state highway, 

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16.7 miles long, 12.59 miles of two or three-lane roadway, with 4.11 miles of roadway divided by median or other division.  P. Ex. 8 at 1-2. 

In its prehearing brief, Petitioner states that TX-36S between Petitioner and Bellville Medical Center is 16.7 miles long with 12.59 miles of two or three lanes and one stretch of 4.11 miles divided by a median or other division of the roadway.  Petitioner’s Prehearing Brief [P. PHB] at 2.  Petitioner subsequently characterizes TX-36S as having a short stretch of four lanes between Petitioner and Bellville Medical Center.  P. PHB at 6. 

In its opposition to the CMS motion for summary judgment (P. Br.), Petitioner states it is undisputed that TX-36S between Petitioner and Bellville Hospital is 16.7 miles, 12.59 miles of which is two or three lanes, and 4.11 miles is four lanes divided by median or other division of the roadway.  P. Br. at 2, 4-5. 

There is no dispute that the CMS policy for calculating the proximity or distance requirement for a CAH is found in the State Operations Manual (SOM), CMS Pub. 100-07, chap.2, § 2256A, rev. 143, which became effective on July 31, 2015.2  Section 2256A provides: 

• Application of the more than 15-mile drive standard, based on secondary roads  
• To be eligible for the lesser distance standard due to the secondary road criteria under [42 C.F.R.] § 485.610(c) the CAH must document that there is a drive of more than 15 miles between the CAH and any hospital or other CAH where there are no primary roads.  A primary road is:  
  • • Any US highway, including any road:  
    • ○ In the National Highway System, as defined in 23 [U.S.C] § 103(b); or
    • ○ In the Interstate System, as defined in [23 U.S.C] § 103(c); or

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• ○ Which is a US-Numbered Highway (also called “US Routes” or “US Highways”) as designated by the American Association of the State Highway and Transportation Officials (AASHTO), regardless of whether it is also part of the National Highway System;
• All US highways are readily identified via signage along the roads and on maps by the presence of “US” or “I” above the highway number, with the letters and number appearing on a distinctive, uniform shield background that is called the six point shield, with five points above and one below.  Note:  Although the National Highway System and the U.S. Numbered Highway system largely overlap, they are not identical.  According to the American Association of the State Highway and Transportation Officials (AASHTO), which is responsible for designation of roads in the U.S. Numbered Highway system, the system is intended to facilitate the movement of interstate traffic in two or more States with the use of uniform markings.  [Footnote omitted.]
• Given the role all US highways are intended to play in interstate commerce, they are, by definition, primary roads.  
• OR
• • A numbered State highway with 2 or more lanes each way;  
• OR
• • A road shown on a map prepared in accordance with the U.S. Geological Survey’s Federal Geographic Data Committee (FGDC) Digital Cartographic Standard for Geologic Map Symbolization as a “primary highway, divided by median strip.”

A CAH may qualify for application of the “secondary roads” criterion if there is a combination of primary and secondary roads between it and any hospital or other CAH, so long as more than 15 of the total miles from the hospital or other  

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CAH consists of areas in which only secondary roads are available.  To apply the secondary roads criterion, measure the total driving distance between the CAH and each hospital or CAH located within a 35-mile drive and subtract the portion of that drive in which primary roads are available.  If the result is more than 15 miles for each drive to a hospital or CAH facility, the 15-mile criterion is met.  

The RO [Regional Office] will review Web-based map servers, such as Google Maps, or NationalAtlas.gov for example, to determine whether the provider meets the requirements of 42 [C.F.R. §] 485.610(c).  The RO will also review any documentation the provider may submit to demonstrate that it meets either the mountainous terrain or secondary roads criterion of [42 C.F.R.] § 485.610(c), but such documentation must satisfy the requirements discussed above.  For example, CMS does not consider any issues raised by CAH applicants or other parties concerning the physical features of any specific US highway, or portion thereof, when making a CAH location determination.  Therefore, documentation submitted by the applicant indicating that a particular portion of a US highway has numerous curves, or a weight limitation, or narrow shoulders, etc. would not affect the RO’s determination that the highway is a primary road.   

CMS Ex. 9 at 9-10. 

Petitioner requested a reconsidered determination by letter dated October 30, 2024.  CMS Ex. 3; P. Ex. 8. 

On January 15, 2025, CMS issued a reconsidered determination.  CMS upheld its initial determination to rescind Petitioner’s CAH designation.  CMS explained that Petitioner did not meet the distance requirements of 42 C.F.R. § 485.610(c) because the distance between Petitioner and Bellville Medical Center in Bellville, Texas, using the shortest route, was fewer than 35 miles on a primary road and fewer than 15 miles on roads through mountainous terrain or on secondary roads.  CMS informed Petitioner that because it did not meet CAH requirements, Petitioner needed to convert to another Medicare provider type by October 1, 2025, to avoid termination of its Medicare provider agreement.  CMS Ex. 1 at 1; P. Ex. 9 at 1. 

On March 14, 2025, Petitioner filed a request for hearing before an administrative law judge (ALJ).  The case was assigned to me for hearing and decision on March 19, 2025. 

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CMS filed its prehearing brief and CMS Exs. 1 through 10 on June 17, 2025.  Petitioner filed its prehearing brief and P. Exs. 1 through 9 on July 17, 2025.  On August 18, 2025, I set this case for hearing on February 11, 2026.  CMS filed a motion for summary judgment on August 18, 2025.  Petitioner filed a response in opposition to the CMS motion for summary judgment (P. Br.) on September 17, 2025. 

No objections have been made to my consideration of CMS Exs. 1 through 10 and P. Exs. 1 through 9, and all are admitted as evidence. 

II. Discussion

1. A. Issue

Whether Petitioner’s designation as a CAH was correctly rescinded because Petitioner does not meet the requirements of 1820(c)(2)(B)(i)(I) of the Act and 42 C.F.R. § 485.610(c) based on its proximity to another hospital. 

1. B. Applicable Law

The Critical Access Hospital Program

A CAH is a facility certified by the Secretary of Health and Human Services (Secretary) as a critical access hospital pursuant to section 1820(e) of the Act.  Act § 1861(mm)(1).  Inpatient CAH services are items and services furnished to an inpatient of a CAH.  Outpatient CAH services are medical and other health services furnished by a CAH on an outpatient basis.  Act § 1861(mm)(2), (3).  A facility enrolled in Medicare as a CAH generally receives higher payments from Medicare than it would if enrolled as a hospital.  Act § § 1814(l), 1834(g), 1861(v).  The Medicare Rural Hospital Flexibility Program was enacted by Congress in 1997 to replace a prior program, the Essential Access Community Hospital/Rural Primary Care Hospital program, which operated in only seven states.  The new program allowed states to designate rural facilities as CAHs and thereby improve access to hospital and other health services for rural residents.  Balanced Budget Act of 1997, § 4201, Pub. L. 105-33 (1997) (codified at 42 U.S.C. § 1395i-4) (Act § 1820); 62 Fed. Reg. 45,965, 45,970 (Aug. 29, 1997). 

The Act provides that a state may apply to the Secretary to establish a Medicare rural hospital flexibility program.  Act § 1820(a)-(b).  The state is required as part of its rural hospital flexibility program to develop at least one rural health network and designate one or more facilities in the state as a CAH.  Act § 1820(c).  The criteria for a state to designate a facility a CAH are: 

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• (B) Criteria for designation as critical access hospital.—A State may designate a facility as a critical access hospital if the facility—
• (i) is a hospital that is located in a county (or equivalent unit of local government) in a rural area (as defined in section 1886(d)(2)(D)) or is being treated as being located in a rural area pursuant to section 1886(d)(8)(E) and that—
  • (I) is located more than a 35–mile drive (or, in the case of mountainous terrain or in areas with only secondary roads available, a 15–mile drive) from a hospital, or another facility described in this subsection; or
  • (II) is certified before January 1, 2006, by the State as being a necessary provider of health care services to residents in the area;
• (ii) makes available 24–hour emergency care services that a State determines are necessary for ensuring access to emergency care services in each area served by a critical access hospital;
• (iii) provides not more than 25 acute care inpatient beds (meeting such standards as the Secretary may establish) for providing inpatient care for a period that does not exceed, as determined on an annual, average basis, 96 hours per patient;
• (iv) meets such staffing requirements as would apply under section 1861(e) to a hospital located in a rural area, except that—
  • (I) the facility need not meet hospital standards relating to the number of hours during a day, or days during a week, in which the facility must be open and fully staffed, except insofar as the facility is required to make available emergency care services as determined under clause (ii) and must have nursing services available on a 24–hour basis, but need not otherwise staff the facility except when an inpatient is present;
  • (II) the facility may provide any services otherwise required to be provided by a full–time, on site dietitian,  

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• pharmacist, laboratory technician, medical technologist, and radiological technologist on a part–time, off site basis under arrangements as defined in section 1861(w)(1); and
• (III) the inpatient care described in clause (iii) may be provided by a physician assistant, nurse practitioner, or clinical nurse specialist subject to the oversight of a physician who need not be present in the facility; and
• (v) meets the requirements of section 1861(aa)(2)(I).   

Act § 1820(c)(2)(B)(i)-(v). 

Congress provided that the Secretary will certify a facility as a CAH if:  (1) the facility is located in a state that has a rural hospital flexibility program established in accordance with the Act, (2) the state has designated the facility a CAH; and (3) the facility meets other criteria established by the Secretary.  Act § 1820(e).  As already mentioned, a CAH is specifically defined by Congress as a facility certified by the Secretary as a CAH pursuant to section 1820(e) of the Act.  Act § 1861(mm)(1).  

The Secretary promulgated regulations that establish conditions and standards for a CAH to participate in Medicare.  42 C.F.R. pt. 485, subpt. F.  A state with a rural hospital flexibility program may designate one or more facilities as CAHs if the facilities meet the conditions of participation set forth in the regulations.  42 C.F.R. § 485.606(a).  CMS is required to certify a facility as a CAH if the facility is designated a CAH by the state in which it is located; the facility has been surveyed by the state survey agency or CMS; and the facility is found to meet the conditions for participation in 42 C.F.R. pt. 485, subpt. F, and pt. 489.  42 C.F.R. § 485.606. 

Right to Hearing and Judicial Review

The Act requires that the Secretary issue regulations that establish a process to enroll providers and suppliers3 in Medicare, including the right to a hearing and judicial review 

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in the event of denial or non-renewal.  Act § 1866(j) (42 U.S.C. § 1395cc(j)).  The procedures for enrollment are found at 42 C.F.R. pt. 424, subpt. P.  Pursuant to 42 C.F.R. § 424.505, a provider or supplier must be enrolled in the Medicare program and be issued a billing number to have billing privileges and to be eligible to receive payment for services rendered to a Medicare eligible beneficiary.  A provider, such as a hospital, must also enter a provider agreement with CMS as described in 42 C.F.R. pt. 489, subpt. B.  A provider must meet the conditions of participation set forth in the regulation.  42 C.F.R. § 489.10(a).  CMS may deny enrollment for any of the reasons listed in 42 C.F.R. § 424.530(a), including failure to give satisfactory assurance of compliance with the Act and Medicare enrollment requirements.  42 C.F.R. §§ 424.530(a)(1), 483.12(a)(4). If enrollment is denied, the prospective provider has a right to request a hearing before an ALJ following the procedures of 42 C.F.R. pt. 498.  Act § 1866(h)(1), (j)(8); 42 C.F.R. § 424.545(a).  A provider or supplier whose enrollment and billing privileges have been revoked or not renewed has a right to request a hearing by an ALJ, further review by the Departmental Appeals Board (Board), and judicial review.  Act § 1866(h)(1), (j)(8); 42 C.F.R. §§ 424.545, 498.3(b)(17), 498.5, 498.90, 498.95.  A hearing on the record, also known as an oral hearing, is required under the Act.  Crestview Parke Care Ctr. v. Thompson, 373 F.3d 743, 748-751 (6th Cir. 2004).  The provider or supplier bears the burden to demonstrate that it meets enrollment requirements with documents and records.  42 C.F.R. § 424.545(c).  

In this case, Petitioner’s enrollment in Medicare as a hospital was not denied and its enrollment and billing privileges were not revoked.  Rather, Petitioner’s designation as a CAH to receive more favorable reimbursement under Medicare was rescinded.  Denial of designation as a CAH or recission of CAH designation are not listed as initial determinations under 42 C.F.R. § 498.3(b).  A right to hearing and review related to denial of CAH designation or recission of CAH designation is also not specifically recognized by 42 C.F.R. § 498.5 or provided for in 42 C.F.R. pt. 485.  No right to administrative or judicial review is established by section 1820 of the Act.  Arguably, Petitioner has no right under the Act or regulations to request an ALJ hearing or to ALJ review even though CMS informed Petitioner in the reconsidered determination that it could appeal.  CMS Ex. 1 at 2-3 (informing Petitioner of its right to appeal and that the procedures governing the appeal are set forth in 42 C.F.R. § 498.40, et seq.).  Nevertheless, I provide Petitioner’s requested review and leave for CMS and the Board to clarify if there is no jurisdiction to provide such review.  The Board has previously considered cases involving CAH designation without addressing the source of the right to 

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review.  See e.g., Baylor Cnty. Hosp. Dist., DAB No. 2617 (2015); Cibola Gen. Hosp., DAB No. 2387 (2011). 

1. C. Findings of Fact, Conclusions of Law, and Analysis

My conclusions of law are set forth in bold text followed by my findings of fact and analysis. 

1. 1. Summary judgment is appropriate.

If the Act and regulations make a hearing before an ALJ available to Petitioner, a hearing on the record, also known as an oral hearing, is required under the Act.  Act §§ 205(b), 1866(h)(1), (j); 42 C.F.R. §§ 498.3(b)(17), 498.5(l); Crestview, 373 F.3d at 748-51.  A party may waive appearance at an oral hearing but must do so affirmatively in writing.  42 C.F.R. § 498.66.  In this case, Petitioner has not waived the right to oral hearing or otherwise consented to decision based only upon the submissions or pleadings.  CMS has filed a motion for summary judgment that Petitioner opposes.  Disposition on the documents is only permissible if disposition by summary judgment is appropriate. 

Summary judgment is not automatic but is limited to certain specific conditions.  The procedures applicable to the adjudication of this case are at 42 C.F.R. pt. 498.  The regulations do not establish or recognize a summary judgment procedure.  However, the Board has long accepted that summary judgment is an acceptable procedural device in cases adjudicated pursuant to 42 C.F.R. pt. 498.  See, e.g., Ill. Knights Templar Home, DAB No. 2274 at 3-4 (2009); Garden City Med. Clinic, DAB No. 1763 (2001); Everett Rehab. & Med. Ctr., DAB No. 1628 at 3 (1997).  The Board has also recognized that the Federal Rules of Civil Procedure do not apply in administrative adjudications such as this, but the Board has accepted that Fed. R. Civ. P. 56 and related cases provide useful guidance for determining whether summary judgment is appropriate.  Furthermore, a summary judgment procedure was adopted as a matter of judicial economy within my authority to regulate the course of proceedings and made available to the parties in the litigation of this case by my Standing Order.  The parties were given notice by the Standing Order that summary judgment is an available procedural device and that the law as it has developed related to Fed. R. Civ. P. 56 will be applied.  Standing Order ¶ II.D.3. 

Summary judgment is appropriate when there is no genuine dispute as to any issue of material fact for adjudication and/or the moving party is entitled to judgment as a matter of law.  The party requesting summary judgment bears the burden of showing that there are no genuine issues of material fact for trial and/or that it is entitled to judgment as a matter of law.  In determining whether there are genuine issues of material fact for trial, the reviewer must view the evidence in the light most favorable to the non-moving party, drawing all reasonable inferences in that party’s favor.  Generally, the non-movant may not defeat an adequately supported summary judgment motion by relying upon the 

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denials in its pleadings or briefs but must furnish evidence of a dispute concerning a material fact, i.e., a fact that, if proven, would affect the outcome of the case.  Mission Hosp. Reg’l Med. Ctr., DAB No. 2459 at 4 (2012) (and cases cited therein); Experts Are Us, Inc., DAB No. 2452 at 4 (2012) (and cases cited therein); Senior Rehab. & Skilled Nursing Ctr., DAB No. 2300 at 3 (2010) (and cases cited therein); see also Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). 

The standard for deciding a case on summary judgment and an ALJ’s decision-making in deciding a summary judgment motion differs from that used in resolving a case on the merits after a hearing or when a hearing is waived.  On summary judgment, the ALJ does not make credibility determinations, weigh the evidence, or decide which inferences to draw from the evidence, as would be done when finding facts after a hearing on the record.  Rather, on summary judgment, the ALJ construes the evidence in a light most favorable to the non-movant and avoids deciding which version of the facts is more likely true.  Holy Cross Vill. at Notre Dame, Inc., DAB No. 2291 at 5 (2009).  The Board also has recognized that on summary judgment it is appropriate for the ALJ to consider whether a rational trier of fact could find that the party’s evidence would be sufficient to meet that party’s evidentiary burden.  Dumas Nursing & Rehab., L.P., DAB No. 2347 at 5 (2010).  The Secretary has not provided in 42 C.F.R. Part 498 for the allocation of the burden of persuasion or the quantum of evidence required to satisfy the burden.  However, the Board has provided some persuasive analysis regarding the allocation of the burden of persuasion in cases subject to 42 C.F.R. Part 498.  Batavia Nursing & Conv. Ctr., DAB No. 1904 (2004).  

Viewing the evidence before me in a light most favorable to Petitioner and drawing all inferences in Petitioner’s favor, I conclude, after reviewing the parties’ briefs and documentary evidence, that summary judgment is appropriate in this case.  There are no disputed issues of material fact related to whether Petitioner satisfies the requirements of 42 C.F.R. § 485.610(c) for designation as a CAH.  Petitioner argues that there is a genuine dispute over the calculation of the secondary road distance.  But Petitioner acknowledges that the facts related to TX-36S are unchanged since Petitioner was designated a CAH in 2022.  P. Br. at 4.  The facts related to TX-36S, including the number of lanes each way and the distance of the lane configurations are not in dispute.  Rather, the issue according to Petitioner is whether CMS correctly characterized TX-36S as a primary or secondary road under the Act, regulation, and CMS policy.  Resolution of the issue before me requires application of the Act and regulations to the undisputed facts.  Accordingly, I conclude summary judgment is appropriate.  The hearing scheduled for February 11, 2026, is cancelled. 

2. 2. Petitioner’s proximity to Bellville Medical Center in Bellville, Texas, makes Petitioner ineligible to be designated a CAH. 42 C.F.R. § 485.610(c). 

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The Secretary adopted conditions for participation of a hospital as a CAH in 42 C.F.R. pt. 485 consistent with the requirements of section 1820 of the Act.  The only issue before me is whether Petitioner meets the location condition of participation established by 42 C.F.R. § 485.610 and section 1820(c)(2)(B)(i) of the Act.  There are no issues before me as to Petitioner meeting the other conditions of participation of 42 C.F.R. pt. 485 or section 1820 of the Act.  There is also no issue that Petitioner was participating in Medicare as a hospital as required by 42 C.F.R. §§ 485.601, 485.606, 485.610(a) and 485.612, when it initially requested designation as a CAH and continues to do so. 

At issue are the regulatory provisions implementing section 1820(c)(2)(B)(i)(I) of the Act published in 42 C.F.R. § 485.610(c): 

• (c) Standard: Location relative to other facilities or necessary provider certification.  
• (1)  The CAH is located more than a 35-mile drive on primary roads (or, in the case of mountainous terrain or in areas with only secondary roads available, a 15-mile drive) from a hospital or another CAH, or before January 1, 2006, the CAH is certified by the State as being a necessary provider of health care services to residents in the area.  A CAH that is designated as a necessary provider on or before December 31, 2005, will maintain its necessary provider designation after January 1, 2006.  
• (2)  Primary roads of travel for determining the driving distance of a CAH and its proximity to other providers is defined as:  
  • (i)  A numbered Federal highway, including interstates, intrastates, expressways, or any other numbered Federal highway with 2 or more lanes each way; or
  • (ii)  A numbered State highway with 2 or more lanes each way.   

42 C.F.R. § 485.610(c).4  The prior version of 42 C.F.R. § 485.610(c) (2020), which was in effect when Petitioner initially filed to be designated a CAH, is the same as the version 

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in effect at the time of the recission of CAH status except the later version includes the definition of “primary roads of travel” in subsection 2 above.  87 Fed. Reg. 71,748, 72,206-207 (Nov. 23, 2023).  When promulgating the change, CMS explained: 

• Our goal for codifying the definition of primary roads in the regulations language at [42 C.F.R.] § 485.610(c) was to provide greater flexibility, consistency and clarity to providers with regards to CAH designations.  Therefore, we are finalizing the definition of ‘‘primary roads’’ at [42 C.F.R.] § 485.610(c) to include numbered Federal highways with two or more lanes each way, similar to the description of numbered State highways, and exclude numbered Federal highways with only one lane in each direction.  With regard to adding a “secondary roads” definition in the CAH distance requirements regulations, we do not believe that it is necessary to include a definition of “secondary roads” in the regulations text at this time.  As stated, we remain committed to providing reducing [sic] burden for providers in meeting the distance criteria.  Currently, we believe the language at [42 C.F.R.] § 485.610(c) coupled with guidance in the SOM, Chapter 2, Section 2256A regarding the application of the 15-mile drive standard based on secondary roads adequately describes how we determine what constitutes a secondary road.  Specifically, this language states that to be eligible for the lesser distance standard due to the secondary road criteria under [42 C.F.R.] § 485.610(c), the CAH would have to document that there is a drive of more than 15 miles between the CAH and any hospital or other CAH where there are no primary roads.  We also plan to continue to allow a CAH to qualify for application of the “secondary roads” criterion if there is a combination of primary and secondary roads between it and any hospital or other CAH, so long as more than 15 of the total miles from the hospital or other CAH consists of areas in which only secondary roads are available.  We will continue to monitor this issue to  

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• determine if further refinements to the description of secondary roads are necessary for future rulemaking.   

87 Fed. Reg. 71,748, 72,207 (emphasis added). 

Petitioner does not assert it is more than 35 miles from another hospital or CAH and eligible for CAH designation under 42 C.F.R. § 485.610(c)(1) on that basis.  Petitioner also does not assert that there is any mountainous terrain involved.  Petitioner’s argument is that it is more than 15 miles from Bellville Medical Center on TX-36S.  Petitioner argues that TX-36S between Petitioner and the Bellville Medical Center should be treated as a secondary road of 16.7 miles and that the four-lane section of the road of 4.11 miles should not be deducted from the total distance of 16.7 miles.  The deduction causes Petitioner to be ineligible for CAH designation because it does not satisfy the 15-mile secondary road requirement of 42 C.F.R. § 485.610(c)(1).  P. Br. at 2, 4-5. 

Petitioner states that the facts related to TX-36S, including the mileage between Petitioner and Bellville Hospital have not changed since CMS designated Petitioner as a CAH in 2022 and the facts are not disputed.  P. Br. at 2. 

Petitioner suggests that there is some ambiguity in 42 C.F.R. § 485.610(c) or section 1820(c)(2)(B)(i)(I) of the Act.  P. Br. at 3.  But I find no ambiguity.  The plain language of section 1820(c)(2)(B)(i)(I) of the Act provides that a facility may be designated a CAH if it is located more than 35 miles from a hospital or another CAH, or more than 15 miles if there is mountainous terrain or only secondary roads are available.  Act § 1820(c)(2)(B)(i)(I).  The Act does not define secondary roads and does not use the term primary roads.  Congress effectively left it to the Secretary to provide the definitions by regulation. 

The Secretary promulgated 42 C.F.R. § 485.610(c), which establishes the proximity or distance standard for location relative to other facilities for purposes of CAH designation.  Under the regulation, a hospital must be more than 35 miles on primary roads from another hospital or CAH or 15 miles if there is mountainous terrain or only secondary roads available.  42 C.F.R. § 485.610(c)(1).  A primary road is a federal or state numbered road with two or more lanes in each direction.  42 C.F.R. § 485.610(c)(2).  A secondary road is not defined.  But the plain language of the regulation is that any road that is not a primary road, i.e., a road with fewer than two lanes in each direction is a secondary road, whether a federal or state road.  My interpretation is supported by the November 2023 rulemaking.  87 Fed. Reg. 71,748, 72,206-207. 

The undisputed fact that TX-36S is a state numbered road does not make it a secondary road.  Whether some parts of TX-36S is divided by median, wall, or other divider is also not relevant to the determination of whether TX-36S is a primary or secondary road.  The criteria established by 42 C.F.R. § 485.610(c)(2) for determining whether a federal or 

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state numbered road is a primary road is whether there are two or more lanes in each direction.  The criteria of 42 C.F.R. § 485.610(c) is the basis for the CMS policy stated in SOM § 2256A.  CMS Ex. 9 at 9-10. 

It is undisputed that a 4.11 mile stretch of TX-36S between Petitioner and Bellville Hospital Center has two lanes in both directions.  Petitioner’s argument is, in essence, that most of TX-36S is a secondary road and the entire 16.7 miles from Petitioner to Bellville should be treated as a secondary road.  P. Br. at 4.  Petitioner’s argument may also be construed to be that a short stretch of road that meets the definition of primary road does not make a secondary road a primary road under 42 C.F.R. § 485.610(c)(2).  P. Br. at 5. 

I conclude that Petitioner’s argument that CMS erred by deducting 4.11 miles for the stretch of TX-36S that has two lanes in each direction from the total distance of 16.7 miles on TX-36S between Petitioner and Bellville Medical Center is unsupported by the language of the Act, the regulation, or CMS policy.  Section 1820(c)(2)(B)(i)(I) of the Act focuses on the distance of the drive from one hospital or CAH to another using the language “is located more than a 35-mile drive” or a “15-mile drive” with only secondary roads available or in case of mountainous terrain.  Therefore, under the Act the question is how long is the drive on secondary roads?  The question is not whether a particular road is part primary and part secondary.  The regulation also focuses on whether the drive is “more than a 35-mile drive on primary roads” or “a 15-mile drive” on only secondary roads or roads with mountainous terrain.  42 C.F.R. § 485.610(c)(1).  Therefore, the regulation focuses on the drive.  CMS policy is consistent with the statute and regulation.  Section 2256A provides that the “CAH must document that there is a drive of more than 15 miles between the CAH and any hospital or other CAH where there are no primary roads.”  CMS Ex. 9 at 9.  The CMS policy further provides that a CAH may meet the 15-mile secondary road criteria “if there is a combination of primary and secondary roads . . . so long as more than 15 miles of the total miles from the hospital or other CAH consists of areas in which only secondary roads are available.”  CMS Ex. 9 at 10.  The CMS policy provides a method for calculating whether the more than 15-mile secondary road criteria is met.  The policy provides that the driving distance between the hospital seeking CAH designation and each other hospital or CAH located within a 35-mile drive should be measured; the length of the part of driving route for which primary roads are available is subtracted; and if the result is more than 15 miles, the 15-mile criteria is met.  CMS Ex. 9 at 10.  The CMS policy stated in SOM § 2256A has been in effect since July 31, 2015.  In this case, deducting 4.11 miles of TX-36S from the total 16.7-mile distance from Petitioner to Bellville Hospital Center is consistent with the Act, the regulation, and CMS policy because the focus is upon the drive and not whether the drive occurs over one or more roadways.  Applying the Act and regulation to the undisputed facts in this case, the drive from Petitioner to Bellville Hospital Center is only 12.59 miles over secondary roadway.  Therefore, Petitioner cannot qualify for application of the 15-mile secondary road exception of the Act or regulation. 

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Petitioner’s arguments could be understood to be requests for equitable relief.  But I have no authority to grant equitable relief.  US Ultrasound, DAB No. 2302 at 8 (2010).  I am bound to follow the Act and regulations, and I have no authority to declare statutes or regulations invalid or ultra vires.  1866ICPayday.com, L.L.C., DAB No. 2289 at 14 (2009) (noting that “[a]n ALJ is bound by applicable laws and regulations and may not invalidate either a law or regulation on any ground.”). 

Petitioner’s arguments can be construed to be that the government should be estopped from rescinding its CAH designation.  The evidence before me provides no explanation for why CMS determined that Petitioner was eligible for CAH designation in 2022.  But as a matter of law, estoppel against the federal government, if available at all, is presumably unavailable absent “affirmative misconduct,” such as fraud.  See, e.g., Pac. Islander Council of Leaders, DAB No. 2091 at 12 (2007); Off. of Pers. Mgmt. v. Richmond, 496 U.S. 414, 421 (1990).  But I find no allegation that any CMS representative or agent acted fraudulently or engaged in any affirmative misconduct that Petitioner acted in detrimental reliance upon.  I conclude that estoppel is not an issue. 

III. Conclusion

For the foregoing reasons, I conclude that Petitioner was not eligible to be designated a CAH because it did not meet the 15-mile secondary road criteria of 42 C.F.R. § 485.610(c).