Compassus Hospice and Palliative Care – St. Louis, DAB CR6228 (2023)

DECISION

Petitioner, Compassus Hospice and Palliative Care – St. Louis (Compassus), challenges the determination by Respondent, the Centers for Medicare & Medicaid Services (CMS) to terminate its participation in the Medicare program based on its failure to comply with a Medicare condition of participation.  As explained herein, I find in favor of CMS and affirm its termination of Petitioner’s Medicare provider agreement. 

I.      Background

Compassus was at times relevant a hospice participating as a provider in the Medicare program.  On September 28, 2018, the Missouri Department of Health and Senior Services (MDHSS or state agency) conducted a complaint investigation survey and found Compassus out of compliance with the Core Services condition of participation found at 42 C.F.R. § 418.64 at the immediate jeopardy level.  CMS Exhibit (Ex.) 1 at 1.  On October 26, 2018, MDHSS conducted a follow-up survey and then a full extended

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survey.¹  Id.  With input from CMS, the state agency found Compassus remained out of compliance and that immediate jeopardy had not been abated.  Id. at 1-2. 

On November 6, 2018, CMS notified Compassus of its noncompliance with the Core Services condition of participation found at 42 C.F.R. § 418.64 at the immediate jeopardy level and advised the facility of the agency’s intent to terminate its Medicare provider agreement on November 22, 2018. 

On November 26, 2018, Compassus filed a request for hearing in the Civil Remedies Division and I was designated to hear and decide this case.  On November 21, 2018, I issued an Acknowledgment and Pre-hearing Order (Pre-hearing Order) that set deadlines for the parties to file pre-hearing briefs, exhibits, witness lists, and the direct testimony of any proposed witnesses.  Pre-hearing Order at 3-4.  CMS and Compassus each filed timely pre-hearing exchanges, including pre-hearing briefs (CMS Br. and P. Br.).  Petitioner requested cross-examination of CMS’ sole witness.  CMS requested cross-examination of four of Petitioner’s witnesses. 

II.      Hearing, Admission of Exhibits, and Post-hearing Briefs

On September 11, 2019, I held a videoconference hearing to allow the parties to cross-examine witnesses.  At the outset and without objection from the parties, I entered CMS’s Exhibits 1 through 15 and Petitioner’s Exhibits 1 through 9 into evidence.  Hearing Transcript (Tr.) at 11.  Compassus cross-examined CMS’ witness, Surveyor Michael Fields, R.N.  CMS withdrew its request to cross-examine Compassus’ witnesses. Following the hearing, the parties filed post-hearing briefs (CMS Closing Br. and P. Closing Br.). 

III.      Issue

Whether CMS had a legal basis to terminate Petitioner’s Medicare provider agreement. 

IV.      Jurisdiction

I have jurisdiction to hear and decide this case.  42 U.S.C. § 1395cc(h)(1)(A); 42 C.F.R. §§ 488.24(c); 498.3(b)(8); 498.5(b).

V.        Statutory and Regulatory Authority

The statutory requirements for hospices providing Medicare services to terminally ill individuals are set forth at section 1861(dd) of the Social Security Act (Act).  The Act

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considers an individual to be “terminally ill” if the individual is expected to live six months or less.  Act § 1861(dd)(3)(A).  The primary purpose of hospice care is to provide palliative care, defined as “patient and family-centered care that optimizes quality of life by anticipating, preventing, and treating suffering.”  42 C.F.R. § 418.3.

To participate in and receive payment from Medicare, a hospice must satisfy all the provisions of section 1861(dd) of the Act and be in substantial compliance with the conditions of participation set forth in 42 C.F.R. Part 418.  42 C.F.R. § 488.3(a).  One condition is to “routinely provide substantially all core services directly by hospice employees.  These services must be provided in a manner consistent with acceptable standards of practice.  These services include nursing services, medical social services, and counseling.”  42 C.F.R. § 418.64.

A “condition of participation” 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).  If a hospice fails to meet one or more of the conditions of participation, CMS may terminate its provider agreement.  42 C.F.R. § 489.53(a)(3).  Whether a hospice complies with a condition of participation depends on “the manner and degree to which [it] satisfies the various standards within each condition.”  42 C.F.R. § 488.26(b).  A condition is not met if the deficiencies “are of such character as to substantially limit the provider’s . . . capacity to furnish adequate care or which adversely affect the health and safety of patients[.]”  42 C.F.R. § 488.24(b).

To monitor compliance, CMS contracts with state agencies to periodically survey hospices.  Act § 1864(a); 42 C.F.R. § 488.10.  Hospices are surveyed as often as CMS deems necessary.  42 C.F.R. § 488.20(a).  A hospice dissatisfied with CMS’ determination to terminate its Medicare participation may request Administrative Law Judge review.  42 C.F.R. §§ 488.24(c); 498.3(b)(8); 498.5(b).  Appeal procedures are governed by 42 C.F.R. Part 498.

VI.      Burdens of proof and persuasion

Neither the Act nor its implementing regulations allocate the burden of proof or the quantum of evidence necessary to meet that burden.  In the context of a regulatory enforcement action, it would perhaps be reasonable to presume the party taking such action would need to establish by proof and persuasion that it was justified to act under the Act or its regulations.  Nevertheless, the Departmental Appeals Board has imposed a burden-shifting regime in cases involving the imposition of regulatory enforcement penalties against providers like Petitioner whose appeals are adjudicated under 42 C.F.R. Part 498.  Hillman Rehab. Ctr., DAB No. 1611 (1997), aff’d, Hillman Rehab. Ctr. v. U.S. Dep’t of Health & Human Srvs., No. Civ. A. 98-3789 (GEB), 1999 WL 34813783 (D.N.J. May 13, 1999); VITAS Healthcare Corp. of Calif., DAB No. 1782 at 4 (2001);

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Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004), aff’d sub nom., Batavia Nursing & Convalescent Ctr. v. Thompson, 143 F. App’x 664 (6th Cir. 2005). 

CMS has the burden to come forward with evidence sufficient to make a prima facie showing²  that it had a basis for termination.  In Hillman, the Board identified the elements it believed necessary for CMS to make such a showing: 

[CMS] must identify the legal criteria to which it seeks to hold a provider.  Moreover, to the extent that a provider challenges [CMS’] findings, [CMS] must come forward with evidence of the basis for its determination, including the factual findings on which [CMS] is relying and, if [CMS] has determined that a condition of participation was not met, [CMS’] evaluation that the deficiencies found meet the regulatory standard for a condition-level deficiency. 

DAB No. 1611 at 8. 

Once CMS makes a prima facie showing of noncompliance, Petitioner bears the burden of persuasion and must prove by a preponderance of the evidence of record that it substantially complied with statutory and regulatory requirements.  See Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004), aff’d sub nom., Batavia Nursing & Convalescent Ctr. v. Thompson, 143 F. App’x 664 (6th Cir. 2005). 

To date, federal district and circuit courts have declined to disturb this burden-shifting regime on due process or other grounds.  See, e.g., Hillman Rehab. Ctr., DAB No. 1611 (1997), aff’d, Hillman Rehab. Ctr. v. U.S. Dep’t of Health & Human Srvs., No. Civ. A. 98-3789 (GEB), 1999 WL 34813783 (D.N.J. May 13, 1999); Fairfax Nursing Home, Inc., DAB No. 1794 (2001), aff’d, Fairfax Nursing Home v. Dep't of Health & Human Srvcs., 300 F.3d 835 (7th Cir. 2002), cert. denied, 2003 WL 98478 (Jan. 13, 2003); Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004), aff’d sub nom., Batavia Nursing & Convalescent Ctr. v. Thompson, 143 F. App’x 664 (6th Cir. 2005).  Until such judicial scrutiny demands otherwise, and absent modification to the Act or its regulations, I apply the Board’s burden-shifting regime.  

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VII.      Discussion

1. Petitioner did not comply with the Medicare condition of participation at 42 C.F.R. § 418.64, Core Services.

The condition of participation for Core Services provides: 

A hospice must routinely provide substantially all core services directly by hospice employees.  These services must be provided in a manner consistent with acceptable standards of practice.  These services include nursing services, medical social services, and counseling.  

42 C.F.R. § 418.64. 

CMS asserts³  Compassus violated three of these standards and that these deficiencies collectively amounted to a violation of the Core Services condition of participation.  CMS Br. at 4.  CMS further contends Compassus’ noncompliance posed an immediate jeopardy to the facility’s residents.  Id. at 4, 10-11.  The three standards under the Core Services condition of participation at issue here are: 

(1) 42 C.F.R. § 418.64(b)(1), L591  Standard:  Nursing Services
(2) 42 C.F.R. § 418.64(d)(1), L596  Standard:  Counseling Services (specifically, Bereavement counseling); and
(3) 42 C.F.R. § 418.64(d)(2), L597  Standard:  Counseling Services (specifically, Dietary counseling). 

CMS Ex. 1 at 3-28. 

The L591 deficiency allegations relate to Patients 1 and 3, while the L596 allegations relate to Patient 10’s family.  The allegations under L597 relate to Patient 3.  As

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discussed below, I conclude Petitioner’s noncompliance with the Nursing Services standard at 42 C.F.R. § 418.64(b)(1) with respect to Patient 3 was severe enough to substantially limit Petitioner’s capacity to furnish adequate care to Patient 3, thereby amounting to a condition-level violation. 

1.  The nursing care Compassus provided to Patient 3 failed to meet the standard-level requirement at 42 C.F.R. § 418.64(b)(1), Tag L591. 

Patient 3 was a 58-year-old man suffering from malignant esophageal cancer and bone cancer.  CMS Ex. 4 at 1; CMS Ex. 10 at 1, 19.  He was admitted to Compassus’ hospice services on July 19, 2018.  P. Ex. 6 at 6-7; CMS Ex. 5 at 1, 11.  That day a Compassus hospice nurse visited Patient 3 at home to perform a comprehensive assessment.  CMS Ex. 5 at 1-14.  The nurse found Patient 3 oriented and cognitively intact.  Id. at 5.  The nurse assessed Patient 3’s cancer-related pain and observed he experienced continuous stabbing and throbbing pain both generalized and in his upper extremity, neck, left shoulder, and spine.  Id. at 2.  Patient 3 described his pain as severe and rated it an 8 on a scale of 1 to 10.⁴  Id.  He desired to reach a pain level of 2 out of 10.  Id. at 3.  Patient 3 stated his pain always interfered with his activities of daily living.  Id. at 2.  He indicated “nothing” relieved his pain and that activity, movement, and exercise made it worse.  Id. at 3.  Patient 3 reported a “fear of drug ineffectiveness,” which presented a “barrier” to effective pain management.  Id.  Patient 3’s current medications at that time included oral morphine (Roxanol), 5 mg./.25 mL administered every hour as needed.  CMS Ex. 5 at 14; CMS Ex. 4 at 3.  

On July 26, 2018, Patient 3 was admitted to a skilled nursing facility [SNF] where he continued to receive hospice services from Compassus.  CMS Ex. 5 at 35; CMS Ex. 10 at 1; CMS Ex. 12 at 53-54.  The SNF’s intake document reflects Patient 3 experienced constant shoulder pain and reported his current medications were “not doing the job.”  CMS Ex. 12 at 53. 

42 C.F.R. § 418.64(b)(1) requires a hospice to:  

. . . provide nursing care and services by or under the supervision of a registered nurse. . . . [and] ensure that the nursing needs of the patient are met as identified in the patient’s initial assessment, comprehensive assessment, and updated assessments. 

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With respect to Patient 3, MDHSS alleged Petitioner did not meet this regulatory obligation when it “failed to ensure effective nursing coordination of care regarding pain management;” “failed to coordinate accurate pain medication orders with the . . . (SNF) where [Patient 3] resided;” and “failed to effectively remedy a pain medication supply problem in the SNF.”  CMS Ex. 1 at 3.⁵ 

Surveyor Fields, who interviewed Patient 3 and wrote the Statement of Deficiencies arising from the October 26, 2018 survey, CMS Ex. 15 at 3; Tr. at 46-52, 63, declared in more detail:

First, Compassus failed to address Patient # 3’s multiple complaints of pain above his pain threshold.  Compassus did not call the physician to adjust the dosage or type of pain medication, despite the patient’s increasing level of acceptable pain and his resignation of pain control. . . . Second, Compassus failed to reconcile the contradictory prescriptions for Roxanol for breakthrough pain and the patient’s ongoing prescription for morphine for chronic pain. . . . Third, Compassus provided deficient care under the nursing standard because [Patient # 3] ran out of medications at least three times while under their care. 

CMS Ex. 15 at 2. 

Compassus responds that it consistently and appropriately addressed Patient 3’s complex pain management needs arising from his unavoidable and long-standing pain.  P. Closing Br. at 9-17.  It contends there were no “contradictory prescriptions” to reconcile.  Id. at 18-19.  And finally, Compassus disputes MDHSS’ contention that Patient 3 ran out of prescription pain medications, instead claiming it promptly addressed any “temporary disruptions.”  Id. at 19-21.  I address MDHSS’s contentions in turn.  

1. Compassus did not violate 42 C.F.R. § 418.64(b)(1) by failing to address Patient 3’s pain complaints.  

MDHSS’ claim that Compassus did not consistently or appropriately address Patient 3’s complaints of pain is not supported by the record.  MDHSS cited 11 instances occurring between July 26, 2018 and October 24, 2018 where it believed Compassus did not respond appropriately to Patient 3’s pain levels.  CMS Ex. 1 at 8-11, 13.  But review of

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these instances reflects Compassus responded appropriately to Patient 3’s complaints of pain. 

July 26, 2018:  MDHSS asserted a Compassus nurse failed to “assess the pain site” after Patient 3’s physician changed his medication.  Id. at 8.  The record confirms a Compassus nurse contacted Patient 3’s physician regarding his pain on this date and that the physician adjusted Patient 3’s pain medication, increasing his hourly and daily doses of Roxanol (short-acting morphine) and adding a daily dose of MS Contin (extended release morphine).  CMS Ex. 4 at 8; CMS Ex. 5 at 35-36; CMS Ex. 10 at 23, 40-41.  MDHSS claim that Compassus’ nurse failed to comply with this order by failing to “assess the pain site” makes little sense, as the nurse’s notes reflect Patient 3’s pain was “generalized.”  CMS Ex. 5 at 33-34.  It is evident the nurse communicated with Patient 3’s physician regarding Patient 3’s pain and that his doctor issued new pain medication orders that same day.  This incident does not support MDHSS’s claim Compassus failed to address Patient 3’s pain. 

July 30, 2018:  MDHSS asserted a Compassus nurse failed to document notification to Patient 3’s physician of his uncontrolled pain on July 30, 2018, when Patient 3 reported a pain level of 9 out of 10.  CMS Ex. 1 at 8.  But the record shows on that date Patient 3 also reported improvement in his pain level resulting from the changes to his pain medications.  CMS Ex. 5 at 43.  In addition, Compassus explains (without dispute from CMS) that Patient 3 was due for another dose of pain medication in 30 minutes.  P. Closing Br. at 13.  This does not demonstrate a lapse in care requiring intervention by the patient’s physician to increase the dosage, as MDHSS suggests.  

August 2, 2018:  On this date, MDHSS again asserts a Compassus “nurse failed to document any notification to the hospice physician regarding [Patient 3’s] uncontrolled pain” where Patient 3 reported back pain rated at 7 out of 10.  CMS Ex. 1 at 8-9.  But the record reflects Compassus’ nurse notified the SNF’s Director of Nursing of Patient 3’s pain and informed her Patient 3 was “due for pain medication.”  CMS Ex. 5 at 50.  The Director of Nursing responded she would “go give him pain meds,” that “with pain medication changes pain has been better managed,” and that she had “no other concerns at this time from staff.”  CMS Ex. 5 at 50.  MDHSS failed to include these pertinent details in its Statement of Deficiencies.  Compassus’ nurse thus communicated with the SNF’s Director of Nursing, who administered another dose of medication to Patient 3 and indicated his “pain has been better managed.”  Id.  These records do not suggest the need for physician intervention to modify Patient 3’s pain regimen, as MDHSS suggests. 

August 9, 2018:  MDHSS claims Patient 3 reported continuous pain rated at 6 out of 10 to a Compassus nurse on this date, apparently without response.  CMS Ex. 1 at 9.  But the same note relied upon by the state agency also indicates Patient 3 was “in good spirits” and reported his “pain medication is helping.”  CMS Ex. 8 at 11.  Critically, Patient 3’s physician issued a new medication order that same day increasing Patient 3’s MS Contin

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dosage, strongly suggesting Compassus’ nurse did in fact relay Patient 3’s report of continuous pain to his physician.  CMS Ex. 4 at 9; CMS Ex. 10 at 21. 

August 13, 2018:  MDHSS contends Patient 3 reported continuous pain rated at 8 out of 10 to a Compassus nurse who “failed to document that the physician was contacted regarding the pain level.”  CMS Ex. 1 at 9.  But Patient 3 also reported that day that “the pain medication is helping” and “that it would be much worse without it.”  CMS Ex. 8 at 10.  Moreover, the SNF held a care plan meeting three days earlier attended by the SNF’s staff, a social worker, and a Compassus nurse.  Id. at 10-11.  The attendees conducted a medication review for Patient 3 to address pain in his shoulders, neck, and spine.  Id. at 11.  MDHSS gave no consideration to these efforts.  It is evident staff from both the SNF and Compassus considered Patient 3’s pain and how best to manage it.  These notes do not corroborate MDHSS’ contention that Patient 3 expressed uncontrolled pain that obligated Compassus’ staff to notify his physician.  

September 5, 2018:  MDHSS asserts a Compassus nurse failed to assess Patient 3’s pain on the 1 to 10 pain scale.  CMS Ex. 1 at 9.  The nurse’s notes indicate she used a “verbal descriptor” pain screening tool.  CMS Ex. 5 at 56.  Patient 3 “said he was doing okay today and that his pain has been more controlled since starting the new orders of mor[p]hine.”  But MDHSS also notes Compassus’ nurse recorded Patient 3 reporting a current pain level of 7 out of 10.  Id. at 58.  MDHSS’s allegation is clearly erroneous.  Compassus’ nurse detailed the nature of Patient 3’s pain, noting he stated that “it is not bad, and he can deal with it being a 7.”  The nurse advised Patient 3 to ask for his as- needed medications when needed and documented “he understood.”  Id.  Nothing about this interaction supports MDHSS’ claim that Compassus failed to address Patient 3’s pain.  

September 10, 2018:  MDHSS asserts Compassus’ nurse failed to document notification to Patient 3’s physician of his complaints of aching and continuous back pain rated at 7 out of 10 where his pain goal was 6 out of 10.  CMS Ex. 1 at 9-10.  But Compassus’ nurse’s note shows Patient 3 rated his pain at 7 out of 10 before taking a dose of as- needed Roxanol (morphine).  CMS Ex. 5 at 73.  The nurse then told him “to make sure to let [SNF] staff [k]now prior to pain getting too bad.”  Id.  Patient 3 responded that the SNF staff did not always remember to bring him his pain medication.  The hospice nurse documented informing a SNF nurse that Patient 3 needed his Roxanol, who responded she would give him the medication after she had finished assisting another resident.  The hospice nurse noted further that Patient 3 told her that “the pain medication does help, and he is used to being in pain.”  Id. 

It is evident the hospice nurse’s note presents a more complete picture of the circumstances than what MDHSS’ surveyors described as a failure to notify Patient 3’s physician of uncontrolled pain.  MDHSS surveyors chose to ignore Patient 3’s statement to the nurse that his pain medication helped, undercutting their premise that he had

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uncontrolled pain.  Compassus’ nurse acted appropriately to address Patient 3’s pain in circumstances that did not require her to notify his physician. 

September 27, 2018:  Here, MDHSS merely notes Patient 3 reported a pain level of 6 out of 10 where his pain goal was 6 out 10, and that he had aching and continuous back pain.  CMS Ex. 1 at 10.  The surveyors failed to identify any deficiency related to this date’s notes, but to be thorough I note Patient 3 reported he was “comfortable at this time.”  CMS Ex. 5 at 119; CMS Ex. 8 at 4.  Patient 3 also told the nurse that he had been using as-needed pain medications more frequently and believed they were “not controlling his pain as well anymore,” causing the Compassus nurse to document contacting Patient 3’s physician “to see if he wanted to do any adjustments.”  Id.  That same day, Patient 3’s physician issued new orders to increase Patient 3’s pain medication dosages.  CMS Ex. 4 at 14; CMS Ex. 5 at 119; CMS Ex. 10 at 31; CMS Ex. 11 at 19.  MDHSS has failed to articulate any possible deficiency that could have arisen on this date.  

October 11, 2018:  MDHSS again asserts Compassus’ nurse failed to document notification to Patient 3’s physician regarding uncontrolled pain where he reported aching and continuous back pain rated at 7 out of 10 and where his goal for pain was 6 out of 10. CMS Ex. 1 at 10.  Again, the record reflects a more complete picture of the efforts undertaken by Compassus to address Patient 3’s pain.  CMS Ex. 5 at 161, 169; CMS Ex. 8 at 2.  While Patient 3 did rate his pain at 7 out of 10, he also “stated he is okay right now and he is getting his noon doses of morphine in about 5 minutes.”  Id.  Patient 3 also reported that his pain while sitting was a “5 or 6, but at this time he will be fine once he gets the morphine.”  Id.  The next day the SNF nurse informed Compassus’ nurse that Patient 3 was “doing well” and had “not needed any breakthrough medication.”  CMS Ex. 8 at 2.  MDHSS’s assertion that Compassus should have characterized Patient 3’s reports as uncontrolled pain and contacted his physician is without merit.  I find no support in the record to conclude Compassus failed to address Patient 3’s pain on this date. 

October 17, 2018:  MDHSS again claimed Compassus failed to document notification to Patient 3’s physician for uncontrolled pain where he reported pain of 6 out of 10 and hoped to reach a pain level of 5 out of 10.  CMS Ex. 1 at 10-11.  Again, the surveyors’ allegations are unsupported by the record.  Patient 3 again reported his pain rating right before receiving a dose of pain medication.  CMS Ex. 5 at 185; CMS Ex. 8 at 19.  By the time she left, Compassus’ nurse described Patient 3 as “comfortable and continuing his normal routines.”  Id.  Patient 3 rated his pain at 5 out of 10 and indicated he had not used breakthrough pain medication since October 9, 2018.  Id.  The next day, the SNF nurse reported Patient 3 was “doing fine today and acting as he normally does.”  CMS Ex. 8 at 19.  MDHSS’ assertion that Compassus had an obligation to notify Patient 3’s physician for uncontrolled pain on this date is without merit. 

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October 24, 2018:  According to the SOD, during a “home visit observation”⁶  from the hospice nurse at 9:15 a.m. on this date, Patient 3 told her that his acceptable level of pain was 6 out of 10 and that his current pain level was 6 out of 10.  Patient 3 stated that his current pain regime “does not hold [him], seems like it[’]s getting worse.”  CMS Ex. 1 at 13. 

MDHSS does not explicitly identify this as a failure to address Patient 3’s pain, but even if it did, the record fails to support such an allegation.  Patient 3 reported he was comfortable that day and declined breakthrough medication.  CMS Ex. 5 at 202.  When he reported the declining effectiveness of his pain medication regimen, Compassus’ nurse notified Patient 3’s physician that same day.  Id.  In response, Patient 3’s physician added another pain medication to his drug regimen and increased the frequency of morphine.  P. Ex. 6 at 33; CMS Ex. 5 at 202, 203; CMS Ex. 10 at 28, 30.  The record reflects Compassus promptly responded to Patient 3’s concern about his pain medications by notifying his physician the same day. 

In sum, review of the record of Patient 3’s treatment on the aforementioned dates fails to corroborate MDHSS’ contention that Compassus failed to ensure its nurses effectively coordinated care regarding Patient 3’s pain management.  Compassus’ nurses communicated promptly with Patient 3’s physician regarding his pain complaints when appropriate.  MDHSS seeks to paint any instance where Patient 3 did not report well-controlled pain as a triggering obligation for Compassus to contact his physician.  But slight fluctuations in pain level and discomfort in a terminally ill patient receiving significant amounts of pain medication required more than robotic requests for intervention from that patient’s physician.  Instead, Compassus’ nurses worked closely with Patient 3 and the SNF staff taking care of him to ensure he received appropriate pain medication dosages and sought intervention from his physician whenever his circumstances changed beyond mild fluctuations one would expect for a complex patient with challenging pain control needs.  MDHSS failed to demonstrate Compassus fell short of its duty to coordinate care to address Patient 3’s pain. 

2. Compassus violated 42 C.F.R. § 418.64(b)(1) by failing to verify Patient 3’s pain medication orders with the SNF where he resided. 

MDHSS contends Compassus failed to account for contradictory pain medication orders for Patient 3.  CMS Ex. 1 at 11-15.  As of October 24, 2018, Patient 3’s physician ordered the SNF’s staff to administer Roxanol every hour as needed for pain, 300 mg Morphine sulfate tablets every eight hours, and 90 mg MSIR tablets every four hours while Patient 3 was awake.  Id. at 11; CMS Ex. 10 at 31. 

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MDHSS alleged Patient 3 received only Roxanol on October 23, 2018 and no doses of Roxanol at all from October 13, 2018 to October 22, 2018.  CMS Ex. 1 at 12.  MDHSS asserted Compassus’ plan of care and medication profile conflicted with the SNF’s orders in that Compassus’ documents did not contain instructions for Roxanol to be held within four hours of giving MSIR to Patient 3.  Id. at 13.  Surveyor Fields explained that “Compassus failed to reconcile the contradictory prescriptions for Roxanol for breakthrough pain and the patient’s ongoing prescription for morphine for chronic pain.”  CMS Ex. 15 at 2.  Compassus responds that Patient 3’s physician issued no contradictory pain medication orders and contends its staff communicated frequently with the SNF staff to ensure Patient 3 continued to receive Roxanol consistent with those orders.  P. Closing Br. at 18-19. 

Compassus is correct no actual contradiction existed; Surveyor Fields acknowledged Patient 3’s physician’s October 4, 2018 order did not prohibit the administration of Roxanol within four hours of MSIR administration.  Tr. 122-24, 126; CMS Ex. 10 at 31.  The surveyor conceded the SNF’s Medication Administration Record (MAR) inaccurately incorporated a restriction on the administration of Roxanol that the physician’s October 4, 2018 order did not contain.  Tr. 122-23, 126, 128-30; CMS Ex. 10 at 5, 7, 31. 

Compassus may not be directly responsible for inconsistencies contained in Patient 3’s MAR.  But it cannot elude responsibility on that basis.  As a hospice provider entitled to seek payment for care provided to Medicare beneficiaries, Compassus was obliged to “provide substantially all core services directly by hospice employees.”  42 C.F.R. § 418.64 (emphasis added).  This included nursing services, which include ensuring a patient’s nursing needs “are met as identified in the patient’s initial assessment, comprehensive assessment, and updated assessments.”  42 C.F.R. § 418.64(b)(1). 

For a terminally ill patient left with no recourse but palliative care, nursing services necessarily include ensuring that patient receives appropriate pain-relieving medications at the appropriate times and dosages set forth by that patient’s physician.  Moreover, hospices are obligated to provide “ongoing sharing of information with other non-hospice healthcare providers furnishing services unrelated to the terminal illness and related conditions.”  42 C.F.R. § 418.56(e)(5).  Thus, while the SNF may have committed the clerical error that resulted in the erroneous notation concerning Patient 3’s physician’s October 4, 2018 order into Patient 3’s MAR, Compassus had an obligation under the regulations to both directly provide core nursing services and an affirmative duty to share information and coordinate with the SNF.  In short, Compassus was required to coordinate the administration of Patient 3’s pain medications with the SNF’s staff.  Such coordination would necessarily have included checking Patient 3’s physician’s orders against the SNF’s MAR and verifying the SNF administered Patient 3’s pain medications as directed. 

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Compassus had several opportunities to catch this clerical error and minimize the unnecessary deprivation of pain-relieving medication to Patient 3; a Compassus nurse visited Patient 3 at the SNF on October 4, October 8, October 11, October 15, October 17, and October 22, 2018.  CMS Ex. 5 at 131, 139, 155, 171, 179, 204; P. Ex. 4 at 8.  But none of these nurses ever reviewed the SNF’s MAR for Patient 3. 

Compassus did not become aware of this clerical error until a SNF nurse sought clarification from Compassus on October 23, 2018, weeks after Patient 3’s physician’s October 4, 2018 order was incorrectly entered into Patient 3’s MAR.  P. Ex. 6 at 20, 27.  Even then, Compassus merely verified the prescribed doses with Patient 3’s physician and relayed that information to the SNF’s staff.  The lack of urgency resulted in an additional two-day delay for the SNF’s Director of Nursing to contact Patient 3’s physician directly to have him issue an order to discontinue the inadvertent Roxanol restriction.  CMS Ex. 1 at 14. 

For these reasons, I conclude Compassus failed to meet its regulatory obligation to ensure Patient 3’s pain medication orders were accurately reflected in the SNF’s medication record and to verify the correct documentation of any changes to his medications.  Compassus fell short of its duty to coordinate Patient 3’s care with the SNF and ensure his pain management needs were met in violation of 42 C.F.R. § 418.64(b)(1).  

3. Compassus did not violate 42 C.F.R. § 418.64(b)(1) when Patient 3 did not receive pain medication refills on three occasions. 

MDHSS alleged Compassus “failed to effectively remedy a pain medication supply problem” that caused the SNF to run out of Patient 3’s pain medications three times between September 16 and October 23, 2018.  CMS Ex. 1 at 3, 14; P. Ex. 4 at 8.  Compassus does not deny this occurred but contends it should not be held responsible for “supply chain” issues.  Compassus otherwise points out Patient 3 never lost access to all his pain medications and that it promptly addressed any “temporary disruptions.”  P. Closing Br. at 19-21; see P. Ex. 3 at 2-3. 

The applicable regulation demands hospices “provide substantially all core services directly by hospice employees.”  This includes physician services, meaning the hospice medical director and its physician employees are, along with a patient’s attending physician, responsible for “palliation and management of the terminal illness . . . .”  42 C.F.R. § 418.64(a). It also includes nursing services, which for a terminally ill patient necessarily includes ensuring that patient receives appropriate pain-relieving medications without interruption.  42 C.F.R. § 418.64. 

The question is whether the three incidents Patient 3’s pain medications went unfilled or dispensed suggest a failure by Compassus to provide undeniably important palliative care required as a Core Service.  Neither MDHSS nor CMS made a sufficient effort to

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establish Compassus played a role in the disruption of dispensing Patient 3’s medications.  On my own review of the record, I cannot say these three incidents reflect such a failure. 

On September 16, 2018, Patient 3’s significant other called a Compassus nurse to report that Patient 3 had run out of morphine and had not taken it for two days.  CMS Ex. 8 at  6-7.  The Compassus nurse contacted Patient 3’s physician, who ordered a refill, and she delivered the medication to Patient 3 at the SNF later that night.  Id. at 7.  Significantly, the SNF nurse admitted facility staff had forgotten to call the pharmacy that weekend to refill Patient 3’s prescription; she also admitted she had provided an incorrect dosage frequency to Patient 3’s physician, necessitating a new prescription be dispensed.  Id.  By contrast, Compassus’ nurse immediately contacted Patient 3’s physician, obtained the prescription, picked up Patient 3’s pain medication, and personally delivered it to him.  She also acted proactively to avoid future problems, offering to see if Patient 3’s physician could resend the prescription every other week.  Id. at 6.  The fault here clearly lies with the SNF, not Compassus. 

Similarly, on October 7, 2018, the SNF contacted a Compassus nurse and reported Patient 3 had run out of MS Contin that morning and their pharmacy could not deliver the medication because it was closed.  Id. at 2-3.⁷    The Compassus nurse again contacted Patient 3’s physician to obtain a refill prescription and personally delivered Patient 3’s pain medication.  Id.  The Compassus nurse noted the pharmacy never received the refill order faxed by the SNF on Friday and then learned new prescriptions were required for both his Extended Release and Immediate Release morphine tablets (MS Contin and MSIR) since the dosages had been increased the previous week.  The Compassus nurse informed Patient 3’s physician that he needed to send in new prescriptions.  Id. at 3.  The fault lay either with the SNF, the pharmacy, or both.  It is unclear what Compassus could have done to avoid this outcome.⁸   

Finally, on October 22, 2018, a Compassus nurse documented Patient 3 would run out of pain medication the next day and that a refill prescription had already been sent to the pharmacy on October 18, 2018.  The SNF expected the medication to be delivered on October 22, 2018.  P. Ex. 6 at 26-27.  But on October 23, 2018, the SNF contacted Compassus to report that the pharmacy had not delivered the medication, again citing the need for an updated prescription.  Id. at 27.  The SNF noted that the pharmacy had not

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contacted them, Compassus, or Patient 3’s physician, to inform them that a prescription was needed.  Id. 

The next day, a Compassus nurse spoke with the SNF Administrator about the situation with the pharmacy to discuss “ways that [they] could prevent this from happening again.”  Id. at 28.  To confirm faxes weren’t getting lost or miscommunicated, the Compassus nurse stated she would call the pharmacy to confirm receipt of prescriptions whenever Patient 3’s physician sent them in.  Id.  They also discussed the option of Compassus bringing in its own pharmacy for its patients.  Id.  Ultimately, due to the three incidents described above, Compassus changed the pharmacy it used to deliver medications to the SNF.  See P. Ex. 4 at 5, 8; P. Ex. 6 at 29. 

On each occasion, once the SNF made Compassus aware of the issue, Compassus quickly took action to remedy the situation and ensure Patient 3 received his pain medication.  After the third incident, Compassus staff worked with the SNF Administrator to ensure the pharmacy received prescriptions.  Compassus eventually solved the problem altogether by changing pharmacies. 

The duty of a hospice to coordinate palliative care for a terminally ill patient under the regulations cannot be overstated.  And I give no weight to Compassus’ efforts to claim Patient 3 did not require all the pain medications prescribed by his physician, or that these lapses amounted to harmless error because the terminally ill man in question was really not in that much pain.  But CMS has failed to even articulate what steps Compassus failed to take to avoid three random instances where the SNF or the pharmacy prevented Patient 3’s medications from being dispensed.  In all three cases, Compassus staff reacted swiftly to address the situation.  After the second instance Compassus provided training to its staff.  After the third, it sought out the SNF Administrator in an effort to avoid future instances, and eventually changed pharmacies altogether.  Absent citation by CMS to any evidence of record that could corroborate its accusations, I decline to find Compassus violated 42 C.F.R. § 418.64(b)(1) based on these three instances.  

2.  Compassus did not violate the standard-level requirement at 42 C.F.R. § 418.64(b)(1), L591, with respect to the nursing care it provided Patient 1. 

MDHSS alleges Compassus failed to meet the nursing needs of Patient 1 because the hospice failed to measure or assess Patient 1’s worsening pressure ulcer on her coccyx for 11 days.  CMS Ex. 1 at 20.  MDHSS cited an order dated October 7, 2018 for Aquacel foam dressing for Patient 1’s Stage II pressure ulcer to be changed every three days.  CMS Ex. 1 at 18.  The state agency asserts a review of Compassus’ nursing notes reveals “no wound assessment was completed” on October 5, 9, 10, 16, or 18, 2018, and “no caregiver [had] completed care” on October 7, 9, 10, and 16.  CMS Ex. 1 at 19-20. 

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MDHSS’ allegations are without merit.  At the time of the survey, Patient 1 was an 88-year-old female transferred from a hospital to a SNF on October 4, 2018.  CMS Ex. 13 at 44-48.  On that date, Patient 1 was admitted to Compassus’ care with a primary diagnosis of congestive heart failure.  CMS Ex. 13 at 42-43, 55, 63-64.  At her admission, Patient 1 had a Stage II pressure ulcer on her coccyx measuring 0.3 cm x 0.3 cm x 0 cm.  CMS Ex. 1 at 19; CMS Ex. 13 at 106; P. Ex. 4 at 2. 

Compassus and the SNF put into place a “coordinated task care plan.”  CMS Ex. 13 at 65, 94-95.  Compassus indicated its nurse would visit Patient 1 twice a week, on Tuesdays and Thursdays.  Id. at 65, 95, 111, 116.  The plan clarified Compassus and the SNF would share wound care duties and specified SNF staff would provide wound care to Patient 1 every two to three days and as needed.  Id. at 65, 95. 

On October 5, 2018, Patient 1’s physician ordered application of Calmoseptine, a topical skin protectant, for the Stage II pressure ulcer on Patient 1’s coccyx.  Id. at 84, 222.  The facility incorporated this order into its treatment record for October 2018 and starting October 5, 2018, instructed its staff to apply Calmoseptine twice daily to Patient 1’s coccyx.  Id. at 33. 

That same day, a Compassus nurse documented several interventions to address Patient 1’s skin issues in a “Hospice POC [plan of care] Report” including assessing the skin for signs and symptoms of breakdown as well as preventive measures to maintain skin integrity, education regarding routine skin inspections and frequent and proper position changes, appropriate hydration and nutrition, and the use of durable medical equipment to prevent further skin breakdown.  P. Ex. 7 at 2-3. 

The Compassus nurse identified corresponding goals:  “integumentary changes are identified promptly and interventions initiated quickly to minimize associated uncomfortable symptoms;” and “patient/caregiver verbalizes the importance and rationale for use of [durable medical equipment] and other protective devices to prevent skin breakdown.”  Id.  The nurse also identified specific interventions for Patient 1’s pressure ulcer:  providing care per the physician’s orders and requiring a complete assessment at every visit with a “focus on integumentary status such as pressure reduction/relief, incontinence, decrease perfusion (circulation), poor nutrition and other disease processes that may contribute to wound development.”  Id. at 3. 

On October 7, the SNF sought emergent care from a Compassus nurse for Patient 1’s pressure ulcer.  CMS Ex. 13 at 86, 117.  That same day, Patient 1’s physician ordered staff to clean her Stage II pressure ulcer with wound cleaner and apply Aquacel foam every three days.  Id. at 87.  The facility incorporated this order into its treatment record for October 2018.  Id. at 33.  On October 10, Patient 1’s physician ordered Calmoseptine for Patient 1’s wound.  Id. at 70, 73, 90.  

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A Compassus nurse visited Patient 1 on October 4, 5, 7, 9, 10, 16, and 18, 2018.⁹    Id. at 42, 96, 125, 136, 146, 156, 166, 176.  At each visit, the Compassus nurse documented assessing Patient 1’s integumentary system.  Id. at 101, 126, 137, 147, 157, 167, and 177.  Surveyor Fields confirmed at the hearing that such an assessment would have included measuring the size of Patient 1’s wound.  Tr. 172.  Nevertheless, MDHSS alleged that Compassus nursing notes demonstrated its nurses failed to assess Patient 1’s pressure wound over the course of several visits in October 2018.  CMS Ex. 1 at 19-20.  Each treatment note at issue contains a section entitled “Wound Assessment” that includes two questions:  “Wound Assessed” and “Wound Care Provided.” 

On October 5, 7, 9, 10, and 16, 2018, the nurse documented no change in Patient 1’s Stage II pressure ulcer.  CMS Ex. 13 at 130, 141, 151, 160-61, 171.  During each of these visits, the nurse reported in response to the question “Wound Assessed:”  “No, [client or caregiver] completed care.”¹⁰    Id.  And for each visit, the nurse reported the same response to the question “Wound Care Provided:”  “Wound care not provided:  caregiver completed care.”  Id. 

At the hearing, Surveyor Fields admitted he and the MDHSS survey team misinterpreted the phrase “No, caregiver completed care” to mean no caregiver had completed care.  Tr. at 174-76;CMS Ex. 1 at 19-20.  Surveyor Fields conceded the SOD misquotes this phrase.  Tr. at 176.  Surveyor Fields also conceded Compassus nursing notes correctly interpreted established the “skilled nursing facility would have provided the care for [the] particular wound on that date.”  Id. at 172-73.  He did not dispute that the SNF’s staff would have been competent to provide wound care.  Id. at 174.  Nor did he dispute that Compassus nurses also treated Patient 1’s pressure ulcer.  Id. at 175. 

This glaring error committed by Surveyor Fields and the survey team undermines CMS’ allegation that Compassus “failed to measure/assess a worsening wound for 11 days.”  CMS Ex. 1 at 20.  Compassus’ nursing notes instead document that the “caregiver” or “client,” i.e., the SNF’s nursing staff, assessed and treated Patient 1’s pressure ulcer prior to the hospice nurse’s visit, obviating the need for Compassus staff to do so as well.

Despite acknowledging Patient 1 in fact received evaluation and treatment for her pressure ulcer, Surveyor Fields nevertheless maintained Compassus was deficient because its staff did not assess her wound weekly in accordance with its policy.  Tr. 175-76; CMS Ex. 1 at 20.  But this position is equally untenable.  To assess Patient 1’s pressure ulcer at each visit, Compassus’ nurses would have had to remove the dressing from the wound.  Surveyor Fields testified a wound should not be re-dressed “just for

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purposes of the assessment” and that certain wound care products should not be disturbed and can “do more damage if they’re removed daily.”  Tr. 173-75. 

Based on Surveyor Fields’ own testimony, Compassus’ nurses would have potentially caused Patient 1 harm by duplicating the SNF’s efforts in assessing and treating her pressure ulcer.  Neither MDHSS nor CMS has established Compassus fell short of its duty to meet Patient 1’s nursing needs on this basis.  Instead, Compassus developed a care plan to address Patient 1’s skin issues and coordinated Patient 1’s wound care with the SNF.  No basis exists to find Compassus violated 42 C.F.R. § 418.64(b)(1) with respect to Patient 1. 

3.  Compassus did not violate the standard-level requirement at 42 C.F.R. § 418.64(d)(1), Tag L596, related to bereavement counseling.  

The governing regulations require a hospice to provide bereavement counseling: 

(1) Bereavement counseling.  The hospice must: 

(i) Have an organized program for the provision of bereavement services furnished under the supervision of a qualified professional with experience or education in grief or loss counseling.

(ii)  Make bereavement services available to the family and other individuals in the bereavement plan of care up to 1 year following the death of the patient. Bereavement counseling also extends to residents of a SNF/NF or ICF/IID when appropriate and identified in the bereavement plan of care.

(iii) Ensure that bereavement services reflect the needs of the bereaved. 

(iv) Develop a bereavement plan of care that notes the kind of bereavement services to be offered and the frequency of service delivery. A special coverage provision for bereavement counseling is specified in § 418.204(c).

42 C.F.R. § 418.64(d)(1). 

Here, MDHSS alleged that following the death of Patient 10, Compassus failed to have an effective bereavement assessment and an effective individualized bereavement care plan to meet the needs of Patient 10’s family members.  CMS Ex. 1 at 21.  MDHSS contended Compassus failed to update the bereavement care plan after Patient 10’s death

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with individualized interventions for a family member whom it identified as being at high risk for bereavement.  Id. at 23, 25.  

CMS offered Patient 10’s hospice records and related surveyor notes as CMS Ex. 14 but made no effort to cite any specific documents in support of this allegation.  CMS instead baldly asserted in its pre-hearing brief that Compassus “provided no effective individualized bereavement plan to” Patient 10’s family.  CMS Br. at 9. 

CMS’ unfounded allegations have no support in the record.  The evidence instead shows Compassus had a high-risk bereavement care plan in place, and that its staff offered bereavement services which met Patient 10’s family’s needs. 

Patient 10 lived with family members but began receiving hospice services on April 3, 2018.  CMS Ex. 14 at 3, 44.  On April 5, 2018, Compassus’ social worker conducted a bereavement risk assessment and assessed it to be “high.”  Id. at 6.  That same day, the social worker created a high-risk bereavement care plan for Patient 10’s family.  Id. at 5.  The care plan identified 18 interventions to implement after Patient 10’s death, including:  “condolence call within 72 hours of death;” “7-14 day contact (call or visit) and completion of post death risk assessment;” “discuss bereavement risk assessment and needs in IDG review within 2 weeks of death;” “assess for assignment of bereavement counselor, volunteer or intern for ongoing support;” “follow-up call or visit 30 to 45 days following death;” “follow-up call or visit 90 to 120 days following death;” “6 month letter and grief support mailing;” “11 month letter and grief support mailing;” and “12 month final call/contact.”  Id. 

Patient 10 died on April 16, 2018.  Id. at 3.  A Compassus bereavement counselor visited the family that same day to give support.  Id. at 7.  The counselor assessed Patient 10’s daughter-in-law, who had recently been hospitalized for suicidal ideation and was currently seeing a psychiatrist and therapist, to be a “high bereavement risk” and implemented a safety plan for her.  Id. 

The counselor called Patient 10’s family on April 19, 23, and 26, 2018 to offer additional support.  Id. at 8-9, 135.  During the April 26 call, Patient 10’s daughter-in-law informed the counselor that she had cancelled her therapy appointment; the counselor encouraged her to go the following week, to which she agreed.  The daughter-in-law declined the counselor’s offer to visit and stated she appreciated the call.  Id. at 9, 135.  The counselor sent a condolence card on April 23.  Id. at 9.  On August 2, 2018, the counselor called the family to confirm her visit the next day and visited them on August 3, 2018.  Id. at 9, 135.  The counselor noted both Patient 10’s son and daughter-in-law were “tearful” and that the latter “still has suicidal thoughts” but “is medicated and meets with her therapist weekly.”  The counselor noted the daughter-in-law has a safety plan in place and would “call her therapist if the thoughts get to be too much.”  Id. 

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The record amply demonstrates Compassus had an organized program to provide bereavement services.  Its social worker developed an appropriate care plan which made bereavement services available to Patient 10’s family for up to a year and followed through with the bereavement plan with great effort.  I conclude Compassus was in compliance with subsections (i), (ii), and (iv) of 42 C.F.R. § 418.64(d)(1). 

As for the allegation that Compassus failed to update the bereavement care plan after Patient 10’s death to include individualized interventions for his daughter-in-law, CMS misunderstands subsection (iii) of 42 C.F.R. § 418.64(d)(1).  That subsection requires a hospice to “[e]nsure that bereavement services reflect the needs of the bereaved.”  Nothing in the language of subsection (iii) suggests that a hospice is required to develop specific, individualized interventions for a particular family member after a patient’s death. 

In any event, CMS offered no evidence that Patient 10’s family’s bereavement needs, including those of Patient 10’s daughter-in-law, were not adequately addressed by Compassus.  The record shows the bereavement counselor contacted Patient 10’s family several times following Patient 10’s death on April 16, offered to visit on April 26, and visited the family approximately four months later.  The counselor in fact provided individualized attention to Patient 10’s daughter-in-law by encouraging her to keep her weekly therapy appointments and offering to visit her individually.  CMS cannot credibly argue the counselor was obliged under the regulations to do more.  Accordingly, I do not find Compassus was deficient in providing bereavement counseling services to Patient 10’s family.  Compassus did not violate 42 C.F.R. § 418.64(d)(1). 

4.  Compassus did not violate the standard-level requirement at 42 C.F.R. § 418.64(d)(2), Tag L597, related to dietary counseling. 

42 C.F.R. § 418.64(d)(2) (Tag L597) requires a hospice to provide dietary counseling: 

(2) Dietary counseling.  Dietary counseling, when identified in the plan of care, must be performed by a qualified individual, which include dietitians as well as nurses and other individuals who are able to address and assure that the dietary needs of the patient are met. 

These allegations pertain to Patient 3, who was admitted to hospice services on July 19, 2018 with malignant esophageal and bone cancers requiring complex pain management. 

MDHSS claims Compassus failed to ensure its interdisciplinary (IDT) team considered a dietary counseling consult for Patient 3, a high-risk dietary patient.  CMS Ex. 1 at 25-26.  The state agency claims IDT meeting documents dated July 25, 2018 and August 8, 2018 set forth only one nutritional intervention for “observation and assessment of nutrition

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and hydration status” and failed to include “discussion or consideration for a dietary consult.”  Id. at 27.  MDHSS observed that as of October 1, 2018, Patient 3 weighed 125.4 pounds and had suffered a 5% weight loss since he began receiving hospice services.  Id.  CMS simply relied on MDHSS’ allegations, making no effort to cite Patient 3’s hospice records to corroborate the state agency’s assertions.  CMS Br. at 9-10. 

Compassus responds that Patient 3 declined to receive dietary counseling services.  P. Closing Br. at 26-27.  Compassus points out that Patient 3’s physician had not ordered dietary counseling for Patient 3.  Id. at 26; Tr. 182-84.  Applying the plain language of 42 C.F.R. § 418.64(d)(2), Compassus contends that because Patient 3’s care plan did not contain an order for dietary counseling, it was not required to provide it.  P. Closing Br. at 26.  

Compassus correctly argues the plain language of 42 C.F.R. § 418.64(d)(2) requires a hospice to provide dietary counseling when it is “identified in the plan of care.”  Id.  On cross-examination, Surveyor Fields admitted dietary counseling was identified only in Patient 3’s initial comprehensive assessment and that his care plan did not contain an order for dietary counseling from his physician.  Tr. at 182-84; CMS Ex. 4 at 1.  Indeed, Patient 3’s plan of care, dated July 26, 2018, only identifies “diet as tolerated” under the category “Nutritional Requirements” and otherwise required nursing staff to observe the patient’s nutrition and hydration status.  CMS Ex. 4 at 1-2.  That care plan specifically accommodates Patient 3’s limited ability to eat and drink as part of his dying process:  “Caregiver(s) verbalizes understanding of lack of appetite and/or dehydration in the dying patient and express comfort with the natural course of the disease process.”¹¹    CMS Ex. 4 at 1; see also CMS Ex. 4 at 26, 31 (July 26, 2018 note from Patient 3’s physician acknowledging Patient 3’s appetite and oral intake had rapidly decreased after he declined further treatment). 

CMS has not addressed Surveyor Fields’ admission that Patient 3’s physician had not ordered dietary counseling in his care plan.  Nor has it made any effort to argue for a broader interpretation of 42 C.F.R. § 418.64(d)(2) beyond its plain meaning.  Accordingly, I conclude Compassus has not violated the requirement set forth at 42 C.F.R. § 418.64(d)(2) because Patient 3 had no physician-ordered plan for dietary counseling in place that would require the hospice to provide such services.  Patient 3’s nutritional issues were evident to all, but his physician acceded to his wishes and did not order dietary counseling as part of his care plan.  Compassus was not deficient with respect to dietary counseling for Patient 3 and did not violate the standard under 42 C.F.R. § 418.64(d)(2). 

Based on my review of the evidence relating to the three standards under the Core Services condition of participation MDHSS accused Compassus of violating, I conclude

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Compassus violated the Nursing Services standard at 42 C.F.R. § 418.64(b)(1) because it failed to ensure effective nursing care with respect to Patient 3’s pain management needs.  While the evidence shows that Compassus was generally responsive to Patient 3’s pain complaints, it failed to ensure that Patient 3’s medication orders were accurately reflected in the SNF’s MAR despite frequent visits to the facility.  MDHSS and CMS have failed to establish a factual basis for any of the other violations alleged in the Statement of Deficiencies. 

5.  Petitioner’s noncompliance with the Nursing Services standard at 42 C.F.R. § 418.64(b)(1) with respect to Patient 3 rose to the condition level and amounted to noncompliance with a Core Services condition because this violation substantially limited Petitioner’s capacity to furnish adequate care to Patient 3 and adversely affected his health and safety. 

Whether a hospice is noncompliant with a condition of participation “depends upon the manner and degree to which [it] satisfies the various standards within [the] condition.”  42 C.F.R. § 488.26(b).  If its “deficiencies are of such character as to substantially limit [its] capacity to furnish adequate care or which adversely affect the health and safety of patients,” the condition has not been met.  42 C.F.R. § 488.24(b). 

Compassus failed to comply with the Nursing Services standard at 42 C.F.R. § 418.64(b)(1) with respect to Patient 3.  Compassus’ noncompliance substantially limited its capacity to furnish adequate care and adversely affected the health and safety of Patient 3.  42 C.F.R. § 488.24(b).  Specifically, Patient 3 was terminally ill and suffered from severe pain.  The primary goal of hospice services for such a patient was to provide him with palliative care through the end stages of his illness, thereby minimizing his pain and discomfort before his death.  To do so, Compassus had to at least ensure Patient 3 received the pain medication his doctor had ordered.  A notation error in the SNF’s records resulted in Patient 3 not receiving Roxanol for several days.  Compassus failed to discover this mistake promptly.  It also failed to address the issue with any urgency even after becoming aware of it, causing Patient 3 to unnecessarily go without all his pain medications for another two days. 

I therefore conclude Compassus’ violation of the Nursing Services standard at 42 C.F.R. § 418.64(b)(1) amounted to a condition-level violation of 42 C.F.R. § 418.64, the Core Services condition.  Compassus’ failure to ensure effective nursing care with respect to Patient 3’s pain management needs was severe enough to substantially limit its capacity to furnish adequate care and adversely affected the health and safety of Patient 3.

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2. Because Petitioner failed to comply with the Core Services condition of participation, CMS was authorized to terminate Petitioner’s Medicare provider agreement.

To participate as a Medicare provider, a hospice must meet the conditions of participation set forth in 42 C.F.R. part 418.  CMS is authorized to terminate a hospice’s provider agreement where the hospice has failed to comply with the applicable conditions of participation.  42 C.F.R. § 489.53(a)(3). 

While I have rejected almost every basis relied upon by CMS to terminate Compassus’ provider agreement, the evidence of record supports the claim that Compassus failed to comply with the Core Services condition of participation found at 42 C.F.R. § 418.64.  Termination is justified based on a hospice’s noncompliance with even a single condition of participation.  42 C.F.R. § 489.53(a)(1), (3).  Thus, CMS remained authorized to terminate Compassus’ Medicare provider agreement.¹²   

Compassus maintains termination was not justified because the evidence relating to the alleged deficiencies did not establish condition-level noncompliance at the immediate jeopardy level.  P. Closing Br. at 30-31.  In claiming CMS improperly found immediate jeopardy, Compassus urges me to consider the “Revisions to Appendix Q,” in CMS’ State Operations Manual (SOM) published on March 5, 2019.  Compassus acknowledges CMS issued this guidance after the October 26, 2018 survey in this case but nevertheless believes it relevant as it reflects CMS’ current guidance to surveyors on how to identify immediate jeopardy.  Id. at 5, 10.  Compassus also argues it was deprived of the opportunity to submit a plan of correction and that its termination based on a finding of immediate jeopardy and one condition-level deficiency violates its due process rights.  Id. at 2 n.2, 30-31. 

Compassus’ immediate jeopardy argument is without merit.  CMS’s authority to terminate a provider from participation in the Medicare program is not contingent on whether noncompliance posed an immediate jeopardy but instead requires only the violation of a single condition of participation.¹³    42 C.F.R. § 489.53(a)(1), (3). 

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Compassus failed to provide effective nursing services to ensure Patient 3’s pain management needs were met.  This failure was severe enough to substantially limit its capacity to furnish adequate care and adversely affected the health and safety of Patient 3.  Compassus failed to comply with the Core Services condition of participation, meaning CMS had the authority to terminate its provider agreement.  

I am equally unpersuaded by Compassus’ due process argument, which in any case I have no authority to consider.  It is true CMS is authorized to afford a hospice the opportunity to submit a plan of correction where it is deficient in one or more of the standards under a condition of participation and the deficiencies, “either individually or in combination neither jeopardize [patient] health and safety . . . nor are of such character as to seriously limit [its] capacity to render adequate care.”  42 C.F.R. § 488.28(a)-(b).  But here, CMS determined Compassus’ noncompliance amounted to a violation of the Core Services condition of participation at 42 C.F.R. § 418.64.  The agency had no obligation to afford Compassus an opportunity to submit a plan of correction but could instead opt to terminate its participation in the Medicare program.  42 C.F.R. § 489.53(a)(1), (3).  Even if I thought termination inappropriate here, I have no authority to substitute my own judgment as to CMS’s choice to opt for termination instead of a lesser remedy. 

Lastly, Compassus argues CMS is not authorized to terminate its Medicare provider agreement because it relied on “sub-regulatory survey ‘tags’” which established substantive legal standards but “were not promulgated by CMS through notice and comment rulemaking.”  P. Closing Br. at 4, 31-33, citing Azar v. Allina Health Servs., 588 U.S. __, 139 S. Ct. 1804 (2019).  Compassus’ reliance on Allina is misplaced.  Under Allina, agency rule makers must comply with notice-and-comment rulemaking under the Administrative Procedure Act to impose any requirements upon regulated entities which constitute a change in a substantive legal standard.  Allina, 139 S. Ct. at 1809-14.  But the deficiency tags cited by state surveyors correspond to specific regulations; the violation identified by MDHSS and relied upon by CMS to terminate Compassus’ provider agreement is set forth at 42 C.F.R. § 418.64.  That substantive legal standard was thus clearly promulgated by notice-and-comment rulemaking and is not susceptible to attack based on the holding in Allina. 

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VIII.    Conclusion

For the foregoing reasons I conclude Compassus was out of substantial compliance with the Core Services condition of participation at 42 C.F.R. § 418.64.  As a result, CMS was authorized to terminate Compassus’ Medicare provider agreement. 

---

Endnotes

¹  CMS Ex. 1 is the Statement of Deficiencies (SOD) for the October 26, 2018 revisit survey.  MDHSS completed a separate SOD containing the results of the extended survey not discussed in this decision.  Id. at 2. 

²  The Board has not specified the quantum of evidence necessary for CMS to show it met its prima facieburden.  But it has observed CMS must produce “evidence related to disputed findings that is sufficient (together with any undisputed findings and relevant legal authority) to establish a prima facie case of noncompliance with a regulatory requirement.”  Evergreene Nursing Care Ctr., DAB No. 2069 at 7 (2007); see also Black’s Law Dict. (8th ed. 2004) at 1228 (“Prima facie” means generally that the evidence is ‘[s]ufficient to establish a fact or raise a presumption unless disproved or rebutted’”).  

³  In its two-page “closing brief,” CMS claimed to rely on arguments made in its pre-hearing brief concerning Patient 3, baldly stating the “evidence showed that Compassus failed to meet the nursing needs of Patient # 3 by under-medicating him, failing to reconcile medication records, and by running out of medications on three different occasions.”  CMS Closing Br. at 1.  CMS offered hundreds of pages of Patient 3’s hospice and SNF records as CMS Exhibits 3 through 12 but its pre-hearing brief merely cites the SOD.  Ironically, CMS counsel stated at the hearing that “this case is based on statements within the CMS 2567 [SOD].  Either that 2567 is supported by records that can be pointed to or it’s not, and to have the witness testify about each piece of paper . . . how it supports or doesn’t support the 2567, it’s not this witness’s job, it’s the job of the attorneys in the post-hearing brief.”  Tr. 36.  CMS counsel obviously did not take the approach for which he advocated at the hearing, leaving it to me to review the evidentiary record to assess whether it supports the state agency’s deficiency findings.  Because CMS has effectively declined to litigate this case, I cite to the state agency’s allegations and findings in this decision.  

⁴  Surveyor Fields testified to several different scales a patient can use to rate pain; he explained for patients able to voice their pain level, clinicians preferred the 1-to-10 scale, with “1 being very little pain, and 10 being like the worst imaginable pain.”  Tr. 52-53. 

⁵  MDHSS references and describes several Compassus policies titled “Nurse Case Manager Home Visit,” “Written Interdisciplinary Plan of Care,” “Patients’ Rights,” “Drugs, Biologicals, Medical Supplies, and DME,” and “Care in the Nursing Facility.”  CMS Ex. 1 at 4-6.  Neither party offered any of these policies into the record. 

⁶   It is unclear why MDHSS referred to a “home visit observation” since Patient 3 resided at Community Care Center of Lemay, a SNF.  See P. Ex. 6 at 1. 

⁷  Petitioner incorrectly states that a Compassus nurse received a call from the SNF on October 8, 2018, that Patient 3 had run out of MS Contin.  P. Ex. 4 at 8.  But nursing notes indicate Patient 3 ran out of the medication on the morning of October 7, 2018.  CMS Ex. 8 at 2. 

⁸  The second instance did motivate Compassus to offer in-service training.  MDHSS noted Compassus held an in-service training for one of its nurses on October 16, 2018 concerning “Medication Reconciliation in Home and Facility” that focused on “accuracy of the medications and adequate supply of medications.”  CMS Ex. 1 at 7; P. Ex. 4 at 8 (citing CMS Ex. 8 at 2).  

⁹   Compassus also alleges a nurse visited Patient 1 on October 23 and 26, 2018, but the record contains no hospice nursing notes for these dates.  P. Closing Br. at 23. 

¹⁰   On October 5 the nurse responded “No, client completed care.”  CMS Ex. 13 at 130.  On the remaining dates, the nurse responded “No, caregiver completed care.”  Id. at 141, 151, 160-61, 171. 

¹¹   Patient 3’s family collaborated with Compassus in creating his care plan.  CMS Ex. 4 at 25, 30. 

¹²   Termination remains the most serious penalty CMS can impose on a provider to the Medicare program.  Such action should not be taken lightly.  As Surveyor Fields’ admissions at the hearing make plain, MDHSS should have taken greater care to identify the deficiencies it cited.  And CMS should have made some marginal effort to justify through argument and citation to the record why it believed termination was necessary, particularly after the hearing in this case brought to light significant errors made by MDHSS and its surveyors that called into question the bases for almost all the deficiencies cited. 

¹³   CMS similarly has the discretion to terminate a SNF’s provider agreement whenever it determines the SNF is out of substantial compliance with one or more participation requirements, regardless of whether immediate jeopardy is present, and without first allowing the SNF an opportunity to correct the deficiencies.  42 C.F.R. §§ 488.412(a), 488.456(b)(1); Oaks of Mid City Nursing & Rehab. Ctr., DAB No. 2375 at 29-30 (2011); Evergreene Nursing Care Ctr., DAB No. 2069 at 5 (2007).