Premier Home Health Services, DAB CR5107 (2018)

DECISION

Petitioner, Premier Home Health Services, is a home health agency (HHA) located in Livonia, Michigan, that participated in the Medicare program until June 28, 2016.  Based on surveys completed December 16, 2015 and January 27, 2016 and the HHA’s subsequent failure to submit an acceptable plan of correction, the Centers for Medicare and Medicaid Services (CMS) terminated its program participation and imposed a $3,000 per-day civil money penalty for 153 days of substantial noncompliance.  Petitioner appealed.

CMS has moved for summary judgment.  However, neither party has any witnesses, so an in-person hearing would serve no purpose.  See Acknowledgment and Initial Pre-hearing Order at 2 (¶ 1.c) (April 29, 2016).  This matter may therefore be decided based on the written record, without considering whether the standards for summary judgment are satisfied.

I find that Petitioner Premier Home Health was not in substantial compliance with Medicare program requirements.  CMS was therefore authorized to impose a civil money

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penalty and to terminate its program participation.  The amount of the penalty is reasonable.

Background

A home health agency is a public agency or private organization that “is primarily engaged in providing” skilled nursing and other therapeutic services to patients in their homes.  Social Security Act (Act) § 1861(o).  It may participate in the Medicare program as a provider of services if it meets that statutory definition and complies with certain requirements, called conditions of participation.  Act §§ 1861(o), 1891; 42 C.F.R. Part 484; 42 C.F.R. § 488.3.

A “condition of participation” represents a broad category of home health services.  Each condition is contained in a single regulation, which is divided into subparts called standards.  42 C.F.R. Part 484.  Compliance with a condition of participation is determined by the manner and degree to which the provider satisfies the standards within the condition.  42 C.F.R. § 488.26(b).  If 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,” the provider is not in substantial compliance with the conditions of participation.  42 C.F.R. § 488.24(b).  If the HHA fails to meet even one condition of participation or to comply with the provisions of section 1861, CMS may terminate its program participation or impose an “alternative sanction” (discussed below).  Act §§ 1866(b)(2)(B), 1861(o)(6); 42 C.F.R. § 489.53(a)(3); Nightingale Home Healthcare, Inc., DAB No. 2784 at 2 (2017).  Uncorrected deficiencies, even at the standard level, may justify sanctions, although the provider usually has 60 days in which to correct a standard-level deficiency.  42 C.F.R. § 488.28.

To monitor compliance, CMS contracts with state agencies that periodically survey the HHAs.  42 C.F.R. § 488.10.

Here, the Michigan Department of Licensing and Regulatory Affairs (state agency) completed Petitioner’s recertification survey on December 16, 2015.  Based on the survey findings, CMS determined that Petitioner did not comply with three conditions of participation:

• 42 C.F.R. § 484.14 (Tag G122 – organization, services, and administration);
• 42 C.F.R. § 484.18 (Tag G156 – acceptance of patients, plan of care, and medical supervision); and
• 42 C.F.R. § 484.30 (Tag G168 – skilled nursing services).

CMS Exs. 1, 4.

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After the state agency completed a follow-up survey on January 27, 2016, CMS determined that Petitioner still did not comply with the condition of participation governing skilled nursing services:  42 C.F.R. § 484.30 (Tag G168).  CMS Exs. 2, 3, 4.

In a notice letter dated March 24, 2016, CMS advised Petitioner of the survey findings and the penalties it was imposing:  a $3,000 per-day civil money penalty, effective January 27, 2016, and termination, effective July 27, 2016.  CMS Ex. 4 at 2.  However, according to the letter, the HHA could remain in the program if it achieved substantial compliance before the termination date.  CMS invited it to submit, within 10 days, a plan of correction setting forth its corrective actions with reasonable completion dates.  If the allegations of compliance were credible, CMS agreed to authorize another survey.  CMS Ex. 4 at 3-4.

Petitioner did not submit a plan of correction.  By letter dated June 10, 2016, CMS advised Petitioner that it was imposing the $3,000 per-day civil money penalty and that it was changing the termination date to June 28, 2016.  CMS Ex. 6.

Petitioner appealed.

CMS has filed a motion for summary judgment and prehearing brief (CMS Br), with 18 exhibits (CMS Exs. 1-18).  After some delay, Petitioner filed its brief (P. Br.).

In the absence of any objections, I admit into evidence CMS Exs. 1-18.

Issues

Notwithstanding the regulatory requirement that it “identify the specific issues, and the findings of fact and conclusions of law” with which it disagrees and that it “[s]pecify the basis for contending that the findings and conclusions are incorrect” (42 C.F.R. § 498.40(b)), Petitioner’s hearing request was not very specific.  Petitioner claims, generally, that it did not violate the conditions of participation and that it submitted a plan of correction within ten days, as instructed.

The Departmental Appeals Board long ago restricted an administrative law judge’s authority to dismiss even an undeniably inadequate hearing request, directing the judges to “exercise discretion” to accept “as adequate to preserve a right to hearing” hearing requests that fail to “identify the specific issues and finding of fact and conclusions of law with which the affected party disagrees” and/or fail to “specify the basis for contending the findings and conclusions are incorrect.”  The Carlton at the Lake, DAB No. 1829 at 9 (2002); Alden Center – Morrow, DAB No. 1825 (2002).  During the pre-hearing process, the judge may, however, require the petitioner to satisfy the requirements of section 498.40(b).

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Here, in my initial order, I gave Petitioner the opportunity to explain its appeal.  I warned that a party’s pre-hearing brief “must contain any argument that a party intends to make” and that I could exclude any argument that a party fails to address in its pre-hearing brief.  Acknowledgment and Initial Pre-hearing Order at 4 (¶ 7).  In response, Petitioner has limited the scope of its appeal.  In its brief, it does not challenge any survey findings; it does not claim to have submitted a plan of correction or to have corrected its deficiencies.  It does not argue that it was in substantial compliance with program requirements.  Instead, Petitioner complains about the civil money penalty and argues that it did not receive adequate notice that such a civil money penalty could be imposed.  Thus, based on Petitioner’s submission, the sole issues before me are:  1) whether CMS has the authority to impose a civil money penalty; and 2) whether the amount of the penalty is reasonable.

Discussion

1. Because Petitioner Premier Home Health did not comply with all Medicare conditions of participation, CMS may terminate its program participation and may impose an alternative sanction, which includes a per-day civil money penalty.My findings of fact/conclusions of law are set forth, in italics and bold, in the discussion captions of this decision.

Petitioner’s noncompliance.  CMS has limited its discussion to deficiencies cited during the January survey, violations of 42 C.F.R. § 484.30.  That regulation requires an HHA to furnish skilled nursing services under the supervision of a registered nurse (RN) and in accordance with each patient’s plan of care.  Among other responsibilities, the RN must initially evaluate the patient’s nursing needs and then regularly re-evaluate them.  (S)he initiates the plan of care and necessary revisions; (s)he furnishes those services that require “substantial and specialized nursing skill.” (S)he informs the physician and other personnel of changes in the patient’s conditions and needs.  42 C.F.R. § 484.30(a).

Here, Petitioner has not challenged CMS’s determination that the HHA’s registered nurses did not provide services in accordance with patients’ care plans.  Among other deficiencies:

• Patient 2 (P2) suffered from diabetes, congestive heart failure, and end stage renal disease.  Her care plan directed that she be weighed at every home visit.  CMS Ex. 10 at 6, 7.  But the RN who provided her care did not weigh her and, in fact, wrote “N/A” in the space for documenting the patient weight.  CMS Ex. 10 at 14, 16.

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• P2’s supplemental plan of care, dated December 30, 2015, added a new medication – Darbepoetin Alfa-Polysorbate – which was supposed to be administered weekly by injection.  CMS Ex. 10 at 6.  Yet, the care plan did not specify who would administer the medication (the patient or the RN), and nothing in the care plan nor the physician order authorized nursing staff to administer the injections.  The nurse did not contact the physician requesting an order to administer the injection.  Nevertheless, although not authorized to do so, the RN administered the injection twice (January 8 and January 15).  CMS Ex. 15 at 3-4 (Van Gansbeke Decl. ¶¶ 19, 20).
• Patient 4 (P4) suffered from diabetes with diabetic neuropathy, heart failure, and hypertension.  CMS Ex. 11 at 4, 44.  For each visit, her care plan directed the nurse to weigh her and to provide diabetic foot care, which included monitoring for skin lesions.  CMS Ex. 11 at 46.  On January 27, 2016, the surveyor accompanied the RN to P4’s home to observe the visit.  The nurse did not weigh the patient nor evaluate her feet.  CMS Ex. 13 at 1; CMS Ex. 15 at 3 (Van Gansbeke Decl. ¶ 17).
• P4’s care plan listed 29 medications that her physician had ordered.  Yet, the surveyor observed that five of those medications were missing from her home: pantoprazole sodium (which blocks the production of stomach acid); propranol HCL (for blood pressure); proctosol HC, (a corticosteroid); lactulose; and cinnamon.  At the same time, P4 had three medications that were not listed in her care plan:  metaxalone (a muscle relaxant); flexeril (a muscle relaxant); and hydrochlorothiazide (a diuretic).  When interviewed by the surveyor, the RN acknowledged that the HHA RNs had not been documenting deviations from the medications listed in care plans and had not consulted physicians about changes in medications.  CMS Ex. 11 at 44, 46; CMS Ex. 14; CMS Ex. 15 at 3 (Van Gansbeke Decl. ¶ 18).
• From December 18 to 22, 2015, P4 was hospitalized and treated for hypoglycemia.  CMS Ex. 11 at 1.  Following her discharge, the HHA implemented a supplemental care plan, effective December 23.  CMS Ex. 11 at 22, 44-47.  Among other instructions, the plan directed the HHA nurse to assess/perform/instruct the patient or caregiver in preparing and administering insulin and in using a glucometer (to measure blood sugar).  CMS Ex. 11 at 46.  But based on the patient’s assessment, her decision-making abilities were impaired, and she had difficulties performing activities of daily living.  CMS Ex. 11 at 31-33.  On January 27, when the surveyor accompanied the nurse to P4’s house, the surveyor noted that the patient had significant difficulty using the blood glucose measuring and lancet devices and could not test her blood sugar by herself.  No one notified her physician of her problems.  CMS Ex. 15 at 4-5 (Van Gansbeke Decl. ¶ 27).

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• P4’s supplemental plan of care also called for Novolog, 20 units, three times a day.  CMS Ex. 11 at 46.  Novolog is fast-acting insulin, used to lower blood sugar.  CMS Ex. 15 at 4 (Van Gansbeke Decl. ¶ 21).  But the RN did not consistently administer the ordered dosage.  On January 15 and January 21, 2016, she administered (or instructed the patient to self-administer) ten units.  CMS Ex. 11 at 54, 66.  On at least one of those days, January 15, the patient’s blood sugar was dangerously high, between 490 and 570.  CMS Ex. 11 at 65, 66.  During her January 27 home visit, the surveyor observed the RN allow P4 to dial 10 units of Novolog on her insulin pen.  CMS Ex. 15 at 4 (Van Gansbeke Decl. ¶ 24).

Thus, the HHA was not furnishing skilled nursing services in accordance with each patient’s care plan.  RNs did not evaluate and re-evaluate patient needs, initiate necessary plan revisions, furnish services as ordered, nor notify physicians and others of changes in patient conditions and needs.  These deficiencies substantially limited the HHA’s capacity to furnish adequate care and adversely affected patient health and safety.  Petitioner therefore did not comply with 42 C.F.R. § 484.30. 

2. The amount of the CMP is reasonable.

In addition to terminating a noncompliant HHA’s Medicare participation, CMS may impose an alternative sanction, including a per-day CMP.  42 C.F.R. §§ 488.820; 488.845.  Per-day CMPs fall into three categories:  upper range ($8,500 to $10,000), middle range ($1,500 to $8,500), and lower range ($500 to $4,000).  42 C.F.R. § 488.845(b)(3).

Penalties in the middle range are imposed for a repeat and/or a condition-level deficiency that does not constitute immediate jeopardy but is “directly related to poor quality patient care outcomes.”  42 C.F.R. § 488.845(b)(4).  Penalties in the lower range are imposed for a repeat and/or a condition-level deficiency that does not constitute immediate jeopardy and is “predominantly” related to “structure or process-oriented conditions” rather than patient care outcomes.  42 C.F.R. § 488.845(b)(5).

CMS justifiably determined that Petitioner’s skilled nursing deficiencies “directly related to poor patient care outcomes,” and, at $3,000, the penalty is at the low end of the middle range (overlapping into the lower range).  One of the factors considered in selecting a sanction is “the extent to which the HHA’s deficiencies are directly related to a failure to provide quality patient care.”  42 C.F.R. § 488.815(d).  In her written declaration, Surveyor Linda Van Gansbeke explained how Petitioner’s deficiencies adversely affected patient care:

• Because nurses did not weigh P2 (who suffered from congestive heart failure and end stage renal disease) or P4 (who suffered from diabetic neuropathy, heart failure, and hypertension), they could not have notified the patient’s physician if

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the patient’s weight fell outside a recommended range, and the physician would not have the information needed to adjust treatment.  CMS Ex. 15 at 2-3 (Van Gansbeke Decl. ¶¶ 13, 17);

• It is important to monitor the feet of someone suffering from diabetic neuropathy.  Otherwise, the patient could develop foot sores and wounds that would go untreated, putting her at risk of serious complications (infection, amputation).  CMS Ex. 15 at 3 (Van Gansbeke Decl. ¶ 17);
• P4 did not have the medication her physician ordered to control her blood pressure; yet she had two muscle relaxants, which were not ordered, and an extra diuretic, also not ordered.  The nurses’ apparent indifference to P4’s medication irregularities put the patient at risk of duplicate therapy, dosage errors, and medication omissions.  That she was administered half the ordered dosage of Novolog put her at risk for hyperglycemia.  Similarly, the ambiguities surrounding P2’s order for Darbepoetin Alfa-Polysorbate put her at risk of receiving double-dosages (if both she and the RN administered it) or none.  CMS Ex. 15 at 3-4 (Van Gansbeke Decl. ¶¶ 18, 20, 25);
• That the nurses didn’t advise P4’s physician of her difficulties using the blood glucose measuring and lancet devices meant that efforts to control her diabetes might not be successful, exposing her to hyperglycemia, which she experienced on January 15, 2016, and hypoglycemia, for which she was hospitalized in December 2015.

3. Petitioner had adequate notice that CMS could impose alternate sanctions

Claiming ignorance of the regulations authorizing alternative sanctions, Petitioner complains that CMS did not provide it adequate notice that a per-day CMP could be imposed.  It is well-settled that the absence of specific notice does not relieve a provider or supplier of its obligations to comply with program requirements or suffer the consequences.  Participants in the Medicare program are presumed to have constructive notice of the statutes and regulations that govern their participation.  Pepper Hill, DAB No. 2395 at 8 (2011), citing Waterfront Terrace, Inc., DAB No. 2320 at 7 (2010) (holding that a provider of Medicare services “should be expected to possess at least a rudimentary understanding of program rules and terminology”);  Heckler v Cmty. Health Servs. of Crawford County, 467 U.S. 51, 63, 64 (1984) (requiring a participant in the Medicare program to familiarize itself with legal requirements);  see also Thomas M. Horras and Christine Richards, DAB No. 2015 at 34 (2006), aff’d, Horras v. Leavitt, 495 F.3d 894 (8th Cir. 2007).

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Conclusion

Because Petitioner Premier Home Health did not comply with all Medicare conditions of participation, CMS properly terminated its program participation and imposed a per-day CMP.  The amount of the CMP, $3,000 per day, is reasonable.