Med Plus Staffing L.L.C. d/b/a Med Plus HealthCare, DAB CR5117 (2018)

DECISION

I sustain the Center for Medicare & Medicaid Services’ (CMS) determination that Petitioner, Med Plus Staffing L.L.C. d/b/a Med Plus HealthCare, a home health agency, failed to comply substantially with a Medicare condition of participation.  I sustain the imposition of the following remedies against Petitioner:

• Termination of its participation in Medicare; and
• Civil money penalties of $3017 per day for each day of a period that began on March 16, 2017, and that continued through July 16, 2017.

I. Background

I scheduled this case for a hearing.  However, the parties subsequently waived their right to an in-person hearing and requested that I decide the case based on their written pre-hearing exchanges.  Those exchanges include CMS’s exhibits, identified as CMS Ex. 1-CMS Ex. 36, and Petitioner’s exhibits, identified as P. Ex. 1-P. Ex. 29.  I receive the

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parties’ exhibits into the record.*  Both parties filed briefs.  To the extent that I cite to them, I refer to them as “CMS brief” and “Petitioner’s brief.”

II. Issues, Findings of Fact and Conclusions of Law

A. Issues

The issues are whether Petitioner failed to comply with conditions governing participation of a home health agency in Medicare and whether CMS’s remedy determinations are reasonable.

B.  Findings of Fact and Conclusions of Law

A home health agency is an entity that provides services to eligible Medicare beneficiaries that include nursing care and related items or services.  The items and services provided by a home health agency are to a large extent offered in lieu of what would be provided in an institutional setting by a skilled nursing facility.  As a general principle, these items or services are subject to quality of care and other requirements that are every bit as stringent and regulated as are items or services that are provided by a skilled nursing facility.

In order to participate in Medicare a home health agency must satisfy – on a continuing basis – all regulatory conditions that govern its participation.  These conditions are stated at 42 C.F.R. Part 484.  Failure by a home health agency to comply with any of these conditions is grounds for termination of its participation in Medicare.  Social Security Act § 1866(b)(2); 42 C.F.R. § 489.53(a).  Failure to comply with a condition of participation is grounds for termination whether or not there is a showing of actual harm or immediate jeopardy to Medicare beneficiaries.  Nat’l Hosp. for Kids in Crisis, DAB No. 1600 at 8 (1996); Excelsior Health Care Servs., Inc., DAB No. 1529 (1995).

The regulations governing a home health agency’s participation are subdivided into standards of participation.  A home health agency’s noncompliance with one or more standards of participation will, if sufficiently serious, justify a finding of condition-level noncompliance.

CMS alleges that Petitioner failed consistently to comply with multiple standards relating to the condition of participation set forth at 42 C.F.R. § 484.18.  CMS asserts that the noncompliance, documented at surveys of Petitioner completed on March 16 and May 24, 2017, was so egregious as to establish condition level noncompliance.

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I address CMS’s allegations of standard-level noncompliance as well as its assertion that Petitioner’s noncompliance violated a participation condition.  I also consider Petitioner’s specific defenses to CMS’s assertions.  I find that the evidence provides overpowering support for CMS’s allegations, both as to the noncompliance manifested by Petitioner and as to CMS’s remedy determinations.

However, I note also and preliminarily that Petitioner raises a defense that I find to be irrelevant to this case and of no import to my decision.  Petitioner argues strenuously, and at great length, that it is a victim of surveyor bias, “fraudulent survey practices,” or fecklessness.  See Petitioner’s brief at 4-9, 14-21.  It contends that any findings that the surveyors made concerning its compliance with participation conditions are so irretrievably tainted by surveyor bias or incompetence as to render invalid all of CMS’s findings of noncompliance and its remedy determinations.

This defense is irrelevant because findings of noncompliance will stand or fall based on the objective evidence obtained by surveyors.  How or why they obtain that evidence doesn’t matter; if the evidence produced by surveyors shows that Petitioner failed to comply with participation requirements, then that establishes grounds for remedial action, whether or not the surveyors complied with applicable protocol or were motivated by animus.  Conversely, if surveyors scrupulously follow protocol or conduct their surveys with the purest of intentions, that level of rigorousness is of no consequence if they fail to obtain evidence establishing noncompliance.  Del Rosa Villa, DAB No. 2458 at 20 & n.10 (2012), aff’d, Del Rosa Villa v. Sebelius, 546 F. App’x 666 (9th Cir. 2013).

Petitioner manifestly did not meet that burden.  Indeed, virtually all of CMS’s allegations stand unrebutted by Petitioner.

It is a condition of participation (and also an embedded standard) that a home health agency accepts patients for treatment “on the basis of a reasonable expectation that the patient’s medical, nursing, and social needs can be met adequately by the [home health] agency in the patient’s place of residence.”  42 C.F.R. § 484.18.  Furthermore, the home health agency must provide care pursuant to a written plan of care that is reviewed periodically by a physician.  Id.

The additional standards that comprise this condition include the following requirements:

• Any plan of care developed by a home health agency must be created in consultation with the agency staff and must cover all pertinent diagnoses.  It must, among other things, address the types of services and equipment required to treat a patient, the frequency of planned visits, the patient’s prognosis, his or her rehabilitation potential, his or her functional limitations, the patient’s activities, his or her nutritional requirements, his or her medications and treatments, and any safety measures designed to protect the patient.  The patient’s physician must be

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consulted if the plan of care cannot be completed pursuant to whatever schedule is developed to address the patient’s needs.  42 C.F.R. § 484.18(a).

• Home health agency staff must, among other things, promptly alert a patient’s physician of any changes in a patient’s condition that suggest a need to alter the patient’s plan of care.  42 C.F.R. § 484.18(b).

The evidence offered by CMS adduced at the March 16, 2017 survey establishes an abject failure by Petitioner to comply with these standards and with the overall condition of participation.  The evidence overwhelmingly proves that Petitioner was simply incapable of meeting its patients’ needs.  It failed to carry out patients’ plans of care, it failed to write plans of care that accurately documented its patients’ conditions, and it failed to provide services that had been ordered by patients’ physicians.

Petitioner’s noncompliance as of that survey includes, among other things, a failure by Petitioner’s staff to address effectively a patient’s persistent complaints of pain.  The staff neither communicated these complaints to the patient’s physician nor did they assure that the patient had the medication she needed to deal with her pain.  These errors are so numerous and in many instances, so serious, that they establish that there was no possibility that Petitioner could meet its patients’ needs consistent with the requirements of 42 C.F.R. § 484.18 and the standard set forth thereunder.

• The plan of care for a patient identified as Patient # 4 listed the wrong physician as the patient’s treating physician.  CMS Ex. 20 at 19, 29-41, 43-44, 46-47, 51, 94, 97-98, 114, 118.  If one of Petitioner’s staff members attempted to contact the physician using the contact information listed on the plan of care he or she would reach the wrong individual.  In fact, on at least two occasions a skilled nurse or clinician relied on the incorrect information.  Id. at 29-32, 34-35, 39-40, 51, 94, 98, 114.
• An occupational therapist visited Patient # 4 on March 1, 2017 and recommended that the patient be seen by a social worker.  But, the patient was not referred to a social worker.  Id. at 118.
• During that same visit this patient complained of pain and manifested a blood pressure of 80/52.  Petitioner’s staff did not report the low blood pressure reading to the patient’s physician even though the patient’s plan of care called for reporting any systolic reading of less than 100.  CMS Ex. 20 at 95, 115-16.
• On March 1, 2017, the patient reported significant pain (8 on a scale of 10).  However, Petitioner’s staff did not notify immediately the patient’s physician about the patient’s complaints.  The staff delayed notifying the physician for seven days.  The patient continued complaining about pain for several days after March

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1, and the staff took no action to attempt to alleviate the pain during this period.  CMS Ex. 20 at 111-28.  Finally, on March 8, 2017, Petitioner’s staff notified the patient’s physician about the pain that the patient experienced.  CMS Ex. 20 at 36.  On March 10, 2017, Petitioner’s staff noted that they had communicated the patient’s increased level of pain to the patient’s physician and stated that the physician was sending an order for pain medication to the patient’s pharmacy.  Id. at 88-89.  However, the prescription was not filled.  CMS Ex. 4 at 26.

• On March 13, 2017, the patient fell from her chair.  Petitioner’s staff again recorded the wrong individual as the patient’s physician.  CMS Ex. 20 at 39-40.
• On March 15, 2017 a surveyor observed the patient at her home.  The patient told the surveyor that she dealt with her pain with Tylenol and that she had not received prescription pain medication since she began receiving home health services.  CMS Ex. 20 at 14-15.
• On March 16, 2017, the patient’s physician advised a surveyor that she was unaware that the patient had been experiencing pain rated at a level of 10 out of 10.  CMS Ex. 20 at 18.

There were additional failures to provide care consistent with patients’ plans of care.  In the case of an individual identified as Patient # 3, the plan of care included an order by a physician directing Petitioner’s staff to instruct the patient about wound care.  There is nothing to show that Petitioner’s staff ever engaged in interactions with the patient that established that he understood and could carry out instructions concerning such care.  CMS Ex. 22 at 13, 15-18, 60-61.  In the case of Patient # 6, Petitioner’s staff failed to assess his/her temperature and breath sounds as was required by Petitioner’s policy and the patient’s plan of care.  CMS Exs. 16 at 10; 19 at 7, 11-26, 40, 62-65.

Evidence shows also that as of the March 16 survey, Petitioner’s staff failed to maintain complete and accurate patient plans of care.  In particular, the staff failed to provide complete information concerning patients’ oxygen therapy, wound care, and medications.  In the case of Patient # 3, for example, the patient’s plan of care did not contain instructions about the frequency of wound care that the patient was supposed to provide pursuant to Petitioner’s staff’s supervision.  CMS Ex. 22 at 2.  In the case of Patient # 6, the patient’s plan of care did not contain particulars for the administration of portable oxygen to the patient.  CMS Ex. 19 at 8.

Furthermore, and in contravention of the requirements of 42 C.F.R. § 484.18(b), Petitioner’s staff failed promptly to notify patients’ physicians of changes in patients’ conditions that suggested a need to alter plans of care.  In the case of Patient # 4, as I have discussed above, Petitioner’s staff did not consult with the patient’s physician about the patient’s complaints of pain.

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Evidence obtained at the survey of May 24, 2017, shows that Petitioner had not corrected the deficiencies that were evident on March 16.  These continuing deficiencies again established standard and condition level noncompliance by Petitioner.

On May 10, 2017 Petitioner accepted into its service a patient identified as Patient # 1.  This patient had a physician’s orders directing that he/she be provided services that included:  physical therapy, occupational therapy, and visits by a social worker.  CMS Exs. 5 at 13; 31 at 51, 62.  However, the patient did not receive physical therapy until May 23, 2017, thirteen days after being admitted for care.  The patient had not received occupational therapy, and, in fact, Petitioner did not have an occupational therapist on its staff as of that May 24, 2017.  CMS Exs. 5 at 14; 31 at 43-48.

In fact, Petitioner did not have a physical therapist on its staff until May 22, 2017, and, as of May 24, 2017, it had not hired an occupational therapist.  CMS Ex. 27.  Thus, Petitioner not only did not provide services ordered for Patient # 1, but it lacked the staff needed to provide such services.

These deficiencies constitute an obvious failure to comply with the requirements of the condition stated at 42 C.F.R. § 484.18.  Petitioner could not provide services to meet the needs of Patient # 1 given that it lacked the trained staff that would have provided such services.  It was, therefore, impossible for Petitioner to satisfy the requirement that it meet its patients’ needs.

Petitioner’s defenses are without merit.  As I have discussed, Petitioner devotes the lion’s share of its brief to attacking the motivation and evidence-gathering of the surveyors who conducted the March 16 and May 24, 2017 surveys.  These attacks are of no relevance for the reasons that I have explained.  As for the specific allegations of noncompliance made by CMS, Petitioner either failed to rebut them or rebutted them with unpersuasive assertions.

For example, Petitioner asserts that, in the case of Patient # 4 (March 16 survey) it notified not one but two physicians concerning the patient’s complaints of pain, contradicting the survey findings that show that there was not effective communication by Petitioner’s staff to the patient’s physician about those complaints.  As support for this assertion Petitioner cites generally to P. Ex. 26.  Petitioner’s brief at 10.  This exhibit is a 159-page document.  Petitioner points to nothing specific in the document that reports consultations with the patient’s physician(s) about the patient’s complaints prior to March 8, 2017, even though the patient had complained of pain beginning several days previous to that date.  I find persuasive the patient’s physician’s reported statement that Petitioner’s staff had not consulted her concerning the patient’s complaints of extreme pain given Petitioner’s failure to point to evidence specifically rebutting that statement.  See CMS Exs. 4 at 26; 20 at 18.

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Petitioner also cites to CMS Ex. 4 at 24-25 as ostensible proof that Petitioner was attentive to Patient # 4’s complaints of pain.  But, that exhibit – the report of the March 16, 2017 survey – doesn’t prove that Petitioner addressed the patient’s complaints of pain.  To the contrary, it shows that Petitioner failed to obtain medication for the patient – Tramadol – that had been prescribed by the patient’s physician.  CMS Ex. 4 at 24.

Petitioner argues also that CMS relies on “clinical documentation prior to the Plan of Correction Date of March 6, 2017.”  Petitioner’s brief at 10.  By this assertion, Petitioner evidently argues that clinical evidence establishing noncompliance with regulatory requirements is of no import if it predates a plan of correction that Petitioner filed that ostensibly showed how Petitioner would cure pre-existing noncompliance.  But, the evidence cited by CMS shows noncompliance occurring well after March 6.  To the extent that CMS has cited to evidence that predates March 6, 2017, that evidence is relevant in establishing a course of deficient conduct by Petitioner that continued after the date that Petitioner filed a plan of correction.

Petitioner asserts that exhibits offered by CMS are incomplete and missing important clinical evidence.  Petitioner’s brief at 11.  But, Petitioner has not shown how clinical evidence not offered by CMS rebuts evidence of its noncompliance.  I afforded Petitioner opportunity to provide its own proof in order to rebut CMS’s allegations.  Petitioner did not cite to specific clinical evidence rebutting the allegedly deficient items offered by CMS.

Petitioner argues that it was in compliance with participation requirements as of the May 24, 2017 survey, asserting specifically, that it had “all core services covered not by one, but two agency contracts.”  Petitioner’s brief at 20 (citing P. Ex. 2).  The exhibit cited by Petitioner is a staffing services agreement dated May 15, 2017.  P. Ex. 2.But, this document does not prove that Patient # 1 actually received the services ordered by the patient’s physician.  It is two separate agreements between Petitioner and two other third parties to provide contract staff to Petitioner to the extent that Petitioner requests such staff, and at agreed rates.  Id.  Moreover, one agreement states only that the third party would “use its best efforts to locate, recruit and refer Health Care Personnel to [Petitioner] to supplement [Petitioner’s] existing staff”—far from a guarantee of the third party’s success—while the other agreement specifically recites that at no time did the other third party guarantee that Petitioner’s staffing requests would be fulfilled.  Id. at 1, 8.  Thus, rather than having staff that met patients’ needs, including a physical and an occupational therapist, Petitioner only had a contract with a third party that promised that such services might be available on Petitioner’s request.  Furthermore, and as I discuss above, such services were not timely provided to Patient # 1.

Petitioner argues that CMS’s allegations of noncompliance are invalid because:  “there were no patient complaints, no family complaints, no negative patient outcomes, and that the remaining alleged condition of participation [noncompliance] was cited using clinical

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documentation prior to the agency’s Plan of Correction’s Completion date of March 6, 2017.”  Petitioner’s brief at 13.  These assertions are irrelevant.  Compliance with participation requirements isn’t measured by the presence or absence of patient or family complaints about a home health agency’s performance.  The measure of compliance is simply whether a facility such as Petitioner does what it is obligated to do by relevant regulations.  Furthermore, and contrary to Petitioner’s assertion, much of the evidence adduced by CMS and that I cite here relates to Petitioner’s treatment of patients after March 6.

Petitioner also recites at length the efforts it undertook to implement its plan of correction and contends that CMS improperly denies it credit for those efforts.  Petitioner’s brief at 13.  However, the measure of compliance is purely and simply whether a facility is performing all that it must do to satisfy regulatory requirements.  Efforts at compliance, if unsuccessful, do not excuse noncompliance.

The remedies that CMS imposed against Petitioner are reasonable.  Termination is justified when a home health agency does not comply with even one Medicare condition of participation.  Here, the evidence overwhelmingly shows that Petitioner was out of compliance with the condition stated at 42 C.F.R. § 484.18 as of March 16 and May 24, 2017.

CMS also determined to impose civil money penalties against Petitioner of $3017 per day for each day of a period that began on March 16, 2017, and that continued through July 16, 2017, and I find these penalty amounts and the duration of penalties to be reasonable.  The penalty is the minimum civil money penalty permitted by regulation that CMS may impose for deficiencies such as those manifested by Petitioner and, therefore, is reasonable as a matter of law.  42 C.F.R. § 488.845(b)(4) (setting the range of penalties for “condition-level deficiency that does not constitute immediate jeopardy, but is directly related to poor quality patient care outcomes” as “$1,500-$8,500 as adjusted annually under 45 CFR part 102”); 45 C.F.R. § 102.3 (setting the minimum civil money penalty under 42 C.F.R. § 488.845(b)(4) as $3,017 for 2017).  I find these penalties to be quite modest given the seriousness of Petitioner’s noncompliance.  The evidence in this case establishes that Petitioner failed to provide services to its patients that were mandated by regulation and to which patients were entitled.  These included failure to treat the complaints of severe pain experienced by a patient (Patient # 4 as identified at the March 16 survey) and failure to provide physician-ordered services to another patient (Patient # 1 as identified at the May 24 survey).  These failures to provide services were egregious in that they either caused patients to suffer unnecessarily or deprived them of services that their physicians had ordered and that Petitioner was obligated to provide.

I find also that the duration of the penalties is reasonable given that it comports precisely with the dates when CMS established that Petitioner was noncompliant with a condition of participation.

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Petitioner argues that the penalties are unfair, but in doing so it does not offer evidence that rebuts either the findings of noncompliance or proof as to the egregiousness of that noncompliance.  Rather, it again falls back on its contention that it is the victim of surveyor bias or incompetence.  I have explained why this argument is without merit.

• *. Petitioner objected to my receiving CMS Ex. 23-CMS Ex. 28 on the grounds that these exhibits are incomplete. I overrule that objection because I gave Petitioner opportunity to supplement any documents offered by CMS.