Department of Health and Human Services DEPARTMENTAL APPEALS BOARD Civil Remedies Division |
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IN THE CASE OF | |
Regency Gardens Nursing Center, |
DATE: June 20, 2002 |
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Centers for Medicare & Medicaid Services
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Docket No.C-99-791
Decision No. CR921 |
DECISION | |
DECISION Petitioner's motion for summary
judgment is granted. The Centers for Medicare & Medicaid Services
(CMS) (1) cannot, as a matter of law, establish
that there was a basis for the remedies imposed or the reasonableness
of those remedies for the period alleged by CMS. CMS's motion for summary
judgment is denied. PROCEDURAL
HISTORY Petitioner, Regency Gardens Nursing Center, is a long-term care facility authorized by the Secretary of the Department of Health and Human Services (Secretary) to participate in Medicare, Medicaid, and other federal health care programs pursuant to Title XVIII of the Social Security Act (the Act) (42 U.S.C. �� 1396-1395ggg). On April 7, 1999, the New Jersey State Department of Health and Senior Services (NJSDHSS or State agency) conducted a complaint survey at Petitioner's facility. The NJSDHSS found the facility not in substantial compliance and declared that there was immediate jeopardy to resident health and safety. CMS accepted the NJSDHSS recommendations. CMS notified Petitioner by letter dated June 24, 1999 of the results of the April 7, 1999 survey and that an April 20, 1999 revisit survey found Petitioner in substantial compliance as of April 20, 1999. CMS further advised that it was imposing "a civil money penalty (CMP) in the amount of $7,500 per day from April 7, 1999 through April 19, 1999, a period 13 days [sic] of noncompliance which constituted immediate jeopardy." The total CMP is $97,500. On August 24, 1999, Petitioner
requested a hearing. (2) The request for
hearing was received by the Civil Remedies Division (CRD) of the Departmental
Appeals Board (DAB) on September 7, 1999. On September 30, 1999, the case
was assigned to Administrative Law Judge (ALJ) Hillson for hearing and
decision. On May 3, 2000, the case was reassigned to Chief ALJ Silva.
On October 11, 2001, the case was reassigned to me for hearing and decision.
In an order dated November 15, 2001, I gave the parties dates for filing
final exchanges, and dispositive motions, and set a schedule leading to
a hearing set to begin on January 14, 2002. Petitioner and CMS filed cross-motions for summary judgment on December 3, 2001. A briefing schedule was set by my Order of December 7, 2001. On December 21, 2001, the parties jointly filed a stipulation of undisputed facts (Joint Stip.) and a joint statement of issues for hearing. The briefing schedule for the cross-motions for summary judgment was subsequently amended on December 28, 2001, and, at the parties' request, the hearing scheduled to begin on January 14, 2002 was postponed pending resolution of the cross-motions. On December 14, 2001, CMS filed its brief in support of its motion for summary judgment (CMS Brief) with the supporting declaration of Ellen Bennet dated December 14, 2001. Petitioner filed its response to CMS's motion for summary judgment on January 11, 2002 (P. Response). CMS filed a reply on January 25, 2002 (CMS Reply). (3) On December 14, 2001, Petitioner filed its brief in support of its motion for summary judgment with a copy of the statement of deficiencies for the survey of Petitioner completed on April 7, 1999 (P. Brief). CMS filed its response on January 11, 2002 (CMS Response). Petitioner filed its reply brief, which was received at CRD on January 28, 2002 (P. Reply). (4) FINDINGS OF FACT These findings of fact are based upon the parties' joint stipulation of undisputed facts filed on December 21, 2001, except where indicated. 1. Petitioner, a long-term care facility, is authorized to participate in Medicare, Medicaid, and other federal health care programs pursuant to a participation agreement with the Secretary under the Act. 2. On March 27, 1999, at approximately 10:45 PM, a facility charge nurse found that Resident 1 had pulled out a recently placed percutaneous endoscopic gastronomy (PEG) tube (a feeding tube surgically passed through the abdominal wall and abdominal cavity to the stomach to permit feeding). 3. The charge nurse, having found the PEG tube removed, inserted a different tube and continued feeding Resident 1 despite some complaint of pain by the resident. 4. Early the next morning, March 28, 1999, leakage was noted around the feeding tube and Resident 1's condition was noted to have deteriorated so she was transported to a hospital. 5. Resident 1 died on March 28,
1999, at the hospital due to complications related to the feeding tube. 6. The charge nurse who inserted the feeding tube on March 27 violated Petitioner's policies and procedures by failing to obtain a physician's approval before inserting the tube. 7. Petitioner's policies regarding PEG tubes and other feeding tubes are consistent with standards of practice. Declaration of Ellen Bennet, at 7, � 20. 8. The charge nurse who inserted the tube was counseled on March 29, 1999 and she continued to work at the facility until April 4, 1999, but resigned at Petitioner's request on April 6, 1999. 9. Petitioner provided in-service training for all nursing staff on March 29, 1999, related to "G tube placement and residual." Joint Stip., para. 17; Declaration of Ellen Bennet, at 14, � 47. 10. Petitioner reported the incident to the New Jersey Board of Nursing (Joint Stip., para. 19) and the NJSDHSS on April 6, 1999 (Declaration of Ellen Bennet, at 2, � 7). 11. On April 7, 1999, the NJSDHSS conducted a complaint survey of Petitioner as a result of Petitioner's April 6, 1999 report. 12. The NJSDHSS cited Petitioner for four regulatory violations in its official report of the April 7, 1999 complaint survey. Statement of Deficiencies (SOD), HCFA Form 2567, dated April 7, 1999, attached to P. Brief. 13. The SOD cited the following violations related to the treatment and death of Resident 1:
14. The NJSDHSS conducted a revisit
of Petitioner on April 20, 1999 and found the facility in substantial
compliance as of that date. 15. CMS notified Petitioner in
a letter dated June 24, 1999 that it was imposing a CMP in the amount
of $7,500 per day for the 13-day period beginning April 7, 1999 and ending
April 19, 1999, a total of $97,500. CONCLUSIONS OF LAW 1. Summary judgment is appropriate because the material facts are not in dispute and this case can be decided as a matter of law. 2. Petitioner has the right to appeal the initial determination of CMS to impose a CMP in this case. 3. Petitioner timely filed a request for hearing. 4. CMS is required to give written notice to the facility of its intent to impose a CMP, and the notice must include, inter alia, the nature of the noncompliance, the statutory basis for the penalty, and the amount of the penalty per day of noncompliance or the amount of the penalty per instance of noncompliance. 5. CMS notified Petitioner by its letter of June 24, 1999, that it was imposing a CMP of $7,500 per day for the period April 7, 1999 through April 19, 1999, which notice was adequate on its face.6. The SOD for the survey ended on April 7, 1999, does not identify any deficiency existing at Petitioner's facility on April 7, 1999 or for the period April 7, 1999 through April 19, 1999. 7. The CMP CMS imposed for the period April 7, 1999 through April 19, 1999 has no basis in the undisputed facts or the facts alleged in the SOD for the survey ended on April 7, 1999. 8. Considering the undisputed facts, the facts alleged in the SOD, and the facts alleged by CMS in its briefs and supporting declaration, in a light most favorable to CMS, there is no basis for the imposition of a CMP for the period April 7, 1999 through April 19, 1999 and, therefore, I do not sustain the CMP. 9. Petitioner has no right to a hearing on deficiencies cited in a survey where no remedy was imposed, specifically for the period March 27, 1999 through April 6, 1999. |
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ANALYSIS | |
ANALYSIS A. Issues Presented The general issues presented in nursing facility compliance enforcement cases are whether there is a basis for the imposition of the remedy and whether the remedy is reasonable. Of course, if there is no basis for imposing a remedy, it is not necessary to review the reasonableness of the remedy as the remedy is inherently unreasonable and a violation of the law. This case is disposed of on the issue of whether there is a basis for the imposition of a remedy. Because I find there is no basis for the imposition of a remedy, the remedy imposed is unreasonable and may not be sustained. B. Governing LawThe Act sets forth requirements for long-term care facilities, both skilled nursing facilities and nursing facilities (nursing facility), participating in the Medicare and Medicaid programs, and authorizes the Secretary to promulgate regulations implementing the statutory provisions. Act, sections 1819 and 1919 (42 U.S.C. �� 1395i-3; 1396r). The Secretary's regulations governing nursing facility participation in the Medicare program are found at 42 C.F.R. Part 483. A nursing facility must maintain substantial compliance with program requirements to participate in the Medicare program. To be in substantial compliance, a nursing facility's deficiencies may pose no greater risk to resident health or safety than the "potential for causing minimal harm." 42 C.F.R. � 488.302. If a facility is not in substantial compliance with program requirements, CMS has the authority to impose one or more of the enforcement remedies listed in section 1819(h) of the Act (42 U.S.C. � 1395i-3(h)) and 42 C.F.R. � 488.406. Congress has granted the Secretary authority to "impose a civil money penalty in an amount not to exceed $10,000 for each day of noncompliance." Act, section 1819(h)(2)(B)(ii). Congress also directed the Secretary to develop regulations implementing the authority to impose authorized remedies. Act, section 1819(h)(2). The Secretary's regulations implementing the authority to impose remedies for the enforcement of Medicare requirements are at 42 C.F.R. Part 488, subpart F. The Secretary has delegated enforcement authority to CMS. The Secretary has authorized CMS to impose a CMP (42 C.F.R. � 488.406(a)(3)), including a CMP ranging from "$3,050 - $10,000 per day" of noncompliance in a case where one or more deficiencies constitute immediate jeopardy to resident health and safety. 42 C.F.R. �� 488.438(a)(1)(i); 488.408(e)(iv). CMS is also authorized to impose a CMP of "$1,000 - $10,000 per instance" of noncompliance that constitutes immediate jeopardy. 42 C.F.R. �� 488.438(a)(2); 488.408(e)(2)(ii). CMS may impose a CMP for either the number of days a facility is not in substantial compliance or for each instance of noncompliance. Further, CMS may impose a CMP for the number of days of past noncompliance since the last standard survey. 42 C.F.R. � 488.430. If CMS elects to impose a remedy,
"the remedies are applied on the basis of noncompliance found during surveys
conducted by CMS or by the survey agency." 42 C.F.R. � 488.402. CMS is
required to give written notice to the facility of its intent to impose
a CMP. The notice must include, inter alia, "[t]he amount of
penalty per day of noncompliance or the amount of the penalty per instance
of noncompliance." 42 C.F.R. � 488.434(a)(2)(iii). The per day CMP may
begin to accrue as early as the date that the facility was first out of
compliance as found by CMS or the State survey agency. 42 C.F.R. � 488.440(a)(1).
A per instance CMP is imposed in a specific amount "for that particular
deficiency." 42 C.F.R. � 488.440(a)(2). Per day CMPs are generally imposed
for the number of days of noncompliance until the date the facility achieves
substantial compliance or the date that the facility's participation agreement
is terminated. 42 C.F.R. � 488.440(b). Whether or not a facility has achieved
substantial compliance is often determined by a revisit of the facility
by CMS or the State agency. If, on revisit the provider supplies documentation
acceptable to CMS or the State agency that shows that substantial compliance
was achieved prior to the revisit, then "penalties imposed on a per day
basis only accrue until that date of correction for which there is written
credible evidence." 42 C.F.R. � 488.440(h)(1). If no revisit is necessary
to determine that the facility has achieved substantial compliance, "penalties
imposed on a per day basis only accrue until the date of correction for
which CMS or the State receives and accepts written credible evidence."
42 C.F.R. � 488.440(h)(2). A nursing facility is precluded
from obtaining ALJ review of deficiencies that are not the basis for a
remedy imposed by CMS. Arcadia Acres, Inc., DAB CR424 (1996);
aff'd, DAB No. 1607 (1997). The DAB has also held that a petitioner
loses its right to pursue a hearing even when CMS rescinds previously
imposed remedies; and that no right to hearing survives to challenge findings
of noncompliance. Lakewood Plaza Nursing Center, DAB No. 1767
(2001). Summary judgment is appropriate
and no hearing is required where either: there are no disputed issues
of material fact and the only questions that must be decided involve the
application of law to the undisputed facts; or, the moving party must
prevail as a matter of law even if all disputed facts are resolved in
favor of the party against whom the motion is made. A party opposing summary
judgment must allege facts which, if true, would refute the facts relied
upon by the moving party. See e.g., Fed. R. Civ. P. 56(c); Garden
City Medical Clinic, DAB No. 1763 (2001), Everett Rehabilitation
and Medical Center, DAB No. 1628, at 3 (1977) (in-person hearing
required where non-movant shows there are material facts in dispute that
require testimony); see also, New Millennium CMHC, DAB CR672
(2000); New Life Plus Center, DAB CR700 (2000). On summary judgment,
if CMS cannot establish its prima facie case, then the petitioner prevails
as a matter of law. C. Discussion The facts in this case are not
disputed except as to their legal impact. (6)
The material facts necessary for disposition are not disputed at all and
are included in a joint stipulation of undisputed facts submitted by the
parties on December 21, 2001. It is clear that late on March 27, 1999,
a nurse found that Resident 1 had pulled her feeding tube from the incision
in her abdomen. The nurse inserted a different tube. Resident 1 died on
March 28, 1999, at the hospital due to complications with the feeding
tube. Food from the tube was released into the abdominal cavity and an
infection developed. The nurse who inserted the tube violated Petitioner's
policy which required that a physician be consulted under such circumstances.
The nurse was counseled about her error on March 29, 1999. The entire
nursing staff was trained related to tube feeding on March 29, 1999.
(7) The offending nurse worked until April 4 but then resigned
on April 6, 1999 at Petitioner's request. The incident was not reported
to NJSDHSS until April 6, 1999. Although the report was late, the adequacy
of the report and investigation are not questioned by the State agency
in the SOD and CMS makes no allegations regarding the adequacy of the
report and investigation once it was done. The SOD cites violations with dates consistent with the undisputed events. F Tag 225 alleges that Petitioner did not notify NJSDHSS until April 6, 1999, of the tube replacement on March 27, 1999. According to the SOD, Petitioner did not "immediately fully investigate the incident of 3/27/99 and Resident #1's subsequent death nor take any corrective action to prevent further incident. The nurse who reinserted the peg tube without an order continued to work on the units until 4/4/99." SOD, at 2 -3. The undisputed facts show that there was no defect in Petitioner's policies in this regard. The offending nurse was counseled on March 29, 1999, which the survey team may have deemed inadequate, and she subsequently resigned on April 6, 1999. The entire staff received training in the area on March 29, 1999. The incident was reported on April 6, 1999 to the NJSDHSS, albeit not within five days of the incident as CMS asserts is required by the regulation. CMS and its declarant cite no other corrective action Petitioner could have or should have taken in regard to this incident. CMS presents no evidence that other corrective action was taken or required before Petitioner was declared to be in substantial compliance effective April 20, 1999. I conclude, therefore, that all the corrective action the State agency deemed necessary or appropriate was accomplished by Petitioner prior to April 7, 1999. There is no evidence of a continuing violation of F Tag 225 after April 7, 1999, and there is no allegation of such a violation after that date. F Tag 281 alleges that the offending
nurse failed to notify the physician of the dislodged PEG tube and violated
Petitioner's policy regarding PEG tubes. There is also the allegation
that the nurse failed to document her assessments of Resident 1. This
violation obviously ended with Resident 1's transfer to the hospital and
her death on March 28, 1999. F Tag 309 alleges that Petitioner's
nursing staff failed to address the needs of Resident 1 on March 27 and
28, 1999. This tag is clearly limited by its terms to an allegation of
a deficiency which existed on March 27 and 28, 1999. F Tag 322 alleges that the nurse
who inserted the feeding tube "on 3/27/99 failed to provide care and service
necessary to prevent complications of a gastrostomy (GT) fed resident."
SOD, at 6. This citation is also specifically limited by its terms to
the actions of the nurse on March 27, 1999. My review of the cross-motions
for summary judgment, the parties' supporting briefs and their supporting
materials, and the parties' response and reply briefs, reveals no specific
allegations of actions or inactions by Petitioner after April 6, 1999,
which are alleged to be a violation of any condition of participation
set forth in the regulations. Further, I find no concession or admission
by Petitioner of any action or inaction after April 6, 1999 that CMS alleges
violates a condition of participation. If CMS had alleged deficiencies
existing on and after April 7, 1999, I would have construed those allegations
in a light most favorable to CMS for purposes of its summary judgement
motion, but CMS is mute as to any deficiencies existing after April 6,
1999, and there is nothing to construe in CMS's favor.
(8) Petitioner argues in its motion
for summary judgment that CMS cannot make a prima facie showing of any
deficiency existing for the period April 7, 1999 through April 19, 1999,
that provides a basis for the CMP. CMS never addresses Petitioner's contention
in its responsive pleading. CMS never states in its pleadings which if
any deficiencies continued after April 6, 1999. CMS's declarant never
states which, if any, deficiencies existed during the period April 7,
1999 through April 19, 1999. The record indicates that this issue was
brought to CMS's attention shortly after the filing of the request for
hearing, but CMS has taken no action to reopen and revise or amend its
imposition of the CMP. My review of the regulations indicates
that the Secretary has delegated authority to CMS to impose a CMP for
each day that a violation existed or for each instance constituting a
violation. It appears that the regulations contemplate that there be some
nexus between the CMP and the violation, e.g. the CMP should
be imposed for the day or days the violation occurred rather than some
other dates picked by the State agency or CMS. (9)
The regulations are clear that if CMS elects to impose a remedy, "the
remedies are applied on the basis of noncompliance found during surveys
. . . ." 42 C.F.R. � 488.402. Before it may impose a CMP, CMS is required
to give written notice and the notice must specifically identify "[t]he
amount of penalty per day of noncompliance or the amount of the penalty
per instance of noncompliance." 42 C.F.R. � 488.434(a)(2)(iii). A per
day CMP may begin to accrue as early as the date that the facility was
first out of compliance as found by CMS or the State survey agency. 42
C.F.R. � 488.440(a)(1). A per instance CMP is imposed in a specific amount
"for that particular deficiency." 42 C.F.R. � 488.440(a)(2). Per day CMPs
are generally imposed for the number of days of noncompliance until the
date the facility achieves substantial compliance or the date that the
facility's participation agreement is terminated. 42 C.F.R. � 488.440(b).
However, "penalties imposed on a per day basis only accrue until that
date of correction for which there is written credible evidence." 42 C.F.R.
� 488.440(h)(1). The regulations do not delegate authority to CMS to impose
a CMP for a day when no violation existed. CMS has the initial burden to make
a prima facie showing that a deficiency existed that provides a "legally
sufficient basis" for imposition of a CMP, including articulation of the
legal standard to which Petitioner is to be held and the facts upon which
CMS relies. Only when CMS makes a prima facie showing, must Petitioner
come forward and show by a preponderance of the evidence that it was in
substantial compliance. Hillman,
DAB No. 1611 (1997). In this case CMS has cited the pertinent statutes
and the regulations which establish the conditions of participation. However,
CMS has not established the factual predicate by showing that any of the
cited conditions of participation were violated on any day during the
period for which CMS imposed the CMP. (10)
Accordingly, I must find that CMS has failed to make a prima facie showing
that there is a basis for the CMP imposed since no violations or deficiencies
have been shown for the period April 7 through April 19, 1999. The CMP
is therefore unreasonable and may not be sustained. No CMP was imposed for the incidents that occurred on March 27 and 28, 1999 or for the period March 27, 1999 through April 6, 1999. Petitioner has no right to review of the allegations of deficiencies occurring on those dates in the absence of the imposition of remedies. See, e.g., Lakewood Plaza Nursing Center, DAB No. 1767 (2001). D. Conclusion For the foregoing reasons, summary judgment is granted for Petitioner. CMS's motion for summary judgment is denied. |
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JUDGE | |
Keith W. Sickendick Administrative Law Judge |
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FOOTNOTES | |
1. Effective July 5, 2001, the Health Care Financing Administration (HCFA) was renamed the Centers for Medicare & Medicaid Services. 66 Fed. Reg. 35,437 (2001) 2. On April 13, 2000, Petitioner moved to amend its request for hearing to provide a more detailed basis for its contentions. No objection has been filed by CMS and good cause for the amendment has been shown. Accordingly the motion to amend is granted. 3. CMS submitted another document styled as a "Declaration of Ellen Bennet" dated January 25, 2002, with its reply brief filed on that date. The only difference I perceive between the Declaration of Ellen Bennet dated December 14, 2001, and the declaration dated January 25, 2002, is the latter contains cites to CMS exhibits and is unsigned. Because the January 25, 2002 declaration is unsigned, it will not be accepted and I will not rely upon it for any purpose. I also note that neither the declaration dated December 14, 2001 nor the document dated January 25, 2002, contains one of the alternate statements required by 28 U.S.C. � 1746; thus neither meets the legal requirement for use in lieu of an affidavit. However, I will consider the signed declaration for purposes of this motion only as I perceive no prejudice to Petitioner and Petitioner raised no objection. 4. Petitioner's Reply is dated December 14, 2001, which appears to be in error because that is also the date of Petitioner's opening brief in support of its motion. 5. According to CMS, SS Level J indicates an isolated event posing immediate jeopardy to resident health or safety. CMS Brief, at 16. 6. Petitioner specifically assumes all factual allegations in the SOD are true for purposes of its motion for summary judgment. P. Brief, at 3. 7. I am aware that CMS implies that the nurse's counseling and the in-service training were inadequate. However, I also note that the facility is not cited in the SOD for either being deficient. I further note that there are no allegations that any of Petitioner's policies are deficient and, in fact, CMS's declarant, Ellen Bennet, indicates that Petitioner's policies to which she refers meet community standards.
8. One might speculate (as CMS's counsel is reduced to do) that the survey team considered that counseling of the charge nurse who inserted the tube was inadequate or that the in service training was deficient, but such would be pure speculation and the law demands more. CMS cannot survive a motion for summary judgment with mere allegations but must present some evidence which can be construed in its favor. CMS has had more than adequate opportunity to interview the survey team to determine what deficiencies were considered. Yet, the SOD has never been amended or revised and CMS's declarant does not address what deficiencies were considered to exist after April 6, 1999, that might provide some basis for the remedy CMS imposed. 9. It is only sensible that CMS be required to demonstrate some nexus between the dates for which it imposes remedies and the alleged deficiencies; otherwise, the agency would constantly face challenges that its actions were arbitrary and capricious. In cases such as this, the absence of a nexus can give rise to allegations that the agency was attempting to maximize the CMP or avoid the cap of a per instance CMP. 10. I am at a complete loss to understand what CMS intended to do in this case. There is no explanation why CMS did not impose remedies for dates supported by the evidence. Even counsel for CMS seems to be at a loss when she states at page 37 of CMS's Reply: "What other conclusion would be logical given the fact that the facility was not placed back into substantial compliance until it developed an adequate plan of correction and completed a more comprehensive in-service training?" Counsel's comment highlights the fact that CMS has failed its regulatory obligation to specifically notify Petitioner of the violations for which the CMP is imposed, and has left all, including its own counsel, to speculate about the true basis for the CMP. |
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