Generations at Neighbors, DAB CR6033 (2022)

DECISION

I find in favor of Respondent, the Centers for Medicare & Medicaid Services (CMS), against Petitioner, Generations at Neighbors (Generations), and sustain the imposition of an $11,000 per-instance civil money penalty.

I.  Background

Generations is a skilled nursing facility doing business in Byron, Illinois, certified by and participating in the Medicare/Medicaid programs.  As a result of annual certification surveys conducted by the Illinois Department of Public Health (IDPH) on October 26 and November 22, 2017, CMS found Generations to be substantially noncompliant with Tag F309 (42 C.F.R. §§ 483.24 and 483.25(k)(l)1 – provide care/services for highest well-

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being) at the “G” scope/severity level (indicating an isolated instance of noncompliance that causes actual harm that is not immediate jeopardy).2   CMS Exhibit (Ex.) 1. 

On November 8, 2017, IDPH advised Generations it had recommended CMS:  (1) deny payment for new admissions (DPNA) beginning January 26, 2018; (2) impose a civil money penalty; and (3) terminate Generations’ provider agreement effective April 26, 2018.  CMS Ex. 3 at 2.

On May 18, 2018, CMS imposed a per-instance civil money penalty of $11,000 for the deficiency identified under Tag F309 and notified the facility that neither the termination nor the DPNA would be imposed.  CMS Ex. 1 at 2.  CMS also acknowledged that IDPH had conducted a revisit survey on December 20, 2017 and found Generations had returned to substantial compliance as of December 8, 2017.  Id.

On July 16, 2018,3 Generations requested a hearing before an administrative law judge, and Judge Bill Thomas was designated to hear and decide this case.  On July 20, 2018,

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Judge Thomas issued an Acknowledgment and Pre-hearing Order (APHO) that set forth deadlines by which the parties were required to file their pre-hearing exchanges, including briefs, exhibits, witness lists, and the direct testimony of any witnesses identified.  APHO at 2-4.  The APHO specified that a hearing in this matter would only be deemed necessary if a party filed written direct testimony for a witness who the opposing party requested to cross-examine.  Id. at 6-7. 

CMS filed its pre-hearing exchange, including the written direct testimony of one witness, and a pre-hearing brief and motion for summary judgment (CMS Br.).  Generations subsequently filed its pre-hearing exchange, identified one witness, and filed a pre-hearing brief and response to CMS’s motion for summary judgment (P. Br.).  Generations reserved the right to but did not specifically request to cross-examine CMS’s witness.  CMS objected to Generations’ witness because Generations did not submit written direct testimony for the witness in accordance with the AHPO.  Because Generations did not request to cross-examine a witness for whom CMS filed written direct testimony and Generations did not file written direct testimony for the witness it identified, the case may be decided based on the written record.  Civ. Remedies Div. P. § 19(d); APHO at 6-7.  On February 2, 2022, the case was transferred to me to hear and decide.

I deny CMS’ motion for summary judgment as moot.

II.  Admission of Exhibits

CMS filed 14 exhibits in its pre-hearing exchange, identifying them as CMS Exhibits 1 through 14.  Generations filed nine exhibits in its pre-hearing exchange, identified as Petitioner’s Exhibits (P. Exs.) 1 through 9.  As discussed above, CMS objected to Generations’ proposed witness on procedural grounds.

Generations objected to all exhibits containing statements from Resident 19 (CMS Exs. 2 and 8) and IDPH Surveyor Donna Sandoval’s notes (CMS Ex. 8) as hearsay.  CMS’s proposed exhibits 1 through 14 and Generations’ proposed exhibits 1 through 10 are included into the evidentiary record and I will consider the parties’ objections in deciding this case.

III.  Statement of Issues

The issues presented are:

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1. Whether Generations was in substantial compliance with 42 C.F.R. §§ 483.24 and 483.25 (Tag F309) at the time of the surveys completed on October 26 and November 22, 2017; 4 and

2. If Generations was not in substantial compliance, whether the civil money penalty imposed by CMS is reasonable.

IV.  Discussion

1. Applicable Legal Authority

The Social Security Act (Act) sets requirements for skilled nursing facilities to participate in the Medicare program.  The Act authorizes the Secretary of the United States Department of Health and Human Services (Secretary) to promulgate regulations implementing those statutory provisions.  Act § 1819 (42 U.S.C. § 1395i-3).  The Secretary’s regulations are found at 42 C.F.R. pts. 483 and 488.

A facility must maintain substantial compliance with program requirements in order to participate in the program.  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 agencies to conduct periodic surveys to determine whether skilled nursing facilities are in substantial compliance with the participation requirements.  Act § 1864(a) (42 U.S.C. § 1395aa(a)); 42 C.F.R. § 488.10.  The Act also authorizes the Secretary to impose enforcement remedies against skilled nursing facilities that do not comply with the participation requirements.  Act § 1819(h)(2) (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.  Among other enforcement remedies, CMS may impose a per-instance civil money penalty (CMP) for each instance of noncompliance.  42 C.F.R. § 488.430(a).  The authorized range for a per-instance CMP is $1,000 to $10,000, adjusted annually for inflation.  42 C.F.R. § 488.438(a)(2).5   In 2017, the applicable range was $2,097 to $20,965.  45 C.F.R. § 102.3.

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If CMS imposes one or more enforcement remedies against a skilled nursing facility based on a noncompliance determination, the facility may request a hearing before an administrative law judge (ALJ) to challenge the noncompliance finding and enforcement remedies.  Act §§ 1128A(c)(2), 1866(h); 42 C.F.R. §§ 488.408(g), 488.434(a)(2)(viii), 498.3(b)(13).  However, the facility may not appeal CMS’ choice of remedies.  42 C.F.R. § 488.408(g)(2).  

CMS has the burden to come forward with evidence sufficient to make a prima facie case that Generations 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 Generations bears the ultimate burden of persuasion as to whether it substantially complied.  In other words, Generations must show by a preponderance of the evidence that it was in substantial compliance with program participation requirements.  Id.  Generations has both the burden of coming forward and the burden of persuasion as to any affirmative defense.  Evergreene Nursing Care Ctr., DAB No. 2069 at 7; Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004), aff’d, Batavia Nursing & Convalescent Ctr. v. Thompson, 129 F. App’x 181 (6th Cir. 2005).

2. Generations failed to substantially comply with 42 C.F.R. §§ 483.24 and 483.25, Tag F309 because it failed to follow Resident 19’s physician’s order regarding the administration of morphine.

1. Relevant Facts

Resident 19, a 71-year-old female, had been a resident at Generations since February 25, 2013.  CMS Ex. 6 at 5, 7.  Resident 19’s diagnoses included arthritis, joint pain, and an above-the-knee amputation of her left leg.  Id. at 25-26.  As a result of these diagnoses, Resident 19 reported during her Minimum Data Set (MDS) interview that she experienced severe pain on an almost constant basis and that pain limited her day-to-day activities.  Id. at 27.  Resident 19’s March 4, 2013 care plan included a physician order for 10mg of morphine to be administered every six hours (four times daily), and Tylenol every four hours as needed.  Id. at 47, 49-50, 62.  Notably, the order for morphine specifically indicated that substitution is permitted by the pharmacy.  Id. at 49.

On October 25, 2017, IDPH conducted an annual certification survey of Generations.  During an interview with Surveyor Donna Sandoval (Surveyor Sandoval), Resident 19 reported that Generations had run out of morphine twice over the past few months.  CMS

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Ex. 2 at 5; CMS Ex. 8 at 4.  Resident 19 reported that she had not been able to sleep, that “everything hurt even my teeth,” that missing her morphine made her depressed, and described her experience as a nightmare.  Id. 

Generations’ controlled drug disposition forms confirmed that Resident 19 missed 10 doses of morphine between August 5-8, 2017 and eight doses between October 20-22, 2017, with no other pain medications given.  CMS Ex. 2 at 6; CMS Ex. 6 at 52-53, 57-58.  As part of the interview process, Surveyor Sandoval interviewed Erin Tremble, Generations’ Director of Nursing (DON).  The DON conceded that pain control could be an issue if medications were  not given as ordered, and confirmed that if the medications were  not listed on Generations’ controlled substance disposition forms, they were not administered.  CMS Ex. 2 at 5; CMS Ex. 8 at 5.  Further, the DON advised that she expected medications to be available to Generations’ residents, reordered in a timely manner, and that the residents’ physicians should have been notified when medications were unavailable in order to supply an alternate medication in the interim.  CMS Ex. 2 at 5; CMS Ex. 8 at 6.

2. Analysis

The regulations at 42 C.F.R. §§ 483.24 and 483.25 encompassed by Tag F309 set forth expectations for the quality of life and care that residents in a skilled nursing facility should receive.  42 C.F.R. § 483.24 requires a skilled nursing facility to provide each of its residents with the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, consistent with that resident’s comprehensive assessment and plan of care, while 42 C.F.R. § 483.25 requires a skilled nursing facility to provide each of its residents with treatment and care in accordance with professional standards of practice, the resident’s comprehensive plan of care, and the resident’s choices.

It is well established that a facility’s obligation to provide necessary care and services includes complying with physician orders to provide a resident both necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, as well as treatment and care in accordance with professional standards of practice, the resident’s comprehensive plan of care, and the resident’s choices.  See Life Care Ctr. of Tullahoma, DAB No. 2304 at 34 (2010), aff’d, Life Care Ctr. Tullahoma v. Sec’y of U.S. Dept. of Health & Human Servs., 453 F. App’x 610 (6th Cir. 2011) (providing “necessary care and services” includes those services ordered by a physician).

CMS argues Generations’ failure to implement Resident 19’s care plan and Resident 19’s physician’s order concerning pain management demonstrated its noncompliance with 42 C.F.R. §§ 483.24 and 483.25(k), Tag F309.  CMS Br. at 7.  CMS also argues that Generations had an obligation to avoid running out of morphine at all, but even if Generations did run out of morphine, it had an obligation to contact Resident 19’s

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physician and obtain an alternative pain medication until it could obtain morphine.  Id. at 8.  These arguments are amply supported by Resident 19’s records, which establish that Resident 19 missed ten doses of morphine between August 5-8, 2017 and eight doses between October 20-22, 2017, with no other pain medications given.  CMS Ex. 2 at 6; CMS Ex. 6 at 52-53, 57-58.  This is further supported by the testimony of Surveyor Sandoval, who interviewed Resident 19 and Generations’ DON, specifically requested documentation that Generations provided Resident 19 with alternate medications in the manner and method prescribed by her physician, and reviewed Generations’ own policies.  See CMS Ex. 14 at 2-3 (discussing the documents Surveyor Sandoval referenced in drafting the F309 tag).  Finally, Generations’ own submissions both in this matter and in the Informal Dispute Resolution process confirm that Generations failed to provide the necessary medication in the manner and method ordered by Resident 19’s physician and as set forth in Resident 19’s care plan, and failed to arrange for alternative medications in the interim.  See P. Br. at 8-9 (“there are processes in place that allows a nurse to contact a resident’s physician to obtain orders for alternative medications to ensure that a resident does not experience unnecessary pain or discomfort.  These processes were not utilized since R19 expressed no pain.”); CMS Ex. 9 at 4 (same).  Accordingly, CMS has established by a preponderance of the evidence that Generations failed to substantially comply with 42 C.F.R. §§ 483.24 and 483.25, Tag F309, based on Generations’ failure to follow Resident 19’s physician’s order regarding the administration of morphine.

Generations failed to provide any documentation to demonstrate it informed Resident 19’s physician it was unable to follow the medication order or that it requested an alternate medication be provided in the interim.  CMS Ex. 2 at 6.  Generations does not dispute it failed to provide morphine to Resident 19, or it was required by her physician’s order.  Instead, Generations argues it should be found it was compliant because Resident 19 did not report pain.  In essence, Generations has put forth a “no documented harm, no noncompliance” theory.  See P. Br.  Generations concedes that Resident 19’s pain medication became depleted and there was a “temporary disruption” to her routine medications.  CMS Ex. 9 at 4; P. Br. at 8.  However, Generations blamed Resident 19’s physician and the pharmacy for the delay in obtaining a refill for the medication.  CMS Ex. 9 at 4.  Generations also argues Resident 19 was capable of reporting any pain she was experiencing and requesting Tylenol, but was likely exhibiting signs and symptoms of her mental illness because she only reported experiencing pain and depression when Surveyor Sandoval prompted her.  CMS Ex. 9 at 1-3; P. Br. at 5-7.  Finally, Generations dismisses Resident 19’s complaints of pain as drug-seeking behavior, for which she was undergoing a controlled reduction of her morphine.  P. Br. at 7, 9.

I find Generations’ arguments unpersuasive.  The record before me reflects Resident 19 missed a total of 18 doses of physician-ordered pain medication over the course of two separate three-day periods.  Although Generations may have contacted Resident 19’s physician to request a refill of the medications, Generations presented no evidence it

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notified Resident 19’s physician it could not provide any morphine to Resident 19 or requested alternate medications be provided until the morphine refills were processed.  On two separate occasions, Generations made no attempt to obtain a morphine refill for Resident 19 on an expedited basis or to obtain an alternate prescription pain medication until the morphine refills were processed.6   It is not a facility resident’s obligation to plead for physician-ordered medication.  Even if Resident 19 was not actively complaining of pain and still able to engage in other daily activities, it was incumbent upon Generations’ staff to provide the physician-ordered treatment, as required by the regulations.  Even if Resident 19 was undergoing a controlled reduction of her morphine and engaging in drug-seeking behavior as Generations alleges, it was incumbent upon Generations’ staff to attempt other measures to provide the medication which was deemed necessary by her physician, in order to provide the quality of care demanded by the regulations.  That Resident 19 was on a controlled reduction yet was denied the prescribed medication likely increases the risk of harm to the resident, since individuals who need controlled reductions are drug-dependent, but I need not find as much here.  Resident 19’s care plan and active physician’s order required the regular administration of morphine, and Tylenol as needed.  The order also specifically authorized substitutions for the morphine.  Unless and until the physician’s order and care plan changed, the morphine is considered necessary care required to attain or maintain Resident 19’s highest practicable physical, mental, and psychosocial well-being.  

By failing to comply with Resident 19’s physician’s order regarding morphine administration or document any efforts to implement alternative measures, Generations failed to provide necessary treatment, care, and services to Resident 19 in violation of 42 C.F.R. §§ 483.24 and 483.25.

3. Generations failed to substantially comply with 42 C.F.R. § 483.25, Tag F309 because it failed to follow its own policy to provide Resident 19 with medications in the manner and method prescribed by Resident 19’s physician.

42 C.F.R. § 483.24 (“Quality of Life”) requires facilities to provide the necessary care and services for residents to attain or maintain their highest practicable physical, mental, and psychosocial well-being, consistent with the resident’s comprehensive assessment and plan of care.  42 C.F.R. § 483.25(k) (“Quality of Care”) requires facilities to provide

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pain management services consistent with professional standards and the resident’s care plan, goals, and preferences.  A facility may set policies in order to require staff to comply with the facility’s obligations under the guidelines, which occurred here. 

Generations’ own Medication Administration Policy mirrors its obligations under 42 C.F.R. §§ 483.24 and 483.25(k), Tag F309.  The Medication Administration Policy requires all medications to be administered to the resident in the manner and method prescribed by the physician, in order to provide the necessary care and services for Generations’ residents.  CMS Ex. 7 at 2.  In the event a medication cannot be given, the reason and the time frame must be documented in the Nurses Medication Notes on the Medication Administration Record (MAR) or Progress Notes.  Id.  At minimum, this suggests Generations recognized and implemented a heightened duty to document the reasons for its inability to provide the necessary care and services ordered by a physician.  In other words, Generations required its staff to document when and why it was unable to meet its obligations under the regulations.  Such a policy seems eminently reasonable, and is supported by the DON’s comments to Surveyor Sandoval that she also expected residents’ physicians would be notified when medications were unavailable so alternative medications could be provided in the interim.  CMS Ex. 2 at 5; CMS Ex. 8 at 6.  As a result, I have no difficulty finding Generations’ Medication Administration Policy demonstrates its attempt to conform to the regulations at issue here, and therefore I will apply that policy in assessing the facility’s compliance.  See Hanover Hill Health Care Ctr., DAB No. 2507 at 6 (2013) (observing “the Board has long held that a facility’s own policy may be sufficient evidence . . . of what the facility has determined is needed to meet the quality of care requirements in section 483.25”). 

As discussed above, Resident 19 missed a total of 18 doses of physician-ordered pain medication over the course of two separate three-day periods.  In other words, Generations did not administer all medications to Resident 19 in the manner and method prescribed by her physician.  Although Generations may have contacted Resident 19’s physician to request a refill of the medications, Generations presented no evidence it notified Resident 19’s physician it could not provide any morphine to Resident 19 or requested an alternate prescription medication be provided until the refills were processed.  There is also no reason or timeframe provided on either Resident 19’s MAR or her medications flowsheet for the inability to provide morphine.  CMS Ex. 6 at 51-60, 64, 71.  The progress notes submitted by Generations also do not include an explanation for the “temporary disruption” to her routine medications.  P. Br. at 8; P. Exs. 3, 4, 8, 9.7

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Generations presented no evidence to establish it followed its own Medication Administration Policy with respect to Resident 19.  Generations concedes Resident 19 experienced a disruption in her routine medications and Resident 19’s Medication Administration Record for October 10-22 does not show any other ordered pain medications being administered while morphine was being refilled.  P. Br. at 8.  However, Generations argues it was still compliant with its obligations because Resident 19 did not actually experience pain, because she did not report discomfort or ask for pain medication as she had done previously, and because her description of unrelieved pain was a sign of mental illness and attention seeking behaviors.  See P. Br.  Generations argues Resident 19 needed psychiatric and behavioral interventions, not pain medication.  P. Br. at 6.  The regulations require facilities to provide the necessary care and services – including pain management services – for residents to attain or maintain their highest practicable physical, mental, and psychosocial well-being, consistent with both professional standards and the resident’s care plan, goals, and preferences.  42 C.F.R. §§ 483.24, 483.25(k).  “Alternative PRN medications” available upon request is insufficient to meet Generations’ obligations to ensure Resident 19’s routine medications were provided and to document the reasons and timeframe for any inability to meet its obligations.  As a result, Generations failed to establish it met the quality of care requirements in section 483.25.

By failing to comply with its own Medication Administration Policy and provide a documented reason and timeframe for the failure to provide medication in the manner and method prescribed by Resident 19’s physician, Generations failed to provide necessary treatment, care, and services to Resident 19 in violation of 42 C.F.R. § 483.25.

4. The $11,000 per-instance CMP imposed by CMS is reasonable.

CMS imposed a per-instance CMP of $11,000 for the noncompliance with 42 C.F.R. §§ 483.24 and 483.25(k).  Generations challenges the scope and severity of the non-compliance, the basis for the penalty, and the reasonableness of the amount imposed. 

1. The scope and severity level of noncompliance is not reviewable because a successful challenge would not affect the range of the CMP that may be imposed.

A facility has a right to appeal a “certification of noncompliance leading to an enforcement remedy.”  42 C.F.R. §§ 488.408(g)(1), 488.330(e), 498.3(b)(13).  However, the choice of remedies, or the factors CMS considered when choosing remedies, are not subject to review.  42 C.F.R. § 488.408(g)(2).  A facility may only challenge the scope and severity level of noncompliance determined by CMS if a successful challenge would affect the range of the CMP that may be imposed or would impact the facility’s authority to conduct a nurse aide training and competency evaluation program (NATCEP).  42 C.F.R. § 498.3(b)(14), (d)(10)(i).  The CMS determination as to the level of

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noncompliance “must be upheld unless it is clearly erroneous.”  42 C.F.R. § 498.60(c)(2); Woodstock Care Ctr., DAB No. 1726 at 9 (2000), aff’d, Woodstock Care Ctr. v. Thompson, 363 F.3d 583 (6th Cir. 2003).  The Departmental Appeals Board (Board) has long held the net effect of the regulations is a provider has no right to challenge the scope and severity level assigned to a noncompliance finding, except in the situation where that finding was the basis for an immediate jeopardy determination.  See, e.g., Ridge Terrace, DAB No. 1834 (2002); Koester Pavilion, DAB No. 1750 (2000).  ALJ review of a CMP is subject to 42 C.F.R. § 488.438(e).

In this case, there has not been a determination of immediate jeopardy.  CMS imposed the penalty in the middle of the authorized range, and there was no loss of NATCEP.  Accordingly, the scope and severity level of the noncompliance is not reviewable.

2. There is a basis for the imposition of a CMP, and the amount of the CMP imposed by CMS is reasonable.

Having determined that the scope and severity level of noncompliance is not reviewable in this case, I turn to the reasonableness of the amount of the CMP.  In determining the reasonableness of the penalty amount imposed by CMS, I look to the factors set forth at 42 C.F.R. §§ 488.438(f) and 488.404 (incorporated by reference into 42 C.F.R. § 488.438(f)(3)).  These factors include the seriousness of the deficiency, the facility’s compliance history, its financial condition, and its degree of culpability.

Neither party argues the facility’s financial condition to be a factor affecting the penalty amount.  Considering the remaining factors, I have no difficulty concluding Generations’ noncompliance was very serious.  It was Generations’ duty to ensure it had all necessary medications available to meet its care requirements under the regulations.  It was Generations’ duty to administer medications to Resident 19 in accordance with her physician’s order and care plan, to immediately notify her physician upon the discovery of its inability to provide care in the manner and method prescribed, and to request an alternative pain medication in the interim.  Generations’ staff merely requested a refill of the morphine.  Generations did not advise the physician it had run out of morphine and did not request the refills be processed in an expedited manner.  Generations also provided no evidence it requested either the pharmacy or Resident 19’s physician authorize an alternate medication until the refills were processed.  On a policy level, the facility understood it was crucial to provide medications in accordance with physicians’ orders and to document the reason and the timeframe for any medications it was unable to administer.  Generations’ DON understood pain control could be an issue if medications are not given as ordered; that if the medications are not listed on Generations’ controlled substance disposition forms, they were not administered; that she expected medications to be available to Generations’ residents and reordered in a timely manner; and that the residents’ physicians are notified when medications are unavailable in order to supply an alternate medication in the interim.  Yet in practice with respect to

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Resident 19, Generations’ staff did not reorder prescription pain medication until it had run out on two separate occasions, and did not request any alternative pain medications to administer until it could obtain refills.  As a result, Resident 19 missed a total of 18 doses of morphine over two separate three-day periods.  Generations plainly failed to provide necessary care and services to Resident 19 or document the reasons for its failure, as required by its own policy, leading to days-long delays in providing necessary pain management medication in the prescribed manner and method, with no alternative pain medication provided in the interim. 

With respect to Generations’ history of noncompliance with Medicare program participation requirements, CMS submitted Generations’ AEM Enforcement History, which includes a synopsis of survey findings for the period of January 10, 2005 through June 13, 2018.  CMS Ex. 13.  Although the AEM Enforcement History shows one prior citation for tag F309 in May of 2017, it was for scope and severity level “D” (indicating an isolated instance of noncompliance that causes no actual harm with the potential for more than minimal harm).  Id. at 2.  There is no evidence CMS imposed a remedy for this prior citation.  See id. (“No remedies in effect for this case.).  CMS urges me to consider other citations as evidence of Generations’ history of noncompliance generally:  one citation from February 26, 2014, which involved immediate jeopardy for a failure to supervise under 42 C.F.R. § 483.25(h) and a CMP of $83,800; one citation from November 17, 2011 which involved a citation at level “G” and a CMP of $1,200; and several other citations, for which there are no remedies in effect.  CMS Br. at 10-11 (citing CMS Ex. 13 at 3-4); CMS Ex. 13 at 4-6.

Generations argues that none of its past deficiencies are sufficiently related to the care and treatment that Generations failed to provide to Resident 19, and the other citations are too far in the past to be relevant to my determination of the reasonableness of the penalty amount imposed by CMS.  P. Br. at 10-11.  Generations argues the February 26, 2014 citation resulted in a CMP in excess of $80,000 was contested and occurred more than three and a half years before the instant case.  Id. at 11.  However, the Board has held the regulation does not require repeated deficiencies or extensive prior noncompliance for a history of noncompliance to be considered.  Burton Health Care Ctr., DAB No. 2051 at 19 (2006).  CMS’ determination and CMP were affirmed by the ALJ and by the Board on appeal, and the citation was also for a deficiency in “quality of care” under 42 C.F.R. § 483.25.  See Neighbors Rehabilitation Ctr., LLC, DAB No. 2859 (2018).  Finally, a review of the remaining citations in the AEM Nursing Home Enforcement History even limited to the two years prior to the citation at issue reveals a number of deficiencies at the “D,” “E,” and “F” level of scope and severity.  CMS Ex. 13. 

I have also considered Generations’ culpability and find it significant.  Generations failed to provide controlled pain management medication to Resident 19 in the manner and method prescribed by her physician and failed to notify her physician when it was unable to do so.  Of notable concern, Generations argues because Resident 19 did not complain

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of pain to or request Tylenol from Generations’ staff, she was attention- and drug-seeking when she described her experience to Surveyor Sandoval.  P. Br. at 5-7, 9.  Generations also argues because Resident 19 did not request Tylenol during the periods of missed morphine doses, she did not experience actual harm and Generations is therefore not culpable.  Id. at 10.  Generations also blames Resident 19’s physician and the pharmacy for the delay in obtaining the morphine refill.  CMS Ex. 9 at 4.  It should be unnecessary for me to point out that the regulations do not require facilities’ residents to prompt facilities to follow physicians’ orders, residents’ care plans, or facilities’ own policies.  Generations worked with Resident 19’s physician to create a comprehensive person-centered care plan to meet Resident 19’s identified needs.  This included regular administration of morphine for pain management. 

Although Resident 19 was on a controlled reduction of her morphine, Generations cannot evade its obligations under the regulations by blaming a resident’s mental illness or alleging she was drug-seeking.  Generations argues Resident 19’s power of attorney reported she “had always liked taking a lot of medication.”  P. Br. at 6.  Generations repeatedly refers to Resident 19 as drug-seeking or “seeking morphine as per habit,” but provides no clinical evidence the morphine was no longer necessary.  Id. at 9.  To the contrary, the exhibit Generations cites to supports the need for the administration of Resident 19’s routine medications in the manner and method prescribed by her physician.  P. Ex. 4.  Resident 19 was approved for further evaluation and the care plan was to continue the planned morphine reduction.  Id.  The June 14, 2017 progress note does not indicate the Morphine could be stopped entirely.  Id.  Further, Generations did not request that Resident 19’s physician evaluate her for a change in her needs if they noticed that Resident 19 appeared to be responding well to the lack of morphine.  In fact, based on the record before me, Generations did not notify Resident 19’s physician she had missed any doses of morphine.  Generations did not request Resident 19’s physician or the pharmacy authorize an alternate medication to ensure Resident 19’s needs were met until the refill was processed.  Generations also failed to document any explanation or time frame for the inability to provide the physician-ordered medication to Resident 19, in violation of its own Medication Administration Policy.  For reasons unexplained, Generations allowed itself to run out of controlled pain-management medication, failed to provide alternative pain medications to Resident 19 until it could obtain the medication she was required to receive by physician’s order, and then blamed Resident 19 for its failure to meet its obligations under the regulations.  For these reasons, the facility is culpable.  

The authorized range for a per-instance CMP is $1,000 to $10,000, with appropriate adjustments for inflation.  42 C.F.R. § 488.438(a)(2).  For violations occurring in 2017, the applicable range was $2,097 to $20,965.  45 C.F.R. § 102.3.  Given the seriousness of Generations’ noncompliance and its high degree of culpability, I find there is a basis for the imposition of a per-instance CMP in this case.  Finally, I find CMS’ imposition of an $11,000 per-instance CMP, which is in the middle of the authorized range, to be more than reasonable.

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V.  Conclusion

WHEREFORE, the above evidence having been read and considered I hereby affirm CMS’ determination and find its imposition of an $11,000 per-instance civil money penalty to be reasonable.

1. Effective November 28, 2016, CMS revised and reorganized many of the participation requirements codified in 42 C.F.R. pt. 483.  Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities; 81 Fed. Reg. 68,688 (Oct. 4, 2016).  Although CMS correctly cited the regulations in effect at the time of the survey, it incorrectly refers to Tag F309, which corresponded to quality of life regulations prior to the November 2016 reorganization.  Since that change, quality of life has been identified under Tags F675 and F684.  Wis. Dep’t of Health Servs., Div. of Quality Assurance, Crosswalk – Old and New Federal Nursing Home Regulations at 3, available at https://www.dhs.wisconsin.gov/publications/p01943.pdf (last visited Feb. 22, 2022).  However, as the actual regulatory deficiencies at issue before me are the same, for the sake of simplicity I will reference this prior tag in this decision.
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2. CMS and state survey agencies consider the scope and severity of deficiencies when selecting enforcement remedies.  The scope and severity level is designated by letters A through L, and CMS summarizes these levels in a matrix published in the State Operations Manual (SOM). The SOM is available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs-Items/CMS1201984.html?DLPage=1&DLEntries=10&DLSort=0&DLSortDir=ascending.
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3. Generations sought administrative law judge review relying on the May 18, 2018 notice of imposition of remedies issued by CMS.  P. Req. for Hearing, Att. 1.  Generations indicated that it contests the factual and legal basis for the imposition of sanctions, including the DPNA and termination of the provider agreement.  Id.  However, the May 18, 2018 notice of imposition of remedies did not impose the DPNA or the termination of the provider agreement; it instead advised the facility that it was only imposing a per-instance CMP of $11,000.  The regulations do not permit a facility to seek a hearing absent the actual imposition of enforcement remedies.  42 C.F.R. § 498.3(b)(13) (providing “a finding of noncompliance leading to the imposition of enforcement remedies specified in [42 C.F.R.] § 488.406 [e.g., CMPs and DPNA]” is an appealable initial determination).  Therefore, my review of the enforcement remedies is limited to the imposition of the $11,000 per-instance CMP.
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4. The Statement of Deficiencies (SOD) alleges Generations’ noncompliance under 42 C.F.R. §§ 483.24 and 483.25(k),(l).  42 C.F.R. § 483.24 relates to provision of services related to quality of life.  Subsections (k) and (l) of 42 C.F.R. § 483.25 relate to provision of pain management and dialysis.
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5. Effective February 3, 2017, CMP amounts increased for deficiencies occurring after November 2, 2015.  See Annual Civil Monetary Penalties Inflation Adjustment; 82 Fed. Reg. 9,174, 9,175 (Feb. 3, 2017).  The range for a per-instance CMP in effect at the time of the survey at issue here was $2,097 to $20,965.  42 C.F.R. § 488.438(a)(2); 45 C.F.R. § 102.3; Annual Civil Monetary Penalties Inflation Adjustment; 82 Fed. Reg. 9,175 (Feb. 3, 2017).
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6. Generations provided excerpts of Resident Progress Notes, one of which indicates that the pharmacy contacted Generations on October 22, 2017 and advised that the prescription for morphine was incomplete.  The note confirms that Generations’ staff facilitated the prescription by calling Resident 19’s physician and the pharmacy, but does not indicate that Resident 19’s physician was aware that Generations was unable to provide any morphine to Resident 19.  See P. Ex. 8 at 2.
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7. Resident 19’s October 22, 2017 Progress Note indicates that the pharmacy contacted Generations to advise that the prescription for morphine was incomplete.  The note confirms that Generations’ staff facilitated the prescription by calling Resident 19’s physician and the pharmacy, but does not indicate the reason for Generations’ inability to provide the morphine to Resident 19.  See P. Ex. 8 at 2.
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