South Bay Post Acute Care, DAB CR6986 (2026)

DECISION

Petitioner, South Bay Post Acute Care, challenges the determination by Respondent, the Centers for Medicare & Medicaid Services (CMS), that it was not in substantial compliance with a participation requirement.  South Bay also challenges CMS’s imposition of a $12,760 civil money penalty (CMP).  As explained herein, I find in favor of CMS and affirm the imposed penalty is reasonable.

I.  Background and Procedural History

The California Department of Public Health (CDPH or state agency) conducted a complaint investigation and survey at Petitioner’s facility completed on January 24, 2020.  CMS Ex. 1.  CDPH found Petitioner did not substantially comply with 42 C.F.R. § 483.25(d), Tag F684 (Quality of Care) at the “G” scope and severity level1 because Petitioner did not provide adequate post-surgical wound care to a resident.  See id.

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On May 5, 2021, CMS notified Petitioner that, based on CDPH’s survey findings, it would impose a per-instance CMP of $12,760.  CMS Ex. 2 at 2.2

Petitioner timely sought hearing before an administrative law judge (ALJ) in the Civil Remedies Division to challenge CMS’s imposition of penalties and the underlying determination of noncompliance, resulting in my designation to hear and decide this case.  I issued an Acknowledgment and Pre-hearing Order (Pre-hearing order) that established a briefing schedule and directed the parties to file pre-hearing submissions that included written direct testimony for all proposed witnesses, proposed exhibits, and pre-hearing briefs.

CMS filed a pre-hearing brief and 19 proposed exhibits (CMS Exs. 1-19).  Petitioner filed a pre-hearing brief and 21 proposed exhibits (P. Exs. 1-21).  CMS identified and provided a declaration (CMS Ex. 16) for one witness, CDPH surveyor Kyle Escobar-Humphries, R.N.  Petitioner identified and provided declarations (P. Exs. 4, 21) for two witnesses:  Pouya Afshar, M.D. and Mushrik Kaisey, M.D.  Both parties sought the opportunity to cross-examine the opposing party’s witnesses.

I scheduled a hearing to proceed by videoconference on July 19, 2022 to allow cross-examination of the parties’ witnesses.  Prior to the hearing, Petitioner withdrew Dr. Kaisey as a proposed witness as well as his declaration, submitted as P. Ex. 21.  After the hearing, the parties submitted post-hearing briefs.

II.   Admission of Exhibits

Neither party objected to the opposing party’s exhibits.  Accordingly, at the outset of the hearing I admitted CMS Exhibits 1 through 19 and Petitioner Exhibits 1 through 20 into the record.

III.  Issues

1. Whether Petitioner was in substantial compliance with Medicare participation requirements at 42 C.F.R. § 483.25(d)(1)-(2) (Tag F689);
2. If Petitioner was not in substantial compliance, whether the CMP imposed by CMS is reasonable.

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IV.  Jurisdiction

I have jurisdiction to hear and decide this case.  42 U.S.C. § 1395i-3(h)(2)(B)(ii), incorporating by reference 42 U.S.C. § 1320a-7a(c)(2); 42 C.F.R. §§ 488.408(g), 488.434(a)(2)(viii), 498.3(b)(13).

V.  Legal Authority for the Imposition of Penalties

The Social Security Act (Act) sets forth requirements for skilled nursing facilities to participate in the Medicare program.  It authorizes the Secretary of Health and Human Services to promulgate regulations implementing those statutory provisions.  42 U.S.C. § 1395i-3.  These regulations are found at 42 C.F.R. parts 483 and 488.

To participate in the Medicare program, skilled nursing facilities must maintain substantial compliance with program participation requirements.  To be in substantial compliance, a facility’s deficiencies may “pose no greater risk to resident health or safety than the potential for causing minimal harm.”  42 C.F.R. § 488.301.  A deficiency is a violation of a participation requirement established by 42 U.S.C. § 1395i-3(b)-(d), or the Secretary’s regulations at 42 C.F.R. pt. 483, subpt. B.  Id.  “Noncompliance” means “any deficiency that causes a facility to not be in substantial compliance.”  Id.

The Secretary contracts with state agencies to conduct periodic surveys to determine whether skilled nursing facilities are in substantial compliance with the participation requirements.  42 U.S.C. § 1395aa(a); 42 U.S.C. § 1395i-3(g); 42 C.F.R. §§ 488.10(a), 488.308.  The Act authorizes state agencies to impose or recommend to the Secretary enforcement remedies to be imposed against skilled nursing facilities not in substantial compliance with program participation requirements.  42 U.S.C. 1396r(h); 42 U.S.C. § 1395i-3(h)(1).

The Secretary can impose enforcement remedies with or without a state agency’s recommendation.  42 U.S.C. § 1395i-3(h)(2).  The Secretary’s regulations specify the enforcement remedies that CMS or a state agency may impose if a facility is not in substantial compliance.  See 42 C.F.R. § 488.406.  Among them, CMS may impose a per-day CMP for the number of days a facility is not in substantial compliance.  42 C.F.R. § 488.430(a).  At the time CMS imposed the penalties at issue here, a per-day CMP could range from $112 to $6,695 for less serious noncompliance and $6,808 to $22,320 for more serious noncompliance that poses immediate jeopardy3 to the health and safety of residents.  42 C.F.R. § 488.438(a)(1); 45 C.F.R. § 102.3; 85 Fed. Reg. 2869, 2880 (Jan. 17, 2020).

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A skilled nursing facility subject to a remedy based on a determination of noncompliance may request a hearing before an ALJ to determine whether a basis existed for the deficiency findings that led to the imposition of the remedy.  42 U.S.C. §§ 1320a-7a(c)(2), 1395i-3(h)(2)(B)(ii); 42 C.F.R. §§ 488.408(g), 488.434(a)(2)(viii), 498.3(b)(13).  However, neither CMS’s choice of remedies nor the process by which it selects remedies are subject to review.  42 C.F.R. § 488.408(g)(2).

VI.  Burdens of proof and persuasion

Congress established that unless otherwise provided by statute, “the proponent of a rule or order has the burden of proof” in adjudications under the Administrative Procedures Act (APA).  5 U.S.C. § 556(d).  The Social Security Act, which authorizes this proceeding, does not “otherwise provide” the burden of proof.  It would therefore be reasonable to conclude that CMS, the party seeking to impose penalties authorized by the Act, bears the burdens of proof and persuasion to justify doing so.

Nevertheless, the Departmental Appeals Board has imposed a burden-shifting regime in cases involving the imposition of enforcement penalties against providers whose appeals are adjudicated under 42 C.F.R. Part 498.  Hillman Rehab. Ctr., DAB No. 1611 (1997), aff’d, Hillman Rehab. Ctr. v. U.S. Dep’t of Health & Human Servs., No. Civ. A. 98-3789 (GEB), 1999 WL 34813783 (D.N.J. May 13, 1999); VITAS Healthcare Corp. of Calif., DAB No. 1782 at 4 (2001); Cross Creek Health Care Ctr., DAB No. 1665 (1998) (applying the burden-shifting regime to cases involving skilled nursing facilities); Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004), aff’d sub nom., Batavia Nursing & Convalescent Ctr. v. Thompson, 143 F. App’x 664 (6th Cir. 2005).

Under this regime, CMS has the burden to come forward with evidence sufficient to make a prima facie showing4 it had a basis to impose a penalty.  In Hillman, the Board identified the elements it believed necessary for CMS to make such a showing:

[CMS] must identify the legal criteria to which it seeks to hold a provider.  Moreover, to the extent that a provider challenges [CMS’s] findings, [CMS] must come forward with evidence of the basis for its determination, including the factual findings on which [CMS] is relying and, if [CMS] has determined that a condition of participation was not met, [CMS’s] evaluation

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that the deficiencies found meet the regulatory standard for a condition-level deficiency.

DAB No. 1611 at 8.

Once CMS makes a prima facie showing of noncompliance, the Board held the facility bears “the ultimate burden of persuasion” and can only prevail if it proves, by a preponderance of the evidence of record, that it substantially complied with statutory and regulatory requirements.  Id. at 7.

A skilled nursing facility subsequently appealed CMS’s imposition of a CMP, arguing the Board’s burden-shifting regime would be improper in hearings proceeding under the APA.  Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004), aff’d sub nom., Batavia Nursing & Convalescent Ctr. v. Thompson, 143 F. App’x 664 (6th Cir. 2005).  The Board rejected this claim, asserting the Supreme Court had, in other contexts, approved placing the burden of proof “on the claimant for governmental benefits when evidence is evenly balanced” because the party seeking the benefit, including a “non-monetary benefit or privilege,” would be “the proponent of the rule or order.”  Id. at 10 (citing Director, OWCP v. Greenwich Collieries, 512 U.S. 267, 276 (1994); U.S. Steel Corp. v. Train, 556 F.2d 822, 834 (7th Cir. 1977) (the applicant for a permit to discharge pollutants is a “proponent”); Day v. NTSB, 414 F.2d 950, 952 (5th Cir. 1969) (placing the burden of proof on a pilot seeking the government’s certification of fitness to fly).

The Board reasoned that by appealing the penalties imposed by CMS, Batavia Nursing in essence sought “from the government an order certifying that it is in substantial compliance with [skilled nursing facility] requirements, so that it may continue to participate in the Medicare program with no restrictions on payment.”  Id.  The Board therefore found it reasonable to place the burden of proof on Batavia to show its return to substantial compliance.  Id.

The Board’s characterization of the nature of the remedy sought in these proceedings would apply more squarely to a provider challenging its termination from the Medicare program.  In that case, the appealing facility would seek a rule or order overturning CMS’s termination action and thus allow its continued participation as a provider.5  But for facilities like Batavia appealing the imposition of lesser penalties like CMPs, the rationale is less persuasive.  Batavia participated in the Medicare program as a provider during the pendency of its appeal.  It did not seek to restore its right to provide services to Medicare beneficiaries; it instead sought a ruling that CMS did not have a basis to impose penalties under the Act.

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Characterizing penalized facilities as proponents of a rule or order is also incongruous with the limitation of ALJ and Board jurisdiction to challenges where CMS opts to impose a penalty.  42 C.F.R. § 488.408(g)(1) (“A facility may appeal a certification of noncompliance leading to an enforcement remedy.”); 42 C.F.R. § 498.3(b)(13); Columbus Park Nursing & Rehab. Ctr., DAB No. 2316 at 7 (2010) (a facility cannot contest survey deficiency findings unless CMS has imposed a remedy).

If facilities penalized for noncompliance with Medicare program participation rules are properly seen as proponents of a rule or order certifying their substantial compliance, it is unclear why Congress would not afford appeal rights under the Act to unpenalized facilities which have been found noncompliant and seek the same certification.  But if CMS is the proponent of a rule or order affirming its choice to impose penalties, the rationale to exclude unpenalized facilities from challenging deficiency findings under the Act becomes appreciable; in that circumstance, there would be no action for which CMS could seek a rule or order from an ALJ or the Board.

The legitimacy of the burden-shifting regime thus rests largely on the notion that facilities who appeal the imposition of a penalty under the Act are in fact proponents of a rule or order certifying their substantial compliance with Medicare program participation rules.  To date, federal district and circuit courts have declined to reach the propriety of the Board’s burden-shifting regime on due process or other grounds.  See, e.g., Hillman Rehab. Ctr., DAB No. 1611 (1997), aff’d, Hillman Rehab. Ctr. v. U.S. Dep’t of Health & Human Servs., No. Civ. A. 98-3789 (GEB), 1999 WL 34813783 (D.N.J. May 13, 1999); Fairfax Nursing Home, Inc., DAB No. 1794 (2001), aff’d, Fairfax Nursing Home v. Dep’t of Health & Human Servs., 300 F.3d 835 (7th Cir. 2002), cert. denied, 2003 WL 98478 (Jan. 13, 2003); Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004), aff’d sub nom., Batavia Nursing & Convalescent Ctr. v. Thompson, 143 F. App’x 664 (6th Cir. 2005).

The Supreme Court has since examined the scope of the Secretary’s rulemaking authority in the context of Medicare reimbursement and held that under section 1871 of the Act, the Secretary must comply with notice-and-comment rulemaking to impose any requirements upon regulated entities constituting a change in a substantive legal standard pertaining to the payment for services by the Medicare program or eligibility to furnish or receive services or benefits to that program.  Azar v. Allina Health Servs., 587 U.S. 566, 139 S. Ct. 1804 at 1809-14 (2019); 42 U.S.C. § 1395hh(a)(2).  It is unclear whether the Board’s imposition of burden-shifting in the adjudication of enforcement penalties and enrollment-related actions against regulated entities, absent statutory or regulatory authority to do so, constituted a change in a substantive legal standard affecting eligibility to furnish services or receive payments from the Medicare program within the meaning of the Allina decision.

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The Court has also formally repudiated its longstanding interpretive rule, known as Chevron deference, which required courts reviewing an agency action to defer to agency interpretation of ambiguity in a statute authorizing or directing that action.  See Loper Bright Enters. v. Raimondo, 603 U.S. 369, 144 S. Ct. 2244 (2024); see also Hillman Rehab. Ctr., DAB No. 1611 at 17-20 (relying in part on the Board’s predecessor body’s “long-standing interpretation” of the Act to justify burden shifting).

It remains to be seen whether federal courts will consider the Board’s burden-shifting regime a “change in a substantive legal standard” under Allina or, in the absence of Chevron deference, more broadly reject the Board’s interpretation of section 7 of the APA to identify entities challenging enforcement actions taken by the government as proponents of an order or rule.  Until such judicial scrutiny demands otherwise, and absent modification of the Act or CMS’s implementing regulations, I apply the Board’s burden-shifting regime.

VII.  Discussion

1. Legal framework for quality-of-care deficiencies

The Act requires skilled nursing facilities to “provide services to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident” as set forth in a written plan of care that accurately sets forth the resident’s needs, is prepared with the resident’s participation by the resident’s physician and the nurse with responsibility for their care, and is periodically reviewed and revised.  42 U.S.C. § 1395i-3(b)(2).

42 C.F.R. § 483.25 prefatorily describes quality of care as a “fundamental principle” skilled nursing facilities must apply in the treatment and care of residents.  It reiterates the Act’s mandate that skilled nursing facilities “ensure that residents receive treatment and care in accordance with professional standards of practice, the comprehensive person-centered care plan, and the resident’s choices.”  Id.; see also Golden Living Ctr. – Foley, DAB No. 2510 at 23 (2013) (section 483.25 obliges facilities to “provide care and services that, at a minimum, meet accepted professional standards of quality.”

The regulation also obliges facilities to follow their own resident care policies.  See Good Shepherd Home for the Aged, Inc., d/b/a The Good Shepherd Home, DAB No. 2858 at 12 (2018) (citations omitted).  A facility’s policy is deemed to be reliable evidence of its own judgment of “what must be done to attain or maintain its residents’ “highest practicable physical, mental, and psychosocial well-being, as required by section 483.25.”  Senior Rehab. & Skilled Nursing Ctr., DAB No. 2300 at 13 (2010) (quoting Sheridan Health Care Ctr., DAB No. 2178, at 15 (2008).

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2. South Bay’s Skin Management Policy

Petitioner maintained that it would provide appropriate measures to ensure residents who entered its facility without pressure ulcers did not develop them, while residents admitted with wounds would not develop signs and symptoms of infection, unless their condition made such development unavoidable.  CMS Ex. 13 at 1.

Petitioner committed to providing newly admitted residents a thorough head-to-toe assessment conducted by a licensed nurse, documenting any skin lesions, and obtaining treatment orders from the resident’s physician for areas requiring treatment.  Id.  The facility also committed to checking surgical wound sites for signs and symptoms of infection until removal of staples or the area healed, and if signs and symptoms of infection were discovered, notifying the resident’s physician and completing a change-of-condition form.  Id.

3. Relevant Facts6

On January 31, 2019, Resident 1 underwent an amputation of her right leg below the knee performed by Stephen Summers, M.D.  CMS Ex. 15 at 2.  On February 5, 2019, Dr. Summers noted Resident 1 would need to be admitted to a skilled nursing facility care for rehabilitation.  P. Ex. 17 at 4.  At that time, he described Resident 1’s wound as “well-healed.”  Id.  Dr. Summers ordered daily dressing changes, placement in a knee immobilizer for at least 12 hours a day, and planned to see Resident 1 in two weeks to remove staples.  Id.

South Bay admitted Resident 1 the next day, February 6, 2019.  CMS Ex. 3 at 1.  Resident 1 was 62 years old on admission and with her surgical amputation presented with significant co-morbidities including stroke, end-stage renal disease, heart failure, atrial fibrillation, depression, hypertension, pulmonary hypertension, peripheral vascular disease, and type 2 diabetes.  Id.  At approximately noon, Registered Nurse Marie Mina entered an admission note indicating a “[h]ead-to-toe assessment [was] performed.”  CMS Ex. 18 at 1.  On February 7, 2019, Registered Nurse Kathleen Eslava documented the initial admission assessment and noted Resident 1’s right knee bore a 13-centimeter surgical incision with eschar (a dark leather patch of dead tissue that forms over severe wounds), 28 staples, nine sutures, and “no signs of infection or bleeding.”  CMS Ex. 6 at 18.  Nurse Eschar did not document the width of Resident 1’s wound.

Treatment orders for Resident 1 directed facility staff to daily cleanse the surgical site with normal saline, pat it dry, cover the wound with dry dressing, and wrap it with Kerlix

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(a loosely woven cotton gauze bandage) for 14 days, subsequently extended to 21 days.  P. Ex. 13 at 6.

South Bay documented wound assessments conducted on February 14, 19, and 26, 2019.  CMS Ex. 8 at 8, 16, 24.  On February 14, facility staff measured the wound at 0.1 cm x 13 cm and described “some black eschar tissue to surgical site 20%, and some erythema to surrounding skin.”  Id. at 8.  On February 19, staff again measured the wound at 0.1 cm x 13 cm and described it as having “staples and sutures intact.”  Id. at 16.  There was no mention of the presence or absence of the eschar tissue or erythema noted in the previous assessment.  Id.  On February 26, staff measured the wound at 3 cm x 13 cm – 30 times larger in width than the prior measurement—and described “30% eschar 70% yellow slough,” while simultaneously characterizing the wound as “stable” with no odor.  Id. at 24.  Facility staff called Dr. Summer’s office the same day to notify him Resident 1’s wound now presented with yellow slough and received new orders to apply Santyl, an enzymatic ointment used to remove dead tissue.  Id. at 31.

Between February 10 and 18, 2019, facility staff documented Resident 1’s pain levels as mostly 0 out of 10 with a maximum score of 3.  CMS Ex. 10 at 2-3.  Beginning February 19, Resident 1’s reported pain increased in both frequency and severity:  5 out of 10 and 6 out of 10 on February 19; 6 out of 10 on February 21; 5 out of 10 on February 22; and 5 out of 10, 8 out of 10, and 7 out of 10 on February 24.  Id. at 1-2.  On February 24, 2019, Resident 1 was “8/10 pain unrelieved by current pain medications” at her amputation site.  CMS Ex. 18 at 3.  Staff notified her physician, who prescribed Norco (a pain reliever combining an opioid and acetaminophen used for severe pain).  CMS Ex. 11 at 6.  Resident 1 reported 5 out of 10 pain on February 26 and on the morning of February 27, 2019, 8 out of 10 pain.  CMS Ex. 10 at 1.

On February 27, 2019, South Bay sent Resident 1 to her previously scheduled follow-up appointment with Dr. Summers.  P. Ex. 13 at 2.  Dr. Summers observed “obvious necrosis of the stump closure” and sent Resident 1 to the hospital for emergent treatment.  CMS Ex. 15 at 11, 16, 35.  Resident 1 presented at the emergency room with “pain and foul-smelling discharge from her stump.”  Id. at 11.  Because her surgical incision had dehisced (split or burst open), Resident 1 required debridement surgery and consultation with an infectious disease specialist.  Id. at 20.  The hospital team admitted Resident 1, placed her on antibiotics, and scheduled her for debridement with vacuum-assisted closure the following day.  Id. at 35, 37, 39.  Resident 1 underwent revision surgery of her amputation site in March 2019.  P. Ex. 16 at 1-2.

4. Petitioner did not substantially comply with 42 C.F.R. § 483.25 (Tag F684).

CMS contends Petitioner did not comply with its obligation to provide the highest attainable quality of care to Resident 1 that met its own policy or the professional

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standard of care.  CMS Br. at 5-14; CMS Closing Br. at 2-12.  CMS asserts that, despite documenting an initial “head-to-toe” assessment, Petitioner failed to conduct a complete assessment of Resident 1’s skin on her admission, evidenced by an admission made by a facility nurse to the surveyor, as well as the fact that the first two documented assessments failed to record the width of the wound.  Id. at 9-10.  CMS next contends Petitioner failed to adequately monitor Resident 1’s wound, evidenced by a lack of documented assessments during daily dressing changes.  Id. at 10.  CMS argues Petitioner could not have reasonably relied on assessments purportedly conducted by Resident 1’s physician because they were facially inauthentic.  Id. at 5.  Finally, CMS claims the facility’s failure to adequately monitor the condition of Resident 1’s wound resulted in its failure to promptly recognize or respond to a change in her condition.  Id. at 6.

Petitioner argues it provided an accurate initial skin assessment to Resident 1 on admission, followed her physician’s orders, conducted appropriate wound assessments, and promptly identified and documented Resident 1’s change in condition.  P. Br. at 7-20; P. Closing Br. at 3-21.  Petitioner contends that absent a change in condition, neither the professional standard of care nor its policies required daily documentation of wound assessments during dressing changes.  P. Closing Br. at 12-13.  Petitioner cites weekly documented skin assessments to establish it provided adequate wound assessment consistent with its stated policy.  Id. at 14-16.  Petitioner asserts it timely identified the change in Resident 1’s wound condition and that CMS improperly inferred a failure to monitor her wound based on its sudden increase in size.  Id. at 18.  Ultimately, Petitioner claims Resident 1’s underlying medical condition made the deterioration of her wound unavoidable.  P. Br. at 18-19; P. Closing Br. at 22.

CMS has established by a preponderance that Petitioner did not provide adequate care for or monitoring of Resident 1’s post-surgical wound and that its subsequent worsening was therefore avoidable.  First, Petitioner did not provide an adequate initial assessment of Resident 1’s surgical wound that its own policy required.  See CMS Ex. 13 at 1 (“Residents will have a head to toe skin assessment by a licensed nurse at the time of admission.”).  The record shows Nurse Mina conducted a cursory initial assessment on the day of Resident 1’s admission while Nurse Eslava did not perform a thorough assessment that included wound measurements until the next day.  Compare CMS Ex. 6 at 17-18, with CMS Ex. 18 at 1.

Petitioner now claims the nurses conducted the assessment of Resident 1 together and their notes, in combination, constitute evidence of an initial assessment consistent with its wound care policy.  P. Br. at 7; P. Closing Br. at 8.  But the record does not support this claim.  Nurse Mina entered her note on February 6, 2019, while Nurse Eslava documented actual measurements on February 7, 2018.  CMS Ex. 6 at 17-18; CMS Ex. 18 at 1.  Neither indicated they performed the assessment with the other.  Nurse Mina in fact admitted to Surveyor Escobar-Humphries that she only performed a partial skin

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assessment on the day of Resident 1’s admission and did not remove the dressing from her wound to examine it.  CMS Ex. 16 at 4; CMS Ex. 12 at 7.7  Nurse Eslava confirmed she conducted an assessment separately at a later time because Nurse Mina did not conduct the initial assessment correctly.  CMS Ex. 16 at 4; CMS Ex. 12 at 16.  According to the surveyor’s notes, Nurse Eslava stated the initial assessment should have included a count of the sutures and staples on the wound, the state of the wound, documentation in the care plan, and a change of dressing.  CMS Ex. 12 at 16.  She emphasized these tasks should have been done at the initial assessment “because something could happen to the wound while the dressing was still there.”  Id. at 17.  And even her own subsequent assessment failed to document the width of Resident 1’s post-surgical wound.  CMS Ex. 6 at 18; see also Hearing Tr. at 51 (Petitioner’s medical director Dr. Afshara admitting proper assessment of a surgical wound included measuring its width).  This omission, as well as the significant delay in assessing Resident 1’s wound and changing the dressing, are inconsistent with the professional standard of care and Petitioner’s own wound care policy.

CMS next claims Petitioner failed to comply with the professional standard of care by failing to document daily wound assessments, including negative assessments.  There is no dispute Petitioner did not document the condition and size of Resident 1’s wound on a daily basis.  In the 21 days between Resident 1’s admission and her readmission to the hospital, facility staff documented three wound assessments conducted on February 14, 19, and 26, 2019.  CMS Ex. 8 at 8, 16, 24.

Citing its wound management and skin management policies, which require only weekly assessments and notification to the resident’s physician if a change in condition occurred, Petitioner asserts it was not required to document the condition of Resident 1’s wound during daily dressing changes absent a change in condition.  P. Closing Br. at 12-13; CMS Ex. 13 at 1; CMS Ex. 14 at 1.  Petitioner contends CMS’s surveyor conceded the professional standard of care in nursing homes did not require daily documentation of wound condition if no change has occurred.  Id. at 13, citing Hearing Tr. 34-35.

CMS has established the professional standard of care obliged Petitioner to assess Resident 1’s wound on a daily basis and document those assessments, even if no change in condition occurred.  It is true Petitioner’s skin management and wound management

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policies required only weekly head-to-toe assessments on a weekly basis, and it appears Petitioner largely8 met this standard.  See CMS Ex. 8 at 8, 16, 24; CMS Ex. 13 at 1; CMS Ex. 14 at 1.  But Surveyor Escobar-Humphries opined the standard of care required daily documentation of all wound assessments, regardless of the findings.  CMS Ex. 16 at 4.  Surveyor Escobar-Humphries based his opinion on seven years of experience working as wound care nurse.  CMS Ex. 16 at 3. 9

Petitioner claims Surveyor Escobar-Humphries conceded at the hearing that nursing facilities were not required to document wound assessments absent a change in condition:

Q.  So in a skilled nursing facility, if there are no changes to the wound during wound changes (sic), wouldn’t you agree that documentation, in a skilled nursing facility, is not mandated?

A.  Yes.

Hearing Tr. at 35; P. Closing Br. at 13.

But as CMS points out, the syntax of the question may have confused the surveyor, who only two questions earlier had confirmed his own practice was to always document wound assessments, “[c]hanges or no changes.”  Hearing Tr. at 35.  On redirect examination, Surveyor Escobar-Humphries clarified the standard practice for nurses would be to document wound assessment each time they changed a dressing.  Id. at 45.  If they noticed a problem, the surveyor stated the standard practice would be to “document and [ ] call the physician, and obtain an order.”  Id.  If there were no reportable issues, the surveyor testified the standard practice would be to “write a quick sentence or two in the

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daily progress notes, indicating that the wound is okay, dressing change performed, no changes from previous ones.”  Id.

This clarification makes plain Surveyor Escobar-Humphries did not change his testimony.  Aside from this so-called concession, Petitioner has not proffered evidence that contradicts the surveyor’s opinion.  Tellingly, neither physician who provided declarations for Petitioner spoke to this precise issue.  Dr. Afshar broadly concluded the facility provided care to Resident 1 “in accordance with professional standards of practice[.]”  P. Ex. 4.  Dr. Kaisey declared only that he was present for evaluations of Resident 1 on four dates in February 2019.  P. Ex. 21.  Neither doctor addressed wound change frequency or the standard of care for wound documentation.  Because Surveyor Escobar-Humphries’ testimony on this topic is unrebutted and based on his clinical experience in wound care, I find it fully credible.

CMS next argues Petitioner cannot rely on the documented visits and examination notes of Resident 1’s physician, Dr. Mushrik Kaisey, to corroborate its claim Resident 1’s wound was closely monitored and her condition did not change until February 26, 2019.  CMS Br. at 16-17.  I agree.  Dr. Kaisey or his nurse practitioner appear to have visited Resident 1 at Petitioner’s facility and evaluated her wound on February 12, 14, 19, and 21, 2019.  P. Ex. 8; P. Ex. 21 at 1.  But the notes pertaining to these examinations are of little probative value.  All four examination notes contain the identical typographical error:  “dneis pain at current time.”  CMS Ex. 5 at 4, 5; CMS Ex. 10 at 1-2; CMS Ex. 11 at 7.  The notes for February 19 and 21 include the “dneis pain” notation even though Petitioner’s staff documented Resident 1 reported pain multiple times on those dates and received medication for that pain.  Id.  Three of the four visits record identical vital signs (blood pressure 129/74, heart rate 76, respiratory rate 18, temperature 97.5), and the physical exam narratives are identical for all four notes.  CMS Ex. 5 at 3-5.

The duplicative and in some instances inaccurate nature of these entries suggests Dr. Kaisey did not conduct thorough examinations of Resident 1 on these dates.  But even if I accept them as accurate, the notes do not indicate Dr. Kaisey or his nurse practitioner examined Resident 1’s amputation site.  They contain no observations concerning the surgical wound at all, an odd omission for a doctor caring for a diabetic patient whose leg had been recently amputated.  CMS Ex. 5; CMS Ex. 16 at 6-7.  Surveyor Escobar-Humphries declared his own clinical experience led him to expect a doctor in this context would examine and assess the patient’s wound.  CMS Ex. 16 at 6.  But even if this omission were clinically appropriate, the point remains that neither Dr. Kaisey nor his nurse practitioner appear to have examined Resident 1’s wound.  Petitioner therefore cannot rely on Dr. Kaisey’s examination notes to corroborate its staff adequately assessed the condition of Resident 1’s wound.

Finally, the record shows Petitioner failed to notify Resident 1’s physician of a change in her condition in a timely fashion in two instances.  Between February 10 and 18, 2019,

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Resident 1 consistently mostly reported no pain levels with an occasional score of up to 3 out of 10.  CMS Ex. 10 at 2-3.  But starting February 19, 2019, Resident 1 reported more frequent and more severe pain:  5 out of 10 and 6 out of 10 on February 19; 6 out of 10 on February 21; 5 out of 10 on February 22; and 5 out of 10, 8 out of 10, and 7 out of 10 on February 24.  Id. at 1-2.  Petitioner’s staff finally documented a change in condition on Februrary 24, 2019 for uncontrolled pain.  Id. at 2.  But the notable increase in pain on February 19, 2019 should have signaled a possible change in condition to Petitioner’s staff.10  See Hearing Tr. at 52 (Dr. Afshar’s admission that pain can be a sign or symptom of infection).  Yet Petitioner’s staff took no action to document a change in condition and contact Petitioner’s doctor for five days, until Resident 1 reported “8/10 pain unrelieved by current pain medications.”  Id. at 2-3.  Petitioner’s failure to grasp the possible clinical significance of Resident 1’s increased pain led to a five-day delay in contacting Resident 1’s physician, which needlessly deprived her of more effective pain-relieving medication and timely assessment of her wound.

The second instance occurred after Petitioner’s staff finally evaluated Resident 1’s wound on February 26, 2019, two days after its staff documented a change in condition and notified Dr. Kaisey.  At that time, Petitioner’s staff recorded a significant change in the size of Resident 1’s wound, which increased in width from 0.1cm to 3cm since the February 19, 2019 evaluation.  CMS Ex. 8 at 16, 24.  Despite that 30-fold increase, Petitioner still took no action, opting to wait for Resident 1’s appointment with her surgeon the next day.11  Petitioner’s decision to wait an additional 24 hours without notifying Resident 1’s attending physician or surgeon of the most recent and dramatic change in the condition of her wound is simply inexplicable.

Petitioner relies on Dr. Afshar’s testimony that a wound “can increase in size suddenly and significantly in a short amount of time” to corroborate the adequacy of its daily assessments and establish the possibility that the condition of Resident 1’s wound deteriorated in the 24 hours between its documented wound assessment on February 26, 2019 and the evaluation by Resident 1’s surgeon on February 27, 2019, which resulted in her immediate transport for emergent care and subsequent admission and revision surgery.  P. Ex. 4 at 2.  I do not find Dr. Afshar’s testimony credible as to this point.  He is not a wound specialist.  He does not appear to have ever examined Resident 1.  As the facility’s medical director, a finding of liability against the facility for failing to meet the

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professional standard of care would reflect poorly on him; he therefore has a compelling and self-interested motive to establish facts that favor Petitioner’s litigation position.

Finally, Dr. Afshar’s testimony only establishes that sudden and rapid unavoidable wound expansion is possible as a general matter.  But he does not provide any basis to find such an event occurred in this specific instance.  The circumstances here make it difficult to credit that possibility as likely.  Resident 1 began to report a significant increase in pain on February 24, 2019.  On February 26, 2019, two days later, Petitioner’s staff examined Resident 1’s wound and discovered it had expanded in size exponentially but still characterized it as “stable” and without odor.  CMS Ex. 8 at 24.  The next day, Resident 1’s surgeon examined the wound, discovered “obvious necrosis of the stump closure,” and directly sent Resident 1 to the emergency department.  CMS Ex. 15 at 11, 16, 35.  Emergency staff described a “foul-smelling discharge” emanating from Resident 1’s wound and noted the surgical incision had dehisced.  Id. at 11, 20.

I find it unlikely Resident 1’s wound deteriorated so rapidly in one day that it evaded detection during daily wound dressing changes through February 26, 2019.  The failure to document findings from daily wound assessments works to Petitioner’s detriment here.  A week-long absence of documentation, followed by a sudden and massive deterioration that outside medical professionals described on February 27, 2019 as “obvious necrosis” with a “foul-smelling discharge” do not support the inference Petitioner’s staff dutifully examined Resident 1’s wound on a daily basis and found no issues.  Even if sudden deterioration is clinically possible, the fact that the day before, on February 26, 2019, Petitioner’s staff documented a 30-fold increase in wound width but nevertheless described the wound as “stable” with no odor suggests their assessment did not accurately capture the condition of Resident 1’s wound.

I have also considered Dr. Afshar’s opinion that the worsening of Resident 1’s surgical wound was unavoidable due to Resident 1’s specific medical conditions as well as studies he cited to establish 25% of patients with below-the-knee amputations eventually required revision surgery.  P. Ex. 4 at 2-3.  The record does support Dr. Afshar’s uncontroversial view that Resident 1 was at an elevated risk for poor wound healing by virtue of her co-morbidities, which included diabetes, end-stage renal disease, hemodialysis dependence, and peripheral vascular disease.12

But the studies Dr. Afshar cited do not support the specific conclusion he drew from them, and his testimony on this point is not persuasive.  On cross-examination, he acknowledged the first study he cited found surgical intervention necessary in 25% of similarly situated patients and that the same study found 38% of amputee patients ultimately healed and were able to ambulate.  Hearing Tr. 65-66.  When asked by CMS

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counsel whether a 25% incidence rate meant the outcome was “unavoidable,” Dr. Afshar answered it was “[u]navoidable. . . . [f]or 25 percent [of patients].”  Id.  This tautology does not constitute a meaningful opinion as to whether this outcome was unavoidable for Resident 1.  In addition, Dr. Afshar appears to have conflated this study with a second study concerning revascularization outcomes among hemodialysis patients generally, which does not address the reintervention rate for below-knee amputations at all.  I therefore do not find his testimony credible to establish Resident 1’s wound deterioration was clinically unavoidable.

In sum, the record demonstrates Petitioner did not meet the professional standard of care when it failed to provide a timely and thorough initial evaluation of Resident 1’s wound on her admission.  It also failed to meet the standard of care by failing to document the condition of Resident 1’s surgical wound on a daily basis during dressing changes.  Petitioner again failed to meet that standard when it did not timely report a change in condition to Resident 1’s physician at two critical stages:  when she began complaining of increasing pain on February 19, 2019, and when its staff evaluated Resident 1’s wound on February 26, 2019 and discovered a massive increase in size.  In the former instance, Petitioner’s staff waited two days to contact Petitioner’s attending physician, even though increased pain is a commonly recognized sign of possible infection.  In the latter instance, they did not contact him at all, opting to wait 24 hours for a pre-scheduled visit with the resident’s surgeon even though Resident 1’s wound had increased in width 30-fold.  Given these circumstances, Petitioner’s week-long failure to assess or evaluate Resident 1’s wound monitoring between February 19 and 26, 2019 is indefensible.  And when it did finally evaluate Resident 1’s wound on February 26, 2019, its findings are suspect; it is unlikely Resident 1’s wound expanded in width by 30 times but displayed no other signs or symptoms, and a mere 24 hours later, showed a complete collapse and noxious odors that required immediate hospitalization.

Whatever the quality of Dr. Kaisey’s sparse evaluations, Petitioner had an independent obligation to furnish Resident 1 with all necessary care and services to promote healing and detect complications as they arose.  Heritage House of Marshall Health and Rehabilitation, DAB No. 3035 at 10 (2021).  This included daily assessment of Resident 1’s wound and documentation of those assessments.  And even if Resident 1’s comorbidities complicated her recovery and made some deterioration of her wound unavoidable, Petitioner’s failure to meet the professional standard of care in assessing, monitoring, and documenting the evaluation of Resident 1’s post-surgical wound amply justifies the deficiency finding here.  Id. at 12 (“The fact that a resident has medical conditions creating very high risk for pressure sores is not a license to stand by as they develop without doing what is possible and necessary to try to forestall their development.”); Gooding Rehab. & Living Ctr., DAB No. 2239 at 15 (2009) (a facility “cannot claim unavoidability unless it first shows that it furnished all necessary treatment and services.”).

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5. The $12,760 per-instance CMP amount is reasonable.

CMS is authorized to impose enforcement remedies against a facility that is not in substantial compliance with a participation requirement.  42 U.S.C. § 1395i-3(h)(2); 42 C.F.R. § 488.406.  Among other enforcement remedies, CMS may impose a per-instance CMP for each instance a facility is not in substantial compliance.  42 C.F.R. § 488.430(a).  At the time CMS imposed remedies in this case, a per-instance CMP could range from $2,233 to $22,320.  42 C.F.R. § 488.438(a)(2); 45 C.F.R. § 102.3 (2020).13

To assess the reasonableness of the CMP, I apply the factors set forth at 42 C.F.R. §§ 488.438(f) and 488.404 (incorporated by reference into 42 C.F.R. § 488.438(f)(3)).  These factors include the seriousness of the deficiency, the facility’s compliance history, its financial condition, and its degree of culpability.  See id.  The Board has held that the CMP amount selected by CMS is presumptively reasonable based on the regulatory factors listed above and that the facility bears the burden “to demonstrate, through argument and the submission of evidence addressing the regulatory factors, that a reduction [in the penalty amount] is necessary to make the CMP amount reasonable.”  Crawford Healthcare & Rehab., DAB No. 2738 at 19 (2016).  I consider whether “the evidence presented on the record concerning the relevant regulatory factors supports a finding that the amount of the CMP is at a level reasonably related to an effort to produce corrective action by [Petitioner] with the kind of deficiencies found and in light of the” factors mentioned above.  Careplex of Silver Spring, DAB No. 1683 (1999).

Here, Petitioner did not challenge the reasonableness of the CMP amount in its pre-hearing brief, instead disputing the level of noncompliance at which CMS assessed the penalty.  P. Br. at 19-20 (arguing a “G” level scope-and-severity finding improper absent a showing of actual harm).  Putting aside the absurdity of claiming no actual harm occurred where the resident in question suffered unnecessary pain and ultimately required a second surgery to amputate more of her leg, the regulations preclude my review of the scope-and-severity determination unless a successful challenge would affect CMS’s decision to impose a penalty in the upper range, or unless the finding resulted in loss of approval for a nurse aide training program.  42 C.F.R. § 498.3(b)(14).

Neither circumstance is present.  The $12,760 CMP selected by CMS falls within the single applicable per-instance range for a non-immediate jeopardy citation.  And nurse aide training program approval is automatically precluded by operation of regulation if the penalty amount exceeds a certain amount, which is the case here.  See 42 C.F.R. §§ 102, 483.151(b)(2)(iv).

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Petitioner has waived argument as to the reasonable of the penalty, but I have nevertheless considered the factors in 42 C.F.R. § 488.438(f).  The deficiency here is serious.  Petitioner’s staff consistently failed to meet the professional standard of care by failing to consistently monitor, evaluate, and document the progression of Resident 1’s post-surgical wound.  Petitioner thus allowed Resident 1 to experience unnecessary pain and ultimately reinfection and dehiscence of her wound, resulting in a second surgery to amputate more of her leg after a mere 22 days in its care.

The facility’s culpability is high – as I have noted, Petitioner’s staff delayed the initial assessment of Resident 1’s wound in the critical 24 hours following her amputation, failed to document daily wound assessments, failed to include a width measurement in the first assessment, failed to document wound characteristics in the second assessment, and failed to note and communicate a change in condition to Resident 1’s physician in at least two instances.

I note Petitioner’s prior survey history included 12 deficiency findings at scope-and-severity level D and one at level E.  CMS Ex. 19 at 3-4.  Petitioner presented no evidence concerning its financial condition for me to consider.  Finally, the $12,760 CMP falls squarely in the middle of the applicable penalty range.  See 42 C.F.R. § 488.438(a)(2); 45 C.F.R. § 102.3 (2020).  I therefore find the $12,760 per-instance CMP to be reasonable.

VIII.  Conclusion

I affirm CMS’s determination that Petitioner was not in substantial compliance with a Medicare program participation requirement and find the $12,760 CMP reasonable.