Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
Franklin-Simpson Nursing and Rehabilitation,
Centers for Medicare & Medicaid Services.
Docket No. C-14-1759
Decision No. CR5206
Petitioner, Franklin-Simpson Nursing and Rehabilitation, was in substantial compliance with program participation requirements established by 42 C.F.R. §§ 483.20(k)(3)(i), 483.25(m)(2), and 483.60(a) and (b), contrary to the findings and conclusions of a complaint investigation completed on June 2, 2014. There is no basis for the imposition of enforcement remedies.
Petitioner is located in Franklin, Kentucky, and participates in Medicare as a skilled nursing facility (SNF) and the state Medicaid program as a nursing facility (NF).
The Centers for Medicare & Medicaid Services (CMS) notified Petitioner by letter dated June 19, 2014, that a complaint investigation was completed by the Kentucky State Survey Agency (state agency) on June 2, 2014. The state agency found that Petitioner was not in substantial compliance with program participation requirements and that Petitioner’s noncompliance posed immediate jeopardy from April 6 through May 29, 2014. CMS advised Petitioner that following removal of immediate jeopardy, Petitioner remained out of substantial compliance. CMS proposed a civil money penalty (CMP) of $5,500 per day for the period of immediate jeopardy from April 6 through May 29, 2014,
reduced to $100 per day effective May 30, 2014, and continuing until Petitioner returned to substantial compliance. CMS advised Petitioner that mandatory termination of Petitioner’s provider agreement would occur on December 2, 2014, and a denial of payments for new admissions (DPNA) would be imposed effective July 4, 2014, if Petitioner did not return to substantial compliance before those dates. CMS also advised Petitioner that it was ineligible to conduct a Nurse Aide Training and Competency Evaluation Program (NATCEP). CMS Exhibit (Ex.) 3.
CMS advised Petitioner by letter dated August 22, 2014, that based upon the recommendation of Independent Informal Dispute Resolution (IIDR), CMS agreed to delete four citations of deficiencies, all alleged to have posed immediate jeopardy. CMS rejected, however, the recommendation of IIDR to reduce the scope and severity finding of immediate jeopardy as to three deficiency citations to a scope and severity of D, which indicates a risk for more than minimal harm, without actual injury, and no immediate jeopardy. CMS advised Petitioner that the proposed enforcement remedies were reduced to a $3,050 per-day CMP for the period of immediate jeopardy April 6 through May 29, 2014, and $100 per day effective May 30, 2014 and continuing until Petitioner returned to substantial compliance. CMS Ex. 4.
CMS notified Petitioner by letter dated October 1, 2014, that a revisit survey conducted by the state agency on August 25, 2014, found that Petitioner returned to substantial compliance effective June 10, 2014. CMS advised Petitioner that the DPNA and termination did not go into effect. There was no change to the proposed CMP announced in the October 1, 2014 CMS letter. Petitioner’s Exhibit (P. Ex.) 9.
Petitioner requested a hearing before an administrative law judge (ALJ) on August 16, 2014. On September 2, 2014, the case was assigned to me for hearing and decision and an Acknowledgement and Prehearing Order (Prehearing Order) was issued. I scheduled a hearing for April 29 and 30, 2015. On April 27, 2015, the hearing was postponed with the agreement of the parties. I rescheduled the hearing for August 6, 2015. On August 5, 2015, Petitioner filed a waiver of oral hearing and requested a schedule for briefing and submission of documentary evidence. I accepted Petitioner’s waiver of oral hearing on August 6, 2015, and set a briefing schedule.
On October 15, 2015, CMS filed its opening brief (CMS Br.) and offered CMS Exs. 1 through 23. Also on October 15, 2015, Petitioner filed its opening brief (P. Br.) and offered P. Exs. 1 through 11. Petitioner filed its reply brief (P. Reply) on November 16, 2015. On December 1, 2015, CMS waived the filing of a reply brief. The parties have not objected to my consideration of CMS Exs. 1 through 23 and P. Exs. 1 through 11 and they are admitted and considered as evidence.
Whether there is a basis for the imposition of an enforcement remedy; and,
Whether the enforcement remedy proposed by CMS 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 42 C.F.R. pt. 483.1 Section 1819(h)(2) of the Act authorizes the Secretary (the Secretary) of Health and Human Services (HHS) 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.2 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 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 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 SNF or NF that is not in substantial compliance with federal participation
requirements. 42 C.F.R. §§ 488.400, 488.402(b). “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. 42 C.F.R. § 488.301. The term “noncompliance” refers to any deficiency (statutory or regulatory violation) that causes a facility not to be in substantial compliance; that is, 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.
Petitioner was notified in this case that it was ineligible to conduct a NATCEP for two years. Ineligibility to conduct a NATCEP is not an enforcement remedy that the state agency and CMS have the authority or discretion to impose. 42 C.F.R. § 488.406. Petitioner became ineligible to be approved to conduct a NATCEP for two years by operation of law. I have no authority to declare the ineligibility invalid except to the extent that I conclude that there was no trigger to the ineligibility. The two-year period of ineligibility began on June 2, 2014 and ended on June 1, 2016 in this case. 42 C.F.R. § 483.151(b)(2). Although the period of ineligibility has already expired, the ineligibility to conduct a NATCEP remains an issue as it triggers Petitioner’s right to request review of the scope and severity determinations and the determination of substandard quality of care that triggered the ineligibility to be approved to conduct a NATCEP. Pursuant to sections 1819(b)(5) and 1919(b)(5) of the Act, SNFs and NFs may only use nurse aides who have completed a training and competency evaluation program. Pursuant to sections 1819(f)(2) and 1919(f)(2) of the Act, the Secretary was tasked to develop requirements for approval of NATCEPs and the process for review of those programs. Sections 1819(e) and 1919(e) of the Act impose upon the states the requirement to specify what NATCEPs they will approve that meet the requirements that the Secretary established and a process for reviewing and re-approving those programs using criteria the Secretary set. The Secretary promulgated regulations at 42 C.F.R. pt. 483, subpt. D. Pursuant to 42 C.F.R. § 483.151(b)(2) and (f), a state may not approve and must withdraw any prior approval of a NATCEP offered by a skilled nursing or nursing facility that has been: (1) subject to an extended or partial extended survey under sections 1819(g)(2)(B)(i) or 1919(g)(2)(B)(i) of the Act; (2) assessed a CMP of not less than $5,000; or (3) subject to termination of its participation agreement, a DPNA, or the appointment of temporary management. Extended and partial extended surveys are triggered by a finding of “substandard quality of care” during a standard or abbreviated standard survey and
involve evaluating additional participation requirements. “Substandard quality of care” is identified by the situation where surveyors identify one or more deficiencies related to participation requirements established by 42 C.F.R. § 483.13 (Resident Behavior and Facility Practices), § 483.15 (Quality of Life), or § 483.25 (Quality of Care) that are found to constitute either immediate jeopardy, a pattern of or widespread actual harm that does not amount to immediate jeopardy, or a widespread potential for more than minimal harm that does not amount to immediate jeopardy and there is no actual harm. 42 C.F.R. § 488.301. In this case, the alleged substandard quality of care triggered an extended or partial extended survey, which triggered the ineligibility to conduct a NATCEP and is a basis for ALJ review. 42 C.F.R. §§ 483.151(b)(2)(iii); 498.3(b)(14)(ii), (16) (finding of substandard quality of care that results in loss of approval of NATCEP is initial determination subject to review). The CMP proposed by CMS also triggered ineligibility to be approved to conduct a NATCEP in this case.
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), 498.3(b)(13). However, the choice of remedies, or the factors CMS considered when choosing remedies, are not subject to review. 42 C.F.R. § 488.408(g)(2). A facility may only challenge the scope and severity level of noncompliance determined by CMS if a successful challenge would affect the range of the CMP that may be imposed or impact the facility’s authority to conduct a NATCEP. 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, 39 (2000), aff’d, Woodstock Care Ctr. v. Thompson, 363 F.3d 583 (6th Cir. 2003). 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 allocation of the burden of persuasion and the quantum of evidence required to meet
the burden is not addressed by regulations.3 Rather, the Board has long held that the 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, i.e., 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 decisions whether CMS can make a prima facie showing with little more than mere allegations or a scintilla of evidence.
C. Findings of Fact, Conclusions of Law, and Analysis
My conclusions of law are set forth in bold 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.4 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).
The Statement of Deficiencies (SOD) for the survey completed on June 2, 2014, cited Petitioner for violations of 42 C.F.R. §§ 483.20(k)(3)(i) (Tag F281,5 scope and severity
J6 ), 483.25(m)(2) (Tag F333, scope and severity J); and 483.60(a) and (b) (Tag F425, scope and severity J). All three deficiency citations (Tags) are based on facts involving the care and treatment of a resident identified as Resident 1. CMS Ex. 1.
In its August 16, 2014 request for hearing, Petitioner challenges the three deficiency citations in the SOD for the survey that ended on June 2, 2014, as well as several deficiencies removed by IIDR. Petitioner also challenged the CMS determination of immediate jeopardy and the reasonableness of the proposed CMP. In post-hearing briefing, Petitioner contests the deficiency citations under Tag F281, F333, and F425 that CMS did not agree to remove based on the IIDR arguing that CMS has failed to make a prima facie showing. There is no question that these are the only three deficiencies at issue before me. Petitioner disputes that any of the deficiencies posed immediate jeopardy. Petitioner also disputes the reasonableness of the proposed remedies. P. Br. at 7-12; P. Reply.
Tag F333 is discussed first followed by Tags F281 and F425, for reasons that should become apparent.
1. Petitioner did not violate 42 C.F.R. § 483.25(m)(2) (Tag F333).
2. Petitioner did not violate 42 C.F.R. § 483.20(k)(3)(i) (Tag F281).
3. Petitioner violated 42 C.F.R. § 483.60(a) (Tag F425), but the violation did not amount to noncompliance because it did not pose a risk for more than minimal harm.
4. The declarations of immediate jeopardy were clearly erroneous.
Resident 1 was admitted to Petitioner’s facility on October 10, 2007, with readmissions on July 1, 2012, February 2, 2013, and February 9, 2014. CMS Ex. 6 at 5-22, 89. He had multiple diagnoses including cerebrovascular disease, renal failure, acute respiratory failure, chronic airway obstruction, anemia, dysphagia, failure to thrive, atherosclerosis, senility, dementia, delusional disorder, psychosis, depression, anxiety, and, most pertinent to this decision, hypothyroidism. CMS Ex. 6 at 64-65, 88-89.
The evidence shows that on January 14, 2014, February 2 and 9, 2014, orders were issued for Resident 1 to be given 100 micrograms (mcg) of levothyroxine once a day. CMS Ex. 6 at 7, 15, 19, 23. There is no dispute that the levothyroxine, the generic form of Synthroid, was ordered for treatment of Resident 1’s hypothyroidism. P. Ex. 2.
On February 11, 2014, Resident 1’s physician increased Resident 1’s dosage to 112 mcg once per day, through a telephone order.7 CMS Ex. 6 at 7, 27, 46. On March 11, 2014, a laboratory report showed that Resident 1’s Thyroid Stimulating Hormone (TSH) level was elevated. P. Ex. 2 at 1. On March 14, 2014, Resident 1’s physician, Karuna Reddy, MD, ordered that Resident 1’s dosage of levothyroxine be increased from 112 mcg to 120 mcg per day, with a follow-up laboratory test for TSH to be done on March 25, 2014. CMS Ex. 1 at 20; CMS Ex. 6 at 30; P. Ex. 2 at 1. I infer that increasing the dose of levothyroxine was intended by Dr. Reddy to reduce Resident 1’s TSH level. On March 16, 2014, Petitioner’s pharmacy requested clarification of Dr. Reddy’s order for 120 mcg of levothyroxine because that dose was not available.8 Due to the request for clarification
Dr. Reddy’s order was rewritten for “levothyroxine 112 mcg 1 tab [by mouth every morning] with 88 mcg = 120 mcg” and “levothyroxine 88 mcg 1 tab [by mouth every morning] with 112 mcg = 120 mcg.” CMS Ex. 6 at 31. The physician order was recorded in Petitioner’s “Physician’s Orders” for Resident 1 as follows:
Give 1 tablet by mouth daily @ 6am with 0.112 mg to = 120 mg
* * * *
LEVOTHYROXINE 0.112 MG TABLET
Give 1 tablet by mouth daily @6am with 0.088 mg to = 0.120 mg
CMS Ex. 6 at 11 (emphasis added). Petitioner’s Regional Nurse Consultant, Regina Hornback, RN, BSN, WCC, states that the nurse who clarified the order with Dr. Reddy made a transcription error. P. Ex. 2 at 1 ¶ 3. The error in recording the physician orders is apparent to even a layperson – 0.088 mg plus 0.112 mg is 0.200 mg not 0.120 mg or 120 mcg. It is also apparent that 120 mg in the first entry is not the same as 0.120 mg in the second entry. Petitioner’s staff and managers did not identify the error. The evidence does not show whether either the actual physician’s order (CMS Ex. 6 at 31) or Petitioner’s “Physician’s Orders” form (CMS Ex. 6 at 11) were sent to the pharmacy. Nurse Hornback concedes that, due to the error, Resident 1 received 200 mcg of levothyroxine daily for 16 days rather than 120 mcg of levothyroxine per day, which was the dose the physician apparently intended, even though the evidence shows that dose is not available in tablet form equivalent to 120 mcg. CMS Ex. 16 at 1.
On April 1, 2014, Dr. Reddy ordered that a levothyroxine dose of 120 mcg be discontinued and that Resident 1 be given 100 mcg daily. CMS Ex. 6 at 35.
I find that Resident 1 received 200 mcg of levothyroxine (112 mcg plus 88 mcg) rather than 120 mcg as the physician apparently intended beginning with the incorrect order on March 16, 2014 to April 1, 2014, a total of 16 doses depending upon the time of administration on the first and last day of the incorrect order. The excess amount of levothyroxine Resident 1 received during the period amounted to 1,280 mcg (80 mcg per
day times 16 days), give or take one or two doses depending again on the time of administration on the first and last days the erroneous order was followed.
On April 6, 2014, Resident 1 was found unresponsive, not breathing, and with no heartbeat and he could not be revived. CMS Ex. 6 at 90; CMS Ex. 7. Although no toxicology or autopsy was done, Inspector Mary Jo Compton9 who conducted the complaint investigation interviewed the coroner who opined that the cause of death was cardio-respiratory failure and congestive heart failure. CMS Ex. 1 at 7, 24. Inspector Compton’s surveyor worksheet shows that she asked the coroner about levothyroxine. However, the coroner said he did not know and would consult his toxicologist but there is no evidence that the coroner called Investigator Compton back. CMS Ex. 18 at 33. No competent medical evidence shows a connection between the incorrect doses of levothyroxine and Resident 1’s cause of death or an exacerbation of the conditions that are listed as his cause of death. As discussed in more detail hereafter, I find that Inspector Compton did not possess the medical education, training, or experience necessary to establish such a connection and neither the coroner nor the hospital records show a connection. In fact, prior to the medication error, Resident 1 was hospitalized for acute respiratory failure and congestive heart failure. Resident 1 was hospitalized on January 27, 2013 for acute respiratory failure, possibly secondary to chronic obstructive pulmonary disease with pleural effusion. CMS Ex. 6 at 102-103. A chest x-ray reported September 28, 2013, indicated light congestive heart failure. CMS Ex. 6 at 120. Resident 1 was admitted to the hospital on April 2, 2014, for shortness of breath and a decreased oxygen saturation. However, there is no expert opinion in the medical evidence or otherwise that the cause for the shortness of breath and decreased oxygen saturation was the medication error which was discovered before the hospitalization, and I draw no inference that there was a connection. CMS Ex. 6 at 135-41.
Inspector Compton reported in the SOD that one of the contract pharmacists that served Petitioner stated that the increased dosage of levothyroxine for 16 to 17 days could affect the heart possibly causing angina, palpitations, edema, and heart failure. CMS Ex. 1 at 7, 23-24. The surveyor notes show that the pharmacist was Monica Goad, a pharmacist with Omnicare Pharmacy in Henderson, Kentucky. The surveyor notes show that, in addition to the statements mentioned in the SOD, Pharmacist Goad told the surveyor that it is not known what levels would be required to cause heart failure. CMS Ex. 18 at 44. The omission of the caveat of Pharmacist Goad raises a significant question as to the objectivity and reliability of Inspector Compton’s findings in the SOD. I accept the
surveyor notes as the surveyor’s contemporaneous recording of what she believes she heard Pharmacist Goad say, rather than the less complete statement in the SOD that clearly implies incorrectly that Pharmacist Goad opined that the excess dose Resident 1 received caused Resident 1 to suffer discomfort or side effects. An email from Pharmacist Goad indicates that she did make the comments to the surveyor but she clarifies that her further research caused her to believe that the effect she described would not likely occur except on a much higher dose than Resident 1 received and over a longer period. CMS Ex. 16 at 2. The email is an unsworn statement that is considered only to the extent that it gives further clarification that the statement of Pharmacist Goad as recorded in the surveyor notes and the SOD are not reliable and lack an adequate scientific basis to be entitled to weight that would trigger an inference of potential discomfort or harm to Resident 1.
Inspector Compton reports in the SOD that she conducted the complaint investigation from April 11 through 30, 2014. She concluded that the complaint was unsubstantiated and she cited unrelated deficiencies. CMS Ex. 1 at 1. She stated in the SOD that “[a]fter consultation with [CMS] the investigation was reopened” on May 27, 2014, and Petitioner was cited with multiple deficiencies, including those that remain at issue before me after IIDR. The new deficiencies were cited as posing immediate jeopardy. CMS Ex. 1 at 2. The CMS representative who caused the investigation to be reopened is not identified. I have no sworn testimony from any CMS official regarding the reason the investigation was reopened, how the risk for harm was determined, or whether CMS had any input into that determination. Inspector Compton indicates in her declaration that she is a nurse but she does not state whether she is a registered nurse or whether she has a bachelors, masters, or doctoral degree in nursing. She does not indicate that she has any training or expertise related to pharmaceuticals beyond what one expects that a nurse would have. In her declaration, Inspector Compton refers to Mosby’s Nursing Drug Reference as the source of available dosages of levothyroxine in pill form ranging from 25 mcg up to 300 mcg tablets – the 300 mcg tablet being 100 mcg more than the dose Resident 1 received. Inspector Compton also listed potential side effects listed in Mosby’s including cardiac arrest. However, Inspector Compton does not state whether Mosby’s described the frequency of the side effects or at what dose and duration of administration they might be triggered. CMS Ex. 22 at 4 ¶ 25. Inspector Compton also referred to the Lippincott Manual of Nursing Practice, which cautions that for geriatric individuals thyroid hormone replacement therapy should be increased gradually especially if the individual has coronary artery disease to avoid cardiac ischemia and increased oxygen demands upon the heart. She also indicates that Lippincott states that hyperthyroidism may be caused by excessive thyroid hormone medication ingestion, which can cause palpitations and atrial fibrillation. Inspector Compton did not state whether Lippincott stated how much thyroid hormone medication is considered excessive or that might trigger any of the side effects described. CMS Ex. 22 at 4 ¶ 29. Inspector Compton does not express in her declaration any opinion that the 200 mcg dose of levothyroxine that was administered to Resident 1 over 16 to 17 days was sufficient to
cause or, in fact, caused any discomfort or side effects suffered by Resident 1. Inspector Compton stated in the SOD that “[t]he facility’s failure to identify a significant medication error has caused or is likely to cause serious injury, harm, impairment, or death to a resident.” CMS Ex. 1 at 3. She stated that Petitioner’s failure to ensure Resident 1 was free of “a significant medication error” posed the same risk for harm. CMS Ex. 1 at 18. She also stated that the failure to “provide pharmaceutical services to meet the needs of each resident” posed the same risk for harm. CMS Ex. 1 at 34. The context of the statement indicates that Inspector Compton was referring to the medication error involving Resident 1, rather than a universe of potential medication errors that might occur under similar circumstances. Inspector Compton does not state the scientific or other basis for her opinions about the risk for harm posed by the medication error that occurred in this case other than her citations to Mosby’s and Lippincott, which are too general to support her opinions that there was a significant medication error or a risk for more than minimal harm. Inspector Compton’s credentials presented to me certainly do not permit an inference that she has the education, training, or experience necessary to render a credible opinion that the medication error posed any risk for harm to Resident 1. Pursuant to 42 C.F.R. § 488.26(c)(3), surveyors and inspectors like Inspector Compton must be professionals. However, the regulation does not establish that surveyors have the expertise necessary to render credible opinions on all medical issues. Accordingly, Inspector Compton’s opinion about potential harm is purely speculative when considered in the context of her qualifications and the clarification of her reporting of Pharmacist Goad’s opinion, which seemed to be the only evidence cited in the SOD by Inspector Compton in support of her opinion that there was a risk for more than minimal harm.
CMS placed in evidence an excerpt from Clinical Pharmacology on Synthroid or Levothyroxine, which shows that in the United States levothyroxine or Synthroid are available in tablet form with dosages ranging from 25 mcg to 200 mcg. CMS Ex. 16 at 1. The excerpt does not describe side effects, the frequency of side effects, or at what dose side effects tend to occur.
CMS also placed in evidence an unsworn statement of Robert T. Wesley, MD, Petitioner’s Medical Director. Dr. Wesley conceded that a medication error occurred. Although his statement is unsworn, I accept the concession that a medication error occurred given his status as Petitioner’s medical director. Dr. Wesley also opined as to the risk for harm related to the medication error in this case. Dr. Wesley explains in his letter that the dose of Synthroid (the proprietary name for levothyroxine) that Resident 1 received was not outside the “realm of some therapeutic doses nor the cause of any adverse effects in the patient in question.” CMS Ex. 17 at 1. Dr. Wesley supports his opinion pointing out that the medical record includes no evidence of tachycardia, no signs of respiratory distress that would indicate an exacerbation of congestive heart failure, and no evidence of weight loss during the period the incorrect dose was administered. He opined that metabolic changes do not result quickly when the medication is taken and the error was identified and corrected prior to any metabolic changes occurring. He opined
that this is a low-risk medication and the likelihood of serious harm or injury is low. CMS Ex. 17 at 1. Dr. Wesley’s statement is unsworn. However, I consider it because it was placed in evidence by CMS and it is inconsistent with and rebuts the risk for harm Investigator Compton identified in the SOD. I consider his unsworn statement for the limited purpose of further reducing the weight that should be accorded to Investigator Compton’s opinion about the risk for harm due to the medication error.
Petitioner presented the sworn affidavit of Karuna Reddy, MD. Dr. Reddy is licensed to practice medicine in Kentucky. He was treating physician for Resident 1. Dr. Reddy admitted that he issued the order for levothyroxine, a thyroid replacement medicine. He stated that the medication error in this case was due to a transcription error and caused Resident 1 to receive incorrect doses. Dr. Reddy did not address his error in failing to recognize that no combination of pills could be administered to equal the dose of levothyroxine he apparently intended Resident 1 to receive. Dr. Reddy stated he reviewed laboratory results for Resident 1 and he did not consider the levels reported to show that the increased dose of levothyroxine taken by Resident 1 was toxic or posed a danger to Resident 1. Dr. Reddy stated that Resident 1 actually gained weight during the period he received the increased dose with no symptoms associated with levothyroxine toxicity. P. Ex. 1. Because he is a practicing physician, I conclude that Dr. Reddy has the education, training, and experience necessary to render the opinions set forth in his affidavit. Arguably as the prescribing physician, Dr. Reddy may be viewed as having some responsibility for Resident 1 receiving the wrong dose, though the error in recording Dr. Reddy’s order more likely than not was committed by Petitioner’s staff rather than Dr. Reddy or his staff. Nevertheless, I recognize that Dr. Reddy may have some self-interest and consider that in weighing his opinions.
Petitioner also presented the affidavit of Leon Butler, MD, whose training, education, and experience are reflected in his resume in evidence as P. Ex. 10. Dr. Butler is licensed to practice medicine in Kentucky. He is board certified in internal medicine and family medicine and has limited his practice to treating residents in nursing facilities. Dr. Butler stated that he is familiar with the medication error involving Resident 1. Dr. Butler does not state which evidence he reviewed but he does describe with accuracy the incident reflected by the evidence before me. Dr. Butler stated that due to an error in the transcription of a physician order, Resident 1 received the wrong dose of levothyroxine, a hormone replacement medication for 14 days.10 Dr. Butler states that the typical dose of
levothyroxine ranges from 25 to 500 mcg, which is consistent with CMS evidence (CMS Ex. 16 at 1). Dr. Butler calculated that during the period Resident 1 received the wrong dose he received “1.05 mg”11 in excess of the intended dose (P. Ex. 11 at 2 ¶ 7). Dr. Butler stated that the excess amount was not dangerous or toxic. He stated that there was no likelihood of serious harm, injury, impairment, or death. Bloodwork showed no signs of toxicity in Resident 1. No blood test for titration of the medication was recommended or necessary. P. Ex. 11. Dr. Butler opined that while Resident 1 received the excess dose of levothyroxine, he actually gained weight and exhibited no symptoms associated with thyroid malfunction or toxicity. He opined that the incorrect dose was well within the normal dosage levels for levothyroxine and the level for toxicity is 25 times the amount given Resident 1. Dr. Butler opined that because no toxicology or autopsy was performed when Resident 1 died, the coroner’s determination of cause of death was based on Resident 1’s diagnoses during his hospitalization in January 2014, diagnoses that existed before the medication error occurred. Dr. Butler opined that Inspector Compton failed to correlate any symptoms associated with levothyroxine toxicity with any symptoms exhibited by Resident 1 and that correlation does not exist in the records which show that Resident 1’s condition was the opposite, i.e., he gained weight, had stable vital signs, and had no cardiac abnormalities. Dr. Butler opined that the medication error in this case is not a significant medication error within the meaning of the Act, regulations, or CMS guidance to surveyors. He opined that nothing in the record shows that the medication error posed any risk of harm. Dr. Butler pointed to evidence from Resident 1’s hospitalization on April 2, 2014, as showing that Resident 1 had improved cardiac function and no evidence of any thyroid toxicity. Dr. Butler also opined that aside from the medication error there is no evidence Resident 1’s needs for medication were not met. Dr. Butler stated that he agreed with the opinion of Dr. Reddy that the excess amount of levothyroxine administered to Resident 1 was not toxic and posed no danger to Resident 1. P. Ex. 11.
Dr. Butler’s affidavit demonstrates his familiarity with Resident 1’s clinical records specifically related to the administration of excess levothyroxine and the evidence is of a kind that medical experts would reasonably rely upon for their opinions. See, e.g., Fed.
R. Evid. 703. Dr. Butler has the skill, experience, training, or education necessary to render the opinions stated in his affidavit. His expertise is helpful to my determination of the fact issues of whether the excess amount of levothyroxine administered to Resident 1 was a significant medication error and posed a risk for more than minimal harm to Resident 1. There is no question that Dr. Butler had the expertise, he applied reliable principles and methods to formulate his opinions, and he reliably applied the principles and methods to the undisputed facts gleaned from Resident 1’s clinical record to formulate his opinions. See, e.g. Fed. R. Evid. 702. I conclude that Dr. Butler’s opinions are credible and worthy of weight.
Dr. Butler’s opinions are not rebutted by any evidence of record. Investigator Compton did not specifically offer opinions as to an amount of levothyroxine that may cause side effects and the evidence does not show that she was qualified by skill, experience, training, or education to render such an opinion. Investigator Compton attempted to rely upon her summary of her interview of Pharmacist Goad as the basis for her finding that any excess dose of levothyroxine could cause side effects. However, Investigator Compton’s notes and the subsequent statement of the pharmacist clearly show that the pharmacist advised Investigator Compton that she did not know at what level levothyroxine might cause side effects. Therefore, there were no bases in fact reflected by the SOD or in Investigator Compton’s affidavit for her to find that the excess dose of levothyroxine administered to Resident 1 constituted a significant medication error or posed a risk for more than minimal harm to Resident 1.
The evidence shows that a medication error occurred. Resident 1 received a daily dose of levothyroxine of 80 mcg in excess of what Dr. Reddy, his physician, intended. The evidence does not show it is more likely than not that Resident 1 suffered any discomfort, that his health was jeopardized, or that he suffered any harm or was at risk for any harm due to receiving the excess daily dose of 80 mcg, or the total excess amount of 1,280 mcg of levothyroxine over a period of approximately 16 days. The weight of the credible expert medical opinion evidence supports a finding that Resident 1 was not at risk for any harm due to the daily excess doses or the total excess dose he received. The clinical records in evidence, considered in light of the credible medical opinions in evidence, do not show Resident 1 suffered any discomfort or other harm. Dr. Butler’s opinions are given greatest weight in making these findings. Dr. Butler’s opinions are consistent with and supported by the opinions of Dr. Reddy. The evidence does not show that Inspector Compton was qualified to render an opinion regarding potential harm; her reliance on a statement of Pharmacist Goad as that opinion was recorded in the surveyor notes does not show it was more likely than not that there was any risk for harm to Resident 1. The statement of Pharmacist Goad as reported in the SOD is not given any weight as it inaccurately reports Pharmacist Goad’s statement to Inspector Compton.
Inspector Compton alleged in the SOD for the survey completed on June 2, 2014, the following noncompliance:
1. Violation of 42 C.F.R. § 483.20(k)(3)(i) (Tag F281) at a scope and severity of J, based on alleged failure of Petitioner to ensure care for Resident 1 met professional standards of quality because Petitioner failed to ensure Resident 1 received the correct dose of levothyroxine. CMS Ex. 1 at 2-17.
2. Violation of 42 C.F.R. § 483.25(m)(2) (Tag F333) at a scope and severity of J, based on Petitioner’s alleged failure to ensure there was no significant medication error in the case of Resident 1. CMS Ex. 1 at 17-32.
3. Violation of 42 C.F.R. § 483.60(a)-(b) (Tag F425) at a scope and severity of J, based on Petitioner’s alleged failure to ensure it provided pharmaceutical services including procedures for accurate acquiring, receiving, dispensing, and administration of medications to meet the needs of Resident 1. CMS Ex. 1 at 32‑49.
The CMS notice dated June 19, 2014, states that immediate jeopardy began on April 6, 2014, rather than March 16 or 17, 2014 when Resident 1 started receiving the incorrect dose of levothyroxine. CMS Ex. 3 at 1. The SOD and the CMS notice both indicate immediate jeopardy was abated May 30, 2014. CMS Exs. 1 at 2; 3 at 1. The SOD states that, based on an on-site revisit on August 25, 2014, Petitioner returned to substantial compliance on June 3, 2014. CMS Ex. 1 at 50. However, the CMS notice dated October 1, 2014, states that Petitioner returned to substantial compliance effective June 10, 2014. P. Ex. 9. It is not necessary to resolve the inconsistency between the dates alleged in the SOD and the October 1, 2014 CMS notice regarding when Petitioner returned to substantial compliance, because I conclude there was no noncompliance.
(i) Petitioner did not violate 42 C.F.R. § 483.25(m)(2) (Tag F333) and the declaration of immediate jeopardy based upon the alleged deficiency under Tag F333 was clearly erroneous.
Long-term care facilities such as Petitioner must comply with the requirements of 42 C.F.R. § 483.25(m)(2):
* * * *
(m) Medication Errors. The facility must ensure that –
* * * *
(2) Residents are free of any significant medication errors.
42 C.F.R. § 483.25(m)(2).12 In order for CMS to make a prima facie showing of noncompliance that permits the imposition of an enforcement remedy, the regulations require that CMS show by some amount of evidence that:
(2) The medication error was significant; and
(3) The medication error posed a risk for more than minimal harm. 42 C.F.R. §§ 488.301, 488.402(b).
The first element CMS must show is that a medication error occurred. According to the State Operations Manual (SOM),13 app. PP, Tags F332 and F333, a medication error is the “observed preparation or administration of drugs or biologicals” not in accordance with: physician’s orders, manufacturer’s specification, or accepted professional standards and principles applicable to the professional preparing or administering the drug or biological. There is no dispute that there was a medication error in this case because Resident 1 received 80 mcg per day more levothyroxine than Dr. Reddy intended
for approximately 16 days. Petitioner has taken responsibility for not catching the medication error, which Petitioner states was due to an error transcribing Dr. Reddy’s order on about March 16, 2014. P. Ex. 2 at 1 ¶ 3.
The second element CMS must establish under 42 C.F.R. § 483.25(m)(2) is whether the medication error was significant. In drafting the regulations, the Health Care Finance Administration (HCFA), predecessor to CMS, recognized that not all medication errors are significant:
Comment: With regard to medication errors in § 483.25(m), a number of commenters wanted “significant” defined. Three commenters, representing both consumer and provider groups, specifically suggested that significant medication error rates should not exceed five percent.
Response: Regarding a facility's responsibility to prevent significant error rates, we have modified § 483.25(m) to state that facilities may not have error rates of five percent or greater. This definition has been used in interpretive guidelines by HCFA since May of 1984 (appendix N, part 2 State Operations Manual Transmittal No. 165). It is used as a measure of a facility’s drug distribution system, which encompasses the entire spectrum of ordering, transcribing, dispensing, preparing, and administering drugs to residents. It has enabled HCFA to establish an outcome measure for the entire process of drug distribution in long-term care facilities. HCFA does not regulate who may prescribe, dispense, or administer drugs. HCFA does not regulate what type of drug distribution system must be used (e.g., unit dose, floor stock). HCFA has only minimal requirements for drug labeling and no requirement as to how an individual administering drugs must go about preparing drugs for administration. HCFA has left a facility free to create and manage its own system in any way it sees fit as long as it does not make “significant” medication errors and has an overall medication error rate of less than five percent.
56 Fed. Reg. 48,826, 48,853 (Sept. 26, 1991). HCFA did not define “significant medication error” in its regulations at 42 C.F.R. pt. 483 and CMS has not subsequently clarified the regulation. CMS did describe a significant medication error in the preamble to the regulations in effect at the time of the medication error and the CMS initial determination in this case:
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? Using these criteria, an example of a significant medication error might be as follows: A resident received twice the correct dose 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.
56 Fed. Reg. at 48,853. The example provided by the drafters is instructive as it shows that they focused on a potentially toxic drug that would exacerbate an existing problem with the pulse rate. CMS provided similar policy guidance to surveyors in the SOM. The SOM instructs surveyors that a significant medication error is one that causes a resident discomfort or jeopardizes his or her health or safety. Discomfort is readily understandable by a layperson without further definition. The CMS policy is specific that a medication error may be found significant if it causes a resident discomfort. According to guidance in the SOM, discomfort may depend upon the individual resident. Arguably, the CMS policy as written can be construed to require evidence that discomfort actually occurred. However, as discussed hereafter, the Board has commented in prior cases that actual harm is not necessary to support a finding that a significant medication error occurred. Under the Board’s view of the regulation and CMS policy, a potential for discomfort may be enough for the Board to conclude that a medication error was significant.
Surveyors are given no definition of the term “jeopardizes” in the SOM. The common meaning of “jeopardize” is “to expose to danger or risk” or to “imperil.”14 The Board has stated that it is not necessary for CMS to show that there was any actual harm to support a conclusion that a medication error is significant. Rather, a medication error may be significant if there is a potential danger or risk to a resident’s health and safety. Furthermore, even a single error may be significant. Life Care Ctr. of Tullahoma, DAB No. 2304 at 35 (2010), aff’d, Life Care Ctr. of Tullahoma v. Sebelius, 453 F. App’x 610 (6th Cir. 2011) (and cases cited therein). The relative significance of medication errors is a matter of professional judgment that considers three factors: (1) resident condition; (2)
drug category; and (3) frequency of the error. The SOM includes a list of examples of medication errors and characterizes them as significant or non-significant. Levothyroxine, the drug at issue in this case, is not listed among the examples or specifically discussed under tags F332 and F333 in the SOM. The fact that the SOM does not list levothyroxine as either significant or not significant, means only that no presumption or inference regarding the significance or non-significance of levothyroxine may be premised upon the CMS policy statement. SOM, app. PP, Tags F332 and F333. Therefore, it is necessary in conducting my de novo review in this case to determine on the evidence presented by the parties whether CMS made a prima facie showing that the medication error was significant and, if so, whether Petitioner rebutted the prima facie showing.
The Board made clear in Avon Nursing Home, that the surveyor’s and CMS’ view of the evidence are irrelevant to my de novo review, except to the extent CMS relies upon unreliable evidence as supporting its findings and conclusions of noncompliance.
An ALJ decides the noncompliance issue de novo – that is, without deference to CMS’s or the state survey agency’s factual findings or legal conclusion and based on her own evaluation of the credibility of the submitted evidence. N.C. State Veterans Nursing Home, Salisbury, DAB No. 2256, at 24 (2009). Because the ALJ reviews CMS’s noncompliance determination de novo, an allegation that the state survey agency used improper methods or personnel to make its findings and conclusions is irrelevant, except to the extent that the state agency’s survey practices undermine the credibility of evidence that CMS identifies as supporting the noncompliance determination.
DAB No. 2830 at 12 (2017). The Board further stated that “the ultimate issue before an ALJ is . . . ‘whether the evidence as it is developed before the ALJ supports’ CMS’s independent ‘finding of noncompliance’ under the relevant participation requirements.” Avon, DAB No. 2830 at 11 (citing Sunshine Haven Lordsburg, DAB No. 2456 at 21 (2012), aff’d in part and transferred, Sunshine Haven Lordsburg v. U.S. Dept. of Health & Human Servs., 742 F.3d 1239 (10th Cir. 2014)).
CMS has not promulgated regulations allocating the burden of persuasion or specifying the quantum of evidence necessary to establish the element of a prima facie case or a defense. In the absence of notice and comment rule making by CMS adopting regulations clearly allocating burdens and the quantum of evidence required to prove or rebut the CMS prima facie case or affirmative defenses, the Board developed interpretive rules in its Hillman and Batavia line of cases and related cases. In Evergreene, the Board
explained its “well-established framework for allocating the burden of proof on the issue of whether [a] SNF is out of substantial compliance” as follows:
CMS has the burden of coming 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. If CMS makes this prima facie showing, then the SNF must carry its ultimate burden of persuasion by showing, by a preponderance of the evidence, on the record as a whole, that it was in substantial compliance during the relevant period.
DAB No. 2069 at 7. The quantum of evidence required for CMS to make the prima facie showing was not clarified by the Board. Indeed, the Board has never specified the quantum of evidence required for CMS to make its prima facie showing and has concluded in some cases that merely the SOD is sufficient even though the SOD may amount to nothing more substantive than mere allegations. The Board has also been willing to find CMS has made its prima facie showing based on evidence offered by the regulated entity. See, e.g., St. Joseph Villa Nursing Ctr., DAB No. 2210 (2008).
Whether CMS makes a prima facie showing is determined by review of the credible evidence CMS presents to establish each element necessary to show that a facility is not in substantial compliance with a statutory or regulatory requirement of participation. To establish a prima facie case of noncompliance, the required basis for imposition of an enforcement remedy, CMS must show that the participation requirement was violated and that one or more residents suffered or were exposed to a risk for more than minimal harm. Whether CMS must show it is more likely than not that the medication error in this case was significant, is not clear from either the regulations or prior Board decisions. However, in this case one may conclude that the evidence presented by CMS does not show it is more likely than not that the medication error was significant.
I have already discussed that the CMS evidence of risk for harm or discomfort in the SOD is not based in fact. Specifically, the statement of Inspector Compton in the SOD that implied that she was told by Pharmacist Goad that the excess doses of levothyroxine given to Resident 1 would cause potential harm or discomfort is incorrect and misleading. CMS Ex. 1 at 7, 23-24. Inspector Compton made notes of her conversation with the pharmacist that show that the pharmacist specifically stated that she did not know what quantity of levothyroxine would be required to cause any side effects. CMS Ex. 18 at 44. The omission of the caveat of the pharmacist makes the allegations of the SOD unreliable regarding the issue of significance of the medication error and the risk for harm. The omission also adversely affects the credibility of the opinions of Inspector Compton expressed in the evidence presented by CMS. The CMS evidence does not establish
Inspector Compton’s education, training, or experience, all of which are necessary to give any weight and credibility to her personal opinions about potential risk for harm and discomfort based on the medication error. CMS also introduced inconsistent evidence in the form of the statement of Dr. Wesley who opined that there was no risk for harm and he had the education, training, and experience and was personally familiar with the facts to make his opinion both credible and weighty. Considering the CMS evidence alone, arguably CMS did not show it was more likely than not that Resident 1 suffered any discomfort or that his heath was jeopardized by the medication error in this case. Therefore, one could conclude that CMS did not make a prima facie showing of noncompliance because CMS did not establish it is more likely than not that Resident 1 suffered discomfort; that his health was jeopardized; or that he was at risk for any harm. However, because the Board has not specifically required that CMS make its prima facie case by a preponderance of the evidence based solely upon its own evidence,15 it is prudent to simply treat the CMS showing as sufficient and proceed to address whether Petitioner rebutted the prima facie case.
Assuming that CMS made a prima facie showing of noncompliance, the issue is whether Petitioner rebutted that prima facie showing by a preponderance of the evidence. In other words, did Petitioner show it was more likely than not that it was not in violation of the regulation or that, if there was a regulatory violation, that the violation did not pose a risk for more than minimal harm. Another formulation of the issue is whether Petitioner showed it was more likely than not that it remained in substantial compliance. In this case, resolution of the issues turns on the facts and must be resolved in favor of Petitioner. There is no dispute and I found as fact that a medication error occurred. However, I also found, based on the weight of the credible medical expert opinion and the clinical records, that the evidence does not show it is more likely than not that Resident 1 suffered any discomfort; had his health jeopardized; or that he suffered any harm or was at risk for any harm, due to receiving the excess daily dose of 80 mcg, or the total excess amount of 1,280 mcg of levothyroxine over a period of approximately 16 days. Because I found that it is more likely than not that Resident 1 suffered no discomfort or other harm, his health was not jeopardized, and he was not at risk for harm, I must conclude as a matter of law that the medication error in this case was not significant. I conclude that Petitioner did not violate 42 C.F.R. § 483.25(m)(2).
The third element that is necessary to conclude that there was noncompliance is that there was a risk for more than minimal harm. Based on the foregoing discussion of the
significance element, I also conclude that the evidence does not support a finding of a risk for more than minimal harm and, therefore, no noncompliance under Tag F333. I further conclude that, because there was no noncompliance under Tag F333, that deficiency citation cannot be the basis for a declaration of immediate jeopardy. 42 C.F.R. § 488.301 (Immediate jeopardy means that noncompliance “caused, or is likely to cause, serious injury, harm, impairment, or death to a resident”).
(ii) Petitioner did not violate 42 C.F.R. § 483.20(k)(3)(i) (Tag F281) and the declaration of immediate jeopardy based on the alleged deficiency under Tag F281 was clearly erroneous.
Long-term care facilities such as Petitioner are required by 42 C.F.R. § 483.20(k)(3)(i) to ensure:
(i) Meet professional standards of quality;
42 C.F.R. § 483.20(k)(3)(i).
The elements that must be shown to establish a violation of this regulation and noncompliance that supports an enforcement remedy are:
(2) The services did not meet professional standards of quality; and
(3) There was a risk for more than minimal harm.
42 C.F.R. §§ 488.301, 488.402(b). The citation of deficiency under Tag F281 is based on the same facts as Tag F333. There is no dispute that Petitioner was required to and did provide and arrange to provide pharmaceuticals and related services for Resident 1.
The second element requires consideration of whether or not the services provided Resident 1 met professional standards of quality. Inspector Compton and CMS both concluded on the facts of this case that the pharmaceutical services provided to Resident 1 did not meet professional standards of quality. However, it is not clear what evidence of professional standards of quality CMS and Inspector Compton considered. For the reasons already discussed, I do not find Inspector Compton qualified by reason of education, training, experience, or otherwise to render opinions or establish as fact what are professional standards of quality for delivery of pharmaceuticals to SNF residents. CMS presented no testimonial or documentary evidence to establish the standards. I do
find that there is good evidence of what constitutes professional standards of quality in the delivery of pharmaceuticals and medication errors in 42 C.F.R. § 483.25(m)(2). In notice and comment ruling making, CMS declared that medication errors are acceptable so long as they do not occur at the rate of five percent or more and do not amount to significant medication errors. 42 C.F.R. § 483.25(m); 56 Fed. Reg. 48,853.
There is no allegation that Petitioner had a medication error rate of five percent or more. I have found that there was no significant medication error. If CMS made a prima facie showing of noncompliance, I conclude that Petitioner has rebutted the prima facie case. Accordingly, I conclude that the facts of this case show that pharmaceutical services provided Resident 1 did not violate professional standards of care as recognized or established by CMS in 42 C.F.R. § 483.25(m). For reasons discussed under Tag F333, I also conclude that the element that requires a showing of a risk for more than minimal harm is not satisfied under this citation of deficiency. I further conclude that, because there was no noncompliance under Tag F281, that deficiency citation cannot be the basis for a declaration of immediate jeopardy. 42 C.F.R. § 488.301 (Immediate jeopardy means that noncompliance “caused, or is likely to cause, serious injury, harm, impairment, or death to a resident”).
(iii) Petitioner violated 42 C.F.R. § 483.60(a) (Tag F425) but the violation did not amount to noncompliance and the declaration of immediate jeopardy based on the alleged deficiency under Tag F425 was clearly erroneous.
Long-term care facilities such as Petitioner are required by 42 C.F.R. § 483.60(a) and (b) to ensure:
(a) Procedures. A facility must provide pharmaceutical services (including procedures that assure the accurate acquiring, receiving, dispensing, and administering of all drugs and biologicals) to meet the needs of each resident.
(b) Service consultation. The facility must employ or obtain the services of a licensed pharmacist who—
(1) Provides consultation on all aspects of the provision of pharmacy services in the facility;
(2) Establishes a system of records of receipt and disposition of all controlled drugs in sufficient detail to enable an accurate reconciliation; and
(3) Determines that drug records are in order and that an account of all controlled drugs is maintained and periodically reconciled.
42 C.F.R. § 483.60(a)-(b) (emphasis in original).
Inspector Compton alleges in the SOD that Petitioner violated this regulation because it failed to ensure it had pharmaceutical services, including procedures for accurate acquiring, receiving, dispensing, and administering of medications, to meet the needs of Resident 1.
The evidence and allegations of the SOD do not describe a violation of 42 C.F.R. § 483.60(b). There is no dispute that Petitioner had a contract pharmacy service with pharmacists and no allegation that service failed to perform the specific functions described by 42 C.F.R. § 483.60(b).
The elements necessary for a violation of 42 C.F.R. § 483.60(a) are:
(2) The violation posed a risk for more than minimal harm.
This allegation of noncompliance is also based on the same facts as those found related to Tags F333 and F281. It is undisputed that a medication error occurred. Petitioner did not provide pharmaceutical services to Resident 1 that were accurate in dispensing and administering levothyroxine because the dose administered was in excess of the dose Dr. Reddy intended to order due, as Petitioner concedes, to a transcription error. Accordingly, 42 C.F.R. § 483.60(a) was violated. Nevertheless, for reasons discussed under Tag F333, I conclude that the element that requires a showing of a risk for more than minimal harm is not satisfied under this citation of deficiency. I further conclude that, because there was no noncompliance under Tag F425, that deficiency citation cannot be the basis for a declaration of immediate jeopardy. 42 C.F.R. § 488.301 (Immediate jeopardy means that noncompliance “caused, or is likely to cause, serious injury, harm, impairment, or death to a resident”).
5. No enforcement remedy is reasonable in this case. 42 C.F.R. § 488.402(b).
The regulations are clear that an enforcement remedy may be imposed only on the bases of noncompliance. 42 C.F.R. § 488.402(b). I have concluded that there was no noncompliance based on the evidence related to the incident involving Resident 1 cited
by the survey completed on June 2, 2014. CMS Ex. 1. Accordingly, I conclude that no enforcement remedy can be reasonable in this case.
For the foregoing reasons, Petitioner was in substantial compliance with program participation requirements contrary to the allegations of the deficiencies cited by the complaint survey completed on June 2, 2014. The declarations of immediate jeopardy based on the alleged deficiencies were clearly erroneous. There is no basis for the imposition of enforcement remedies.
Keith W. Sickendick Administrative Law Judge
1. Citations are to the 2013 revision of the Code of Federal Regulations (C.F.R.), unless otherwise stated.
- back to note 1 2. Participation of a nursing facility (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. SNFs and NFs are commonly referred to as long-term care facilities.
- back to note 2 3. Congress granted the Secretary authority to impose enforcement remedies for noncompliance. Act § 1819(h)(2) (42 U.S.C. § 1395i-3(h)(2)). The Secretary is authorized to impose CMPs as an enforcement remedy by section 1128A of the Act (42 U.S.C. § 1320a-7a). 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 (42 U.S.C. § 405) 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 been left to fill the gap with its interpretative rules allocating the burden of persuasion to the nongovernmental party, the party defending against the imposition of the CMP.
- back to note 3 4. Credible evidence” is evidence that is worthy of belief. Black’s Law Dictionary 596 (8th ed. 2004). The “weight of evidence” is the persuasiveness of some evidence compared to other evidence. Id. at 1625.
- back to note 4 5. This is a “Tag” designation as used in CMS Pub.100-07, State Operations Manual (SOM), Appendix 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 policy guidance to surveyors. Although the SOM does not have the force and effect of law, the provisions of the Act and regulations as interpreted in the SOM clearly do have such force and effect. State of Ind. by the Ind. Dep’t of Pub. Welfare v. Sullivan, 934 F.2d 853 (7th Cir. 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.
- back to note 5 6. Scope and severity levels are used by CMS and a state 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.
- back to note 6 7. The order on February 11, 2014, was for a 0.112 milligram (MG) tablet once per day. CMS Ex. 6 at 7, 27. One milligram is equivalent to 1000 micrograms so a 0.112 milligram tablet is equivalent to 112 micrograms (mcg). Micrograms are referred to in most of the documents in evidence and are used in this decision without converting to the milligram measurement in most instances.
- back to note 7 8. The evidence shows that Synthroid or levothyroxine is available in pill form in doses of 25 mcg, 100 mcg, 112 mcg, and 125 mcg. There are no 10, 20, 40, 60, or 120 mcg pills nor other doses that could be combined as whole tablets to amount to 120 mcg. CMS Ex. 16.
- back to note 8 9. Inspector Mary Jo Compton conducted the complaint investigation in this case. CMS Exs. 18, 22. Inspector Compton’s findings and conclusions are recorded in the SOD (CMS Ex. 1), her surveyor worksheets (CMS Ex. 18), and her declaration (CMS Ex. 22).
- back to note 9 10. Regina Hornback states in her affidavit that Resident 1 received the dose of 200 mcg for 16 days. The source of the two-day discrepancy is not clarified by Petitioner. However, there is no evidence that a difference of two days affects the outcome and Nurse Hornback’s opinions about the effect of the excess dose of levothyroxine are consistent with those of Dr. Butler.
- back to note 10 11. I have found based on all the evidence that Resident 1 received an excess dose of 80 mcg per day over approximately 16 days, a total excess dose of 1,280 mcg (1.28 mg). It is not clear how Dr. Butler calculated a total excess dose of 1.05 mg (1,050 mcg). However, his opinions are based primarily upon there being no observed signs of side effects or harm, so his opinions are not undermined by the apparent math error.
- back to note 11 12. Pursuant to 42 C.F.R. § 483.25(m)(1), a facility must ensure it is free of medication error rates of five percent or more. There is no allegation in this case that Petitioner had a medication error rate of five percent or more.
- back to note 12 13. 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, 934 F.2d 853; Northwest Tissue Ctr., 1 F.3d 522. 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.
- back to note 13 14. Merriam-Webster www.m-w.com (last visited Oct. 17, 2018).
- back to note 14 15. See, e.g., St. Joseph Villa, DAB No. 2210 (Board commented in case in which CMS did not offer any evidence, that the legal sufficiency of the CMS case does not depend solely upon evidence submitted by CMS).
- back to note 15