Austinwoods Rehab Health Care, DAB CR5309 (2019)

DECISION

Petitioner, Austinwoods Rehab Health Care, did not violate 42 C.F.R. § 483.10(b)(11)(i)(B)1  as alleged by the complaint investigation completed at Petitioner’s facility on May 28, 2015. Accordingly, the alleged noncompliance under 42 C.F.R. § 483.10(b)(11)(i)(B) (Tag F157) is not a basis for the imposition of a per instance civil monetary penalty (PICMP) in the amount of $3,300.

Petitioner withdrew its request for review of the alleged noncompliance based on a violation of 42 C.F.R. § 483.25(j) (Tag F327) and the $3,300 PICMP based on that noncompliance. Accordingly, the determination of the Centers for Medicare & Medicaid Services (CMS) of noncompliance under Tag F327 is administratively final and is a basis for the imposition of a $3,300 PICMP. Petitioner did not request review of the reasonableness of the amount of the PICMP.

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I. Background

Petitioner is located in Austintown, Ohio, and participates in Medicare as a skilled nursing facility (SNF) and the state Medicaid program as a nursing facility (NF). CMS Exhibit (Ex.) 1. On May 28, 2015, the Ohio Department of Health (state agency) completed a complaint investigation at Petitioner. Petitioner was found not in substantial compliance with program participation requirements due to violations at 42 C.F.R. §§ 483.10(b)(11) (Tag F1572 ) and 483.25(j) (Tag F327). CMS Ex. 2. On July 9, 2015, and September 15, 2015, CMS notified Petitioner that it proposed a PICMP of $3,300 for the noncompliance under Tag F157 and a PICMP of $3,300 for the noncompliance under Tag F327. CMS Ex. 1.

Petitioner requested an administrative law judge (ALJ) hearing on September 9, 2015. The case was assigned to Judge Joseph Grow on October 6, 2015, and an Acknowledgment and Prehearing Order (Prehearing Order) was issued at his direction. On December 29, 2015, Petitioner filed a motion to dismiss its request for hearing regarding Tag F327 and the PICMP based on that noncompliance. Petitioner stated it intended to persist in its request for review of the noncompliance cited under Tag F157 and the related PICMP of $3,300. CMS did not oppose the motion. Judge Grow did not rule on the motion. The parties have treated the request for hearing as to Tag F327 and the related PICMP as withdrawn. CMS Prehearing Brief at 2; Petitioner’s Prehearing Brief; CMS Brief (CMS Br.) at 1. Petitioner’s motion is granted. The CMS findings and conclusions of noncompliance under Tag F327 based on a violation of 42 C.F.R. § 483.25(j) that posed a risk for more than minimal harm and the proposed PICMP of $3,300 based on that noncompliance are administratively final and not subject to further review in this proceeding.

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CMS timely submitted its prehearing exchange on January 4, 2016, including CMS Exs. 1 through 16. On February 8, 2016, Petitioner timely submitted its prehearing exchange including Petitioner’s exhibits (P. Exs.) 1 through 14.

On April 1, 2016, this case was reassigned to me upon Judge Grow’s departure. On April 15, 2016, I issued a supplemental prehearing order. On May 27, 2016, I set this case for hearing on August 8 and 9, 2017. On January 5, 2017, the case was rescheduled for hearing on August 29 and 30, 2017. On July 5, 2017, the parties filed a joint motion to waive oral hearing. On July 11, 2017, I accepted the waiver of oral hearing, cancelled the hearing, and set a briefing schedule for the submission of opening and reply briefs.

On August 25, 2017, Petitioner waived further briefing. Petitioner also requested leave to supplement the record with the declaration of Michael Devine, MD, dated August 12, 2016, which was attached to the waiver and motion to supplement. Petitioner failed to mark the affidavit as evidence, and I treat it as if marked P. Ex. 15.

CMS filed a brief on the merits on August 25, 2017, with proposed findings of fact and conclusions of law. On October 6, 2017, Petitioner waived a reply brief. CMS waived a reply brief on October 17, 2017.

On February 17, 2016, CMS filed an objection to P. Ex. 6 on grounds that it is duplicative of CMS Ex. 14. The documents are identical and are cumulative. There is no risk for confusion and the document consists of a single page. The objection is overruled. CMS did not object to my consideration of the declaration of Michael Devine, MD (P. Ex. 15) and cites the declaration in support of its case-in-chief. CMS Br. at 4. CMS Exs. 1 through 16 and P. Exs. 1 through 15 are admitted as evidence.

II. Discussion

A. Issues

Whether there is a basis for the imposition of an enforcement remedy; and,

Whether the remedy proposed is reasonable.

B. Applicable Law

The statutory and regulatory requirements for participation of a SNF in Medicare are at section 1819 of the Social Security Act (Act) and at 42 C.F.R. pt. 483. Section 1819(h)(2) of the Act authorizes the Secretary of the U.S. Department of Health

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& Human Services (Secretary) to impose enforcement remedies against a SNF for failure to comply substantially with the federal participation requirements established by sections 1819(b), (c), and (d) of the Act.3  The Act requires that the Secretary terminate the Medicare participation of any SNF that does not return to substantial compliance with participation requirements within six months of being found not to be in substantial compliance. Act § 1819(h)(2)(C). The Act also requires that the Secretary deny payment of Medicare benefits for any beneficiary admitted to a SNF, if the SNF fails to return to substantial compliance with program participation requirements within three months of being found not to be in substantial compliance – commonly referred to as the mandatory or statutory denial of payments for new admissions (DPNA). Act § 1819(h)(2)(D). The Act grants the Secretary discretionary authority to terminate a noncompliant SNF’s participation in Medicare, even if there has been less than six months of noncompliance. The Act also grants the Secretary authority to impose other enforcement remedies, including a discretionary DPNA, CMPs, appointment of temporary management, and other remedies, such as a directed plan of correction. Act § 1819(h)(2)(B).

The Secretary has delegated to CMS and the states the authority to impose remedies against a long-term care facility that is not complying substantially with federal participation requirements. “Substantial compliance means a level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm.” 42 C.F.R. § 488.301 (emphasis in original). A deficiency is a violation of a participation requirement established by sections 1819(b), (c), and (d) of the Act or the Secretary’s regulations at 42 C.F.R. pt. 483, subpt. B. Noncompliance refers to any deficiency (statutory or regulatory violation) that causes a facility not to be in substantial compliance; i.e., a deficiency that poses a risk for more than minimal harm. 42 C.F.R. § 488.301. Therefore, even if, a facility violates a statutory or regulatory requirement, CMS may not impose enforcement remedies if the deficiency does not pose a risk for more than minimal harm.

State survey agencies survey facilities that participate in Medicare on behalf of CMS to determine whether the facilities are complying with federal participation requirements. 42 C.F.R. §§ 488.10-.28, 488.300-.335. The regulations specify the enforcement remedies that CMS may impose if a facility is not in substantial compliance with Medicare requirements. 42 C.F.R. § 488.406. CMS is authorized to impose a PICMP

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against a facility in the range of $1,000 to $10,000 per instance. 42 C.F.R. §§ 488.438(a)(2), 488.408. The only enforcement remedy at issue in this case is the proposed PICMP of $3,300.

The Act and regulations make a hearing before an ALJ available to a long‑term care facility against which CMS has determined to impose an enforcement remedy. Act §§ 1128A(c)(2), 1866(h); 42 C.F.R. §§ 488.408(g), 498.3(b)(13). A facility has a right to appeal a “certification of noncompliance leading to an enforcement remedy.” 42 C.F.R. §§ 488.408(g)(1), 488.330(e), 493.3. However, the choice of remedies, or the factors CMS considered when choosing remedies, are not subject to review. 42 C.F.R. § 488.408(g)(2). A facility may only challenge the scope and severity level of noncompliance determined by CMS if a successful challenge would affect the range of the CMP that may be imposed or impact the facility’s authority to conduct a nurse aide training and competency evaluation program. 42 C.F.R. § 498.3(b)(14), (d)(10)(i). The CMS determination as to the level of noncompliance, including the finding of immediate jeopardy, “must be upheld unless it is clearly erroneous.” 42 C.F.R. § 498.60(c)(2); Woodstock Care Ctr., DAB No. 1726 at 9, 38 (2000), aff’d, 363 F.3d 583 (6th Cir. 2003). The Departmental Appeals Board (the Board) has long held that the net effect of the regulations is that a provider has no right to challenge the scope and severity level assigned to a noncompliance finding, except in the situation where that finding was the basis for an immediate jeopardy determination. See, e.g., Ridge Terrace, DAB No. 1834 (2002); Koester Pavilion, DAB No. 1750 (2000). ALJ review of a CMP is subject to 42 C.F.R. § 488.438(e).

The hearing before an ALJ is a de novo proceeding, that is, “a fresh look by a neutral decision‑maker at the legal and factual basis for the deficiency findings underlying the remedies.” Life Care Ctr. of Bardstown, DAB No. 2479 at 33 (2012) (citation omitted); The Residence at Salem Woods, DAB No. 2052 (2006); Cal Turner Extended Care, DAB No. 2030 (2006); Beechwood Sanitarium, DAB No. 1906 (2004); Emerald Oaks, DAB No. 1800 at 11 (2001); Anesthesiologists Affiliated, DAB CR65 (1990), aff’d, 941 F.2d 678 (8th Cir. 1991).

The allocation of the burden of persuasion and the quantum of evidence required to meet the burden is not addressed by regulations.4  Rather, the Board has long held that the

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petitioner, the nongovernmental party, bears the burden of persuasion to show by a preponderance of the evidence that it was in substantial compliance with participation requirements or any affirmative defense. Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004); Batavia Nursing & Convalescent Ctr., DAB No. 1904 (2004), aff’d, Batavia Nursing & Convalescent Ctr. v. Thompson, 129 F. App’x 181 (6th Cir. 2005); Emerald Oaks, DAB No. 1800 (2001); Cross Creek Health Care Ctr., DAB No. 1665 (1998); Hillman Rehab. Ctr., DAB No. 1611 (1997) (remand to ALJ), DAB No. 1663 (1998) (after remand), aff’d, Hillman Rehab. Ctr. v. United States, No. 98-3789 (GEB), 1999 WL 34813783 (D.N.J. May 13, 1999). The Board has indicated that only when CMS makes a prima facie showing of noncompliance, is the facility burdened to show, by a preponderance of the evidence on the record as a whole, that it was in substantial compliance or had an affirmative defense. Evergreene Nursing Care Ctr., DAB No. 2069 at 7 (2007). The Board has not specified how much evidence CMS needs to present to meet its burden of making a prima facie showing. The Board has stated that CMS must come forward with “evidence related to disputed findings that is sufficient (together with any undisputed findings and relevant legal authority) to establish a prima facie case of noncompliance with a regulatory requirement.” Id.; Batavia Nursing & Convalescent Ctr., DAB No. 1904. “Prima facie” means generally that the evidence is “[s]ufficient to establish a fact or raise a presumption unless disproved or rebutted.” Black’s Law Dictionary 1228 (8th ed. 2004). One might conclude that if the preponderance of the evidence is required in these proceedings, that standard would also apply to the requirement for CMS to make a prima facie showing, that is, CMS should be burdened to present evidence sufficient to establish a fact as more likely true and to raise a presumption. However, the Board has never ruled that CMS must establish its prima facie case by a preponderance of the evidence. Indeed, it is unclear from prior Board

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decisions whether CMS can make a prima facie showing with little more than mere allegations or a scintilla of evidence. In this case, I conclude that CMS has made its prima facie showing by a preponderance of the evidence.

C. Findings of Fact, Conclusions of Law, and Analysis

My conclusions of law are set forth in both text followed by my findings of fact and analysis. I have carefully considered all the evidence and the arguments of both parties, though not all may be specifically discussed in this decision. I discuss in this decision the credible evidence given the greatest weight in my decision‑making.5  I also discuss any evidence that I find is not credible or worthy of weight. The fact that evidence is not specifically discussed should not be considered sufficient to rebut the presumption that I considered all the evidence and assigned such weight or probative value to the credible evidence that I determined appropriate within my discretion as an ALJ. There is no requirement for me to discuss the weight given every piece of evidence considered in this case, nor would it be consistent with notions of judicial economy to do so. Charles H. Koch, Jr., Admin. L. & Prac. § 5:64 (3d ed. 2013).

1. Judgment on the written pleadings and documentary evidence is permissible in this case.

Pursuant to 42 C.F.R. § 498.66(a), an affected party, such as Petitioner, may waive its right to appear and present evidence at an oral hearing by filing a written waiver. When Petitioner files a written waiver, an ALJ need not conduct an oral hearing except in two circumstances: (1) the ALJ concludes witness testimony is necessary to clarify facts at issue; or (2) CMS shows good cause for presenting oral testimony. 42 C.F.R. § 498.66(b). Petitioner waived its right to an oral hearing consistent with the requirements of 42 C.F.R. § 498.66(a). After review of the evidence and pleadings of the parties, I conclude that oral testimony is not necessary for clarification of the facts at issue. CMS has not argued that oral testimony is necessary or otherwise shown good cause to convene an oral hearing.

In accordance with 42 C.F.R. § 498.66, the record of the hearing in the case without oral testimony consists of the documentary evidence admitted and the parties’ pleadings. The parties had a reasonable opportunity for rebuttal as reflected by their various filings.

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2. CMS has made a prima facie showing that Petitioner violated 42 C.F.R. § 483.10(b)(11)(i)(B) (Tag F157).

3. Petitioner has rebutted the CMS prima facie showing of the regulatory violation by a preponderance of the evidence.

4. There is no basis for CMS to impose a PICMP because there was no violation of 42 C.F.R. § 483.10(b)(11)(i)(B) (Tag F157) and no noncompliance, and therefore the PICMP is not reasonable.

CMS alleges, based upon the complaint investigation, that Petitioner was not in substantial compliance with program participation requirements based upon violation of 42 C.F.R. § 483.10(b)(11) (Tag F157, scope and severity (s/s) G6 ). The cited noncompliance involved the alleged failure of Petitioner’s staff to consult immediately with Resident 2’s physician regarding a significant change in her condition. CMS Br. at 1.

a. Facts

Surveyor Melissa White, RN, conducted the complaint investigation that was completed at Petitioner’s facility on May 28, 2015. A complaint to the state agency’s complaint hotline triggered the investigation. CMS Exs. 2, 3. Surveyor White opined in her declaration that a patient at risk for dehydration should be monitored closely and that a physician should be notified if there is no intake in a 24-hour period or no urine output during a 12-hour period. She also opined that a physician should be contacted for

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persistent or continued vomiting. CMS Ex. 2 at 5 ¶ 23. Her opinions are based on her previous nursing experience (CMS Exs. 2 at 5 ¶ 23; 4) and are considered weighty.

Inconsistencies among the allegations in the Statement of Deficiencies (SOD) (CMS Ex. 2 at 2-7); Surveyor White’s declaration (CMS Ex. 3); and the CMS arguments (CMS Br.) require consideration to determine which provision of 42 C.F.R. § 483.10(b)(11) was allegedly violated and the period during which the violation allegedly occurred.

Surveyor White states in her declaration that she cited Petitioner under Tag F157 for failure to follow its policy (CMS Ex. 12) regarding physician notification.7  CMS Ex. 2 at 6 ¶ 29. Surveyor White alleged in the SOD for the survey completed on May 28, 2015, that the facility failed to notify promptly Resident 2’s physician of her ongoing nausea and vomiting, poor oral intake, poor urine output, and refusal of mediations. She alleged that actual harm occurred because Resident 2 suffered from dehydration and had to be hospitalized from April 28, 2015 to May 7, 2015. CMS Ex. 2 at 3. Surveyor White alleged more specifically in the SOD that from April 15 to 28, 2015, she found no evidence that Resident 2’s physician was notified of Resident 2’s inadequate oral intake, repeated complaints of nausea, and little or no urine output. Surveyor White stated in her declaration that her review of Resident 2’s records show that Resident 2’s “physicians were not updated regarding her refusal to eat and/or her low urine output, between at least, April 22 and 27, 2015.” CMS Ex. 3 at 6 ¶ 25. Surveyor White testified by her declaration that Resident 2 was admitted to the hospital intensive care unit on April 28, 2015, suffering from altered mental state, dehydration, hypernatremia, metabolic acidosis, and leukocytosis. CMS Ex. 2 at 6 ¶¶ 26-27. Surveyor White indicates in the SOD that Petitioner’s Director of Nursing (DON) produced a document dated April 27, 2015, documenting a physician assessment on that date, but she apparently rejected the notion that the visit actually occurred on April 27, noting the related orders were actually dated April 28, 2015. CMS Ex. 2 at 6. It is not clear why the inconsistency in the period upon which Surveyor White focused between her sworn declaration and the SOD.8

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However, I give greater weight to Surveyor White’s sworn testimony than her statements in the SOD. Based on the SOD and Surveyor White’s testimony, I conclude that the period during which it was alleged by the surveyor that Petitioner failed to give Resident 2’s physician notice of a significant change in her condition was from April 22 to April 28, 2015.

CMS states in its brief that Surveyor White concluded that Petitioner waited three days before notifying Resident 2’s physicians of the resident’s decreased appetite, vomiting, and refusal of medication. CMS Br. at 2. CMS argues that Petitioner did not notify Resident 2’s physicians of Resident 2’s condition from April 19 through 21, 2015 or on April 23, 24, or 26, 2015. CMS agrees that the physicians were notified on April 22, 25, 27, and 28, 2015. CMS Br. at 4-5. CMS argues that Resident 2’s refusal of medication, decreased appetite, and vomiting were the significant changes in Resident 2’s condition that required immediate consultation with Resident 2’s physicians. CMS argues that, between April 19 and 28, 2015, Resident 2’s refusal of medications due to nausea and vomiting was increased over her baseline and her appetite declined. CMS argues that Petitioner violated 42 C.F.R. § 483.10(b)(11)(i)(B) because it waited three days to notify Resident 2’s physicians of her changed condition. CMS Br. at 5-7. I conclude that the CMS position is that Petitioner failed to consult with Resident 2’s physician from April 19 through 21, 23, 24, and 26, 2015.

The factual issues that require resolution under 42 C.F.R. § 483.10(b)(11)(i)(B) are whether there was a significant change in Resident 2’s condition and whether Petitioner failed to immediately consult with Resident 2’s physicians when a significant change occurred.9  Based on the foregoing discussion, the more specific issues are whether Resident 2 suffered a significant change within the meaning of the regulation that required immediate consultation with her physician from April 19 through 21, and 23, 24, and 26, 2015.

The SOD cites 42 C.F.R. § 483.10(b)(11) without referring to a specific subsection. CMS Ex. 2 at 2-3. However, Surveyor White makes clear that it was the requirement of 42 C.F.R. § 483.10(b)(11)(i)(B), i.e., the requirement to notify the resident’s physician of

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a significant change in condition, that she concluded was violated by Petitioner. CMS specifically cites 42 C.F.R. § 483.10(b)(11)(i)(B) as the regulation at issue. CMS Br. at 1, 5-7.

Resident 2 was an 82‑year old female at the time of the events described in the SOD. She was admitted to Petitioner on October 23, 2014. She was readmitted on November 4, 2014, following hospitalization. CMS Ex. 5 at 1; P. Ex. 8 at 1; P. Ex. 10. Resident 2’s diagnoses included: acute respiratory failure, congestive heart failure, hypertension, hyperlipidemia, hypothyroidism, anemia, chronic kidney disease, renal failure, hypernatremia, high potassium level, and hiatal hernia. CMS Ex. 5 at 1, 18; P. Ex. 7 at 2.

Resident 2’s care plan shows that due to her Alzheimer’s dementia she may refuse tube feeding and medications, and the intervention was to allow a brief period to pass and then re-approach the resident. CMS Ex. 5 at 10-12. Resident 2’s care plan also reflected that she suffered from a poor appetite and refused tube feeding; she was at risk for both dehydration and fluid overload, weight loss, constipation, gastrointestinal (GI) distress, and aspiration. Interventions included monitoring her hydration levels and encouraging Resident 2 to drink water; encouraging tube feeding; monitoring weight; laboratory tests as ordered; monitoring diet tolerance, signs of GI distress, bowel movement frequency, signs of fluid overload, signs of difficulty swallowing and aspiration; among others. The care plan also instructed staff to monitor, document, and report any signs or symptoms of dysphagia, pocketing, choking, coughing, drooling, holding food in her mouth, repeated attempts to swallow, or refusals to eat. Resident 2 had a goal of consuming 25 to 50 percent of her meals. Further, staff was to notify Resident 2’s physician of “any significant problems” regarding her intake. CMS Ex. 5 at 15-16.

During the month of April 2015, doctors repeatedly evaluated Resident 2 because of her GI related issues. The following list is intended to help identify problems and interventions. The period at issue is April 19 to 28, 2015, for reasons already discussed; however, earlier dates are included for context.

	PROBLEM / INTERVENTION SUMMARY	EXHIBIT
MEAL INTAKE	During the period 2/2-28/2015, Resident 2 was offered 42 meals, she consumed some of 37, and refused 5, which is an 11.9% refusal rate.	P. Ex. 9 at 2-5
	During the period 3/1-31/2015, Resident 2 was offered 35 meals, she consumed some of 29, and refused 6 which is a 17% refusal rate.	CMS Ex. 7 at 1-5; P. Ex. 9 at 6-10
	During the period 4/1-14/2015, Resident 2 was offered 26 meals, she ate some of 22, and refused 4, a 15.4% refusal rate.	CMS Ex. 7 at 7; P, Ex. 9 at 10-12

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	PROBLEM / INTERVENTION SUMMARY	EXHIBIT
	On 4/15/2015 she was offered 3 meals and she rejected 1 or 33%. The meal consumption report does not show any meals for 4/16 and 17/2015, and Petitioner cannot prove any were offered or eaten.	CMS Ex. 7 at 7; P. Ex. 9 at 12
	On 4/18/2015 she was offered 3 meals and refused 1 or 33%. The report does not show any meals for 4/19, 20, 21, or 26, 2015, and Petitioner cannot prove any were offered or eaten.	CMS Ex. 7 at 7; P. Ex. 9 at 12
	During the period 4/22-28/2015, the evidence shows she was offered 16 meals, she ate some of 7, and she refused 9 or 56%. This was a significant decline in meal intake that began about April 15, 2015.	CMS Ex. 7 at 8
URINE OUTPUT	Records are for 4/22-28/2015 only. Toilet use recorded for 4/22, 23, 24/2015, during day and night shift. No use is recorded during the day shift on 4/25 and 26/2015. Toilet use is recorded for night shift on 4/25 and 26/2015. It is not possible to determine whether there was actually any urine output based on this document. There is no evidence before me from which to determine normal or baseline output for Resident 2 prior to 4/22/2015. A Bowel and Bladder Elimination Record for Resident 2 shows she was incontinent of urine on both the day and night shift each day from 4/22 through 28/2015, except for the 12-hour day shifts on 4/25 and 26/2015. The recording of urinary incontinence permits an inference there was some urine output each shift during the period except the 12-hour day shifts on 4/25 and 26/2015. The absence of any entry for the day shift on 4/25 and 26/2015, does not permit any inference but prevents Petitioner from establishing that there was any urine output during those shifts. This document was not provided to or considered by Surveyor White.	CMS Ex. 3 at 5 ¶ 21; CMS Ex. 8; P. Ex. 12 at 2 ¶ 6 P. Exs. 12 at 2 ¶¶ 7-8; 13

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	PROBLEM / INTERVENTION SUMMARY	EXHIBIT
ORDERS	11/24/2014 Promethazine HCL Tablet as needed every 6 hours for vomiting.	CMS Ex. 10 at 5
	1/28/2015 High protein house supplement as needed if does not eat meals.	CMS Ex. 10 at 1
	2/26/2015 Megace oral suspension for poor appetite.	CMS Ex. 10 at 4; P. Ex. 9 at 1
	3/9/2015 High protein house supplement as needed if does not eat meals.	P. Ex. 9 at 1
	3/24/2015 Recheck hemoglobin and potassium level 3/26/2015.	CMS Ex. 10 at 5
	4/16/2015 Iron infusion for anemia.	CMS Ex. 10 at 2
	4/28/2015 IV (intravenous) fluids two times per day.   4/28/2015 Sodium Chloride IV for poor intake by mouth.	CMS Ex. 10 at 1-2, 6
NAUSEA & EMESIS	3/16/2015 Nutritional risk assessment noted current food and fluid intake less than 50%; low hemoglobin, albumin, creatinine; nausea and emesis sometimes; she was to have a supplement if refused to eat; significant weight loss of 17 pounds since admission in November 2014; and she was assessed as at risk for weight loss, dehydration, and GI distress. A goal was set for her to eat 50 percent of meals and to maintain her weight. Laboratory reports for 3/3, 4, 16, 24, 26, and 30/2015 show low hemoglobin consistent with anemia. Laboratory reports for 3/24, 26, and 30/2015 also reflect high BUN, chloride and/or potassium consistent with possible dehydration.	CMS Ex. 16 CMS Ex. 6

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	PROBLEM / INTERVENTION SUMMARY	EXHIBIT
	4/1/2015 Emesis while eating lunch. No ongoing complaint of nausea but resident expressed concern about taking afternoon prescriptions.	CMS Ex. 11 at 1
	4/2/2015 Decreased episodes of nausea noted.	CMS Ex. 11 at 2
	4/9/2015 Emesis twice in morning. Ferosul tablet for nausea and Promethazine HCL tablet for vomiting noted to be effective.	CMS Ex. 11 at 2
	4/16/2015 Ondansetron HCL tablet for nausea noted to be effective.	CMS Ex. 11 at 3
	4/19/2015 Nausea complaints various times during day with Promethazine HCL given during day and noted effective.	CMS Ex. 11 at 3-4
	4/22/2015 Promethazine HCL given for emesis and other medications held.	CMS Ex. 11 at 4-6
	4/23/2015 Ondansetron HCL tablet for nausea noted to be effective. Nutrition/Dietary Note: Resident noted to have lost 3 pounds in past week, underweight, nausea and vomiting continue, appetite poor with many refusals, drinking 2 to 4 supplements per day, physician declines to add back nutrition supplement due to nausea and emesis, encourage fluid and monitor weight and appetite, spoke with physician last week regarding concerns and he ordered change of medications and reevaluation of iron infusion and anemia workup.	CMS Ex. 11 at 6
	4/24/2015 Promethazine HCL for emesis noted to be effective.	CMS Ex. 11 at 7
	4/25/2015 Ondansetron HCL tablet for nausea and emesis noted to be effective.	CMS Ex. 11 at 7

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	PROBLEM / INTERVENTION SUMMARY	EXHIBIT
	4/26/2015 Refused morning medication due to nausea and emesis including medication for nausea.	CMS Ex. 11 at 7
	4/27/2015 Refused all medications due to nausea including nausea medication. No emesis noted. In afternoon ate couple bites jello and had small emesis, urinated one time and urine was dark in color with strong odor, continued to refuse medications including for nausea. Physician noted nausea and vomiting; to order IV fluids; and noted Resident 2 may need a feeding tube.	CMS Ex. 11 at 7-8  CMS Ex. 14; P. Ex. 6
	4/28/2015 Refused all medications due to nausea, no emesis, and couple sips of water. New orders for laboratory work and for IV fluids. Resident had couple bites of food and sips of supplement. Laboratory reports received are abnormal with reported critical values for sodium, chloride, and BUN. Dr. Kennedy ordered to hospital.	CMS Ex. 11 at 8   CMS Ex. 15
	5/7/2015 Resident 2 returned from hospital with feeding tube.	CMS Ex. 11 at 9
	5/8/2015 Resident 2 returned to hospital for transfusion due to low hemoglobin (anemia) per order of Dr. Shina.	CMS Ex. 11 at 9-10
PHYSICIAN ACTIONS	4/16/2015 Dr. Shina was asked to evaluate Resident 2’s continued GI upset. Who requested the evaluation is not stated, but I infer based on Dr. Shina’s relationship to Petitioner, his relationship to Resident 2, and the totality of the evidence that the request was made by Petitioner’s staff. Dr. Shina ordered that her potassium and iron supplements be held as a common side effect is GI upset. He reviewed her laboratory reports and ordered continuation of anti-nausea medications Zofran® (ondansetron HCL) and Phenergan® (promethazine). He also recommended a consultation with a facility that specialized in blood disorders regarding Resident	P. Exs. 1 at 3 ¶ 8; 3; CMS Ex. 11 at 3 (progress note 4/16/2015, 1:50 p.m. iron and potassium discontinued)

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	PROBLEM / INTERVENTION SUMMARY	EXHIBIT
	2’s iron-deficiency anemia.
	4/17/2015 Dr. Shina attended Petitioner’s quality assurance meeting at which Resident 2’s condition was discussed at length including her poor appetite and nausea. Based on the discussion, he decided not to change orders, wanting to give time for further evaluation based on his prior order to hold iron and potassium supplements. He declined to order an appetite stimulant so as not to aggravate Resident 2’s GI problem.	P. Ex. 1 at 3 ¶ 9
	April 22, 2015 Dr. Devine was contacted by Petitioner and informed of Resident 2’s continued refusal of meals and nausea. He did not issue new orders to allow more time to determine effect of discontinuation of iron and potassium supplements and to allow the consultation regarding Resident 2’s anemia.	P. Ex. 15 at 3 ¶ 9
	4/25/2015 Dr. Kennedy was contacted by Petitioner regarding Resident 2’s continued refusal of meals and nausea. He elected not to change orders for the same reasons as Dr. Devine.	P. Exs. 4 at 3 ¶ 10; 5
	4/27/2015 Dr. Kennedy was contacted by Petitioner, evaluated Resident 2, and issued no new orders.	P. Exs. 4 at 3 ¶ 11; 6; CMS Ex. 14
	4/28/2015 Dr. Kennedy was contacted regarding Resident 2; he ordered laboratory work and IV fluids. Upon receipt of the laboratory report, he ordered that Resident 2 be sent to the hospital.	P. Ex. 4 at 4 ¶ 12

P. Ex. 1 is the declaration of James F. Shina, MD. P. Ex. 4 is the declaration of David Kennedy, MD. P. Ex. 15 (attached to Petitioner’s motion to supplement and waive prehearing brief) is the declaration of Michael Devine, MD. These physicians contracted with Petitioner to serve as Petitioner’s co-medical directors. P. Exs. 1 at 1; 4 at 1; 16 at 1.

All three served as treating physician for Resident 2 during April 2015. The doctors testified that Resident 2 had chronic GI problems that existed at the time of her admission

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and were attributable to severe gastroesophageal reflux disease (GERD). Resident 2 was also diagnosed in March 2015 with a hiatal hernia (P. Ex. 7). The combination of GI distress and GERD made it difficult for Resident 2 to swallow, resulting in dietary refusal and persistent problems with nausea and vomiting, with more than one related hospitalization. Her chronic kidney disease and renal failure caused low urine output. P. Exs. 1 at 2 ¶¶ 5, 7; 4 at 2 ¶¶ 5-6; 15 at 2 ¶¶ 5-6. Their interventions related to Resident 2 as described in their declarations are listed in the foregoing table. The doctors opined that Resident 2 had chronic problems with refusal of food, nausea, and decreased urine output since her admission to Petitioner. They were well aware of her problems and believed that there was no significant change in her condition that warranted any change or alteration in treatment between April 17 and 28, 2015.10  P. Exs. 1 at 4 ¶ 14; 4 at 4 ¶ 13; 8; 9; 10; 15 at 4 ¶ 13. I find their testimony credible, unrebutted, consistent with all the evidence of record, and entitled to weight. Although the three physicians were Petitioner’s medical directors and treating physicians for Resident 2, Surveyor White failed to interview them and did not have the benefit of their evidence when she cited the noncompliance. CMS Ex. 9.

b. Analysis

I conclude, considering only the evidence offered by CMS, that CMS has made a prima facie showing that Petitioner violated 42 C.F.R. § 483.10(b)(11)(i)(B) (Tag F157) and that the violation posed a risk for more than minimal harm. However, I further conclude Petitioner has rebutted the CMS prima facie showing of a violation of 42 C.F.R. § 483.10(b)(11)(i)(B) by a preponderance of the evidence. Because there was no violation of 42 C.F.R. § 483.10(b)(11)(i)(B) there was no noncompliance under Tag F157.

A long-term care facility is required to recognize certain resident rights specified by the Act and the Secretary’s regulations. Section 483.10(b)(11)(i) of 42 C.F.R. entitled “Resident rights” requires:

(11) Notification of changes. (i) A facility must immediately inform the resident; consult with the resident’s physician; and if known, notify the resident’s legal representative or an interested family member when there is –

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(A) An accident involving the resident which results in injury and has the potential for requiring physician intervention;

(B) A significant change in the resident’s physical, mental, or psychosocial status (i.e., a deterioration in health, mental, or psychosocial status in either life-threatening conditions or clinical complications);

(C) A need to alter treatment significantly (i.e., a need to discontinue an existing form of treatment due to adverse consequences, or to commence a new form of treatment); or

(D) A decision to transfer or discharge the resident from the facility as specified in § 483.12(a).

The surveyor and CMS allege violation of 42 C.F.R. § 483.10(b)(11)(i)(B) because Petitioner failed to immediately consult with Resident 2’s physicians when a significant change in her condition occurred. The language of the regulation is very specific that the facility “consult with the resident’s physician.” 42 C.F.R. § 483.10(b)(11)(i). It is clear from the language of the regulation that the requirement to consult is not discretionary and requires more than merely informing or notifying the physician. The preamble to the final rule reflects the drafters’ specific intention that the facility should “consult with the physician about actions that are needed” to provide proper care for the resident. 56 Fed. Reg. 48,826, 48,833 (Sept. 26, 1991).

Thus, it is clear from the language of the regulation and its history that the requirement of the regulation to consult with the physician means more than to simply notify the physician. Consultation implies the requirement for a dialogue with and a responsive directive from the resident’s physician as to what actions are needed. It is not enough to merely notify the physician or leave a message for the physician.

The regulation also requires notification and consultation “immediately” upon perceiving a significant change in condition of the resident, the occurrence of an accident that may require physician intervention, or the occurrence of any of the other triggers in the regulation. The use of the term “immediately” in the regulatory requirement indicates that consultation is expected to be done as soon as the change is detected, without any intervening interval of time. It does not mean that the facility can wait hours or days before notifying the resident and his or her representative and consulting with the physician. The preamble to the final rule indicates that originally the proposed rule granted the facility up to 24 hours in which to consult with the resident’s physician and to notify the legal representative or family. However, after the receipt of comments that time is of the essence in such circumstances, the final rule amended that provision to require that the physician be consulted and the legal representative or family be notified

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immediately. 56 Fed. Reg. at 48,833. The point of using the word “immediately” is to recognize that in such situations, a delay could result in a situation where a resident is beyond recovery or dies. The Board has been consistent in its interpretation of the regulation that consultation with a physician must occur immediately, that is, without delay, after a significant change is detected or observed. Magnolia Estates Skilled Care, DAB No. 2228 at 9 (2009).

The regulation is clear that it is triggered by a significant change. A significant condition is “a deterioration in health, mental, or psychosocial status in either life-threatening conditions or clinical complications.” 42 C.F.R. § 483.10(b)(11)(i)(B).

CMS alleges the violation based on Petitioner’s failure to consult Resident 2’s physicians regarding her condition from April 19 through 21, 2015 and on April 23, 24, and 26, 2015. CMS agrees that the physicians were notified on April 22, 25, 27, and 28, 2015. CMS Br. at 4-5. The significant changes alleged by CMS are Resident 2’s refusal of medication, decreased appetite, and vomiting above her baseline. CMS argues that Petitioner violated 42 C.F.R. § 483.10(b)(11)(i)(B) because it waited three days to notify Resident 2’s physicians of her changed condition. CMS Br. at 5-7. My understanding of the CMS position is that, on the facts of this case, consultation should have occurred daily from April 19 through 28, 2015.

The evidence presented in this case shows that Resident 2 had ongoing problems from her admissions to Petitioner in October and November 2014, with nausea and vomiting and low intake of food due to her GERD, low urine output due to renal failure, and anemia. I accept, for purposes of this decision, that Resident 2 experienced an increase in her symptoms beginning about April 16, 2015, and that is consistent with the fact Petitioner consulted with Dr. Shina on that date. I also accept that Resident 2’s increased symptoms satisfy the regulatory definition for a significant change in her condition, “i.e., deterioration in health, mental, or psychosocial status in either life-threatening conditions or clinical complications.” 42 C.F.R. § 483.10(b)(11)(i)(B). Her symptoms clearly increased and, given her frailty, the increase indicated a clinical complication and a potentially life threatening condition.

I conclude, however, that Petitioner rebutted the CMS prima facie showing based on the declarations of Resident 2’s physicians whose factual assertions are unrebutted and supported by clinical evidence in the record. CMS alleges the duty to consult was triggered on April 19, 2015. However, the record shows that Resident 2’s increased symptoms caused Petitioner to consult with Dr. Shina on April 16, 2015, and he conducted an evaluation and decided upon an approach. He then participated in Petitioner’s Quality Assurance meeting on April 17, 2015, during which Resident 2’s condition was specifically discussed and he determined to continue with his plan of treatment implemented on April 16, 2015. Follow-up consultation with Dr. Kennedy and Dr. Devine, also Resident 2’s treating physicians occurred on April 22, 25, and 27, 2015,

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and they determined to follow the April 16, 2015 plan of Dr. Shina. On April 28, 2015, Dr. Devine decided to order IV fluids and laboratory tests, and, based on the test results, he decided to send Resident 2 to the hospital. P. Exs. 1 at 3 ¶¶ 8-9; 3; 4 at 3 ¶¶ 10-12; 5; 6; 15 at 3 ¶ 9; CMS Ex. 11 at 3 (progress note 4/16/2015, 1:50 p.m. iron and potassium discontinued); 14;.

I conclude the evidence shows that Petitioner’s staff recognized the significance of Resident 2’s symptoms and the need to consult Resident 2’s physicians on April 16, 2015, before even CMS and Surveyor White allege consultation was required. The evidence shows thereafter that Resident 2’s physicians where actively and consistently engaged in a course of treatment that they agreed to, until such time as Dr. Devine decided to implement IV fluids and laboratory testing based on which he then ordered Resident 2 to the hospital. I conclude that the consultation requirement was satisfied, contrary to the assertions of CMS. In this case, the regulation does not require, contrary to the suggestion of CMS, repeated or daily consultations once the physicians were consulted on April 16, 2015, and undertook a plan for treatment of Resident 2.

Accordingly, I conclude Petitioner did not violate 42 C.F.R. § 483.10(b)(11)(i)(B) and there was no noncompliance under Tag F157 that provides a basis for the imposition of an enforcement remedy. Because there was no violation and no noncompliance, the PICMP of $3,300 proposed by CMS for Tag F157, is not reasonable.

III. Conclusion

For the foregoing reasons, I conclude that Petitioner did not violate 42 C.F.R. § 483.10(b)(11)(i)(B) and that a PICMP of $3,300 proposed by CMS for this alleged violation is unreasonable.

• 1.Citations are to the 2014 revision of the Code of Federal Regulations (C.F.R.), unless otherwise stated.
• 2.This “Tag” designation is used in CMS Publication 100-07, State Operations Manual (SOM), app. PP – Guidance to Surveyors for Long Term Care Facilities (http://www.cms.hhs.gov/Manuals/IOM/list.asp).  The “Tag” refers to the specific regulatory provision allegedly violated and CMS’s related policy guidance to surveyors.  Although the SOM does not have the force and effect of law, the provisions of the Act and regulations interpreted clearly do have such force and effect.  Ind. Dep’t of Pub. Welfare v. Sullivan, 934 F.2d 853 (7th Cr. 1991); Northwest Tissue Ctr. v. Shalala, 1 F.3d 522 (7th Cir. 1993).  Thus, while the Secretary may not seek to enforce the provisions of the SOM, he may seek to enforce the provisions of the Act or regulations as interpreted by the SOM.
• 3.Participation of a NF in Medicaid is governed by section 1919 of the Act.  Section 1919(h)(2) of the Act gives enforcement authority to the states to ensure that NFs comply with their participation requirements established by sections 1919(b), (c), and (d) of the Act.
• 4.Congress granted the Secretary authority to impose enforcement remedies for noncompliance.  Act § 1819(h)(2).  The Secretary is authorized to impose CMPs as an enforcement remedy by section 1128A of the Act.  CMPs are imposed by CMS with delegated authority of the Secretary.  42 C.F.R. § 488.2.  Pursuant to subsection 1128A(j) of the Act, section 205 of the Act is applicable to the imposition of CMPs, and that section is applicable to the imposition of CMPs by both the Secretary and the Commissioner of Social Security under the authority of section 1128A of the Act.  The Inspectors General (IGs) for both HHS and the Social Security Administration also exercise delegated authority to impose CMPs pursuant to section 1128A of the Act.  Both IGs engaged in rulemaking to specify the allocation of the burden of persuasion and the quantum of evidence required when proceeding upon a case involving a CMP.  Both the SSA IG and the HHS IG imposed upon the government in CMP cases the burden of persuasion on all issues other than affirmative defenses and mitigating factors for which the burden is upon the nongovernmental party.  The regulations of the IGs for SSA and HHS provide that the burden of persuasion is to be judged by a preponderance of the evidence.  20 C.F.R. § 498.215(b), (c); 42 C.F.R. § 1005.15(b), (d).  CMS failed to promulgate a regulation similar to those of the HHS and SSA IGs, and the Board has filled the gap with its interpretative rules allocating the burden of persuasion to the nongovernmental party, the party defending against the imposition of the CMP.
• 5.“Credible evidence” is evidence that is worthy of belief.  Blacks’s Law Dictionary 596 (8th ed. 2004).  The “weight of evidence” is the persuasiveness of some evidence compared to other evidence.  Id. at 1625.
• 6.CMS and the state agency use scope and severity levels when selecting remedies.  The scope and severity level is designated by an alpha character, A through L, selected by CMS or the state agency from the scope and severity matrix published in the SOM, Chap. 7, § 7400E.  A scope and severity level of A, B, or C indicates a deficiency that presents no actual harm but has the potential for minimal harm, which is an insufficient basis for imposing an enforcement remedy.  Facilities with deficiencies of a level no greater than C remain in substantial compliance.  42 C.F.R. § 488.301.  A scope and severity level of D, E, or F indicates a deficiency that presents no actual harm but has the potential for more than minimal harm that does not amount to immediate jeopardy.  A scope and severity level of G, H, or I indicates a deficiency that involves actual harm that does not amount to immediate jeopardy.  Scope and severity levels J, K, and L are deficiencies that constitute immediate jeopardy to resident health or safety.  The matrix, which is based on 42 C.F.R. § 488.408, specifies which remedies are required and optional at each level based upon the frequency of the deficiency.
• 7.The regulation does not require that Petitioner develop or implement a policy.  42 C.F.R. § 483.10(b)(11).  The violation cited in this case is not based on failure to follow a required policy but, rather, violation of the requirements of the regulation.  The surveyor’s testimony as to the erroneous legal basis for the citation of deficiency is not binding upon me and is given no weight.  Further, the SOD accurately states the regulatory requirement and reflects the citation of noncompliance is based on a violation of the regulation not a violation of Petitioner’s policy.  I find no prejudice to Petitioner due to defective notice.
• 8.Counsel should take caution when drafting written direct (affidavits and declarations) to avoid creating inconsistencies that adversely affect the weight of the evidence provided by a witness.  If the evidence is, in fact inconsistent, then counsel should explain the reason for the inconsistency.
• 9.Inconsistencies between counsel’s theory of the case and the evidence and among the various pieces of evidence should be avoided or at least explained.  In this case, the inconsistencies are distracting but do not affect the factual issues that must be resolved.
• 10.All three declarations refer to the period August 17 through 28, 2015.  Given the context of each declaration, it is clear the reference to period August 17 through 28, 2015, is a scrivener’s error and that the correct period intended was April 17 through 28, 2015.  P. Exs. 1 at 4 ¶ 14; 4 at 4 ¶ 13; 15 at 4 ¶ 13.