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                              Generations at Lincoln, DAB CR5832 (2021)
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Generations at Lincoln, DAB CR5832 (2021)








  
  
    

  
      
Department of Health and Human Services 
    DEPARTMENTAL APPEALS BOARD
          Civil Remedies Division





Generations at Lincoln,
(CCN: 14-5719),
Petitioner,

v.

Centers for Medicare & Medicaid Services.
Docket No. C-19-390Decision No. CR5832March 11, 2021

        
              
    

      DECISION

The case before me involves a long-term-care facility’s responsibility to keep residents free of significant medication errors, to treat and prevent residents’ pressure ulcers, and to provide pain management for residents.

Petitioner, Generations at Lincoln (also the facility), is a skilled nursing facility (SNF) in Lincoln, Illinois, that participates in the Medicare program.  Following Complaint, Life Safety Code, and Health Surveys conducted on September 20, 2018, October 17, 2018, October 24, 2018, and October 29, 2018, the Centers for Medicare & Medicaid Services (CMS) determined that the facility was not in substantial compliance with participation requirements and found the most serious deficiencies were at scope and severity (S/S) level G (isolated instance of substantial noncompliance that causes actual harm that is not immediate jeopardy).  CMS imposed a per-instance civil money penalty (CMP) of $12,500 for each of three cited deficiencies.

For the reasons discussed below, I find that there is no dispute as to any material fact, and CMS is entitled to judgment as a matter of law because the facility was not in substantial compliance with Medicare program requirements (42 C.F.R. §§ 483.25(b)(1)(i)-(ii),  483.25(k), and 483.45(f)(2)) and that the penalties imposed are reasonable.

**Page 2**

I.         Procedural Background

By letter dated January 28, 2019, Petitioner appealed the determination of CMS and requested a hearing before an Administrative Law Judge (ALJ).  In an Acknowledgment and Pre-Hearing Order that issued on February 7, 2019, the presiding ALJ1
 set deadlines for the parties to file pre-hearing briefs in this matter.  The Order further set deadlines for the parties to submit their written request and intention to cross-examine opposing party witnesses.  CMS submitted its Pre-Hearing Brief and Motion for Summary Judgment (CMS Brief) on May 7, 2019.  CMS submitted 42 exhibits, including the written declarations for two witnesses.  Petitioner filed its Pre-Hearing Brief and Response to CMS’ Motion for Summary Judgment (Pet. Brief) on June 10, 2019.  Petitioner submitted five exhibits and no witness declarations.2

The Social Security Act (Act) sets forth requirements for nursing facilities to participate in the Medicare program and authorizes the Secretary of Health and Human Services (Secretary) to promulgate regulations implementing those statutory provisions.  Act § 1819.  The Secretary’s regulations are found at 42 C.F.R. Part 483.  To participate in the Medicare program, a nursing facility must maintain substantial compliance with program requirements.  To be in substantial compliance, a facility’s deficiencies may pose no greater risk to resident health and safety than “the potential for causing minimal harm.”  42 C.F.R. § 488.301.

The Secretary contracts with state survey agencies to survey skilled nursing facilities in order to determine whether they are in substantial compliance.  Act § 1864(a); 42 C.F.R. § 488.20.  Each facility must be surveyed annually, with no more than fifteen months elapsing between surveys, and must be surveyed more often, if necessary, to ensure that identified deficiencies are corrected.  Act § 1819(g)(2)(A); 42 C.F.R. §§ 488.20(a), 488.308.  The state agency must also investigate all complaints.  Act § 1819(g)(4).

In this case, the Illinois Department of Public Health (IDPH or state agency) completed Complaint, Life Safety Code, and Health Surveys on September 20, 2018, October 17, 2018, October 24, 2018, and October 29, 2018.  Based on the state agency’s findings, and

**Page 3**

citing the regulatory sections below, CMS determined that the facility was not in substantial compliance with multiple program requirements:

42 C.F.R. § 483.25(b)(1)(i)-(ii) (Failure to treat residents for and prevent/heal pressure ulcers) cited at scope and severity level G (Tag F0686);
	42 C.F.R. § 483.25(k) (Failure to provide pain management for residents) cited at scope and severity level G (Tag F0697); and
	42 C.F.R. §§ 483.45(f)(2) (Failure to keep residents free of significant Med Errors) cited at scope and severity level G (Tag F0760).CMS has imposed a per-instance CMP of $12,500 for each of these deficiencies.

II.        Issues

The issues before me are:

Whether Petitioner can challenge deficiencies for which no remedy was imposed.
	Whether summary judgment is appropriate.
	Whether the facility was in substantial compliance with 42 C.F.R. §§ 483.25(b)(1)(i)-(ii), 483.25(k), and 483.45(f)(2).
	If the facility was not in substantial compliance with 42 C.F.R. §§ 483.25(b)(1)(i)-(ii), 483.25(k), and 483.45(f)(2), are the three per-instance penalties imposed, $12,500 each, reasonable.III.      Findings of Fact and Conclusions of Law

*1.         Review is appropriate only for those deficiencies for which CMS seeks to impose a remedy*

In the Statement of Deficiencies (SOD), CMS includes a list of all deficiencies that were identified during the inspections conducted between September 20, 2018, and October 29, 2018.  CMS Exs. 1-3.  CMS lists, however, only three deficiencies for which it imposes a remedy.  CMS alleges noncompliance with respect to treatment/services to prevent/heal pressure ulcers, pain management for residents, and a resident’s freedom from significant medication errors.  CMS Ex. 7 at 1.  In its Request for Hearing, Petitioner cites the 31 regulatory sections for which CMS found deficiencies.  In its pre-hearing brief and response to CMS’ motion for summary judgment, Petitioner asserts that it must be granted the right to request a hearing on each and every citation issued.  Petitioner asserts that “any and all citations trigger a hearing right because each citation carries with it a variety of penalties, including points deducted from their star rating, placement on lists of potential special focus facilities, difficulty obtaining financing for resident environment improvement initiatives and other penalties created by these citations.”  Pet. Brief at 3.  Petitioner specifically argues that deficiency citations that are used by CMS to calculate a facility’s 5-Star quality rating affect various financial

**Page 4**

relationships and opportunities.  Further, Petitioner argues that documented deficiencies negatively affect the facility’s reputation in the community, deter resident admissions, referrals, insurance programs and other business opportunities.  Pet. Brief at 4.  In essence, Petitioner asserts that it has a “property interest” in its reputation and that failure to litigate all of the cited deficiencies will cause Petitioner to “suffer adverse and direct legal consequences.”  Pet. Brief at 4-5.
The hearing rights of a long-term care facility are established by federal regulations at 42 C.F.R. Part 498.  A provider dissatisfied with CMS’ initial determination is entitled to further review, but administrative actions that do not constitute initial determinations are not subject to appeal.  42 C.F.R. § 498.3(d).  A finding of noncompliance that results in the imposition of a remedy specified in 42 C.F.R. § 488.406 is an initial determination for which a facility may request a hearing.  42 C.F.R. § 498.3(b)(13).  Unless the finding of noncompliance results in the actual imposition of a specific remedy, the finding is not an initial determination.  42 C.F.R. § 498.3(d)(10)(ii).

CMS imposed per-instance CMPs for the deficiencies cited under 42 C.F.R. §§ 483.45(f)(2), 483.25(b)(1)(i)-(ii), and 483.25(k).  My review is limited to only those alleged deficiencies.  I have no authority to review those deficiencies for which no penalty is imposed.  The Departmental Appeals Board (the Board) has long held that a facility has no right to a hearing unless CMS seeks to impose or actually imposes a remedy.  *The Lutheran Home – Caledonia*, DAB No. 1753 (2000); *Schowalter Villa*, DAB No. 1688 (1999); *Arcadia Acres, Inc.*, DAB No. 1607 (1997); *see also San Fernando Post Acute Hosp.*, DAB No. 2492 at 7-8 (2012).  The remedy, not the citation of a deficiency, triggers the right to a hearing.  *Schowalter Villa,*DAB No. 1688; *Arcadia Acres, Inc*., DAB No. 1607*.*  Where CMS does not impose a remedy, Petitioner has no hearing right.  *See Fountain Lake Health & Rehab., Inc.*, DAB No. 1985 (2005).

In its decision in *Generations at Regency Center*, DAB No. 2950 (2019), the Board examined arguments that are similar to those Petitioner raises.  In that case, the Board rejected the facility’s argument that it has “a right to a hearing based on the ‘detrimental effect’ that the deficiency findings have on its ‘protected property rights.’”  DAB No. 2950 at 7.  The Board looked to its earlier decision in *San Fernando Post Acute Hosp*., DAB No. 2492 (2012), in which it found that “the claimed collateral consequences” of “survey noncompliance findings” such as the effect that the citations have on a facility’s Five-Star Rating, “do not rise to the level of a constitutionally protected interest.”  DAB No. 2950 at 7 (citing *S**an Fernando Post Acute Hosp.*, DAB No. 2492 at 15 (citing *Bryn Mawr Care* *v. Sebelius*, 898 F. Supp. 2d 1009 (N.D. Ill. Sept. 26, 2012)*, aff’d, Bryn Mawr Care*, *Inc., v. Sebelius,* 749 F.3d 592 (7th Cir. 2014)).  The Board in *Generations at Regency Center* also cited its earlier ruling in *San Fernando Post* *Acute Hosp*. in which it found that “the potential harm to a facility’s reputation or financial status that may flow from the publication of deficiency findings does not trigger appeal rights under the Act or regulation.”  *Generations at Regency Ctr.*, DAB No. 2950 at 7 (citing *San Fernando Post Acute Hosp.*, DAB No. 2492 at 13).

**Page 5**

I reject Petitioner’s argument that it has a right to a hearing or a right to litigate those deficiencies for which CMS seeks no remedy.  Accordingly, Petitioner’s request to litigate those deficiencies for which CMS seeks no remedy is dismissed.  42 C.F.R. § 498.70(b).

*2.         Summary Judgment is appropriate*

On May 7, 2019, CMS filed its pre-hearing brief and motion for summary judgment.  On June 10, 2019, Petitioner filed its pre-hearing brief and response to CMS’ motion for summary judgment.  I note that Petitioner does not submit a list of witnesses and provides no written declarations to rebut or address CMS’ evidence.  It is well established that an ALJ is empowered to decide a case on a motion for summary judgment without an evidentiary hearing.  *Shah v. Azar*, 920 F.3d 987, 996 (5th Cir. 2019).  To obtain summary judgment, the moving party must show that there is no genuine dispute of material fact requiring an evidentiary hearing and it is entitled to judgment as a matter of law.  *Mission Hosp. Reg’l Med. Ctr.*, DAB No. 2459 at 5 (2012).  To show that there are no genuine issues of a material fact, the movant must show that there is no evidence in the record that supports a judgment for the non-movant.  *Celotex Corp. v. Catrett*, 477 U.S. 317, 322-325 (1986).  In other words, where the record taken as a whole could not lead a rational trier of fact to find for the nonmoving party, there is no “genuine issue for trial.”  *Matsushita Elec. Indus. Co. v. Zenith Radio,* *Ltd.,* 475 U.S. 574, 586 (1986).

“To defeat an adequately supported summary judgment motion, the non-moving party may not rely on the denials in its pleadings or briefs, but must furnish evidence of a dispute concerning a material fact—a fact that, if proven, would affect the outcome of the case under governing law.”  *Senior Rehab. & Skilled Nursing Ctr*., DAB No. 2300 at 3 (2010), *aff’d**, Senior Rehab. & Skilled Nursing Ctr. v. Health & Human Servs*., 405 F. App’x 820 (5th Cir. 2010).  In fact, it is well established that general denials do not satisfy a party’s burden to identify specific evidence demonstrating a material fact is in dispute.  *Shah v. Azar*, 920 F.3d 987, 995 (5th Cir. 2019); *Forsyth v. Barr*, 19 F.3d 1527, 1533 (5th Cir. 1994).

In examining the evidence for purposes of determining the appropriateness of summary judgment, I must draw all reasonable inferences in the light most favorable to the non-moving party.  *See* *Brightview Care Ct*., DAB No. 2132 at 2, 9-10 (2007).  Nevertheless, drawing factual inferences in the light most favorable to the non-moving party does not require that I accept the non-moving party’s legal conclusions.  *W. Tex. LTC Partners,* *Inc*., DAB No. 2652 at 6-7 (2015), *aff’d*, *W. Tex. LTC Partners, Inc. v. U.S.* *Dep’t of Health & Human Servs*., 843 F.3d 1043 (5th Cir. 2016).

Petitioner asserts that summary judgment cannot be granted as there are disputed material facts for review.  Pet. Brief at 3.  Specifically, Petitioner argues that CMS has failed to properly prove that any of the alleged violations caused “actual harm” to the resident in issue (R132).  *Id*.

**Page 6**

Despite Petitioner’s assertions, the Board has clearly held that “proof that a deficiency caused actual harm is not a prerequisite to finding a lack of substantial compliance.”  *N. Las Vegas Care Ctr.*, DAB No. 2946 at 9 (2019) (citing *Libertyville Manor* *Rehab. & Healthcare Ctr*., DAB No. 2849 at 17-18 (2018) and *Oaks of Mid City Nursing* *and Rehab. Ctr*., DAB No. 2375 at 16-17 (2011)).  The Board explained in *North Las* *Vegas Care Center* that a skilled nursing facility “may be found out of substantial compliance (and thus subject to CMPs and other remedies) if the deficiency has the ‘potential’ to cause more than minimal harm to resident health or safety.”  *Id.*

In the instant case, and as discussed more fully below, CMS presented evidence that Petitioner omitted 27 doses of a resident’s prescribed diabetes medication over nine consecutive days, following which the resident was hospitalized.  CMS submits evidence and argument that Petitioner failed to treat the pressure ulcer on the resident’s left ear for nine days.  Additionally, and in the presence of the state’s surveyor, Petitioner failed to follow its pain management guidelines when cleaning the resident’s Stage IV pressure ulcers on October 22 and 23, 2018.  Petitioner does not deny the specific allegations and presents no evidence to rebut CMS’ evidence that the resident was denied prescribed medication, denied treatment for the pressure ulcer, or denied pain management procedures as alleged.  To argue that there was no “actual” harm is not only disingenuous, but fails to establish that there is a genuine dispute of a material fact.  Despite Petitioner’s assertions, and as discussed below, the evidence supports a finding that Petitioner’s omissions went well beyond “the potential to cause more than minimal harm.”  *N. Las Vegas Care Ctr.*, DAB No. 2946 at 9 (2019).

I also note that Petitioner’s argument that there is no evidence of actual harm focuses on exhibits that Petitioner terms as hearsay and includes the “charging documents” identified as CMS Exs. 1-3.  In *Oak Ridge Center,* DAB No. 2913 (2018), the skilled nursing facility posed a similar argument.  In that case, the facility contended that summary judgment may not be based on “unsworn” factual “allegations” in a Statement of Deficiencies (SOD) or “charging document.”  DAB No. 2913 at 8.  The facility argued that CMS “must offer undisputed evidence” substantiating statements and findings in order to support a summary judgment motion.  *Id.*  The Board confirmed that it has rejected that proposition, finding that a SOD “may constitute prima facie *evidence* of the undisputed facts asserted in it.”  *Id.*; *see also* *Laurels at Forest Glenn*, DAB No. 2182 (2008) (noting that a SOD may function as both a “notice document” and as evidence of the facts asserted there).  Noting the fact that Petitioner has provided no evidence to rebut the charging documents and does not deny CMS’ factual allegations, I find Petitioner’s arguments lack merit.

Accordingly, Petitioner’s arguments do not raise any genuine dispute about a fact or facts material to the outcome of this case.  Rather, Petitioner’s contentions challenge the legal consequences of the undisputed facts.  For the reasons discussed below, I reject Petitioner’s arguments, and I find that summary judgment is appropriate.

**Page 7**

*3.         The facility did not substantially comply with 42 C.F.R. §§* *483.45(f)(2), 483.25(b)(1)(i)-(ii) and 483.25(k).*

Background

Resident 132 (R132) was 53 years old upon her admission to the facility on October 2, 2018.  Prior to her admission, R132 was hospitalized in three separate hospitals beginning in mid-July 2018.  Because of mental retardation, R132 has a state appointed guardian.  During the hospitalization prior to her admission to the facility, R132’s primary diagnoses included:  (1) Acute hypoxemic respiratory failure; (2) Pneumonia; (3) multiple pressure ulcers; (4) Acute on chronic anemia; (5) Diabetes insipidus; (6) Critical illness myopathy; (7) Seizure disorder; (8) Deep Vein Thrombosis (DVT); (9) Acute encephalopathy; (10) Coronary artery disease; and (11) Mentally challenged.  Over the course of her hospitalizations prior to admission to the facility, she was also treated for acute osteomyelitis, acute pancreatitis, diverticular fibrillation cardiac arrest, hypernatremia, hypercalcemia, and low blood pressure.  Her treatment involved a tracheostomy and PEG tube insertion as well as inferior vena cava (IVC) placement because of the right lower extremity DVT.  CMS Ex. 22 at 1-3.

The facility’s failure to administer Desmopressin

A facility must ensure that residents are “free of any significant medication errors.”  42 C.F.R. § 483.45(f)(2).  A “medication error” includes failure to administer medication in accordance with the prescriber’s order.  CMS Ex. 19 at 1 (State Operations Manual, CMS Pub. 100-07, Appendix PP – Guidance to Surveyors for Long Term Care Facilities (Rev. 173, eff. Nov. 28, 2017)).

Having a history of Diabetes Insipidus, R132 received Desmopressin IV three times a day during the hospitalization that preceded her admission to the facility.  The October 2, 2018, hospital discharge orders include an order for Desmopressin 3 mcg (Micrograms) to be given by IV push to R132 every eight hours.  CMS Ex. 3 at 71.  R132’s Medication Administration Record (MAR) from October 2, 2018, through October 11, 2018, does not document Desmopressin as being an ordered medication by the facility physician or a medication given to R132.  *Id.*

Resident progress notes, dated October 11, 2018, at 1:55 p.m. document that R132 was “not usual self” and low blood sugar was noted.  The physician ordered Glucagon 1 mg (milligram) as well as additional blood work.  At 2:00 p.m., the respiratory therapist noted that because R132 was not responding, the therapist performed a respiratory check.  CMS Ex. 24 at 3-4.  The therapist reported that after the administration of Glucagon, the resident’s breathing was at a faster rate but very shallow.  The resident did not respond to a sternal rub.

After being updated about R132’s vitals and her short, shallow breathing, the physician ordered that the resident be sent to the Emergency Room for evaluation and treatment at 3:50 p.m.  CMS Ex. 24 at 3.  The resident was admitted to the hospital and remained

**Page 8**

hospitalized for eight days.  CMS Ex. 30 at 1.  The hospital record confirms that R132 was transferred from the Emergency Room for management of severe hypernatremia (elevated sodium level), hypoglycemia (low blood sugar), elevated procalcitonin, and a left lower lobe infiltrate.  *Id.*

The October 11, 2018 Hospital Admission Laboratory report documents that R132 had a “critical high” sodium level of 178 mmol/L (normal range 133-145 mmol/L) and “critical low” glucose level of 44 mg/d (normal range of 70-105 mg/d) at the time of her admission to the hospital.  CMS Ex. 3 at 71.  A hospital consult on October 12, 2018 documents R132’s sodium level at 180 and her blood sugar level at 31.  CMS Ex. 30 at 3.  The hospital record specifically notes, “From records, she has not gotten desmopressin since she has been admitted at Generations of Lincoln Nursing Home.”  *Id.* at 1.  Another hospital consult dated October 12, 2018 documents “She is severely hypernatremic and has abnormal renal function, azotemia from dehydration and/or from not receiving desmopressin, which she was to have received at the nursing home.”  *Id.* at 19.  The hospital discharge summary further confirms that while the resident was given Desmopressin every eight hours during her previous hospitalization, records indicate that “she has not gotten desmopressin since she has been admitted at Generation of Lincoln Nursing Home.”  *Id.* at 1, 18.  The hospital’s discharge assessment for R132 lists severe hypernatremia as the first diagnosis to be addressed in the plan of care and includes the assessment that the hypernatremia could be attributed to R132’s not being given her Desmopressin for central diabetes insipidus.  *Id.* at 3-4.

The state surveyor documented a conversation with the facility’s Medical Director on October 25, 2018.  During the conversation, the Medical Director confirmed that Desmopressin is a medication that cannot be abruptly stopped and that this could be the reason for R132’s having elevated sodium and decreased glucose levels on October 11, 2018 and requiring hospitalization.  The state surveyor also documented a conversation with the facility’s Director of Nursing on October 24, 2018.  During the conversation, the Director of Nursing stated that because the facility does not administer IV push medications, the admitting nurse should have clarified that order with the physician.  The Director of Nursing could not locate any documentation that the physician was contacted to clarify R132’s order for Desmopressin or a physician’s order to discontinue the medication upon admission to the facility.  CMS Ex. 3 at 72-73.  Petitioner submitted no witness testimony to contradict the surveyor’s documented conversations with either the facility’s Medical Director or Director of Nursing.

Petitioner’s Defense

In its submissions, CMS presented the sworn affidavit of Dr. Dan R. Berlowitz, a professor at the Boston University Schools of Public Health and Medicine and a physician since 1982.  Specifically, Dr. Berlowitz states in his affidavit that he reviewed CMS Exs. 21-34 and 36.  Dr. Berlowitz explained in his sworn affidavit:

**Page 9**

Central diabetes insipidus is a disease that results in a person’s kidneys being unable to concentrate the urine so that there is a loss of too much fluid from the body and an increase in the concentration of salt in the body.  A person who suffers from central diabetes insipidus produces less vasopressin, a hormone that promotes reabsorption of water back into the body’s circulation.  Desmopressin is a drug that replaces vasopressin and is used to treat persons with central diabetes insipidus.  This disease, if untreated, can be life threatening.

Dr. Berlowitz opined that in his professional opinion, the failure to administer Desmopressin to R132 was the “major cause leading” to R132’s hospitalization on October 11, 2018.  CMS Ex. 41 at 3.

In its pre-hearing brief and response to CMS’ motion for summary judgment, Petitioner contends that CMS erred by relying primarily on its expert, Dr. Dan R. Berlowitz, in finding that R132’s medical condition was related to the “alleged medication error.”  Petitioner argues that Dr. Berlowitz’s opinion is “only speculative as it is based on a small subset of facility records, and was formed without actually examining the resident herself, or speaking [with] any of the staff involved.”  Pet. Brief at 10.  Petitioner asserts that without Dr. Berlowitz’s testimony, which Petitioner contends is flawed, CMS cannot prove that any alleged noncompliance caused actual harm to R132.

Petitioner also asserts that Dr. Berlowitz’s expert opinion is hearsay and should be stricken from the record and cannot be a basis for determining that R132 suffered actual harm.  Further, Petitioner contends that R132 had multiple co-morbidities and other issues could have led to her ultimate hospitalization.  Pet. Brief at 12.

Despite Petitioner’s arguments concerning CMS’ expert witness, Petitioner presented no evidence to contradict Dr. Berlowitz’s testimony.  While I do not find anything in the record that contradicts Dr. Berlowitz’s opinion, I do not find it material and I need not rely on this testimony in finding that Petitioner committed a significant medication error and thus violated 42 C.F.R. § 483.45(f)(2).  Petitioner does not deny that R132 was discharged from the hospital to Petitioner’s facility on October 2, 2018, with an order for Desmopressin to be administered three times a day.  Petitioner does not deny that it failed to administer Desmopressin to R132 at any time between her October 2, 2018 admission and her admission to the hospital on October 11, 2018.  Petitioner asserts, however, that there is no proof that this “alleged instance of non-compliance” caused actual harm.  A review of the undisputed record evidence reflects, however, that this is not merely an “instance,” but rather a sustained period of nine days when R132 was denied a medication which had been routinely administered to her prior to her admission to Petitioner’s facility.  After her emergency admission to the hospital on October 11, hospital records confirm that her hospitalization was likely a result of the denial of Desmopressin for nine days.  The hospital discharge summary, dated October 19, 2018, documents R132’s hypernatremia as resolved, and R132 was discharged back to the facility with orders to receive Desmopressin 0.1 mg twice a day.  CMS Ex. 3 at 72.

**Page 10**

Clearly, there is no dispute that there was a medication error when Petitioner withheld R132’s ordered medication for nine days.  The relative significance of a medication error is judged by three factors:  the resident’s condition, the drug category, and the frequency of the error.  *Life Care Ctr. of Elizabethton,* DAB No. 2367 at 6 (2011); *Franklin Care Ctr*., DAB No. 1900 at 8 (2003); *see also* 56 Fed. Reg. 48,826, 48,853 (Sept. 26, 1991).  The undisputed record reflects that R132 received Desmopressin IV three times a day during her hospitalization preceding her admission to Petitioner’s facility and that she was discharged from the hospital with orders to be given Desmopressin by IV push every eight hours after admission to Petitioner’s facility.  CMS Ex. 3 at 71.

The record also reflects that R132’s medical history was significant for mental retardation.  Although I need not rely on it here, it is likely that R132 may not have understood the change in her medication and did not have the ability to adequately communicate to staff that she was not receiving the prescribed medication for her diabetes or to communicate the physical results of not having this medication.  After 27 omitted doses of Desmopressin over a nine-day period, R132 was hospitalized for severe hypernatremia, a condition believed to be attributable to her not receiving the Desmopressin for her central diabetes insipidus.  CMS Ex. 30 at 3.  Thus, considering all three factors, it is apparent that Petitioner’s failure to administer Desmopressin was a significant medication error that had the potential to cause more than minimal harm.

The facility’s failure to treat R132’s pressure ulcer

42 C.F.R. § 483.25(b)(1)(i)-(ii) provides that a facility “must” ensure that 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.”  When the hospital discharged R132 to the facility’s care on October 2, 2018, the hospital’s discharge paperwork noted several pressure ulcers:  one on each knee, each heel, the left foot, the coccyx (tailbone) area, and the left ear.  CMS Ex. 21 at 3.  Petitioner’s Pressure Ulcer Risk Assessment Policy provides that all residents will be assessed for pressure ulcer risk by a licensed nurse on admission to the facility and reassessed weekly for three weeks thereafter.  CMS Ex. 13.  Petitioner’s Skin Assessment Policy and Procedure provides that upon a resident’s admission, a licensed nurse will conduct a head to toe assessment of the resident’s skin along with an admission nursing history.  Thereafter, all residents, regardless of their risks for the development of pressure ulcers will have a documented weekly review of their skin condition.  CMS Ex. 15 at 1.  Residents who are determined to be “AT HIGH RISK” for the development of pressure ulcers will have a head-to-toe assessment by a licensed nurse or certified nursing assistant daily with documentation on the Treatment Administrative Record (TAR) or Daily Skin Assessment Sheet.  *Id.*

Upon R132’s admission to the facility on October 2, 2018, a Licensed Practical Nurse completed an admission assessment.  A portion of the assessment describes R132 as:  (1) confined to bed all or most of the time; (2) completely immobile (does not make even slight changes in body or extremity position without assistance); and (3) requires

**Page 11**

moderate to maximum assist in moving.  In using the Braden scale for predicting pressure ulcer risks, the nurse assessed R132 a score of 8.000, placing her at “VERY HIGH RISK.”  CMS Ex. 23 at 3.  In the section of this assessment form which requires the measurement and location of pressure ulcers, the nurse simply included “see progress notes.”  *Id.* at 2.  The following day, a Licensed Practical Nurse entered a progress note at 5:38 a.m. confirming R132’s pressure ulcers on her heels, knees, coccyx, and her left ear.  The nurse simply included “Wound nurse to assess.”  CMS Ex. 24 at 9.  Later that same day at 4:59 p.m., a wound nurse documented the stages and measurements of each pressure ulcer with the exception of the pressure ulcer on R132’s left ear.  CMS Ex. 25.  On October 5, 2018, a Licensed Practice Nurse identified the pressure ulcers on R132’s heels, knees, left foot and coccyx and documented goals and treatment plans to address those pressure ulcers.  Not only was the pressure ulcer on R132’s left ear not listed, there were no established goals or treatment plan included for the pressure ulcer on the left ear.  CMS Ex. 26 at 16-28.

On October 8, 2018, the facility’s Medical Director referred R132 to a specialty physician for an initial wound assessment and for treatment plan recommendations.  CMS Ex. 27.  The six-page assessment documents the stage, size, and recommended treatment plan for the pressure ulcers on R132’s knees, heels, left foot and coccyx.  There is no reference, however, to the pressure ulcer on R132’s left ear.  The assessment documents that the data and history pertinent to R132’s care (and presumably the supporting referral documents) were obtained from the facility’s nursing staff.  On October 9, 2018, a wound nurse completed a 10-page Wound Assessment Details Report giving detailed information for the pressure ulcers on R132’s knees, heels, and sacrum.  The pressure ulcer on R132’s left ear is not identified or assessed.  CMS Ex. 28.

While the LPN simply noted the existence of a pressure ulcer on the left ear on October 3, 2018, there is no documentation of its size.  For the next eight days and prior to R132’s hospital admission on October 11, there is no documentation of an assessment or treatment plan for this pressure ulcer.  Clearly, the facility did not include information about the pressure ulcer when referring R132 to a specialist for an assessment on October 8.  Thus, even after R132 was seen by a specialist and a treatment plan was recommended for other pressure ulcers, the pressure ulcer on the left ear was not included in the specialist’s assessment or treatment plan.

Thus, there is nothing in the treatment administrative record or the physician’s orders to indicate that there was any treatment of the pressure ulcer on R132’s left ear during the period from October 2, 2018 until October 11, 2018, when she was transferred to the hospital.  The surveyor documents a conversation with the facility’s Medical Director on October 25, 2018 at 10:10 a.m.  The Medical Director stated that he was unaware of the wound on R132’s left ear.  He noted while the pressure ulcer may have been acquired prior to her admission to the facility, a lack of treatment for nine days would lead to its progression.  CMS Ex. 3 at 47.  Petitioner submits that the CMS documented conversation is inadmissible as it is “pure hearsay.”  Petitioner asserts that this records

**Page 12**

only the memory of the surveyor’s conversation rather than a word for word transcription of the interview.  Petitioner submits that “[i]t alone is not enough to prove, by a preponderance of the evidence, that any alleged non-compliance here caused R132 actual harm.”  Pet. Brief at 10.

While I do not rely on the documented interview with the Medical Director as an admission of non-compliance, I also note that Petitioner has not submitted any evidence to demonstrate that the facility treated R132’s wound on her left ear at any time between October 2, 2018 and October 11, 2018.  A failure to assess, let alone a failure to treat, a pressure ulcer is in contradiction to Petitioner’s own Pressure Ulcer Risk Assessment Policy and Petitioner’s Skin Assessment Policy and Procedure.  CMS Ex. 13; CMS Ex. 15 at 1.  The undisputed record evidence demonstrates that Petitioner did not provide the necessary treatment and services as mandated by 42 C.F.R. § 483.25(b)(1)(i)-(ii).

The facility’s failure to provide pain management to R132

42 C.F.R. § 483.25(k) requires that a facility “ensure that pain management is provided to residents who require such services, consistent with professional standards of practice, the comprehensive person-centered care plan, and the residents’ goals and preferences.”  The facility’s Pain Management policy provides that upon admission, all residents will be screened for the presence of pain symptoms.  If a resident scores a total of 5 or more on the admission paper screening form, a Comprehensive Pain Assessment will be completed.  CMS Ex. 10 at 1.  The policy further provides that “It is the policy of this Facility to screen all residents for pain . . . and assess and develop an effective individualized pain management care plan.”  *Id.*

R132’s October 12, 2018 care plan for pain cites R132’s multiple wounds, contractures, seizures, diabetes, osteomyelitis, pancreatitis, and non-ambulatory status in noting that she is at risk for alteration in comfort/pain.  Accordingly, the care plan instructs the staff to offer analgesics prior to activities of daily living (ADLs) or rehab if indicated.  The plan also provides:  “Administer medication as ordered” and “screen for pain when conversing with resident.”  Further, staff is instructed to notify the physician if current pain medication management is not effective.  CMS Ex. 26 at 8.  A Braden Scale (Skin Risk Assessment) dated October 5, 2018, documents that R132 “Responds only to painful stimuli.  Can’t communicate discomfort except by moaning, or restlessness.”  CMS Ex. 3 at 58.

Upon R132’s initial admission to the facility on October 2, the physician’s orders included 650 milligrams of acetaminophen every four hours PRN.  CMS Ex. 34 at 7.

On October 22, 2018, and during the surveyor’s visit to the facility, a wound nurse and a licensed practical nurse provided wound care to the Stage IV pressure ulcers on R132’s heels.  When R132’s legs were repositioned to provide the wound care, R132 began to grimace, clench her mouth, and close her eyes.  As the nurse began to cleanse the wound, R132 clenched her jaw, grimaced and stopped making eye contact.  Although the nurses provided verbal consolation to R132, there is no record that pain medication was

**Page 13**

administered before, during, or after the wound cleansing on October 22, 2018.  CMS Ex. 39 at 2.

On the following day and during the surveyor’s visit to the facility, a registered nurse and nursing assistant began wound care to the Stage IV pressure ulcer on R132’s heels.  Prior to the procedure, R132 was soundly sleeping.  Once the nurse and nursing assistant began the wound care, R132 began rapid breathing and grimacing.  As with the day before, the nurse and nursing assistant provided verbal consolation, however, no pain medication was administered.  CMS submits that during R132’s wound care on October 22 and October 23, 2018, the nurses did not provide any analgesics or pain medication.  Further, there is no evidence that there was any attempt to notify the physician that R132 was experiencing pain during wound care.  CMS Ex. 39 at 3; CMS Ex. 3 at 56, 59.

Petitioner presents no evidence that R132 was given any pain medication before, during, or after the wound treatment on October 22 and 23, 2018.  Petitioner does not dispute that the surveyor was present and observed the wound care that R132 received on October 22 and 23, 2018.  Petitioner asserts that even though the surveyor interpreted R132’s behavior to mean that she was experiencing pain during these procedures, Petitioner argues the surveyor “does not know R132” and “is not familiar with R132’s behaviors.”  Pet. Brief at 11.  Petitioner opines that there are a “multitude of reasons why R132 would make a face during care, not the least of which, having a stranger observe treatment.”  Thus, Petitioner neither disputes that R132 may have experienced pain nor that the nurses tried to verbally console her during the procedures on October 22 and October 23.  Petitioner’s argument that R132’s behavior may have been caused by the surveyor’s presence or for a “multitude of reasons” lacks merit.

The facility’s policy for pain management provides that an Individualized Pain Management Care Plan will be developed for each resident who experiences pain.  “Interventions may include both Pharmacological and Non Pharmacological Interventions.”  CMS Ex. 10 at 1.  In accordance with that policy, R132’s October 12, 2018 care plan for pain documented that R132 was at risk for pain because of a number of factors including her multiple wounds.  The plan further provided for the administration of medications as ordered and the “offer of analgesics” as needed prior to ADLs or rehabilitation.  CMS Ex. 26 at 8.  The care plan’s long-term goal includes:

Resident will verbalize or Acknowledge pain when screened by staff and will express effectiveness after analgesic administration.  Non-verbal signs/symptoms of pain (grimacing, moaning, anxiety/agitation) will be decreased after staff intervention through the next review date.

*Id.*  Petitioner does not dispute that while a care plan was in place to intervene in R132’s risk for pain, the facility provided no medication or analgesics to R132 during the wound care procedures on October 22, 2018 and October 23, 2018.  Petitioner does not even dispute that R132 experienced pain during these procedures.  Petitioner only disputes the

**Page 14**

reason for R132’s behavior and asserts that there is insufficient evidence to show the causation of actual harm.3

Clearly, Petitioner’s existing pain management policies establish a procedure to assess, monitor, and reduce a resident’s pain level.  The wound treatment provided to R132 on October 22, 2018 and October 23, 2018 was administered without adhering to these policies and constitutes a deficiency under 42 C.F.R. § 483.25(k).

*4.         The CMPs imposed are reasonable*

In appealing a determination of noncompliance, a SNF may challenge the reasonableness of the amount of any CMP imposed.  *Crawford Healthcare & Rehab.*, DAB No. 2738 at 2 (2016).  In deciding whether a CMP is reasonable, I may consider only the factors specified in 42 C.F.R. § 488.483(f).  Those factors include:  (1) the facility’s history of noncompliance; (2) the facility’s financial condition; (3) factors specified in 42 C.F.R § 488.404; and (4) the facility’s degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort or safety.  The absence of culpability is not a mitigating factor.  The factors in 42 C.F.R. § 488.404 include:  (1) the scope and severity of the deficiency; (2) the relationship of the deficiency to other deficiencies resulting in noncompliance; and (3) the facility’s prior history of noncompliance in general and specifically with reference to the cited deficiencies.

I must consider whether the evidence supports a finding that the amount of the CMP is at a level reasonably related to an effort to produce corrective action by a provider with the kind of deficiencies found and in light of the above factors.  I am neither bound to defer to CMS’ factual assertions, nor free to make a wholly independent choice of remedies without regard for CMS’ discretion.  *Barn Hill* *Care Ctr*., DAB No. 1848 at 21 (2002); *Cmty. Nursing Home,* DAB No. 1807 at 22 *et. seq*. (2002); *Emerald Oaks,* DAB No. 1800 at 9 (2001); *CarePlex of Silver Spring*, DAB No. 1683 at 8 (1999).

The daily or per-instance penalty amount selected by CMS is presumptively reasonable based on the regulatory factors found in 42 C.F.R. § 488.438(f). *N. Las* *Vegas Care Ctr.*, DAB No. 2946 at 16 (2019) (citing *Crawford*, DAB No. 2738 at 19).  The burden is on the SNF “to demonstrate, through argument and the submission of evidence addressing the regulatory factors, that a reduction is necessary to make the CMP amount reasonable.”  *N. Las Vegas*, DAB No. 2946 at 16; *Crawford*, DAB No. 2738 at 19.  Here, CMS imposes a per-instance penalty of $12,500 for each of the three deficiencies.

CMS submits that the CMP is reasonable in light of Petitioner’s history of noncompliance.  CMS asserts that in 2018, IDPH conducted 16 surveys and cited the facility for “dozens of deficiencies, including five deficiencies from the complaint survey completed the month before, and one deficiency from the complaint survey completed that same month.”  CMS Brief at 21-22 (citing CMS Exs. 1-3, 5).  CMS also contends

**Page 15**

that it seeks to impose a CMP for only three deficiencies from the underlying survey despite that there were 23 other deficiencies from the same survey.  *Id.* at 22; CMS Ex. 3.

Petitioner argues that CMS has only provided written notice of a hearing right in relation to three deficiencies and that “other citations cannot be used to augment the fine amount charged if they were not granted a similar right to a fair hearing.”  Pet. Brief at 17.  Regardless of Petitioner’s noncompliance history, Petitioner’s culpability in this case alone justifies the CMP amounts.

As discussed above, there is no dispute that Petitioner failed to administer Desmopressin to R132 for nine days despite the prescriber’s order to do so.  Further, the record reflects that Petitioner failed to follow its own policy and procedures in assessing and treating R132’s pressure ulcer on her left ear.  Finally, there is no dispute that Petitioner did not follow its existing pain management policies when providing wound treatment to R132 on October 22, 2018, and October 23, 2018.  Accordingly, I find that the facility is culpable for all of these serious failings.  Finally, Petitioner has not asserted that its financial condition affects its ability to pay the CMP.  For all these reasons, I find the CMP amounts reasonable.

IV.      Conclusions

For the reasons set forth above, I conclude that Petitioner was not in substantial compliance with the participation requirements at 42 C.F.R. §§ 483.25(b)(1)(i)-(ii),  483.25(k), and 483.45(f)(2).  I further conclude that the CMPs at issue are reasonable.


          /s/
        Margaret G. Brakebusch

                      Administrative Law Judge
      1. The case was initially assigned to a different ALJ and then later transferred to the undersigned. back to note 1
                      2. Petitioner states in its list of proposed exhibits and witnesses:  “At this time, Generations does not intend to produce additional witnesses should this matter proceed to hearing.  However, the Facility does reserve the right to amend this list if leave is granted to address the additional citations cited by CMS in the instant survey cycle.”  Petitioner further added:  “The Facility further reserves the right to call in its case in chief any witnesses identified by CMS, and to call additional witnesses for purposes of impeachment or rebuttal.  Finally, the Facility reserves the right to amend this list at any time prior to the hearing.” back to note 2
                      3. Petitioner has not submitted any evidence to show that R132’s facial reaction was caused by something other than the wound treatments. back to note 3 Back to top
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