Victoria Falls Skilled Nursing and Rehab, DAB CR6071 (2022)

DECISION

As explained herein, I find in favor of Respondent, the Centers for Medicare & Medicaid Services (CMS), and against Petitioner, Victoria Falls Skilled Nursing and Rehab.  I sustain the imposition of a denial of payment for new Medicare and Medicaid admissions from February 28 through April 24, 2018.

I.  Background

Petitioner is a skilled nursing facility (SNF) in Andover, Kansas participating in the Medicare program.  Surveyors from the Kansas Department for Aging and Disability Services (KDADS or state agency) completed a complaint survey at Petitioner’s facility on February 7, 2018.  The state agency determined the facility was not in substantial compliance with 42 C.F.R. § 483.45(a), (b)(1)-(3) (Tag F755), at scope and severity (s/s) level “G.”  CMS Exhibit (Ex.) 1 at 1.

Based on these survey findings, KDADS informed Petitioner on February 13, 2018 that it imposed a mandatory denial of payment for new Medicare and Medicaid admissions (DPNA) effective February 28, 2018 that would remain in effect until Petitioner achieved substantial compliance or its provider agreement was terminated.  CMS Ex. 4 at 1.

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KDADS stated that Petitioner would not be given an opportunity to correct the deficiencies before the imposition of remedies.  Id.  In response, facility Administrator Tiffany Yenor prepared and implemented a plan of correction which she submitted to KDADS on February 22, 2018.  P. Br. at 4; P. Closing Br. at 1-2; P. Ex. 22 ¶ 5; CMS Ex. 9.  Administrator Yenor asserted the facility would complete corrections to address the Tag F755 deficiency by February 20, 2018.  CMS Ex. 9 at 11. 

On March 21, 2018, the state agency completed a revisit survey of Petitioner’s facility for the deficiency cited on February 7, 2018 and determined Petitioner had corrected the deficiency as of February 20, 2018.  P. Ex. 21 at 3.  That same day, KDADS conducted another complaint survey of Petitioner’s facility.  Based on its findings, the state agency determined that Petitioner was not in substantial compliance with the following program requirements:  

• 42 C.F.R. § 483.20(g) (Tag F641), s/s level “D”;
• 42 C.F.R. § 483.21(a)(1)-(3) (Tag F655), s/s level “D”;
• 42 C.F.R. § 483.21(b)(1) (Tag F656), s/s level “D”;
• 42 C.F.R. § 483.21(b)(2)(i)-(iii) (Tag F657), s/s level “D”;
• 42 C.F.R. § 483.24(a)(2) (Tag F677), s/s level “D”;
• 42 C.F.R. § 483.24(a)(3) (Tag F678), s/s level “E”;
• 42 C.F.R. § 483.25(b)(1)(i), (ii) (Tag F686), s/s level “G”;
• 42 C.F.R. § 483.25(d)(1), (2) (Tag F689), s/s level “D”;
• 42 C.F.R. § 483.25(e)(1)-(3) (Tag F690), s/s level “D”;
• 42 C.F.R. § 483.25(g)(4), (5) (Tag F693), s/s level “D”;
• 42 C.F.R. § 483.25(k) (Tag F697), s/s level “D”;
• 42 C.F.R. § 483.25(l) (Tag F698), s/s level “D”;
• 42 C.F.R. § 483.35(a)(1), (2) (Tag F725), s/s level “F”;
• 42 C.F.R. § 483.45(c)(1), (2), (4), (5) (Tag F756), s/s level “D”;
• 42 C.F.R. § 483.45(f)(2) (Tag F760), s/s level “G”;
• 42 C.F.R. § 483.45(g), (h)(1), (2) (Tag F761), s/s level “D”;
• 42 C.F.R. § 483.75 (Tag F867), s/s level “F”;
• 42 C.F.R. § 483.80(a)(1), (2), (4), (e), (f) (Tag F880), s/s level “D”; and
• 42 C.F.R. § 483.80(a)(3) (Tag F881), s/s level “F.”

CMS Ex. 2. 

Based on these survey findings, KDADS informed Petitioner on April 2, 2018 that it would impose a mandatory DPNA effective April 17, 2018 which would remain in effect until Petitioner achieved substantial compliance or its provider agreement was terminated.  P. Ex. 5 at 1.  KDADS again stated that based on the deficiencies cited in the March 21, 2018 survey and the facility’s history of noncompliance on February 7, 2018,

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Petitioner would not be given an opportunity to correct the cited deficiencies before the imposition of remedies.  Id.

KDADS issued a revised enforcement letter on April 2, 2018 that modified the effective date of the DPNA to February 28, 2018.  P. Ex. 12 at 3; CMS Ex. 5 at 1; P. Br. at 7.  KDADS explained “this action is based on the fact that deficiencies that constitute a level of actual harm or above were found on the current survey and the complaint survey completed on 02/07/2018.  You were notified of your denial of payment and right to appeal this action in our letter on 02/13/2018.”  Id.

KDADS conducted a revisit survey at the facility on May 3, 2018, found no new deficiencies, and determined Petitioner had corrected all the deficiencies identified in the March 21, 2018 survey as of April 25, 2018.  CMS Ex. 3.  Id.

On June 1, 2018, Petitioner timely requested a hearing before an Administrative Law Judge in the Civil Remedies Division to challenge CMS’s determination of noncompliance and the imposition of the DPNA.  I was designated to hear and decide this case and 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 (CMS Br.) and 16 proposed exhibits (CMS Exs. 1-16), which included written direct testimony for four witnesses (CMS Exs. 13-16).  Petitioner filed a pre-hearing brief (P. Br.) and 24 proposed exhibits (P. Exs. 1-24), which included the written direct testimony of three witnesses (P. Exs. 22-24).  Petitioner requested cross-examination of CMS’s witnesses.  P. Br. at 11.

II.  Hearing and Admission of Exhibits

On November 6, 2019, I held a hearing by videoconference to allow Petitioner to cross-examine CMS’s witnesses.  At the outset of the hearing, absent objection I entered both parties’ proposed exhibits into the record.  Hearing Transcript (Tr.) at 16.  Following the hearing, Petitioner timely filed its post-hearing brief (P. Closing Br.).  Two days after the deadline and without explanation, CMS untimely filed a “post-hearing brief” in which it declined to make further arguments (CMS Closing Br.).1

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III.  Statement of Issues

The issues presented are: 

1. Whether Petitioner was in substantial compliance with 42 C.F.R. § 483.45(a), (b)(1)-(3) (Tag F755) at the time of the February 7, 2018 survey;
2. Whether Petitioner was in substantial compliance with 42 C.F.R. § 483.25(b)(1)(i)(ii) (Tag F686) and 42 C.F.R. § 483.45(f)(2) (Tag F760) at the time of the March 21, 2018 survey;
3. If Petitioner was not in substantial compliance with program requirements, whether CMS had the authority to impose a DPNA on Petitioner. 

IV.  Jurisdiction

I have jurisdiction to hear and decide this case.  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). 

V.  Statutory and Regulatory Background

The Social Security Act (Act) sets forth requirements for a SNF’s participation in the Medicare program and authorizes the Secretary of Health and Human Services to promulgate regulations implementing those statutory provisions.  42 U.S.C. § 1395i-3.  These implementing regulations are found at 42 C.F.R. Parts 483 and 488. 

To participate in the Medicare program, a SNF must maintain substantial compliance with program participation requirements.  To be in substantial compliance, a SNF’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 SNFs are in substantial compliance with the participation requirements.  42 U.S.C. § 1395aa(a); 42 C.F.R. § 488.10.  The Act also authorizes the Secretary to impose enforcement remedies against SNFs that are not in substantial compliance with the program participation requirements.  42 U.S.C. § 1395i-3(h)(2).  The regulations specify the enforcement remedies that CMS may impose if a facility is not in substantial compliance.  42 C.F.R. § 488.406. 

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Among other remedies, CMS may impose a DPNA when a SNF is not in substantial compliance.  42 U.S.C. § 1395i-3(h)(2)(B)(i); 42 C.F.R. §§ 488.406(a)(2)(ii), 488.417(a).  Before denying payments, “notice must be given at least 15 calendar days before the effective date of the enforcement action in situations where there is no immediate jeopardy.”  42 C.F.R. § 488.402(f)(4).  The notice given includes the “[n]ature of the noncompliance,” “[w]hich remedy is imposed,” the “[e]ffective date of the remedy,” and the “[r]ight to appeal the determination leading to the remedy.”  42 C.F.R. § 488.402(f)(1)(i)-(iv).

If CMS imposes a DPNA based on a noncompliance determination, then the facility may request a hearing before an ALJ to challenge the noncompliance finding and enforcement remedy.  See 42 C.F.R. §§ 488.330(e), 488.408(g), 498.3(b)(13), 498.40(a).  The hearing before an ALJ is a de novo proceeding.  CarePlex of Silver Spring, DAB No. 1683 (1999) (providing ALJs hold de novo hearings based on issues permitted under the regulations and their review is not a quasi-appellate review); see also Claiborne-Hughes Health Ctr. v. Sebelius, 609 F.3d 839, 843 (6th Cir. 2010) (the Departmental Appeals Board (DAB) “reviewed the finding under the de novo standard that the ALJ would have applied.”).  Although the facility has a right to appeal a “certification of noncompliance leading to an enforcement remedy,” CMS’s choice of remedies and the factors CMS considered when choosing remedies are not subject to review.  42 C.F.R. § 488.408(g).

CMS has the burden to come forward with evidence sufficient to make a prima facie showing that Petitioner is out of substantial compliance with participation requirements to establish a basis to impose an enforcement remedy.  See, e.g., Evergreene Nursing Care Ctr., DAB No. 2069 at 7 (2007).  If CMS makes this prima facie showing, then Petitioner bears the ultimate burden of persuasion as to whether it substantially complied.  In other words, Petitioner must show by a preponderance of the evidence of record that it was in substantial compliance with participation requirements.  Id.  Petitioner has both the burden of coming forward and the burden of persuasion as to any affirmative defense.  Id.; Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004), aff’d, Batavia Nursing & Convalescent Ctr. v. Thompson, 129 F. App’x 181 (6th Cir. 2005).

VI.  Discussion

1. CMS has established by a preponderance of the evidence that Petitioner failed to substantially comply with 42 C.F.R. § 483.45(a), (b)(1)-(3) (Tag F755), 42 C.F.R. § 483.25(b)(1)(i)(ii) (Tag F686), and 42 C.F.R. § 483.45(f)(2) (Tag F760).

KDADS completed a complaint survey at Petitioner’s facility on February 7, 2018 and determined the facility was not in substantial compliance with 42 C.F.R. § 483.45(a), (b)(1)-(3) (Tag F755).  CMS Ex. 1.  On March 21, 2018, the state agency completed a

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revisit survey and determined that Petitioner was not in substantial compliance with 19 deficiencies, including 42 C.F.R. § 483.25(b)(1)(i)(ii) (Tag F686) and 42 C.F.R. § 483.45(f)(2) (Tag F760).  CMS Ex. 2 at 41-73, 119-128.

Petitioner does not dispute CMS’s noncompliance findings from either survey.  Tr. at 9.  Nevertheless, to provide a factual and legal framework for my analysis, I set forth relevant facts and findings.

On February 7, 2018, KDADS conducted a sample review of records for three out of 71 residents.  CMS Ex. 1 at 1.  CMS based its imposition of remedies of KDADS’s determination that Petitioner failed to comply with the requirements of 42 C.F.R. § 483.45(a) and (b) with respect to each of these three residents, identified as Residents 1, 2, and 3.

Resident 1

On February 5, 2018, at 10:16 a.m., facility staff transferred Resident 1 to the hospital for emergent care due to lethargy, low blood oxygen saturation, and elevated pulse and temperature.  Id. at 4.  Hospital staff discovered two Fentanyl patches on the resident’s body.  Id. at 5.  One patch was dated February 4, 2018 while the other patch was undated.  Id.  Hospital staff diagnosed Resident 1 with an opiate overdose, administered Narcan twice, and closely monitored Resident 1 in the intensive care unit.  Id.

Certified medication aide (CMA) Melissa Hernandez reported that around 9:00 p.m. on February 4, 2018, Licensed Practical Nurse (LPN) Douglas Sunder instructed her to apply a fentanyl patch to Resident 1.  Id. at 6, 7.  CMA Hernandez found the resident sleeping in her room and was unable to access her back in order to remove the old patch.  Id.  LPN Sunder therefore instructed CMA Hernandez to place the patch on Resident 1’s shoulder.  Id.  CMA Hernandez did not remove the fentanyl patch already placed on Resident 1’s back.  Id.  LPN Sunder admitted he should have applied the patch himself rather than delegating the task to CMA Hernandez.  Id. at 6.

Resident 2

Review by KDADS surveyors of a Medication Error report and a January 2018 medication administration record (MAR) revealed that on January 30, 2018 and January 31, 2018, facility staff provided Resident 2 only one 100-milligram dose of Gabapentin instead of the three 100-milligram doses ordered by her physician.  Id. at 10-11. 

Upon investigation of these medication errors, Registered Nurse (RN) Shirley Sims explained the error occurred as a result of the pharmacy failing to provide consistent packaging to the facility, as well as members of staff failing to accurately complete medication administration procedures.  Id. at 11.

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Resident 3

On February 7, 2018, a state agency surveyor observed Resident 3 did not appear to have a Fentanyl patch placed, though Resident 3’s MAR indicated facility staff had placed one two days earlier.  Id. at 9.  LPN Crystal Thompson explained that she checked Resident 3 for a Fentanyl patch on February 6, 2018.  Id.  When she did not find a patch in place, LPN Thompson decided to wait for the second shift nurse to come on duty to confirm its absence before documenting the error.  Id.  When the second shift nurse came on duty, both nurses checked for the patch but did not find it.  Id.  LPN Thompson reported she planned to place another patch on Resident 3 but got “side tracked” and did not do so.  Id.  LPN Jvonne Love admitted that on February 6, 2018, she erroneously documented Resident 3’s Fentanyl patch was in place and failed to notify anyone of the error.  Id.  Director of Nursing (DON) Kelly Johnson confirmed LPN Love’s mistake.  Id. at 9-10.

1. Petitioner was not in substantial compliance with 42 C.F.R. § 483.45(a), (b)(1)-(3) (Tag F755) because it did not provide pharmaceutical services to meet the needs of three residents.

The regulations governing skilled nursing facilities require them to provide pharmaceutical services (including implementation of procedures that assure the accurate acquiring, receiving, dispensing, and administering of all drugs and biologicals) to meet the needs of each resident.  42 C.F.R. § 483.45(a).  Such a facility must also employ or obtain the services of a licensed pharmacist who:  (1) provides consultation on all aspects of pharmacy services in the facility; (2) establishes a system of records of receipt and disposition of all controlled drugs in sufficient detail to enable an accurate reconciliation; and (3) determines that drug records are in order and that an account of all controlled drugs is maintained and periodically reconciled.  42 C.F.R. § 483.45(b)(1)-(3).

Here, the record demonstrates Petitioner did not provide pharmaceutical services to meet the needs of its residents.  With respect to Residents 1 and 3, Petitioner failed to follow its own policy regarding transdermal drug delivery, which requires staff to identify the location on a resident’s body for patch placement using a coding system, remove the old patch from the body, cleanse the area with an alcohol wipe, firmly apply the new patch, and document the site of the patch placement.  CMS Ex. 7 at 14.  The facility effectuated this policy to ensure its residents received continuous and appropriate doses of medication through skin absorption.  Id.  Consistent with this policy, physician’s orders for Residents 1 and 3 required a new transdermal Fentanyl patch be placed every 72 hours for pain and removal of the old patch prior to application of the new patch.  CMS Ex. 1 at 3, 8-9.  However, Petitioner’s staff failed to identify the location of Resident 1’s old Fentanyl patch and remove it before placing a new one.  Id. at 7; CMS Ex. 7 at 6.  As a result, Resident 1 suffered an opioid overdose and required hospitalization for emergent care, including two doses of Narcan.  CMS Ex. 1 at 4-5.

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Petitioner’s staff committed the opposite error concerning Resident 3 by failing to document the resident was missing a prescribed Fentanyl patch or administering a new patch to ensure she received the continuous dosage ordered by her physician.  Id. at 9-10; CMS Ex. 7 at 8, 12.  Petitioner similarly failed to administer the proper dose of Gabapentin to Resident 2 on two different occasions.  Where Resident 2’s physician had ordered facility staff to administer 300 milligrams of Gabapentin three times daily to Resident 2, they instead administered only one 100-milligram capsule to her two days in a row in January 2018.  CMS Ex. 1 at 10-11.

Petitioner did not rebut CMS’s prima facie showing that Petitioner violated 42 C.F.R. §§ 483.45(a) and (b) with respect to these residents, and as I have already noted, conceded these deficiencies at the hearing.  Tr. at 9.  I therefore find Petitioner did not comply with its own policies or relevant physician’s orders to meet the pharmaceutical needs of its residents.  Petitioner was not in substantial compliance with 42 C.F.R. § 483.45(a), (b)(1)-(3).

2. Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(b)(1)(i), (ii) (Tag F686) because it failed to develop and implement timely and effective interventions to prevent the development and promote healing of pressure ulcers for four residents.

Under the Act and the “quality of care” regulation, each resident must receive, and the facility must provide, necessary care and services.  Act § 1819(b); 42 C.F.R. § 483.25.  To this end, based on the comprehensive assessment of a resident, the facility must ensure that:  (1) a resident receives care, consistent with professional standards of practice, to prevent pressure ulcers and not develop avoidable pressure ulcers; and (2) a resident with pressure ulcers receives necessary treatment and services, consistent with professional standards of practice, to promote healing, prevent infection and prevent new ulcers from developing.  42 C.F.R. § 483.25(b)(1).

Here, CMS alleges that Petitioner failed to comply with the regulatory requirements of 42 C.F.R. § 483.25 with respect to four residents – Residents 10, 22, 25 and 29 – by failing to develop and implement timely and effective interventions to prevent the development and promote healing of pressure ulcers.  CMS Ex. 2 at 42.  Petitioner does not contest the point, but I set forth relevant facts and findings to provide a framework for my analysis.

Resident 10

Resident 10 was readmitted to the facility on September 11, 2017 after acute care at a specialty wound center for pressure ulcers occurring on both his right and left hips.  Id. at 42.  He returned to the facility with a stage IV pressure ulcer on his sacrum (base of the

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spinal column) and a stage II pressure ulcer on his right hip bone.  Id. at 44.  The facility updated Resident 10’s care plan on December 26, 2017 to include the use of a pressure-reducing cushion in the resident’s wheelchair and in January 2018, updated it to discontinue treatment of his sacral wound.  Id.  In early February 2018, staff discovered a stage II pressure wound on Resident 10’s left hip.  Id. at 46.  On February 28, 2018, Resident 10’s physician provided orders to staff to treat a stage II pressure ulcer on the resident’s right hip as well as an unstageable2 pressure area on his left hip.  Id. at 45.  These orders included instructions that Resident 10 be on bed rest with off-loading of his right hip except for meals, three times a day, one hour at a time, when he could sit upright in a chair.  Id. at 46. 

On March 12, 2018, Resident 10’s physician ordered treatment at a wound clinic because the stage II pressure ulcers on his left hip had progressed to stage III.  Id. at 47.  Resident 10 required monitoring at least every two weeks at the wound clinic, but facility staff believed the wound clinic had discharged him and thus did not return Resident 10 to the wound clinic for follow-up visits, resulting in deterioration of his left hip pressure ulcer.  Id. at 50, 52-53. 

On March 13, 2018, state surveyors observed that Resident 10 was seated in a wheelchair for a meal from 11:15 am to 12:48 pm, 33 minutes longer than allowed for in the care plan.  Id. at 50.  On March 14, 2018, at 9:26 am, facility staff transferred Resident 10 to a wheelchair and took the resident to the dining area.  Id. at 51.  The resident remained in his wheelchair until 11:15 am, 49 minutes longer than prescribed in the care plan.  Id.  Petitioner’s staff reported being unaware Resident 10’s care plan only allowed for the resident to be seated upright for a total of one hour at mealtime.  Id. 

On March 14, 2018, at 8:20 am, a state surveyor observed Resident 10’s bed sheets appeared wrinkled.  Id. at 50.  Resident 10’s left torso contained red indentations from the wrinkles.  Id.  The facility’s staff stated that the sheets did not stay in place over the mattress.  Id. 

Resident 22

Resident 22, whose right leg was amputated below the knee, was admitted to the facility with a stage III pressure ulcer on the right leg stump and a vascular/diabetic ulcer on the left leg.  Id. at 70-71.  Staff identified Resident 22 to be at risk for further skin issues due

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to poor tissue perfusion (blood flow), poor healing, and skin breakdown on his/her buttocks due to frequent incontinence.  Id. at 71.  The resident’s care plan, updated March 12, 2018, advised staff to check Resident 22 frequently for appropriate positioning in the wheelchair, offer to lay the resident down frequently throughout the day, especially after meals, and to provide an opportunity to use the toilet at least every two hours and as needed.  Id.

On March 14, 2018, surveyors observed facility staff allowed Resident 22 to sit in a wheelchair without offering repositioning or an opportunity to use the toilet for two and half hours, from 8:45 to 10:15 a.m.  Id. at 71-72.  At 1:55 p.m., when staff did transfer Resident 22 to the toilet, the resident’s incontinence brief was saturated with urine.  Id. at 72.  The staff member responsible for Resident 22’s care that day stated the resident had not used the toilet that day and did not know when the resident had last toileted.  Id. 

Resident 25

Resident 25 was admitted to the facility with a stage II pressure ulcer on his left buttocks.  Id. at 54.  The resident’s MDS evaluation on admission memorialized care interventions to manage his skin problems including use of a pressure-reducing device for the resident’s bed and wheelchair, a turning and repositioning program, and nutrition and hydration.  Id.  The resident’s January 11, 2018 care plan required staff to provide a pressure-relieving cushion for use in his wheelchair and instructed staff to observe the resident’s skin for redness, swelling, or open areas and report any changes.  Id.  Resident 25’s March 13, 2018 care plan instructed staff to reposition him every two hours and as needed.  Id. at 55.  Staff were also required to add protein powder to the resident’s meals, provide a high-protein snack daily, provide protein shakes three times daily, and provide extra protein at meals.  Id. at 55-56. 

By March 21, 2018, Resident 25 had developed three new pressure ulcers, one of which progressed from a stage II pressure ulcer to a stage III pressure ulcer.  Id. at 56-62.  On numerous occasions, facility staff did not reposition Resident 25 in accordance with the care plan.  Id. at 59, 61-62.  Staff members failed to provide treatment ordered by Resident 25’s physician, including administration of barrier cream to the resident’s pressure ulcers.  Id. at 56, 61-62.  They did not comply with Resident 25’s care plan or dietitian’s orders to ensure the resident received snacks and shakes.  Id. at 59-62.  Staff members explained Resident 25 did not care for the supplemental protein shakes and the facility did not provide other options.  Id. at 60-62.  Finally, the clinical record does not demonstrate Petitioner’s staff notified Resident 25’s physician of the development and progression of the resident’s pressure ulcers.  Id. at 56, 58.  DON Johnson acknowledged Resident 25 developed several pressure ulcers and one pressure ulcer worsened to a stage III pressure ulcer because of lack of repositioning and an insufficient amount of protein.  Id. at 62.

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Resident 29

Resident 29 was admitted to the facility with no skin issues but was identified to be at moderate risk for development of pressure ulcers owing to impaired mobility and incontinence.  Id. at 64-65.  Resident 29 had a prior sacral wound on October 14, 2017, which healed later that month.  Id.

As of January 1, 2018, Resident 29’s care plan directed facility staff to reposition the resident every two hours and as needed.  Id. at 64.  But on numerous occasions (March 12, 13, and 15, 2018), Petitioner’s staff did not reposition Resident 29 at the required frequency.  Id. at 67-69.

On March 15, 2018, a state agency surveyor noted an open area near the base of Resident 29’s spine (sacrum).  Id. at 68.  An administrative nursing staff member explained the white scar on the resident’s sacrum was the location of the healed sacrum wound.  Id. at 69.  However, a wound review conducted March 15, 2018 documented a new pressure area on Resident 29’s sacrum.  Id. at 65-66.  The surveyor observed a standard mattress in the resident’s bed.  Id. at 69.

42 C.F.R. § 483.25 does not impose strict liability on a facility whenever a resident develops pressure sores.  Instead, in assessing the facility’s compliance with this requirement, the relevant question is:  did the facility “take all necessary precautions” to promote healing, prevent infection, and prevent new sores from developing?  If so, the fact that a resident develops sores does not demonstrate a deficiency.  But if the evidence establishes that the facility fell short of taking all necessary precautions, it has failed to meet the demands of the regulation.  Senior Rehab. & Skilled Nursing Ctr., DAB No. 2300 at 13-14 (2010), aff’d, Senior Rehab. & Skilled Nursing Ctr. v. Health & Human Servs., 405 F. App’x 820 (5th Cir. 2010); Koester Pavilion, DAB No. 1750 at 32 (2000).

Petitioner’s own quality of care policy concerning skin care requires its staff to ensure any resident who enters the facility without pressure ulcers not develop pressure ulcers, and that any resident with pressure ulcers receive the necessary treatment and services to promote healing, prevent infection, and prevent new ulcers from developing.  CMS Ex. 2 at 69-70.  Petitioner’s skin care policy more specifically mandated staff to change a resident’s position at least every two hours (or as directed by resident’s care plan, or more frequently if needed while in bed), to use pillows or wedges to assist in keeping the resident positioned, and to change the resident’s position at least every two hours or as directed by the resident’s care plan while sitting in a chair.  Id. at 53.

In this case, the evidence establishes Petitioner’s staff did not follow care plans, physician’s orders, or even the facility’s own policies for promoting healing of pressure ulcers and preventing new sores from developing for any of these residents.  Petitioner’s staff failed to timely return Resident 10 to bed on two different occasions and ensure

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linens on the resident’s bed were appropriately applied.  CMS Ex. 2 at 50-51.  Given this sporadic compliance with protocols designed to improve or prevent pressure ulcers, it is unsurprising one of Resident 10’s stage II pressure ulcers worsened to a stage III pressure ulcer and required specialized treatment at a wound clinic.  Id. at 47.  More inexplicably, Petitioner’s staff failed to ensure Resident 10 received continuing treatment at the wound clinic for his stage III pressure ulcer.  Id. at 50, 52-53.

Resident 25 also had a stage II pressure ulcer that worsened to stage III because Petitioner’s staff did not provide protein supplements, timely change the resident’s position, or care for the pressure ulcer in accordance with his physician’s orders.  Id. at 56, 58, 59, 61-62.  Petitioner also failed to timely notify Resident 25’s physician when he developed three new pressure ulcers or when one of the pressure ulcers worsened.  Id. at 56-62.

Meanwhile, Resident 29 developed a stage II pressure ulcer on the tailbone because Petitioner did not reposition the resident every two hours and failed to provide a pressure-relieving mattress.  Id. at 67-69.  Petitioner’s staff similarly failed to reposition Resident 22 every two hours and failed to keep track of the resident’s toileting schedule, resulting in Resident 22 soiling an incontinence brief with urine, a condition likely to promote the development of pressure sores.  Id. at 72.

Given these uncontested observations, I have no difficulty concluding Petitioner’s failure to follow residents’ care plans, orders from their physicians, and its own policies demonstrates the facility was not in substantial compliance with 42 C.F.R. § 483.25.

3. Petitioner was not in substantial compliance with 42 C.F.R. § 483.45(f)(2) (Tag F760) because the facility administered the wrong dose of long-acting insulin to Resident 71, resulting in the resident’s hospitalization for hypoglycemia.

The Secretary’s regulations require a skilled nursing facility to ensure its residents are not subject to significant medication errors.  42 C.F.R. § 483.45(f)(2).  CMS alleges Petitioner failed to comply with 42 C.F.R. § 483.45(f)(2) because the facility failed to follow the physician orders to provide medication accurately and safely to Resident 71. CMS Ex. 2 at 128.  Again, Petitioner does not contest this assertion, but I set forth relevant facts and findings.

Resident 71 was diagnosed with diabetes mellitus.  Id. at 119.  In February 2018, Resident 71’s physician ordered the resident be given 12 units of long-acting insulin at a concentration of 100 units per milliliter once a day before supper.  Id. at 120.  Petitioner’s staff entered this order as a request for 112 units of long-acting insulin instead of 12 units.  Id.  The pharmacy order status form documented the filled order as “Tresiba flex

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touch, Units-100, provided 15 ml (or 5 flex pens), with directions for staff to inject 112 units subcutaneous, one time a day before supper.”  Id.

On February 17, 2018, Petitioner’s staff found Resident 71 unresponsive and sent her to the hospital for emergent care.  Id. at 121-122.  Emergency medical service responders determined Resident 71’s blood sugar was 54.  Id. at 122.  They also noted Petitioner’s staff had not checked Resident 71’s blood sugar at that time, and indeed, had apparently not checked her blood sugar for five days.  Id.  The hospital emergency room diagnosed Resident 71 with hypoglycemia and possible seizure.  Id.  Resident 71 was ultimately transferred and admitted to another hospital.  Id. at 123.

Petitioner’s investigation of the incident concluded Resident 71 was given the wrong dosage of insulin because RN Shirley Sims entered the wrong dosage in the resident’s case records.  Id. at 123.  That error resulted in an order for Resident 71 to receive 112 units of insulin daily instead of the 12 units ordered by her physician.  Id.  Three different facility nurses administered that incorrect dosage for five days.3   Id.  Indeed, several members of Petitioner’s nursing staff thought the putatively prescribed dosage to be unusually high; in response, one gave Resident 71 only 40 units of insulin while another gave her only 12 units.  Id. at 124.  A third member of staff gave the resident an altogether different dosage of insulin but could not recall the amount.  Id.  Despite the unusually high amount of insulin apparently ordered for Resident 71, however, no member of Petitioner’s staff double-checked the order with either the pharmacy or Resident 71’s physician.  Id. at 125-27.

The record amply demonstrates Petitioner failed to ensure Resident 71 was free of significant medication errors.  Petitioner’s policy concerning physician’s orders required the facility to develop, implement, and maintain policies and procedures to support prescribing and ordering of drugs.  Id. at 127.  Here, however, one member of Petitioner’s nursing staff entered the wrong information in the order sent to the pharmacy and failed to verify the order was correct.  Id. at 124.  Other members of staff took note of the unusually high dosage of insulin putatively ordered for Resident 71 but failed to verify the correct dosage.  They instead bizarrely chose to adjust the amount to Resident 71 without recording the actual doses given or even advising following shifts of the actual amount of insulin given to the resident.

Because of this haphazard and reckless approach to the administration of insulin, Resident 71 received almost five times the amount of insulin ordered by her physician, resulting in the resident’s emergency transfer and hospitalization for hypoglycemia.  Id. at 121-123.  Clearly, whatever Petitioner’s policy on paper might have been concerning the effectuation of physician’s medication orders, its staff were not adequately trained to

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follow it.  By failing to accurately enter the proper dosage ordered by Resident 71’s physician and randomly administering different dosages to that resident, Petitioner’s staff failed to ensure Resident 71 was free of significant medication errors in violation of 42 C.F.R. § 483.45(f)(2). 

2. CMS had the authority to impose a DPNA on Petitioner from February 28 through April 24, 2018.

1. Petitioner was not in substantial compliance with Medicare participation requirements from February 28, 2018 through April 24, 2018.

Despite finding significant errors that adversely affected the quality of care received by residents at Petitioner’s facility during two survey visits on February 7, 2018 and March 21, 2018, CMS ultimately opted not to impose financial remedies against Petitioner.  Instead, CMS adopted KDADS’ imposition of a DPNA beginning February 28, 2018 and ultimately concluding April 25, 2018, the date KDADS determined Petitioner returned to substantial compliance concerning the deficiencies discovered March 21, 2018.  CMS Ex. 3 at 1; CMS Ex. 5 at 1.

Petitioner does not contest the deficiencies discovered during either survey.  It instead objects to the fact that KDADS imposed a DPNA effective February 28, 2018, even though the facility corrected the Tag F755 deficiency which formed the basis for the imposition of remedies to KDADS’ satisfaction on February 20, 2018.  P. Br. at 9; P. Closing Br. at 5; Tr. at 10-13.  Petitioner argues KDADS improperly imposed a DPNA because the facility returned to substantial compliance before the effective date of its imposition for the Tag F755 deficiency.  P. Br. at 7; P. Closing Br. at 8.

Petitioner similarly argues that KDADS improperly imposed a DPNA for deficiencies identified at the March 21, 2018 survey because KDADS accepted the facility’s plan of correction for those deficiencies on April 12, 2018, before the effective date for the DPNA identified in KDADS’ initial notice of imposition of remedies, April 17, 2018.  P. Br. at 7-8; Tr. at 13; P. Ex. 11.

CMS contends that while KDADS found Petitioner had corrected the Tag F755 deficiency by February 20, 2018, CMS relied on the deficiencies cited from the March 21, 2018 survey to determine Petitioner remained in substantial noncompliance with Medicare participation requirements after February 20, 2018 and continuing until the facility established its return to compliance on April 12, 2018.  CMS Br. at 12.

While Petitioner’s argument has some merit as a matter of common sense, it does not comport with the Act, the governing regulations, or applicable Board law, and therefore must fail.  First, a skilled nursing facility does not enjoy a presumptive return to

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substantial compliance simply by correcting a deficiency.  The Act authorizes the Secretary to deny payments under the Medicare program after the effective date of a penalty arising from a deficiency finding.  42 U.S.C. § 1395i-3(h)(2)(B)(i).  The Act explicitly provides that “[a] finding to deny payment . . . shall terminate when the Secretary finds that the facility is in substantial compliance with all [Medicare program participation] requirements.”  42 U.S.C. § 1395i-3(h)(3) (emphasis added).  The Secretary’s regulations specify that upon imposition of a DPNA, a skilled nursing facility cannot receive payments for new admissions until “the date that the facility achieves substantial compliance, as indicated by a revisit or written credible evidence acceptable to CMS (under Medicare) or the State (under Medicaid).”  42 C.F.R. § 488.417(d); see also 42 C.F.R. § 488.454(a)(1) (specifying alternative remedies like DPNAs continue until “the facility has achieved substantial compliance, as determined by CMS or the State based upon a revisit or after an examination of credible written evidence that it can verify without an on-site visit.”

In short, Petitioner must demonstrate an earlier date of return to substantial compliance than April 12, 2018, the date determined by CMS, in order to prevail.  See Chicago Ridge Nursing Ctr., DAB No. 2151 at 26 (2008) (“ . . . CMS may impose remedies on a facility found out of substantial compliance ‘beginning as early as the date that the facility was first out of substantial compliance and continuing in effect until the facility establishes that it has achieved substantial compliance or is terminated from the program.’”).

It cannot do so.  Petitioner relies on evidence it offered showing KDADS found the facility corrected the Tag F755 deficiency resulting in the first imposition of a DPNA on February 20, 2018.  P. Ex. 21.  But this finding by KDADS does not equate to a determination by CMS of the facility’s return to substantial compliance.  Instead, as Benton Williams, a Health Insurance and Enforcement Specialist for CMS’s Survey and Certification Branch testified, CMS determined Petitioner never achieved substantial compliance in between the surveys conducted in February and March of 2018.  CMS Ex. 13 ¶ 13; Tr. at 53.  Mr. Williams explained that CMS determined Petitioner had not yet returned to substantial compliance on February 20, 2018 for three reasons.  CMS Ex. 13 ¶ 15; Tr. at 54.  First, CMS found the facts underlying the Tag F755 deficiency cited in February 2018 and the Tag F760 deficiency cited in March 2018 were similar in nature, as both arose from serious errors in the administration of medication to residents (Fentanyl and insulin, respectively).  CMS Ex. 13 ¶ 15; Tr. at 59-60.  Second, CMS determined that because of the circumstances of the deficiency cited under Tag F686 (the worsening of existing or development of new pressure sores), it was clear the facility had not substantially complied with 42 C.F.R. § 483.25(b)(1)(i)(ii) prior to the March 21, 2018 survey.  CMS Ex. 13 ¶ 15; Tr. at 60-61.  Finally, Mr. Williams declared that “nursing homes must be in compliance with all requirements all the time and there were several deficiencies other than the ‘G’ level ones that indicated continuing non-compliance.”  CMS Ex. 13 ¶ 15; see also Tr. at 61-62.

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I find Mr. Williams’ testimony credible, and no basis in the record before me to reject it.  Despite Petitioner’s claim to the contrary, the record before me demonstrates it did not return to substantial compliance on February 20, 2018 merely by correcting the one G-level deficiency cited in the first survey.  Instead, as Mr. Williams explained, KDADS surveyors found Petitioner’s staff committed grave medication mismanagement errors at both the February and March 2018 surveys, errors that could have easily resulted in the death of residents.  It is unlikely Petitioner’s staff only mismanaged medication during the February 2018 survey, returned to substantial compliance on February 20, 2018, and less than a month later, demonstrated new medication mismanagement errors unrelated to the prior ones.

Similarly, several residents exhibited pressure sores that came into being or worsened during the period of time between the two surveys, strongly suggesting an ongoing deficiency concerning pressure wound care.  Finally, as Mr. Williams noted, there were numerous lower-level deficiencies cited during both surveys, not discussed here because they were unpenalized, that bely Petitioner’s claim it returned to substantial compliance on February 20, 2018 and remained free of deficiencies until the March 21, 2018 survey.

In sum, there is ample evidence in the record before me to substantiate Mr. Williams’ testimony and provide a factual basis for CMS’s determination that Petitioner remained out of substantial compliance even after correcting the deficiency identified during the February 2018 survey on February 20, 2018.  Because the record before me provides a factual basis to conclude Petitioner remained out of substantial compliance between the two surveys, CMS was entitled under the law and regulations to impose a DPNA beginning February 28, 2018 and continuing until the facility corrected all the deficiencies cited in both surveys.

Relevant analysis from the Departmental Appeals Board (Board) also contravenes Petitioner’s assertion that curing the deficiency identified during the first survey precluded CMS from initiating a DPNA earlier than the date of the second survey.  In W. Tex. LTC Partners, Inc., d/b/a Cedar Manor, DAB No. 2652 (2015), CMS imposed a DPNA on the facility (West Texas) from January 24, 2014 through January 31, 2014.  West Texas, DAB No. 2652 at 1.  CMS imposed the DPNA based on two surveys, one completed on December 20, 2013 and a second survey completed on January 28, 2014.  Id.  The deficiencies cited in the December 2013 survey differed from the deficiencies cited in the January 2014 survey.  Id.  West Texas argued that because it returned to substantial compliance concerning the first set of deficiencies on January 16, 2014, CMS should not have imposed the DPNA at all, as it was not scheduled to take effect until January 24, 2014.  Id. at 17.  West Texas relied on a determination made by state agency surveyors during the January 2014 survey that the December 2013 deficiencies had been corrected January 16, 2014.  Id.

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The Board rejected West Texas’ argument, observing that even if West Texas had corrected the deficiencies from the first survey, “a finding that deficiencies have been corrected is not the same as a determination that a SNF has achieved substantial compliance with all participation requirements.”  W. Tex., DAB No. 2652 at 18 (quoting Meadowbrook Manor – Naperville, DAB No. 2173 at 13 (2008), aff’d sub nom. on other grounds, Butterfield Health Care II, Inc. v. Johnson, No. 1:08cv-03604 (N.D. Ill. June 16, 2009)).  In accord with the statutory and regulatory framework I have already discussed, the Board affirmed that remedies imposed as a result of previously cited deficiencies, even when corrected prior to their effective date, remain in effect until such time as CMS determines the facility has achieved substantial compliance.  Id. 

The facts before me are much the same.  KDADS conducted surveys in February and March 2018 and found different instances of noncompliance in each survey.  CMS Exs. 1, 2.  And while KDADS determined Petitioner corrected the deficiency cited in the February 2018 survey by February 20, 2018, the DPNA took effect on February 28, 2018 because CMS determined, based on the findings in the March 21, 2018 survey, that Petitioner had remained out of compliance with Medicare participation requirements at 42 C.F.R. § 483.25(b)(1)(i)(ii) (Tag F686) and 42 C.F.R. § 483.45(f)(2) (Tag F760).  CMS Ex. 2; see also 42 C.F.R. § 488.452(a)(2) (in the absence of immediate jeopardy, where CMS and a state agency disagree as to whether a facility has achieved substantial compliance, CMS’s determination takes precedence). 4  Petitioner has not met its burden to show an earlier date of return to substantial compliance than that established by CMS,

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in this case April 25, 2018. Therefore, I affirm CMS’s determination that Petitioner was not in substantial compliance with Medicare participation requirements from February 28 through April 24, 2018.

2. CMS gave adequate notice of the DPNA to Petitioner in accordance with 42 C.F.R. § 488.402(f)(4).

Petitioner also argues that following the March 21, 2018 survey, KDADS was required to issue a new 15-day notice before the imposition of the DPNA, in accordance with 42 C.F.R. § 488.402(f)(4).  P. Br. at 10-11; P. Closing Br. at 7-8.  Here, KDADS issued notice to Petitioner on April 2, 2018 of a new DPNA to go into effect April 17, 2018.  P. Ex. 5 at 1.  However, KDADS issued a revised enforcement letter on the same day tying the imposition of the DPNA to the February 2018 complaint survey and adopting the effective date for the DPNA from the first notice.  P. Ex. 12 at 3.  Petitioner asserts it did not receive this revised notice until April 24, 2018, a claim supported by its evidence and not contested by CMS.  Id. at 1.  Accordingly, Petitioner argues I should modify the effective date of the DPNA to May 9, 2018, 15 days from the date it received the revised letter.  P. Br. at 10-11; P. Closing Br. at 8.  And because the facility had corrected all deficiencies by April 26, 2018, Petitioner asserts I should rescind the DPNA altogether.  P. Br. at 10-11; P. Closing Br. at 8; Tr. at 13.  CMS contends it provided sufficient notice to Petitioner in accordance with 42 C.F.R. § 488.402(f) because Petitioner received sufficient notice of the DPNA in the initial February 13, 2018 enforcement letter.  CMS Br. at 12.

Absent a finding of immediate jeopardy, skilled nursing facilities are entitled to notice of at least 15 calendar days before the effective date of an enforcement action.  42 C.F.R. § 488.402(f)(4).  The notice given must include the nature of the noncompliance, the remedy to be imposed, the effective date of the remedy, and the right to appeal the determination leading to the remedy.  42 C.F.R. § 488.402(f)(1)(i)-(iv).

Considering these requirements, I find CMS gave sufficient notice to Petitioner to begin the DPNA on February 28, 2018.  KDADS’s February 13, 2018 notice letter included the elements required by 42 C.F.R. § 488.402(f)(1)(i)-(iv) and satisfies the 15-day notice requirement at 42 C.F.R. § 488.402(f)(4).  KDADS informed Petitioner of the nature of the noncompliance to be penalized, the remedy to be imposed (a DPNA), the effective date of the DPNA (February 28, 2018), and Petitioner’s appeal rights.  CMS Ex. 4.  KDADS stated that “based on the deficiency cited on this survey your facility will not be given an opportunity to correct deficiencies before remedies are imposed.”  Id. at 1.  Finally, KDADS advised Petitioner that the DPNA would “remain in effect until your facility has achieved substantial compliance or your provider agreement is terminated.”  Id. 

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And while KDADS notified Petitioner it would impose the DPNA due to the noncompliance cited in the February 7, 2018 survey, its notice also specifically stated that Petitioner could avoid imposition of the DPNA by returning to substantial compliance with all program requirements before February 28, 2018.  As explained above, CMS had a factual basis to determine Petitioner had not returned to substantial compliance before the DPNA went into effect.  Petitioner therefore has no basis to argue the DPNA should have ended, and no basis to argue CMS was obliged to issue a new notice of imposition of remedies for a DPNA based on the March 2018 survey.  Therefore, KDADS’s February 13, 2018 letter provided adequate notice to Petitioner of the imposition of the DPNA.  Subsequent notices did not change the nature of the earlier noncompliance; they only extended the duration of the penalty.  The fault for that outcome rests squarely with Petitioner.

Petitioner was not in substantial compliance with Medicare participation program requirements from February 28, 2018 to April 25, 2018.  CMS gave Petitioner adequate notice on February 13, 2018 of a DPNA to begin February 28, 2018, in accordance with 42 C.F.R. § 488.402(f)(4).  CMS had the authority to impose a DPNA beginning from the date Petitioner was first found out of substantial compliance, the effective date of February 28, 2018, and continuing until April 25, 2018, the date CMS determined Petitioner returned to substantial compliance.  42 C.F.R. §§ 488.417(d), 488.454(a)(1).

VII.  Conclusion

I affirm CMS’s determination that Petitioner was not in substantial compliance with the regulatory tags discussed above and conclude CMS was authorized to impose a DPNA from February 28 through April 24, 2018.

1. Had CMS sought to make post-hearing arguments, I would have declined to consider them.  It should go without saying that parties are not permitted to file out of time without first seeking leave to do so.  See Civ. Remedies Div. P. § 9.
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2. “Unstageable” refers to full-thickness skin and tissue loss where the extent of damage cannot be assessed because of obscuration by dead tissue referred to as slough or eschar.  If the dead tissue were removed, a Stage 3 or 4 pressure injury would be revealed.  Nat’l Pressure Ulcer Advisory Panel, NPUAP Pressure Injury Stages at 1, available at https://cdn.ymaws.com/npiap.com/resource/resmgr/online_store/npiap_pressure_injury_stages.pdf (last visited Apr. 21, 2022).
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3. Resident 71 should have received 60 units of long-lasting insulin over a period of five days, but because of the error made by Petitioner’s staff instead received approximately 278 units in that time.  Id. at 121.
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4. Petitioner might reasonably be frustrated by the fact that CMS never revealed it disagreed with KDADS about the facility’s return to substantial compliance or why.  It appears CMS opted to act through the state agency to revise the effective date of the DPNA, giving the appearance that KDADS revised the DPNA effective date of its own accord.  See CMS Ex. 5 at 1 (notice from KDADS to Petitioner revising the effective date of the DPNA from April 17, 2018 to February 28, 2018); P. Ex. 12 at 1 (e-mail notice from KDADS to Petitioner of the revised effective date CC’ing Benton Williams); CMS Ex. 13 ¶ 13 (Mr. Benton’s sworn testimony that CMS rejected KDADS’ initial finding of return to compliance concerning the February 2018 survey and instead found “the noncompliance continued because Victoria Falls never achieved substantial compliance in between the surveys.”).  CMS’s involvement in or rationale for this revision were not made evident to Petitioner in KDADS’ revised notice.  Indeed, Petitioner could not have known of CMS’s involvement until CMS filed the testimony of Benton Williams in this proceeding.  CMS Ex. 13.  The regulations do not require CMS to issue a reconsidered determination to skilled nursing facilities concerning the imposition of remedies when it opts to supersede a state agency’s findings, but agencies of the federal government should not act cloaked in bureaucracy, particularly where they intend to impose substantial penalties on regulated entities.  Had Petitioner understood that CMS, not KDADS, determined it never returned to substantial compliance after correcting the deficiency discovered at the February 7, 2018 survey, and if Petitioner had been given the reasons for that determination, it may have been better situated to either develop its litigation position or opt not to pursue its appeal, in which it did not contest the deficiencies discovered at either survey but only questioned the basis for the apparent combination of two separate DPNA periods into one.  I have found Mr. Williams’ explanation for revising the DPNA effective date to February 28, 2018 credible and well-supported by the evidence.  As such, there was no reason to shroud the fact of CMS’s involvement in the revision of the DPNA effective date or its reasons for doing so.
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