The Oaks, DAB CR5285 (2019)

DECISION

The Oaks (Petitioner or “the facility”) is a skilled nursing facility located in New Bedford, Massachusetts, that participates in the Medicare program. Following a survey that was completed on October 7, 2016, the Centers for Medicare & Medicaid Services (CMS) determined that the facility was not in substantial compliance with Medicare program participation requirements. CMS imposed a civil money penalty (CMP) of $1,103 per day for 109 days of noncompliance, for a total CMP of $120,227.

In its request for hearing, Petitioner contested the deficiencies cited under 42 C.F.R. § 483.20(k)(3)(i) (Tag F281 (professional standards of quality)) and 42 C.F.R. § 483.25(m)(2) (Tag F333 (significant medication errors)). For the reasons discussed below, I find that there is 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.

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I. Background

The Social Security Act (Act) establishes requirements for skilled nursing facility (SNF) participation in the Medicare program and authorizes the Secretary of Health and Human Services (“the Secretary”) to promulgate regulations implementing those statutory provisions. See 42 U.S.C. § 1395i-3; 42 C.F.R. pts. 483 and 488. To participate in the Medicare program, an SNF must maintain substantial compliance with program participation requirements. In order to be in substantial compliance, an SNF’s deficiencies may “pose no greater risk to resident health or safety than the potential for causing minimal harm.” 42 C.F.R. § 488.301. “Noncompliance” means “any deficiency that causes a facility to not be in substantial compliance.” Id.

The Secretary contracts with state agencies to conduct periodic surveys to determine whether SNFs are in substantial compliance with participation requirements. 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. 42 U.S.C. § 1395i-3(g)(2)(A); 42 C.F.R. §§ 488.20(a), 488.308. 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 U.S.C. § 1395i-3(h)(2)(B)(ii); 42 C.F.R. § 488.430(a).The per-day CMP range applicable to this case is $103 to $6,188, which “reflect[s] 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 inflation adjustment was mandated pursuant to the Federal Civil Penalties Inflation Adjustment Improvements Act of 2015, 104 Pub. L. No. 114-74, § 701.  The Secretary determined that inflation-adjusted 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 Mar. 15, 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.”).

If CMS imposes a remedy based on a noncompliance determination, then the facility may request a hearing before an administrative law judge (ALJ) to challenge the noncompliance finding and enforcement remedy. 42 U.S.C. §§ 1320a-7a(c)(2), 1395i‑3(h)(2)(B)(ii)); 42 C.F.R. §§ 488.408(g), 488.434(a)(2)(viii), 498.3(b)(13).

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The Commonwealth of Massachusetts, Department of Health, Division of Health Care Facility Licensure and Certification (state agency), completed a survey at Petitioner’s facility on October 7, 2016, and cited, as relevant here, noncompliance with 42 C.F.R. § 483.20(k)(3)(i)Federal nursing home regulations substantially changed beginning on November 28, 2016.  81 Fed. Reg. 68,688 (Oct. 4, 2016).  I cite to the version of the regulations in effect at the time of the survey.  In addition, CMS revised the F-Tags in November 2017, and I refer to the deficiencies under the F-Tags that were in effect at the time of the survey.  See List of Revised F-Tags, https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/GuidanceforLawsAndRegulations/Downloads/List-of-Revised-FTags.pdf (last visited Mar. 15, 2019). (Tag F281 (professional standards of quality)) and 42 C.F.R. § 483.25(m)(2) (Tag F333 (significant medication errors)) 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, § 7400.3.1 (Matrix for Scope & Severity), https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/som107c07.pdf (last visited Mar. 15, 2019); see 42 C.F.R. § 488.408.  As relevant here, a scope and severity level of “G” corresponds to a deficiency that involves actual harm that does not amount to immediate jeopardy. CMS Exhibit (Ex.) 1. In a letter dated January 11, 2017, CMS informed Petitioner that it would impose, inter alia, a per-day CMP of $1,103 from July 18 through November 3, 2016.CMS imposed a prohibition against the provision of a nurse aide training and competency evaluation program (NATCEP) for a two-year period.  CMS Ex. 1 at 4.  Petitioner “did not operate a NATCEP at the pertinent time, so that that remedy is not at issue in this appeal.”  P. Br. at 4. CMS Ex. 1 at 1.

Petitioner timely requested a hearing on March 7, 2017. Pursuant to my Acknowledgment and Pre-Hearing Order (Pre-Hearing Order), CMS filed a pre-hearing brief with incorporated motion for summary judgment, along with 21 proposed exhibits (CMS Exs. 1-21), and Petitioner filed a pre-hearing brief and response to CMS’s motion for summary judgment and sixteen proposed exhibits (P. Exs. 1‑16). I granted the parties an opportunity to submit additional briefing, and CMS filed a reply and Petitioner filed a response (P. Response) to CMS’s reply.

In my Pre-Hearing Order, I explained that “[a] party must exchange as a proposed exhibit the complete, written direct testimony of any proposed witness.” Pre‑Hearing Order, § 8. I further explained that a party has the right to cross-examine any witness for whom direct testimony has been offered. Pre‑Hearing Order, § 9. In compliance with my Pre‑Hearing Order, the parties submitted the written direct testimony of several witnesses

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(CMS Exs. 20 and 21, and P. Exs. 15 and 16). Both parties requested an opportunity to cross-examine the opposing party’s witnesses. As I rely on undisputed material facts in granting CMS’s motion for summary judgment, a hearing for the purpose of cross-examination of witnesses is unnecessary.

II. Issues

The issues presented are:

Whether summary judgment is appropriate;

Whether Petitioner was in substantial compliance with 42 C.F.R. §§ 483.20(k)(3)(i) and 483.25(m)(2);

If Petitioner was not in substantial compliance, whether a per-day CMP of $1,103 from July 18 through November 3, 2016, is reasonable.

III. Discussion

A. Summary judgment is appropriate because material facts are not in dispute.Findings of fact and conclusions of law are in bold and italics.

Summary judgment is appropriate when there is no genuine dispute as to any issue of material fact for adjudication and 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 issues 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, 475 U.S. 574, 587 (1986). “To defeat an adequately supported summary judgment motion, the non-moving party may not rely on the denials in its pleadings or briefs, but must furnish evidence of a dispute concerning a material fact – a fact that, if proven, would affect the outcome of the case under governing law.” Senior Rehab., 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.

Petitioner does not dispute any of the following material facts cited by CMS in its motion for summary judgment:

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• Resident # 8 had a physician’s order prescribing 75 mg of MS Contin (one 60 mg tablet and one 15 mg tablet) by mouth three times daily in the morning, afternoon, and nighttime;
• MS Contin’s labeling includes boxed warnings that patients should be instructed to take tablets whole to avoid exposure to a potentially fatal dose of morphine and that crushing MS Contin tablets can cause the rapid release and absorption of a potentially fatal dose of morphine;
• On July 18, 2016, a nurse administered three crushed 60 mg tablets of MS Contin, along with one uncrushed 60 mg MS Contin tablet and one uncrushed 15 mg MS Contin tablet, for a total dose of 255 mg of MS Contin;
• Vital signs obtained after the overdose included a hypotensive blood pressure measurement of 86/46 mmHg, and an on-call physician ordered that Resident # 8 be transferred to the hospital by ambulance;
• While at the hospital, Resident # 8 reported being in a euphoric mood, which is a listed common adverse reaction to MS Contin, and the hospital physician diagnosed an accidental narcotic overdose;
• On July 23, 2016, a different nurse administered crushed MS Contin tablets to Resident # 8.

Petitioner “stipulates that a nurse did make a medication error, but . . . disputes the nature, severity and effect of that error.” P. Br. at 7. The relevant material facts are that on at least two occasions, Petitioner administered crushed MS Contin to Resident # 8 in contravention of the boxed warning on the medication’s labeling, and on one of those occasions it administered more than three times the prescribed dose of MS Contin, which resulted in her transfer to a hospital. Petitioner does not dispute these facts and summary judgment is appropriate in favor of CMS.

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B. Petitioner does not dispute CMS’s argument that it was not in compliance with 42 C.F.R. § 483.20(k)(3)(i).

CMS argues that “Petitioner did not meet the regulatory requirements of 42 C.F.R. § 483.20(k)(3)(i) when it failed to comply with its own policies and applicable clinical guidelines, state law, physician’s orders, and the medication’s label.” CMS Br. at 16. In support, CMS explained that “Petitioner trained its staff on the clinical guideline ‘the 8 Rights of Medication Administration for Nurses’ published in the Nursing 2012 Drug Handbook issued by Lippincott, Williams & Wilkins, thus indicating that it was its policy to follow the guideline when administering medication.” CMS Br. at 16, citing CMS Ex. 10 (Reportable Event of 7-18-16) (explaining that to prevent reoccurrence, Petitioner re-educated its licensed nursing staff on the “8 Rights of Medication Administration”); see CMS Ex. 2 (plan of correction reporting that “Nursing staff was re-educated on the six rights of medication administration.”). CMS also cited provisions of the Code of Massachusetts Regulations, to include the requirement that nurses “incorporate the prescribed medical regimen into the nursing plan of care.” CMS Br. at 16, citing 244 C.M.R. § 3.04 (CMS Ex. 18 at 2). CMS also cited a statement in the Reportable Event narrative in which the nurse who administered the overdose on July 18, 2016, admitted that “she didn’t follow the accepted standards of nursing practice related to medication administration.”The Incident Report form regarding the July 18, 2016 incident likewise reports the following: “The nurse was interviewed on 7/19/2016 and she stated she did not follow the accepted standards of nursing practice related to medication administration” and that she “tendered her resignation voluntarily effective immediately.” CMS Ex. 19 at 1. CMS Br. at 18, citing CMS Ex. 10. Petitioner does not argue in its briefing that it substantially complied with section 483.20(k)(3)(i), nor does it dispute CMS’s arguments that it failed to comply with its own policy regarding professional standards of quality. In the absence of any argument by Petitioner regarding this deficiency, I uphold CMS’s determination that Petitioner did not substantially comply with 42 C.F.R. § 483.20(k)(3)(i).

C. Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(m)(2).Although the per-day CMP at the low end of the penalty range is supported alone by the deficiency cited under 42 C.F.R. § 483.20(k)(3)(i), I nonetheless address Petitioner’s significant medication error.

The opening provision of 42 C.F.R. § 483.25 (quality of care), which implements section 1819(b)(2) of the Act, requires:

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Each resident must receive and the facility must provide 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.

As part of the quality of care requirement, a facility “must ensure that . . . [r]esidents are free of any significant medication errors.” 42 C.F.R. § 483.25(m)(2).

During the rulemaking process that implemented section 483.25(m)(2), several commenters requested that the Secretary provide a definition of “significant medication error.” 56 Fed. Reg. 48,826, 48,853 (Sept. 26, 1991). In response, the Secretary provided three factors for consideration:

A significant medication error is judged by a surveyor, using factors which have been described in interpretive guidelines since May 1984. The three factors are: (1) Drug category. Did the error involve a drug that could result in serious consequences for the resident? (2) Resident condition. Was the resident compromised in such a way that he or she could not easily recover from the error? (3) Frequency of error. Is there any evidence that the error occurred more than once?

Id. The Secretary explained that these factors had been used in interpretive guidelines dating back to May 1984. Id. The final rule explained that “medication errors vary in their significance (e.g., from significant errors such as a double dose of a potent cardiac drug like digoxin to a small error in the dose of an antacid like milk of magnesia),” and that “if a facility has a significant medication error, then it is sanctioned.” Id. The rulemaking gave the following example of a significant medication error: “A resident received twice the correct does of digoxin, a potentially toxic drug. The resident already had a slow pulse rate, which the drug would further lower. The error occurred three times last week.” Id.

The interpretive guidelines found in the State Operations Manual explain that a “significant medication error” is “one which causes the resident discomfort of jeopardizes his or her health or safety.”This language is contained in the version of the State Operations Manual that was in effect at the time of the survey. Pub. 100-7, Appendix PP, § F760 https://www.cms.gov/medicare/provider-enrollment-and-certification/guidanceforlawsandregulations/downloads/appendix-pp-state-operations-manual.pdf (last visited Mar. 15, 2019). The current version of the State Operations Manual includes a list of examples of medication errors, along with classifications of whether such errors would be “significant” or “insignificant”; a medication error

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involving the administration of twice the prescribed dose of morphine sulfateThe medication’s labeling alternatively identifies MS Contin as “morphine sulfate extended-release tablets.” CMS Ex. 5 at 5. is listed as an example of a significant medication error. Id

In Blossom South Nursing & Rehab Ctr., DAB No. 2578 at 18 (2014), the Departmental Appeals Board (DAB), citing its own decisions, discussed that it “has held that actual harm is not a prerequisite for concluding that a medication error was significant.”

I make the following factual findings that will be more fully addressed below:

1. 1. Resident # 8 had a physician’s order prescribing 75 mg of MS Contin (one 60 mg tablet and one 15 mg tablet) by mouth three times daily in the morning, afternoon, and nighttime;
2. 2. MS Contin’s labeling includes boxed warnings that patients should be instructed to take tablets whole to avoid exposure to a potentially fatal dose of morphine and that crushing MS Contin tablets can cause the rapid release and absorption of a potentially fatal dose of morphine;
3. 3. At approximately 9:15 pm on July 18, 2016, a nurse administered three crushed 60 mg tablets of MS Contin to Resident # 8, along with one uncrushed 60 mg tablet of MS Contin and one uncrushed 15 mg tablet of MS Contin, for a total dose of 255 mg of MS Contin;
4. 4. Vital signs obtained after the overdose included a blood pressure measurement of 86/46 mmHg, which is lower than the threshold for a hypotensive blood pressure reading, and an on-call physician ordered that she be transferred to a hospital by ambulance;
5. 5. Resident # 8 reported a “euphoric mood” at the hospital, and the hospital physician provided a final diagnosis of an accidental narcotic overdose;
6. 6. On July 23, 2016, a different staff member administered crushed MS Contin to Resident # 8.

Resident # 8 was 55 years old at the time of her admission on December 11, 2015. CMS Ex. 3. Her diagnoses included corticobasal degeneration, chronic pain, chronic obstructive pulmonary disease, ataxia, anxiety disorder, idiopathic peripheral autonomic neuropathy. CMS Ex. 3.

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On April 6, 2016, Resident # 8’s physician, Dr. Restituyo, ordered that she be given a 60 mg tablet and 15 mg tablet of MS Contin three times daily at 6:00 am, 2:00 pm, and 10:00 pm. CMS Ex. 4 at 2. Dr. Restituyo had previously ordered that staff “[m]ay crush meds and add to food if not in conflict with crushing guidelines [e]very shift.” CMS Ex. 4 at 1.

CMS submitted the labelingWith respect to prescription medication, “‘labeling’ means all labels, all other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.” 21 U.S.C. § 321(m). for MS Contin. CMS Ex. 5 at 1-16. The first half page of information contains the “HIGHLIGHTS OF PRESCRIBING INFORMATION,” which includes a “boxed warning” that has been included in the labeling for MS Contin since April 2014. CMS Ex. 5 at 1; see https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019516s042lbl.pdf (last visited Mar. 15, 2019); see also 21 C.F.R. § 201.56, 201.57. The boxed warning cautions:

CMS Ex. 5 at 1 (bold, capitalization, and italics in original). The full prescribing information for MS Contin includes a separate and a complete “boxed warning” that provides additional information, to include the following information:

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CMS Ex. 5 at 3.

Petitioner does not dispute that, on July 18, 2016, one of its nurses “administered an accidental overdose of a narcotic pain medication” to Resident # 8. P. Br. at 2. The nurse who administered the overdose provided the following report that same evening:

On 7/18/16 at approximately 9:15 pm I administered medications to [Resident # 8]. I accidentally administered three tab[let]s of MS Contin [extended release (ER)] 60 mg ea[ch] & crushed them along with one tab[let] MS Contin ER 60 mg uncrushed and MS Contin ER 15 mg uncrushed. Resident also takes Valium 5 mg three tab[let]s at this time which was not given to her because I accidentally popped t[w]o MS Contin 60 mg ER instead of the valiums. I realized the error while I was signing out her medications. During this time there was a lot of confusion at the Nurses Station. Two residents were consistently getting up and their alarms were constantly beeping and we had only two [nursing] assistants on the [floor] at that time. . . .

CMS Ex. 9. In a “Reportable Event” report, Petitioner provided the following summary regarding the July 18, 2016 overdose:

At approximately 9:15pm a nurse administered three tablets MS Contin ER 60mg crushed, along with one tab[let] MS Contin ER 60mg uncrushed and one tablet MS Contin ER 15mg uncrushed. The order was for one MS Contin ER 15mg, to be given with MS Contin ER 60mg to equal a total dose of 75mg at ten P.M. The resident was also to receive three Valium 5mg tab[let]s (15mg total) at 8:30 pm. The

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resident was immediately assessed after the medication error was identified. Vital signs were temp[erature] 96.6, [blood pressure] 86/46, [pulse] 63, Resp[irations] 16. Resident was alert and oriented moving all extremities well, no [signs or symptoms] of confusion . . . MD was called and resident was transferred to St. Luke’s Hospital for evaluation. According to nurses notes, resident ambulated to the ambulance.

Resident did not receive Narcan and remained stable in the hospital. Resident returned from hospital on 7/19/16 at 6:00am. According to hospital discharge documentation, resident remained alert with some complaints of nausea but with no other acute complaints.

CMS Ex. 10 at 1.

A July 18, 2016 progress note indicates that Petitioner recorded Resident # 8’s vital signs following the overdose, and vital signs included a hypotensive blood pressure reading of 86/46 mmHg.The National Institutes of Health defines hypotension as blood pressure lower than 90/60 mmHg.  See https://www.nhlbi.nih.gov/health-topics/hypotension (last visited Mar. 15, 2019). CMS Ex. 7. Petitioner notified the on-call physician of the overdose, and the physician ordered that Resident # 8 be transferred by ambulance to the hospital. CMS Ex. 7.

Records from St. Luke’s Hospital document that Resident # 8 arrived at the hospital at 10:41 pm on July 18, 2016, and returned from the hospital at 6:00 am on July 19, 2016. CMS Exs. 8 at 1, 3; 10 at 1. Her blood pressure was monitored throughout her overnight hospitalization, and all blood pressure readings were higher than the 86/46 mmHg blood pressure reading that Petitioner obtained immediately following the overdose (CMS Ex. 10 at 1), ranging from a low of 90/54 mmHg to a high of 104/60 mmHg. CMS Ex. 8 at 1. The emergency department physician remarked (despite the late hour of the night) that Resident # 8 “feels subjectively euphoric after receiving the medication . . . .” CMS Ex. 8 at 3. The physician listed a final diagnosis of “Narcotic overdose, accidental or unintentional . . . .” CMS Ex. 8 at 3.

Only four days after Resident # 8’s release from the hospital, Petitioner again administered crushed MS Contin in contravention of the boxed warning on the medication’s labeling. A July 23, 2016 progress note, recorded by a licensed practical nurse at 2:46 pm, documents that Resident # 8’s “Meds [were] crushed in applesauce with thin liquids without difficulty” and that no signs or symptoms or respiratory distress

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were assessed or reported.Petitioner does not point to any evidence disputing CMS’s allegation that Petitioner crushed and administered MS Contin on July 23, 2016.  Referencing other medication errors alleged by CMS, Petitioner argues that “the evidence indicates that the Resident took most of her medications crushed because of her swallowing problems, so it is not surprising that the nurses occasionally crushed MS Contin along with other medications before remembering that it should not be crushed, and then discarding it.”  P. Br. at 10 n.4.  To the extent that Petitioner disputes other medication errors cited by CMS, I agree with Petitioner that CMS has not demonstrated medication errors occurred on dates other than July 18 and 23, 2016.  See CMS Br. at 2 (alleging Petitioner crushed medication on August 5, 2016, whereas the medication administration record (CMS Ex. 5 at 2) indicates that Petitioner “dropped” the medication and wasted it;  CMS Br. at 7 (alleging Resident # 8’s medication was “crushed in error and wasted,” meaning that the medication was not administered to Resident # 8). P. Ex. 4 at 4. Resident # 8’s medication administration record indicates that the same nurse administered the 3:00 pm dose of MS Contin at approximately the same time as she recorded the progress note. CMS Ex. 6 at 2.

Petitioner committed a significant medication error when it crushed MS Contin and administered more than three times the scheduled dose of MS Contin on July 18, 2016, and when it crushed and administered the MS Contin on July 23, 2016, only days after Resident # 8 was transferred to the hospital due to an overdose of the same medication.

Although Petitioner concedes that a medication error occurred, it argues that the medication error was not significant. Petitioner alleges that Resident # 8 was not actually harmed by any medication error.I decline to address whether Resident # 8 had lasting neurological effects of the overdose, as CMS suggests (CMS Br. at 14). While it is unnecessary to make a finding of actual harm in order to uphold the deficiency and the reasonableness of the CMP, I nonetheless point out that the evidence suggests that Resident # 8 had an adverse reaction following the overdose of MS Contin on July 18, 2016. The medication labeling warns that MS Contin can have a hypotensive effect, and the labeling also cautions that one of the most frequently observed “adverse reactions” is a “euphoric mood.” CMS Ex. 5 at 1, 5, 9. Even though Resident # 8 did not have an ongoing diagnosis of hypotension, she had a single hypotensive blood pressure reading following the overdose. CMS Ex. 7. And although Petitioner feels that Resident # 8’s report of being “euphoric” following the overdose “hardly describes harm” (P. Br. at 11), I note that a “euphoric mood” is one of the “most common adverse reactions” to MS Contin. CMS Ex. 5 at 9. Further, Petitioner reported Resident # 8 was nauseous upon her return from the hospital (CMS Ex. 10 at 1), and she was “drowsy and in bed most of the day” and declined her morning dose of MS Contin “because she said she felt a little off and she would rather skip this dose of medication.” (CMS Ex. 13). Petitioner’s observations of Resident # 8 following her return from the hospital on July 19, 2016, evidence “discomfort” resulting from the overdose. Pub. 100-7, State Operations Manual, § 760. A significant medication error occurred, regardless of

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whether Resident # 8 was actually harmed, based alone on the fact that an overdose of MS Contin can be potentially lethal. In addition, Petitioner made significant errors in its administration of MS Contin on more than one occasion. Serious consequences could have resulted from either instance in which Petitioner gave Resident # 8 crushed tablets, or when Petitioner administered an overdose of the medication that required her transfer to a hospital. Petitioner, by administering more than three times the prescribed nighttime dose of MS Contin on July 18, 2016 (with most of that dose in the form of crushed tablets), committed a significant medication error. In fact, MS Contin’s labeling warns patients of the risk of death or serious injury with an overdose: “When you first start taking MS CONTIN, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur.” CMS Ex. 5 at 22. Petitioner administered more than three times the prescribed dose of MS Contin at the time of the first cited significant medication error, and CMS has listed an example of a significant medication error involving a far lower threshold of just twice the prescribed amount of morphine sulfate. Pub. 100-7, State Operations Manual, § 760. Further, a significant medication error occurred when Petitioner crushed Resident # 8’s MS Contin on July 18 and 23, 2016, even though the labeling contains a boxed warning that “crushing, chewing, or dissolving MS CONTIN tablets can cause rapid release and absorption of a potentially fatal dose of morphine.” CMS Ex. 5 at 3 (emphasis omitted). Petitioner committed a significant medication error by administering an overdose of MS Contin and administering crushed MS Contin, and its repeated medication errors could have had serious consequences. See 56 Fed. Reg. 48,853. Petitioner did not substantially comply with 42 C.F.R. § 483.25(m)(2).

Petitioner argues that CMS committed a due process error and took an “extreme position” in rejecting the state agency’s independent informal dispute resolution (IIDR) recommendation. P. Response at 3; see P. Br. at 4 n.3. In a letter dated April 21, 2017, the state agency informed Petitioner that although “the Committee recommended to delete both tags,” CMS “has determined that the deficiencies cited at F281 and F333 should remain as written.” P. Ex. 2. Petitioner argues that “several ALJs, have held, and the [DAB] at least has strongly suggested, that unless CMS ‘explicitly overrules’ an IDRIDR is an acronym for “informal dispute resolution.” /IIDR recommendation or decision favorable to a petitioner and provides an explanation for that action, a citation set aside at IDR/IIDR cannot form the basis for an enforcement penalty as a matter of fact or law.” P. Br. at 4 n.3 (emphasis in original); P. Response at 4 (containing identical language). Despite alluding to the DAB’s favorable treatment of this issue in other cases, Petitioner does not cite to any DAB decisions in support of its argument and cites only to two older ALJs decisions, to include Ridgely Care & Rehab. Ctr., DAB CR1258 (2004). P. Br. at 4 n.3; P. Response at 4. Petitioner is

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correct that the DAB distinguished the facts of Ridgely in its decision in Britthaven of Chapel Hill, DAB No. 2284 (2009); in fact, the circumstances of the Britthaven case with respect to the IDR/IIDR process are analogous to the circumstances presented here. In Britthaven, the DAB determined that the ALJ decision in Ridgely “is neither binding nor apposite,” and explained the following:

Moreover, the ALJ in Ridgely decided that case based on revisions made following the IDR only because CMS offered no evidence that it had reviewed and rejected those results, or even considered them, not because he concluded that CMS did not have authority to reject those results. Indeed, the ALJ expressly recognized “that CMS’s findings of noncompliance take precedence where it and the State disagree” and stated that “CMS could have, but did not, overrule the IDR findings.”

****

Ridgely also is inapposite because in that case, CMS ignored the IDR results. Here, CMS did not ignore the IDR results but affirmatively rejected them, as well as the associated revised SOD. . . . Given CMS’s explicit rejection of the IDR results and its explanation that it was continuing to rely on the findings in the unrevised SOD for the November survey, Petitioner’s assertion that CMS “without comment, analysis, independent findings or investigation simply overturned this decision and re-imposed the immediate jeopardy finding” is simply not correct, and Petitioner’s reliance on Ridgely is misplaced.

Britthaven of Chapel Hill , DAB No. 2284 at 10 (internal citations omitted). Just as it did in the Britthaven case, CMS considered the IIDR recommendation and expressly rejected that recommendation. P. Ex. 2 (stating “CMS has completed its review . . . and determined that the deficiencies cited as F281 and F333 should remain as written.”). There is no due process error with respect to the IIDR recommendation.

C. A per-day CMP of $1,103 from July 18 through November 3, 2016, is a reasonable enforcement remedy for Petitioner’s substantial noncompliance with Medicare participation requirements.

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, to include a CMP. In determining whether the CMP imposed

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against Petitioner is reasonable, I apply the factors listed in 42 C.F.R. § 488.438(f). 42 C.F.R. § 488.438(e)(3). These factors include: 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. 42 C.F.R. § 488.438(f). The absence of culpability is not a mitigating factor. The factors in 42 C.F.R. § 488.404 include: 1) the scope and severity of the deficiency; 2) the relationship of the deficiency to other deficiencies resulting in noncompliance; and 3) the facility’s prior history of noncompliance in general and specifically with reference to the cited deficiencies.

I consider whether the evidence supports a finding that the amount of the CMP is at a level reasonably related to an effort to produce corrective action by a provider with the kind of deficiencies found, and in light of the above factors. I am neither bound to defer to CMS’s factual assertions, nor free to make a wholly independent choice of remedies without regard for CMS’s discretion. See, e.g., Barn Hill Care Ctr., DAB No. 1848 at 21 (2002).

CMS imposed a per-day CMP of $1,103 for 109 days from July 18 through November 3, 2016, for a total CMP of $120,227. Petitioner was out of compliance with 42 C.F.R. §§ 483.20(k)(3)(i) and 483.25(m)(2) from July 18, 2016 (when it gave Resident # 8 an overdose of MS Contin and also crushed her pills in contravention of the medication’s labeling), and remained out of compliance until November 3, 2016 (when it reported that all corrective actions had been completed). See CMS Ex. 2 at 18. Specifically, Petitioner asserted, in its October 29, 2016 plan of correction, that the date of completion would be November 4, 2016, at which time it would have, inter alia, completed medication audits for those residents who are prescribed MS Contin, included a list of medications that cannot be crushed in every medication administration record, and provided training to nursing staff. CMS Ex. 2 at 18-19.

Petitioner argues that there was no actual harm,To the extent that Petitioner may be challenging the scope and severity of the cited deficiency, the regulations are clear that an ALJ may review CMS’s scope and severity findings only if a successful challenge would affect:  (1) the range of the CMP amounts that CMS could collect; or (2) a finding of substandard quality of care that results in the loss of approval of a facility’s nurse aide training program.  42 C.F.R. § 498.3(b)(14), (d)(10)(i)-(ii); NMS Healthcare of Hagerstown, DAB No. 2603 at 6-7 (2014).  Neither of these factors apply. and “there is no evidence, nor any reason to conclude, that this medication error illustrates or represents continuing noncompliance (and thus any basis for a 109 day “per diem” CMP).” P. Br. at 15. As I previously mentioned, Petitioner did not present any argument regarding the deficiency cited under 42 C.F.R. § 483.20(k)(3)(i) (professional standards of quality), and it has conceded that it committed a medication error in its administration of MS Contin to

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Resident # 8. Petitioner does not argue that a $1,103 per-day CMP is unreasonable for the deficiencies, and I find that a $1,103 per-day CMP for either deficiency, alone, would support the CMP based on the factors set forth in section 488.438(f).

The per-day CMP of $1,103 is at the low end of the penalty range, in that the maximum per-day penalty could have been $6,188. The deficiencies here are serious, as evidenced by the failure of Petitioner’s staff to adhere to professional standards of quality and to administer medications in compliance with the prescription labeling’s boxed warnings; Petitioner’s errors could have resulted in death or serious harm to Resident # 8. And it was not just a lone nurse who committed the significant medication error; only a few days after a nurse provided an overdose of crushed MS Contin, a different nurse administered crushed MS Contin to Resident # 8. Petitioner has not offered a regulatory basis to challenge the CMP, and it has not offered any evidence showing an inability to pay the per-day CMP. Unless a facility contends that a particular regulatory factor does not support the CMP amount, an ALJ must sustain it. Coquina Ctr., DAB No. 1860 (2002).

It is “well-settled” that “the period of noncompliance continues until the facility affirmatively demonstrates a return to substantial compliance.” Ridgecrest Healthcare Ctr., DAB No. 2493 at 15 (2013) (citing Premier Living & Rehab. Ctr., DAB No. 2146 at 23 (2008) and Lake City Extended Care Ctr., DAB No. 1658 at 12-15 (1998)). Petitioner alleges that its burden to establish that it returned to substantial compliance is inconsistent with the Administrative Procedure Act, U.S.C. § 556(d); the DAB has rejected this argument numerous times. See, e.g., Owensboro Place & Rehab Ctr., DAB No. 2397 at 8-9 (2011); Azalea Court, DAB No. 2352 at 16 (2010), quotingCarrington Place of Muscatine, DAB No. 2321 at 24 (2010);Batavia Nursing & Convalescent Ctr., DAB No. 1904 (2004), aff’d Batavia Nursing & Convalescent Ctr. v. Thompson, 129 F. App’x 181 (6th Cir. 2005). Petitioner did not allege it returned to compliance until November 4, 2016, and it has not asserted otherwise in its briefing. CMS Ex. 2 at 18-19. A per-day CMP is appropriate from July 18 through November 3, 2016, and the per-day CMP of $1,103 is at the low end of the authorized penalty range. 42 C.F.R. §§ 488.408(d)(1)(iii), 488.438(a)(1)(ii).

Petitioner has not invoked any basis to reduce the CMP, and based on consideration of the relevant regulatory factors, the CMP is reasonable.

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IV. Conclusion

For the reasons discussed above, I grant summary judgment in favor of CMS. There is no genuine dispute of material facts, and I find that the facility was not in substantial compliance with the Medicare participation requirements. A $1,103 per-day CMP from July 18 through November 3, 2016, is reasonable.