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                              C@A Hospice, Inc., DAB CR5628 (2020)
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C@A Hospice, Inc., DAB CR5628 (2020)








  
  
    

  
      
Department of Health and Human Services 
    DEPARTMENTAL APPEALS BOARD
          Civil Remedies Division





C@A Hospice, Inc.,
	(CCN: 551792)
	Petitioner,
v.
Centers for Medicare & Medicaid Services.
Docket No. C-17-1224Decision No. CR5628June 3, 2020

        
              
    

      DECISION
Located in Glendale, California, C@A Hospice, Inc., was, until recently, a hospice that participated in the Medicare program.  Following a complaint validation survey and a follow-up full survey completed October 26, 2016, and July 25, 2017, the Centers for Medicare & Medicaid Services (CMS) determined that the facility did not comply with multiple conditions of participation and that one of its deficiencies posed immediate jeopardy to resident health and safety.  CMS terminated Petitioner's Medicare participation.
Petitioner appealed the termination.  CMS has moved for summary judgment, and Petitioner has not responded.
For the reasons set forth below, I grant CMS's motion.  Based on the undisputed evidence, I find that CMS properly terminated Petitioner's Medicare participation because the hospice did not comply with one or more conditions of participation.1
**Page 2**
Background
**Statutory and regulatory framework**.  Sections 1812(d) and 1861(dd) of the Social Security Act (Act) extend Medicare coverage to hospice services if certain conditions are met.  To participate in and receive payment from Medicare, a hospice must satisfy all the provisions of section 1861(dd) of the Act and it must 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).
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 that periodically survey the hospices.  Act § 1864(a); 42 C.F.R. § 488.10.2
  Hospices are surveyed as often as CMS deems necessary.  42 C.F.R. § 488.20(a).
If a hospice is dissatisfied with CMS's determination to terminate its Medicare participation because it does not comply with the conditions of participation, it may request review by an administrative law judge.  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.
**The October 26, 2016 survey**.  Responding to a complaint, surveyors from the California Department of Public Health (state agency) surveyed the hospice and found that it did not comply with seven conditions of participation:
42 C.F.R. § 418.52 (patient's rights);**Page 3**
42 C.F.R. § 418.54 (initial and comprehensive patient assessment);
	42 C.F.R. § 418.56 (care-planning and coordination of services);
	42 C.F.R. § 418.58 (quality assessment and performance improvement);
	42 C.F.R. § 418.64 (core services);
	42 C.F.R. § 418.102 (medical director); and
	42 C.F.R. § 418.104 (clinical records).CMS Ex. 1 at 1.
In a letter dated June 13, 2017, CMS advised Petitioner that, based on the survey findings, it was subject to termination.  CMS Ex. 1 at 1.  Petitioner submitted a plan of correction, claiming that all of its deficiencies had been corrected and that it complied with all applicable Medicare conditions of participation.  CMS Ex. 1 at 2.
**The July 25, 2017 survey**.  Surveyors returned to the hospice and completed a full survey on July 25, 2017.  They found that it did not comply with multiple conditions of participation and that one of its deficiencies posed immediate jeopardy to patient health and safety.  Specifically:
42 C.F.R. § 418.52 (patient's rights) (*repeat deficiency*);
	42 C.F.R. § 418.54 (initial and comprehensive patient assessment) (*repeat deficiency*);
	42 C.F.R. § 418.56 (care-planning and coordination of services) (*repeat deficiency*);
	42 C.F.R. § 418.58 (quality assessment and performance improvement) (*repeat deficiency*);
	42 C.F.R. § 418.60 (infection control);
	42 C.F.R. § 418.76 (hospice aide and homemaker services);
	42 C.F.R. § 418.78 (volunteers);
	42 C.F.R. § 418.102 (medical director) (*repeat deficiency*);**Page 4**
42 C.F.R. § 418.104 (clinical records) (*repeat deficiency*);
	42 C.F.R. § 418.106 (drugs, biologicals, medical suppliers, and DME); and
	42 C.F.R. § 418.116 (compliance with federal, state, and local laws and regulations), posing immediate jeopardy to patient health and safety.CMS Ex. 1 at 2; CMS Ex. 2.  In a notice letter dated September 12, 2017, CMS advised Petitioner that its Medicare agreement would terminate effective October 12, 2017.  The letter referred Petitioner to the regulations governing the appeals process, advised Petitioner of its appeal rights, and cautioned that a request for hearing "*should identify the specific issues, findings of fact and conclusions of law with which you disagree*.  It should also specify the basis for contending that the findings and conclusions are incorrect."  CMS Ex. 1 at 4 (emphasis added).
**Petitioner's appeal**.  Petitioner's appeal falls short of the regulatory requirements.  Instead of identifying the findings and conclusions with which it disagrees, it charges that its (then) employees, working with other hospices, "created the complaint allegations" against it, withheld and delayed putting documentation into patient medical records, and, in fact, falsified patient and nurse signatures.  The appeal also complains about the conduct of the state surveyors.  Finally, the appeal claims that, following the July 25 survey, the hospice corrected the cited deficiencies.
The hearing request *does not* claim that, at the times of the surveys, the hospice complied with any of the cited conditions of participation.  On its face, the appeal does not raise any issue that I have the authority to review.  *See* 42 C.F.R. §§ 42 C.F.R. 498.3(b) (listing initial determinations that are reviewable); 498.70(b) (directing dismissal if the party requesting review does not have a right to a hearing).
CMS did not attack the quality of the hearing request, but filed a prehearing brief with 21 exhibits (CMS Exs. 1-21).
Petitioner missed the deadline for its prehearing submissions, but responded to my order to show cause by submitting its own brief, with exhibits.  Petitioner's submissions are confusing and do not conform to Civil Remedies Division procedures nor to my pre-hearing order.  CRD Procedures at 14 (¶ 14); Acknowledgment and Initial Pre-hearing Order at 6 (¶ 13) (October 5, 2017).  The electronic file menu identifies three documents (e-file documents # 11, 12, and 13) as P. Exs. 1-3.  Yet, the documents themselves are marked as CMS Exs. 1-3.  Adding further confusion, Petitioner's remaining proposed exhibits (e-file documents # 17-32) are not identified by exhibit number on the e-file menu, but the documents themselves are marked as P. Exs. 1-15 – there are two
**Page 5**
documents marked P. Ex. 4.  *See*e-file documents # 20 and 21.  I will refer to Petitioner's documents by e-file document number.
Finally, among its exhibits, Petitioner submitted patient admission records – e-file documents # 22-31.  Petitioner unnecessarily confused this record by disregarding the identifying numbers that CMS assigned to individual patients and assigning its own.  *Compare*CMS Ex. 3 *with*e-file document # 16.  I will refer to the patients by the numbers CMS assigned.
I reviewed the parties' submissions, and, pursuant to Rule 56(f) of the Federal Rules of Civil Procedure, I issued an order identifying material facts not in dispute and affording the parties an opportunity to respond.  Order (March 31, 2020).  CMS responded with its own motion for summary judgment.  Petitioner did not respond.
Issues
As a threshold matter, I explain why summary judgment is appropriate in this case.
On the merits, the sole issue is whether Petitioner complied with all conditions of participation for hospices.
To the extent that Petitioner attacks the quality of the survey, it is well-settled that the conduct of the survey is irrelevant.  *Angel Kidney Care of Inglewood, Inc.*, DAB No. 2795 at 10-11 (2017) and cases cited therein.
Discussion
**Summary judgment**.  Summary judgment is appropriate if a case presents no genuine issue of material fact, and the moving party is entitled to judgment as a matter of law.  *Bartley Healthcare Nursing & Rehab.*, DAB No. 2539 at 3 (2013), (citing*Celotex Corp. v. Catrett*, 477 U.S. 317, 322-25 (1986)); *Ill. Knights Templar Home*, DAB No. 2274 at 3-4 (2009), and cases cited therein.
The moving party may show the absence of a genuine factual dispute by presenting evidence so one-sided that it must prevail as a matter of law or by showing that the non-moving party has presented no evidence "sufficient to establish the existence of an element essential to [that party's] case, and on which [that party] will bear the burden of proof at trial."  *Livingston Care Ctr. v. Dep't of Health & Human Servs.,*388 F.3d 168, 173 (6th Cir. 2004) (quoting *Celotex Corp. v. Catrett*, 477 U.S. 317, 322).  To avoid summary judgment, the non-moving party must then act affirmatively by tendering evidence of specific facts showing that a dispute exists.  *Matsushita Elec. Indus. Co. v. Zenith Radio Corp.,*475 U.S. 574, 586 n.11 (1986); *Vandalia Park,*DAB No. 1939
**Page 6**
(2004); *Lebanon Nursing & Rehab. Ctr.,*DAB No. 1918 (2004); *Crestview Parke Care Ctr*., DAB No. 1836 at 5-6 (2002).
General denials do not satisfy a party's burden to identify *specific* evidence demonstrating a material fact is in dispute.  *Shah v. Azar*, 920 F.3d 987, 995 (5th Cir. 2019); *Forsyth v. Barr*, 19 F.3d 1527, 1533 (5th Cir. 1994); *Pearsall Nursing & Rehab. Ctr. - North*, DAB No. 2692 at 7 (2016) (affirming summary judgment where Petitioner "refers broadly to 'the evidence presented in [its] response'" but "identifies no specific evidence relevant to the material facts . . . ."); *Ill. Knights Templar*, DAB No. 2274 at 4 (finding that the non-moving party must furnish admissible evidence of a dispute concerning a material fact); *Livingston Care Ctr*., DAB No. 1871 at 5 (2003).  In doing so, the non-moving party must show more than "some metaphysical doubt as to the material facts[.]"  *W. Tex. LTC Partners, Inc.*, DAB No. 2652 at 6 (2015), *aff'd, W. Tex. LTC Partners, Inc. v. U.S. Dep't. of Health & Human Servs.*, 843 F.3d 1043 (5th Cir. 2016); *1866ICPayday.com L.L.C.*, DAB No. 2289 at 3 (2009) (quoting *Matsushita Elec. Indus. Co.*, 475 U.S. at 587).
In examining the evidence for purposes of determining the appropriateness of summary judgment, I must draw all *reasonable* inferences in the light most favorable to the non-moving party.  *See Brightview Care Ctr.*, DAB No. 2132 at 2, 9-10 (2007) (entry of summary judgment upheld where inferences and views of non-moving party are not reasonable); *Livingston Care Ctr.*, 388 F.3d at 172; *Guardian Health Care Ctr.,*DAB No. 1943 at 8 (2004).  However, drawing factual inferences in the light most favorable to the non-moving party does not require that I accept the non-moving party's legal conclusions.  *W. Tex. LTC Partners, Inc.*, DAB No. 2652 at 6-7, 14-15; *cf. Guardian Health Care Ctr.*, DAB No. 1943 at 11 ("A dispute over the conclusion to be drawn from applying relevant legal criteria to undisputed facts does not preclude summary judgment if the record is sufficiently developed, and there is only one reasonable conclusion that can be drawn from those facts."); *see Green Valley Health Care & Rehab. Ctr.*, DAB No. 2947 at 8 (2019) (quoting*Johnson v. Perez*, 823 F.3d 701, 705 (D.C. Cir. 2016) (noting that a genuine factual dispute does not exist "when a putatively disputed body of evidentiary material could not, even assuming a sympathetic factfinder, reasonably support a finding crucial to the nonmoving party's legal position.")).
Because the evidence in this case is so one-sided that CMS must prevail as a matter of law, and because Petitioner did not tender arguments or evidence of specific facts showing that a dispute exists, I grant CMS's motion for summary judgment.
***1. CMS is entitled to summary judgment because the undisputed evidence establishes that the hospice did not comply with each and every condition of participation.***3
**Page 7**
**Scope of review**.  So long as I find that the hospice failed to meet even one condition of participation, I must sustain the termination.  42 C.F.R. § 489.53(a)(3).  It would therefore serve no purpose to review all of the conditions cited, and I decline to do so.  *Perry Cty. Nursing Ctr. v. U.S. Dep't. of Health & Human Servs.*, 603 F. App'x. 265, 271 (5th Cir. 2015) (agreeing that the regulations require ALJs to review only those findings that are material to the outcome of a case); *Claiborne-Hughes Health Ctr. v. Sebelius*, 609 F. 3d 839, 847 (6th Cir. 2010); *Rockcastle Health and Rehab. Ctr.*, DAB No. 2891 (2018); *Carrington Place of Muscatine*, DAB No. 2321 at 20-21 (2010).
In a decision not relevant to this situation, the Ninth Circuit deviated somewhat from the other circuits that have considered this issue.  In *Plott Nursing Home v. Burwell*, 779 F.3d 975 (9th Cir. 2015), a divided court concluded that, because un-reviewed deficiencies may have supported the amount of a civil money penalty and could be used to enhance penalties in future proceedings, each cited deficiency should be reviewed.  *Plott*, however, involved civil money penalties imposed against a skilled nursing facility, whose program participation continued.  Under the regulations governing skilled nursing facilities, CMS considers the nature and number of deficiencies as well as a facility's history of noncompliance when it determines penalties.  The Ninth Circuit's concerns do not apply in this hospice case, where the sole remedy imposed is termination.
CMS has presented persuasive and unrebutted evidence of the hospice's noncompliance with multiple conditions.  However, in the interests of administrative economy, I decline to review all of them.  I consider the hospice's noncompliance with two conditions of participation:  sections 418.106 (drugs, biologicals, medical supplies, and durable medical equipment) and 418.58 (quality assessment and performance improvement program).
**The hospice's noncompliance with 42 C.F.R. § 418.106 (drugs, biologicals, medical supplies, and durable medical equipment)**.  Providing patients with appropriate medications and supplies is a major component of hospice care.  Section 418.106 provides that, while a patient is under hospice care, the hospice *must* provide medical supplies and appliances, durable medical equipment, and drugs and biologicals "related to the palliation and management of the terminal illness and related conditions, as identified in the hospice plan of care . . . ."  42 C.F.R. § 418.106.
CMS has come forward with evidence that the hospice did not provide necessary drugs to multiple patients.  Specifically:
**Patient 9** was an 88-year-old man, suffering from Alzheimer's disease.  CMS Ex. 12 at 1.  His appetite was poor and he suffered from chronic venous stasis (slow**Page 8**
blood flow) and a chronic low grade infection of the lower leg stasis.  CMS Ex. 12 at 3.  He was admitted to hospice care on April 15, 2017, with prescriptions for the Alzheimer's drug, **Nameda**; the prostate medications, **Finasteride** and **Zulotam** (Tamsulosin); **Pentoxifilina**, to improve his blood flow; and **Oxybutnin**, to treat an overactive bladder.  These medications were incorporated into his plan of care.  CMS Ex. 12 at 9, 11.  On June 9, his physician prescribed Albuterol because he was having difficulty breathing.  CMS Ex. 12 at 9; *see* CMS Ex. 12 at 28.
		CMS has presented evidence – the pharmacy invoice – indicating that, between May 19 and July 3, 2017, the hospice did not order or supply these medications.  CMS Ex. 12 at 29.  Marie Byrne, R.N., a health facilities evaluator nurse who participated in the July survey, reviewed Patient 9's clinical records and found no indication that the hospice had obtained these drugs.  The hospice's director of patient care services conceded that the hospice had not done so.  CMS Ex. 21 at 3 (Byrne Decl. ¶ 6).  Surveyor Byrne also interviewed the hospice's "payables clerk," who confirmed that the hospice's pharmacy invoices reflected the medications purchased; she provided the July 3 invoice for Patient 9, showing that the necessary drugs were neither ordered nor supplied.  CMS Ex. 21 at 3, 4 (Byrne Decl. ¶ 6, 7).
		Petitioner tenders no evidence suggesting that it disputes any of these facts.  Neither Petitioner's brief nor any of its exhibits even mentions Patient 9.**Patient 10** (Petitioner's Patient 7) was an 84-year-old woman suffering from end-stage coronary artery disease and heart failure, along with multiple other disorders.  She was admitted to hospice care on June 2, 2017.  CMS Ex. 13 at 1, 2.  At that time, to treat her multiple medical conditions, her physician prescribed (and her care plan called for):  the diuretic, **Furosemide**, which is used to treat water retention caused by congestive heart failure and other medical conditions; the blood thinner, **Warfarin**; **Allopurinol**, to treat her gout; the thyroid medication, **Methimazole**; **Simavastatin**, a cholesterol-lowering medication; **Losartan**, which lowers blood pressure; **Omeprazole**, to treat her gastroesophageal reflux disease; the beta blocker, **Atenolol**; **AREDS**, to treat cataracts; and **Vitamin C**.  CMS Ex. 13 at 1, 35-37.
		On June 8, Patient 10's physician prescribed the NSAID, **Voltaren**, to treat her pain.  She complained of severe back pain and, on June 16, her physician prescribed **Anecream**, a topical anesthetic.  CMS Ex. 13 at 16, 37.
		Of all these medications, the hospice invoices show that just three were ordered and supplied to Patient 10:  **Simvastatin** (Rx No. 326456), which the hospice ordered and delivered on June 7; **Voltaren** (Diclofenac) (Rx No. 326798), delivered June 9; and the **Anecream** (Lidocaine) (Rx No. 328387), delivered June**Page 9**
16.  CMS Ex. 13 at 39, 40, 41, 42; CMS Ex. 21 at 3, 4 (Byrne Decl. ¶ 7).  The hospice's director of patient care services confirmed that the hospice had not supplied the remaining medications.  CMS Ex. 21 at 3 (Byrne Decl. ¶ 6).
		Petitioner has produced no evidence suggesting that it disputes these facts.  It produces some of Patient 10's admission records, but nothing to suggest that the hospice, in fact, ordered and supplied the missing drugs.  *See* e-file document # 28.4**Patient 11** (Petitioner's Patient 9) was a 56-year-old woman, diagnosed with chronic obstructive pulmonary disease, congestive heart failure, and other diseases; she was admitted to hospice care on March 10, 2017.  CMS Ex. 14 at 1, 4.  She required multiple medications to help with her breathing:  **Albuterol**; **Ipratropium Bromide** and **Albuterol sulfate; Spiriva**; **Symbicort**; and **Montelukast**.  For hypertension, she was prescribed **Benazepril Hydrochloride** and **Amlodipine**.  To treat her Type II diabetes, her physician prescribed **Januvia and Metformin Hydrochloride**.  She was also supposed to take the diuretic **Fuosemide**; a calcium supplement, **Oyster Shell Calcium with Vitamin D**; **Tylenol**, as needed for pain; and **potassium chloride** to increase her level of potassium.  CMS Ex. 14 at 53.
		The hospice invoice shows that, between March 10 and July 24, 2017, the hospice obtained only four medications:  Montelukast (Rx No. 308817), which was not delivered until March 22; Amlodipine (Rx No. 317998), not delivered until May 2, almost two months after it was prescribed; Potassium chloride (Rx No. 317999), also delivered May 2; and Azithromycin (Rx No. 327666), an antibiotic (delivered June 13).  CMS Ex. 14 at 55-58; CMS Ex. 21 at 3, 4 (Byrne Decl. ¶ 7).  Again, the hospice's director of patient care services confirmed that the hospice had not provided the remaining medications.  CMS Ex. 21 at 3 (Byrne Decl. ¶ 6).
		Surveyor Byrne interviewed Patient 11, who complained that she had a difficult time getting the hospice to provide her medications.  In fact, she had been visiting an unaffiliated physician, who gave her free samples of the medications she needed.  CMS Ex. 21 at 4 (Byrne Decl. ¶ 7).**Page 10**
Petitioner tenders no evidence suggesting that it disputes these facts.  It produces some of Patient 11's admission records, but nothing to suggest that the hospice, in fact, ordered and supplied the missing drugs.  *See* e-file document # 30.**Patient 12** (Petitioner's Patient 2) was a 76-year-old man, suffering from prostate cancer, who was admitted to hospice care on March 23, 2017.  CMS Ex. 15 at 1, 3.  He experienced severe pain in his lower back, radiating to his legs.  The pain was managed with opioid analgesics.  CMS Ex. 15 at 52.  His physician prescribed (and his care plan called for) multiple medications:  **Oxycodone HCL** for pain and **Gabapentin** for neuropathic pain; **Promethazine with codeine** for a cough; **Tamsulosin**, which treats an enlarged prostate; the anti-inflammatory, **Prednisone**; and **Losartan** for hypertension.  CMS Ex. 15 at 57.
		The pharmacy invoices show that the hospice did not order these medications until April 19, 2017, and Patient 12 did not receive them until April 20, 2017, almost a full month late.  CMS Ex. 15 at 60, 61.  For the Losartan and the Gabapentin, Patient 12 initially received a 30-day supply, so he would have run out of these medications on about May 19.  CMS Ex. 15 at 60.  Yet, the hospice did not submit refill orders until July 18, 2017.  CMS Ex. 15 at 59.  Patient 12 would have gone for two months without these necessary medications.
		Surveyor Byrne interviewed Patient 12, who also complained that he had a difficult time getting the hospice to provide his medications.  CMS Ex. 21 at 4 (Byrne Decl. ¶ 7).
		Petitioner has produced no evidence suggesting that it disputes these facts.  It produces some of Patient 12's admission records, but nothing to suggest that the hospice, in fact, ordered and supplied the missing drugs.  *See* e-file document # 23.**Managing drugs and biologicals**.  An interdisciplinary group is made up of individuals who work together to plan and supervise patient care.  The group must include a doctor of medicine or osteopathy (employed by or under contract with the hospice); a registered nurse; a social worker; and a pastoral or other counselor.  42 C.F.R. § 418.56(a).  The hospice must ensure that the patient's interdisciplinary group confers with an individual who has been educated and trained in drug management (as defined in the hospice's policies and procedures and state law), who is employed by or under contract with the hospice, "to ensure that drugs and biologicals meet each patient's needs."  42 C.F.R. § 418.106(a)(1).
Here, to demonstrate that the appropriate individuals were properly overseeing the patients' medication regimens, the medication documents include signature lines, certifying that the appropriate individuals reviewed medication profiles ("Medication Profile Reviewed:  Contraindications, Side Effects, Interactions, Duplication, and Lab
**Page 11**
therapy Drugs") and monitored patient compliance ("Patient is Compliant with Meds/Treatment").  In several instances, however, these signature lines were left blank, showing that the appropriate individuals were not monitoring the drug regimens.  CMS Ex. 8 at 6 (Patient 5); CMS Ex. 9 at 5 (Patient 6/Petitioner's Patient 3); CMS Ex. 12 at 10 (Patient 9).
Petitioner gratuitously asserts that the interdisciplinary committee addressed "patients' medication reconciliation . . . to ensure patients' medication profiles are reviewed."  P. Br. at 5.  I'm not sure what this means, but, in any event, Petitioner submits no actual evidence suggesting any dispute over whether the hospice ensured appropriate drug oversight in the cases CMS has cited.  Its blanket denial does not create a dispute concerning a material fact and does not preclude my entering summary judgment.  *Ill. Knights Templar*, DAB No. 2274 at 4; *Livingston Care Ctr*., DAB No. 1871 at 5.
**Ordering drugs**.  Only a physician or nurse practitioner may order drugs and must do so in accordance with the plan of care and state law.  If the drug order is verbal or transmitted electronically, it must be given to a licensed nurse, nurse practitioner, pharmacist, or physician.  The individual who receives the order must record and sign it immediately and have the prescriber sign it in accordance with state and federal regulations.  42 C.F.R. § 418.106(b).
Here, the hospice was not ensuring that patient drug orders were signed.  CMS has produced evidence of multiple instances in which drug orders went unsigned.  CMS Ex. 5 at 6, 8-9 (Patient 2/Petitioner's Patient 1); CMS Ex. 6 at 28, 30-32 (Patient 3/Petitioner's Patient 10); CMS Ex. 9 at 44-46 (Patient 6); CMS Ex. 10 at 18-20 (Patient 7/Petitioner's Patient 8); CMS Ex. 11 at 25-29 (Patient 8/Petitioner's Patient 5); CMS Ex. 13 at 35-36 (Patient 10/ Petitioner's Patient 7); CMS Ex. 14 at 52 (Patient 11/Petitioner's Patient 9).
Petitioner gratuitously asserts that "[a]ll patients' medication orders are documented and signed by the ordering physician" and that "[d]ocumentations are maintained in the patients' chart."  P. Br. at 5.  Again, it submits no evidence showing a dispute over whether the multiple drug orders documented by CMS were, in fact, signed as required.
The undisputed evidence thus establishes that the hospice did not ensure that medication orders were signed by the appropriate individuals; that patient drug regimens were monitored by the appropriate individuals; and, most significant, that prescribed medications were provided to the patients who needed them.  These deficiencies are "of such character as to substantially limit the provider's . . . capacity to furnish adequate care" and adversely affected patient health and safety, which puts the hospice out of compliance with the condition.  42 C.F.R. § 488.24(b).
**The hospice's noncompliance with 42 C.F.R. § 418.58 (quality assessment and performance improvement)**.  The hospice must develop, implement, and maintain an
**Page 12**
effective, on-going, hospice-wide data-driven quality assessment and performance improvement program.  The hospice's governing body must ensure that the program reflects the complexity of its organization and services, involves all hospice services, focuses on indicators related to improved palliative outcomes, and acts to demonstrate improvement in hospice performance.  The hospice must document its quality assessment and performance improvement program and be able to demonstrate its operation to CMS.  42 C.F.R. § 418.58.  To meet this requirement, the regulation lists five standards:  program scope (must be capable of showing and must show measurable improvement); program data (must collect and use quality indicator data); program activities; performance improvement projects; and executive responsibilities.
Surveyor Marina Bridgman, R.N., is also a health facilities evaluator nurse who participated in the July survey.  The hospice's director of patient care services told her that she did not know who was responsible for the quality assessment and performance improvement program and that the facility did not have one.  CMS Ex. 20 at 4 (Bridgman Decl. ¶ 9).  Surveyor Byrne spoke to the hospice's owner, Adolfo Catbagan, who told her that he was the sole member of the hospice's governing body and had not implemented a program nor appointed anyone to operate it.  CMS Ex. 21 at 5 (Byrne Decl. ¶ 9).
Here, Petitioner concedes that, at the time of the survey, its quality assessment and performance improvement program was not implemented due to staffing shortages.  P. Br. at 5.
Obviously, because the hospice did not have in place a quality assessment and performance improvement program, it did not meet the condition of participation requiring one, 42 C.F.R. § 418.58.  I find this all the more disturbing, because the condition had been cited during the October 2016 survey.  The hospice had many months to put one in place, but failed to do so.
Because Petitioner did not meet these conditions of participation, CMS was authorized to terminate its provider agreement.  42 C.F.R. § 489.53(a)(1).
Conclusion
Based on the undisputed evidence, I find that CMS properly terminated Petitioner's Medicare participation because the hospice did not comply with one or more conditions of participation.  I therefore grant CMS's motion for summary judgment.


          /s/
        Carolyn Cozad Hughes

                      Administrative Law Judge
      1. Even if summary judgment were not appropriate, an in-person hearing would serve no purpose, and the case could be resolved on the written record.  Responding to my initial order, CMS listed two witnesses; Petitioner listed no witnesses.  See Acknowledgment and Pre-hearing Order at 2(¶ 1).  My March 31, 2020 order directed Petitioner to indicate whether it intended to cross-examine CMS's witnesses.  Petitioner did not respond and has therefore waived its right to cross-examine. back to note 1
                      2. Section 1865(a) of the Act also provides that, if an institution is accredited by a national accrediting organization recognized by the Secretary, it may be deemed to have met the applicable conditions.  42 C.F.R. § 488.10(b).  Here, based on the October 26, 2016, state survey findings, CMS removed Petitioner's deemed status and transferred survey jurisdiction to the state agency, an action that is wholly within CMS's discretion and not reviewable.  E-file document # 12; 42 C.F.R. § 498.3(d)(12). back to note 2
                      3. I make this one finding of fact/conclusion of law. back to note 3
                      4. Petitioner complains that the surveyors did not visit patient homes to observe the care provided.  Although this is irrelevant, it is also incorrect.  The record shows that surveyors visited Patient 10 and other hospice patients.  CMS Ex. 13 at 11; CMS Ex. 14 at 20. back to note 4 Back to top
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