Golden State Manor and Rehabilitation Center, DAB No. 1597 (1996)

Department of Health and Human Services

DEPARTMENTAL APPEALS BOARD

Appellate Division

In the Case of:

Golden State Manor and Rehabilitation Center,
Petitioner,

- v. -

Health Care Financing Administration.

DATE: September 16, 1996
Civil Remedies CR412
App. Div. Docket No.
A-96-116
Decision No. 1597

FINAL DECISION ON REVIEW OF
ADMINISTRATIVE LAW JUDGE DECISION

Golden State Manor and Rehabilitation Center (Petitioner)
appealed a February 28, 1996 decision by Administrative
Law Judge (ALJ) Edward Steinman. See Golden State Manor
Nursing and Rehabilitation Center, DAB CR412 (1996) (ALJ
Decision). Petitioner had requested a hearing before the
ALJ on the determination by the Health Care Financing
Administration (HCFA) that January 31, 1994 should be the
effective date of Petitioner's participation as a
provider in the Medicare program. The ALJ affirmed
HCFA's determination. Petitioner contended that the ALJ
Decision contained clear error with regard to three
conclusions of law, described by Petitioner as follows:
(1) that HCFA may deny certification pursuant to 42
C.F.R. § 489.13, even if a single deficiency is found,
until a plan of correction addressing all cited
deficiencies is submitted; (2) that the procedures to be
followed by the state surveyors in 42 C.F.R. § 488.110
were superseded by the procedures set forth in State
Operations Manual (SOM) 250; and (3) that the ALJ is
powerless to rectify or provide any remedy for HCFA's
failure to provide the Statement of Deficiencies to
Petitioner within the time required. 1/

Our standard for review of an ALJ decision on a disputed
issue of law is whether the ALJ decision is erroneous.
As discussed below, we conclude that the ALJ Decision on
the matters in dispute is not erroneous. Accordingly, we
sustain the decision.

The record on appeal consists of the record before the
ALJ and the parties' briefs on appeal.

Factual and Legal Background

The relevant facts were fully developed by the ALJ and
were not disputed by the parties on appeal. We briefly
summarize the background facts here for the reader's
convenience. Petitioner was a skilled nursing facility
(SNF) with approximately 300 beds. On November 25, 1993,
it filed a request for certification to participate as a
provider in the Medicare program. DHS-San Diego, the
California State survey agency, began a certification
survey of the facility on December 14, 1993, which was
completed on December 23, 1993. The State surveyors
found Petitioner in compliance with all Level A
requirements for SNFs but found numerous Level B
deficiencies. The State survey agency issued a Statement
of Deficiencies and Plan of Correction, HCFA Form 2567,
describing the deficiencies to the facility. 2/
Petitioner submitted a Plan of Correction on January 31,
1994. On February 23, 1994, HCFA informed the Petitioner
by letter that it was being certified as a Medicare
provider, effective January 31, 1994, the date the
acceptable plan of correction was submitted.

Petitioner twice sought reconsideration of HCFA's
determination regarding the effective date of its
certification, but HCFA found no basis to alter its
initial determination. Petitioner argued that it should
have been certified either as of December 23, 1993, the
last day of the survey, since Petitioner met all Level A
requirements, or as of January 11 or 12, 1994, the date
on which Petitioner claims it would have submitted its
plan of correction had the State survey agency provided
the HCFA Form 2567 to Petitioner within ten calendar days
following the survey. Petitioner then requested a
hearing to contest HCFA's determination of the effective
date, which was held before the ALJ and resulted in the
decision presently being appealed.

Title XVIII of the Social Security Act establishes a
federally subsidized health insurance program for the
elderly and disabled, commonly known as Medicare.
Medicare provides reimbursement for certain services
rendered by providers, such as SNFs, who participate in
the Medicare program under "provider agreements" with the
Department of Health and Human Services. In order to
enter into such an agreement to participate in the
Medicare program, SNFs must meet certain requirements
imposed by applicable statute and regulations. 42 U.S.C.
§ 1395i-3 and 42 C.F.R. Part 483, subparts A through C,
and Part 489. 3/

The survey process is the means by which State surveyors
on HCFA's behalf assess providers' compliance with these
requirements. The State survey agency performs the
surveys of SNFs and makes recommendations to HCFA on
whether such facilities meet the federal requirements for
participation in the Medicare program. The results of
such surveys are used by HCFA as the basis for its
decisions regarding a facility's initial or continued
participation in the program. HCFA, therefore, makes the
determination as to whether a facility is eligible to
participate or to remain in the program.

Analysis

I. The ALJ correctly held that the phrase "any other
requirements" in 42 C.F.R. § 489.13(a) includes Level B
requirements and therefore certification could not be
effective until the date an acceptable plan of correction
was submitted.

The regulation at 42 C.F.R. § 489.13, as applicable here,
stated:

Effective date of agreement.

(a) All Federal requirements are met on the day of
the survey. The agreement will be effective on the
date the onsite survey is completed (or on the day
following the expiration date of the current
agreement) if, on the date of the survey, the
provider meets all the Federal health and safety
conditions of participation or Level A requirements
(for SNFs), and any other requirements imposed by
HCFA.

(b) All Federal requirements are not met on the date
of the survey. If the provider fails to meet any of
the requirements specified in paragraph (a) of this
section, the agreement will be effective on the
earlier of the following dates:
(1) The date on which the provider meets all
requirements.
(2) The date on which the provider submits a
correction plan acceptable to HCFA or an
approvable waiver request, or both.

The ALJ Decision rejected Petitioner's interpretation of
section 489.13(a) "as requiring that Petitioner can be
denied certification only when it fails to meet a Level A
requirement or, alternatively, when `the Level B
deficiencies are of a sufficient number or type so as to
render the facility in non-compliance with a Level A
requirement.'" ALJ Decision at 68. The ALJ reached the
following conclusions:

108. The parties do not disagree that 42 C.F.R. §
489.13 requires Petitioner to be in compliance with
Level A requirements on the date of the survey.

109. The final regulations published by HCFA on
February 2, 1989 (effective August 1, 1989, except
where specified otherwise) made clear that all
regulatory requirements were to be enforced to the
fullest extent possible, not just the more serious
Level A type of deficiencies. 54 Fed. Reg. 5317-
5318 (1989).

110. In the Federal Register preamble to the
publication of the September 1991 regulations, HCFA
reiterated that long term care facilities, including
SNFs, were subject to enforcement for all violations
of requirements and that it was never intended that
the Level A and Level B designations imply a
hierarchy of importance. 56 Fed. Reg. 48,827.

111. There no longer exists any distinction between
Level A and Level B requirements because every
violation is considered potentially sufficient to
deny certification.

112. The phrase "all other requirements" contained
at 42 C.F.R. § 489.13 means that SNFs not only must
meet all requirements established by regulation, but
that any violation of the requirements can provide a
basis to deny certification. Transitional Hospitals
Corporation -- Las Vegas, DAB CR350 (1995); SRA,
Inc. D/B/A St. Mary's Parish Dialysis Center, DAB
CR341 (1992).

The ALJ Decision thoroughly discussed the basis for these
conclusions. ALJ Decision 67-74.

Petitioner argued that the ALJ erred in concluding that
the phrase "any other requirements" contained in the
regulations means that any violation of the regulatory
requirements, including Level B requirements, may provide
a basis to deny certification. In disputing this
conclusion, Petitioner argued:

o It is inconceivable that the regulation was intended
to require 100 percent compliance with every single
requirement as a condition of certification.

o If Level B deficiencies are "merely elements" or
requirements within Level A as HCFA counsel stated
below, then certification can be denied only when
the Level B deficiencies are of a sufficient number
or type so as to render the facility in non-
compliance with a Level A requirement. Thus,
compliance with Level A conditions, and not the
failure to meet certain standards or elements within
those standards, determines certification.

o If a number of Level B deficiencies must exist
before a Level A requirement is deemed not met, then
the phrase "any other requirements" cannot refer to
Level B deficiencies.

o If the phrase "any other requirements" was intended
to refer to Level B deficiencies, the regulation
would have specifically stated that in order to be
certified a provider was required to meet all Level
A and Level B requirements or simply all
requirements. If HCFA "intended that § 489.13
should be interpreted to require compliance with
each and every regulation, it would never have
singled out Level A requirements and then added the
vague phrase `any other requirements' if it intended
to include Level B requirements."

o The other ALJ decisions cited in the ALJ Decision
are not relevant as precedent and, even if they
were, are not persuasive because they do not provide
anything more than a conclusion about the "other
requirements" language, unsupported by analysis or
reasoning.

o The preambles relied on by the ALJ are not authority
and are only guides to interpretation.

Petitioner Appeal Brief (P. app. br.) at 3-6; P. app.
reply at 2.

The ALJ correctly concluded that, under 42 C.F.R.
§ 489.13, certification could not be effective until the
date an acceptable plan of correction was submitted.
The Level B requirements Petitioner was found to have
violated fall within the plain meaning of the phrase "any
other requirements" in that regulation, and, indeed,
Petitioner did not directly dispute the ALJ's conclusion
to that effect. Moreover, as we discuss in this section,
the survey and certification regulations as a whole
clearly provided that certification here could not be
effective until an acceptable plan of correction was
submitted.

Petitioner's argument that it does not make common sense
to read the regulation as requiring compliance with all
requirements because full compliance is impossible and
that an isolated failure to meet a minor requirement for
only one patient should not result in denial of
certification misstates the issue. 4/ While Petitioner
referred to HCFA's interpretation as permitting denial of
certification based on failure to meet any requirement
and the ALJ adopted this language, the real issue raised
is whether HCFA properly set the effective date of
certification. We do not read HCFA's interpretation as
authorizing denial of certification based on failure to
meet any requirement. Indeed, the regulations
specifically permit certification of an SNF found to be
deficient in meeting Level B requirements. 42 C.F.R.
§§ 488.28; 488.50. 5/ However, 42 C.F.R. § 488.28
states that if an SNF is found to be deficient with
respect to Level B requirements, it may participate in
Medicare "only if" it has submitted an acceptable plan of
correction for achieving compliance within a reasonable
period of time acceptable to the Secretary. Under these
provisions, the submission of a plan of correction is
clearly a condition precedent to the SNF's ability to
begin or to continue its program participation.
Consistent with these provisions, certification here was
granted, effective on the date Petitioner submitted an
acceptable plan of correction.

Petitioner's arguments take the wording in section
489.13(a) out of its regulatory and historical context.
In addition to the provisions in sections 488.28 and
488.50 (which permit certification of an SNF deficient
with respect to Level B requirements only if the facility
submits an acceptable plan of correction), other
provisions state that an SNF must meet all requirements.
For example, section 489.10 states that in order to be
accepted for participation in Medicare, an SNF must meet
the "requirements (for SNFs) set forth elsewhere in this
chapter" and certain civil rights requirements. This
section does not distinguish Level A and Level B
requirements.

Two situations are addressed in the provision at section
489.13 on the effective date of a provider agreement:
subsection (a) addresses the situation where "All Federal
requirements are met on the date of the survey"; and
subsection (b) addresses the situation where "All Federal
requirements are not met on the date of the survey." In
the second situation, the agreement will be effective on
the earlier of the date the provider meets "all
requirements" or the date on which the provider submits
an acceptable plan of correction or waiver request, or
both. The lead-in phrase in section 489.13(a) clearly
indicates an intent that the effective date of
certification will be the date the survey is completed
only if all federal requirements are met on that date.

That the phrase "all federal requirements" was meant to
encompass not only the statutory conditions for
participation for SNFs (referred to as Level A
requirements during the period relevant here), but also
the standards established by HCFA by regulation (later
referred to as Level B requirements) is clear not only
from the context, but also from the history of the
provision. The regulation, prior to the 1989 amendment,
specifically referred to the standards for SNFs. The
preamble language to the original rule, relied on by the
ALJ and HCFA, stated:

The final regulations have been revised to specify
that "all Federal requirements" includes the health
and safety requirements, financial interest
disclosure, and the civil rights provisions of 45
C.F.R. Parts 80, 84 and 90.

45 Fed. Reg. 22,933, 22,934 (1980).

On February 2, 1989, HCFA amended its regulations at 42
C.F.R. § 489.13 to substitute for the term "standards"
the phrase "conditions of participation or level A
requirements (for SNFs)". 54 Fed. Reg. 5316, at 5373.
The preamble explained:

The condition of participation (COP) format
traditionally used by Medicare and Medicaid consists
of condition level statements. It has been based on
the principle that each condition level statement
would be a statutory requirement while standard
level statements would be lesser requirements. A
facility could be found to have deficiencies in the
standard level and be making efforts to correct them
while it continued to participate in the Medicare
program but was subject to termination if it failed
to meet a condition level (i.e. statutory)
requirement. Regardless of the significance of the
requirement, that is, whether the requirement was a
COP or a standard within a condition, the facility
was responsible for fully complying with all
requirements.

Notwithstanding this long standing agency policy, we
wish to be certain that the public realize that all
requirements for certification must be met by
nursing facilities if they are to avoid some measure
of adverse action. We believe that, to the extent
that Federal requirements were set forth in what
appeared to be a qualitative [hierarchy], that there
might be some misunderstanding that "lesser"
requirements would not be subject to Federal
enforcement.

Additionally, the OBRA '87 requirements have recast
substantive requirements so as not to use the
traditional "conditions" and "standards"
terminology.

Accordingly, in this final rule, we have attempted
where appropriate to retain the organization of the
various proposed requirements, but have revised the
terminology. Thus, those requirements that
previously were identified as conditions of
participation (appearing as individual sections
within a subpart) are now designated as level A
requirements. Those requirements that previously
were identified as standards (appearing as
individual paragraphs within a section) are now
designated as level B requirements. These
designations are intended to communicate that all of
the nursing facility requirements are binding and
are not part of a qualitative hierarchy, while at
the same time recognizing that violations of these
requirements (depending on their type or severity)
may be remedied through the different enforcement
mechanisms available to the Department.

In light of the revised nomenclature of these
regulations, it is our expectation that it will be
the Department's enforcement regulations that will
be the vehicle to describe the manner in which we
will choose among the various enforcement devices
available under the statute to remedy the different
kinds of violations of Federal certification
requirements that can occur in nursing facilities. .
. . We have made conforming technical changes to
Parts 442, 488, 489, and 498 . . . to reflect the
revised terminology . . . .

Contrary to what Petitioner argued, this preamble
language, as well as other preamble language discussed in
the ALJ Decision, is relevant here because it is
consistent with the plain meaning of section 489.13. 6/

In light of the regulatory context, preamble statements,
and the reference to amendments to Part 489 as merely
technical, section 489.13(a) as in effect during the
relevant time period cannot reasonably be read as
requiring compliance only with Level A requirements in
order for certification to be effective on the date the
survey is completed.

Finally, while ALJ decisions may not have precedential
value, the decisions cited by the ALJ here do illustrate
that the questioned language has been consistently read
to encompass health and safety regulatory requirements
imposed by HCFA. Moreover, Petitioner did not deny that
decisions by our predecessor, the Appeals Council, are
consistent with the conclusion reached here. See River
North Treatment Center v. Health Care Financing
Administration, OHA Appeals Council Docket No. 000-61-
7052 (1993) (cited in DAB CR341, supra) and Charter
Hospital of Indianapolis, OHA Docket No. 000-51-7186
(September 16, 1991) (cited in HCFA's br. at 11).

Therefore, we conclude that the ALJ did not err in
reaching conclusions regarding the meaning of 42 C.F.R.
§ 489.13. We affirm and adopt each of the ALJ's
conclusions in FFCLs 108 through 112.

II. The ALJ did not err in finding that the regulations
on which Petitioner relied were not applicable and that,
in any event, the remedy Petitioner proposed would not be
appropriate.

The ALJ reached the following conclusions, discussed in
the ALJ Decision at pages 40-67 and 76-83:

77. The nursing home reform provisions of the
Omnibus Budget Reconciliation Act of 1987 (OBRA '87)
set minimum statutory standards that skilled nursing
facilities (SNFs) must meet to participate in
Medicare and nursing facilities (NFs) must meet to
participate in Medicaid, provided nursing home
residents with certain rights, and established a
structure for State and federal surveys and
certifications of nursing homes. 42 U.S.C. §§
1395i-3 and 1396r. These requirements were in
effect as of October 1, 1990. Sections 4202(a) and
4214(a) of OBRA '87.

78. OBRA '87 specifies the content, procedures, and
frequency of surveys as well as survey team
composition. 42 U.S.C. § 1395i-3(g)(2) and 42
U.S.C. § 1396r(g)(2).

79. Under OBRA '87, each state is responsible for
certifying that SNFs are in compliance with the
requirements of the Act through the use of surveys
conducted pursuant to certain specified protocols.

80. Congress specified in OBRA '87 that by no later
than January 1, 1990, the Secretary develop, test,
and validate survey protocols for the standard and
extended surveys required by law.

81. Congress stated further that the failure of the
Secretary to carry out these mandates by January 1,
1990 shall not relieve any state or the Secretary of
the responsibility to conduct surveys required by
OBRA '87. 42 U.S.C. §§ 1395i-3 and 1396r.

82. OBRA '87 fundamentally changed the survey and
certification process by establishing a patient-
oriented system to assess the quality of care
actually furnished. See 42 U.S.C. § 1395i-3(f) and
(g); 42 U.S.C. § 1396r(f) and (g).

83. The legislative history regarding OBRA '87
confirms the intent of Congress to implement major
reforms in nursing home care and to create a
resident-centered, outcome-oriented survey process.
See H.R. Rep. No. 391, 100th Cong., 1st Sess., pts.
1 & 2 (1987), reprinted in 1987 U.S. Code Cong. &
Admin. News 2313-1; and H.R. Conf. Rep. No. 495,
100th Cong., 1st Sess. (1987), reprinted in 1987
U.S. Code Cong. & Admin. News 2313-1245.

84. In July, October, and November 1987, HCFA
published proposed rules which dealt with the survey
and certification process, conditions of
participation, and enforcement regulations. 52 Fed.
Reg. 24,752 (1987); 52 Fed. Reg. 38,582 (1987); 52
Fed. Reg. 44,300 (1987).

85. On June 17, 1988, HCFA, acting in accordance
with a February 18, 1988 court order in Estate of
Smith v. Bowen, 656 F. Supp. 1093 (D. Colo. 1987),
promulgated final regulations amending the Medicare
and Medicaid survey regulations then in effect.
These final regulations were based on the proposed
regulations published in July 1987. 53 Fed. Reg.
22,850 (1988).

86. Among the new regulations promulgated were 42
C.F.R. Part 488, Subpart C. In the preamble, HCFA
acknowledged Congress' enactment of OBRA '87 and
stated, among other things, that "[a] new survey
process is required by OBRA '87, effective in 1990."
53 Fed. Reg. at 22,853.

87. The survey procedures and guidelines in 42
C.F.R. Part 488, Subpart C were revised by HCFA to
comply with congressional directives in OBRA '87 to
develop new protocols. These protocols were
published in April 1992 as SOM 250.

88. In August 1992, HCFA published proposed
regulations which would further implement provisions
of OBRA '87, as further amended by 1988, 1989, and
1990 legislation. 57 Fed. Reg. 39,278 (1992).

89. The Federal Register preamble to the final
publication of 42 C.F.R. Part 488, Subpart C,
notified interested parties that (1) this Subpart
pertained to conditions of participation for long-
term care facilities that were in effect at the time
of publication and (2) HCFA was, at the time of
publication, in the process of making significant
and wide-ranging changes to the existing conditions
of participation based on various amendments to the
law, principally OBRA '87. 53 Fed. Reg. 22,850-
22,853 (1988).

90. At least as of August 1992, HCFA put SNFs on
notice that the interpretive guidelines and survey
procedures used in federal and state surveys were
revised in April 1992. 57 Fed. Reg. at 39,283
(1992).

91. At the time of its December 1993 survey,
Petitioner was bound by the survey protocols and by
the applicable regulations pertaining to the
conditions of participation found at 42 C.F.R. §
483, Subpart B.

92. The survey procedures set out in 42 C.F.R. Part
488, Subpart C do not reflect the new and expanded
requirements created by OBRA '87, including those in
the areas of residents' rights, quality of patient
life, quality of care, and dietary, dental,
pharmacy, nursing, and physician services. See 42
U.S.C. §§ 1395i-3(b)-(d); 1396r-3(b)-(d); 42 C.F.R.
§ 483.10-483.75; 54 Fed. Reg. 5354-5355 (1989).

93. Subpart C is inconsistent with and does not
implement the OBRA '87 revisions to the health and
safety requirements that a long-term care facility
must meet to participate in the Medicare and
Medicaid programs.

94. Subpart C pertains to survey methodology and
conditions of participation which became obsolete
with the implementation of the new conditions of
participation and survey processes mandated by OBRA
'87, which did not go into effect until October
1990.

95. HCFA's failure to withdraw Subpart C and to
formally publish the revised protocols in formal
regulations does not elevate outdated, obviously
obsolete, survey procedures and guidelines to a
legal status which is inconsistent with
congressional intent.

96. The contents of 42 C.F.R. Part 488, Subpart C
were never modified and HCFA never formally repealed
or withdrew Subpart C.

97. Where an administrative regulation conflicts
with a statute, the statute controls. U.S. v. Doe,
702 F.2d 819, 823 (9th Cir. 1983).

98. A federal court ordered HCFA not to repeal
Subpart C. Estate of Smith v. Sullivan, (D. Colo.
1990). (HCFA Attachment 2 at 1, 3).

99. A federal court permitted HCFA, on an interim
basis, to use the new survey protocols. Id.

100. Any alleged non-conformity with the
requirements of the Administrative Procedure Act
(APA) on HCFA's part is moot in light of the
district court's interim order.

101. HCFA has followed its regulations, procedures,
and precedents. Because Subpart C became null and
void and, thus, without any operative effect, HCFA's
departure from this subsection was justified.

102. HCFA did not violate any administrative norm
by its non-adherence to the survey procedures and
guidelines contained in Subpart C.

103. HCFA was not legally required to formally
withdraw or repeal Subpart C in order for this
subsection to be rendered inoperative by the passage
of OBRA '87, the provisions of which became
effective on October 1, 1990.

104. The provisions of SOM 250 are not
"substantive," but "interpretive". Alcarez v.
Block, 746 F.2d 593, 613 (9th Cir. 1984); American
Hospital Association v. Bowen, 834 F.2d 1037, 1045
(D.C. Cir. 1987); Guadamuz v. Bowen, 859 F.2d 762,
771 (9th Cir. 1988).

105. HCFA published SOM 250 to provide guidance to
state surveyors, who are responsible for determining
compliance by long-term care facilities with federal
requirements imposed by statute and regulations.

106. SOM 250 was not intended to impose any
requirements that are not otherwise set forth in the
statute or regulations (HCFA Ex. 13 at 2-137);
therefore, HCFA was not required to formally publish
these instructive guidelines to state surveyors in
the form of a regulation.

107. SOM 250 must be read in connection with the
statutory and regulatory provisions regarding SNFs
to determine the operative protocols, definitions,
and standards that were applicable at the time of
the survey in issue.

122. SOM 250 contains detailed instructions and
guidance to enable surveyors to carry out "case-mix
stratified sampling." HCFA Ex. 13 at P-9 - P-12.

123. The regulation set out at 42 C.F.R. §
488.110(d) ("Task 2 -- Resident Sample -- Selection
Methodology") refers to a random sample.

124. Subpart C of 42 C.F.R. Part 488, which
describes random sampling, does not conform to the
case-mix stratified sampling requirement of OBRA '87
(and codified at 42 U.S.C. §§ 1395i-3(g)(2)(A)(ii)
and 1396r(g)(2)(A)(ii)).

125. The correct and appropriate sampling
methodology to be used, since the enactment of OBRA
'87, is the case-mix sampling approach, which is
elaborated upon in the SOM 250.

126. The survey team members referred to the SOM
250 in selecting resident samples. Tr. 2136.

127. The surveyors' use of a case-mix stratified
sample was in accordance with the law. Tr. 1648-
1650, 1670, 2450, 2456.

128. The provisions of SOM 250 are the applicable
criteria to follow in determining whether a
deficiency has been established.

129. SOM 250 directs the surveyor to analyze the
frequency and severity of noncompliance with
regulatory requirements and to determine whether the
facility is in compliance with an individual
requirement by assessing the frequency or severity
of the alleged violation.

130. Specifically, SOM 250 directs the surveyor to
take into account negative resident outcomes.

131. A deficiency can occur when there is evidence
of noncompliance with a regulatory requirement in 42
C.F.R. § 483, and the noncompliance has a serious
negative impact on the resident or residents, such
as harm or a strong potential for harm.

Petitioner argued here, as it did before the ALJ, that
HCFA was obligated to use the survey process detailed in
42 C.F.R. § 488.110 (one section of Subpart C) and that
HCFA's failure to use that process rendered any
conclusions based on the survey unenforceable.
Petitioner contended that in such circumstances, 42
C.F.R. § 489.13 requires certification on December 23,
1993, the date of the completion of the survey.
Petitioner further contended that despite HCFA's view
that 42 C.F.R. § 488.110 was impliedly nullified or
repealed by OBRA '87 and that the appropriate survey
process was the one contained in SOM 250, the APA
requires that repeal of a rule or regulation must be
accomplished through notice and comment rulemaking.
Moreover, Petitioner argued that the provisions of SOM
250 were substantive or legislative rather than
interpretative rules and should also have been issued
pursuant to notice and comment rulemaking (as they
ultimately were). Thus, Petitioner contended that the
conclusion of the ALJ that 42 C.F.R. § 488.110 was
superseded by SOM 250 was legal error.

As we discuss in detail in this section, we conclude that
the ALJ's conclusion that the regulations relied on by
Petitioner were not applicable was correct. First and
foremost, the State survey agency was not required to use
the process in Subpart C, because Subpart C by its own
terms applied to statutory requirements in effect prior
to the effective date of OBRA '87. After the effective
date of OBRA '87, the Subpart C process was inapplicable.
Until new regulations were promulgated implementing OBRA
'87, the SOM provided the only appropriate guidelines for
State survey agencies. Nevertheless, even if the Subpart
C process did in fact apply (rather than the SOM),
Petitioner failed to establish that the State survey
agency's use of any particular guideline in the SOM led
to a finding that Petitioner was deficient in meeting a
substantive requirement when Petitioner otherwise would
have been found in compliance. Finally, even if
Petitioner had been able to establish that the State
survey agency violated applicable survey guidelines
(which it did not), such failings clearly should not
invalidate adequately documented deficiencies. The
purpose of the ALJ hearing process is to afford
Petitioner an opportunity to contest the findings of non-
compliance regardless of the protocol that may have been
used. Petitioner failed to contest with persuasive
evidence before the ALJ that it was out of compliance
with numerous Level B requirements cited in the survey
findings, and indeed in its Board appeal did not take
exception to any of the factual findings concerning its
non-compliance made by the ALJ. 7/

Before discussing Petitioner's arguments concerning the
applicable survey procedures, we note that, while
Petitioner did not directly dispute the ALJ's factual
findings based on evidence presented by the surveyors,
Petitioner did challenge the conclusion that its failures
constituted deficiencies, alleging that the surveyors had
not properly analyzed the results of the survey in
accordance with section 488.110. Petitioner argued that
there was "no proof that any of the alleged deficiencies
adversely impacted any patient" and "no indication in any
of the alleged deficiencies of how frequently they
occurred." P. app. br. at 8. Petitioner alleged
(without citation) that the surveyors were repeatedly
asked whether what they found represented isolated
occurrences or a pattern prevalent in the facility and
had answered that they did not know. Id.

This argument regarding evaluation of the survey findings
has no merit. Petitioner did not allege that the survey
performed in December 1993 violated the procedures set
forth in SOM 250. Both section 488.110 and SOM 250
instruct surveyors to consider frequency and/or severity
in evaluating whether a deficiency should be found. 42
C.F.R. § 488.110(i)(2); HCFA Ex. 13 (SOM 250) at P-29 -
P-30. The ALJ set out and applied the SOM provisions on
how to evaluate whether a deficiency exists, including
whether there is a serious negative impact on the
resident or residents, such as harm or a strong potential
for harm. ALJ Decision at 79-83. Contrary to what
Petitioner implied, nothing in either section 488.110 or
the SOM requires that there be actual harm to patients or
that any particular frequency of occurrence be
established. To the contrary, both imply that a finding
regarding one patient, if of sufficient severity (which
includes potential for harm), can constitute a
deficiency.

Thus, the allegation that the surveyors did not properly
evaluate whether deficiencies existed is unsupported,
and, in any event, the ALJ correctly determined that the
survey here supported findings of deficiencies in meeting
Level B requirements. In light of this determination,
Petitioner's arguments must be viewed as asking us to
ignore findings of deficiencies that are adequately
supported, solely on the basis that the State survey
agency failed to follow procedures specified in an
applicable regulation. We agree with HCFA and the ALJ
that it is the substance of the compliance findings that
must take precedence under the statute, not whether a
particular process or protocol was followed in compiling
evidence regarding compliance. Petitioner pointed to
nothing in either Subpart C or any other regulation that
would bind HCFA to certify Petitioner as of a particular
date or would provide any other remedy to a provider if a
State survey agency failed to follow procedural
guidelines.

Moreover, HCFA has reasonably interpreted the statute to
provide a remedy for failure by a State survey agency to
follow procedures different from what Petitioner
advocated here. In 42 C.F.R. § 488.318(b), proposed in
1992 and made final in 1994, HCFA specified that State
survey agency failure to follow the procedures "does not
relieve a SNF or NF of its obligations to meet all
requirements for program participation or invalidate
adequately documented deficiencies." 8/

In response to comments, HCFA explained in 1994:

Sections 1819(g)(2)(C) and 1919(g)(2)(C) of the Act
reveal the intent of the Act very clearly. These
sections state that standard surveys must be based
upon a protocol, but add that the failure of the
Secretary to develop, test or validate such a
protocol will not relieve any State or the Secretary
of the responsibility to conduct surveys. Because
the Congress intended for survey results to be
binding even when surveys were conducted in the
absence of a formal protocol, it is clear that
Congress views the substance of survey findings to
be of greater importance than the process used to
identify them. . . . We recognize that protocols and
guidelines are necessary to promote consistent
survey practice. However, whether or not a surveyor
follows protocols must be subordinate in importance
to whether or not a facility meets Federal
participation requirements. Violations must be
recognized and remedied appropriately if resident
interests are to be protected and integrity is to
remain in the enforcement system.

59 Fed. Reg. 56,116, 56,133-34 (Nov. 10, 1994).

Not only is this a reasonable interpretation of the
statute based on the cited statutory language, but, in
our view, is the only reasonable reading of the statute
and regulations as a whole. The primary goal of the
statute and the reason for the survey process is to
protect program patients and to ensure that they are
receiving quality care. Section 1819(g)(3) of the Act,
added by OBRA '87, provides that, if a HCFA validation
survey shows that State survey agency performance is not
adequate, the Secretary should provide for an appropriate
remedy by regulation, such as training of survey teams in
the State. The remedies suggested by the legislative
history include "the training of the survey team or the
designation of another State to perform survey and
certification functions" but do not include any remedy
for providers. H.R. Rep. 391, 100th Cong. 1st Sess. Pt.
2 at 940. The regulations discussed above clearly
communicated that HCFA would certify a facility only if
HCFA had adequate assurance of compliance, which, in the
case of an SNF with deficiencies in meeting Level B
requirements, meant submission of an acceptable plan of
correction. Thus, we conclude that Petitioner could not
reasonably have thought that it could be certified based
merely on a State survey agency failure to follow an
applicable procedure.

In any event, the procedural guidelines at 42 C.F.R.
§ 488.110 are by their own terms intended to apply only
to surveys performed using the requirements in effect
prior to the effective date of OBRA '87. That section
refers to surveys of SNFs and ICFs (intermediate care
facilities), but OBRA '87 changed the terminology for
Medicaid from ICFs to NFs (nursing facilities) and
ICFs/MR (intermediate care facilities for the mentally
retarded). Section 488.110 also states that it is
intended to set out a new process, but indicates that the
new process does not change the requirements of
participation that had been applied in the "traditional"
survey process, that is, the pre-OBRA '87 requirements of
participation. As the ALJ noted and explained in detail,
OBRA '87 changed the substantive requirements, rendering
Subpart C as a whole (including § 488.110) incapable of
application, since Subpart C refers to the requirements
in effect prior to OBRA '87. See ALJ Decision at 40-63.

The ALJ also thoroughly examined the regulatory history
of Subpart C, explaining how that history gave Petitioner
notice that the Subpart C process was intended to
implement the Smith court decision, not the OBRA '87
requirements, which contemplated that the Secretary would
develop a new survey protocol, including new procedures
consistent with the OBRA '87 provisions on surveys. The
ALJ correctly concluded that the particular sample
selection methodology set out in Subpart C is
inconsistent with the OBRA '87 mandate for a "case mix
stratified sample". 9/

Petitioner pointed to nothing in the statute, or in the
language or history of Subpart C, which could have
reasonably led Petitioner to believe that the Subpart C
process would apply after the effective date of OBRA '87.
The mere fact that Subpart C remained in the Code of
Federal Regulations is insufficient to show that it was
applicable, particularly in light of the regulatory
history, cited by the ALJ, and the Smith court order.
Petitioner could not have reasonably thought that Subpart
C should be considered applicable.

Even if Subpart C were applicable, however, Petitioner
failed to substantiate that the guidelines followed by
the State survey agency adversely affected Petitioner.
Petitioner alleged the following four inconsistencies:
A. sample size and selection; B. review of certain
needs/treatments; C. observation of drug pass; and D.
analysis of findings to determine whether a deficiency
existed. P. app. br. 6-8. We have already rejected
Petitioner's arguments regarding the alleged failure by
the surveyors to analyze the findings consistent with the
procedural guidelines at section 488.110. With respect
to sample selection, Petitioner alleged that the
surveyors selected only residents who seemed to have
problems indicating potential violations of regulations
and only did a drug pass of one resident, rather than 20.
The procedural guidelines specifically state at section
488.110(d) that "neither the random selection approach
nor the review of residents within the specified care
categories precludes investigation of other resident care
situations that you believe might pose a serious threat
to a resident's health or safety. Add to the sample, as
appropriate." Thus, nothing in these guidelines
precluded the surveyors from examining the patients they
did. If the surveyors were required to also follow the
sample size and selection methods in section 488.110 and
to include all of the specified care categories, as well
as observing more patients in the drug pass, this would
not preclude the use of the evidence of non-compliance
substantiating the deficiencies found here. Petitioner,
moreover, had the opportunity to contest this evidence in
the hearing before the ALJ and was nonetheless found to
be deficient in meeting numerous Level B requirements.

Finally, we reject Petitioner's arguments that its
certification should have a different effective date
because the SOM had not been published, nor Subpart C
repealed, using APA notice and comment procedures.
Petitioner relied on the ALJ decision in Devon Gables
Healthcare Center v. HCFA for the proposition that no
exemption to the APA applies. HCFA pointed out that
Devon had been reversed by the Appeals Council, and
relied on the exemption at 5 U.S.C. § 553(b)(A) for
"interpretative rules, general statements of policy, or
rules of agency organization, procedure, or practice; . .
. ." 10/ Petitioner argued that the SOM provisions
were "substantive" or "legislative" rules, that
rulemaking was defined in the APA to include repeal of a
rule, and that the fact that the Secretary ultimately
used notice and comment rulemaking for the survey
protocols mandated by OBRA '87 is an acknowledgment that
the APA applies. Petitioner cited to court decisions and
the Attorney General's Manual on the APA for the
proposition that an interpretative rule simply states
what the administering agency thinks a statute means, but
that a legislative rule creates new law, rights or
duties. P. app. br. at 9-15.

Petitioner's arguments contain two major flaws. First,
they assume that Subpart C is an applicable rule that
would control unless repealed. As discussed above, this
assumption is not warranted. Second, Petitioner pointed
to nothing in SOM 250 that creates any new law, right or
duty to which Petitioner was found to be subject. The
SOM 250 provisions include interpretative guidelines
which clearly do no more than interpret substantive
statutory and regulatory requirements governing
providers' participation. Petitioner pointed to nothing
specific in these guidelines that created new law,
rights, or obligations. 11/

Other than establishing interpretative guidelines for the
substantive OBRA '87 requirements, the main function of
SOM 250 is to set out procedural guidelines for State
survey agencies. Some of these procedural guidelines
interpret statutory provisions on the survey process (for
example, by describing what is meant by a "case-mix
stratified sample"). Moreover, these guidelines could be
considered as exempted from the APA as related to agency
practice or procedure since the State survey agency
arguably acts as HCFA's agent for determining compliance
with Medicare requirements. Finally, the APA provides
for notice of proposed rulemaking, unless persons subject
thereto have actual notice. 5 U.S.C. § 553(b); see also
5 U.S.C. § 552(a)(1). With respect to what procedures
the State survey agency was bound to follow for Medicaid
purposes, that agency presumably had actual notice and
opportunity to comment on the SOM provisions and
therefore could still be bound by the SOM under the APA.


In sum, there is no merit to Petitioner's procedural
arguments, and, in any event, Petitioner established
neither that it was adversely affected by any failure to
follow the Subpart C procedures, nor that a change in the
certification date would be an appropriate remedy for any
such failure. The ALJ properly concluded that the focus
of the hearing should be on the facility's practices in
complying with the participation requirements, not on the
State survey agency process. Thus, we affirm and adopt
the ALJ's FFCLs 77 through 107 and 122 through 131.

III. The ALJ did not err in concluding that HCFA was not
required to alter the effective date of certification on
the basis that the State survey agency failed to present
the Statement of Deficiencies to Petitioner within 10
days, according to 42 C.F.R. § 488.110(j).

The regulation at 42 C.F.R. § 488.110(j) states:

In accordance with your Agency's policy, present the
Statement of Deficiencies, form HCFA 2567, on site
or after supervisory review, no later than 10
calendar days following the survey.

The ALJ reached the following conclusions, discussed in
the ALJ Decision at 74-76:

115. The only issues that are relevant to the
determination of the effective date in this
proceeding relate either to the date the
deficiencies were corrected or the date HCFA
accepted Petitioner's plan of correction.

116. Section 488.110(j) provides that the state
agency is to forward HCFA 2567 to facilities within
10 days after a survey is completed. Ten calendar
days from December 23, 1993 is January 2, 1994.

117. Neither 42 C.F.R. § 488.110(j), nor any other
provision in this section, contains any penalty
provision for the agency's failure to comply with
this 10-day requirement.

118. There is no provision in 42 C.F.R. § 489.13 to
respond to situations where HCFA delays transmittal
of the form 2567 to a SNF.

119. An administrative law judge does not have the
authority to equitably split the difference or
fashion a remedy based on HCFA's noncompliance with
the 10-day requirement.

120. As an administrative law judge, I do not have
the authority to find the regulations ultra vires
the Act, which is what I would have to do in order
to grant Petitioner the relief it seeks.

121. I interpret the alleged 10-day "requirement"
as a goal which HCFA should strive to meet in all
cases, but not as something which should either
invalidate the survey nor mandate that HCFA grant
the SNF with an earlier certification date than it
was given, in cases where this goal is not met.

Petitioner argued that HCFA was bound to follow its own
regulations. Petitioner argued that the 10-day provision
was a mandatory requirement in a published regulation,
not merely a permissive guideline, as HCFA had argued.
Petitioner said it did not understand the ALJ's finding
that he was powerless to sanction HCFA, since the
consequence of an agency's failure to follow its own
rules must be that actions resulting from the failure are
invalid. According to Petitioner, this means that
certification was improperly denied as of December 23,
1993.

We first note that what is at issue here is not whether
to "penalize" or "sanction" HCFA for failure to follow
its own regulation: the issue is whether Petitioner's
provider agreement should have an earlier effective date
on the basis that the State survey agency did not follow
Subpart C and present the Statement of Deficiencies to
Petitioner within 10 days of the survey. The remedy
Petitioner seeks here is a different effective date. If
Petitioner were entitled to this under the regulations
(which we hold Petitioner is not), any increased payments
to Petitioner would simply be reimbursement for services
provided, not a penalty or sanction.

The record indicates conflicting testimony on when the
Statement of Deficiencies was presented to Petitioner.
The ALJ stated that it was admitted that Petitioner did
not "get" (that is, receive) the Statement until January
19 or 22, 1994. ALJ Decision at 75. A surveyor
testified, however, that the survey team informed
Petitioner of the deficiencies at the exit conference
held December 23 and that the form was made available for
the Petitioner to pick up the week of January 3. Tr.
1597-1600; 1605. If this testimony were accepted as
credible, the State survey agency could be said to have
"presented" the Statement of Deficiencies to Petitioner
before the Petitioner actually received the Statement.

The ALJ did not err, however, in determining that, even
if the State survey agency did not present the written
Statement of Deficiencies to Petitioner within 10 days of
the survey, the effective date for Petitioner's provider
agreement was the date set according to 42 C.F.R.
§ 489.13(b).

First, as the ALJ noted, the 10-day period is set out in
Subpart C of Part 488, as promulgated in 1989. The ALJ
correctly concluded that Subpart C was not an applicable
regulation because it established procedures for surveys
performed to determine compliance with requirements
applicable prior to the effective date of the OBRA '87
provisions.

Second, even if Petitioner were correct that this
provision of Subpart C applied and the State survey
agency should have provided the Statement of Deficiencies
sooner than it did, the remedy for the State survey
agency's failure would not necessarily be an earlier
effective date. As discussed above, HCFA has reasonably
interpreted the statute as intending that a State survey
agency's failure to follow procedures will not be a basis
for challenge to certification determinations, and that
the primary concern should be the health and safety of
the program patients.

The ALJ Decision is primarily based on 42 C.F.R.
§ 489.13, which specifies what will be the effective date
of a provider agreement. 12/ In the absence of this
provision, 42 C.F.R. § 489.10 (which states that HCFA
sets the effective date of an agreement in its notice to
the provider) might be considered as giving discretion to
HCFA to set an earlier effective date if HCFA found that
the State survey agency did not act in timely manner. In
light of the specific guidance in section 489.13 on
setting effective dates, however, HCFA could reasonably
read its regulations as requiring actual submission of an
acceptable plan of correction before an agreement could
be effective, irrespective of any State survey agency
failure to follow procedures.

Contrary to what Petitioner argued, it has no property
interest that was denied without due process. In light
of the statutory and regulatory provisions, Petitioner
could have no expectation of receiving reimbursement
until it was either certified as meeting program
requirements or certified with deficiencies addressed in
an approved plan of correction.

Thus, we conclude that the ALJ did not err in determining
that HCFA correctly set the effective date of
certification, regardless of any State survey agency
failure to present the Statement of Deficiencies within
10 days of the completion of the survey. We affirm and
adopt the ALJ's FFCLs 115-121, with the modification to
FFCL 115 in the footnote above.

Conclusion

For the reasons set out above, we conclude that the ALJ
did not err when he concluded that HCFA properly set the
effective date of January 31, 1994 for Petitioner's
provider agreement. Accordingly we sustain the ALJ
Decision, as modified above with respect to FFCL 115.

_____________________________
Cecilia Sparks Ford

_____________________________
Donald F. Garrett

_____________________________
Judith A. Ballard
Presiding Board Member

* * * Footnotes * * *


1. Petitioner specifically took exception to the
following Findings of Facts and Conclusions of Law
(FFCLs): FFCLs 77 through 112, inclusive, FFCLs 115
through 121, inclusive, and FFCLs 122 through 131,
inclusive. Petitioner did not take exception to any
factual findings with respect to the cited deficiencies.
We affirm and adopt all of the FFCLs to which Petitioner
did not except.
2. The record did not establish a date certain
for when the HCFA 2567 was issued by the State survey
agency. The ALJ noted that the Petitioner "admittedly
did not get the HCFA 2567 until January 19, or January
22, 1994." ALJ Decision at 75. See our discussion in
section III. below.
3. Unless otherwise indicated, the statutory and
regulatory citations in this decision are to the version
in effect in December 1993, when the survey was
performed.
4. Petitioner, both here and below, contended
that a single violation, such as a "dirty plate, failed
light bulb, unmade bed, late meal, or documentation
error, can all violate some regulation governing skilled
nursing facilities." P. app. br. at 4; ALJ Decision at
68. We note, however, that the kind of deficiencies
found by the surveyors and upheld below by the ALJ are
far more significant than merely a dirty plate or failed
light bulb. Rather, the cited deficiencies in large part
were found to directly impact on and have potential (or
actual) negative consequences for individual patients.
Petitioner gave an example of one of its violations,
describing it as related to only one patient. P. app.
reply at 2. Yet, the ALJ found a deficiency based on
testimony relating to observations of "residents" during
a tour of the facility, interviews, and room visits that
indicated the problem was pervasive and formed a pattern,
not an isolated incident. FFCLs 139-144; ALJ Decision at
90-93. Thus, Petitioner's characterization of the
deficiencies involved here as somehow trivial, minor, or
of little consequence is not supported by the record.
5. Under the regulations, the State survey agency
would recommend denial of certification only based on
failure to meet Level A requirements where "the
deficiencies are of such character as to substantially
limit the provider's . . . capacity to render adequate
care or which adversely affect the health and safety of
patients." 42 C.F.R. § 488.24(a).
6. We note that the 1989 technical changes for
the most part substituted Level A requirements only for
references to conditions for participation, whereas in
section 489.13(a) the phrase "Level A requirements" was
substituted for the word "standards." We do not think
this difference is meaningful for several reasons. The
preamble indicated that no substantive change was
intended. Moreover, as amended, section 489.13(a) still
contained the lead-in phrase referring to all federal
requirements and Level B requirements are clearly federal
requirements. HCFA could reasonably have determined that
Level A requirements for SNFs should be put with health
and safety conditions of participation for other
providers since the Level A requirements were statutory
in origin like the conditions for other providers, and
that the phrase "any other requirement imposed by HCFA"
was sufficient to encompass Level B requirements.

7. Thus, Petitioner conceded that at the time of
the survey the facility was not in compliance with
numerous nursing home requirements such as requirements
pertaining to a resident's right to be free from
restraints, 42 C.F.R. § 483.13(a); quality of life, 42
C.F.R. § 483.15(h)(2); making comprehensive resident
assessments, 42 C.F.R. § 483.20(b)(1); using these
assessments to develop a comprehensive plan of care, 42
C.F.R. § 483.20(b)(6); development of such plans of care,
42 C.F.R. § 483.20(d)(1); periodic review of such plans,
42 C.F.R. § 483.20(d)(2)(iii); provision of care in
accordance with such plans, 42 C.F.R. § 483.20
(d)(3)(ii); treatment of pressure sores, 42 C.F.R.
§ 483.25(c)(2); provision of bedtime snacks, 42 C.F.R.
§ 483.35(f)(3); and control and prevention of infection,
42 C.F.R. § 483.65(a)(1). ALJ Decision at 19-32.
8. Traditionally, failure of a State survey
agency to follow HCFA's survey procedures simply allowed
HCFA to look behind a State's Medicaid provider
agreement, which would no longer be considered valid
evidence that the facility met the requirements for
Medicaid participation. See 42 C.F.R. § 442.30(a)(first
published in 1978 and still in effect during the period
at issue here).
9. We note that a stratified sample could still
be a "randomly" selected sample within each strata. The
legislative history indicates with reference to the
requirement to use a "case mix stratified sample" that
the purpose was that the sample would be "statistically
valid" (or "statistically significant") and comprehensive
in nature. H.R. Rep. 391, 100th Cong. 1st Sess., Pt. II,
939 (1987). Generally, a statistically valid sample is
drawn using a random selection method, irrespective of
whether it is drawn from particular strata or from the
sampled universe as a whole. The conflict between
section 488.110 and the statute arises primarily because
1) the methodology in section 488.110 does not require
that the universe first be stratified to reflect a mix of
cases in the facility; and 2) the sample drawn pursuant
to OBRA '87 must have different contents, specified in
the Act, including a sample of the resident assessments
newly required under OBRA '87. See Section
1819(g)(2)(A)(ii) of the Act.

10. There is an additional exemption in 5 U.S.C.
§ 553(a)(2) for matters relating to "grants, benefits, or
contracts." Medicaid is clearly a grant program. In
addition, at least one court has said this exemption
applies to Medicare (presumably as a benefit program, or
perhaps because parts of the program are administered
through agreements with providers or states). Humana of
South Carolina, 419 F.Supp. 253 (D.D.C. 1976).
Presumably, HCFA did not rely on this exemption either
because 1) the Secretary waived application of the
exemption in 1971, and courts have held that an agency
that has waived the exemption is bound by APA procedures,
Rodway v. U.S. Dept. of Agriculture, 514 F.2d 809 (D.C.
Cir. 1975); State of Florida v. Weinberger, 401 F.Supp.
760 (D.D.C. 1975); or 2) Congress has provided in section
1871 of the Act for publication generally of any "rule
requirement, or other statement of policy (other than a
national coverage determination) that establishes or
changes a substantive legal standard governing . . . the
eligibility of individuals, entities or organizations to
furnish or receive services . . . ."
11. We note that Petitioner did not deny HCFA's
assertion that Petitioner had actual notice of the SOM
250 provisions because Petitioner had been through three
prior surveys in 1993, all of which were performed in
accordance with the guidelines in SOM 250. HCFA app. br.
at 30.
12. In FFCL 115, the ALJ referred to one option
as "the date HCFA accepted Petitioner's plan of
correction." The ALJ should have referred to the "date
on which the provider submits a correction plan
acceptable to HCFA." 42 C.F.R. § 489.13(b). Thus, we
modify FFCL 115 to read as follows:

115. The only issues that are relevant to the
determination of the effective date in this
proceeding relate either to the date the
deficiencies were corrected or the date on which the
provider submitted a correction plan acceptable to
HCFA.

This error by the ALJ was harmless, however, since the
ALJ used the correct wording in the body of his
discussion. ALJ Decision at 74. Also, the effective
date set here was the date of submission of the plan of
correction accepted by HCFA.