GAB Decision 209
August 31, 1981 California Department of Health Services; Docket No.
79-66-CA-HC Garrett, Donald; Settle, Norval Ford, Cecilia
The California Department of Health Services (State) appealed a
determination by the Director, Medicaid Bureau, Health Care Financing
Administration (Agency), disallowing $5,029,165 in Federal financial
participation (FFP) claimed under Title XIX (Medicaid) of the Social
Security Act for sterilization procedures paid for between May 13, 1975
and June 30, 1977. Negotiations between the parties have resulted in
resolution of a number of issues involved in the appeal. For reasons
stated below, we have decided the remaining issues, primarily concerning
adequacy of consent to be sterilized, in part for the State and in part
for the Agency.
This decision is based on the State's application for review and its
supplement; the Agency's response; the transcript of a hearing held on
May 6, 1981; exhibits submitted at the hearing; post-hearing briefs;
and other submissions by the parties.
General Background
Congress provided in Title XIX that a State is entitled to FFP (at a
90% rate) in the costs of family planning services meeting certain
requirements. Section 1903(a)(5). The Secretary has interpreted family
planning to include sterilization services, although initially there
were no specific rules or regulations governing sterilizations.
Congress had provided, however, that all family planning should be on a
voluntary basis. See, e.g., Sec. 1905(a)(4)(C). After national
attention was drawn to the problem of needy persons coerced to submit to
sterilization by threat of loss of welfare benefits, the Department (the
HEW, now HHS) began to develop regulations to ensure informed consent
and voluntariness in Federally funded sterilizations. The history of
these proceedings is discussed in detail in previous Board decisions.
Maryland Department of Health and Mental Hygiene, Decision No. 85,
February 28, 1979; California Department of Health Services, Decision
No. 123, October 2, 1980. For purposes of this decision, these are
relevant: a 1973 "moratorium" on FFP in certain sterilizations; the
court's decision in the case of Relf v. Weinberger, 372 F. Supp. 1196
(D.D.C. 1974); and regulations at 45 CFR 205.35, published April 18,
1974 (39 FR 13887).
(2) The "moratorium" was a direction to heads of HEW components
administering family planning programs to withhold FFP in sterilization
of individuals "under the age of 21" or legally incapable of giving
consent, pending issuance of regulations requiring informed consent in
Federally funded sterilizations. The moratorium accompanied
Departmental guidelines for development of informed consent regulations,
and was published with the guidelines as a Federal Register Notice on
August 3, 1973. 38 FR 20930. Regulations issued pursuant to the
guidelines on February 6, 1974 were struck down in the Relf litigation.
The District Court in that case permanently enjoined the use of Federal
funds "for the sterilization of any person . . . legally incompetent
under the applicable state laws to give informed and binding consent . .
. ." 372 F.Supp. at 1204. The District Court further found the February
6 rules to be defective because they authorized Federal funds without
requiring that legally competent persons be advised that their Federal
benefits could not be terminated by reason of a decision not to be
sterilized and without requiring that such advice "appear prominently at
the top of the consent document. . . ." 372 F.Supp. at 1205.
The April 18, 1974 regulations were published to replace those struck
down in Relf. Section 205.35 of 45 CFR contained requirements for Title
XIX state plans, including that nonemergency sterilization could be
performed unless "legally effective" consent was obtained. No minimum
age for consent was specified in the regulation; however, the preamble
to the regulation referred to "continuing in effect the moratorium set
forth in the previous notice of the Department with respect to
sterilization of individuals under the age of 21 or legally incapable .
. . ." 39 FR 13873.
In addition to the requirement for "legally effective" consent,
Section 205.35 provided that no nontherapeutic sterilization could be
performed sooner than 72 hours following the giving of consent.
Paragraph 205.35(a)(2)(i) defined informed consent as --
. . . the voluntary, knowing assent from the individual . . . after
he has been given (as evidenced by a document executed by such
individual):
(A) A fair explanation of the procedures to be followed;
(B) A description of the attendant discomforts and risks;
(C) A description of the benefits to be expected;
(D) Counseling concerning appropriate alternative methods; and the
effect and impact of the proposed sterilization including the fact that
it must be considered to be an irreversible procedure;
(3) (E) An offer to answer any inquiries concerning the procedures;
(F) An instruction that the individual is free to withhold or
withdraw his or her consent to the procedure at any time prior to the
sterilization without prejudicing his or her future care and without
loss of other project or program benefits to which the patient might
otherwise be entitled. . . .
Paragraph 205.35(a)(2) provided for two possible methods of
documentation: provision of either (1) a written document "detailing
all of the basic elements of informed consent" (referred to by the
parties as a "long form") or (2) a "short form written document
indicating that the basic elements of informed consent have been
presented orally to the patient."
Finally, Paragraph 205.35(a)(2) provided that each consent document
--
. . . shall display the following legend printed prominently at the
top:
NOTICE: Your decision at any time not to be sterilized will not
result in the withdrawal or withholding of any benefits provided by
programs or projects.
The California State Medicaid (Medi-Cal) plan provided, effective
February 21, 1975, that "requirements of 45 CFR 205.35(a) are met . . .
which include those related to: (1) Voluntary request, legally
effective informed consent, time limits . . . , and written consent
documents; . . . ."
Case Background
In 1977, the Regional Medicaid Bureau (Region IX) undertook a review
to determine whether the State had obtained informed consent for all
sterilizations for which claims were paid between May 13, 1975 and June
30, 1977. Since, at the time, the State had not established procedures
to collect informed consent documents at a central place and since
approximately 20,000 sterilizations had been performed during the review
period, the reviewers determined to use statistical sampling methods for
their review. The reviewers requested the State to provide a summary of
the universe of claims and then a sample listing of 440 sterilization
"cases."
(4) Each "case" in the sample consisted of provider claims for
services to the same recipient. /1/
The reviewers found, based on their examination of consent forms for
the sample cases, that although the State had promulgated informed
consent regulations and had transmitted the requirements to all Medicaid
physician providers, the consent forms used were "eclectic in design and
rarely in compliance with federal regulations." (Report on California's
Informed Consent Sterilization Review, Fall 1977 (Report), p. 3,
Attachment to Exhibit I, State's Application for Review.) The reviewers
attributed this to the State's regulations, which left the
responsibility for design of an informed consent form to the individual
providers. Out of the "final sample" of 418 cases, /2/ the reviewers
found that 188 cases failed to meet one or more Federal requirements.
The reviewers found that 1) in 176 cases there was either no informed
consent form at all or the consent form used did not contain a notice
concerning benefits; 2) in 20 cases the recipient was under 21 years of
age; and 3) in 2 cases the recipient was not mentally competent to give
informed consent. (Report, p. 6.) The reviewers did not base their
findings on Section 205.35, but described these "requirements" as
deriving from the court's order in the Relf case, relating to notice
that benefits could not be lost, and from the "moratorium." Additional
findings, since resolved, related to whether the sample claims were for
family planning services and to the rate of FFP properly claimed for the
services. (Report, pp. 5, 7.) Although the State had been involved
initially in drawing the sample for the reviewers, the State was not
informed of the results of the review until it received the Director's
disallowance letter, dated March 9, 1979. (Application for Review, p.
2; Transcript, pp. 29, 202.) The (5) disallowance letter described the
reviewers' findings in generally the same terms as the report. /3/
Extrapolating from the sample findings on the 188 cases and from
findings relating to the proper rate of FFP, the Director determined
that the State had claimed $5,029,165 in unallowable costs.
This determination was appealed to the Board by letter dated March
23, 1979, in which the State raised various issues related to the
adequacy of consent, the rate of FFP, and the sampling methodology. The
appeal was supplemented by letter dated June 1, 1979. In the
supplementary letter, the State indicated that it was undertaking a
survey of patient consent information for each of the 188 sample cases.
Board proceedings were delayed while the State attempted to accumulate
documentation of informed consent. The State's efforts included mailing
a form letter, dated June 13, 1979, requesting documentation from
providers on the sample listing.A follow-up letter, dated October 10,
1979, was sent in those cases where the response to the first letter was
insufficient. Where the provider had refused to release information
without the patient's permission, a letter was sent from the State's
Office of Legal Services, advising the provider of its legal obligation
to produce the documents. Documentation gathered through this effort
was analyzed and presented to the Agency's regional office for review.
The regional office disagreed with the State's evaluation that some of
the documentation was adequate. When Board proceedings resumed, the
Agency responded to the appeal on September 5, 1980, stating for the
first time that the sample cases failed to meet Federal requirements
based on Section 205.35.
The State has never factually disputed the reviewers' findings that
20 of the persons sterilized were under age 21 or that 2 persons were
mentally incompetent (State's Post-Hearing Brief, p. 7, n. 4.), but
challenges the legal basis for the disallowance based on age. In
addition, the State has now accepted the disallowance with respect to
148 of the 188 questioned sample cases (Confirmation of Prehearing
Conference Calls, Attachment II), and certain issues regarding the rate
of FFP claimed and the sampling methodology have been resolved (6) by
the parties as a result of post-hearing negotiations. At the hearing,
the State presented evidence and argument concerning 40 "contested"
cases which the State asserts meet informed consent requirements.
This decision will first discuss the "age 21" issue, then address
general legal arguments relevant to all 40 contested cases, and,
finally, examine individual issues raised in the 40 cases.
Individuals Under Age 21
The State admits that some of the disallowed claims were for
sterilization of individuals between the ages of 18 and 21. The
Agency's position is that the disallowance is required by the
"moratorium" on sterilization of individuals "under age 21"
continued in
effect by the Federal Register preamble to Section 205.35. /4/ The State
argues that the regulation requires only "legally effective" informed
consent, that 18 was the age of consent in California, and that an
ambiguous statement in a preamble should not take precedence over the
wording of a codified regulation. The State further argues that it did
not have actual notice that the term "under age 21" in the moratorium
was not intended to refer to age of majority under State law, and,
therefore, under the Board's rationale in California Department of
Health Services, Decision No. 123, October 2, 1980, the disallowance
should be reversed.
Decision No. 123 involved sterilization costs claimed by the State of
California for the period February 21 to May 12, 1975. The Board held
that consent of individuals between the ages of 18 and 21 in California
was "legally effective" within the meaning of Section 205.35. The
Board
reversed the disallowance insofar as it related to individuals between
18 and 21, since the preamble statement concerning the "moratorium"
was
ambiguous and inconsistent with the regulation. The Board agreed with
the State, given the history of the development of the informed consent
requirements, that it was reasonable for the State to interpret the age
reference in the "moratorium" to mean age of majority, finding also
that
the State did not have actual notice of a contrary interpretation.
Since the disallowance before us now involves a later time period,
the threshhold issue is whether the State had actual notice during that
period that the "moratorium" was intended as an absolute prohibition
on
FFP in sterilization of individuals under age 21, regardless of State
law. The Agency relies on Identical Memorandum No. 75-16, dated
September 24, 1975, and addressed to State Title XIX Agencies, (7)
including California, from a Regional Commissioner. (Agency Hearing
Exhibit D.) This memorandum advises that FFP will be withheld for
certain violations, including "sterilization of an individual under the
age of 21." Like Agency transmittal MSA-PI-474-14, discussed in Decision
No. 123, however, the memorandum suffers from the same ambiguity as the
preamble statement concerning the "moratorium," given the circumstances.
We do not think it sufficient to give the State notice that the State's
interpretation, which was consistent with the regulation, was incorrect.
Moreover, the State has testified without rebuttal that an Identical
Memorandum is a type of transmittal generally used by the Agency for
information purposes, not for action purposes. (Transcript, p. 246.)
Our conclusion that the State did in fact view the requirement as
majority rather than "age 21" is supported by the fact that a Medi-Cal
Bulletin issued May 1975, informing providers of sterilization
requirements, included that the "beneficiary is 18 years of age or
older. . . ." (Exhibit 2, Supplement to Application for Review.)
According, for reasons stated above and explained more fully in
Decision No. 123, the disallowance is reversed with respect to the
grounds that the individuals sterilized were under age 21.
General Issues Common to the 40 Cases
Parties' Arguments
The State claims that it was extremely prejudicial to the State that
the only legal defect cited in the Director's disallowance letter with
respect to the consent forms was the lack of notice concerning benefits,
whereas the Agency now relies on other requirements of Section 205.35 as
a basis for the disallowance.
The State points out that the record retention requirement for
support of Medicaid claims is three years and that, by the time the
State learned (in March 1981) of other alleged defects in the consent
forms, "no records concerning the audit period (1975-1977) remained
within the retention period." (State's Post-Hearing Brief, p. 8.) In
view of its "good faith" in accepting the disallowance for those cases
which it determined clearly violated Section 205.35, the State argues,
the Board should consider the prejudicial effect of the Agency's actions
in reviewing the 40 contested cases and "apply a lenient standard to the
documentation in view of the State's inability to do a fair records
search directed at the non-compliance first alleged" two years after the
disallowance letter. (State's Post-Hearing Brief, p. 9.) (8)
The Agency responds that the State itself delayed in requesting
details on the additional legal bases (after receiving the Agency
response in September 1980) and that the State had ample opportunity to
prepare its case for the evidentiary hearing held on May 5 and 6, 1981.
The State also argues that the Board's general approach in reviewing
the documentation should be "to determine whether the process of
informed consent . . . appears to have been fairly complied with."
(State's Post-Hearing Brief, p. 9.) While recognizing that Section
205.35 provides both for a process of informed consent and for
documentation that the process occurred, the State has "concentrated on
showing that the first element exists, even where the documentation
might be less complete than one might expect the State to produce had it
been fairly asked to do so." (State's Post-Hearing Brief, p. 10; see,
also, Transcript, p. 374.) In support of this position, the State asks
the Board to contrast the "general requirements" of Section 205.35
with
current regulations at 42 CFR 441.250 et seq., which require use of a
specific consent form (published as an appendix to the regulation) or
"another form approved by the Secretary." (42 CFR 441.258(a).) According
to the State, strict compliance can only be demanded "(where) the
regulations make it eminently clear what is required. . . ." (State's
Post-hearing Brief, p. 10).
The Agency's position is that the regulations are clear, that the
State incorporated the regulatory provisions in its State plan effective
February 21, 1975, and that the disallowed amounts, not expended as
medical assistance in accordance with the State plan, are therefore
unallowable under Section 1903(a)(1) of the Act.
Discussion
The State has not advanced its arguments as a basis for overturning
the entire disallowance. Rather, the State has asked us to use a
"lenient" standard because of prejudice and to focus on the "process"
of
informed consent rather than the documentation requirements. We are not
persuaded to adopt the State's approach for several reasons.
First, the State has not shown that Section 205.35 does not apply
here. Under 45 CFR 16.8(a), the Board is bound by applicable laws and
regulations. Thus, we cannot substitute our view of what constitutes
the "process" of informed consent for requirements clearly established
by Section 205.35. In particular, Section 205.35, while not as explicit
as the current informed consent provisions, specifically addresses
methods of documentation. Thus, we are dealing with more than a general
requirement for documentation of grant costs. In fact, under the
regulation, the written consent document executed by the patient is part
of the consent process itself and cannot be viewed as a separate, merely
administrative requirement.
Second, while the State's argument concerning prejudice does raise a
serious question as to whether the State has had a meaningful
opportunity to show that it did meet Section 205.35 requirements, this
argument is highly speculative. The State has not alleged, nor produced
any evidence, that any provider possessed documentation (other than that
already submitted) but had destroyed it when the retention period
expired. It is highly unlikely that this occurred in view of the
reviewers' efforts, within the retention period, to obtain the
documentation (Transcript, pp. 49-54; Report, pp. 2-3). Also, while
the specific objective of subsequent efforts by the State was to show
that the notice concerning benefits had, in fact, been given, the June
13, 1979 letter to providers also requested documentation which, if
provided, would have shown whether other requirements were met. /5/
We also note that the reviewers' report, transmitted to the State
with the disallowance letter, mentioned the general insufficiency of the
forms examined. (Report, p. 3.) The report stated that in some of the
176 cases the reviewers were unable to obtain any informed consent
document at all. (Report, p. 6.) The Agency cannot be expected to
detail defects in documents which it has never seen and should not be
precluded from amending a disallowance when subsequently documentation
is produced.
On the other hand, the State's efforts to overcome the disallowance
were initially directed primarily at showing that the notice concerning
benefits was actually given (Transcript, pp. 369-370), and it is
reasonable to conclude that the State's approach might have been
different had it been informed that it would need to produce
documentation on all Section 205.35 requirements. Some of the providers
did respond to the State's letters and submit documentation solely on
the notice requirement, which had been emphasized. (See Letter of
October 10, 1979, Exhibit 3 to State's Submission dated November 6,
1979; Transcript, pp. 229-230.) Because the disallowance is based on
extrapolation from a sample, each case for which the State could have
shown compliance has increased significance.
Moreover, while Section 205.35 is not as vague as the State would
have us believe, it does lack clarity in certain respects. Even the
Federal reviewers were confused on some aspects of the requirements,
such as the distinction between the notice and an instruction concerning
benefits (See, e.g., Transcript, pp. 102, 104, 127, 132), and, while the
State did not develop a model form for its providers to use during the
relevant time period, the Agency itself, as late as May 13, 1975 (over a
year after publication of Section 205.35), was reluctant to designate
any particular form as an "official" one.
Based on these considerations, where Section 205.35 requirements are
clear, we have examined the 40 cases primarily to determine whether the
provider has produced doccumentation defective on its face. In these
cases, it is improbable that additional documentation sufficient to
overcome any defect would have been produced even if requested in a
timely manner. Where the requirements are unclear, however, we have
taken this into account in deciding what is necessary to show
compliance.
This approach is consistent with the original Agency position, which
was based primarily on the lack of the Relf notice, but also recognizes
that Congress intended family planning to be voluntary and that the
State plan had incorporated all Section 205.35 requirements.
Below, we discuss issues common to more than one contested case from
the sample. Our examination of the individual items, in light of our
decisions on the common issues, is set forth in an Appendix to the
decision.
The "F Instruction"
Paragraph (a)(2)(i)(F) of Section 205.35 requires as a basic element
of informed consent --
An instruction that the individual is free to withhold or withdraw
his or her consent to the procedure at any time prior to the
sterilization without prejudicing his or her future care and without
loss of other project or program benefits. . . .
The parties have referred to this element as the "F instruction."
(11) Documentation requirements of the section include that each
consent document shall display "printed prominently at the top" the
following:
NOTICE: Your decision at any time not to be sterilized will not
result in the withdrawal or withholding of any benefits provided by
programs or projects.
This is sometimes called a Relf notice since it is derived from the
court's decision in that case.
With respect to certain documents submitted by the State during these
proceedings, the Agency alleges that, although the notice requirement is
met, the document is defective because there is no "F instruction."
This
position is based on an interpretation that the notice and instruction
requirements are separate. The State argues that it is an "equally fair
reading" of the regulation that the notice and instruction can be one
and the same. In support of its argument, the State points to testimony
of the Federal reviewer in which he failed to clearly distinguish the
notice and the instruction. (Transcript, pp. 102, 104, 127, 132.)
Even if the reviewer had not confused the requirements, however, we
would agree with the State that the regulation is not clear on this
point. The instruction is one of the basic elements of informed
consent. The notice is part of the documentation requirements and could
reasonably be viewed as a method of implementation of the instruction.
The Agency has pointed to nothing which would have given the State
timely notice that the regulation required that a consent document
contain both the notice at the top and an instruction in the body of the
document. The regulation is reasonably susceptible of an interpretation
which would allow the notice effectively to subsume the instruction. To
hold to the contrary would favor an interpretation fostering a redundant
action not specified in the regulation. Accordingly, we reverse the
Agency's findings based on this alleged defect.
Location and Form of the Notice
Section 205.35 provides that each consent document shall display the
notice concerning benefits "printed prominently at the top." A number
of
the consent forms submitted in the 40 cases do not have the required
notice at the top, but do contain statements concerning benefits; in
some cases, these statements are prominent.
The State's explanation is that, during the early period of
implementing informed consent requirements, ". . .consent forms were not
printed by the State, but were composed by the physicians. On occasion,
a document would evidence a clear intent to be fairly in compliance with
the requirements, but would contain a defect in form." (Post-Hearing
Brief, p. 12.) The Agency has held the State to a strict interpretation
of the regulation.
(12) We do not agree with the State's position that any statement
concerning benefits shows fair compliance with the requirements. The
requirement that the notice be "printed prominently at the top" is
clear
and goes to the substance of whether the document evidences that the
patient actually received the notice. Accordingly, we uphold the Agency
on this point, even where the form contains a statement concerning
benefits if it is not both prominent and at the top.
Group 6 Cases -- CONSENT FOR NONEMERGENCY STERILIZATION Form
Background and Argument
The State's letter of October 10, 1979, informed each provider to
whom it was sent that the provider's response to the June 13 letter "did
not provide sufficient evidence to support our claim that your patient
was informed of the right of refusal." The October 10 letter further
stated, "If the basic elements of informed consent . . . were presented
orally and a signed consent form . . . was not obtained from this
patient and signed by an auditor-witness to the oral presentation,
please send the enclosed form to the patient to confirm he or she has
been given the required information prior to the sterilization
services." The wording of the form enclosed, titled CONSENT FOR
NONEMERGENCY STERILIZATION, is as follows:
This is to advise (physician), M.D. regarding the elective
sterilization performed on (date).
I gave my consent and approval for the elective sterilization. I was
also informed I would not lose or jeopardize any public benefits or
future medical services to which I might otherwise be entitled if I
changed my mind at any time before the sterilization was performed.
Date Signed
Witness
In the cases referred to by the parties as the Group 6 cases, a
signed CONSENT FOR NONEMERGENCY STERILIZATION form has been submitted,
together with other documents. The State argues, "We do not claim that
this type of retroactive documentation may ever be substituted for
pre-sterilization compliance with the process required by the
regulations. However, we do believe that such a statement by the
patient may fill in for missing or ambiguous documentation where there
is other evidence tha adequate pre-sterilization consent was obtained."
(Post-Hearing Brief, p. 12.)
(13) We agree with the State that this retroactive documentation
cannot be substituted for pre-sterilization compliance with the process
required by the regulation. However, we view the process of consent
required by the regulation to mean more than that the patient must have
received the notice concerning benefits prior to the sterilization. The
process of consent contemplated by the regulation includes provision of
a written consent document containing the required notice. This ensures
that the patient receives the notice prior to giving consent by signing
the form. Otherwise, the information provided through the notice to the
effect that the patient may withhold consent in the first instance
without loss of benefits would be meaningless. The Relf decision
indicates that voluntariness encompasses both the right to withhold
consent and the right to withdraw it once it is given, and the
regulation reflects both aspects.
Thus, the State's after-the-fact CONSENT is insufficient in two
respects: it does not evidence that the notice was given in the
prescribed manner nor that the information provided allowed the patient
to refuse to give consent initially as well as to change his or her mind
after consenting.
On the other hand, there are three of the Group 6 cases (Nos. 378,
394, and 400) where the State has submitted other documents which
evidence that the patient actually signed a consent form containing the
required notice printed prominently at the top. Although the October 10
letter requested CONSENT forms "if a signed consent form was not
obtained," the physicians in these cases have stated that they used a
form containing the notice. The Agency has not challenged the veracity
of those statements. In these cases, the CONSENT provides additional
evidence to show that the notice was actually given in the manner
required by the regulations.
Accordingly, we sustain the disallowance on the basis of lack of the
proper notice in all the Group 6 cases except the three mentioned above,
where the Agency is upheld on other grounds.
Long Form/Short Form
Section 205.35 contemplates two possible methods of documentation of
informed consent: a written consent document "detailing" all of the
basic elements (long form) or a "short form written consent document
indicating that the basic elements of informed consent have been
presented orally to the patient." The short form must be signed by the
patient and by an auditor-witness to the oral presentation, and be
supplemented by a written summary, signed by the person obtaining the
consent and the auditor-witness. (Documentation requirements (1) and
(2) of Paragraph (a(2)(i)(F).)
The alleged defect with respect to a number of the cases is that the
consent document is a short form, not supplemented by a written summary.
The State points to the confusion exhibited by the reviewers (14) as
well as the Agency's witness at the hearing as to whether certain forms
were intended as long or short forms, and contends that a number of the
forms which the Agency designated as short forms could have qualified as
long forms.
The regulation draws a distinction between "detailing" the basic
elements and "indicating" that the elements have been presented orally.
The State' witness testified that "in describing a medical procedure,
that medical description can be extremely brief or it can be extremely
lengthy. To a physician, the term tubal ligation, bilateral or
unilateral, is a term of art. It has a description . . . It means a
certain type of procedure . . . ." (Transcript, pp. 382-383.) The State
in its Post-Hearing Brief, however, refers to the "requirement of the
regulations" as "that a 'long' form must contain in its body the
information provided to the patient, while a 'short' form must only
state that it was provided. . . ." (p. 15). Since what is important in
the long form is that it provide information to the patient regarding
the basic elements, cryptic language which would be sufficient for a
medically trained person would not appear to qualify a form as long.
While the State is correct that the regulation does not give adequate
notice of the "precise limits" of what constitutes a long form, the
regulation is clear enough to inform the State that a document merely
listing what the basic elements are would not be sufficient. The long
form must not just list elements such as "a description of the benefits
to be expected" but must, in the State's own words, provide information
to the patient concerning those discomforts, risks, and benefits.
Moreover, some of the documents which the State seeks to characterize as
long forms are signed by an auditor-witness, which further indicates
that they were intended as short forms.
Based on this analysis, we have concluded that most of the forms
which the State contends are long forms do not "detail" the basic
elements. /6/
The Written Summary
With respect to those cases where we have concluded, either based on
the above analysis or the State's admission, that the form submitted is
a short form, we must address the Agency's allegation that Section
205.35 requirements were not met because the short form was not
supplemented by a written summary.
(15) In determining whether the State's evidence is sufficient to
show that the written summary requirements were met, we have considered
the following factors: the regulatory requirement for a written summary
is not entirely clear; the State was possibly prejudiced since lack of
a written summary was not originally cited as a defect in the cases;
and, a transmittal to Medi-Cal providers failed to reference the written
summary requirements. While the first two favor the State, the third
does not.
The Federal regulation is clear that the short form should be
supplemented by a written summary and that that summary should be signed
by the person obtaining consent and by the auditor-witness. As the
State points out, however, the regulation does not clearly require that
the written summary be retained. The regulations can reasonably be read
to provide for the written summary as a document to be given to the
patient, since it is to summarize the oral presentation given to the
patient and be signed by the physician rather than the patient. In
light of this ambiguity, the State's general request to the providers
for documentation (in its June 13, 1979 letter quoted in footnote 5
above) may have been insufficient to produce the written summaries.
Thus, there is some question whether the State's opportunity to dispute
the Agency on this point was meaningful. On this basis, it might have
been reasonable to presume compliance with the requirement had the State
shown that it was properly implemented.
A Medi-Cal Bulletin, issued May 1975, sets forth Medi-Cal regulations
on sterilizations. (Exhibit 2 to State's Submission of June 1, 1979.)
Although those regulations provide for evidencing informed consent by
means of a short form document, there is no reference in the publication
to the need to supplement the short form with a written summary. (p. 7,
citing Section 51305(e) of Medi-Cal regulations.) Although an earlier
Medi-Cal Bulletin set forth the Federal requirements, in view of this
defect in the requirements as transmitted to the providers in May 1975,
we cannot presume that written summaries complying with Federal
requirements existed and were given to the patients.
These considerations have lead us to adopt the following approach in
reviewing the State's evidence with respect to the written summary
requirement. Where the State has provided a signed consent form which
itself refers to supplementation by a written summary, we have accepted
that as sufficient to show that Federal requirements were met and a
complying summary existed. Where there is no statement in the form that
a written summary was provided, we have examined the evidence to
determine whether any of the State's documentation constitutes a written
summary complying with the requirements or otherwise shows that a
complying summary existed, but have not required of the State the
quantum of evidence which we might have required under other
circumstances. This approach is reflected in our analysis of specific
cases.
(16) The 40 Contested Cases
The attached Appendix contains our findings on the 40 contested cases
from the sample. To the extent that our findings rest on the legal
conclusions discussed in the body of the decision, we have only
indicated the result, either for the Agency or for the State. Where our
findings turn on the sufficiency of the evidence, we have included a
discussion of the specific documentation submitted. (State's Hearing
Exhibit D, Agency's Hearing Exhibit G.) The cases are discussed in the
order in which the parties addressed them at the hearing. Except where
necessary to the discussion, we have not repeated for each case the
defects alleged by the Agency, since they are clearly set out in the
Agency's Post-Hearing Brief.
Calculation of the Disallowance
Subsequent to the hearing in this case, having resolved issues
related to the statistical sampling methods used and the rate of FFP
claimed, the parties recalculated disallowance amounts based on
assumptions as to whether the Board would find for the State or the
Agency on various issues. Except for a small adjustment to which the
parties have agreed, the maximum disallowance (if we found for the
Agency on all 40 contested cases) would be $2,377,001, and the minimum
disallowance (if we found for the State on all 40 contested cases) would
be $1,807,391, since the State had admitted violations in 148 sample
cases. (Agency's Submission of August 10, 1981, p. 2.)
Since our decision is split, part for the State, part for the Agency,
the precise amount disallowed will need to be recalculated. While we
uphold the Agency's findings on 27 of the contested cases, we note that
the final findings in some of those cases are based on defects which the
Agency might reasonably consider to be de minimis. For example, certain
findings are based solely on the defect that the notice, otherwise
prominent, is not "at the top" or that the written summary was not
signed by the witness. While we are compelled to find for the Agency in
these cases by the clear wording of the regulation, the Agency may
decide that it does not wish to extrapolate these de minimus violations
to the entire universe of the State's claims.
Since the parties have agreed on the method of calculation, we assume
that there will be no further dispute concerning this.If there is, the
parties may return to the Board.
Conclusion
For reasons stated above, we uphold the Agency's findings in 27 of
the 40 contested cass and reverse those findings in 13 cases. The
precise amount of the disallowance based on these findings is to be
determined by the parties.The parties have already agreed that the (17)
disallowance for the 148 uncontested cases should be $1,807,391, and
that the Agency overstated the unallowable cost by approximately
$2,652,164 ([$5,029,165 -- 2,377,001). (18)
APPENDIX
This Appendix contains our findings on the 40 contested cases, as
explained at page 16 of the decision. Findings for the State are are
indicated by State, and for the Agency by Agency.
#8 State.
#42 Agency. The Agency determined that this was a short form not
supplemented by a written summary. We agree that the form is not a long
form, since it merely lists the basic elements rather than providing
information concerning them. We also agree that a "Sterlization
Consent" document, primarily designed to release the physician of any
liability, does not evidence compliance with written summary
requirements. There is a typewritten statement on this document
followed by typed initials which are apparently those of the physician
and witness. Even though this statement says that the patient
"understands that the procedure is designed to produce sterility but
that it has a failure rate of 4 to 5 per thousand and if successful is
irreversible," there is no reference to other basic elements. Thus,
this is insufficient as a summary of the oral presentation.
#129 Agency. The Agency determined that this was a short form not
supplemented by a written summary. We agree that the form is not a long
form, since it merely lists the basic elements. The State has submitted
a letter from the physician, dated in 1979. While this letter describes
what the physician explained to the patient, it is not signed by the
auditor-witness. Moreover, it does not refer to a written summary
supplied at the time. It is, therefore, insufficient to show compliance
with the requirements.
#275 Agency. The physician's consent document does not indicate that
the patient was given an explanation of the procedures as required by
Paragraph (a)(2)(i)(A). Although there is in the record a hospital form
which states that the patient has a right to be informed of the nature
of the procedure, this form specifically states that it "is not intended
to be a substiture for THOSE EXPLANATIONS which ARE TO BE PROVIDED BY MY
(PHYSICIANS)." Moreover, this form was not signd until 2/15/77 and
therefore is insufficient to show that the patient received and
explanation prior to signing the consent document on 1/27/77.
#317 State. The Agency determined that the long form submitted for
this case was defective since it did not detail counseling concerning
alternative methods as required by Paragraph (a)(2)(i)(D). The form
does state, however, that "All other alternative methods for
contraception have been considered," and we think that this is
sufficient detail for this particular patient since notes from the
patient's records indicate previous use of such alternatives. (19)
#319 State. The Agency argued that the State's documentation in this
case constituted only a short form. We disagree. One of the documents
submitted would only qualify as a short form if taken alone. However,
it may be reasonably read together with three other documents signed
tthe same day. These four pages described the basic elements in
reasonable detail, and qualify as a long form.
#220 State.
#325 State.
#74, 84, 114, 214, 229 Agency. There is a statement concerning
benefits on each form but it is not printed "at the top," and therefore,
does not meet the notice requirement, clearly specified in the
regulation.
#257 Agency. There is a statement concerning benefits but it is not
"prominently at the top" and, also, refers only to withdrawal of
consent, not withholding of consent.
#29 Agency. The Agency determined that this was a short form not
supplemented by a written summary.No documentation has been submitted
except the form, which merely lists the elements and does not refer to a
written summary. Thus, there is no basis on which to conclude that the
requirement was met.
# 13 State. The Agency determined that the short form was not
supplemented by a written summary. The form does, however, contain a
handwritten note from the witness, who was also the interpreter, saying
she explained the procedure. Signed physician's records state that the
procedure was thoroughly explained to the pattient and note, "of
interest is the fact that the interpreter herself has had a laparoscopic
tubal transsection and therefore was able to verbalize the concepts
adequately." The statement also mentions other basic elements. We do
not think this documentation fails to meet the requirements merely
because the physician and witness signed different summaries.
#40 Agency. The Agency determined that this was a short form not
supplemented by a written summary. The State contends that there is a
form which should qualify as a long form and which was first called that
by the Federal reviewer. Although the documentation submitted includes
two forms, one apparently obtained by the doctor and one by the
hospital, both merely list the basic elements rather than providing
information concerning them. Nothing in the documentatiofn indicates
that either form was supplemented by a written summary.
(20) #59 Agency. The Agency determined that this was a short form
not supplemented by a written summary. A statement by the physician,
dated 1979, indicates that the patient was given a Planned Parenthood
booklet concerning sterilization during prenatal visits and
sterilization was discussed and that, when it was determined that a
"C-section" was necessary for the delivery of the patient's baby,
the
physician rediscussed the matter since this required a change in method
of sterilization. While there is nothing in the regulation concerning
the time at which the written summary must be drafted, the regulation
does require that the written summary be signed by the auditor-witness.
This statement was not. Also, while it may be reasonable to assume that
the Planned Parenthood booklet summarized the basic elements which were
provided orally to the patient, there is nothing in the record on which
to base a finding that the booklet itself was signed and could,
therefore, meet the written summary requirement.
#172 State. The Agency determined that this was a short form not
supplemented by a written summary. The form itself refers to "an oral
explanation supplemented by a written summary" of the basic elements and
this is sufficient to show that the Federal regulation was met.
#178 State. The Agency determined that there was no written summary,
but the form itself refers to one.
#231 Agency.The Agency determined that, among other defects, the form
failed to indicate that an offer to answer inquiries was made, as
required by Paragraph (a)(2)(i)(E). We agree. In addition, a letter
from the physician dated in 1979 does not mention any such offer, and
there is no other evidence that it was made.
#236 State. The Agency determined that this was a short form not
supplemented by a written summary. The State contends that the form
qualifies as a long form, but we do not need to reach this issue since
there is a document in the record which complies with the written
summary requirements. A document signed by the patient and a witness
states that "I have read and I understand Dr. Moss's brochure entitled
'Vasectomy' . . . I have discussed the operation of vasectomy with Dr.
Moss and all of our/my questions have been answered." Although the State
has not pointed it out, this document also contains handwriting which we
have determined is Dr. Moss's signature, since it is practically
identical to his signature on another document in the file. Reference
to the brochure, which was the basis of the oral discussion, is
sufficient to summarize that discussion.
(21) #238 Agency. The Agency determined that this was a short form
not supplemented by a written summary. We agree that the form is not a
long form, since it merely lists the basic elements. An after-the-fact
letter from the physician states: "This 23 year old woman had chronic
pelvic inflamatory disease with irregular periods and did not desire any
more children nor did she wish to take birth control pills. She
strongly wished not to become pregnant and at her insistence I performed
the tubal ligation after repeatedly discussing the situattion with her
for about three months." Even if this were sufficient to summarize a
discussion of all the basic elements, however, it fails to comply in
that it is not signed by the auditor-witness.
#251 Agency. The Agency determined that this was a short form not
supplemented by a written summary. We agree that the form is not a long
form, since it merely lists the basic elements. There is in the record
an after-the-fact statement by the physician performing the
sterilization as to what he explained to the patient "following
notification of the delivery (of the patient's baby) by the attending
physician." The delivery was on September 22, 1975. The consent form
was signed by the patient on September 8, 1975, however. Space on the
form for the physician's name was not filled in. Based on this evidence
we conclude that the alleged summary was signed neither by the
auditor-witness nor by the person obtaining the consent and, in any
event, did not summarize the oral presentation on which consent was
based.
#264 Agency. The Agency determined that this was a short form not
supplemented by a complying written summary. The patient's charts
contain doctor's notes stating, "Desires sterilization -- understands
and accepts risks and complications. Understands possibility of failure
and irreversibility." These notes also refer to the procedure to be
performed but are not signed by an auditor-witness. Although other
documents in the record, apparently intended as releases of liability,
are witnessed, they do not summarize the basic elements. Therefore,
none of the documents shows compliance with the regulation.
#272, 276, 309, 413 State. The Agency determined that there was no
written summary, but the form itself refers to one.
#175 Agency. The Agency determined that, among other defects, the
form did not contain the notice. While there is a statement concerning
benefits on the form, it is not printed "at the top."
#184 Agency. The Agency determined that, among other defects, the
form did not contain the notice. There is a statement concerning
benefits on the form, but it is not printed "at the top."
(22) #157, 237, 300, 388, 399, 432 Agency. These are "Group 6" cases
where the State attempted to cure the alleged defect of the lack of the
proper notice through its CONSENT form, obtained after-the-fact. We
agree with the Agency in these cases for reasons stated in the body of
this decision and since there is no other evidence that a complying
notice actually was "printed prominently at the top" of a consent
form.
#378, 394, 400 Agency. These are "Group 6" cases where there is
evidence in the file sufficient to show that the patient actually
received a short form containing the required notice. However, there is
no documentation to show that the short form was supplemented by a
written summary and other documents submitted, while arguably
summarizing the oral presentation, are not signed by an auditor-witness.
/1/ There was some misunderstanding between the State and the
Agency as to whether the sample listing included only services directly
related to the sterilization procedure, for which the State had claimed
90% FFP, or included other services, provided to the same recipient, for
which the State had claimed only 50% FFP. Subsequent to the Board's
hearing, the parties informally resolved issues related to the rate of
FFP claimed. (See Agency's Submission of August 10, 1981.) /2/ There
were 22 cases originally included in the sample of 440 and then
dropped by the reviewers (generally because of inability to locate
providers or providers' position that the information was confidential).
Treatment of these 22 cases was the subject of extensive testimony at
the hearing but is no longer in dispute. /3/ There was some question
within the Agency at the time as to whether the regulations at 45 CFR
205.35 would provide an independent basis for disallowance, since those
regulations impose State plan requirements but do not specifically
address the availability of FFP. (Transcript, pp. 241,283). The Agency
has since taken the position that, where a State plan requires
compliance with Section 205.35, payments which do not comply are not
payments "under the State plan" within the meaning of Section 1903(a)(1)
of the Social Security Act. (Agency response, p. 10.) /4/ Age
is the sole basis for the disallowance in 2 of the 40 contested cases
(Case Nos. 220 and 325) and an additional ground in 9 other cases.
/5/ The June 13 letter requested the provider to submit the following
data: a. A copy of any consent (forms), any variety, given by the
patient. b. A statement from you, the provider, as to your practice or
procedures used on verbal presentations to patients on sterilizations.
c. A copy of the patient's file relative to the sterilization process
or procedures. d. Copies of any documents signed by a witness relative
to the sterilization of the patient. . . /6/ With respect to the
documentation in Case No. 379, however, we agree with the State
that it qualifies as a long form for reasons stated more fully in the
Appendix.
OCTOBER 22, 1983