$05:Exclusion Case
Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
In the Case of:
T. Bruce Vest, M.D.,
Petitioner,
- v. -
The Inspector General.
DATE: December 1, 1995
Docket No. C-95-035
Decision No. CR405
DECISION
This case comes before me pursuant to the request for hearing
timely filed by Petitioner to contest the Inspector General's
(I.G.'s) determination that he should be excluded from
participation in the Medicare program and the State health care
programs defined in section 1128(h) of the Social Security Act
(Act) for a period of five years under section 1128(b)(6)(B) of the
Act. By delegation from the Secretary of Health and Human Services
(Secretary), the I.G. may impose and direct an exclusion against an
individual who has
furnished or caused to be furnished items or services to
patients (whether or not eligible for services under title XVIII
[Medicare]
. . .) substantially in excess of the needs of such patients
or of a quality which fails to meet professionally recognized
standards of health care.
Act, section 1128(b)(6)(B); see also 42 C.F.R. 1001.701(a)(2).
For the reasons discussed below, I conclude that the I.G. has
failed to prove that Petitioner furnished items or services that
were either substantially in excess of his patients' needs or that
failed to meet professionally recognized standards of health care.
Therefore, there is no basis for Petitioner's exclusion.
PROCEDURAL HISTORY
The I.G. may make exclusion determinations under section 1128(b)(6)
of the Act based upon a sanction report from "[f]iscal agents or
contractors" or information from "[a]ny other sources deemed
appropriate" by the I.G. 42 C.F.R. 1001.701(b)(3) and (5). The
exclusion in this case was requested by the Health Care Service
Corporation, which does business as Blue Cross and Blue Shield of
Illinois (Illinois Carrier or Carrier), the fiscal agent in the
State of Illinois for the Medicare Part B program. 1/ I.G. Ex. 11.
The sanction request was based on an analysis done by the Illinois
Carrier's Medical Director, Douglas Busby, M.D., who concluded that
Petitioner had rendered 77 services that were medically unnecessary
or of poor quality in treating 10 Medicare patients during visits
that occurred between April 9, 1992 and September 6, 1993. I.G.
Ex. 11 at 1; I.G. Ex. 12. 2/
On May 25, 1994, the I.G. notified Petitioner of the intent to
exclude him based on most, but not all, of the services criticized
by Dr. Busby. I.G. Exs. 1, 2, 12.
Petitioner then submitted a written response, arguing, inter alia,
that "the review of each visit does not take into account the past
records of the patient's visits nor the immediate follow-up
examinations, all of which were available to Medicare" as part of
Petitioner's prior submissions for Medicare reimbursement. P. Ex.
5 at 2. He availed himself also of the opportunity to make an
in-person presentation to Kenneth Nelson, M.D., of the I.G.'s
Office. P. Ex. 4; I.G. Ex. 4.
Subsequently, the I.G. notified Petitioner by letter dated November
18, 1994 that the determination to exclude him had not been
altered. However, the I.G., by Mr. James Patton, deleted seven
more services, while agreeing with all other "violations"
identified in the notice of intent to exclude Petitioner. I.G. Ex.
5.
The Secretary's implementing regulation states that an exclusion
pursuant to section 1128(b)(6)(B) will be for a period of three
years, unless one or more of the enumerated aggravating or
mitigating factors exist and warrant modifying the three-year
benchmark period. 42 C.F.R. 1001.701(d)(1). In the notice of
exclusion, the I.G. states that the exclusion of five years is
based upon the following two aggravating factors:
The violations were serious in nature and occurred over a
period of one year or more;
The violation resulted in financial loss to Medicare . . . of
$1,500 or more.
I.G. Ex. 4 at 2 - 3; 42 C.F.R. 1001.701(d)(2)(i) and (iv).
During a prehearing conference held on January 13, 1995, the
parties agreed that they would endeavor to proceed on the basis of
written arguments and documentary evidence alone. Order and
Schedule for Filing Briefs and Documentary Evidence 2 (Jan. 17,
1995). Accordingly, Petitioner submitted a Motion to Reverse
Denial of Certain Laboratory Tests . . . and to Dismiss Exclusion
Decision (P. Prehrg. Br.) along with various exhibits. However, in
her response brief (I.G. Prehrg. Br.), the I.G. requested an
in-person hearing because there is no regulatory definition for
"substantially in excess of such patients' needs" and the exclusion
"turn[s] on the consideration of medical records which must be
evaluated by medical experts." I.G. Prehrg. Br. at 4, 35.
I granted the I.G.'s motion for an in-person hearing for the reason
argued by the I.G. Order and Notice of Hearing (May 18, 1995). My
prehearing order also identified the issues as:
Whether the I.G. had a basis for excluding Petitioner; [and,]
Whether the exclusion of five years imposed and directed
against Petitioner by the I.G. is reasonable.
Order and Notice of Hearing 2. Pursuant to 42 C.F.R.
1005.15(c), my Order stated also that the I.G. would have the
burden of coming forward with evidence proving that there is a
basis for the exclusion and that the length of the exclusion is
reasonable; Petitioner would have the burden of coming forward with
evidence in support of Petitioner's arguments. Id. 3/ As
specified by regulation, the standard of proof at a hearing is a
preponderance of the evidence. 42 C.F.R. 1001.2007(c).
During the final prehearing conference, held on July 7, 1995, I
considered Petitioner's motion to strike various of the I.G.'s
proposed exhibits, as well as Petitioner's motion, in the
alternative, to subpoena several categories of witnesses (totalling
53 witnesses) in order to refute the truth of those proposed
exhibits offered by the I.G. I granted Petitioner's motion to
strike the specified proposed exhibits. Ruling Excluding Certain
Proposed Exhibits and Summary of Prehearing Conference (July 10,
1995). 4/
The in-person hearing took place July 13 through 15, 1995, in
Alton, Illinois.
FINDINGS OF FACT AND CONCLUSIONS OF LAW
For the reasons discussed in the designated sections of this
Decision, I make the following findings and conclude that the
exclusion imposed and directed by the I.G. under section
1128(b)(6)(B) of the Act must be set aside for lack of a proven
basis:
1. The facts of record do not establish the merits of the
Carrier's conclusion that Petitioner had a history of
"overutilization," which was unchanged despite efforts to educate
him. See Section I of Discussion, below.
2. The I.G.'s reliance on the Carrier's inadequately supported
conclusion does not establish a basis for Petitioner's exclusion.
Finding 1; See Section I, below.
3. The evidence fails to prove that the criteria and instructions
Dr. Busby followed in reaching his opinions in support of the
Carrier's exclusion recommendation were reasonable or related to
the requirements of section 1128(b)(6)(B) of the Act. See Section
II.A., below.
4. Dr. Busby did not testify as an independent medical expert
concerning the totality of relevant medical evidence in this case;
Dr. Busby's role at hearing was limited to explaining his creation
of the written report in support of the Carrier's exclusion
recommendation. See Section II.B., below.
5. Dr. Busby's opinions fail to prove the I.G.'s contention that
the care rendered by Petitioner was substantially in excess of his
patients' needs. See Section II.C., below.
6. Dr. Busby's opinions fail to prove the I.G.'s contention that
Petitioner rendered care that failed to meet professionally
recognized standards. See Section II.D., below.
7. The I.G. did not prove a basis for the exclusion with Dr.
Busby's opinions. Findings 3 - 6; see Section II, below.
8. The medical records Petitioner submitted to the Carrier in
support of particular claims for Medicare reimbursement are
insufficient to prove a basis for the exclusion in this case. See
Section III, below.
9. The I.G. did not prove that other evidence or medical opinions
support her determination that a basis for the exclusion exists.
See Section IV, below.
10. Petitioner is entitled to rely on medical opinions regarding
his patients' complete medical records. See Section V.A., below.
11. Based on the experts' professional experiences and the
documents they reviewed, the opinions of Petitioner and his expert
witness are entitled to greater weight than the contrary opinions
of Dr. Busby. See Section V.B., below.
12. The evidence introduced by Petitioner is more credible than
that introduced by the I.G. Findings 1 - 11; see Section V, below.
13. The I.G. lacked a basis for imposing and directing an
exclusion against Petitioner pursuant to section 1128(b)(6)(B) of
the Act. Findings 1 - 12.
SUMMARY OF THE PARTIES' EVIDENCE AND THEORIES
The I.G. argues that she is authorized to exclude Petitioner
pursuant to section 1128(b)(6)(B) of the Act. According to the
I.G., Petitioner rendered services that were: 1) substantially in
excess of patients' needs, and 2) of a quality which failed to meet
professionally recognized standards of care. I.G. Prehrg. Br. 35.
According to the I.G., both components are proven by the
inadequacies in the medical records Petitioner submitted to the
Carrier in order to seek payment for his services under the
Medicare program. Tr. 216; I.G. Proposed Findings 84, 85.
The merits of the I.G.'s case rest entirely on the opinions of
Douglas Busby, M.D., the Illinois Carrier's current Medical
Director. Dr. Busby was the I.G.'s only witness at hearing, and
the I.G. has submitted only his written medical report into
evidence. Dr. Busby formed his opinions based on a document review
process which the I.G. argues was thoughtful and complete. I.G.
Prehrg. Br. at 16 ; I.G. Posthearing (Posthrg.) Br. at 2.
However, as discussed herein, Dr. Busby testified only concerning
the circumstances under which he prepared a sanction recommendation
to the I.G. and the limited documents he reviewed in reaching the
opinions expressed in that recommendation. He based his selection
and review of documents on instructions given to him by the I.G.
during September 1993. The I.G. has not shown that the
instructions followed by Dr. Busby relate reasonably to the
exclusion criteria. Even though the I.G. had persuaded me to hold
an in-person hearing in this case based on her argument that expert
medical testimony was critical to the issues in this case (I.G.
Prehrg. Br. at 35), the I.G. chose to limit her proof to the
opinions of Dr. Busby, who did not review any of the medical
records referenced or submitted by Petitioner subsequent to the
time that the I.G. issued her notice of intent to impose an
exclusion. The I.G. contends that Dr. Busby's conclusions, based
on his review of selected records, conclusively establish a basis
for the exclusion. She vigorously objected to my admitting into
evidence any information Dr. Busby had failed to review, such as
the patients' complete medical files and Medicare reimbursement
determinations made by the Carrier based on the same medical
records Dr. Busby criticized.
The I.G. did not offer the medical opinions of any other expert or
of anyone else who may have reviewed additional medical records and
helped form conclusions on the I.G.'s behalf. In addition, the
I.G. chose not to offer any rebuttal evidence concerning the merits
of the contrary medical opinions given by Petitioner and his expert
witness.
At the hearing, Petitioner introduced his own medical opinions, as
well as the written report and testimony of Rodolfo U. Beer, M.D.,
a general surgeon who has been practicing in the Alton area since
1967. E.g., P. Exs. 79, 80; Tr. 517 - 19. Petitioner and Dr. Beer
have more experience than Dr. Busby in the diagnosis and treatment
of elderly patients. Moreover, both Dr. Beer and Petitioner
testified that they had reviewed the complete patient files, which
Dr. Busby did not do for the reasons detailed herein. The medical
opinions of Petitioner and Dr. Beer contradict the conclusions
reached by Dr. Busby on the medical necessity and quality of care
issues.
During the hearing, Petitioner made available, on more than one
occasion, the complete patient files for the I.G.'s review or use
in cross-examination. E.g., Tr. 433 - 35, 506 - 08. The I.G.
objected and declined to review them each time. Id.
Petitioner asserted also as part of his defense that approximately
50 of the more than 70 services criticized by Dr. Busby have been
approved for Medicare reimbursement, based on a full prepayment
review of the same records considered by Dr. Busby. E.g., Tr. 8 -
12; P. Exs. 9, 88. Therefore, Petitioner argues that there exists
a difference of professional opinion even within the Carrier, and
such a difference of professional opinion does not establish a
basis to exclude Petitioner. Tr. 8 - 12. 5/ Petitioner believes
that approval of his Medicare claims pursuant to a full prepayment
review, or pursuant to an on-merits hearing of a claim that was
initially denied by the Carrier, must at least create the
presumption that Petitioner's diagnosis and procedures were in fact
proper under Medicare guidelines. P. Posthrg. Br. at 10.
As I explain in more detail below, I conclude that neither the
documentary evidence of record nor Dr. Busby's testimony at hearing
establishes a basis for Petitioner's exclusion. Therefore, I do
not reach the issue of whether the length of exclusion is
reasonable.
DISCUSSION
I. The I.G. did not prove a factual basis for the exclusion by
adopting the Carrier's opinion that Petitioner has a history of
"overutilization," which did not change despite the Medicare
prepayment review process instituted by the Carrier in September of
1989.
The Illinois Carrier requested Petitioner's exclusion because, in
the opinion of the Illinois Carrier, more than 70 services "show
unchanged pattern of medical management [by Petitioner] over time"
and "educational efforts directed at reducing [Petitioner's]
overutilization ha[d] no discernable effect." I.G. Ex. 11. The
I.G. apparently adopted the Carrier's conclusion, making the same
contention in her prehearing brief, in her opening statement at
hearing, and through witness testimony. E.g., I.G. Prehrg. Br. at
15; Tr. 29, 55 - 74. The I.G. maintained also after the hearing
that the "[C]arrier and OIG struggled to educate Dr. Vest for six
years after identifying him as a problem provider." I.G. Posthrg.
Reply at 3. The I.G.'s position appears to be that the merits of
the I.G.'s exclusion determination, based on the approximately 70
services identified by the I.G., are supported by the Carrier's
determination that Petitioner has a history of "overutilizing"
services and that the full prepayment review procedures imposed by
the Carrier have not changed his practice pattern.
The I.G.'s evidence shows that, in the opinion of the Carrier,
Petitioner was significantly "overutilizing" diagnostic procedures
and services under the Medicare program. E.g., I.G. Ex. 11; Tr. 4
- 7. "Overutilization" is a term used by the Carrier to describe
a provider who is submitting claims which the Carrier considers to
be excessive. Tr. 55. The Carrier concluded that Petitioner's
utilization of medical procedure(s) was excessive after several
audits conducted between 1987 and September 1988 showed that his
utilization exceeded by 95 percent to 96 percent the utilization of
the same procedure(s) by his peer group in the locality designated
by the Carrier. Tr. 59 - 60.
After Petitioner's name had appeared repeatedly on the Carrier's
list of "aberrant" providers and the Carrier had conducted audits
for that reason, the Carrier followed the I.G.'s advice and placed
all of Petitioner's Medicare claims under a full prepayment review
process, beginning in September 1989. Tr. 55 - 56, 91. As noted
by the I.G., Medicare Part B payments cannot be authorized "for any
expenses incurred for items or services . . . which . . . are not
reasonable and necessary for the diagnosis or treatment of illness
or injury or to improve the functioning of a malformed body member
. . . ." Section 1862(a)(1)(A) of the Act; I.G. Prehrg. Br. at 8.
It is the duty of each carrier to "make such audits of the records
of providers of services as may be necessary to assure that proper
payments are made . . . ." Act, section 1842(a)(1)(C).
I conclude that the I.G. has not introduced evidence sufficient to
prove the merits of the Carrier's conclusions that Petitioner was
overutilizing services prior to September 1989, that placing and
maintaining him under full prepayment review process was
appropriate, or that his overall pattern of "overutilization" has
remained unchanged despite the prepayment review process. The
evidence concerning these conclusions merely explains why the
Carrier was interested in having Petitioner excluded from the
Medicare program. Such evidence does not establish the correctness
of the I.G.'s conclusion that Petitioner should be excluded for
having rendered the approximately 70 services to 10 patients during
1992 and 1993.
First of all, the Carrier's determination that Petitioner's
practice patterns were aberrant, compared with others in his peer
group and locality, is not supported by credible evidence. Dr.
Busby, as the Carrier's Medical Director, could not specify the
locality or peer group applicable to Petitioner during the time
when the "overutilization" determination was made -- except that
St. Louis, Missouri, and its practitioners were not considered,
despite their proximity to the Alton area, because the Carrier did
not do any work outside of Illinois. Tr. 56 - 59, 80 - 81. Nor
did Dr. Busby know whether Petitioner was "aberrant" with respect
to one or more procedures, or with respect to which procedures.
Tr. 58, 150.
Dr. Busby conceded that it would be very difficult to find a peer
group for Petitioner, given his dual specialties (42 years of
general practice with Board Certification in Radiology) and the
amount of sophisticated diagnostic equipment in his office (e.g.,
MRI and CAT Scan). Tr. 149. At one point, Dr. Busby even
suggested that it might have been appropriate to compare
Petitioner's practice patterns to Chicago's Rush Presbyterian
Hospital or the State's other large health care centers, which
tended to have more sophisticated equipment and more specialists
than other locations in Illinois. Tr. 151 - 52. Dr. Busby did not
know information such as how many CAT scanners are in the various
counties in the vicinity of Alton, or whether a particular county
was large, small, or rural. Tr. 152 - 53. However, after Dr.
Busby claimed also that no location in the United States is unique,
he acknowledged that the Carrier divided the State of Illinois into
localities in its evaluations only because the Carrier could not
handle the entire population of the State as a whole. Tr. 151 - 52
("What we try to do is we try to group into large segments of the
population").
In addition, one key factor in the Carrier's decision to request
Petitioner's exclusion was its concern for the amount of money
(estimated by the Carrier to be approximately $200,000 per year 6/)
Petitioner's prepayment reviews were taking out of the Carrier's
budget. Tr. 86, 91. At the beginning of each year, the Illinois
Carrier must negotiate with HCFA for a fee to process all Medicare
claims in the State, and the Illinois Carrier believed it must stay
competitive with other carriers in its bids. Tr. 89. The Carrier
was concerned that the approximately $200,000 it took to conduct
prepayment reviews of Petitioner's claims each year was cutting
into its operating costs and that it needed a profit margin in
order to expand and to be competitive in the marketplace. Tr. 90.
In addition, the Carrier was also concerned about whether it could
"increase our salaries? Is there enough money to increase salaries
from profit?" Tr. 90 - 91.
Based on the Illinois Carrier's concerns for its finances, Dr.
Busby suggested to the I.G. that the Carrier pay all of
Petitioner's claims out of the Medicare Trust Fund rather than
review each claim at the expense of the Carrier's budget. Tr. 90.
However, his suggestion was rejected. Tr. 90, 91. Nevertheless,
Dr. Busby's testimony leaves no doubt that the Carrier's financial
wellbeing was a major factor in the Carrier's decision to recommend
Petitioner's exclusion from the Medicare program.
The I.G. has placed into evidence the fact that the Carrier
projected a Medicare overpayment to Petitioner of more than
$1,700,000 based upon a sampling of claims submitted by Petitioner
during the period October 1, 1988 through September 30, 1991. I.G.
Ex. 10. However, I cannot adopt this projection, because the
merits of the Carrier's determinations are pending adjudication in
another forum. E.g., Tr. 4 - 5, 516. In fact, after an objection
from Petitioner, the I.G. stipulated that the document containing
the projected overpayment (I.G. Ex. 10) was offered to show that
Petitioner was placed under full prepayment review and that the
Carrier escrowed the funds. Tr. 4 - 7.
Another problem with the I.G.'s use of the Carrier's conclusion
that Petitioner failed to change his overall pattern of
overutilization, is the fact that the I.G. has not endeavored to
show how many claims were filed by Petitioner and the disposition
of those claims pursuant to full prepayment reviews. Instead, the
I.G. relies upon the implications of her argument that, for six
years, the Carrier and the I.G. "struggled" to educate Petitioner
after having identified him as a "problem provider." I.G. Posthrg.
Reply at 3. The record does not adequately support the I.G.'s
argument or the inferences she would have me draw concerning the
justification for Petitioner's exclusion.
For example, the fact that the Carrier did not remove Petitioner
from the prepayment review plan does not indicate that the Carrier
continued to find problems with the Medicare claims submitted by
Petitioner. Dr. Busby testified that the prepayment review for a
physician would not end unless the physician promised the Carrier,
in writing, to refrain from billing Medicare for a disputed
procedure or represented, in writing, that the physician had
changed practice patterns. Tr. 77 - 79. (This information is not
contained in any of the Carrier's correspondence with Petitioner.)
Therefore, even though the Carrier may be approving most of a
provider's claims after reviewing a provider's records under the
full prepayment review process, the prepayment review process would
continue. Tr. 79.
As part of his defense, Petitioner contended that, of those
services specifically criticized by Dr. Busby in his exclusion
recommendation: 1) approximately 50 were actually reimbursed under
the Medicare program during the time that Petitioner was under the
full prepayment review process; and 2) payments for the other
services denied by the Carrier are pending review and may be
subject to on-merits hearings before other administrative law
judges. E.g., Tr. 8 - 12, 19; P. Prehrg. Br. at 3, 5; P. Exs. 9,
88. The evidence establishes that, under the prepayment review
process, the Illinois Carrier was reviewing each of Petitioner's
services and supporting documents before deciding whether to
authorize Medicare payments. E.g., Tr. 69 - 73, 76 - 77. The
Illinois Carrier had assigned the prepayment review of Petitioner's
claims to its most experienced analysts (Tr. 160), to two nurses on
staff (Tr. 70), and to physicians contracted by the Carrier when
more complicated issues arose (Tr. 76, 163). The instructions
issued by the Carrier to its staff stated that, unless Petitioner
attached the patient's complete history and physical to each claim,
and unless the diagnostic procedures related to a specific
diagnosis or symptoms, Medicare payment would be denied. P. Ex. 9
at 87. There were repeated contacts between the Carrier's Medical
Director and the reviewing staff to ensure that the staff was
functioning appropriately. Tr. 76. Questions concerning the
medical necessity of procedures were supposed to have been referred
to the Carrier's Medical Director. P. Ex. 9 at 87.
The I.G. objected to Petitioner's use of any Medicare payment
information, based on the following arguments: 1) the payment
evidence is irrelevant because the I.G. did not base the exclusion
on considerations of Medicare payments (I.G. Prehrg. Br. at 15); 2)
a payment summary prepared by Petitioner as P. Ex. 88 should not be
considered the "authoritative word" due to possible conflicts with
copies of actual government issued payment records contained in P.
Ex. 9 (Tr. 18); 3) ascertaining the accuracy of Petitioner's
payment summary by comparing it with the copies of government
records would be complicated (Tr. 19 - 20); and 4) it would be very
time-consuming to retrieve and review the relevant microfiches
maintained by the Illinois Carrier (Tr. 19 - 20).
I do not find any of these objections to be meritorious. The I.G.
has had ample time to ascertain the accuracy of the payment
information. Petitioner first raised the issue in his January 1995
prehearing brief, which included the payment summary and copies of
government generated payment records that are now in evidence as P.
Ex. 9. 7/ In addition, when I admitted Petitioner's Exhibit 88 at
the hearing, I informed the I.G. that she was free to develop the
accuracy issue through witness testimony and bring inaccuracies in
the summary to my attention in her posthearing brief. Tr. 18.
Therefore, in the absence of any contrary evidence from the I.G.,
I consider to be true Petitioner's representations that he was paid
under the Medicare program for approximately 50 of the services
criticized by Dr. Busby and that the remaining services are under
review and may result in decisions favorable to him on the payment
issue. Petitioner's evidence concerning the Carrier's payment of
the approximately 50 services is relevant at least to refute the
I.G.'s contention that efforts to educate him under the prepayment
review process have failed.
For the foregoing reasons, I have concluded that the I.G. has
failed to prove the merits of the Carrier's determinations that
Petitioner was an "aberrant provider" whose Medicare claims needed
to be placed and maintained under a full prepayment review process
beginning in September of 1989, or that the Carrier's efforts to
educate Petitioner failed. Accordingly, these determinations made
by the Carrier and adopted by the I.G. do not establish a factual
basis for the exclusion in controversy.
II. The I.G. did not prove, with the use of Dr. Busby's opinions,
that a basis for the exclusion exists.
A. The evidence fails to prove that the criteria and
instructions Dr. Busby followed in reaching his opinions in support
of the Carrier's exclusion recommendation were reasonable or
related to the requirements of section 1128(b)(6)(B) of the Act.
I will discuss in this section the problems with the foundation of
Dr. Busby's opinions and their consequences for the I.G.'s case.
The evidence establishes that, in 1992, Charles C. Henderson, M.D.,
the Carrier's Medical Director at that time, submitted records of
10 cases to the I.G. and recommended that the I.G. exclude
Petitioner under section 1128(b)(6)(B) of the Act. Tr. 77; P. Ex.
82. The I.G., by James Patton, rejected the recommendation in a
memorandum dated April 27, 1992. P. Ex. 82. Among the problems
found by Mr. Patton was the fact that the medical reviewer did not
adequately clarify why the care provided was unnecessary, what the
proper care should be, and why. P. Ex. 82 at 1. Mr. Patton stated
also:
medical reviewers should, if appropriate, review the medical
records of the care provided by the physician to the patient prior
to and/or subsequent to the care in question. We have frequently
found when the case has reached the administrative review level,
the physician has been able to justify his/her treatment as being
appropriate based on the treatment prior to or subsequent to the
care in question.
P. Ex. 82 at 2.
Thereafter, Dr. Busby assumed the position of the Carrier's Medical
Director and began working on the Carrier's second request to
exclude Petitioner from participation in the Medicare program. In
August of 1993, Dr. Busby went to the I.G.'s office and received
training on how the I.G. wished to have the Carrier prepare its
submission. Tr. 93. The training was provided because this was
the first case in which a carrier had requested an exclusion under
section 1128(b)(6)(B) of the Act. Tr. 93, 94. The I.G.'s staff
instructed Dr. Busby to focus on three issues: 1) the reason for
requesting the exclusion; 2) the selection of cases; and 3) the
medical necessity and quality of care. Tr. 93 - 94.
Dr. Busby testified that, under the first issue, the sole reason
for requesting the exclusion was "financial to the carrier; that
is, how it is costing the carrier out of its budget -- not the
Medicare trust fund, but out of its budget -- to operate." Tr. 93
- 94. There was no evidence explaining the relationship between
the Carrier's concern for its budget and the exclusion criteria
established by statute.
Dr. Busby testified also that, under the second issue the I.G.
instructed him to consider, the case selection criterion, was "what
the carrier perceives are costing the carrier to review." Tr. 94.
There was no explanation of what this selection criterion meant,
except that the medical records reviewed by Dr. Busby were not
selected randomly, and the I.G. told Dr. Busby to disregard the
issue of whether Medicare payments have been made pursuant to a
review of those records. Tr.
94 - 95.
With respect to the third criterion (the medical necessity and
quality of care issues), Dr. Busby testified that the I.G.'s
attorney told him: "Present the records that you have available to
you that were submitted by the provider; your comments don't mean
anything to us, except we want to see how you are thinking, but we
are going to review these entirely independently." Tr. 95. After
his training at the I.G.'s office, Dr. Busby found medical records
submitted with Petitioner's claims which indicated to him that,
between April 9, 1992 and September 16, 1993, Petitioner provided
more than 70 services that were either "medically unnecessary" or
of "poor quality" to 10 Medicare patients. I.G. Ex. 12.
However, the evidence does not disclose whether the I.G. informed
Dr. Busby of the requirement that, to exclude Petitioner, there
must be services substantially in excess of the patients' needs or
care of a quality which fails to meet professionally recognized
standards of care. Act, section 1128(b)(6)(B). The evidence also
does not disclose how many other claims and associated records Dr.
Busby reviewed before he located those he placed into his report,
or what significance, if any, Dr. Busby placed on the size of
Petitioner's patient base during the relevant time period. (In
1992, for example, Petitioner had approximately 19,000 registered
patients, out of which 30 to 35 percent were Medicare
beneficiaries. Tr. 512.)
Nor does the evidence establish the reasonableness of Dr. Busby's
failure to heed Mr. Patton's 1992 letter to the Carrier concerning
the evaluation of pre- and post- treatment records. According to
Dr. Busby's testimony, even though he disregarded the determination
of whether Medicare payment had been authorized for any given
claim, he based his opinions on a review of only the records
submitted by Petitioner to claim Medicare reimbursement for
particular services. See Tr. 153, 178, 245. He said he reviewed
only those records because the I.G.'s office had instructed him to
render opinions "based on information at hand." Tr. 121. He asked
the I.G. if he should get more information and was told "no." Tr.
183. He testified that he did not review the records pertaining to
the care rendered prior to or after the services he considered
because an attorney from the I.G.'s office and Dr. Nelson, the
Medical Advisor or Medical Director on the I.G.'s staff, had
directed him not to do so. Tr. 250 - 51.
Dr. Busby said he would have preferred to have had additional
records to review in formulating his opinions. Tr. 245.
Additional records may have clarified matters, eliminated his
concerns, or changed his opinions. E.g., Tr. 109, 126, 182. Dr.
Busby thought that having knowledge of whether Petitioner had
referred his patients to other physicians, for example, would have
helped him form his opinion on a given service. Tr. 182. He did
not consider it appropriate to ask Petitioner for the information
"when we knew we were going for an exclusion with the Office of
Inspector General[.]" Tr. 182. Dr. Busby testified also that he
thought asking Petitioner for additional records might have
afforded Petitioner the opportunity to create information. Tr.
127.
However, neither did Dr. Busby attempt to retrieve any additional
records Petitioner previously had submitted to the Carrier. Dr.
Busby indicated that retrieval of records other than those he
reviewed for his exclusion recommendation would have added work for
the Carrier because, according to Dr. Busby, the records Petitioner
submitted were voluminous -- possibly requiring the lease of a
separate building and the employment of three individuals to
maintain. Tr. 259. When asked if reviewing other records was too
heavy a burden for the Carrier to bear, Dr. Busby answered that the
Carrier retires records on microfiche and maintains them in
archives, and that, even though he had access to hard copies or
microfiche of such records, it would have been a sizeable
undertaking to retrieve all relevant records, such as those of
other doctors who treated the same patients and all the diagnostic
tests undergone by the patients. 8/ Tr. 260 - 61.
When Dr. Busby was asked whether he had an opinion as to
Petitioner's overall pattern of treatment based upon his review of
the records, Dr. Busby responded in the affirmative. Tr. 348.
However, he was not asked what that opinion was, and he did not
volunteer that opinion. When asked if his overall impression of
Petitioner's practice pattern would have been changed if he had
reviewed additional evidence, he answered: "My view would not have
changed." Id. He provided no explanation of why no evidence could
change his overall impression. There is inadequate basis in the
record to reconcile his professed intransigence with his earlier
testimony that his opinions on individual services could have been
changed by additional information.
In sum, the I.G. failed to prove the relationship between the
requirements of the statute and the criteria and instructions
followed by Dr. Busby in preparing the Carrier's exclusion
recommendation. Nor do the methods applied by Dr. Busby in
reaching his opinions of record appear to be fair or valid on their
face. Dr. Busby lacked conviction in his own opinions due to the
limitations imposed by the I.G. and the Carrier's own
record-keeping system. In addition, the evidence shows that Dr.
Busby formulated his opinions based only on the instructions he
received in August 1993, which are not fully consistent with the
instructions the I.G. had issued to the Carrier in 1992 concerning
the additional medical documents which might need to be reviewed.
The existence of these apparently conflicting instructions, and the
absence of any evidence to reconcile them, further undermines the
validity of Dr. Busby's opinions. For the reasons stated earlier,
I give no weight to his assertion that no additional documents
would have changed his opinion concerning Petitioner's overall
pattern of treatment.
B. Dr. Busby did not testify as an independent medical expert
concerning the totality of relevant medical evidence in this case;
Dr. Busby's role was limited to explaining his creation of the
written report supporting the Carrier's exclusion recommendation.
Even though the I.G. persuaded me to hold an in-person hearing due
to the importance of having the medical records explained by
medical experts (I.G. Prehrg. Br. at 35), the I.G.'s only witness
was Dr. Busby, who did not review all of the medical records which
were submitted by Petitioner for the I.G.'s review or made
available to the I.G. during the course of these proceedings. At
the hearing, the I.G. made clear that Dr. Busby was not qualified
as an independent medical expert to render opinions on documents he
neither created nor reviewed. The I.G. called him to testify only
about the circumstances under which he rendered the opinions
contained in his report in support of the Carrier's sanction
request, which report the I.G. has introduced into evidence. Tr.
239; I.G. Ex. 12. Dr. Busby stated that his purpose in appearing
at the hearing was not to present evidence in order to exclude
Petitioner, but to testify about what he had presented to the I.G.
originally. Tr. 237; see I.G. Ex. 12.
Dr. Busby testified that the I.G.'s office told him during his
training in August of 1993 that his opinions on Petitioner's
services would not mean anything except to show how he thinks, and
that the I.G. would review the matter independently. Tr. 95. Dr.
Busby was told by the I.G. that his involvement in the case would
be over after he prepared his report to the I.G. based on a review
of the records he selected to support the Carrier's exclusion
request. Tr. 177 - 78; see I.G. Ex. 11.
Dr. Busby was aware that a "hearing" (i.e., the presentation to and
review by Dr. Nelson of the I.G.'s office on the proposal to
exclude Petitioner) had occurred on July 26, 1994, but Dr. Busby
was given no information concerning it, nor was he invited to
attend or provide comments. Tr. 96. Even when he asked about the
status of his report and opinions after the "hearing," he was told
by the I.G.: "It is none of your concern. We are managing it. We
make the decision." Tr. 96. Moreover, Dr. Busby did not read
Petitioner's exhibits in his preparation for the hearing. Tr. 270.
Dr. Busby believed that his lack of knowledge regarding the
remaining evidence in the case was brought about by a directive
from the I.G. Tr. 183.
C. Dr. Busby's opinions fail to prove the I.G.'s contention
that the care rendered by Petitioner was substantially in excess of
his patients' needs.
The I.G. chose to make her case at the hearing based solely on the
testimony of Dr. Busby. However, among the many problems with the
I.G.'s reliance upon Dr. Busby's testimony is her failure to elicit
from him an opinion that Petitioner rendered care substantially in
excess of the needs of his patients. In his written report to the
I.G., and in his testimony at hearing explaining the contents of
that report, Dr. Busby consistently used the term "medically
unnecessary." However, he never stated in his written report or
during his testimony whether "medically unnecessary" meant the same
thing to him as "substantially in excess of the needs of such
patients." Nor has he indicated that he was even aware of the
latter phrase's place in an exclusion proceeding. See I.G. Ex. 12;
Tr. 122. 9/ It is true that, under most circumstances, whatever
Dr. Busby may have meant by "medically unnecessary" would not be
binding on the I.G. under her exclusion authority. However, here,
the I.G. chose to rely on his opinion.
Dr. Busby's testimony shows that he has consistently used the same
definition of "medically necessary" that the Carrier should have
used in determining Medicare payments. 10/ See Act, section
1862(a)(1)(A) (Part B payments cannot be authorized "for any
expenses incurred for items or services . . . not reasonable and
necessary for the diagnosis or treatment of illness or injury or to
improve the functioning of a malformed body member"). For example,
in describing the instructions the I.G. gave him, he noted: "[W]e
deal, on the side of Medicare Part B, with what is medically
reasonable and necessary" (Tr. 95), but he did not testify that the
I.G. instructed him to consider the issue of whether the care was
"substantially in excess of the needs of such patients." Tr. 93 -
95. When asked during the hearing to describe the problems created
for the Medicare program by Petitioner's medical records, Dr. Busby
spontaneously identified the difficulties with training the
Carrier's analysts and others in the review of such records. Tr.
104. When asked on cross-examination: "[Y]ou don't like the way
he practices medicine. Is that correct?" -- Dr. Busby responded:
"I don't care for the way he is billing the Medicare program trust
fund[,]" and "I believe that it is the responsibility of another
organization to determine whether or not his practice is
appropriate." Tr. 168.
In the single instance during the hearing when the I.G. used the
term "in excess of the patient's needs" in questioning Dr. Busby,
11/ Dr. Busby gave an explanation for "medical necessity." Tr.
122. According to Dr. Busby, "[m]edical necessity is based
principally on prudence" -- as exemplified by, "Is it necessary to
establish a diagnosis, and do we expect that the diagnosis is going
to lead to a definitive form of treatment or a modification of the
treatment?" Id. His definition of "medical necessity" is
essentially the same as the Carrier's explanation of the same
matter for payment purposes: "Medicare does not pay for screening
tests that have no clinical application in the patient's care."
I.G. Ex. 9 at 2.
To justify an exclusion under section 1128(b)(6)(B) of the Act, it
is not enough to apply the definition of "medically unnecessary"
under section 1862(a)(1)(A) of the Act. Even a service that was
not needed at all by the patient under section 1862(a)(1)(A) of the
Act does not automatically mean that it substantially exceeds the
patient's needs within the meaning of section 1128(b)(6)(B) of the
Act. This is so because, when Medicare payment is under
consideration, the medical necessity determination is limited to
whether a particular service was medically reasonable and necessary
for "the diagnosis or treatment of illness or injury or to improve
the functioning of a malformed body member." Act, section
1862(a)(1)(A). Certain medical services are excluded from Medicare
coverage and the concept of medical reasonableness under section
1862(a)(1)(A) of the Act because they do not relate to the
diagnosis or treatment of an illness, injury, or a malformed body
part. 12/ By contrast, the exclusion statute and its implementing
regulation relied upon by the I.G. do not limit the issue of
patients' needs to the consideration of whether a patient is a
Medicare beneficiary or whether the service is covered under the
Medicare program. The statute and implementing regulation specify
consideration of the needs of patients "whether or not eligible for
services under Title XVIII," and "whether or not covered by
Medicare," respectively. Act, section 1128(b)(6)(B); 42 C.F.R.
1001.701(a)(2).
Even though the statute and its implementing regulation do not
define those services that are "substantially in excess of the
needs of such patients," this fact does not mean that the I.G.
should omit expert medical testimony explaining which services were
considered by the I.G. to be substantially in excess of the
patient's needs and why. See 57 Fed. Reg. 3306 (Jan. 29, 1992)
("This determination is always made on the basis of expert medical
opinion").
In her posthearing brief, the I.G. uses the language in the
regulation's preamble concerning a "pattern of violations" to argue
that Petitioner had furnished services substantially in excess of
his patients' needs. I.G. Posthrg. Br. at 8. The preamble
referenced by the I.G. states that the I.G. has discretion to
impose an exclusion even where there is no pattern of violations.
However, Congress did not intend that the I.G. automatically
exclude an individual where the violation was an isolated or
inadvertent instance. 57 Fed. Reg. 3306 (Jan. 29, 1992). The
preamble does not state, as alleged by the I.G., that "a 'pattern
of violations' may result in a finding that care has been furnished
'substantially in excess of patient's needs' . . . ." I.G.
Posthrg. Br. at 8. According to the preamble, there must be at
least one service that substantially exceeds the patient's needs to
form a "violation" in the first instance; this single violation, or
several of these violations (whether or not in a pattern), may then
result in an exclusion. The I.G.'s authority to impose an
exclusion based on a "pattern of violations" does not establish
that any of the services in the alleged pattern substantially
exceeded a patient's needs and therefore constitutes a "violation."
D. Dr. Busby's opinions fail to prove the I.G.'s contention
that Petitioner rendered care that failed to meet professionally
recognized standards.
Just as Dr. Busby's opinions were insufficient to establish that
Petitioner furnished services that were excessive within the
meaning of the statute, his opinions are similarly unpersuasive on
the I.G.'s contention that Petitioner provided services that were
not of a quality that meets professionally recognized standards.
The I.G. relies upon Dr. Busby's designation of numerous services
as being of "poor quality" when the statutory requirement is that
the services were of a quality which failed to meet professionally
recognized standards of health care. I will discuss separately,
below, Dr. Busby's testimony concerning the professionally
recognized standard for medical documentation and its relationship
to the poor quality of care alleged by the I.G. In this section,
I discuss only my conclusion that Dr. Busby's definition of "poor
care" for particular services was ambiguous, based on wholly
subjective criteria, and not in accord with the statutory
requirement for an exclusion.
Dr. Busby concluded that certain services or care rendered by
Petitioner were of "poor quality" (e.g., Tr. 119 - 23, 138) without
ever having defined "poor quality" and without having ever
correlated his opinions with any spectrum of care or standards for
the same services that are generally recognized in the medical
community. When the I.G.'s counsel provided him with an
opportunity to define his terms at hearing, Dr. Busby merely
equated "good medical practice" with "good quality of care".
Tr.
122. This equation is ambiguous, as is his testimony that every
hospital and school across the U.S. train to the same standard of
care (Tr. 82), that the Medicare carriers' Medical Directors have
agreed at their meetings that the standard of care is the same
throughout the United States (Tr. 84), and that he believes every
patient in Illinois deserves the best and most aggressive possible
care (Tr. 142).
The standard applied by Dr. Busby for evaluating the quality of
care was, basically, "[W]ould I have, on the basis of the
information that was available to me, placed this individual on
this particular drug, conducted this particular treatment" (Tr. 121
- 22), or "Was it clinically necessary, based on my level of
knowledge and understanding of medicine" (Tr. 155). Dr. Busby
testified also that, to treat an individual appropriately requires
an appropriate level of knowledge, an understanding, and in
dealing with the individual taking a comprehensive medical history,
conducting a thorough medical examination, a judicious or prudent
use of diagnostic tests, appropriate interpretation of all
information that has been gathered, and the application of any
treatment that is necessary or the referral of that individual for
appropriate specialist care.
Tr. 225. Petitioner agrees. Tr. 429.
Even though Dr. Busby asserted baldly that the standard he applied
meant no reasonable physician would have done what Petitioner did
(Tr. 155), I do not find his assertion persuasive, for several
reasons. Dr. Busby could not explain why some of his opinions were
reversed by Dr. Nelson of the I.G.'s office or whether Dr. Nelson
and Petitioner were acting as reasonable or unreasonable physicians
in disagreeing with his opinions. Tr. 155 - 56. He cited no
medical literature to support his opinions. Tr. 208. Because he
did not know why the Carrier paid many of the services he
criticized or whether Medicare payments for those services had been
approved by other physicians, he conceded the possibility that
there might have been a difference of medical opinion on those
services. Tr. 164.
In addition, some of Dr. Busby's testimony, such as his criticism
of Petitioner's use of the C reactive protein test because it is
considered to be antiquated by the medical community at large and
is seldom used (Tr. 200; I.G. Posthrg. Reply at 5) simply fails to
articulate the existence of a professionally recognized standard of
health care which Petitioner has failed to meet. As shown by the
report of Petitioner's expert, Dr. Beer, there is a difference of
professional opinion concerning the usefulness of the test. E.g.,
Tr. 521; P. Ex. 79 at 4.
The I.G. argues that the term "professionally recognized standards
of care" is applied subjectively because, as explained in the
preamble to the implementing regulation, "[i]t would be very
difficult to formulate a wholly objective standard in the area of
medical practice, where a certain amount of subjectivity in
judgment is inevitable." I.G. Posthrg. Br. at 8, 9 n.4 (citation
omitted). However, this does not mean that Dr. Busby, in applying
his own level of knowledge and understanding of medicine, thereby
applied the "professionally recognized standards of care" to
determine the quality of care issue. As stated in the regulation,
"professionally recognized standards of health care" are statewide
or national standards of care that professional peers of the
individual 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. This regulatory definition implies
the existence of some specific, quantifiable level of quality on
which professional peers as a group can agree.
The evidence of record establishes that Dr. Busby has specialties
and qualifications which are different than Petitioner's (see
section V.B., below). His testimony did not establish the
professionally recognized standards of Petitioner's peers, against
which each of the services in issue should be measured and deemed
deficient. Therefore, I am unable to conclude from Dr. Busby's
testimony and written report that Petitioner's treatment failed to
meet such a standard.
III. The medical records Petitioner submitted to the Carrier in
support of particular claims for Medicare reimbursement are not
sufficient to prove a basis for the exclusion in this case.
The I.G. failed to establish a basis for Petitioner's exclusion by
relying upon Dr. Busby's opinions. Likewise, the I.G.'s reliance
on only the medical records Petitioner submitted to the Carrier
seeking payment of particular Medicare claims fails to establish a
basis for Petitioner's exclusion.
The I.G. argues that Dr. Busby's testimony establishes that not
having enough medical documentation violates common or acceptable
standards of medical practice. Tr. 216. By medical
"documentation," Dr. Busby meant the requirement for documenting a
comprehensive history and a thorough examination before ordering a
diagnostic test or rendering an opinion leading to treatment. 13/
Tr. 130 - 31.
The I.G. argues that it was not necessary for Dr. Busby or the I.G.
to review the full medical file of each patient, or even any other
medical records than those reviewed by Dr. Busby. The I.G. reasons
that the "requirements of claims submission under prepayment review
in this case and good medical practice in general demands that
contemporaneous support for all tests and services be recorded on
the date rendered, and a reviewer or tribunal, consequently, need
look no further than the contemporaneous record made . . . in order
to evaluate the reasonableness of the services rendered" that day.
I.G. Posthrg. Reply at 3 (citations omitted). The I.G. has framed
the issues thus throughout the hearing:
[A]s we have stated from the beginning the issue is not
whether these tests are useful in diagnosing disease.
The question is whether they are called for based upon the
medical records which were submitted by Dr. Vest for the purpose of
having his claims paid after being repeatedly instructed as to what
was necessary to put into those tests [sic] . . . .
Tr. 214.
And I believe that that is the ultimate issue in this case:
medical necessity as defined by the submission of medical records
for the purpose of payment.
Tr. 215.
And more important to the issue here today, for the purpose of
reimbursement, you have to have the documentation.
Tr. 216. The I.G. argues that inadequacies in the documents
Petitioner submitted to the Carrier in order to seek Medicare
reimbursement prove that he provided services in substantial excess
of patients' needs and of a quality which failed to meet
professionally recognized standards of care. Tr. 216; I.G.
Proposed Findings 84, 85. The I.G. contends that the Carrier's
prepayment review process placed obligations upon Petitioner to
submit comprehensive documentation with his claims. I.G. Posthrg.
Br. at 12; I.G. Proposed Finding 40.
I reject the I.G.'s premise that the prepayment review process
imposed documentation submission obligations upon Petitioner, which
entitled the I.G. to impose an exclusion based only on those
documents Petitioner submitted with his Medicare claims. The
testimony before me indicates that the Carrier utilizes
professionally recognized standards for documentation in
determining whether payment is due under the Medicare program. Tr.
129 - 30, 216. But it does not follow that a physician's failure
to satisfy Medicare reimbursement procedures conclusively proves
that he has violated the professionally recognized standard for
medical documentation.
Physicians participate in Medicare Part B on a voluntary basis.
Act, section 1842(h)(1). If physicians do not submit documents
which will enable the carrier to make its determinations, the
physicians should not receive Medicare payments, whether or not
they are under a prepayment review system. The mere failure to
send the necessary documents to the carrier in support of a claim,
even assuming that the carrier had denied payment for that reason,
should not cause the I.G. to conclude that a physician must be
excluded under section 1128(b)(6)(B) of the Act. As stated in the
preamble to the Secretary's regulations, the I.G. is to determine
liability under section 1128(b)(6)(B) of the Act based on "all of
the facts available." 57 Fed. Reg. 3306 (Jan. 29, 1992).
I have noted already Dr. Busby's testimony that he was told by the
I.G. not to review certain types of records in preparing his
exclusion recommendation, that he did not select patient services
randomly for his review, and that he reviewed only the medical
records associated with particular claims because to do otherwise
would have been very time-consuming under the Carrier's record
maintenance system. In essence, the I.G. and Dr. Busby limited
"all of the facts available" for the determination of Petitioner's
liability to only those facts that would support the Carrier's
recommendation to exclude Petitioner.
I find relevant and persuasive the testimony of Petitioner's expert
witness, Dr. Rodolfo Beer, who stated that no physician would
diagnose or treat a patient based on only part of the patient's
available records. Tr. 519 - 20. Dr. Beer testified that it was
bad practice for any physician to provide an opinion without
reading a patient's full chart. Tr. 520. Nowhere in the record is
there any testimony that any physician considers it appropriate to
evaluate a patient's medical needs or the quality of health care
services provided to a patient by using only the documents
associated with Medicare claims for services rendered on particular
days. As discussed earlier, even Dr. Busby indicated that he did
not think the limitation was proper, in that he had repeatedly
asked the I.G. if he should consider additional information. E.g.,
Tr. 183. The memorandum Mr. Patton issued earlier on behalf of the
I.G. to the Carrier shows also that an exclusion may not be
appropriate based only on an evaluation of a patient's needs on a
given day or on the quality of services reviewed in isolation. See
P. Ex. 82.The memorandum notes that providers have been able to
justify their services at the administrative review level based on
pre-service and post-service records. Id.
It is true that the I.G. reasonably could have inferred that
certain documents were never created, or certain information was
never taken, when Petitioner did not submit them to the Carrier in
support of his Medicare claims for reimbursement. However, such
inferences have been rebutted by Petitioner in several ways.
First, there is Dr. Beer's testimony, which was based on a full
evaluation of each of the 10 patients' complete medical records.
Tr. 519. His conclusion was that the information Dr. Busby thought
missing was in the patients' files and that the information
contained in the patients' files exceeded the standards of the
medical community. Tr. 523. I find Dr. Beer's testimony on these
matters to be credible for the following reasons: 1) his testimony
was based on a review of the entire patient files; 2) he did not
have anything to gain if the decision to exclude Petitioner is
reversed; 3) he is a practicing physician who actually diagnoses
and treats patients; and 4) he Beer is familiar with the standard
of practice applicable to the area where Petitioner practices. Tr.
518.
In addition, Petitioner has demonstrated good reasons for having
failed to send the Carrier more records in support of each Medicare
claim. Petitioner acknowledges that he did not submit cumulative
records with each Medicare claim. However, he testified, and his
counsel argued, that he had sent the Carrier "everything,"
including prior and subsequent records for patients, and that the
Carrier had patient files in their entirety in its possession. Tr.
247, 386 - 87. Petitioner's testimony is consistent with the
I.G.'s stipulation that the patient files in their entirety are in
the possession of the program. Tr. 506 - 08.
I find credible Petitioner's explanation that, when he was
receiving payments from the Carrier for services claimed pursuant
to the full pre-payment review process, such payments led him to
believe that the records he submitted to the Carrier were adequate,
proper, and satisfactory to the Carrier to show the medical
reasonableness and necessity of such services under Medicare
payment criteria. See Tr. 162 - 63. His explanation is consistent
with his testimony that he thought he was doing things correctly
but would have sent in additional records if he had perceived a
need to do so. Tr. 386 - 87. Even Dr. Busby acknowledged that it
was "possible" for Petitioner to reach a reasonable conclusion
that, because the Carrier was authorizing Medicare payments for
these claims, Petitioner need not send additional supporting
medical records. Tr. 162 - 63.
The totality of the evidence fails to support the I.G.'s contention
that a valid basis for this exclusion has been proven by Dr.
Busby's evaluation of medical records submitted by Petitioner only
for the purpose of claiming Medicare reimbursement.
IV. The I.G. did not prove that other evidence or medical opinions
supports her determination that a basis for the exclusion exists.
The I.G. has alleged on at least one occasion that Mr. Patton of
the I.G.'s staff made the exclusion determination "upon
consultation with OIG's own medical advisors." I.G. Posthrg. Br.
at 8. However, the I.G. has never attempted to introduce into
evidence the identities and opinions of these medical advisors. I
agree with Petitioner that, if the I.G. had resorted to other
medical experts' advice in imposing the exclusion, these experts'
qualifications and opinions are not of record, and the I.G. cannot
rely on the existence of such experts or opinions. See P. Posthrg.
Reply at 1.
The I.G. alleged also that Mr. Patton had reviewed all of the
evidence alluded to by Petitioner during an earlier administrative
proceeding conducted by the I.G.'s office. I.G. Posthrg. Reply at
2. Again, the I.G.'s evidence does not establish the truth of that
representation. The I.G.'s evidence establishes only that Dr.
Busby did not have knowledge of such evidence. Tr. 96.
As a result of the I.G.'s decision to present only the medical
report and testimony of Dr. Busby, the gaps in Dr. Busby's
knowledge concerning the I.G.'s reasons for excluding Petitioner
reinforce Petitioner's argument that physicians may have legitimate
bases for their disagreements and mere differences in their
professional opinions cannot suffice as a basis for an exclusion.
See, e.g., Tr. 155 - 56.
I note, for example, that Dr. Busby, in recommending that the I.G.
exclude Petitioner, provided opinions adverse to Petitioner on 77
services, which were described in 75 paragraphs of his report.
I.G. Ex. 12. In the notice of the I.G.'s intent to exclude
Petitioner, Mr. Libercci of the I.G.'s staff omitted at least three
of those services without explanation. See I.G. Ex. 12 at 123
(X-rays of the cervical spine and X-rays of lumbosacral spine and
MRI of lumbar spine for Patient L.W. on August 5, 1993); I.G. Exs.
1, 2 at 12. After Petitioner appeared in person for the submission
of documents and oral arguments to Dr. Kenneth Nelson of the I.G.'s
office in Baltimore, Maryland (Petitioner had no opportunity to
examine or cross-examine witnesses during this presentation (P. Ex.
4)), Mr. Patton of the I.G.'s staff summarily eliminated seven
additional findings when he issued the notice of exclusion. I.G.
Ex. 5.
The I.G. has not attempted to prove what evidence was considered by
anyone other than Dr. Busby. Even though the I.G. points out that
Petitioner had the opportunity to submit additional medical records
to the I.G.'s medical reviewer, Dr. Nelson (I.G. Posthrg. Br. at 11
n.5), the problem here is that, even though Petitioner appears to
have submitted additional medical records, the I.G.'s evidence does
not show that the additional records were analyzed.
There is, moreover, no adequate evidence explaining how the I.G.
equated Dr. Busby's findings that certain services were medically
unnecessary or of poor quality with the requirements for an
exclusion under section 1128(b)(6)(B) of the Act: that the care
substantially exceeded the patients's needs or was of a quality
that failed to meet professionally recognized standards of health
care. Act, section 1128(b)(6)(B). The notice of the I.G.'s intent
to exclude Petitioner under section 1128(b)(6)(B) of the Act
contains the first of many instances in which the services
characterized by Dr. Busby as "medically unnecessary" and of "poor
quality" were described by the I.G. as "substantially in excess of
the needs of such patients" and failed to meet professionally
recognized standards of health care. I.G. Ex. 1.
The I.G. argues in her brief that, because the diagnostic tests and
medical services furnished to 10 patients were not justified by the
medical findings reviewed by Dr. Busby, they were therefore "in
excess of the patient's needs," and the I.G. was entitled to
conclude that Petitioner provided services "substantially [in the
main, in substance] in excess of the patients' needs." I.G.
Posthrg. Br. at 8. Elsewhere in the Decision, I discuss in detail
the consequences of the I.G.'s failure to analyze additional
evidence. I note here, however, that the I.G.'s alleged limitation
of her exclusion determination to only those documents reviewed by
Dr. Busby does not comport with Petitioner's opportunity to submit
additional evidence for the I.G.'s consideration in response to the
notice of intent to exclude him, and such a limitation does not
comport with the I.G.'s prior representation to Petitioner that
everything he submitted would be used in the exclusion
determination. 42 C.F.R. 1001.2001(b); P. Ex. 4.
Based on the record as a whole, there is an inadequate basis to
conclude that the I.G.'s exclusion determination had greater
factual support or was better reasoned than the opinions provided
by Dr. Busby, which also do not establish a basis for the
exclusion.
V. The evidence introduced by Petitioner is more credible than
that introduced by the I.G.
A. Petitioner is entitled to rely on medical opinions
regarding his patients' complete medical records.
In her reply brief, the I.G. argues that the additional medical
documents alluded to by Petitioner and Dr. Beer at the hearing are
not of record, and, therefore, they are not before me. I.G.
Posthrg. Reply at 2. The I.G. argues also that it is illogical for
Petitioner to require Dr. Busby, and me -- by extension, to review
a patient's entire medical history before rendering an informed
opinion. Id. at 3.
I find these arguments to be without merit.
Petitioner is properly arguing the consequences of Dr. Busby's
failure to conduct as complete a review of the available medical
records as he (Petitioner) and Dr. Beer testified to have done. It
may be that, in the example cited by the I.G. (the X-ray of the
left foot when there were documented complaints for the right
foot), no additional amount of document review could have changed
Dr. Busby's opinion that the procedure was unnecessary. Id.; but
see P. Ex. 79 at 1 (Dr. Beer's Affidavit with contrary opinion and
reasons). However, there are other opinions rendered by Dr. Busby
which, on their face, could have benefitted from the review of
additional medical records. For example, Dr. Busby criticized the
MRI done for Patient G.N. as medically unnecessary, partly because
a prior hospitalization with a diagnostic workup "may have included
this study." I.G. Ex. 12 at 194 (emphasis added). Other examples
include the CBC and differential WBC and 23-test blood chemistry
panel performed on August 19, 1993 for Patient J.M., which Dr.
Busby found to be medically unnecessary because they had already
been done during the patient's July 3, 1993 visit. I.G. Ex. 12 at
113. However, Dr. Busby acknowledged that there are frequently
justifications for repeating tests. Tr. 204 - 05. Dr. Beer
pointed out that some of the tests were repeated after a few days
of treatment in order to track the effectiveness of treatment. Tr.
533. Dr. Busby testified also that having additional records may
have clarified matters, eliminated some of his concerns, or altered
his opinions. E.g., Tr. 109, 126, 182. I cannot agree with the
I.G. that Dr. Busby rendered informed opinions when other
physicians who are no less qualified than he is have reached
contrary conclusions based on medical records he failed to read.
With respect to the I.G.'s argument that the additional medical
documents referenced by Petitioner and Dr. Beer are not of record,
I note that Petitioner moved to introduce them at the hearing. Tr.
506 - 08. Petitioner explained his failure to offer the additional
medical records prior to hearing by alleging that he was surprised
by the I.G's reliance at the hearing on a theory of inadequate
documentation. Tr. 214 - 15, 506. I find Petitioner's explanation
to be reasonable. As I have noted previously, the I.G. has an
obligation to determine the exclusion based on "all of the facts
available" (57 Fed. Reg. 3306 (Jan. 29, 1992)), Petitioner had
informed the I.G. that she should consider other records he had
submitted to the Medicare program (P. Ex. 5 at 2), and the I.G.
represented to Petitioner that any additional evidence provided by
Petitioner would be considered in the exclusion determination (P.
Ex. 4). Nothing in the exclusion notice or the I.G.'s prehearing
brief had placed Petitioner on notice that the I.G. would then
describe her position thus at hearing:
[I]t has been the Inspector General's position all along that
Dr. Vest had provided care which is medically unnecessary and
substantially in excess of the patient's needs, because the
treatments and the diagnostic tests which he is administering are
not borne out by the medical records which he submitted in support
of their payment.
Tr. 507. Moreover, despite the I.G.'s additional contention at
hearing that Petitioner should be able to point to information in
his medical records that "substantiates [his] follow-up actions"
(id.), the I.G. objected to Petitioner's introducing the records
favorable to Petitioner at the hearing. Tr. 508.
The additional medical documents considered by Petitioner and Dr.
Beer were not admitted into the record only because Petitioner
withdrew his motion to have them admitted upon the I.G.'s
stipulation that copies of those documents were in fact received by
the "Medicare program." Tr. 507 - 08. Implicit in the I.G.'s
stipulation is the fact that the Carrier, Dr. Busby, and the I.G.
have had the opportunity to evaluate the additional documents and
to refute the conclusions of Dr. Beer and Petitioner. Moreover,
Petitioner had also made available at the hearing the additional
medical records for the I.G.'s review and use during
cross-examination. Tr. 434 - 35. At no time did the I.G. review
or make use of the additional medical records, or refute the merits
of the medical opinions based on a review of the patient records in
their entirety. 14/
For the foregoing reasons, I find it proper to give weight to the
opinions of Dr. Beer and Petitioner based on the contents of the
complete patient files even though these patient files are not of
record.
B. Based on the experts' professional experiences and the
documents they reviewed, I have given greater weight to the
opinions of Petitioner and his expert witness than the contrary
opinions of Dr. Busby.
The I.G. contends that a recurring pattern in the records reviewed
by Dr. Busby is that the medical findings in the records submitted
by Petitioner in support of his Medicare claims do not correspond
to or substantiate the need for the diagnostic tests that were
ordered. See I.G. Proposed Finding 49 (citing Tr. 105). Dr.
Busby's qualifications bear on the weight to be accorded his
observations because, as discussed above, Dr. Busby was applying an
evaluation standard based on his personal level of medical
knowledge and understanding. He and Petitioner agree that, in
order to treat an individual appropriately, there must be an
appropriate level of knowledge or understanding of the disease
process, which will then permit an appropriate interpretation of
all the information gathered from a comprehensive medical history
and a thorough medical examination. Tr. 225, 429. I believe the
same is true in the situation where a physician is reviewing
medical records in order to determine the patient's needs or the
appropriateness of the care rendered to that patient. Even the
definition of professionally recognized standards of health care
refers to the "peers" of the individual whose services are at
issue. See 42 C.F.R. 1001.2. Therefore, I have analyzed the
professional experiences of the three physicians whose opinions are
of record.
I agree with Petitioner that Dr. Busby lacks experience in
diagnosing and evaluating the ailments of elderly patients who may
have multisystem disorders that may not be manifested in the same
way as in younger patients. Dr. Busby has a subspecialty in
aerospace medicine, which is a specialized form of occupational
medicine. Tr. 39 - 40. His principal responsibility as the
Carrier's Medical Director is interpreting Medicare coverage for
purposes such as the reimbursement of services. Tr. 41. He has
experience in containing health care costs from his current
position with the Carrier as well as from his prior position as the
medical director for LTV Steel. Tr. 44, 147 - 48.
Whereas Dr. Beer and Petitioner have been involved in direct
patient care for a number of years, there is no evidence that Dr.
Busby has maintained a medical practice or has provided direct
patient care since assuming his position as the Carrier's Medical
Director. In the past, Dr. Busby has covered a general practice
intermittently over a period of 25 years, but he could not say how
many patients he had actually treated. Tr. 145 - 46. Even though
the services in issue were provided to elderly Medicare patients,
Dr. Busby has never specialized in geriatric medicine and could not
say how many geriatric patients he has treated. Tr. 221. He has
never conducted a health examination on patients over 60 years of
age. Tr. 147. He has diagnosed and treated patients in their 70's
when he worked in an emergency room or covered a general practice;
but he has not treated such patients on a regular basis. Tr. 147
- 48. He agreed that geriatric medicine usually involves
multi-system diseases; that, as a general rule, certain diseases
would present classical signs and symptoms in the young but not in
the elderly; and that, in some cases, treating one disorder without
treating associated disorders can accelerate complications. Tr.
221, 223, 224. He did not use any medical literature in reaching
his conclusions that the 72 services he reviewed were medically
unnecessary or of poor quality. Tr. 208.
I find the foregoing evidence to be relevant to the issue of which
medical expert's opinions are entitled to greater weight with
respect to the services in controversy. I use as examples the
multi-panel tests criticized by Dr. Busby, because the I.G. alleged
that it was Petitioner's pattern of ordering blood chemistry panels
which caught the attention of the Carrier, and for which Petitioner
was excluded. I.G. Prehrg. Br. at 22.
The I.G. cited 13 instances in which Petitioner ordered such tests
for 10 Medicare patients he saw during 1992 and 1993. I.G. Prehrg.
Br. at 20. Most of Dr. Busby's opinions concerning these tests
indicate that he felt them medically unnecessary because either no
test within the panel was indicated by the patients' symptoms or
complaints in the documents he reviewed, or only a small number of
tests within the panel were indicated. I.G. Ex. 12. 15/
Petitioner and Dr. Beer disagree with Dr. Busby's conclusions. In
addition to discussing information not mentioned by Dr. Busby, Dr.
Beer and Petitioner also cited Medicare reimbursement rules
concerning the payment of full, automated panel tests on the
patient's initial visit when one or more tests is needed. E.g., P.
Ex. 79 at 6, 8. Dr. Busby agreed that Medicare payment regulations
provide for payment of the initial battery of tests if one of the
tests in the battery relates to the patient's complaints. Tr. 186
- 88.
However, Dr. Busby insisted that performing the additional tests in
the battery would not be appropriate even though the full panel
would be paid under Medicare reimbursement criteria. Tr. 186 - 87,
190 - 91. His reasoning was that he conducted his review under the
I.G.'s guidelines, and the I.G. told him not to consider prices in
his analysis. Tr. 190 - 91. 16/ He testified, however, that if he
had a medical practice and were billing for his services, he would
consider cost, and that a doctor diagnosing patients in his office
would consider the cost of the tests to be used. Tr. 196 - 97.
Petitioner and Dr. Beer testified concerning the atypical
presentation of disease symptoms, the likelihood of multi-system
ailments in the elderly, and the difficulties in diagnosing the
elderly as justifications for some of the multi-panel tests at
issue. E.g., Tr. 361 - 64, 521, 531. As noted by Dr. Beer, the
youngest of the patients considered in Dr. Busby's report was 69
years old, and the oldest was 84 or 85 years old. Tr. 521. Dr.
Beer, who has practiced as a general surgeon in the Alton area
since 1967 (Tr. 517 - 18), and who has no interest in the outcome
of this case, felt the full panel tests were important because all
systems have some sort of derangement at these advanced ages, and
the full panel tests provide a good means to obtain quick
information and evaluation of practically every system. Tr. 521,
531.
Also according to Petitioner, the full-panel automated test costs
approximately $26 under the Medicare program guidelines; it gives
valuable information quickly; its results are simpler to obtain
than reprogramming the equipment to obtain separate test results;
and having the full panel done is less costly in the long run
because it avoids the physician's having to guess at some of the
results. Tr. 359, 361. Petitioner's cost information is
consistent with the information contained in the Medicare Carrier
Manual, which acknowledges that the cost of a battery of tests is
ordinarily low as compared with the cots of tests performed
individually. See I.G. Prehrg. Br. at 22. 17/
For these reasons, I did not find Dr. Busby's opinions on the
multi-panel tests and other services more credible or persuasive
than the contrary medical opinions submitted by Petitioner and his
expert witness, Dr. Beer.
CONCLUSION
The totality of the record before me reveals numerous problems with
Dr. Busby's opinions and the I.G.'s case. In addition, I found more
persuasive the contrary medical opinions submitted by Petitioner
and Dr. Beer, who are experienced in the diagnosis and treatment of
geriatric patients and have reached their conclusions based on a
review of complete patient files. I conclude that the I.G. has
failed to prove a basis for the exclusion under review.
Accordingly, I set aside the five year exclusion imposed and
directed by the I.G.
Mimi Hwang Leahy
Administrative Law Judge
1. Section 1842 of the Act specifies the use of carriers for
the administration of benefits under the Supplementary Medical
Insurance Benefits for the Aged and Disabled program, known as
Medicare Part B. As explained by regulation, the term "carrier"
means an entity that has a contract with the Health Care Financing
Administration (HCFA) of the Department of Health and Human
Services (HHS) to determine and make Medicare payments for Part B
benefits and to perform other related functions. 42 C.F.R.
400.202.
2. In two instances, Dr. Busby's report included several
services in a single paragraph. In reporting on the treatment of
Patient L.W. on August 5, 1993, Dr. Busby included in one paragraph
two services: X-rays of lumbosacral spine and MRI of lumbar spine.
I.G. Ex. 12 at 123. Also, in reporting on the treatment of the
same patient on August 13, 1993, Dr. Busby included in one
paragraph these three services: CT abdomen, CT pelvis, and X-ray
abdomen. I.G. Ex. 12 at 148.
3. In order to permit administrative law judges to continue
their practice of allocating the burden of proof as they see fit,
the regulations do not specify which party bears the burden of
going forward or which party has the burden of persuasion in cases
involving exclusions under section 1128(b) of the Act. 57 Fed.
Reg. 3326 - 27 (Jan. 29, 1992).
4. After the hearing, the I.G. reargued the relevancy and
weight of certain of the I.G.'s proposed exhibits which I had
excluded. I have treated those arguments as the I.G.'s motion for
reconsideration, which I deny in a ruling issued concurrently with
this decision.
5. During the hearing, Petitioner requested partial summary
judgment based on these arguments. Tr. 8 - 12. I denied the
motion. However, Petitioner's arguments established the relevancy
of his Medicare payment evidence.
6. Even though the I.G. used the aggravating factor codified at
42 C.F.R. 1001.701(d)(2)(iv) to allege a financial loss to the
Medicare program of $1500 or more due to the prepayment review of
Petitioner's claim and Petitioner's exercise of his administrative
appeal rights (I.G. Ex. 4 at 3), there is no proof what funds the
I.G. considers to be from the "Medicare program," and there is no
evidence explaining the source of funds HCFA provides to the
Carrier each year to process Medicare claims. The I.G. evidence
shows only that the amount of financial loss alleged to support
this aggravating factor came from the Carrier's budget. Tr. 91.
7. At the hearing, the I.G. did not object to P. Ex. 9, and I
admitted it. Tr. 3.
8. I assume this is the reason why Dr. Busby and the I.G.
reached certain conclusions, such as that an MRI service provided
by Petitioner was medically unnecessary in part because a
diagnostic workup done during the patient's prior hospitalization
"may have included this study." I.G. Ex. 2 at 17; I.G. Ex. 12 at
194.
9. I do not imply that Dr. Busby's conclusions on "medical
necessity" are immaterial to the issue of whether the I.G. had a
basis for imposing the present exclusion under section
1128(b)(6)(B) of the Act. "Unnecessary" could mean not needed at
all in ordinary usage, and it is possible to construe several of
Dr. Busby's opinions as meaning that the services were not needed
at all by the patients (as opposed to being merely non-essential).
However, as noted elsewhere in this Decision, there are contrary
medical opinions concerning the patients' needs.
10. In her prehearing brief, the I.G. generally stated that the
Carrier's payment was based on a "different standard" than that
considered by Dr. Busby. I.G. Prehrg. Br. at 15. However, the
different standard appears to relate only to the allegedly more
thorough review done by Dr. Busby. For example, when the I.G.
opposed Petitioner's use of the Medicare payment evidence, she
argued only that the Carrier's prior Medical Director did not
personally approve the claims, that the qualifications of those who
approved the claims were not of record, and that Dr. Busby
conducted a more thorough review for the I.G.'s sanction action.
Tr. 12 - 14.
11. "Q: And how, if at all, does that differ from a finding
that the care was medically unnecessary or in excess of the
patient's needs?" Tr. 122.
12. Such services include eye examinations for the purpose of
prescribing, fitting, or changing eyeglasses or contact lenses;
examinations for prescribing, fitting, or changing hearing aids;
immunizations; dental services in connection with the care,
treatment, filling, removal, or replacement of teeth, or structures
directly supporting the teeth. 42 C.F.R. 411.15.
13. One of the significant documentation problems alleged by the
I.G. is the absence of notation in any of the records reviewed by
Dr. Busby concerning whether Petitioner had discussed with the
patient why a test was ordered, what the tests results were or what
they meant, or why a prescribed course of treatment was needed.
See, I.G. Proposed Finding 51 (citing Tr. 106). However, the
evidence is unclear as to which records submitted to the Carrier
should have contained a physician's discussions of treatment
courses and needs with his patient. Moreover, the Carrier's letter
to Petitioner specifies that the patient's "initial history and
physical" must be submitted, whereas the Carrier's internal
memorandum to staff states that the patient's "complete history and
physical to each claim" must be submitted. I.G. Ex. 9 at 2; P. Ex.
9 at 87.
14. In my Ruling Denying the I.G.'s Motion for Reconsideration
Concerning the Exclusion of I.G.'s Proposed Exhibits 17 to 24, I
discuss and reject the possible inference that the I.G.'s proposed
exhibits pertaining to criminal proceedings involving the
falsification of different patient records may suggest that
Petitioner has fabricated or lied about the medical records in this
case. For this Decision, I re-emphasize that the use of such an
inference is inappropriate, since the I.G. has had ample
opportunity to gather and introduce proof of any alleged
fabrication of the records used in this case. There is no proof
that Petitioner has fabricated or lied about any medical record
used in this case.
15. Elsewhere in this Decision, I have noted Dr. Busby's
conclusion that Petitioner unnecessarily ordered at least two of
the same tests for a patient on a subsequent visit. There are
contrary medical opinions concerning the necessity of those
repeated tests, including the testimony of Dr. Beer, who explained
that Petitioner ordered the same tests after a few days of
treatment in order to evaluate the success of the treatment. Tr.
533.
16. There were extensive objections and argument by the I.G.,
as well as statements by Dr. Busby, concerning why Petitioner
should not delve into or rely on Medicare payment rules concerning
these laboratory tests. Tr. 189 - 96. To the best of my
understanding, Dr. Busby's position is that payment information is
not relevant to his opinion because he received the I.G.'s
directive not to consider cost or payment information. To the best
of my understanding, the I.G.'s objections and arguments are that,
because Dr. Busby did not consider Medicare payment codes or
outcomes in recommending Petitioner's exclusion, Dr. Busby
conducted a review for medical necessity that is distinct from the
review done for Medicare payment purposes pursuant to the statutory
prohibition against reimbursing for services that are medically
unreasonable and unnecessary. See Act, section 1862(a)(1)(A). I
do not think either the I.G. or her witness has adequately
addressed the inference from the payment rule or regulation cited
by Petitioner that there exist administratively noticed facts and
determinations favorable to Petitioner with respect to the medical
necessity and reasonableness of ordering full panel tests on a
patient's initial visit when only one test of the panel is
warranted by the patient's condition.
17. The I.G. noted also the part of the Medicare Carrier Manual
which states that the periodic auditing of bills, reviewing
physician service profiles, and analyzing large volumes of
continuing batteries of tests for possible repeat tests, creates a
financial burden on the Medicare program. I.G. Prehrg. Br. at 22
(citation omitted). However, the cost of auditing providers or
analyzing tests does not provide a basis for exclusion under
section 1128(b)(6)(B) of the Act.