SRS – Nashville HH, LLC d/b/a Sanderling Dialysis of Nashville, DAB CR6953 (2026)

DECISION

Located in Nashville, Tennessee, Petitioner, SRS-Nashville HH, LLC d/b/a Sanderling Dialysis of Nashville, was an end stage renal disease (ESRD) facility that supplied dialysis services and participated in the Medicare program as a supplier of services.  Following a second revisit survey, completed on June 8, 2022, the Centers for Medicare & Medicaid Services (CMS) determined, for the third time, that the facility did not meet requirements for Medicare participation and that some of its deficiencies posed an immediate and serious threat to patient health and safety.  CMS terminated Petitioner’s Medicare participation.

Petitioner appealed.

The matter was initially assigned to a different administrative law judge (ALJ).  In the wake of that judge’s announced departure from the Civil Remedies Division, the case was reassigned to me for decision.  The parties were advised of the transfer, and neither objected nor requested a second in-person hearing.

Page 2

For the reasons set forth below, I find that Petitioner did not comply with the Medicare conditions for coverage, and I sustain CMS’s determination to terminate its Medicare provider agreement.1

BACKGROUND.

End Stage Renal Disease occurs when the kidneys fail to cleanse the blood of potentially lethal toxins.  Kidney dialysis is a means of treating the disease by extracting the patient’s blood, cleansing it mechanically of waste and toxins, and reinserting it into the patient.  Angel Kidney Care of Inglewood, Inc., DAB No. 2795 at 3 (2017).  For those who receive it, kidney dialysis is “a treatment that is fraught with peril.”  Id. at 9.  Patients are at increased risk of strokes, heart attacks, and lethal infections.  Because of these risks “those who provide dialysis must be especially scrupulous in assuring that the care they give and the patients’ responses to that care are monitored and assessed.”  Id. (emphasis added).

Statutory and regulatory background.  Section 1881 of the Social Security Act (Act) (codified at 42 U.S.C. § 1395rr) extends Medicare coverage to ESRD patients.  The Act establishes the general scheme by which participating individuals qualify, and facilities deliver ESRD services.  Implementing regulations fill in the details and are found at 42 C.F.R. Part 494.

Medicare classifies most healthcare delivery entities as either “providers” or “suppliers.”  42 C.F.R. § 488.1.  Although classified as “suppliers,” ESRD facilities are subject to the same application, survey, certification, and enforcement requirements that apply to “providers.”  42 C.F.R. §§ 488.3(a)(2), 488.10-20.  To qualify as an approved supplier of Medicare services, an ESRD must be surveyed on-site as if it were a provider, so that its compliance with the requirements of Part 494 can be assessed and certified.  Each facility should be surveyed approximately every 12 months.  42 C.F.R. § 488.20(a).2

To participate in and receive payment from Medicare, an ESRD facility must satisfy all the provisions of section 1881 of the Act, and it must meet Part 494’s conditions for

Page 3

coverage.  42 C.F.R. §§ 488.3(a), 488.604(a).  A “condition for coverage” represents a broad category of services.  Each condition is contained in a single regulation, which is divided into subparts, called standards.  See 42 C.F.R. § 488.26(b).  A facility fails to meet a condition for coverage when its deficiencies “substantially limit” its “capacity to furnish adequate care” or “adversely affect the health and safety of patients.”  42 C.F.R. § 488.24(b).  With one exception (not applicable here), if an ESRD supplier fails to meet one or more of the conditions for coverage set forth in Part 494, CMS terminates Medicare coverage for the services it furnishes.  42 C.F.R. § 488.604(a); Dialysis Ctr. at Moreno Valley, Inc., DAB No. 2193 at 3 (2008).3

If the facility is deficient with respect to one or more standards, it may participate in the Medicare program only if:  1) it has submitted a plan of correction, acceptable to CMS, for achieving compliance within a reasonable period of time; and 2) the deficiencies “neither jeopardize the health and safety of patients nor are of such character as to seriously limit the [supplier’s] capacity to render adequate care.”  42 C.F.R. § 488.28(a), (b).  Nothing in this or any other regulation authorizes a period of correction where a facility is found out of compliance at the condition level.

Procedural Background:  the April 1, 2022 survey.  On June 8, 2022, surveyors from the Tennessee Health Facilities Commission (state agency) completed its second revisit survey of the ESRD facility.  CMS Ex. 2.  That revisit survey is the subject of this appeal.

Significantly, this was the facility’s third failed survey in under three months.  Following a recertification survey, completed on April 1, 2022, CMS determined that the facility did not comply with five conditions for coverage and that its deficiencies represented immediate jeopardy to patient health and safety:

• 42 C.F.R. § 494.62 (emergency preparedness)
• 42 C.F.R. § 494.90 (patient plan of care)
• 42 C.F.R. § 494.100 (care at home)
• 42 C.F.R. § 494.110 (quality assessment and performance improvement)
• 42 C.F.R. § 494.140 (personnel qualifications)

CMS Ex. 51; see CMS Ex. 50.

In a notice letter, emailed to the facility on April 7, 2022, CMS advised Petitioner that, based on the survey findings, it no longer met the requirements for participation in the Medicare program and that its “deficiencies represent an immediate jeopardy to patient

Page 4

health and safety.”  CMS Ex. 51 at 1.  The letter warned that the facility’s Medicare supplier agreement would be terminated effective April 30, 2022, if the facility were not in compliance by that date.  Id.  The letter then advised Petitioner of its appeal rights.

Petitioner did not appeal.  CMS’s determination is therefore final and binding.  42 C.F.R. § 498.20(b).  Through April 1, 2022, the facility was not in compliance with five conditions for coverage.  See Donelson Place Care & Rehab. Ctr., DAB No. 3046 at 15, 30 (2021); Rockcastle Health & Rehab. Ctr., DAB No. 2891 at 17 n.22 (2018) (explaining that the deficiencies and CMPs that Petitioner did not appeal are final); Taos Living Ctr., DAB No. 2292 at 10 (2009).

Acknowledging that the facility is not entitled to review of the April 1 survey findings, CMS asserts that “only the noncompliance identified in the June 8 survey is at issue in this appeal.”  CMS Br. at 1 n.1.  This is true, as far as it goes.  I do not here readjudicate the April 1 survey findings; they have been resolved in CMS’s favor.  But the un-appealed April 1 survey findings should not be considered irrelevant.  Failing to appeal a survey does not grant the facility a “get-out-of-jail-free” card, as though the survey had no significance.  In addition to settling any questions about the facility’s noncompliance as of April 1, the findings have an impact on how future appeals are reviewed.

Petitioner argues throughout its closing brief that CMS “failed to make a prima facie case of noncompliance with the cited conditions for coverage.”  See, e.g., P. Post-hrg. Br. at 9.  Given the compelling evidence of noncompliance (discussed below), on its face, this is not a serious argument.  Moreover, the argument fails as a matter of law.  Once a facility has been found to be out of compliance, it remains so until it affirmatively demonstrates that it has returned to compliance.  Ridgecrest Healthcare Ctr., DAB No. 2493 at 2-3 (2013); Taos Living Ctr., DAB No. 2293 at 20 (2009); Premier Living & Rehab Ctr., DAB No. 2146 at 3 (2008); Lake City Extended Care Ctr., DAB No. 1658 at 12-15 (1998).  The burden is on the facility to prove that it is back in compliance, not on CMS to prove that deficiencies continue to exist.  Asbury Care Ctr. at Johnson City, DAB No. 1815 at 19-20 (2002).  The facility must show that the incidents of noncompliance have ceased and that it has implemented appropriate measures to ensure that similar incidents will not recur.  Libertywood Nursing Ctr., DAB No. 2433 at 15 (citing Life Care Ctr. of Elizabethton, DAB No. 2356 at 16 (2011)).4

Page 5

CMS did not terminate the facility’s Medicare participation based on the April 1, 2022 survey findings but instead gave it opportunities to correct.

The May 3, 2022 survey.  Notwithstanding CMS’s uncontested determination that the ESRD was not in compliance, the agency twice extended the facility’s termination date – from April 30 to May 13, 2022 (CMS Ex. 52), and from May 13 to May 20, 2022.  CMS Ex. 54 at 2.

Surveyors returned to the facility on May 3, 2022, to conduct an “Immediate Jeopardy Removal survey.”  CMS Exs. 53, 54.  Based on those survey findings, CMS determined that the facility failed to comply with four conditions for coverage.  All were repeat deficiencies:

• 42 C.F.R. § 494.90 (patient plan of care)
• 42 C.F.R. § 494.100 (care at home)
• 42 C.F.R. § 494.110 (quality assessment and performance improvement)
• 42 C.F.R. § 494.140 (personnel qualifications).

CMS also found that the facility’s noncompliance with sections 494.100 and 494.140 posed an immediate and serious threat to patient health and safety.  CMS Exs. 53, 54.

In yet another notice letter, dated May 19, 2022, CMS advised Petitioner of the May 3, 2022 survey findings.  Notwithstanding the facility’s ongoing noncompliance, CMS again extended the facility’s termination date until June 11, “to allow the facility to demonstrate full compliance.”  CMS Ex. 54 at 2.

Page 6

The June 8, 2022 survey.  Based on the results of the second revisit survey, completed on June 8, 2022, CMS determined that the facility’s noncompliance continued; it had not corrected four deficiencies, all of which were cited during the April and May surveys.  Specifically, CMS again found that the facility did not comply with:

• 42 C.F.R. § 494.90 (patient plan of care)
• 42 C.F.R. § 494.100 (care at home)
• 42 C.F.R. § 494.110 (quality assessment and performance improvement)
• 42 C.F.R. § 494.140 (personnel qualifications)

CMS also found that the facility’s noncompliance with sections 494.100 and 494.140 continued to pose an immediate and serious threat to patient health and safety.  CMS Exs. 1, 2.

In a notice letter, dated June 28, 2022, CMS advised the facility that, based on the identified deficiencies, it was terminating the facility’s Medicare participation, effective July 13, 2022, pursuant to 42 C.F.R. § 489.53.  CMS Ex. 1.

Petitioner appealed.  The then-presiding ALJ conducted a hearing by video teleconference on October 28-29, 2024.

EXHIBITS.

In response to the ALJ’s pre-hearing order (and in accordance with Civil Remedies procedures), CMS proffered 58 exhibits (CMS Exs. 1-58).  Petitioner initially proffered 17 exhibits (P. Exs. 1-17).  On June 24, 2024, when the ALJ and the parties were scheduling the hearing, Petitioner submitted P. Exs. 18-23, its witnesses’ written direct testimony.

In the absence of any objections, the ALJ presiding at the hearing admitted into evidence CMS Exs. 1-58 and P. Exs. 1, 4-23.  Transcript (Tr.) at 11, 12.  I will not disturb that ruling.

Petitioner’s (very) late submissions.  On August 29, 2022, the (then) presiding ALJ issued a prehearing order.  Among other provisions, the order directed CMS to submit a prehearing exchange within 90 days, which meant that its submissions were due no later than November 28, 2022 (November 27 was a Sunday).  Petitioner’s prehearing exchange was due within 125 days or no later than January 3, 2023 (January 1 was New Year’s Day; January 2 was a federal holiday).  Prehearing Order (E-file # 2a) at 2 (¶ 4(a), (b)).  Among the submissions, the order directed the parties to submit a “copy of each proposed exhibit.”  Id. at 3 (¶ 4(e)(iii)).

Page 7

The order imposed on the parties a “continuing duty to exchange” relevant materials discovered after the initial exchange date.  Id. at 4-5 (¶ 4 (g)).  It warned of sanctions for failing to disclose evidence timely:

Upon a showing of prejudice to the opposing party, evidence, including documents and witness testimony, not timely disclosed during the exchange process may be excluded as evidence and not considered in the decision.  The exception is evidence that is offered solely in rebuttal when the offering party might not reasonably have known of the need to offer such evidence in support of its case-in-chief.

Id. at 5 (¶ 4(h)).

Civil Remedies Division Procedures contain a similar warning:

Untimely submissions are prohibited.  A party may not . . . offer an exhibit not listed or timely furnished to the opposing party.  If the opposing party objects, the offering party must persuade the ALJ why the . . . exhibit [should be] admitted, inasmuch as the party did not comply with the prehearing requirements for providing the ALJ and the opposing party with . . . a copy of the proposed exhibits.

Civil Remedies Division Procedures ¶ 13(d).

CMS timely submitted its prehearing brief and proposed exhibits.  After obtaining an extension, Petitioner submitted its brief and 17 proposed exhibits (P. Exs. 1-17) on January 18, 2023.  To save time at the hearing, Petitioner subsequently submitted its witnesses’ written direct testimony as P. Exs. 18-23.

Again complying with the pre-hearing order, on February 2, 2023, CMS filed its reply to Petitioner’s submissions, timely objecting to the admission of P. Exs. 2 and 3.  CMS’s Pre-hrg. Reply.  P. Exs. 2 and 3 are charts that purport to be the hypertension histories for Patients 1 and 2.  Citing Fed. R. Evid. 901, which requires the proponent to “produce evidence sufficient to support a finding that the item is what the proponent claims it is,” CMS pointed out that the charts “include no identifying information – such as the patients’ names – demonstrating that the evidence is what Petitioner claims it to be.”  Id. at 1-2.  CMS also pointed out that Petitioner produced no witness, such as direct-care staff, who might have been in a position to authenticate the documents.  Id. at 2.  Petitioner’s proposed witnesses, who were not direct-care staff and did not claim to have had direct contact with these patients, likely could not and, in any event, did not authenticate the documents.

Page 8

The regulations governing these proceedings gave Petitioner 20 days “to submit any rebuttal statement or additional evidence” in response to CMS’s objections.  42 C.F.R. § 498.17(b).  Petitioner did not submit a rebuttal statement nor additional evidence.  The ALJ did not rule on CMS’s objections.

CMS’s objections were compelling – no evidence supported a finding that the documents were what Petitioner claimed they were – and Petitioner did not respond to CMS’s objections.  Petitioner neither corrected the problems nor explained why the documents should be admitted.  Nevertheless, during the hearing, without explanation, the ALJ “provisionally admitted” P. Exs. 2 and 3.  Tr. 11, 204.

Petitioner, however, all but conceded that, based on the exhibits it had timely proffered, it could not authenticate P. Exs. 2 and 3.  Tr. 200-204.  Instead, it proffered two additional exhibits, P. Exs. 24 and 25, claiming that they were the more accurate versions of what P. Exs. 2 and 3 purported to be.  Without explaining any apparent inconsistency, Petitioner also promised a third exhibit that “would establish the accuracy and relevance of Petitioner’s Exhibits 2 and 3.”  CMS again objected, and the ALJ again deferred ruling.  Tr. 201-204.

Following the hearing, Petitioner proffered the promised document, P. Ex. 26, the written declaration of Jerome S. Tannenbaum, M.D., the facility’s Chairman and Chief Executive Officer.  Petitioner claimed that Dr. Tannenbaum’s declaration authenticated the challenged exhibits and that CMS was not prejudiced by the (very) late filing because it could ask for a supplemental hearing in which to cross-examine Dr. Tannenbaum.

The ALJ admitted the documents.  She did not do so in an order.  Atypically, the determination was inserted into a by-direction-of letter, signed by an attorney advisor, and not by the ALJ (see 42 C.F.R. § 498.61).  E-file # 56.  The ALJ completely disregarded CMS’s objections and did not explain why she admitted the documents.  The ALJ thus admitted P. Exs. 1-26.

I reverse that ruling with regard to P. Exs. 2, 3, and 24-26.

Obviously, a party is prejudiced when blind-sided by exhibits, proffered for the first time, at a hearing held a year and ten months after the documents were due and more than two years after the prehearing order was issued.  Moreover, Dr. Tannenbaum was present and testified at the hearing.  If he were capable of authenticating any records, he could, at the very least, have done so then.  Requiring a party to expend additional time and resources at a supplemental hearing in order to respond to new evidence (which could have been timely submitted) is inherently prejudicial.

Page 9

Petitioner should have submitted authenticated documents in the first instance, as required by the pre-hearing order and Civil Remedies procedures.  Having failed to do that, it should have responded to CMS’s objections, as required by the governing regulation, 42 C.F.R. § 498.17(b).  To this day, Petitioner has not shown good cause (or any cause) for flouting the prehearing order, CRD procedures, and the regulation.  See Heritage Manor – Carlinville, DAB No. 3231 at 9-11 (2026) (holding that the ALJ properly excluded exhibits that, in contravention of the judge’s prehearing order and without a showing of good cause, were submitted three months after the filing deadline.).

I sustain CMS’s objections to the late-filed documents and strike P. Exs. 24-26 from the record.  I also sustain CMS’s objections to P. Exs. 2 and 3 because Petitioner did not authenticate them.

Moreover, even if Petitioner had shown good cause for the late submission of P. Ex. 26, the document does not, in fact, authenticate P. Exs. 2, 3, 24, and 25.  First, with respect to P. Ex. 2, Dr. Tannenbaum explicitly did the opposite – he admitted that he cannot authenticate P. Ex. 2 because, in preparing that document, the facility “inadvertently included the wrong patient data.”  P. Ex. 26 at 2 (Tannenbaum Decl. ¶ 6).

Petitioner subsequently conceded that it “discovered a discrepancy in Exhibit 2” and suggests that I may “disregard the exhibit.”  P. Post-hrg. Br. at 18 n.2.  Yet, Petitioner did not withdraw it.  Worse, its witnesses have repeatedly cited the exhibit to support assertions they made in their written declarations.  See, e.g. P. Ex. 18 at 8 (Tannenbaum Decl. ¶ 23) (citing P. Ex. 2 as a “report showing . . . Patient 1 routinely hypertensive and holding antihypertensives.”); P. Ex. 21 at 3 (Dyer Decl. ¶ 10).  Such reliance on an admittedly bogus exhibit raises significant questions about the reliability of Petitioner’s assertions.  Remarkably, in replying to CMS’s post-hearing brief, Petitioner again cited P. Ex. 2.  See P. Reply at 24.

Nor did Dr. Tennenbaum establish that he is in any position to know whether the documents are authentic.  He describes what the exhibits look like; that is not the same as verifying that those entries represent a patient’s clinical records.  He does not claim personal knowledge regarding the data nor does he identify anyone who has that knowledge.5

Page 10

For these reasons, I admit into evidence CMS Exs. 1-58 and P. Exs. 1 and 4-23.

The parties have submitted prehearing briefs (CMS Br.; P. Br.); Joint Stipulations (Joint Stip.); post-hearing briefs (CMS Post-hrg. Br.; P. Post-hrg. Br.); and post-hearing replies (CMS Reply; P. Reply).

ISSUE.

The sole issue before me is whether the ESRD facility complied with all Medicare conditions for coverage.

The relevant time period here is after the April 1 survey and before the June 8 survey.  Evidence prior to April 1 is irrelevant because that un-appealed survey established the facility’s noncompliance up until that time.  Evidence after June 8 is irrelevant because it does not show the facility’s compliance (or noncompliance) at the time of the survey, upon which CMS made its determination.

DISCUSSION.

Preliminary Matters:

CMS determined that the facility did not comply with four conditions for coverage under Part 494.  CMS may terminate the facility’s Medicare participation based on any one of them.  42 C.F.R. § 488.604(a); Dialysis Ctr. at Moreno Valley, DAB No. 2193 at 3 (2008).  In determining whether the facility complies with any condition for coverage, I consider the statute, applicable regulation, and the facility’s policies.

Because I conclude that the facility did not comply with three conditions for coverage – 42 C.F.R. §§ 494.90, 494.100, and 494.140 – any one of which justifies termination, I need not address the allegations of compliance involving section 494.110.  See Perry Cnty. Nursing Ctr. v. U.S. Dep’t of Health & Hum. Servs., 603 F. App’x 265, 271 (5th Cir. 2015); Claiborne-Hughes Health Ctr. v. Sebelius, 609 F.3d 839, 847 (6th Cir. 2010); Carrington Place of Muscatine, DAB No. 2321 at 20-21 (2010); Moreno Valley, DAB No. 2193 at 5, 23.

The significance of facility policies.  Petitioner suggests that it was not required to follow its own policies for the care and treatment of its patients because policies are not conditions for coverage.  P. Post-hrg. Br. at 9.  In fact, the Departmental Appeals Board has long held that a facility’s policies regarding the care and treatment of its patients/residents demonstrate the facility’s understanding of what it must do to protect

Page 11

their health and safety, as required by the Medicare conditions for coverage/conditions of participation.  See Heritage House of Marshall Health & Rehab., DAB No. 3035 at 10-11 (2021); Green Valley Healthcare & Rehab. Ctr., DAB No. 2947 at 6 (2019) (citing The Laurels at Forest Glenn, DAB No. 2182 at 18 (2008)); N. Las Vegas Care Ctr., DAB No. 2946 at 6 (2019).  Indeed, a policy evidences the standard of care the facility expects its staff to provide.  The Laurels, DAB No. 2182 at 18 (citing Oxford Manor, DAB No. 2167 at 5-6 (2008).  If facility staff legitimately determine that a policy exception is appropriate for a particular resident, they must document that exception and explain why it is appropriate.  Oxford Manor, DAB No. 2167 at 5.

The patients.  By its own admission, the facility provided home hemodialysis care to “some of the most vulnerable individuals in Tennessee.”  P. Ex. 18 at 2 (Tannenbaum Decl. ¶ 5).  Patients 1 and 2 were among them.6   The facility repeatedly violated the conditions for coverage in its treatment of these seriously ill and medically unstable individuals.

Patient 1 was a 49-year-old woman, suffering from end stage renal disease, primarily caused by hypertensive chronic kidney disease.  CMS Ex. 23 at 1.

She had a history of hypertension, congestive heart failure, and asthma.  Id. at 4.  Her general health was “poor.”  Id. at 3.  In her initial care plan, dated May 13, 2022, the evaluating nurse considered Patient 1 “stable,” but, by June, she was listed as “unstable” because of her frequent hospitalizations.  Id. at 3, 4; CMS Ex. 30; see CMS Exs. 22, 27.  She began home dialysis on May 11, 2022.  CMS Ex. 21.

On May 14, Patient 1 became “acutely short of breath” and was hospitalized, suffering from acute respiratory failure requiring oxygen, asthma exacerbation, and pulmonary edema.  CMS Ex. 27 at 8, 10.  Her condition worsened and, by May 15, she was described as “critically ill” and put on a ventilator.  Id. at 20.  She was diagnosed with sepsis, acute respiratory failure with hypoxia, pericardial effusion, and many other serious impairments.  Id. at 22.  Nevertheless, on May 28, she left the hospital against medical advice.  Id. at 28.

Patient 2 was a 60-year-old man, suffering from chronic kidney disease.  CMS Ex. 36 at 1.  He had a history of hypertension and had been hospitalized for seizures, pneumonia, and thrombocytopenia (low blood platelets).  CMS Ex. 32 at 2-4.  He was deemed “unstable” because of his frequent hospitalizations.  CMS Ex. 30; CMS Ex. 32 at 1; see CMS Ex. 36 at 6.  He was hospitalized on May 25, 2022, diagnosed with Chronic Obstructive Pulmonary Disease, and on May 27-31, diagnosed with hypotension.  CMS Ex. 35 at 3-4; CMS Ex. 36

Page 12

Patient 2’s care plan, dated March 31, 2022, recognized that, because he had been hospitalized for seizures and pneumonia, he needed to be monitored closely.  CMS Ex. 32 at 4.  Patient 2 received home hemodialysis.  Id. at 1.

1. The facility did not comply with 42 C.F.R. § 494.90 because:  1) it did not develop and implement plans of care that addressed patients’ needs and changes in condition; 2) it did not ensure that a registered nurse timely assessed its unstable residents so that appropriate interventions could be added to patient care plans; and 3) it did not properly address its patients’ hypertension.7

Regulatory requirement:  42 C.F.R. § 494.90 (patient plan of care).  Section 494.90 requires that each patient’s interdisciplinary team “develop and implement a written, individualized[,] comprehensive plan of care that specifies the services necessary to address the patient’s needs, as identified by [the patient’s] comprehensive assessment and changes in the patient’s condition, and must include measurable and expected outcomes and estimated timetables to achieve [the] outcomes.”  42 C.F.R. § 494.90 (emphasis added).  The outcomes specified in the care plan must be consistent with current evidence-based professionally-accepted clinical practice standards.  42 C.F.R. § 494.90.

Among other factors, the care plan must address “the necessary care and services to manage the patient’s volume status” or fluid removal and “achieve and sustain the prescribed dose of dialysis . . . .”  42 C.F.R. § 494.90(a)(1).  “Volume status” refers to the patient’s dose of dialysis and involves management of the patient’s dry weight and blood pressure.  CMS Ex. 57 at 7-8 (Wehner Decl. ¶ 22).8

At a minimum, the interdisciplinary team consists of the patient or designee, a registered nurse, a physician treating the patient for end stage renal disease, a social worker, and a dietician.  42 C.F.R. § 494.80.

The interdisciplinary team is also responsible for the patient assessment.  The assessment must include:  1) an evaluation of the patient’s current health status and medical condition, including co-morbidities; 2) an evaluation of the appropriateness of the

Page 13

dialysis prescription, blood pressure, and fluid management needs; 3) laboratory profile, immunization history, and medication history; 4) an evaluation of factors associated with anemia; 5) an evaluation of factors associated with renal bone disease; 6) a dietician’s evaluation of the patient’s nutritional status; 7) a social worker’s evaluation of the patient’s psychosocial needs; 8) an evaluation of access type and maintenance; 9) an evaluation of the patient’s abilities, interests, preferences, and goals, including desired level of participation in the dialysis care process, preferred modality and setting, and expectations for care outcomes; 10) an evaluation of suitability for transplantation referral; 11) an evaluation of family and other support systems; 12) an evaluation of the patient’s current physical activity level; and 13) an evaluation for referral to vocational and physical rehabilitation services.  42 C.F.R. § 494.80(a).

For patients admitted to a dialysis facility, the interdisciplinary team must conduct an initial comprehensive assessment on all new patients; it must reassess all stable patients at least annually.  The team must assess “unstable patients” at least monthly.  Unstable patients are those with the following:  i) extended or frequent hospitalizations; ii) marked deterioration in health status; iii) significant change in psychosocial needs; or iv) concurrent poor nutritional status, unmanaged anemia, and inadequate dialysis.  42 C.F.R. § 494.80(b), (d).

Facility Policies Implementing 42 C.F.R. § 494.90:

Facility policy:   interdisciplinary team and plans of care.  The facility had in place a policy designed to ensure that plans of care and patient assessments were performed timely and that adequate data would be “available for presentation [at the] Inter-Disciplinary Team Meetings.”  CMS Ex. 18 at 1.

Consistent with the regulation, the policy dictated that the team include:  a registered nurse assigned to care for the patient; a social worker (either a licensed clinical social worker or an individual with a master’s level education in social work); a registered dietician; and a nephrologist (either the patient’s nephrologist of record or the facility’s medical director).  Id.

The plan required that each patient be evaluated by each member of the team, in accordance with the following schedule:

• An initial assessment by each member at the earlier of 30 days from the day of admission or after the patient has undergone 13 hemodialysis sessions at the facility;
• A follow-up assessment within 90 days of admission (but not less than 60 days);

Page 14

• If the patient is unstable, the follow-up assessment by each team member must occur monthly until the patient is deemed stable;
• The social worker screens for depression within 30 days of admission and annually.  If the patient is unstable, the depression screening is repeated every three months;
• The social worker performs a Kidney Disease Quality of Life (KDQOL) survey within 30 days of admission and annually.  If the patient is unstable, the survey is performed every six months.

Id.

The policy defines as “unstable” a) a patient whose laboratory values meet listed criteria; b) a patient who has been admitted as a hospital in-patient in the past 30 days; c) a patient who resides in a skilled nursing facility; or d) a patient with a severe depression score, as judged by the social worker.  CMS Ex. 18 at 1-2.

Finally, the policy requires documentation as follows:

• The nurse, social worker, and dietician each complete initial and follow-up assessments, using the facility’s on-line interdisciplinary team’s “Assessment and Plan of Care forms” specific to the team member’s discipline.
• A copy of each form is reviewed and signed by the patient’s nephrologist or the medical director.
• A copy of each form is presented to the patient, and the patient signs it.
• The three parts of the form plus documentation of the four team members’ discussion are collated and uploaded into the patient’s electronic medical record under the heading “[Interdisciplinary Team] and Plans of Care.”
• The KDQOL is performed with the 3rd Party Online service.
• The depression screening uses the on-line form created for that purpose.  It is uploaded into the patient’s electronic medical record after the social worker completes it.

CMS Ex. 18 at 2.

Page 15

Facility policy:  against medical advice (AMA).  The facility had in place a policy titled “Against Medical Advice.”  CMS Ex. 38.  According to the policy, a patient is considered “AMA” when, after being fully informed of the risks involved with an action or nonaction, the patient refuses to follow medical advice.  Id. at 1.  The patient is informed of the consequences of that decision.  Id.

Specifically, a patient asking to shorten dialysis treatment should be encouraged to complete the entire treatment and the licensed caregiver9 provides a full explanation of the benefits of completing the treatment and the risks associated with early termination.  CMS Ex. 38 at 1.  “Every effort” is made to persuade the patient to comply with the dialysis prescription or medical orders.  The appropriate health care team members (social worker, physician) should be included.  If the patient still refuses to comply, he/she must sign the AMA form on each occasion.  If the patient refuses to sign, the refusal is noted on the form and witnessed by a second caregiver.  Id.

Staff notify the nephrologist and document how long the patient was dialyzed, what the current prescription is, what counseling was given, what physician was notified, and the patient’s response.  The nephrologist is responsible for regular assessment of the non-compliant patient, which is evidenced by written updates or progress notes.  The Clinic Manager and nephrologist encourage the patient to participate in the plan of care to address specifically the patient’s status.  Id.

Staff inform the patient that the facility cannot assume further responsibility for the patient’s decision.

AMA forms are scanned into the patient’s medical record.

Facility trends of AMAs are followed monthly through the Quality Assessment and Performance Improvement Program process.  Id.

Facility policy:  hypertension.  The facility had in place a policy titled “Hypertension.”  Its purpose was to “recognize and appropriately treat symptomatic high blood pressure and prevent its recurrence.”  CMS Ex. 5 at 1.  The policy characterizes hypertension as the most common complication that occurs pre-dialysis, occurring in about 80% of

Page 16

patients with chronic renal failure.  It may lead to a heart attack or stroke and may result in death.  Id.

Among the policy’s requirements:

1. In an effort to prevent undesirable complications or outcomes, patient care staff are trained to recognize and treat signs and symptoms of hypertension.
2. The Charge Nurse must assess dialysis patients found to be hypertensive.
3. Staff notify the nephrologist if the patient’s pre-dialysis diastolic blood pressure is greater than 120mm/Hg, unless this is normal for the patient.  If the diastolic blood pressure is greater than 110 mm/Hg after one hour of treatment, staff will notify the physician.10
4. Staff notify the physician if the patient’s pre-dialysis systolic blood pressure is greater than 200mm/Hg, unless this is normal for the patient.
5. The Charge Nurse reports to the nephrologist hypertension that does not respond to prescribed antihypertensives.
6. Hypertensive patients will have their blood pressure monitored every 15 minutes until the diastolic blood pressure falls below 110 mm/Hg.
7. Patients must have standing blood pressure measured pre and post dialysis, while the venous bloodline is still attached to the venous needle.
8. Staff will make every effort to identify and correct the cause of the patient’s hypertension.  The physician, nurse, and dietician will counsel patients who gain excessive amounts of fluid between treatments.  All counseling will be documented in the patient’s chart.
9. Hypertension will be marked on the patient’s flow sheet under adverse events for evaluation of the patient’s response to antihypertensives over time.

Id.

Page 17

The policy lists causes of hypertension:

• Hyporesponse (insufficient reaction) to antihypertensives.
• Fluid overload due to failure to follow prescribed diet and water restrictions.
• Side effects of other medications.
• Renin-angiotension-aldosterone system (hormone system that regulates long-term blood pressure, blood volume, and sodium balance) dysfunction.
• Inadequate ultrafiltration during dialysis.
• Altered sympathetic nervous system activity.
• Altered baroreceptor (nerve endings that detect changes in blood pressure by sensing the stretch in arterial walls) and chemoreceptor (sensory cells that detect chemical changes in the body) response.
• Altered calcium levels (that can restrict smooth muscle of blood vessels).

CMS Ex. 5 at 2. 

The policy also lists signs and symptoms of hypertension:  seizure, headache, elevated diastolic blood pressure, altered vision.  Id.

Among procedures listed in the policy, staff are directed to:

1. Take the patient’s blood pressure and compare it with previous blood pressure readings.
2. Notify the physician if diastolic blood pressure is greater than 110mm/Hg.
3. Monitor blood pressure every 15 minutes until diastolic blood pressure falls below 110mm/Hg.
4. Assess for related conditions, such as smoking, diabetes, atherosclerosis, renal artery stenosis, obesity, and family history.
5. Counsel patient regarding fluid and dietary restrictions, as needed.
6. Assess dry weight (weight without fluid overload) and adjust down, as needed.

Page 18

7. Counsel patient regarding taking antihypertensives as prescribed.

Id.

Facility policy:  monitoring during patient’s treatment.  The facility had in place a policy for monitoring a patient who is receiving dialysis treatment.  Its stated purpose was to ensure that the patient and the dialysis machine were “under constant observation to prevent, detect, and treat complications” and to provide “an effective, safe, and comfortable dialysis treatment to every patient[,] in accordance with his/her individual plan of care.”  CMS Ex. 16 at 1.  The policy required staff to observe the patient “at least every 30 minutes.”  Id.  Negative arterial pressure was not to exceed 250 mm/Hg; venous pressure was not to exceed 250 mm/Hg.  Id.

The policy listed specific procedures:

• Check blood pressure every 30 minutes or more frequently, depending on the patient’s needs.  Staff are required to record all blood pressure checks on the patient’s flow sheet and to report to the nurse in charge blood pressure greater than 200 mm/Hg systolic, less than 90 mm/Hg diastolic, and less than 80 mm/Hg systolic and any significant changes or trends.  These requirements are to ensure that the patient’s blood pressure remained stable and to treat unstable blood pressure.
• Check the patient’s pulse every 30 minutes and record it on the flow sheet.  This is to make the patient as comfortable as possible.
• Observe the patient for level of consciousness (alert, drowsy, sleepy? Respond when spoken to?).  This is to determine alertness as an indicator of the patient’s condition.
• Check the temperature of the patient’s skin (cold? clammy? warm? hot?  Is the patient perspiring?).  This is to alert staff to the beginnings of a hypotensive episode.
• Check the color of the patient’s skin (pink? flushed? gray? yellow? pale?).  This is because skin color may change with decreasing blood pressure.
• Is the patient breathing normally?  (labored? shallow? deep? rapid? slow?)  A change in heart rate indicates cardiac status, which may indicate the onset of a hypotensive episode.  Difficulty breathing may indicate fluid overload or pulmonary edema.

Page 19

• Monitor the patient’s access with each check to ensure there is no unusual bleeding or infiltration.  The patient’s access should not be covered.

The policy emphasizes that staff should report to the charge nurse anything unusual and follow the nurse’s instructions.  Document all assessments, interventions, and “follow up in the comments section of the flow sheet.”

CMS Ex. 16 at 1-2.

The policy also requires specific machine checks:

• Visually check that the dialysis lines are properly attached (to assure optimum clearance occurs).
• Trace machine lines to patient’s needle lines for correct hook-up (to assure optimum clearance).
• Verify normal saline line is double clamped.  Verify at least 300 cc of saline is present in the bag; change bag if less than 300cc (to prevent air from entering the extracorporeal system and to prevent saline from entering the extracorporeal system, and possible fluid overload).
• Check the TMP gauge/UFR readout and record on flow sheet (to assure proper amount of fluid is removed during treatment).
• Verify that the venous chamber is  full and venous chamber medication line is clamped (to prevent air or clots).
• Check venous pressure monitor and transducer filter for proper functioning.  Check to be sure venous pressure limits are set (if applicable).  Report to the charge nurse trends noted in the venous pressure readings.   (If blood or fluid is noted in the transducer filter, change the transducer and flush the line clear of fluid to assure an accurate reading.  If blood was noted on the back side of the external transducer, at the end of treatment, pull the machine and check the internal transducer for contamination before using the machine on another patient.
• Verify air detector is armed at all times.  (An armed air detector will alert you to air entering the extracorporeal system).
• Check heparin line and record the amount infused since last check.

Page 20

• Check the blood flow rate and document if unable to achieve prescribed rate.

The policy emphasizes:  the patient should be observed constantly for possible complications.

CMS Ex. 16 at 2-3.

Section 494.90 Deficiencies:

Section 494.90 deficiency:  deviations from patient care plans.  Surveyor Sherry Wehner, R.N., observed a discrepancy between the equipment ordered for Patient 2’s dialysis, as described in his care plan, and the equipment that was being used.  According to Patient 2’s March 31, 2022 care plan, he was prescribed a “Fresenius 2008 Series” dialysis machine.  CMS Ex. 32 at 3.  The surveyor observed that he had a Tablo machine instead.  CMS Ex. 2 at 18; CMS Ex. 57 at 7 (Wehner Decl. ¶ 20).

Also, according to the care plan, Patient 2’s vascular access site was supposed to be in his right arm.  CMS Ex. 32 at 3.  Hemodialysis flowsheets also indicated that the access site was the patient’s upper right arm.  CMS Ex. 37.  Yet, the surveyor observed the technician using an access site in Patient 2’s left arm, which indicates “that either the patient’s care plan was inaccurate or the [technician] was ignoring it.”  CMS Ex. 57 at 7 (Wehner Decl. ¶ 20); CMS Ex. 2 at 18.

Section 494.90 deficiency:  failing to assess patients following their hospitalizations and other medical events.  As the following discussion explains, the facility’s professional staff – particularly registered nurses – were not sufficiently involved in patient care.  Tasks that should have been performed by nurses or other professionals were delegated to certified – and even un-certified – technicians.

For example, an unstable patient’s interdisciplinary team was required to assess the patient at least monthly.  The parties also agree that, following a hospitalization, a nurse, not a technician, should have assessed the patient.  “Assessments require nursing education, skill and judgment that [technicians] do not have.”  CMS Ex. 57 at 9 (Wehner Decl. ¶ 25); Tr. 172 (Tannenbaum testimony) (“After the patient comes from the hospital, a nursing assessment is appropriate.”).

Notwithstanding Patient 1’s serious illness and two-week hospitalization, which ended on May 28 (when she left the hospital against medical advice) (CMS Ex. 27), no documentation establishes that a nurse assessed Patient 1 when she resumed home dialysis.  When surveyors visited her home on June 6, to observe her home treatment, she appeared “very sick,” and was having difficulty breathing, “taking lots of breaths while talking.”  CMS Ex. 58 at 3 (Rickman Decl. ¶ 10).  Yet, no nurse was there.  Only an un-certified patient care technician was there to provide the patient’s home treatment.  Id.

Page 21

Dr. Tannenbaum agreed that Patient 1 “was pretty sick” and that a nursing assessment would have been “a good idea.”  Tr. 172.

Similarly, no documentation establishes that a nurse assessed Patient 2 following his hospitalizations.  According to Patient 2’s hemodialysis flow sheets, a technician conducted his post-hospitalization dialysis.  CMS Ex. 37 at 4-12;11 CMS Ex. 57 at 4 (Wehner Decl. ¶ 11).

Patient 2 experienced significant complications during his post-hospitalization home dialysis treatments, which underscores why a nurse should have assessed him prior to treatment.  During his May 27 treatment, his blood pressure dropped, forcing him to stop his dialysis early and sending him to the hospital two hours later with “severe hypotension.”  CMS Ex. 33 at 5; CMS Ex. 36 at 1, 6; CMS Ex. 37 at 5; CMS Ex. 57 at 4-5 (Wehner Decl. ¶¶ 12-14).

Because low blood pressure can be life threatening, it was essential that the [technician] notify [a registered nurse] or physician about the patient’s hypotension so qualified professionals could determine whether to continue treatment as prescribed, adjust treatment (such as by pulling less fluid), or stopping treatment altogether.  This sort of oversight would have been available to the patient if he were in the center, and he was entitled to such care at home.

CMS Ex. 57 at 5 (Wehner Decl. ¶ 13).12

During his June 3 treatment, Patient 2 suffered a seizure.  Again, notwithstanding this significant medical event, a registered nurse did not assess him.  CMS Ex. 57 at 6 (Wehner Decl. ¶ 17); see CMS Ex. 37 at 10-12.

Thus, no documentation establishes that a registered nurse or any other member of the   patient’s interdisciplinary team responded to changes in the patient’s condition and

Page 22

provided the care necessary to ensure that the patient’s dialysis prescription was still appropriate.

Section 494.90 deficiency:  improper responses to treatments shortened against medical advice.  The care plans for both Patients 1 and 2 required home dialysis three days per week (Monday, Wednesday, Friday).  Each session was supposed to last for 240 minutes (four hours).  CMS Ex. 23 at 1-2; CMS Ex. 32 at 3.  Patient 2, however, would frequently end his treatments early, against medical advice.  CMS Ex. 33.  When that happened, his care plan directed staff to “continue with patient education regarding complications associated with shortened and missed dialysis treatments.”  CMS Ex. 32 at 3-4.  However, if those efforts failed – which they frequently did – the plan did not call for any follow-up interventions.  Nor did the facility adjust Patient 2’s care plan to add interventions addressing the underlying causes of his refusing to complete the ordered treatments.  CMS Ex. 57 at 8 (Wehner Decl. ¶ 23).

From May 10 through June 6, 2022, Patient 2 ended his treatments early – against medical advice – eight times.  CMS Exs. 33, 37.  On May 23, June 1, and June 3, his sessions lasted 2 hours and 25 minutes, 2 hours and 2 minutes, and 2 hours and 34 minutes, respectively.  CMS Ex. 37 at 1-3, 7-12.  On May 27, his session was 1 hour.  CMS Ex. 37 at 4-6.  And, on June 6, his session lasted just 35 minutes.  CMS Ex. 37 at 13-15.

A certified dialysis technician prepared, and Patient 2 signed, an “Against Medical Advice” form on each of these occasions.  The forms were all signed by the technician (referred to as CCHT or Certified Clinical Hemodialysis Technician) who administered the dialysis.  CMS Ex. 33; CMS Ex. 57 at 3 (Wehner Decl. ¶ 8).  On seven of the forms (May 10, May 13, May 17, May 23, May 27, June 3, June 6), the reason given for the shortened session was that he “just wants to get off early.”  CMS Ex. 33 at 1-5, 7-8.13

There is no AMA form dated June 1.  The dialysis technician prepared and dated one June 2.  The form does not indicate that the dialysis was provided on the day before; it does not explain why the AMA form was not prepared at the time the patient ended his treatment early; and it gives no reason for his doing so.  CMS Ex. 33 at 6.

The facility’s policy required that:  1) a licensed caregiver provide a “full explanation of the benefits of completing the treatment and the risks associated with early termination” and 2) “every effort” be made to persuade the patient to comply with his dialysis

Page 23

prescription, including involving “the appropriate health care team members (i.e., social worker, physician).”  CMS Ex. 38 at 1.  Yet, the documentation establishes that licensed personnel were not involved in explaining the benefits and risks and attempting to persuade the residents to comply with their dialysis prescriptions; the technicians alone were involved in those efforts.  CMS Ex. 57 at 3 (Wehner Decl. ¶¶ 7, 8).

Patient 2’s care plan also required staff to monitor him closely.  CMS Ex. 32 at 4.  Yet, members of the patient’s disciplinary team did not meet with him monthly as required by 42 C.F.R. § 494.80(d)(2) and the facility’s policies, which, given Patient 2’s fragility and reckless behaviors, was especially important.  CMS Ex. 18 at 1 (requiring each member of the disciplinary team to assess the resident monthly),

Similarly, according to Patient 1’s May 11 hemodialysis flowsheet, her treatment began at 7:00 a.m. and was completed at 9:00 a.m.14   The flowsheet identifies the certified technician (“Admin. David”) as the nurse.  The patient signed an “AMA” form.  Yet, the record includes no indication that anyone, much less a licensed caregiver, explained to her the benefits of completing treatment and the risks associated with early termination.  CMS Ex. 24 at 1, 3.

Section 494.90 deficiency:  inaccurate, incomplete medical records.  The interdisciplinary team must have accurate data in order to develop a care plan that adequately addresses the patient’s needs, as required by 42 C.F.R. § 494.90; see Angel Kidney Care, DAB No. 2795 at 12; Tr. 187 (Dr. Tannenbaum confirming that patient health records should be “accurate” and should reflect the date and time the data was collected).  Whenever something significant happens regarding the patient’s care (hospitalization, adverse medical episode, modality change such as moving from home to in-center dialysis), it should be documented in the patient’s medical record.  CMS Ex. 58 at 6-7 (Rickman Decl. ¶ 19).

Yet, the medical records for both Patients 1 and 2 were riddled with inaccuracies and omissions, compromising the facility’s ability to ensure that adequate and accurate data would be available to the interdisciplinary team for its use in assessing and care-planning the patient.  See CMS Ex. 18 at 1; see Angel Kidney Care of Inglewood, DAB CR4669 at 6 (2016), aff’d, DAB No. 2795 (finding that a dialysis facility’s “omissions and errors” demonstrated that it was “slipshod in assuring that its patients received the monitoring and care planning that they needed.”).

The technician who provided Patient 1’s June 3 dialysis inaccurately documented that the patient had not been hospitalized prior to her dialysis treatment.  Despite her two-week

Page 24

hospitalization, which ended on May 28, the June 3 hemodialysis flow sheet indicates no hospitalization or physician visit since her last treatment.  CMS Ex. 24 at 11; CMS Ex. 27.

Although Patient 1’s care plan called for home dialysis, on May 13 and June 3, 2022, she was treated in the dialysis center rather than at home.  CMS Ex. 24 at 5; CMS Ex. 58 at 6 (Rickman Decl. ¶ 18).  Staff did not document the reason for the change.15

I have discussed the erroneous entry in Patient 2’s “Against Medical Advice” form, which attributed his short dialysis session on May 27 to “just wants to get off early,” when, in fact, the session was cut short because of his severe hypotension.  CMS Ex. 33 at 5; CMS Ex. 36 at 6, 1; CMS Ex. 37 at 5; CMS Ex. 57 at 4-5 (Wehner Decl. ¶¶ 12-14).  I have also discussed the problems with his June 2 AMA form.  Compare CMS Ex. 33 at 6 with CMS Ex. 37 at 7.

Patient 2’s medical records were inaccurate in other significant respects:

• Surveyor Wehner interviewed the technician who provided home dialysis to Patient 2 on June 3.  The technician told the surveyor that, during the dialysis treatment on June 3, Patient 2 suffered a seizure.  CMS Ex. 57 at 6 (Wehner Decl. ¶ 17).  Yet, his hemodialysis flow sheet describes the patient as “tolerating treatment well” up until he refused to continue (2 hours and 34 minutes after it began).  CMS Ex. 37 at 11; see CMS Ex. 33 at 7 (not mentioning a seizure).  No documentation establishes that the technician informed the interdisciplinary team that Patient 2 had had a seizure.  CMS Ex. 57 at 6 (Wehner Decl. ¶ 17).

  Dr. Tannenbaum questioned whether Patient 2 had a “real” seizure.  Falling back on a circular reasoning fallacy, he claimed that the patient did not have a seizure because the seizure was not documented.  Tr. 234-236 (Tannenbaum testimony).  Again, Dr. Tannenbaum was not there.  He does not claim to have interviewed the technician, and the technician did not testify.  No reliable evidence refutes the fact that she made the statement nor that the statement was true.  See Beatrice State Developmental Ctr., DAB No. 2311 at 17, 18 (2010) (pointing out that the facility could have, but did not present employee testimony that refuted the statements that surveyors claimed they made); Omni Manor Nursing Home, DAB No. 1920 at 11 (2004) (holding that statements of facility employees to the surveyors may constitute substantial evidence).

• On June 6, Surveyor Wehner visited Patient 2’s home and observed the technician initiate the patient’s treatment.  The technician did not listen to the patient’s lung

Page 25

• or heart sounds.  She did not conduct a remote assessment with a registered nurse so that the nurse could listen to the lung and heart sounds.  These omissions were particularly significant because Patient 2 had a history of pneumonia and, in talking to the patient, the surveyor noticed that he was wheezing, which indicated that he was having respiratory problems.  CMS Ex. 57 at 7 (Wehner Decl. ¶ 19).

  Petitioner, however, questions whether Patient 2’s wheezing was attributable to respiratory problems, citing Dr. Tannenbaum’s claim that the surveyor’s assessment was incorrect, “and it was more likely that the wheezing was associated with fluid overload, a common occurrence in dialysis treatment.”  P. Post-hrg. Br. at 20 (citing Tr. at 237-238).  Even putting aside the undisputed facts that Dr. Tannenbaum was not there, did not examine the patient, and points to no actual evidence as to what was causing the patient’s wheezing, Petitioner’s argument is irrelevant and misleading.

  Petitioner mischaracterizes the surveyor’s findings.  The surveyor did not diagnose the cause of Patient 2’s wheezing.  As a registered nurse, she is well-qualified to identify wheezing.  She merely pointed out two indisputable facts:  that the patient was wheezing; and that the patient had a history of respiratory problems, including pneumonia.  He had recently been taken to the hospital because he was unable to breathe.  CMS Ex. 35 at 3.  She determined that the technician should have listened to Patient 2’s lungs, which, of course, the technician should have done, even if the patient hadn’t been exhibiting respiratory symptoms.

  Moreover, wheezing is unquestionably a symptom of respiratory difficulties.  Dr. Tannenbaum does not explain why breathing difficulties caused by fluid overload require less attention than breathing difficulties caused by other factors.  Nor does he explain why the possibility that Patient 2’s wheezing was caused by fluid overload rather than an infection or chronic obstructive pulmonary disease would excuse the technician from listening to the patient’s heart and lung sounds.

  Nor does Petitioner dispute or justify the technician’s falsifying the patient’s record.  Even though she did not listen to Patient 2’s lung or heart sounds, the technician documented that she had, writing that his heart rate was “regular,” and his lung sounds “clear.”  CMS Ex. 37 at 13.

• The technician did not accurately document Patient 2’s hospitalizations.  The patient underwent dialysis on May 23, 2022.  CMS Ex. 37 at 1-3.  He went to the hospital on May 25 because he could not breathe.  CMS Ex. 35 at 3.  Yet, when he next underwent dialysis, on May 27, 2022, the technician reported that he had not been hospitalized nor visited a physician since his last treatment.  CMS Ex. 37 at 6.

Page 26

• Patient 2 was again hospitalized from May 27 through 31, 2022, diagnosed with septic shock, pyelonephritis (serious kidney infection), pancytopenia (low levels of all three types of blood cells), coronary artery disease, hypoglycemia, and edema of the right upper extremity.  CMS Ex. 36 at 11.  Yet, the technician who provided his dialysis treatment on June 1 documented that he had not been hospitalized since his last treatment.  CMS Ex. 37 at 9.

A registered nurse explained these inaccuracies, telling surveyors that “all information is not given to the nurse for home patients.”  CMS Ex. 2 at 18.

Section 494.90 deficiency:  inadequate responses to patients’ hypertension.  Additional deficiencies involve two other patients, whom (unfortunately) CMS identified as Patients 1 and 2.  These individuals, however, were treated exclusively in-center.  See, e.g., CMS Exs. 6, 11.

These patients were unstable and suffered significant hypertensive episodes while undergoing dialysis.

Patient 1 had a history of hypertension and her care plan required that she be monitored closely while on dialysis.  CMS Ex. 7 at 2, 4.  Both her care plan and facility policy dictated that her blood pressure be monitored at least every 15 minutes until it fell below 110 mm/Hg.  CMS Ex. 5 at 1; CMS Ex. 7 at 4.  Staff, however, did not do so.  On at least three occasions – May 27, May 30, and June 1 – she was not monitored as required, and her blood pressure was elevated for extended periods.

• While undergoing dialysis on May 27, 2022, Patient 1’s blood pressure reached 185/113 at 2:00 p.m.  Between then and 3:30 p.m., when it measured 194/115, staff monitored her blood pressure every 30 minutes.  Identical entries (signed by the patient care technician) say that the patient is “resting with eyes closed”; “[d]ialysis in progress”; “respirations present”; “access visualized and no problems noted.”  CMS Ex. 8 at 2.
• While undergoing dialysis on May 30, 2022, Patient 1’s blood pressure was 204/122 at 1:30 p.m.  No blood pressure is recorded until one hour later, at 2:30 p.m., when it measured 209/121.  Id. at 5.  It was next recorded at 3:00 p.m. and then at 3:30 p.m.  At 3:37, the patient signed out against medical advice.  Her blood pressure was 205/117.  Id. at 6.
• While undergoing dialysis on June 1, 2022, Patient 1’s blood pressure was 181/116 at 12:30 p.m.  Again, staff measured it every half hour until 2:02 p.m. (207/113; 194/112; 209/112).  Id. at 9.  At 2:06 p.m., the patient signed out against medical advice.  Id. at 10.

Page 27

Petitioner dismisses the significance of pre-dialysis hypertension, declaring that “it is common” for a dialysis patient to be hypertensive at the start of dialysis and to be hypotensive at the end.  This is because dialysis removes large amounts of fluid from the blood vessels.  P. Post-hrg. Br. at 13-14.  Accepting this as true, staff should have been deeply concerned and hypervigilant when Patient 1’s blood pressure increased during dialysis.  Yet, nothing indicates that they were.

According to his care plan, Patient 2 also had a history of hypertension, and hypertension was listed as an adverse effect of dialysis.  CMS Ex. 11 at 3.  Facility policy dictated that a hypertensive patient’s blood pressure must be monitored every 15 minutes until the diastolic pressure falls below 110/Hg.  CMS Ex. 5 at 1.  Yet, at 7:30 a.m. on June 3, 2022, Patient 2’s blood pressure rose to 158/115.  The technician did not check it again until 8:00 a.m., 30 minutes later.  CMS Ex. 13 at 3.  Similarly, at 8:30 a.m. on June 6, his blood pressure rose to 177/115.  The technician did not check it again until 9:00.  Id. at 7.

According to the facility’s hypertension policy, “every effort” would be made to “identify and correct” the cause of a patient’s hypertension.  The physician, nurse, and dietician would counsel patients who gained excessive amounts of fluid between treatments, and “all counseling would be documented in the patient’s chart.”  CMS Ex. 5 at 1.  Patient 2’s care plan directed staff to continue reviewing blood pressure medications with the patient and physician, and to educate the patient on “compliance with medications, fluid management, and dialysis prescription.”  CMS Ex. 11 at 4.  Patient 2’s medical records do not reflect that any staff – much less a physician, nurse, and dietician – provided such counseling or education.

On June 9, Patient 2 was hospitalized, suffering from a “hypertensive emergency.”  CMS Ex. 15 at 1, 4, 12.

Remarkably, Petitioner argues that, in determining the facility’s noncompliance, CMS may not consider blood pressure management “because blood pressure management is not a part of the Conditions for Coverage and therefore cannot be a basis for termination.”  P. Post-hrg. Br. at 10.  This position is not simply wrong, it is dangerously wrong.  As the facility’s policies reflect, hypertension in dialysis patients is common and potentially deadly.  “It may lead to a heart attack or stroke and may result in death.”  CMS Ex. 5 at 1.  Section 494.90 requires facilities to develop and implement care plans that specify “the services necessary” to address patient needs.  By failing to implement the services necessary, the facility failed to comply with section 494.90.16

Page 28

Thus, the evidence establishes that:

• The facility deviated from Patient 2’s care plan regarding the equipment used and the dialysis access site.
• Professional staff did not assess the unstable patients monthly nor following significant medical events.
• Contrary to the requirements of the regulation, the patient care plans, and the facility’s policies, licensed personnel did not intervene when patients shortened their dialysis sessions against medical advice.  At most, unlicensed technicians explained the risks and, with the resident, signed AMA forms.
• The patient treatment records were inadequate and inaccurate, which hampered the interdisciplinary team’s ability to develop and implement adequate care plans.
• The facility did not adequately monitor its hypertensive patients’ blood pressures, and it did not provide adequate counseling and education to help its patients identify and correct the causes of their hypertension.

These deficiencies substantially limited the facility’s capacity to furnish adequate care and adversely affected the patients’ health and safety, which put the facility out of compliance with 42 C.F.R. § 494.90.  42 C.F.R. § 488.24(b).  Because the facility did not meet this one condition for coverage, CMS was authorized to terminate its Medicare coverage, without regard for its other deficiencies.  42 C.F.R. § 488.604(8).

2. The facility did not comply with 42 C.F.R. § 494.100 because it did not ensure that its home dialysis services were at least equivalent to those provided to in-facility patients, specifically:  1) it did not properly train home dialysis caregivers; and 2) its staff did not ensure that a resident’s home was appropriate for home dialysis.

The facility violated section 494.100 in two critical respects:  1) it did not properly train its caregivers; and 2) it did not ensure that a resident’s home was appropriate for dialysis

Regulatory requirement:  42 C.F.R. § 494.100(a) (care at home – training).  Home dialysis means “dialysis performed at home by [an ESRD] patient or caregiver who has completed an appropriate course of training as described in [section] 494.100(a).”  42 C.F.R. § 494.10.  A dialysis facility that is certified to provide services to home patients

Page 29

must ensure, through its interdisciplinary team, that home-dialysis services are at least equivalent to those provided to in-facility patients.  42 C.F.R. § 494.100.

Section 494.100(a) describes the training standard with which the facility must comply.   The interdisciplinary team must oversee the training of the home-dialysis patient, the designated caregiver, or self-dialysis patient before home-dialysis or self-dialysis is initiated.  The training must:

• Be provided by a dialysis facility that is approved to provide home dialysis services;
• Be conducted by a registered nurse who meets the requirements of section 494.140(b)(2) (have at least 12 months experience in providing nursing care plus an additional three months of experience in the specific modality for which the nurse will provide self-care training);17 and
• Be conducted for each home dialysis patient and address the specific needs of each patient in the following areas:  i) the nature and management of ESRD; ii) the full range of techniques associated with the selected treatment modality; iii) how to detect, report, and manage potential dialysis complications, including water treatment problems; iv) availability of support resources and how to access and use them; v) how to self-monitor health status and record and report health status information; vi) how to handle medical and non-medical emergencies; vii) infection control precautions; and viii) proper waste storage and disposal procedures.

Regulatory requirement:  42 C.F.R. § 494.100(c)(1)(i) (care at home – support services).  A home dialysis facility must furnish home dialysis support services, including periodic monitoring of the patient’s home adaptation.  This means that facility personnel must visit the patient’s home in accordance with the patient’s plan of care.

Facility Policies Implementing 42 C.F.R. § 494.100:

Facility policy:  home dialysis.  Consistent with the regulatory requirements, the facility had in place a policy addressing home dialysis.  CMS Ex. 17; see Joint Stip. at 2 (Facts ¶ 1).  The policy requires that the home training registered nurse observe each caregiver, including the facility’s certified hemodialysis technicians, for three full treatments, regardless of the caregiver’s prior level of experience.  The policy allows the M.D. to

Page 30

waive the “3-treatment rule,” if the patient is stable, has dialyzed in the center, and is already known to the RN.  However, the RN must be present at a minimum of the first treatment in the home.  CMS Ex. 17 at 1.

The policy lists the purposes for the RN’s observations:  1) to familiarize the caregiver with the patient’s unique requirements; 2) to confirm that the patient is comfortable with the caregiver; 3) to educate the patient or other member of the household about home dialysis; and 4) to confirm that the caregiver is truly competent and familiar with the patient and emergency procedures for evacuation at the home location.  CMS Ex. 17 at 1.

Facility policy:  home hemodialysis.  Consistent with the regulation, the facility’s home hemodialysis policy requires that a staff member, who has been trained to use the designated home screening form, “[p]romptly (same day if possible) . . . go to the patient’s home for the purpose of evaluating the physical acceptability of the home dialysis.”  CMS Ex. 17 at 1.  The staff member must fill out the “Formstack Home Screening form.”  The policy lists three goals: 1) within 24 hours of notification, assess the patient’s home; 2) determine if the home is suitable for the dialysis equipment; and 3) determine what electrical and plumbing changes are required.  CMS Ex. 17 at 1.

The facility’s section 494.100 deficiency:  inadequate training and monitoring of home caregivers.  The facility did not adequately train the certified technicians who were conducting home treatments and even allowed a wholly unqualified and unsupervised patient care technician to provide a particularly vulnerable resident’s home dialysis.

Certified hemodialysis technicians and patient care technicians – not licensed nurses – provided dialysis treatment for the facility’s home patients.  Joint Stip. at 3 (¶ 8); see CMS Exs. 24, 37 (hemodialysis flow sheets for home patients, showing that dialysis treatments were performed by technicians).  Those technicians should have been trained by qualified registered nurses before the patient’s initial dialysis treatment.   42 C.F.R. § 494.100(a).  The training should have been specific to each home dialysis patient, covering the nature and management of the patient’s kidney failure, how to manage and report potential complications, how to record and report health status information, and how to handle emergencies.  42 C.F.R. § 494.100(a)(3)(i), (iii), (v), (vi).

Contrary to the requirements of the section 494.100(a) and the facility’s policy, a certified technician – not a registered nurse – oversaw the training of home dialysis caregivers.  In a June 7 interview, the technician, identified as CCHT #6 (see CMS Ex. 4), told the surveyors that she was the “lead” technician and that she trained the technicians to be caregivers.  She also acknowledged that the facility had no “formal” training program or materials except the facility’s home dialysis policy (CMS Ex. 17).  CMS Ex. 2 at 46; see CMS Ex. 25 at 1, 4 (describing Technician #6 as “the evaluator”);

Page 31

CMS Ex. 39 at 1, 6, 7; CMS Ex. 58 at 3 (Rickman Decl. ¶ 9).  Such inadequate training jeopardizes patient health and safety.

As discussed above, Patient 1 was very ill.  On May 7, 2022, she was hospitalized, suffering from heart failure.  CMS Ex. 22.  She began home dialysis treatment on May 11.  CMS Ex. 21; CMS Ex. 23 at 1; CMS Ex. 24 at 1-3.  Because she was unstable, the facility’s policy required that a registered nurse observe her first three home treatments.  Contrary to the requirements of the regulation and the facility’s policy, a technician – not a registered nurse or any other member of the interdisciplinary team – oversaw Patient 1’s initial home dialysis treatment.  Joint Stip. at 3 (¶ 11); 42 C.F.R. § 494.100(a)(3); see CMS Ex. 17 at 1.

I do not accept Dr. Tannenbaum’s unsupported (and inconsistent) speculation that a nurse was present for Patient 1’s May 11 home dialysis treatment.  Compare Tr. 185, with Tr. 169-172 (justifying the absence of a nurse at the patient’s initial home dialysis treatment).  A physician’s unsupported testimony does not substitute for documentation.  I may reject the physician’s claims if they are not supported by contemporaneous documentation.  Putnam Ctr., DAB No. 2850 at 20 (2018); see Autumn Ridge Rehab. Ctr., DAB No. 2467 at 20 (2012); Embassy Health Care Ctr., DAB No. 2327 at 6 (2010) (emphasizing the importance of documentation).

On June 6, 2022, Surveyor Candice Rickman, a medical social worker, and her colleague went to Patient 1’s home to observe the patient’s second home dialysis treatment.  A patient care technician (not a certified dialysis technician) was there to administer the home treatment.  Patient 1 had been seriously ill and hospitalized, leaving the hospital against medical advice on May 28.  CMS Ex. 27 (see discussion above).  The patient care technician told the surveyors that this was the first time she had treated Patient 1.  No nurse was present.  Joint Stip. 3-4 (¶ 14); CMS Ex. 58 at 3-4 (Rickman Decl. ¶ 10).

A patient care technician is not certified to provide dialysis services and should not have been providing home treatment.  Tr. at 211 (Tannenbaum testimony); see CMS Ex. 17 at 1 (authorizing a certified technician to provide home dialysis after performing three full treatments under the observation of the home training registered nurse).

Petitioner suggests that, because its home dialysis program was “innovative,” it should not be required to meet the training and observation requirements of section 494.100, which requires that all caregivers be trained by a registered nurse before providing home dialysis.  See P. Reply at 17-20.  Nothing exempts technicians from this requirement, no matter how well trained they purportedly are.  See NMS Healthcare of Hagerstown, DAB No. 2603 at 7 (2014) and cases cited therein.  Moreover, the patient care technician – who was not even certified – could hardly be considered qualified to provide dialysis services unless she were properly trained.

Page 32

The facility’s section 494.100 deficiency:  failing to ensure that a patient’s home was appropriate for dialysis.  Patient 1 began home dialysis on May 11.  The facility provides no documentary evidence that it promptly evaluated her home.  According to Dr. Tannenbaum, staff “would have done the home assessment at the same day that they started treatment.”  Tr. 167.  No reliable evidence supports this assertion.  Dr. Tannenbaum does not claim to have been there; he does not claim any personal knowledge of the home visit; he does not even claim to have spoken to the staff member who purportedly evaluated the home.  Again, the facility could have called that staff member as a witness, but it did not.

Further, Petitioner has not produced the Formstack Home Screening form – or any other documentation – showing that a trained staff member went to Patient 1’s house to determine if it was a suitable location for dialysis.  Joint Stip. at 3 (¶ 12); CMS Ex. 2 at 47-48; CMS Ex. 58 at 2-3 (Rickman Decl. ¶ 7).  Because it is not supported by any documentation, I reject the physician’s claim that someone actually evaluated Resident 1’s home.  Putnam Ctr., DAB No. 2850 at 20.

CMS points to additional evidence that no qualified staff evaluated Patient 1’s home.  When the surveyors arrived there on June 6, the (non-certified) patient care technician told them that the dialysis machine was not working.  The “breaker was not producing enough power for the machine[,] and it would not start up.”  CMS Ex. 2 at 29.18

Thus, the facility did not properly train its home dialysis caregivers.  Its staff did not ensure that a patient’s home was appropriate for home dialysis.  These failures put the facility out of compliance with section 494.100 because they meant that home dialysis services were not equivalent to those provided to in-facility patients.  The deficiencies substantially limited the facility’s capacity to furnish adequate care and adversely affected the patients’ health and safety.  Because the facility did not meet this one condition for coverage, CMS properly terminated its Medicare participation, without regard to its other deficiencies.  42 C.F.R. § 488.604.

3. The facility did not comply with 42 C.F.R. § 494.140 because its technicians did not meet Tennessee’s requirements for education, training, credentialing, competency, standards of practice, certification, and licensure.

Page 33

Regulatory requirement:  42 C.F.R. § 494.140 (personnel qualifications).  All dialysis facility staff must meet the applicable scope and practice board and licensure requirements in effect in the state in which they are employed.  Staff must be able to demonstrate and sustain the skills they need to perform the duties of their positions.

Patient-care dialysis technicians (this includes the facility’s certified dialysis technicians and those who were not certified) must “meet all applicable State requirements for education, training, credentialing, competency, standards of practice, certification and licensure in the State in which he or she is employed as a dialysis technician.”  42 C.F.R. § 494.140(e)(1)

Section 494.140 deficiency:  violating the Tennessee Nurse Practice Act.  The Tennessee Nurse Practice Act mandates that only those qualified and licensed by the Tennessee Board of Nursing can perform “professional nursing duties,” which include administering medication and supervising a patient “requiring skill and observation of symptoms and reactions and accurate recording of the facts.”  Tenn. Code Ann. §§ 63-7-01, 63-7-103(a)(2)(A), (D).

Tennessee law defines a dialysis technician (also referred to as a patient care technician or dialysis assistant) as an “individual who is not a registered nurse or physician and who provides dialysis care under the direct supervision of a registered nurse or physician.”  Tenn. Comp. R. & Regs. 0720-33-.01(17) (emphasis added).  But, as the above discussion establishes, the facility’s dialysis technicians were not providing care “under the direct supervision of a registered nurse or physician.”  They were trained and evaluated by another certified dialysis technician, Technician #6.  CMS Ex. 2 at 46; CMS Ex. 25 at 1, 4.

Even when a patient had an adverse reaction to dialysis treatments, the technician did not contact the registered nurse or nephrologist.  Patient 2 had a seizure during his June 3 treatment.  The technician did not contact a registered nurse or nephrologist.  CMS Ex. 57 at 6 (Wehner Decl. ¶ 17).  In fact, it seems that the technicians were not always aware that, when faced with a medical emergency, they should contact a registered nurse for guidance.  As noted above, when the surveyors went to Patient 1’s home on June 6, an uncertified, unsupervised patient care technician was there to administer dialysis.  Joint Stip. at 3-4 (¶¶ 14).  Surveyors asked her what she would do in a hypotensive emergency if a patient’s blood pressure did not respond to saline.  CMS Ex. 58 at 4 (Rickman Decl. ¶ 11).  The facility’s policy directs the technician to “notify your dialysis nurse or nephrologist” if blood pressure does not come up after saline is administered.  CMS Ex. 19.  But the technician did not know that.  She told Surveyor Rickman that she would administer more saline and that “blood pressures always go back up after the second dose of saline.”  CMS Ex. 58 at 4 (Rickman Decl. ¶ 11).  This is not true.  See, e.g., Andrew Davenport, Why is Intradialytic Hypotension the Commonest Complication of Outpatient Dialysis Treatments?, 8 Kidney Int’l Rep. 405 (2023)

Page 34

https://pmc.ncbi.nlm.nih.gov/articles/PMC10014354/.  By allowing technicians to provide dialysis care without supervision, the facility was not only violating state law, but it was also endangering the health and safety of patients.

Petitioner suggests that, by reviewing patient medical records, its professional staff “supervised” the dialysis technicians.  Even assuming this might otherwise qualify as “direct supervision,” the data the technicians entered on the flowsheets was not always reliable, and they omitted important information.  See, e.g., CMS Ex. 2 at 17; CMS Ex. 33 at 7; CMS Ex. 37 at 10-12.

As I have also discussed above, the facility’s dialysis technicians were performing nursing assessments for recently-hospitalized patients and those experiencing a significant medical event (such as a seizure).  CMS Ex. 37 at 4-12; CMS Ex. 57 at 4 (Wehner Decl. ¶ 11); CMS Ex. 57 at 6 (Wehner Decl. ¶ 17).  This violates Tenn. Comp. R. & Regs. 0720-33-.06(3)(c) and (h), which provide that a registered nurse should perform such assessments:  “A registered nurse shall conduct a patient assessment when indicated by a question relating to a change in the patient’s status or at the patient’s request.”

Finally, Tennessee does not allow dialysis technicians to administer medications, except normal saline and lidocaine (a local anesthetic) “during initiation or termination of dialysis.”  Tenn. Code Ann. § 63-7-103(a)(2)(D); Tenn. Comp. R. & Regs. 0720-33-.04(12)(1).  Yet, violating the scope of her practice, a dialysis technician administered 200 mg of Mircera, intravenously, to Patient 2 during his home treatment on June 1, 2022.  CMS Ex. 37 at 7; CMS Ex. 57 at 6 (Wehner Decl. ¶ 15).  Mircera is an anemia medication with potentially significant side effects.

Although Petitioner’s witnesses characterize Mircera as a “standard drug” that requires “a minute degree of skill to administer,” allowing unqualified individuals to administer it violated the state statute.  Tr. 233, 284.  That a drug is easy to administer does not make it safe for an unqualified person to administer.  Mircera has a black box warning (the FDA’s most stringent safety notice) of increased risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access, and tumor progression or recurrence.  In any event, the facility was not free to ignore state licensing and practice requirements.

Because the facility staff did not meet Tennessee scope and practice board and licensing requirements in significant respects, which limited the facility’s ability to furnish adequate care and affected patient health and safety, the facility did not comply with section 494.140.  Without regard to the facility’s other condition-level deficiencies, CMS properly terminated its Medicare participation based on this one condition for coverage, without considering the other conditions.  42 C.F.R. § 488.604.

Page 35

CONCLUSION

Based on the findings of the April 1, 2022 survey, which Petitioner did not appeal, the dialysis facility was not then in compliance with five Medicare conditions for coverage.  Notwithstanding repeated opportunities to correct those deficiencies, as of June 8, 2022, the dialysis facility did not comply with at least three of the cited conditions for coverage:  42 C.F.R. §§ 494.90 (patient care plan), 494.100 (care at home), and 494.140 (personnel qualifications).  CMS therefore properly terminated the facility’s Medicare participation.