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Fetal Distress Birth Malpractice Lawsuit
Mildred J. Stevens, M.D., CR No. 314 (1994)
$05:Exclusion Case
Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
In the Case of:
Mildred J. Stevens, M.D.,
Petitioner,
- v. -
The Inspector General.
DATE: May 9, 1994
Docket No. C-93-057
Decision No. CR314
DECISION
By notice letter dated February 11, 1993, the Inspector General
(I.G.) informed Petitioner of her determination that, in a single
instance involving a newborn patient named Amanda, Petitioner had
grossly and flagrantly violated her professional obligations under
section 1156(a)(2) of the Social Security Act (Act). 1/ Using the
problems identified in Petitioner's care of Amanda and 13 other
patients, the I.G. determined also that Petitioner had demonstrated
an unwillingness or inability to substantially comply with the
obligations imposed on her by section 1156(a)(2) of the Act. The
I.G. notified Petitioner that she was to be excluded from
participation in the Medicare, and any State health care program as
defined in section 1128(h) of the Act, for a period of three years.
2/
On February 13, 1993, the I.G. sent Petitioner another letter to
inform her of her option to have the effective date of the
exclusion stayed pending an evidentiary hearing on the issue of
whether she poses a serious risk to patients. Section 1156(b)(5)
of the Act specifies such an option for program providers whose
practices are located in a rural health manpower shortage area or
in a county with a population of less than 70,000. Petitioner
requested a hearing on the serious risk issue and also on the issue
of whether there was a gross and flagrant violation of her
professional obligations. The case was assigned to me for a
hearing and a decision.
In my prehearing order dated April 6, 1993, I noted additional
relevant procedural history on the serious risk issue. 3/ I denied
the I.G.'s motion that I hold a separate hearing on that issue.
However, in ruling that the hearing on all issues should be
consolidated, I granted the I.G.'s motion that I issue an expedited
ruling on the serious risk issue.
I held an in-person hearing in this case on September 13 and
September 14, 1993 in Kansas City, Missouri. At the close of the
hearing, I established a schedule for the parties to brief the
issues before me. On December 16, 1993, I issued a ruling in which
I found that Petitioner posed a serious risk to patients and
directed that the exclusion be implemented immediately pending a
final decision in this case. My December 16th ruling did not
address the issues of whether the I.G. had authority to exclude
Petitioner or whether the exclusion imposed against Petitioner by
the I.G. is reasonable. In my ruling on serious risk, I extended
the parties' deadline for filing briefs on the remaining issues.
By ruling dated December 16, 1993, I denied Petitioner's motion to
supplement the record with a memorandum prepared by Dr. David
Johnsen for Petitioner's defense of a medical malpractice lawsuit.
Thereafter, on December 22, 1993 (by correspondence pro se) and on
January 14, 1994 (by correspondence through counsel), Petitioner
attempted to file the same memorandum by Dr. Johnsen once again,
along with a copy of a document that was already admitted into the
record at hearing as Petitioner's Exhibit 19. Petitioner has not
explained why her Exhibit 19 should be admitted a second time, and
her reasons for resubmitting the same memorandum from Dr. Johnsen
do not establish any good reason for me to modify my earlier denial
of her first motion. Therefore, I am denying her motions of
December 22, 1993 and January 14, 1994 to supplement the record
with the same memorandum.
Having considered the applicable legal principles, the evidence I
received at hearing, and the arguments raised by the parties in
their posthearing briefs and other submissions, 4/ I conclude that
the I.G. proved that she had the authority under section 1156 of
the Act to impose and direct Petitioner's exclusion from
participating in Medicare and Medicaid. I find also that the
three-year exclusion is reasonable.
ISSUES
The issues in this case are:
1. Whether Petitioner has grossly and flagrantly violated her
obligations under section 1156(a)(2) of the Act;
2. Whether Petitioner has demonstrated a lack of ability or
unwillingness to comply with her obligation under section
1156(a)(2) of the Act; and
3. Whether the three-year exclusion imposed and directed by
the I.G. is reasonable.
FINDINGS OF FACT AND CONCLUSIONS OF LAW
Statutory and regulatory framework
1. The Kansas Foundation for Medical Care, Inc. (KFMC) is a peer
review organization (PRO), within the meaning of section 1154 of
the Act.
2. The PRO's duties include reviewing the professional activities
of physicians in Kansas for the purpose of determining whether the
quality of services that physicians provide to Medicare
beneficiaries and Medicaid recipients meets professionally
recognized standards of health care. Social Security Act, section
1154(a)(1)(B); 42 C.F.R. 1004.10(b).
3. Professionally recognized standards of care are "statewide or
national standards of care, whether in writing or not, that
professional peers of the individual or entity whose provision of
care is an issue, recognize as applying to those peers practicing
or providing care within a State." 42 C.F.R. 1001.2.
4. A PRO has the discretion to establish specific criteria and
standards to be applied to certain locations and facilities in the
PRO area if the PRO determines that both the following conditions
have been satisfied:
(a) the patterns of practice in those locations and facilities
are substantially different from patterns in the remainder of the
PRO area; and
(b) there is a reasonable basis for the difference which makes
the variation appropriate.
5. 42 C.F.R. 466.100(d).
6. Where the PRO has determined that a physician has violated the
obligation to provide services of a quality that meets
professionally recognized standards, the PRO is required to give
the physician reasonable notice and an opportunity for discussion,
and, if appropriate, a suggested method for correcting the
situation during a designated period of time under a corrective
action plan. 42 C.F.R. 1004.30(c), 1004.40(c)(4).
7. If a physician has grossly and flagrantly violated the
aforesaid obligation in one or more instances, the PRO must also
submit a report of the violation to the I.G. 42 C.F.R.
1004.30(c).
8. A "gross and flagrant violation" is the violation of an
obligation to provide care in one or more instances which presents
an imminent danger to the health, safety, or well-being of a
Medicare beneficiary or places the beneficiary unnecessarily in a
high-risk situation. 42 C.F.R. 1004.1(b).
9. The Secretary of the Department of Health and Human Services,
or by delegation, the I.G., may impose and direct the exclusion of
a health care practitioner from participating in Medicare and
Medicaid where the Secretary determines, based on a recommendation
by a PRO, that the practitioner has: (1) in one or more instances,
grossly and flagrantly violated the obligation to provide health
care of a quality which meets professionally recognized standards
of care; and (2) demonstrated an inability or unwillingness to
substantially comply with the obligation to provide such care.
Social Security Act, section 1156(b)(1).
10. In determining the appropriateness of a sanction after the
practitioner has been found to have grossly and flagrantly violated
the aforesaid obligation, the I.G. must consider factors that
include the PRO's recommendations, the type of offense at issue,
the severity of the offense, the availability of alternate sources
of service in the community, and whether the practitioner has
entered into corrective actions plans (CAPs) prior to the PRO's
recommendation and, if so, whether she has successfully completed
such plans. 42 C.F.R. 1004.90(d).
11. A party subject to an exclusion determination under section
1156(b)(1) of the Act has a right to a de novo administrative
hearing on all relevant issues. Section 205(b) of the Act (as
incorporated by section 1156(b)(4) of the Act).
Background facts
12. In the notice letter, the I.G. imposed and directed an
exclusion on the basis of the PRO's finding that Petitioner, in
treating a newborn patient named Amanda, had grossly and flagrantly
violated her obligation to provide services of a quality that meets
professionally recognized standards of health care. I.G. Ex. 25.
13. Petitioner delivered Amanda on May 19, 1991 at Anderson County
Hospital. I.G. Ex. 1.
14. After the delivery, Petitioner also cared for Amanda at
Anderson County Hospital, until the afternoon of May 20, 1991. Id.
15. Anderson County Hospital is a small hospital located in
Garnett, Kansas. Tr. at 553; I.G. Ex. 1.
16. Garnett, a rural community of approximately 3200 people, is
the county seat of Anderson County, Kansas, which has a population
of 7000. Tr. at 413.
17. Petitioner has practiced general medicine in Garnett, Kansas,
since 1948. Tr. at 468 - 69.
18. Of the approximately 4000 babies Petitioner has delivered over
the past 45 years, only a few were delivered by Petitioner during
the years immediately preceding Amanda's birth. I.G. Ex. 14 at 47,
66; Tr. at 554 - 56.
19. Few babies with health conditions like Amanda's have been born
at Anderson County Hospital. Tr. at 450, 504 - 05.
20. Petitioner has 4000 active patient charts, of which 50 percent
are for Medicare beneficiaries and Medicaid recipients. Tr. at
580.
21. During the period in issue, there were five doctors practicing
medicine in Garnett: Petitioner, who practiced full time; two
other doctors, who practiced full time; a doctor who practiced part
time; and another doctor who occasionally treated patients. I.G.
Ex. 17 at 2.
22. Petitioner's husband, who also was on the medical staff of
Anderson County Hospital, was included among the physicians
practicing in Garnett. Tr. at 409 - 10.
23. All five doctors on the medical staff of Anderson County
Hospital were eligible to vote on applications (including their
own) for privileges to practice particular types of medicine at
that hospital. Tr. at 407 - 10.
24. In 1991, Petitioner and Dr. David Henderson were the only
physicians practicing obstetrical medicine in Garnett and at
Anderson County Hospital. Tr. at 397.
25. At the time Petitioner delivered and cared for Amanda,
Petitioner was the chief of the obstetrical department at Anderson
County Hospital. Tr. at 371.
26. At the time of Amanda's birth, Dr. Henderson was the chief of
the pulmonary medicine department and the emergency department, as
well as the chief of staff at Anderson County Hospital. Tr. at
362, 460 - 61.
27. The foregoing titles do not signify medical expertise in the
respective fields because, due to the small size of the medical
staff, the department chief positions are given to whichever
doctors are willing to assume them. Tr. at 461.
28. Dr. Henderson saw Amanda on the night of her birth in his
capacity as the chief of staff for Anderson County Hospital. Tr.
at 366, 430 - 34.
29. Both Petitioner and Dr. Henderson have been sued in a
malpractice action involving the care given to Amanda. Tr. at 446
- 47.
30. During the time that Petitioner delivered and cared for Amanda
at Anderson County Hospital, some health care employees of the
hospital disagreed with Petitioner's actions and decisions with
respect to Amanda's treatment. See, e.g., Tr. at 430, 487 - 88;
I.G. Ex. 1 at 17.
31. After Amanda's birth, Anderson County Hospital suspended
Petitioner's privileges to practice obstetrical medicine there.
Tr. at 407 - 10.
The applicable "professionally recognized standards of health care"
32. Neither the I.G. nor the PRO had attempted to develop or apply
any professionally recognized standards of health care that are
unique to Anderson County Hospital or Garnett, Kansas. Tr. at 45
- 46; P. Br. at 7.
33. The PRO applied a statewide standard in evaluating the quality
of care at issue. Tr. at 46 - 47.
34. The focus of the inquiries by the I.G. and the PRO was whether
Petitioner had certain minimum medical knowledge of a sufficiently
current nature that would enable her to provide reasonably
up-to-date care that meets currently recognized standards of health
care. Tr. at 39, 42, 285; I.G. Ex. 21 at 2.
35. No matter where a physician practices, there are minimum
professional standards that each physician must satisfy under the
Act. Tr. at 285; see section 1158(a)(2) of the Act.
36. Petitioner recognizes that a physician must have the requisite
knowledge base in order to make use of available resources, tests,
or procedures in the physician's treatment of patients. I.G. Ex.
14 at 7.
37. Anderson County Hospital had the basic resources and equipment
-- e.g., oxygen, a delee catheter, a fetalscope or fetal monitor,
a telephone -- that would have enabled a physician to assess and
treat Amanda in the manner described by the I.G.'s experts. Tr. at
203 - 04, 406, 437, 452; I.G. Ex. 1 at 17 - 20, 45 - 49.
38. There has been no effort by the PRO or the I.G. to hold
Petitioner to a standard of care applicable to medical specialists
or to physicians practicing in large urban health care facilities
with state-of-the art equipment. Tr. at 285, 350 - 51.
39. Petitioner does not contend that she would have given
different treatment to Amanda had Petitioner been practicing in a
different hospital with different resources or more advanced
technologies. See Tr. at 501 - 09.
40. The issues in this case do not involve a physician's need to
accommodate geographical differences or limitations in available
health care resources in order to avoid placing her patients
unnecessarily in high-risk situations.
41. Given the unique issues and factual background of this case,
the PRO and the I.G. were not required to develop any relevant
professionally recognized standards of health care that are unique
to Anderson County Hospital or Garnett, Kansas. See Findings 31 -
39.
42. In alleging local standards as an affirmative defense,
Petitioner has not proven that there exists local factors or
standards of practice in Garnett or Anderson County Hospital that
would eliminate a physician's need to have at least a minimal level
of reasonably up-to-date knowledge concerning those commonly known
medical facts and procedures which will enable the physician to
meet patients' needs by making appropriate use of available medical
resources.
43. The evidence does not credibly establish the existence of any
relevant pattern of practice in Garnett or Anderson County Hospital
that is substantially different from the patterns of practice in
the rest of Kansas, which has many other small rural communities as
well. See 42 C.F.R. 466.100(d); Findings 31 - 40; P. Ex. 10.
44. The evidence also does not establish the existence of a
reasonable basis for any variation between whatever pattern of
practice may exist in Petitioner's locality or at Anderson County
Hospital and the pattern of practice in the rest of Kansas. See 42
C.F.R. 466.100(d); Findings 31 - 37.
45. The evidence does not establish that Petitioner's treatment of
Amanda conformed to any professionally recognized standards of
health care. See P. Exs. 1 - 4, 8, 9; Tr. at 439.
46. Petitioner's actions at issue cannot constitute a
professionally recognized standard within the meaning of the Act,
even though she has no doubt contributed significantly to shaping
the quality level of the treatment available to patients in Garnett
and at Anderson County Hospital due to the length of her
professional career, the small size of the medical staff, her high
number of patients, and her having been only one of two doctors
practicing obstetrics in the area until her hospital privileges
were revoked. Section 1156(a)(2) of the Act; Findings 31 - 44.
47. The PRO and the I.G. correctly applied an appropriate standard
in this case. Findings 31 - 45.
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