GAB Decision 353
September 30, 1982 Tennessee Department of Public Health; Docket No.
82-76-TN-HC Ford, Cecilia; Garrett, Donald Teitz, Alexander
The Tennessee Department of Public Health (appellant) appealed
$289,280 of a total disallowance of $298,494, by the Health Care
Financing Administration (HCFA or respondent), of federal financial
participation (FFP) in costs claimed as Medicaid expenditures. The
issues in this case are: (1) whether failure by the appellant to
complete all the blank spaces on sterilization consent forms resulted in
the failure to obtain fully informed consent; and (2) whether the
burden should be placed on tthe appellant to produce records to show the
actual amount of certain hospital costs, disallowed by the respondent
based on interim rates of reimbursement, not the actual rates finally
paid to the hospitals. /1/
For reasons stated below, we conclude that some, but not all, blanks
need be filled in for there to be informed consent. We also conclude
that respondent was reasonable in using interim rates, and the appellant
has the burden to provide documentation of actual costs. This decision
is based on the written record, including an additional submission from
the appellant that was requested by the Board.
A. The Sterilization Consent Forms
The regulations require that the sterilization consent forms be
complete; however, this is not a requirement that every blank be filled
in.
The Office of the Inspector General Audit Agency conducted an audit
of the appellant's implementation of the revised sterilization
regulations, under Title XIX (Medicaid), for the period March 8, 1979
through June 20, 1980.The Regional Administrator based the disallowance
on the audit report. (2)
The auditors stated that $207,472 of FFP claimed for sterilizations
in 555 Medicaid cases were unallowable because the appellant did not
fully comply with regulations at CFR Part 441. (Audit Report, p. 4)
Under the Medicaid regulations, FFP is available for sterilization
expenditures only if the sterilized individual has the requisite age and
mental capacity and has voluntarily given informed consent within a
specified time period. Section 441.253. For consent to be "informed,"
the individual must have been given certain information about the
sterilization procedure (as specified in the regulations), under
circumstances which ensure that the information was properly
communicated and understood, including that an interpreter was used if
necessary. Section 441.257.
A further condition is that the "consent form requirements of Sec.
441.258 were met; . . ." Section 441.257(a)(5).
Section 441.258 specifies that the consent form "must be a copy of
the form appended to this subpart or another form approved by the
Secretary." The form must be signed and dated by the individual to be
sterilized, the interpreter (if any), the person who obtained the
consent, and the physician who performed the operation. By signing,
these last three persons each certify that certain specified conditions
were met.
Documentation that all the regulatory requirements were met,
including a consent form, must be obtained by a state Medicaid agency
before it pays for the sterilization.
Nowhee in the Medicaid regulation is there an explicit requirement
that all of the blanks be filled in. However, comparable regulations
applicable to Public Health Service (PHS) family planning programs do
specify that consent forms for sterilizations funded by those programs
must be "completed." 42 CFR 50.204. The PHS regulations, codified
at 42
CFR Part 50, were published in the Federal register at the same time as
the Medicaid regulations, codified at Part 441.
The auditors relied on an Office of the General Counsel opinion which
stated that implicit within both the preamble and the regulatory
language, for 42 CFR Parts 50 and 441, is the concept that informed
consent requires that all blanks of the consent form be completed.
Further, the opinion stated that failure to fully complete the consent
form raised issues of whether there was informed consent by the
individual. The opinion acknowledged that this could be determined on a
case-by-case basis, but stated that this would be contrary to
Departmental policy. (Audit Report, pp. 6-7) (3)
The appellant contested 517 of the 555 Medicaid cases found to have
improper consent forms, and argued that the issue is whether the
respondent incorrectly applied the Department's published regulations
and thus arbitrarily denied FFP for sterilization claims. The appellant
argued that all that is required by the regulations are certifications,
signatures and dates, and to require that all the blanks on the form be
filled in would impose a new and unpublished obligation on the providers
and the states.
Also, the appellant argued that 42 CFR Parts 50 and 441 could not be
given the same interprestation, as in the General Counsel opinion,
because the regulatory language in each program was different. The
appellantt argued that since the regulations give complete instructions
for claims under different programs, each set of regulations should be
considered mutually exclusive. (Appellant's appeal file, p. 3)
Analysis
We conclude that the respondent's interpretation that all of the
blanks on the sterilization consent form must be filled in in order to
comply with the regulations is incorrect. However, we disagree with the
appellant's argument that the regulations require only the
certifications, signatures, and dates. Some of the blanks in addition
to those provided for signatures and dates must be filled in for the
regulatory requirements to be met.
The preamble to the sterilizattion regulations, published at 43 Fed.
Reg. 52146, November 8, 1978, states, in part,
The Department is promulgating new rules to govern expenditures for
sterilizations provided under various Department programs. Three
parallel sets of regulations are being issued. . . .
Supplementary information provided with the Medicaid portion of the
regulations refer to a "single preamble," explaining the regulations
for
all the programs, published with the PHS regulations. 43 Fed. Reg.
52171.
On the issue of informed consent, this preamble and 42 CFR 50.204
both contain the following language:
Informed consent does not exist unless a consent form is completed
voluntarily and in accordance with the requirements of this section . .
. .
(emphasis added)
The preamble refers to completion of the forms and states that the
regulations being issued are parallel. Therefore, we find that the
appellant's argument that each set of regulations should be considered
mutually (4) excclusive is without merit. Although the wording in the
PHS regulations is different from the Medicaid regulations, we think
that the substantive requirements were intended to be the same. /2/
However, even in light of the preamble and regulations, there remains a
question of whether "complete" means that every single blank of the
form
must be filled in. We think not. Completion, in this regulatory
context, means to provide as much information as necessary to ensure
that the informed consent requirements have been met. We note that
there are forms that specifically require that all blanks must be filled
in, and that, where a question is not applicable, "N/A" should be
entered. In this case, there is no such requirement and we do not
impose one.
Although the General Counsel opinion referred to in the audit report
stated that it would contravene Department policy to examine the forms
on a case-by-case basis, the opinion did not cite to any specific policy
statement for this position. indeed, the auditors did examine the
forms, and we do not think it is too much of a burden to require the
Agency to consider whether information missing from each individual form
is critical to meeting the regulatory requirements.
In order to ascertain which blanks of the sterilization consent form
are critical to informed consent, the sterilization consent form must be
examined. All of the information necessary to show informed consent
must be found within the four corners of the document, and each separate
certification must be clear and stand independent of the others. The
appellant submitted a copy of the sterilization consent form, having
numbered all of the blanks and listed the blanks which it considered
(5)requirements. The appellantt listed a total of twenty blanks. (A
copy of this form is included as an Appendix to this decision.) /3/
The form is divided into four sections which require information,
signatures, /4/ and dates from the following individuals:
a. the individual to be sterilized;
b. the interpreter (if necessary);
c. the person obtaining the consent; and d.the physician performing
the operation.
We discuss below the blanks in each of the four sections, indicating
whether the information to be filled in is critical in order to meet the
regulatory requirements. However, since the auditors noted that, with
some exceptions, the forms were properly signed and dated by each party
(Audit Report, p. 7), and the requirement that the forms be signed and
dated is not contested by the appellant, blanks numbered 7, 8, 8B, 11,
12, 19, and 20 will not be discussed.
a. The individual's consent section
The appellant argued that, out of a total of eight blanks in the
individual's consent section, only the signature and date (blanks
numbered 7 and 8) were required. We agree that the signature and date
are required; however, we also find that additional information related
to other blanks is necessary. Following are rationales for each:
Blank 1 -- Not critical. The regulations do not require that the
individual to be sterilized identify the source of the (6) required
information. Furthermore, to the extent identification of the source is
necessary for a determination by someone reviewing the form that the
information was provided by an appropriate person, that is fully taken
care of in other sections of the form.
Blank 2 -- Critical if blank 6 is not filled in. This blank or blank
6 is necessary in order to comply with the regulation. The regulation,
at 441.257, requires that the individual be given certain information
regarding the "specific sterilization procedure to be performed" and
attending risks and discomforts. The name of the operation or method
explained must be given to ensure that the individual was informed
concerning the procedure actually performed.
Blank 3 -- Not critical. The regulations do not require an
individual's exact date of birth, only that the individual be at least
21 years old. By signing the printed statement "I am at least 21 years
of age," the consenting individual attests that the requirement is met.
Thus, this blank may be considered redundant.
Blank 4 -- Not critical. It is clear from this blank that the intent
is to assure that the named individual has given the required consent.
This intent is fulfilled by the required signature (blank 7) in this
section. In context, the "I" prior to blank 4 refers to the person
signing, and it is clear who is giving consent.
Blank 5 -- Not critical. To the extent that the identification of
the physician is required in the regulation, that is fully taken care of
in the physician's section of the form. There is nothing in the
regulation which requires that the individual to be sterilized know the
name of the physician at the time of giving consent.
Blank 6 -- Critical if blank 2 is not filled in. See the rationale
for blank 2 above.
b. The interpreter's section
Blank 8A -- Not critical. The regulations do not require the name of
the language used by the interpreter in this section. What is being
certified in this section is the fact that the language used by the
interpreter was understood by the individual to be sterilized, and this
is clearly stated in the printed text. (7)
c. The section for the person obtaining the consent
Blank 9 -- Critical. Section 441.258 requires that the individual
obtaining the consent must provide the individual to be sterilized with
certain specific information. In order to certify that the specific
individual was given that information, the name of the individual must
be provided.
Blank 10 -- Critical. In keeping with the intent discussed in the
rationale for blank 9, the name of the operation must also be provided.
Blank 13 -- Not critical. Even though it is useful to provide
information concerning the facility involved, the regulations do not
require it.
Blank 14 -- Not critical. See the rationale for blank 13 above.
d. The physician's section
Blank 15 -- Cricital. Section 441.258 requires that the physician
performing the sterilization provide the individual to be sterilized
with certain specific information. In order for the physician to
certify that the specific individual was given that information, the
name of the individual must be provided.
Blank 16 -- Critical. The date of the sterilization is necessary to
ensure that the required information was provided prior to the operation
in accordance with 42 CFR 441.258.
Blank 17 -- See above, the discussion in footnote 3.
Blank 18 -- Critical. In accordance with 42 CFR 441.258, this blank
is necessary to the required certification that must be made by the
physician.
B. The Amount of the Disallowance
The appellant has the burden of providing the documentation to show
the actual amount of hospital costs.
The appellant argued that the respondent based the disallowed amount
for hospital costs on a per diem rate established as an interim payment
which does not reflect the actual amount of the payments. The appellant
submitted an affidavit to show that, for outpatient services, in most
cases the actual cost to the program is less than the interim payment.
(8)
The respondent has agreed to review any documentation submitted by
the appellant to establish the actual amount of the hospital costs;
however, the appellant argued that the Inspector General Audit Agency is
the appropriate auditor, not the state. (Appellant's reply brief, p. 2
of 3 unnumbered pages)
The Board has held in previous cases that a grantee generally has the
burden of documenting costs. Neighborhood Services Department, Decision
No. 110, July 15, 1980; National Urban League, Inc., Decision No. 289,
April 30, 1982. This does not mean the respondent can arbitrarily
choose a disallowance figure and then expect a grantee to provide
documentation showing how that figure is wrong. Here, however, the
respondent had a reasonable basis for its calculations, and it is not
unfair to expect the appellant to show if any adjustments are necessary.
The auditors were examining billing procedures for sterilization claims,
and the bills would have been based on the interim rates. The appellant
did not allege that the actual cost information was readily available to
the auditors, and, indeed, since it usually takes some time for actual
costs to be determined, the information might not have been available at
the time of the audit. Moreover, these claims are for both inpatient
and outpatient services. While appellant alleged that, in most cases,
interim rates for outpatient services would be higher than actual costs,
the appellant acknowledged that for inpatient services the interim rates
might be higher or lower than actual costs. It is the appellant which
sets the interim rates, and the appellant could be expected to try to
set them as close to actual costs as possible. Moreover, in this case
the appellant is the party with the appropriate records. We conclude,
therefore, that, under these circumstances, it is not unreasonable to
require the appellant to provide documentation to show the actual amount
of the hospital costs.
Conclusion
Based on the foregoing reasons, the Board concludes: (1) that it was
not necessary to fill in each blank of the sterilization consent form in
order to have informed consent, and, therefore, subject to the
determinations made in this decision, the respondent is directed to
review promptly the forms of the 555 Medicaid cases in question and make
adjustment to the disallowance consistent with this decision; and (9)
(2) that the use of interim rates is sustained unless the appellant
produces documentation of the actual hospital costs in question. /1/
The appellant does not contest the finding that certain costs
were claimed at an FFP rate higher than allowable. Accordingly, we
uphold the disallowance of the $81,808 associated with this finding,
subject to adjustment to reflect actual costs, as discussed below. /2/
Moreover, although the appellant made this argument, it is clear
that the appellant recognized the intent of the Title XIX regulations.
In response to a request from the Board, the appellant submitted a copy
of instructions given to Tennessee Medicaid providers, which stated, in
pertinent part, The sterilization consent form is a legal document,
therefore, every item must be completed whether or not it applies to the
individual case. . . . The appellant objected to the introduction of
these instructions into the record, contending that they were immaterial
and irrelevant to the issue of interpretation of the federal
regulations. We do not rely on the instructions as a basis for our
interpretation of the regulations. However, we do think the instructions
have some relevance in that they indicate that appellant understood that
more than the signatures and dates was required, and, therefore, we
include the instructions in the record. /3/ The appellant listed
a number 17 on the form; however, it is unclear whether this blank is a
continuation of blank number 16. In the form provided in the
regulation, we are unable to determine whether the information required
is the date of the sterilization operation, or the date of the
sterilization and the name of the operation. The text as it appears in
the preamble to the final rule shows one blank for "date of
sterilization operation." 43 Fed. Reg. 52160. Therefore, we find that
if 17 is a blank it is not required, and if the respondent penalized the
appellant for not filling in this blank the respondent should make an
adjustment to the disallowance. /4/ Three of the signatures also
serve as certificcations that the individual to be sterilized received
certain required information.
OCTOBER 22, 1983