Medford Rehabilitation and Nursing Center, DAB CR5436 (2019)

DECISION

Medford Rehabilitation and Nursing Center (Petitioner or “the facility”) is a skilled nursing facility (SNF) located in Medford, Massachusetts, that participates in the Medicare program. Following a standard survey that was completed on June 8, 2016, and a revisit survey that was completed on August 24, 2016, the Centers for Medicare & Medicaid Services (CMS) determined that the facility was not in substantial compliance with Medicare program requirements. CMS imposed a per-day civil money penalty (CMP) of $1,850 for 96 days of noncompliance, for a total CMP of $177,600; imposed a denial of payment for new admissions (DPNA), effective September 8 through 11, 2016; and informed Petitioner that it was prohibited from receiving approval for a nurse aide training and competency evaluation program (NATCEP), effective June 8, 2016 through June 7, 2018.

Petitioner contests the deficiencies cited under 42 C.F.R. § 483.20(d), (k)(1) (Tag F279 (develop comprehensive care plans)), cited at the “D” level of scope and severity during the June 8 survey and at the “G” level of scope and severity during the August 24 survey, and 42 C.F.R. § 483.25(f)(1) (Tag F319 (provide treatment and services for mental or psychosocial difficulties)), cited at the “G” level of scope and severity, and broadly requests the elimination of the CMP. For the reasons discussed below, I find that there is

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no genuine 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 and the CMP imposed is reasonable.

I. Background

The Social Security Act (Act) sets requirements for SNF participation in the Medicare program. The Act authorizes the Secretary of the United States Department of Health & 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. part 483.Federal long-term care facility regulations substantially changed beginning on November 28, 2016.  81 Fed. Reg. 68,688 (Oct. 4, 2016).  Based on the dates of the surveys and the notification letters regarding the imposition of remedies, all of which preceded the regulatory revisions, I refer to the regulations that were in effect at the time of the surveys.

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 SNFs are in substantial compliance with the participation requirements. Act § 1864(a) (42 U.S.C. § 1395aa(a)); 42 C.F.R. §§ 488.10, 488.20. The Act and its implementing regulations require that facilities be surveyed on average every twelve months, and more often if necessary, to ensure that identified deficiencies are corrected. Act § 1819(g)(2)(A) (42 U.S.C. § 1395i-3(g)(2)(A)); 42 C.F.R. §§ 488.20(a), 488.308.

The Massachusetts Department of Public Health (state agency) conducted a standard survey of Petitioner that was completed on June 8, 2016. CMS Exhibit (Ex.) 6; Petitioner’s (P.) Ex. 32 at 1-59. In a sampling of 24 residents, the state agency cited seven deficiencies that collectively involved seven of those residents. CMS Ex. 6.In this decision, I have not discussed all of these deficiencies because the deficiency I uphold below is sufficient to justify both a finding of noncompliance and CMS’s imposition of remedies.  See Claiborne-Hughes Health Ctr. v. Sebelius, 609 F.3d 839, 847 (6th Cir. 2010) (affirming the authority of ALJs, “in the interests of judicial economy,” to review “only those deficiencies that have a material impact on the outcome of the dispute”); Carrington Place of Muscatine, DAB No. 2321 at 20-21 (2010).  For this reason, I do not discuss further Petitioner’s arguments regarding its compliance (or not) with 42 C.F.R. § 483.20(d), (k)(1) (Tag F279 (develop comprehensive care plans)). As

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relevant here, the state agency determined that Petitioner was not in substantial compliance with one of the aforementioned regulatory requirements, found at 42 C.F.R. § 483.25(f)(1), at the “G” level of scope and severity.Scope and severity levels are used by CMS and state survey agencies when selecting remedies.  The scope and severity level is designated by letters A through L.  Pub. 100-7, State Operations Manual (SOM), chap. 7, § 7400.5.1 (Factors That Must be Considered When Selecting Remedies), “Assessment Factors Used to Determine the Seriousness of Deficiencies Matrix” (table) (Rev. 63, effective Sept. 10, 2010 (applicable at the time of the survey at issue)); see SOM, chap. 7, § 7400.3.1 (Rev. 63, effective November 16, 2018) (current version)); see also 42 C.F.R. § 488.408.  As relevant here, a scope and severity level of “G” indicates an isolated deficiency that caused actual harm to resident health or safety. CMS Ex. 6 at 7. By letter dated July 28, 2016, CMS notified Petitioner that it concurred with the state agency’s findings that Petitioner was not in substantial compliance with participation requirements. CMS Ex. 1 at 1. CMS imposed a per-day CMPThe Act authorizes the imposition of enforcement remedies against SNFs that are not in substantial compliance with program participation requirements, and the regulations specify the enforcement remedies that can be imposed.  42 U.S.C. § 1395i-3(h)(2); 42 C.F.R. § 488.406.  Among other enforcement remedies, CMS may impose a per-day CMP for the number of days an SNF is not in substantial compliance or a per-instance CMP for each instance of the SNF’s noncompliance.  42 C.F.R. § 488.430(a). of $1,850 based on noncompliance with the requirement at 42 C.F.R. § 483.25(f)(1) beginning June 8, 2016, and warned that, if Petitioner did not return to substantial compliance, a statutorily-mandated DPNA would take effect beginning September 8, 2016, and Petitioner’s provider agreement would be terminated by operation of law effective December 8, 2016. CMS Ex. 1 at 2. The letter also warned Petitioner that a NATCEP prohibition would automatically take effect on June 8, 2016, if, inter alia, a CMP of no less than $5,000 was assessed. CMS Ex. 1 at 4.

The state agency conducted a revisit survey of Petitioner from August 23-24, 2016. CMS Ex. 7; P. Ex. 32 at 60-86. The state agency found that Petitioner had not corrected its “G” level noncompliance with the requirement at 42 C.F.R. § 483.25(f)(1). CMS Ex. 7 at 5. By letter dated September 6, 2016, CMS notified Petitioner that, based on the state agency’s findings, it was continuing the $1,850 per-day CMP and reminded Petitioner that, if it did not return to substantial compliance, a DPNA would go into effect on September 8, 2016, and Petitioner’s provider agreement would be terminated on December 8, 2016. CMS Ex. 2 at 2. The letter also informed Petitioner that a NATCEP prohibition had been imposed, effective June 8, 2016 through June 7, 2018, because Petitioner had been assessed a total CMP of not less than $5,000. CMS Ex. 2 at 3.In its initial hearing request, Petitioner appealed the NATCEP denial, but it did not address the NATCEP denial in its pre-hearing brief.  Because the NATCEP prohibition lapsed on June 7, 2018, that issue is now moot.  Nonetheless, because CMS had a basis for imposing CMPs in excess of $5,000 and a DPNA against Petitioner, the NATCEP denial was mandated by law and merits no further discussion.  Act § 1819(f)(2)(B)(iii)(I)(c) (42 U.S.C. § 1395i-3(f)(2)(B)(iii)(I)(c)).

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In an October 5, 2016 letter, CMS advised Petitioner that it had achieved substantial compliance, effective September 12, 2016, at which point the CMP ceased accruing and the DPNA, which took effect September 8, 2016, ended; CMS also notified Petitioner that its provider agreement would not be terminated. CMS Ex. 3 at 1.

On November 10, 2016, Petitioner, through counsel, requested a hearing before an administrative law judge (ALJ).In a footnote within its brief, CMS initially took issue with the timing of Petitioner’s hearing request, to which Petitioner responded in a footnote within its opposition brief.  After I ordered the parties to either brief this issue or submit a joint filing indicating agreement, the parties jointly stipulated on November 17, 2017, that Petitioner did not receive CMS’s July 28, 2016 letter until October 31, 2016, and that it timely appealed the enforcement remedies that had been imposed on July 28, 2016.  Pursuant to my Acknowledgment and Pre-Hearing Order (Pre-Hearing Order), CMS filed a pre-hearing brief with incorporated motion for summary judgment (CMS Br.), along with seven exhibits (CMS Exs. 1-7), and Petitioner submitted a pre-hearing brief with incorporated memorandum in opposition to CMS’s motion for summary judgment (P. Br.), along with 41 exhibits (P. Exs. 1-41).Although Petitioner’s exhibit list indicates that “P. Ex. 24” is a “Complete Set of Progress Notes of Dr. Urkevic for Resident 8 (7 Pages)” (footnote omitted), Petitioner marked the 7-page exhibit containing Dr. Urkevic’s progress notes for Resident # 8 as “P. Ex. 7.”  Similarly, although Petitioner’s exhibit list indicates that “P. Ex. 32” is “Surveyor Notes (96 Pages),” Petitioner marked the 96-page exhibit containing surveyor notes as “P. Ex. 232.”  I refer to the exhibits in question, respectively, as P. Ex. 24 and P. Ex. 32. 

With its submissions, Petitioner listed several witnesses for whom it did not obtain and submit sworn written direct testimony, but rather, submitted as exhibits the “expected testimony” of those witnesses (i.e., statements written by Petitioner about what it expected those witnesses to say); for purposes of summary judgment, I have accepted the veracity of the expected testimony. P. Exs. 3, 9, 11, 41. Petitioner indicated that it planned to request subpoenas for those witnesses in advance of an oral hearing in this case.It is wholly unclear why Petitioner believes a subpoena would be necessary for these witnesses.  Petitioner appears to be under the misapprehension that if a witness is not one of its employees, it need not ask that witness to testify voluntarily.  That is not the standard; pursuant to 42 C.F.R. § 498.58(a), I may issue a subpoena only when it is “reasonably necessary for the full presentation of a case.”  Further, a party seeking issuance of a subpoena must “[s]pecify the pertinent facts the party expects to establish by the witness . . . and indicate why those facts could not be established without use of a subpoena.”  42 C.F.R. § 498.58(c)(3).  In fact, in the expected testimony for E.D. (P. Ex. 3) and Michael Maliszewski (P. Ex. 9), Petitioner stated that both witnesses continued to provide services to Petitioner’s residents and listed its own address as the mailing address for these witnesses.  Therefore, it is unclear why a subpoena compelling these witnesses to testify is necessary, and there is absolutely no indication that these witnesses would not voluntarily testify.  Likewise, Petitioner submitted the expected testimony of Ashley Vecchione (P. Ex. 11) and Gina Malvarosa (P. Ex. 41), indicating that a subpoena to compel their testimony is necessary on the sole basis that neither is an employee of Petitioner.  Again, Petitioner has not claimed, much less demonstrated, that either prospective witness refused to provide written direct testimony, and I add that Petitioner has not submitted any records generated by Ms. Vecchione, who it reports was its “certified recovery coach.”  P. Ex. 11.  Further, I note that after CMS filed a motion for summary judgment with its pre-hearing exchange, Petitioner was on notice that an oral hearing would not be necessary if I ruled favorably on CMS’s motion; Petitioner still did not file a motion seeking issuance of a subpoena.  CMS did not object to those exhibits but did object to those witnesses. Because I

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am granting CMS’s motion for summary judgment, an oral hearing is unnecessary in this case, rendering moot CMS’s objections to those witnesses.

II. Evidentiary Ruling

CMS objects to P. Exs. 5, 13, and 15, which are “affidavits” Petitioner submitted from three of its witnesses, because portions of the affidavits are identical to each other and, according to CMS, “do not appear to set forth individualized opinions by [their] signatories.” CMS does not cite any authority supporting a requirement that affidavits contain “individualized opinions” to be admissible in this proceeding. This may be because the regulations governing this proceeding direct that I “receive[] in evidence the testimony of witnesses and any documents that are relevant and material,” 42 C.F.R. § 498.60(b)(1), even evidence that would be “inadmissible under the rules of evidence applicable to court procedure.” 42 C.F.R. § 498.61. To the extent there is overlap between the affidavits of Petitioner’s witnesses, at most, that is an issue affecting the credibility of the statements contained therein and the weight to be accorded those statements, not the affidavits’ admissibility. It would be especially inappropriate at the summary judgment stage, where I do not weigh evidence or determine credibility, to refuse to consider such evidence. I overrule CMS’s objections to P. Exs. 5, 13, and 15.

As neither party objected to any of the remaining exhibits, I admit all submitted exhibits.

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III. Issues

The issues are:

IV. Findings of Fact, Conclusions of Law, and AnalysisFindings of fact and conclusions of law are in bold and italics.

A. Summary judgment is appropriate because the material facts are not in dispute.

Summary judgment is appropriate when there is no genuine dispute as to any issue of material fact for adjudication and/or the moving party is entitled to judgment as a matter of law. Senior Rehab. & Skilled Nursing Ctr., DAB No. 2300 at 19-20 (2010), aff’d, Senior Rehab. & Skilled Nursing Ctr. v. Health & Human Servs., 405 F. App’x 820 (5th Cir. 2010); see Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). The moving party must show that there are no genuine disputes of material fact requiring an evidentiary hearing and that it is entitled to judgment as a matter of law. Anderson, 477 U.S. at 248. If the moving party meets its initial burden, the non-moving party must “come forward with ‘specific facts showing that there is a genuine issue for trial.’” Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986) (emphasis omitted). “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., DAB No. 2300 at 3. In determining whether there are genuine issues of material fact for hearing, an ALJ must view the evidence in the light most favorable to the non-moving party, drawing all reasonable inferences in that party’s favor. Id.

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) (citing Cedar Lake Nursing Home v. U.S. Dep’t of Health & Human Servs.,

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619 F.3d 453, 457 (5th Cir. 2010)); see Fal-Meridian, Inc. v. U.S. Dep’t of Health & Human Servs., 604 F.3d 445, 449 (7th Cir. 2010) ( “All it means for a decision to be based on a grant of summary judgment is that there are no issues that would benefit from being resolved in an evidentiary hearing.”) (emphasis added); Crestview Parke Care Center, 146 F.3d 425, 428-29 (6th Cir. 2004) (explaining that [t]he statute authorizing the imposition of penalties requires a hearing ‘on the record,’ and that the use of summary judgment is “valid” and “provides an alternative to in-person, oral hearings.”).

The material facts establishing Petitioner’s noncompliance with 42 C.F.R. § 483.25(f)(1), discussed in detail below, are not disputed. Further, Petitioner has not adduced evidence to demonstrate that it returned to substantial compliance earlier than September 12, 2016; to the contrary, Petitioner’s own evidence, in particular the plans of correction it drafted and submitted to the state agency, shows that it remained out of substantial compliance at least until that date. Finally, Petitioner does not dispute, and the evidence supports, the reasonableness of the amount of the CMP imposed by CMS. Therefore, there is no genuine dispute as to any material fact that requires a hearing, and summary judgment in CMS’s favor is warranted.

Resident # 8

Resident # 8 was initially admitted to the facility on October 13, 2015, following a 16-day admission at an acute care hospital. P. Ex. 22 at 1, 7. At the time, Resident # 8 was a 57-year-old homeless man with a reported medical history that included type 2 diabetes with neuropathic complications, a history of osteomyelitis resulting in a below-the-knee amputation of his left leg, colectomy, chronic pain syndrome, a history of polysubstance and injection drug abuse, alcohol dependence, depression, and post-traumatic stress disorder (PTSD). CMS Ex. 4 at 2-7, 12-14, 28-29; P. Exs. 7 at 1 ¶ 3; 15 at 3 ¶ 9; 22 at 1; 23 at 1-2; 24 at 1; 34. Resident # 8 had a prosthetic leg and used a wheelchair to ambulate, which he was able to propel himself. CMS Ex. 4 at 2, 20, 23. Resident # 8’s alcohol dependence and substance abuse history were documented to be “severe,” and he exhibited drug-seeking behavior. He smoked a pack of cigarettes and drank a half gallon of vodka on a daily basis.Resident # 8 reported that he had quit using cocaine and heroin.  CMS Ex. 4 at 3, 6. CMS Ex. 4 at 3, 6, 13, 17, 49-56; P. Exs. 5 at 4 ¶ 11; 24 at 1-2, 4; 34 at 2. At the time of his admission, Resident # 8 was taking a number of medications, to include oxycodone.According to the PubChem website maintained by the National Institute of Health’s U.S. National Library of Medicine’s National Center for Biotechnology Information, oxycodone is a “semi-synthetic, morphine-like opioid alkaloid with analgesic activity.” https://pubchem.ncbi.nlm.nih.gov/compound/Oxycodone (last visited September 23, 2019), citing the National Cancer Institute’s NCIthesaurus website, https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=NCI_Thesaurus&code=C29309. CMS Ex. 4 at 8, 52; P. Ex. 24 at 1.

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The day after Resident # 8’s initial admission, Petitioner developed a care plan containing a variety of mostly pre-printed approaches to address Resident # 8’s “medical cond[ition] polysubstance abuse,” with the general goal that Resident # 8 would “participate in diversional activities (group or individual) daily [for] 90 days.” P. Ex. 25 at 1. Among the approaches listed were “[s]ocial [w]orker consult as needed” and “[p]sych consult as ordered.” P. Ex. 25 at 1. That same day, Petitioner’s social work staff noted, among other things, his history of polysubstance abuse, intravenous drug use, and alcohol dependence, and assessed that he was “triggered for depression and potential for self[-]harm,” although he had no immediate intent or plan to harm himself. P. Ex. 22 at 1. The next day, Petitioner provided Resident # 8 the services of Licensed Mental Health Counselor, “Counselor E.D.”Because Petitioner authored this witness’s testimony and it does not appear that Petitioner offered Counselor E.D. an opportunity to submit her own testimony, I redact her name. CMS Ex. 4 at 28-44; P. Ex. 23. Counselor E.D. conducted a diagnostic evaluation in which she identified his history of depression, alcohol and drug abuse, and PTSD as issues factoring into his need for treatment. CMS Ex. 4 at 28-29; P. Ex. 23 at 1-2. She listed the primary treatment goals to be stabilization of mood, decrease in anxiety, and maintaining sobriety. Petitioner also provided Resident # 8 with the services of a psychiatrist, Dr. Jan Urkevic, who first saw Resident # 8 on October 23, 2015. P. Ex. 24 at 1. Dr. Urkevic assessed that Resident # 8 had “ETOH [alcohol] use [disorder],” “opiate use [disorder],” and “mood disorder [secondary to ETOH].” P. Ex. 24 at 1. Dr. Urkevic also directed that Resident # 8 not be prescribed benzodiazapines or opiate agonists due to “ongoing severe ETOH use [disorder].” P. Ex. 24 at 1.

For the duration of his initial admission, from October 13, 2015 through January 15, 2016, Resident # 8 continued to receive care from social work staff, Counselor E.D., and Dr. Urkevic. P. Exs. 22 at 1-4; 23 at 3-13; 24 at 1-3; see also P. Exs. 1 at 3 ¶ 11; 5 at 4 ¶ 12; 7 at ¶¶ 4, 7; 15 at 3 ¶ 12. Dr. Urkevic’s notes from his three sessions with Resident # 8 discuss Resident # 8’s substance abuse and alcohol dependence problems, including entries that Resident # 8 said that he “love[s] booze” and that he was “focused on pain meds.” P. Ex. 24 at 1-3. Dr. Urkevic also directed that Resident # 8 taper his oxycodone and Ativan use due to his severe abuse history. P. Ex. 24 at 2. By contrast, social work records and progress notes by Counselor E.D. contain little to no mention of any discussion about those problems. P. Exs. 22 at 1-4; 23 at 3-13.Some of the progress notes list Resident # 8’s substance use as a problem from his treatment plan that was addressed in the session, but Counselor E.D.’s progress notes largely omit discussion of Resident # 8’s substance abuse as being a “focus” of those sessions.  P. Ex. 23 at 6-8, 10, 12. Counselor E.D.’s

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progress notes generally focused on Resident # 8’s difficulty coping with his poor physical condition, his numerous health problems (particularly his colostomy), and the challenges of living in a nursing home. P. Ex. 23 at 3-13. A single progress note dated November 7, 2015, memorializes that she discussed with Resident # 8 a change in his medications, which had resulted in an increase in his agitation, frustration, and anger, and that progress note specifically indicates that “[n]o [s]ignificant [c]hanges” related to Resident # 8’s substance use were reported or observed. P. Ex. 23 at 5.

During the initial admission, Petitioner developed two other care plans in addition to the care plan generated the day after his arrival. P. Ex. 25 at 3-6. The second care plan, initiated in early November 2015, contained the same pre-printed goal and approaches as the initial care plan, along with handwritten notes to “set limits” with Resident # 8, send him “in for psych eval” and a nurse practitioner visit, and encourage him specifically to attend alcoholics anonymous (AA) or narcotics anonymous (NA) meetings. P. Ex. 25 at 3. Based on another handwritten note on this care plan, it appears Petitioner developed the care plan in response to Resident # 8’s “multiple violent outbursts[,] x2 in one day.” P. Ex. 25 at 3. Petitioner developed a third care plan, which it initiated on December 29, 2015, to address Resident # 8’s need to follow Petitioner’s drug and alcohol policies, with a stated goal that Resident # 8 would “be free of alcohol/drug intake within the next 90 days.” It contained some pre-printed approaches, which did not entirely mirror those found in the first two care plans, as well as two handwritten approaches (“labs as ordered” and “encourage support groups”). P. Ex. 25 at 5.

On January 15, 2016, Petitioner transferred Resident # 8 to a hospital to undergo a surgical procedure; due to the prolonged length of his hospitalization, Resident # 8 was discharged from the facility. P. Exs. 5 at 4 ¶ 11; 22 at 4, 7. During his hospitalization, on January 28, 2016, Petitioner’s social work staff entered several handwritten notes on his care plans. P. Ex. 25 at 2, 4, 6; see also P. Ex. 7 at 1 ¶ 1. The first handwritten note, which was a stand-alone note on a separate page of the first care plan, states that Resident # 8 “appears to be med[ication] seeking, looking for narcotic [with] angry violent outburst” and instructs staff to “cont[inue] to monitor” him. P. Ex. 25 at 2. Another stand-alone note on the second care plan states that Resident # 8 had increased “anger looking for narcotic increase” and increased “physical aggression.” P. Ex. 25 at 4. A third stand-alone note on a separate page of the third care plan also directed staff to “cont[inue] to monitor” Resident # 8, presumably for the same reason given in the note included in the first care plan. P. Ex. 25 at 6.

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Resident # 8 was readmitted to the facility on February 12, 2016. P. Exs. 5 at 4 ¶ 11; 22 at 5. At that time, he had prescriptions for various opioids,“Opioids are like opiates . . . but are not made from opium . . . [and] used to be called narcotics.”  https://www.cancer.gov/publications/dictionaries/cancer-terms/search?contains=false&q=opioid (last visited September 23, 2019). to include methadone, oxycodone, and hydromorphone (Dilaudid).“Methadone is a synthetic opioid with analgesic activity.”  https://pubchem.ncbi.nlm.nih.gov/compound/Methadone (last visited September 23, 2019).   Hydromorphone, also referred to as Dilaudid, “is the hydrogenated ketone of morphine, a semi-synthetic opioid with analgesic effects.”  https://pubchem.ncbi.nlm.nih.gov/compound/Hydromorphone (last visited September 23, 2019). CMS Ex. 4 at 11-12, 49-50, 52; P. Ex. 24 at 4. Upon returning to the facility, Resident # 8 resumed seeing Counselor E.D., Dr. Urkevic, and social work staff. P. Exs. 22 at 5; 23 at 14; 24 at 4; see also P. Exs. 1 at 3 ¶ 11; 5 at 4 ¶ 12; 7 at ¶¶ 4, 7; 15 at 3 ¶ 12.

Social service progress notes from February 12 and 17, 2016, do not mention any discussion between the social work staff and Resident # 8 about his substance abuse or alcohol dependence problems. P. Ex. 22 at 5. In her first session with Resident # 8 after his return to the facility, conducted on February 18, 2016, Counselor E.D. also did not document any substance abuse or alcohol dependence problems and marked that there were no significant changes reported or observed in his substance use. P. Ex. 23 at 14. However, during Resident # 8’s first visit with Dr. Urkevic, on February 19, 2016, Dr. Urkevic noted that he displayed angry behavior and had recently been pulling at his stoma, his NG (nasogastric) tube, his stitches, and the incision site of his colostomy. CMS Ex. 4 at 27; P. Ex. 24 at 4. Dr. Urkevic further noted that “staff believe[d] all behaviors are an effort to get more pain meds” and that Resident # 8 was “shadowing nurse for pain meds.” CMS Ex. 4 at 27; P. Ex. 24 at 4. Dr. Urkevic also recommended against any dose increase in opioids or benzodiazepines given Resident # 8’s “severe substance abuse” problem. CMS Ex. 4 at 27; P. Ex. 24 at 4.

Not long thereafter, on February 25, 2016, Petitioner initiated a new care plan for Resident # 8 intended to address the “[p]roblem” of his “med seeking” behavior. CMS Ex. 4 at 19; P. Ex. 25 at 7. The plan instructed that Resident # 8 “shall follow [Petitioner’s] policies related to alcohol and/or drugs,” with a goal that he would “be free of alcohol/drug intake within the next 90 days.” CMS Ex. 4 at 19; P. Ex. 25 at 7. As first initiated, the care plan contained five pre-printed approaches for dealing with Resident # 8’s medication-seeking behavior, including the following: “Administer meds as ordered,” “Discourage visitors from bringing alcohol to resident,” “Listen to resident with sympathy. Do not deny the problem,” “Observe after LOA [leave of absence] for

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alcohol/drug use,” and “Observe for signs/symptoms of detox.” CMS Ex. 4 at 19; P. Ex. 25 at 7.

In the months following his readmission, Resident # 8 saw Counselor E.D. approximately weekly and Dr. Urkevic approximately monthly. CMS Ex. 4 at 27, 30-46; P. Exs. 23 at 14-31; 24 at 4-7. In notes for counseling sessions through April 25, 2016, Counselor E.D. consistently reported that there were no significant changes reported or observed in Resident # 8’s substance use. CMS Ex. 4 at 30-40; P. Ex. 22 at 14-25. As with her earlier progress notes (P. Ex. 23 at 3-13), Counselor E.D.’s progress notes from those sessions again generally focused on Resident # 8’s difficulty coping with his poor physical condition, his numerous health problems, and the challenges of living in a nursing home, with none of the sessions focusing directly on his substance abuse. CMS Ex. 4 at 30-40; P. Ex. 22 at 14-25.This despite the fact that a number of progress notes listed Resident # 8’s substance use disorder as a “[p]roblem from [p]lan addressed in session.”  CMS Ex. 4 at 30-31, 33-34, 37-39; P. Ex. 23 at 14-16, 18-19, 22-24.  Just one of the progress notes, from April 11, 2016, indicates an at-best oblique focus on Resident # 8’s alcohol dependence as part of the session focused on Resident # 8’s brother, discussing the “helpfulness of attending AA meetings.”  CMS Ex. 4 at 38; P. Ex. 23 at 23. In an April 1, 2016 visit with Resident # 8, Dr. Urkevic noted that he “remains angry,” smokes, and “wakes up . . . for [as needed] pain meds,” and Dr. Urkevic added a diagnosis of psychosis, not otherwise specified. CMS Ex. 4 at 45; P. Ex. 24 at 5.

Beginning on or around May 1, 2016, Resident # 8 began exhibiting problematic behaviors. A resident ongoing education record indicates that Resident # 8 was caught smoking in his room on or about May 1, 2016, and was educated that “it is not acceptable to smoke in room.” CMS Ex. 4 at 25. A May 5, 2016 progress note by Counselor E.D. indicates that Resident # 8 was smoking in his room “following suspension of smoking privileges [because of an] altercation [with] another resident at smoking time.” CMS Ex. 4 at 42; P. Ex. 23 at 27. In that progress note, Counselor E.D. marked that there was a “Notable Change” in Resident # 8’s substance use, and she specifically explained that this notable change in his substance use was “nicotine-cigarette in room.” CMS Ex. 4 at 42; P. Ex. 23 at 27. On top of these issues, a May 2, 2016 note on Resident # 8’s care plan stated he “continuously attempts to manipulate [nursing staff] to document incorrect times [that his as needed] narc[otic]s are given in order to receive extra doses.” CMS Ex. 4 at 19; P. Ex. 25 at 7.

In addition to the May 1, 2016 education record and May 5, 2016 progress note from Counselor E.D., Resident # 8’s improper smoking and conflict with another resident featured prominently in treatment notes from May 2016. For example, in her May 2, 2016 session, Counselor E.D. focused on Resident # 8’s conflict with another resident, and found the conflict to be a notable change in Resident # 8’s behavior/functioning.

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CMS Ex. 4 at 41; P. Ex. 23 at 26. She also focused on the loss of his smoking privileges in their May 9, 2016 session. CMS Ex. 4 at 43; P. Ex. 23 at 28. In the May 2, May 5, and May 9, 2016 sessions, Counselor E.D. also focused on coping with multiple stressors, particularly the “challenges of living in a [nursing home].” CMS Ex. 4 at 41-43; P. Ex. 23 at 26-28. Social service progress notes from May 5 and May 11, 2016, focused on the conflict between Resident # 8 and another resident and strategies to deal with further conflict. P. Ex. 22 at 8. Dr. Urkevic met with Resident # 8 on May 6, 2016, and discussed both the conflict with another resident and Resident # 8’s improper smoking. CMS Ex. 4 at 46; P. Ex. 24 at 6. However, neither Counselor E.D., Dr. Urkevic, nor social service staff discussed in these notes Resident # 8’s attempts to manipulate nursing staff into giving him more opioids.

Nursing notes on May 16, 2016, document two separate incidents involving Resident # 8, one of which involved a verbal altercation between Resident # 8 and another resident in which Resident # 8 was “yelling [and] swearing [and] verbally threatening” the other resident. CMS Ex. 4 at 22. In the other incident, a nurse was “passing by” Resident # 8’s room and “[n]oted him pounding on his bedside . . . table.” CMS Ex. 4 at 22. When the nurse entered the room, she observed that Resident # 8 “had some white substance in hand wrapped in a dollar bill and [he] quickly swallowed it.” CMS Ex. 4 at 22. Resident # 8 claimed that he had wrapped the pill in a dollar bill because he “was crushing a Colace,”According to the National Institute of Health’s U.S. National Library of Medicine, Colace is a stool softener and has “product characteristics” of being oval-shaped and red in color.  https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7793fced-e8ee-44e2-b212-dd2a59a5f462 (last visited September 23, 2019). but based on the apparent belief that the crushed white substance may be a controlled substance, Petitioner obtained an order for and conducted a room search that revealed he had stored five methadone pills in a napkin inside his prosthetic leg.Petitioner documented that the five pills were each stamped “ASC 116,” which it determined, based on its consultation with the “Drugs.com” website, were 10 mg methadone tablets.  CMS Ex. 4 at 20.  A review of this website entry indicates that a tablet imprinted with “ASC 116” is a white-colored methadone hydrochloride tablet that was manufactured by Ascend Laboratories.  https://www.drugs.com/imprints/asc-116-18926.html (last visited September 23, 2019).  The website entry also states that the labeling for methadone cautions, in pertinent part: “Abuse or misuse of Methadone hydrochloride tablets by crushing, chewing, snorting, or injecting the dissolved product will result in the uncontrolled delivery of the Methadone and can result in overdose and death . . . .”  https://www.drugs.com/pro/methadone.html (last visited September 23, 2019).  Despite the fact that Petitioner witnessed Resident # 8 ingesting a crushed white substance that it appeared to believe was methadone or another controlled substance, the record indicates that Petitioner did not obtain Petitioner’s vital signs until an hour after the incident.  CMS Ex. 4 at 23. CMS

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Ex. 4 at 20, 23-24. An incident report stated that Resident # 8’s prescriptions for Dilaudid and oxycodone “may have contributed to the occurrence” and that Resident # 8 was “also known to regurgitate meds.” CMS Ex. 4 at 24. The incident report indicated that Resident # 8’s doctors “order[ed] to taper down to one pain med[ication]” and placed him on a gradual dose reduction and oral checks to ensure he swallowed his pain medications. CMS Ex. 4 at 24. Petitioner’s staff also educated Resident # 8 on alternative pain management methods and indicated that a “30 day discharge notice will be given.” CMS Ex. 4 at 21, 25-26.

On May 16, May 23, and May 26, 2016, Resident # 8 had counseling sessions with Counselor E.D. Although the progress notes from these sessions list Resident # 8’s substance use disorder as a problem that was addressed in the session, Counselor E.D. marked on each note that there were “No Significant Changes Reported or Observed” related to his substance use. CMS Ex. 4 at 44; P. Ex. 23 at 29-31. In addition to denying any significant changes involving substance abuse, the progress notes documenting the focus of the sessions lacked even the barest reference to the May 16 incident in which Resident # 8 had been caught misusing medication and stockpiling methadone, in that he had crushed, wrapped in a dollar bill (presumably to snort), and ultimately swallowed the substance when caught by Petitioner’s staff, and had also hidden five methadone pills in his prosthetic leg. CMS Ex. 4 at 44; P. Ex. 23 at 29-31. Rather, the focus of the May 16 session was not on substance abuse, but instead on the conflict Resident # 8 had with another resident that day (which was also listed as a “Notable Change” change in his behavior/functioning), coping with stressors like his limited physical condition and the challenges of living in a nursing home, and behavioral strategies for managing distress. CMS Ex. 4 at 44; P. Ex. 23 at 29. In the next session on May 23, the focus was not on substance abuse, but rather was on “[r]ecent angry outbursts” (which was listed as a “Notable Change” in his behavior/functioning), managing conflict with others, and strategies for managing his frustration, which otherwise might escalate to anger or agitation. CMS Ex. 3 at 21; P. Ex. 23 at 30. Finally, the focus of the May 26 session was on coping with multiple stressors, again including his limited physical condition and the challenges of living in a nursing home, and his difficulty interacting with others. P. Ex. 23 at 31. These notes contrast sharply with notes from Dr. Urkevic’s May 20, 2016 meeting with Resident # 8, which focused in large part on Resident # 8’s methadone stockpiling and vehement desire to continue taking opioid painkillers. P. Ex. 24 at 7. They also contrast sharply with Counselor E.D.’s progress notes from sessions with Resident # 8 in July and August 2016, after the initial June 8 survey. CMS Ex. 4 at 57-61, P. Ex. 23 at 32-36. Those sessions all explicitly focused at least in part on helping Resident # 8 avoid another substance abuse relapse and develop strategies to manage stressors and triggers of his substance abuse problem without using substances—including attending AA meetings, which Resident # 8 described as “helpful.” CMS Ex. 4 at 57-61; P. Ex. 23 at 32-36.

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Resident #23

Resident # 23 was initially admitted to the facility on February 18, 2016. CMS Ex. 5 at 1; P. Ex. 33 at 3. At the time, Resident # 23 was a 46-year-old homeless man with a history of alcohol and substance abuse, and diagnoses that included poorly controlled type 1 diabetes due to underlying condition, schizophrenia, tobacco use, chronic viral hepatitis, bipolar disorder, and cocaine dependence, in remission. CMS Ex. 5 at 1, 8; P. Exs. 5 at 4 ¶ 15; 13 at 4 ¶ 14; 15 at 4 ¶ 13; 27 at 1; 33; 35 at 1. Despite his history of alcohol and substance abuse, Resident # 23 reported being sober for two years prior to his admission. CMS Ex. 5 at 4, 8; P. Exs. 5 at 5 ¶ 17; 13 at 4 ¶ 14; 15 at 4 ¶ 13; 27 at 1. Prior to entering the facility, Resident # 23 had an ongoing relationship with an outside psychiatrist, which continued while he resided in the facility. P. Exs. 5 at 4-5 ¶ 15; 7 at 2 ¶ 5; 13 at 4 ¶ 13; 15 at 4 ¶ 14; 28.

On the same day that Resident # 23 was admitted to the facility, Petitioner developed a care plan to address his history of alcohol and drug abuse. CMS Ex. 5 at 3; P. Ex. 26. The care plan, as first initiated, was nearly identical to the February 25, 2016 care plan for Resident # 8’s medication-seeking behavior. Compare CMS Ex. 5 at 19 and P. Ex. 25 at 7 with CMS Ex. 5 at 3 and P. Ex. 26 at 1. The plan instructed that Resident # 23 “shall follow [Petitioner’s] policies related to alcohol and/or drugs” (including a handwritten note that he had a history of cocaine abuse), with a goal that he would “be free of alcohol/drug intake within the next 90 days.” CMS Ex. 5 at 3; P. Ex. 26 at 1. It contained the same pre-printed approaches as Resident # 8’s care plan, as well, including: “Administer meds as ordered,” “Discourage visitors from bringing alcohol to resident,” “Listen to resident with sympathy. Do not deny the problem,” “Observe after [leave of absence] for alcohol/drug use,” and “Observe for signs/symptoms of detox.” CMS Ex. 5 at 3; P. Ex. 26 at 1.

In April 2016, Resident # 23 took a leave of absence from the facility. He returned on April 13, 2016, with a visitor. CMS Ex. 5 at 11; P. Ex. 18 at 1 ¶ 2. The visitor, who acted suspiciously, could not provide identification upon request, and staff contacted police, who escorted the visitor off the property. CMS Ex. 5 at 11; P. Ex. 18 at 1 ¶ 3. For reasons that are not documented in the record, police also searched Resident # 23’s person; the search “did not find any drugs, contraband, or inappropriate items.”Although police searched Resident # 23’s person, there is no indication that police or the facility searched Resident # 23’s room. P. Ex. 18 at 2 ¶ 4. Jessica Plante, one of Petitioner’s registered nurses, states in her written direct testimony that she “was on duty on April 13, 2016.” P. Ex. 18 at 1 ¶ 2. She explains that, at the time Resident # 23 returned, she “was aware . . . that [he] had a history of substance abuse” and “diligently observed his behavior in accordance with his

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care plan.” P. Ex. 18 at 2 ¶ 5. She asserts that she did not observe Resident # 23 to be impaired that day. P. Ex. 18 at 2 ¶ 5.There is no contemporaneous documentary evidence supporting Nurse Plante’s claim that she “diligently” observed Resident # 23 after his return from a leave of absence, as required by his care plan.  Nonetheless, because I decide this case on summary judgment, I accept Nurse Plante’s testimony as true.

Petitioner’s observations of Resident # 23 were quite different only a day later. At approximately 2:00 p.m. on April 14, 2016, Nurse Plante observed Resident # 23 “to have mental status changes, tremors to his upper extremities, slurred speech, difficulty balancing, and slow response times.” P. Ex. 18 at 2 ¶ 6; CMS Ex. 5 at 11. Resident # 23 admitted to Nurse Plante that he had smoked synthetic marijuana in the bathroom, and he tested positive for both THCOn its website, the Food and Drug Administration (FDA) explains that THC is an abbreviation for delta-9-tetrahydrocannabinol, which is a chemical compound of a cannabis plant that is in marijuana, a Schedule I drug pursuant to the Controlled Substances Act (21 U.S.C. § 802(16)).  21 U.S.C. § 812(c).  The FDA noted that marijuana has a “high potential for abuse, which is attributable in large part to the psychoactive effects of THC.”  https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-questions-and-answers (last visited September 23, 2019). and cocaine. CMS Ex. 5 at 11, 12 (“Resident stated that he smoked K2.^[The National Institute on Drug Abuse explains the following with respect to “K2”: “Synthetic cannabinoids are human-made mind-altering chemicals that are . . .  sprayed on dried, shred plant material so they can be smoked . . . . they are not safe and may affect the brain much more powerfully that marijuana; their actual effects can be unpredictable and, in some cases, more dangerous or even life-threatening.”   https://www.drugabuse.gov/publications/drugfacts/synthetic-cannabinoids-k2spice (last visited September 23, 2019).^]”), 14. In accordance with an order from Resident # 23’s nurse practitioner, Petitioner transferred Resident # 23 to the emergency room for evaluation. CMS Ex. 5 at 13. An incident report noted the following preventative measures were taken or recommended in response to the incident: “re-educated on smoking policy[,] drug use[,] and the[ir] interactions safety [sic] and encourage to go to AA/NA meetings. Room search. Contacted Tewksbury State Hospital and other detox centers for assistance. Spoke [with] social worker . . . for alternate placements. Called Medford police.” CMS Ex. 5 at 13. The incident report also noted that Resident # 23’s interdisciplinary team developed the following steps to avoid reoccurrence of the incident: “education, room searches, closely monitor for [changes in] smoke detectors, assessments.” CMS Ex. 5 at 13. However, the only change Petitioner made to Resident # 23’s care plan was to note that he had been re-educated on safety, Petitioner’s smoking

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policy, drug use, and interactions and that staff would encourage him to attend AA meetings. CMS Ex. 5 at 3; P. Ex. 26 at 1. Based on a transportation log entry, it appears that Resident # 23 had an appointment with his psychiatrist the day after the incident. P. Ex. 28 at 1.

Ultimately, Petitioner was unable to find an alternate placement for Resident # 23. Less than three weeks later, on May 3, 2016, staff found him disoriented in the bathroom, which smelled like smoke. Petitioner again transported Resident # 23 to the hospital. CMS Ex. 5 at 15. Upon his return from the hospital the same day, Resident # 23 left the facility against medical advice. CMS Ex. 5 at 15.

Plans of Correction

In response to the surveyors’ findings during the June 8 survey, Petitioner developed a plan of correction (POC) and submitted it to the state agency. CMS Ex. 6. Included in the POC were detailed corrective actions that Petitioner indicated it would take to correct its alleged noncompliance with 42 C.F.R. § 483.25(f)(1) (Tag F319). Among other things, Petitioner wrote that it had audited resident charts to identify the residents who had a history of substance abuse; the residents so identified would, among other things, “have a follow-up visit with Psychiatric services to discuss support and interventions regarding polysubstance abuse” and “be offered weekly sessions with a Licensed Drug and Alcohol Abuse Counselor.” CMS Ex. 6 at 8. Petitioner’s Director of Nursing Services (DON), Denise Belliveau, states in her written direct testimony that she conducted the audit, during which she generated “a list of 49 residents who had a history of prior substance abuse.” P. Ex. 15 at 5 ¶ 19; see also P. Ex. 32 at 65. Petitioner wrote that its “[c]ontracted Psych services [wa]s providing the facility with a Licensed Drug and Alcohol Counselor (LDAC)[ ]to provide weekly therapeutic sessions for residents who have polysubstance abuse or addiction issues.” CMS Ex. 6 at 9. Petitioner also indicated in its POC that it would train its staff with regard to substance abuse, stating: “All licensed staff will receive education from the LDAC/CDAC ^[Presumably, “CDAC” stands for “certified drug and alcohol counselor.”^] on substance abuse, identification, and strategies for success.” CMS Ex. 6 at 7, 10. Petitioner listed July 22, 2016, as the date it would complete the corrective actions to ensure compliance with 42 C.F.R. § 483.25(f)(1) (Tag F319). CMS Ex. 6 at 7.

Prior to the August 24 revisit survey, Petitioner had engaged an LDAC, Gina Malvarosa, to assist it with implementing its POC. LDAC Malvarosa visited the facility four times between the June 8 and August 24 surveys, on July 8, July 11, July 25, and August 4, to conduct intakes for residents who had requested LDAC counseling. CMS Ex. 7 at 8; P. Ex. 32 at 72. She conducted intakes for at least four such residents, but she had not yet begun providing weekly therapeutic sessions to those residents. CMS Ex. 7 at 7-8;

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P. Ex. 32 at 71, 72. LDAC Malvarosa also denied having conducted any training for Petitioner’s staff, although she indicated that she had discussed training with Petitioner’s staff; however, one of Petitioner’s staff members asserted that LDAC Malvarosa in fact had helped conduct an in-service training for Petitioner’s nurses. CMS Ex. 7 at 8; P. Ex. 32 at 72, 74, 76. Training documentation dated July 22, 2016 (the date Petitioner had indicated this POC corrective action would be complete), which Petitioner provided to the surveyors, showed that “19 licensed staff were provided education on substance abuse, identification and strategies of success provided by the CRAC.” CMS Ex. 7 at 8.Presumably, “CRAC” stands for “certified recovery and addiction counselor.”  Separately, I cite to the statement of deficiencies from the August 24 survey as evidence for the in-service trainings provided by Petitioner because neither party submitted direct evidence, such as a sign-in sheet, of those trainings.  The only direct evidence of in-service training that Petitioner provided was an in-service record from a 30-minute training on January 28, 2016, for 17 members of the nursing department that included the topics of “assessing for drug overdose” and “how to administer Nasal Narcan” to treat an overdose.  P. Ex. 20. However, Petitioner’s human resources department provided documentation that “there are 36 licensed staff that are employed by the facility”; based on the fact that only 19 of 36 licensed staff receiving this training, Petitioner failed to provide evidence demonstrating that “[a]ll licensed staff [received] education from the LDAC/CDAC on substance abuse, identification, and strategies for success” by the promised completion date of July 22, 2016. CMS Ex. 7 at 8. 

In response to the surveyors’ findings during the August 24 survey, Petitioner again developed and submitted a POC to the state agency. CMS Ex. 7. As with the first POC, Petitioner included detailed corrective actions that it would take to ensure compliance with 42 C.F.R. § 483.25(f)(1) (Tag F319). In the second POC, Petitioner noted that an LDAC “ha[d] assessed those residents who were identified as having a history of substance abuse,” although it did not indicate precisely when that happened. CMS Ex. 7 at 7. Petitioner also indicated “[a]ll full time licensed staff will receive education on substance abuse, identification, and strategies for success,” which education would “remain ongoing and will also be completed during the orientation process.” CMS Ex. 7 at 6-7. Petitioner listed September 12, 2016, as the date it would complete these corrective actions to ensure compliance with 42 C.F.R. § 483.25(f)(1) (Tag F319). CMS Ex. 7 at 5.

B. Petitioner did not substantially comply with 42 C.F.R. § 483.25(f)(1) because it did not provide appropriate treatment and services for residents with substance abuse issues.

1.   Undisputed evidence shows that Resident # 8 was discovered crushing a white substance that was wrapped up in a dollar bill,

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which he swallowed when discovered in the act, and was also found to be stockpiling opioids.

2.   Undisputed evidence shows that Resident # 23 admitted that he smoked K2 in the facility, which necessitated hospital evaluation that yielded positive toxicology results for both THC and cocaine, and that less than three weeks later, Resident # 23 was again found to be disoriented in a smoky bathroom and required another hospital evaluation.

3.   Undisputed evidence supports that Petitioner did not complete the corrective actions listed in its two plans of correction prior to September 12, 2016.

The quality of care regulation at 42 C.F.R. § 483.25 provides generally that SNFs must provide to each resident “the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care.” To achieve that general goal, a facility must ensure, among other things, that “[a] resident who displays mental or psychosocial adjustment difficulty, receives appropriate treatment and services to correct the assessed problem . . . .” 42 C.F.R. § 483.25(f)(1). CMS’s published interpretive guidance for this requirement gives examples of appropriate treatment that may be provided for residents with mental or psychosocial adjustment difficulty, to include “crisis intervention services; individual, group or family psychotherapy, drug therapy and training in monitoring of drug therapy and other rehabilitative services.” SOM, App’x PP – Guidance to Surveyors for Long Term Care Facilities, Tag F319 (rev. 107, effective April 4, 2014).

Following the June 8 survey, the surveyors determined that Petitioner did not comply with 42 C.F.R. § 483.25(f)(1) because it “failed to provide a comprehensive effective behavioral health program to treat and manage residents’ substance abuse to prevent relapse for 2 . . . of 24 sampled residents [to include Resident # 8 and Resident # 23].” CMS Ex. 6 at 7-8. In a similar vein, CMS charges that Petitioner did not comply with 42 C.F.R. § 483.25(f)(1) because it “failed to identify and implement appropriate individualized interventions to address [Resident # 8’s and Resident # 23’s] history of substance abuse” and further “failed to provide adequate services to address [Resident # 8’s and Resident # 23’s] history of past substance abuse.” CMS Br. at 13. Petitioner does not take issue with the surveyors’ or CMS’s formulation of what 42 C.F.R. § 483.25(f)(1) requires. Instead, Petitioner contends that it complied with that requirement by providing “a level of services in excess of the industry standard of care” to its residents with substance abuse issues, including Resident # 8 and Resident # 23. P. Br. at 17. As I discuss below, however, the undisputed facts demonstrate that Petitioner did not, in fact, provide an effective behavioral health program to treat and manage Resident # 8’s and Resident # 23’s severe substance abuse issues.

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Resident # 8 undisputedly had severe alcohol dependence and substance abuse issues, which Counselor E.D., Dr. Urkevic, and social work staff clearly recognized. CMS Ex. 4 at 3, 6, 13, 17, 28-29, 49-56; P. Exs. 5 at 4 ¶ 11; 22 at 1; 23 at 1-2; 24 at 1-2, 4; 34 at 2. Moreover, Resident # 8 was prescribed and received controlled substances throughout his stay at the facility, particularly upon his readmission in February 2016, at which time he was exhibiting medication-seeking behavior. CMS Ex. 4 at 8, 11-12, 19, 27, 49-50, 52; P. Exs. 24 at 1-4; 25 at 2, 4, 6, 7. Yet prior to the June 8 survey, only Dr. Urkevic, who saw Resident # 8 on a monthly basis, documented ongoing efforts to specifically address Resident # 8’s alcohol and substance abuse issues. CMS Ex. 4 at 27, 45-46; P. Ex. 24. Social work staff did little more than acknowledge those issues and reported that he exhibited medication-seeking behavior while in the hospital in January 2016. P. Ex. 22; see P. Ex. 25 at 2, 4, 6 (care plan entries that Resident # 8 is medication-seeking and was looking for a narcotics increase, along with an unclear reference to “crushing methadone”). In fact, despite the incident involving Resident # 8’s ingestion of crushed medication and the discovery of a stockpile of methadone in his prosthetic leg on May 16, 2016, there are no social services notes dated between May 11, 2016, and October 16, 2016.Petitioner argues in its brief that Resident # 8 “met regularly with Medford social workers who worked to support him in achieving and maintaining sobriety.”  P. Br. at 20.  While Petitioner cites to P. Ex. 22, I note that Petitioner’s reference lacks a pinpoint citation, which is significant owing to the gap in social services documentation between May and October 2016.  P. Br. at 20; P. Ex. 22. P. Ex. 22. And while Counselor E.D. set maintaining Resident # 8’s sobriety as a treatment goal, the notes from her sessions with Resident # 8 between October 2015 through May 2016 largely did not document any direct “focus” on addressing that goal, instead focusing on his problems coping with his poor health and the challenges of living in a nursing home. CMS Ex. 4 at 30-44; P. Ex. 23 at 3-31. In fact, the sole occasion when Counselor E.D. reported that Resident # 8 had a “Notable Change” in his substance use was on May 5, 2016, in which she referred to “nicotine – cigarette in room” (when Resident # 8 was caught smoking in his room). CMS Ex. 4 at 42. Otherwise, Counselor E.D. did not report changes in substance use, even after Resident # 8 was found crushing a white substance that was wrapped in a dollar bill and stockpiling methadone. CMS Ex. 4 at 42-44. Only after the June 8 survey did she begin to report that she focused her efforts on helping Resident # 8 avoid further substance abuse relapses. CMS Ex. 4 at 42-43, 57-61; P. Ex. 23 at 27-28, 32-36.Petitioner’s “expected testimony” of Counselor E.D that “during all visits with residents with histories of substance abuse, she addresses such substance abuse issues, either directly, or indirectly” is not to the contrary and fails to raise a dispute of material facts.  P. Ex. 3.  In fact, with the exception of an April 4, 2016 progress note that documents a “Notable Change” in “Behavioral/Functioning” of “attending AA meetings” and a corresponding reference in the narrative discussion (CMS Ex. 4 at 38), Counselor E.D. did not document any discussion of substance use or abuse when she recorded the “Focus of session and person’s response to interventions” narrative in progress notes prior to June 8, 2016.  CMS Ex. 4 at 28-44; P. Ex. 23.  The only other occasion that Counselor E.D. directly addressed “substance use” was when she reported a “Notable Change” in “Substance Use” on May 5, 2016, after Resident # 8 smoked a cigarette in his room, at which time, in the narrative “Focus of session and person’s response to interventions,” she documented her discussion with Resident # 8 of his nicotine usage.  CMS Ex. 4 at 42.  Therefore, based on Counselor E.D.’s failure to note that any session “focus” was otherwise on substance use or abuse, Counselor E.D. largely addressed substance abuse issues indirectly prior to June 8, 2016, which is not inconsistent with her expected testimony.”  P. Ex. 3.

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As concerning as the foregoing pattern is, the clearest manifestation of Petitioner’s noncompliance with 42 C.F.R. § 483.25(f)(1) occurred in a roughly two-week period in May 2016. The initial triggering event came on May 2, 2016, when Petitioner’s staff added a handwritten note to Resident # 8’s care plan identifying his medication-seeking behavior, saying he “continuously attempts to manipulate [nursing staff] to document incorrect times [that his as needed] narc[otic]s are given in order to receive extra doses.” CMS Ex. 4 at 19; P. Ex. 25 at 7. Yet, despite identifying this problem, Petitioner did not identify any new approaches or interventions to address the problem of the escalation of Resident # 8’s medication-seeking behavior. CMS Ex. 4 at 19; P. Ex. 25 at 7. Further, in the immediate aftermath, neither Counselor E.D., Dr. Urkevic, nor social work staff addressed the escalation, instead focusing on an interpersonal conflict he had with another resident, the suspension of his smoking privileges, and the fact that he was caught smoking in his room. CMS Ex. 4 at 41-43, 46; P. Exs. 22 at 8; 23 at 26-28; 24 at 6; see also CMS Ex. 4 at 25. In essence, Petitioner did nothing to respond to Resident # 8’s escalating medication-seeking behavior beyond documenting that he had medication-seeking behavior.

Unsurprisingly, two weeks later, Resident # 8 was caught crushing a white substance that was wrapped up in a dollar bill and then immediately ingested the substance, and was thereafter found to have a stockpile of five methadone pills hidden in his prosthetic leg. CMS Ex. 4 at 20, 22-24. Counselor E.D. made no mention of this incident in her notes from her sessions with Resident # 8 on May 16 and May 23, 2016, even though she documented Resident # 8’s angry outbursts, difficulty interacting with others, trouble coping with his poor health and the challenges of living in a nursing home, and unspecified change in medications. CMS Ex. 4 at 44; P. Ex. 23 at 29-30.Dr. Urkevic at least discussed the crushing and stockpiling incident with Resident # 8 four days afterward.  P. Ex. 24 at 7. Astonishingly, Counselor E.D. determined that smoking a cigarette in the room was a “Notable Change” in Resident # 8’s substance abuse, yet following the May 16, 2016

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incident in which Resident # 8 crushed and ingested a white substance, and also was discovered stockpiling opioids, she reported no significant change in Resident # 8’s substance use in her progress notes. CMS Ex. 4 at 42, 44; P. Ex. 23 at 29-31. These undisputed facts related to Resident # 8’s escalating medication-seeking behavior, culminating in the discovery of him crushing medication that was wrapped up in a dollar bill and ingesting it when caught, along with his stockpiling of methadone pills in his prosthetic leg, demonstrate that Petitioner failed to provide Resident # 8 with “a level of services in excess of the industry standard of care.” See P. Br. at 17. The undisputed evidence demonstrates that Petitioner failed to ensure that Resident # 8, who “display[ed] mental or psychosocial adjustment difficulty . . . received appropriate treatment and services to correct the assessed problem,” as required by 42 C.F.R. § 483.25(f)(1).

Resident # 23 also had substance abuse issues, particularly involving cocaine abuse, that Petitioner recognized upon his admission to the facility. CMS Ex. 5 at 1, 8; P. Exs. 5 at 4 ¶ 15; 13 at 4 ¶ 14; 15 at 4 ¶ 13; 27 at 1; 33; 35 at 1. Yet when he relapsed during his stay, as evidenced by his admission to smoking K2 and positive toxicology results for both cocaine and THC, Petitioner did little to help him regain sobriety: Petitioner simply “re-educated [him] on smoking policy, drug use and interactions, safety, and encourage[d] to go to AA meetings,” and otherwise contacted the police, looked for other placements, and arranged transportation to his psychiatrist’s office. CMS Ex. 5 at 3, 13; P. Exs. 26 at 1; 28 at 1.Petitioner offered only evidence that it transported Resident # 23 to his psychiatrist’s office on April 15, 2016, not that he in fact saw his psychiatrist for a session.  P. Ex. 28 at 1.  Even inferring from this that Resident # 23 in fact saw his psychiatrist on that date, Petitioner offered no evidence, such as treatment notes or a report of consultation, about what happened or was discussed during the session. The inadequacy of Petitioner’s interventions is evident based on the fact that only weeks after Resident # 23 was transferred to the hospital on April 14, 2016, as a result of mental status changes after smoking K2 (CMS Ex. 5 at 11, 14), he again required hospital evaluation on May 3, 2016, after Petitioner found him disoriented in a bathroom that smelled like smoke. CMS Ex. 5 at 15. As with Resident # 8, these undisputed facts related to Resident # 23’s relapse and the aftermath, especially when viewed in conjunction with Petitioner’s deficient care of Resident # 8, undermine Petitioner’s contention that it provided Resident # 23 with “a level of services in excess of the industry standard of care.” See P. Br. at 17. To the contrary, these facts demonstrate that Petitioner failed to ensure that residents who “display[ed] mental or psychosocial adjustment difficulty . . . received appropriate treatment and services to correct the assessed problem,” as required by 42 C.F.R. § 483.25(f)(1).

The undisputed evidence shows that Petitioner failed to ensure that Resident # 8 and Resident # 23 received the treatment and services they needed for their assessed mental or psychosocial adjustment difficulties. Petitioner’s failure had the potential to cause

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more than minimal harm—and indeed caused or contributed to actual harm—to Resident # 8 and Resident # 23 in the form of the negative health effects of a drug abuse relapse. Therefore, Petitioner did not substantially comply with 42 C.F.R. § 483.25(f)(1).The parties addressed another deficiency involving care planning that was cited under 42 C.F.R. § 483.20(d).  As I previously explained, I need not address this issue.  See Claiborne-Hughes Health Ctr. v. Sebelius, 609 F.3d 839 at 847.  However, assuming, for the sake of discussion, that Petitioner fully complied with the care plans it developed for these two residents, then the care plans did not yield adequate treatment and services for residents with substance abuse as required by section 483.25(f)(1).

C. Petitioner has not raised a genuine dispute as to the date it returned to substantial compliance, and CMS’s determination as to the duration of Petitioner’s noncompliance is appropriate.

Following the August 24 survey, the surveyors alleged that Petitioner remained out of compliance with 42 C.F.R. § 483.25(f)(1) because it “failed to operationalize a comprehensive effective behavioral health plan to treat and manage residents with substance abuse and prevent relapse as alleged in the Plan of Correction” Petitioner submitted following the June 8 survey. CMS Ex. 7 at 5. By contrast, Petitioner asserts that, even assuming it was not in substantial compliance with program requirements, it corrected its noncompliance (i.e., returned to substantial compliance) as of either July 22 or August 24, 2016. P. Br. at 2, 15. Petitioner neither identifies a specific date that it returned to compliance, nor cites to any evidence supporting such a claim.

Returning to substantial compliance means not only that the facility corrected the specific cited instances of substantial noncompliance but also that it implemented a plan of correction designed to assure that no additional incidents would occur in the future. See North Las Vegas Care Ctr., DAB No. 2946 at 2 (2019) (“If a survey reveals that a SNF is not in substantial compliance with Medicare participation requirements, the SNF must promptly submit a plan of correction acceptable to the state survey agency or CMS . . . [a] plan of correction specifies the remedial measures the SNF has taken, or intends to take, to correct the cited deficiencies as well as a timetable for completion of corrective action.”) (internal citations omitted). Once a facility is found to be out of substantial compliance, it remains so until it affirmatively demonstrates that it has achieved substantial compliance once again. Premier Living & Rehab Ctr., DAB No. 2146 at 23 (2008); Lake City Extended Care Ctr., DAB No. 1658 at 12-15 (1998). The burden is on the facility to prove that it is compliant with program requirements, and not on CMS to prove that deficiencies continued to exist after they were discovered. Asbury Ctr. at Johnson City, DAB No. 1815 at 19-20 (2002); see also Grace Living Ctr. – Northwest OKC, DAB No. 2633 at 3 (2015) (citing Owensboro Place & Rehab. Ctr., DAB

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No. 2397 at 12 (2011)). Noncompliance found during a survey is “presumed to continue until the facility demonstrates it has achieved substantial compliance.” Taos Living Ctr., DAB No. 2293 at 20 (2009). “The Board has long rejected as contrary to the goals of the program the notion[] . . . that a facility can belatedly claim to have achieved substantial compliance at a date earlier than it even alleged that it had done so . . . .” Cal Turner Extended Care Pavilion, DAB No. 2030 at 18 (2006). Furthermore, the Board has rejected the “claim that steps short of those which the facility itself identified as necessary for it to correct the problems found (and to achieve substantial compliance) should nevertheless be accepted as adequate to require lifting the remedies imposed.” Id. at 19.

Petitioner fails to support its conclusory assertion that “any non-compliance that might be found was corrected on or before July 22, 2016 or August 24, 2016.” P. Br. at 15. Petitioner’s arguments solely focus on its erroneous belief that it was in substantial compliance at all times, and it makes no specific argument and points to no evidence supporting a finding that it achieved substantial compliance any earlier than September 12, 2016. In pursuing this course, Petitioner has failed to raise a “genuine” dispute of fact because it has failed to “come forward with ‘specific facts showing that there is a genuine issue for trial,’” Matsushita, 475 U.S. at 587, regarding the duration of its noncompliance. For this reason alone, I could grant summary judgment favoring CMS regarding the duration of Petitioner’s noncompliance.

In any event, the evidence, even when viewed in the light most favorable to Petitioner, does not support a finding that Petitioner returned to substantial compliance before September 12, 2016. As part of its initial POC following the June 8 survey, Petitioner stated that, to correct its noncompliance with 42 C.F.R. § 483.25(f)(1) (Tag F319) by July 22, 2016, it would, among other things, do the following:

(1) offer weekly counseling sessions with an LDAC to any residents with a history of substance abuse,

(2) obtain the services of an LDAC “to provide weekly therapeutic sessions for residents who have polysubstance or addiction issues,” and

(3) provide all licensed staff with training by the LDAC or CDAC on substance abuse, identification, and strategies for success.

CMS Ex. 6 at 8-10. Petitioner identified 49 such residents (CMS Ex. 7 at 6; P. Exs. 15 at 5 ¶ 19; 32 at 65), yet the undisputed evidence shows that LDAC Malvarosa had conducted only a handful of resident intakes (at least four) prior to the August 24 survey and had not even begun providing weekly therapeutic sessions to those residents by that time. CMS Ex. 7 at 7-8; P. Ex. 32 at 72.Given that 49 residents were eligible for LDAC counseling, it is unclear whether only four residents had expressed interest in such services; indeed, some evidence suggests that far more than four residents requested LDAC counseling—perhaps as many as 25.  CMS Ex. 7 at 8 (“The LDAC said she was aware that there were ‘quite a few residents needing services’ . . . .”); P. Ex. 32 at 73, 76.  A failure even to have the LDAC conduct intakes for residents interested in LDAC counseling before the August 24 survey would further evidence lack of completion of Petitioner’s POC for the June 8 survey.  However, DON Belliveau states in her written direct testimony that she “offered the services of LDAC [sic] to all of the 49 residents” who had a history of substance abuse, “[m]ost residents who were offered the services of the LDAC rejected such services,” and “[t]he LDAC assessed each of the residents who accepted her services.”  P. Ex. 15 at 5 ¶¶ 19-20.  This testimony is rather vague, giving no dates and lacking a precise enumeration of how many residents rejected or accepted LDAC counseling, and is not supported by any contemporaneous documentary evidence, such as medical records, nursing notes, or other sources.  Nevertheless, because I decide this case on summary judgment, I only point out my observations without ascribing any particular significance to them.  In the end, it is not material whether Petitioner offered LDAC counseling to all 49 residents by the POC’s completion date (July 22, 2016) or whether 45 of those residents rejected this counseling.  Regardless, as of the August 24 survey, Petitioner had not obtained the services of an LDAC to provide weekly counseling sessions to the (at least) four residents for whom the LDAC conducted intakes, despite its inclusion as a corrective action in its initial POC. In addition, undisputed evidence shows that,

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at a minimum, as of the August 24 survey, almost half of Petitioner’s licensed staff had not received training from LDAC Malvarosa or a CDAC/CRAC. CMS Ex. 7 at 8; P. Ex. 32 at 72, 74, 76.Petitioner’s second POC, following the August 24 survey, supports this insofar as Petitioner once again listed as a corrective action that “[a]ll full time licensed staff will receive education on substance abuse, identification, and strategies for success.”  CMS Ex. 7 at 6-7.  Petitioner would have had little reason to include this same corrective action if it had already been completed prior to the August 24 survey.

Notably, although Petitioner drafted and submitted as “evidence” the “expected testimony” of LDAC Malvarosa, it did not even propose that LDAC Malvarosa would testify that, prior to either July 22 or August 24, 2016, she had trained all of Petitioner’s licensed staff and begun providing weekly therapeutic sessions to the residents who had requested them. P. Ex. 41. Even having authored this testimony on behalf of LDAC Malvarosa, Petitioner could only muster vague phrases, such as that Petitioner “offered her services to all residents who were then-identified as having histories of substance abuse” without explaining when she offered those services. P. Ex. 41 at 1. Likewise, the expected testimony stated, “she provided services to all such residents who accepted her services,” without explaining which services she provided and which residents accepted her services. P. Ex. 41 at 1. The expected testimony of LDAC Malvarosa fails to create

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any dispute of fact regarding the duration of Petitioner’s noncompliance, much less a genuine dispute involving a material fact.

The above-discussed undisputed facts show that Petitioner did not complete the corrective actions it identified in its initial POC as necessary to correct its noncompliance with 42 C.F.R. § 483.25(f)(1) (Tag F319) prior to July 22 or August 24, 2016, despite what it offered in its initial POC. By extension, therefore, Petitioner had not returned to substantial compliance by July 22 or August 24, 2016, and Petitioner failed to explain otherwise in its brief. Cal Turner, DAB No. 2030 at 19; Libertyville Manor Rehab. & Healthcare Ctr., DAB No. 2849 at 14 (2018) (A facility “cannot be considered to have corrected a deficiency and achieved substantial compliance based on remedial measures short of those specified in its plan of correction.”). Absent evidence to the contrary, the earliest date I could find to be the date by which Petitioner returned to substantial compliance is the completion date listed in its second POC—September 12, 2016. CMS Ex. 7 at 5; see Cal Turner, DAB No. 2030 at 18. CMS determined that Petitioner returned to substantial compliance on that date. CMS Ex. 3 at 1. I therefore sustain CMS’s determination regarding the duration of Petitioner’s noncompliance.

D. Petitioner does not challenge the remedies imposed, and the CMP and DPNA imposed are reasonable.

If a facility is not in substantial compliance with program requirements, CMS has the authority to impose one or more of the enforcement remedies listed in 42 C.F.R. § 488.406, including a DPNA or a CMP. Act § 1819(h)(2)(B) (42 U.S.C. § 1395i-3(h)(2)(B)); 42 C.F.R. §§ 488.417(a), (b), 488.430(a). CMS must impose a DPNA against a facility that has been out of compliance for three months after the conclusion of a survey identifying noncompliance. Act § 1819(h)(2)(D) (42 U.S.C. § 1395i-3(h)(2)(D)); 42 C.F.R. § 488.417(b)(1). Payment does not resume until the facility achieves substantial compliance. Act § 1819(h)(3) (42 U.S.C. § 1395i-3(h)(3)); 42 C.F.R. § 488.417(d). Petitioner’s noncompliance began at least as early as June 8, 2016, and I have determined that Petitioner did not achieve substantial compliance until September 12, 2016. Thus, a DPNA beginning September 8, 2016, three months after the conclusion of the June 8 survey, and running through September 11, 2016, was required by statute and is reasonable as a matter of law.

In its briefing, Petitioner does not dispute the CMP. Nonetheless, I will examine whether the amount of the CMP is reasonable by applying the factors listed in 42 C.F.R. § 488.438(f): 1) the facility’s history of noncompliance; 2) the facility’s financial condition; 3) the 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 listed 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

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facility’s prior history of noncompliance in general and specifically with reference to the cited deficiencies.

The regulations specify that a CMP imposed against a facility on a per-day basis will fall into one of two ranges.The applicable CMP range increased to $103 to $6,188, beginning August 1, 2016, for deficiencies cited after November 2, 2015, to “reflect the statutorily mandated amounts and ranges as adjusted for inflation.”  See 81 Fed. Reg. 61,538, 61,573-61,574 (Sept. 6, 2016); 45 C.F.R. § 102.3.  The cost-of-living adjustment was mandated pursuant to the Federal Civil Penalties Inflation Adjustment Improvements Act of 2015, 104 Pub. L. No.  114-74, which was enacted on November 2, 2015.  The Secretary determined that the new CMP amounts would apply to any CMP imposed on or after September 6, 2016, regardless of the date of the survey, so long as the noncompliant conduct occurred on or after November 2, 2015.  See S&C: 16-40-NH/HHA/CLIA (Sept. 8, 2016), https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-16-40.pdf, last visited February 19, 2019; 81 Fed. Reg. 61,538 (discussing that the law “provides a clear formula for adjustment of the civil monetary penalties, leaving agencies little room for discretion,” and that the increased penalties will apply to “penalties assessed after August 1, 2016, whose associated violations occurred after November 2, 2015, the date of  enactment of the 2015 Amendments.”).  Because the CMP was initially imposed on July 28, 2016, I apply the CMP range that was in effect at that time. 42 C.F.R. §§ 488.408; 488.438. The upper range of a CMP, $3,050 per day to $10,000 per day, is reserved for deficiencies that pose immediate jeopardy to a facility’s residents and, in some circumstances, for repeated deficiencies. 42 C.F.R. § 488.438(a)(1)(i), (d)(2). The lower range of CMP, $50 to $3,000 per day, is reserved for deficiencies that do not pose immediate jeopardy, but either cause actual harm to residents, or cause no actual harm but have the potential for causing more than minimal harm. 42 C.F.R. § 488.438(a)(1)(ii). In assessing the reasonableness of a CMP amount, the per-day amount, rather than the total accrued CMP, is at issue. See Kenton Healthcare, LLC, DAB No. 2186 at 28 (2008). Pursuant to 42 C.F.R. § 488.408(g)(2), a facility cannot appeal CMS’s choice of a remedy, and an appeal of a CMP is limited to review based on the regulatory factors set forth at 42 C.F.R. §§ 488.438(f) and 488.404(a)-(c). See, e.g., Senior Rehab., DAB No. 2300 at 19-20.

I must sustain a CMP unless a particular regulatory factor does not support the CMP amount imposed by CMS. Coquina Ctr., DAB No. 1860 at 32 (2002). CMS imposed a $1,850 per-day CMP effective June 8 through September 11, 2016. 42 C.F.R. § 488.438(a)(1)(ii); CMS Ex. 3 at 1. Petitioner does not dispute that this amount, which is slightly more than half the maximum penalty in the lower range, is reasonable. P. Br. 24. For this reason alone, I could find that the CMPs imposed are reasonable. Petitioner’s noncompliance was serious and failed to meet the needs of two vulnerable residents who had substance abuse problems prior to and during their admission to the

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facility. Even when viewing the evidence in the light most favorable to Petitioner, I cannot conclude but that Petitioner neglected the needs of these vulnerable residents. These factors amply justify a $1,850 per day CMP.

V. Conclusion

For the reasons discussed above, I find that CMS imposed reasonable enforcement remedies for Petitioner’s substantial noncompliance with Medicare requirements.