Unpublished Disposition, 917 F.2d 566 (9th Cir. 1986)

MEMORANDUM^* 

Kenneth J. Coffield appeals from a decision of the district court affirming a final decision of the Secretary of Health and Human Services (the Secretary), to suspend Coffield's Medicare and Medical reimbursement privileges for a period of ten years beginning October 17, 1982. Cases involving the standard for such sanctions are hard to find. As a matter of first impression in this circuit, we examine a process at the heart of governmental funding of health services--the process in which peers judge the performance of peers in observing professional standards of medical care.

BACKGROUND

Coffield is a physician who graduated cum laude from Harvard College in 1948 and received an M.A. in chemistry from Harvard in 1949. He graduated in 1953 from the School of Medicine of the University of Chicago. He was board-certified in internal medicine in 1965 and recertified in 1974. He was a clinical instructor in medicine at the University of California School of Medicine from 1964-1967. From 1963 to 1982 he practiced in Vallejo, California, with staff privileges at Vallejo General Hospital. He was reimbursed by the United States under Medicare. Half of his patients were paid for by this source. When Coffield was threatened with their loss he fought hard. Still perceiving himself as unfairly treated, he continues to fight hard.

Physicians reimbursed by Medicare must supply care "of a quality which meets professionally recognized standards," 42 U.S.C. § 1320c-9(a) (1).¹  In order to assure such professional standards in the delivery of health care under Medicare, Congress has provided for the establishment in each local area of a Professional Standards Review Organization (PSRO). A PSRO is a nonprofit professional association composed of licensed doctors of medicine or osteopathy with a membership "which includes a substantial proportion of all such physicians" in the area and whose membership is open to all such physicians in the area. 42 U.S.C. § 1320c-1(b). The Secretary must designate the area and approve the organization, whose purpose is to make available professionals competent to review health care services for which the United States pays under Medicare and to determine whether the quality of the service "meets professionally recognized standards of health care." 42 U.S.C. § 1320c-4(a).

When a doctor may have violated the standards of health care a PSRO is to give him "reasonable notice and opportunity for discussion." 42 U.S.C. § 1320c-9(b) (1). If the PSRO then determines that the doctor has violated the obligations imposed by the statute it must submit a report and recommendations through the Statewide Professional Standards Review Council (the Council) to the Secretary. If the Secretary determines that the doctor in providing health care services has "demonstrated an unwillingness or a lack of ability substantially to comply" with the obligation imposed by the statute of supplying care "of a quality which meets professionally recognized standards," the Secretary may exclude the doctor permanently from reimbursement. Id. Demonstration of such unwillingness of lack of ability is made, according to the statute, in even one case of a doctor "grossly and flagrantly violating" his obligation to provide professional quality care.

In July 1980 the North Bay PSRO (NBPSRO) for Solano, Marin and Napa counties sent two internal medicine consultants to the hospital to review 20 of Coffield's cases. The cases reviewed were one group consisting of his most recent admissions to the hospital; a second group chosen at random; and a third group furnished by the Utilization Review Committee of the hospital. The consultants found problems in the charts they reviewed. The NBPSRO then selected 10 of the cases for review by two internists from its board of directors plus one internist from each of the three counties. This committee recommended that the NBPSRO consider recommending sanctions against Coffield for gross and flagrant violations of his duty to provide professional care.

The NBPSRO concentrated on five of the 10 cases. The five consultants reviewed them further. After receiving the consultants' report, the NBPSRO Board on September 25, 1980 recommended unanimously that Coffield be excluded from participation in the Medicare program.

Coffield was notified that within 20 days he could request a meeting with the NBPSRO to review the recommendation. Represented by counsel, Coffield had two meetings with the NBPSRO on November 13 and 25, 1980. On January 12, 1981 the Board voted unanimously to reaffirm its initial determination.

On March 13, 1981 the NBPSRO notified the Council of its recommendations. On April 20, 1981 the Council affirmed the NBPSRO's finding that Coffield had violated his obligations and recommended to the Secretary that sanctions be imposed.

On March 21, 1982 the Secretary informed Coffield that it proposed to exclude him from Medicare reimbursements for 10 years. The Secretary also informed Coffield of his right to object to this exclusion. In response, Coffield on April 8, 1982 submitted additional information as to the five cases in the form of a review by Paul A. Fitzgerald, M.D.

On September 17, 1982 the Secretary notified Coffield that, based on a review of all the evidence in the record, he was being excluded from the Medicare program for 10 years because he had failed to meet professionally recognized standards of health care. The suspension went into effect October 17, 1982.

Pursuant to 42 U.S.C. § 1320c-9(b) (4) Coffield requested a hearing on his suspension before an administrative law judge. The hearing was held before Judge Gilbert Pavlovsky in a series of sessions between September 1983 and January 1984, totaling over 21 days. On August 16, 1984 Judge Pavlovsky affirmed the Secretary's decision. He found that four of the five cases showed Coffield rendering services grossly and flagrantly below professionally recognized standards and that in the fifth case he had grossly overused hospital services. He concluded that Coffield had demonstrated an unwillingness and a lack of ability substantially to comply with his obligation to provide professional health care.

Coffield appealed from this decision to the Appeals Council of the Secretary. On December 31, 1985 the Appeals Council issued a decision affirming Judge Pavlovsky's decision.

On March 4, 1986 Coffield filed suit in the district court challenging the Secretary's action under 42 U.S.C. § 1320c-9(b) (4) and 42 U.S.C. § 405(g). The district court granted summary judgment for the Secretary. Coffield appeals.

ANALYSIS

The findings of the Secretary will be upheld unless they are not supported by substantial evidence in the record as a whole. 42 U.S.C. § 405(g). Substantial evidence is more than a scintilla and less than a preponderance and is "such relevant evidence as a reasonable mind might accept as adequate to support a conclusion." Richardson v. Perales, 402 U.S. 389, 401 (1971). Substantial evidence supports the Secretary's findings here. Reviewing the grant of summary judgment de novo, we conclude that there is no issue as to the existence of any material fact and that as a matter of law the Secretary is entitled to judgment.

Under the statute a single example of gross and flagrant violation of professional standards suffices to demonstrate a doctor's inability to comply with professional standards. The key statutory language is "grossly and flagrantly." We look first to the agency charged with the administration of the statute to interpret these terms. The Secretary has taken a pass.²  He has declined to define the terms because "they should be interpreted in accordance with common usage. They do not have a special meaning in this context." 45 Fed.Reg. 11436, 11437 (Feb. 20, 1980). Accordingly, we go to the dictionary. "Gross" refers to "inexcusable faults or offenses displayed blatantly, callously, coarsely, and without mitigation or palliation." "Flagrant" refers to "offense or errors so conspicuously or outstandingly bad that it is impossible not to notice them." Webster's Third New International Dictionary (1981) at "flagrant." We conclude: What is done grossly and flagrantly is "error committed blatantly and conspicuously, without mitigation." What is blatant must be flagrant. The terms "grossly and flagrantly" do not point to different kinds of conduct. They reinforce each other. What is gross and flagrant is not medical treatment so bad that a layperson would recognize it and be shocked. What is gross and flagrant in this context is what qualified, unbiased physicians, familiar with the facts, find gross and flagrant. In the hearing by the administrative law judge the government's medical experts stated that they understood the terms to mean a major deviation from the community standard that a reasonable physician would apply. This view is congruent with the definition here established. Cf. Varandani v. Bowen, 824 F.2d 307, 312 (4th Cir. 1987) ("The definition of adequate medical care cannot be boiled down to a precise mathematical formula; it must be grounded in what, from time to time, other health professionals consider to be acceptable standards of health care."), cert. denied, 484 U.S. 1052 (1988).

Case 3, as set out by the administrative law judge, shows such gross and flagrant failure. In Case 3, a 31 year-old man, a long-standing patient of Coffield, was admitted by him from the emergency room to Vallejo General Hospital. He complained of abdominal pain. Coffield's immediate diagnosis was that he suffered from diabetes mellitus, out of control because the patient had not been taking his insulin. Coffield also noted a history of recurrent pancreatitis and severe bronchial asthma. Twenty days after admission the patient died.

The NBPSRO's summary of the case, along with Coffield's responses, is as follows:

Substandard Care, of a gross and flagrant nature, as evidenced by:

Diabetic control erratic. It was inappropriate to increase the Lente Insulin without monitoring afternoon blood sugars.

* * *

* * *

Doctor Coffield's written response

It is well recognized that the patient's diabetic control was erratic as it could be nothing else in face of infection, emaciation and anti-asthmatic medication.

In the face of persistent glycosuria the monitoring of glucose would have been utterly meaningless.

At 12:40 the patient was in extremis, glucose was given without effect, essentially ruling out hypoglycemia [low blood sugar] as a cause of the patient's death.

Doctor Coffield's response

Nowhere in any textbook of medicine that I searched or in any article that I searched could I find any statement to the effect that it was a standard of anybody's care, except the reviewer, that any time you increase the Lente Insulin, an afternoon blood sugar has to be taken.

How often do you get blood sugars? I don't think anybody can say. I think it depends on your experience in treating diabetes and your feeling when do you need one. I can clutter up blood sugar charts with blood sugars daily and four times a day. The question is, would it have made any difference in this period? He was clinically well. He was not spilling any sugar. He had no signs or symptoms of hypoglycemic reaction during this period. If I got a, say a 7--A 60 or a 100, say the range of possibility between 60 and 140 on a fasting, would I have done much differently? I don't think so. I think I would have left him on the 70 units.

I don't think anybody here ... could have expected any better care of this diabetes.

I chose to treat him as tightly as I could, running the risk of hypoglycemic reactions which he had.

If a patient is truly in a hypoglycemic episode and you kick the blood sugar up to 150, I get a response within 5 minutes.

Let me say I think clearly hypoglycemia was not the cause of death.

NBPSRO Final Comment

Although his patient's course contains many elements making diabetic control difficult, review of the records reflects inattention to numerous occasions with low fasting blood sugars and negative urine glucoses all day long. Twice in the last two weeks (12 days and 4 days before he died) Doctor Coffield increased the insulin-causing reactions (blood sugars of 35 and 38 are recorded). Twice, the on-call physician had to order extra glucose and decrease the insulin order. Nurses notes on the patient's last two days frequently mention his shakiness, tremors, weakness, and sweating. It is likely that the patient became hypoglycemic, vomited and aspirated. IV glucose couldn't revive him because his airway was blocked with vomitus.

Conidering Doctor Coffield's other diabetic cases that we have reviewed as well as this one, we must conclude that his approach to the control of patients with diabetes is erratic.

Conclusion:

This is substandard care of a gross and flagrant nature.

Among the directors of NBPSRO joining in this conclusion were Gerson Jacobs and David Stanley, both board-certified in internal medicine. Half of Stanley's practice was in the treatment of diabetes.

An evaluation of the care provided by Coffield was again made at the hearing before the administrative law judge by Alan Margolin, board-certified in internal medicine and pulmonary diseases. According to Margolin's testimony, Coffield had mismanaged the insulin treatment of the patient with the result that the patient's blood sugar became abnormally low, causing the hypoglycemic episodes that led to his death.

The pathology report listed the cause of death as "obstruction tracheobronchial system due to aspiration gastric contents," with a note adding that "the reason for the regurgitation and aspiration was not clearly established by the autopsy." Margolin concluded that the reason was the patient's reaction to his low level of blood sugar. Coffield's expert Fitzgerald did not dispute this conclusion, stating: "It appears to me that the cause of death maybe had been precipitated by hypoglycemic episode with nausea and vomiting and aspiration." In Margolin's opinion, Coffield's care was grossly in violation of professional standards.

We need not recite in detail the other evidence before the administrative law judge as to Coffield's failure to provide proper treatment for this patient. Substantial evidence exists in the findings of the NBPSRO and in the testimony of a competent peer that professional standards were violated in a gross and flagrant way by Coffield's management of the patient's level of blood sugar in all probability leading to the patient's death.

In his brief Coffield attacks a number of medical opinions received in evidence in the administration hearing. That an argument can be made interpreting the facts differently from the interpretation given in the opinion does not undermine the force of the opinion. By the very nature of professional judgment, the substance of that judgment will be an opinion. If a competent, unbiased physician, who is familiar with the evidence, gives an opinion, specifying the basis for it, the NBPSRO and the Secretary are entitled to rely on it. Unrefuted, such an opinion is substantial evidence.

Much of Coffield's appeal is devoted to a claim that Vallejo General Hospital was maliciously motivated when it asked the NBPSRO to investigate him. According to Coffield, he had testified in 1979 against the hospital before the Joint Commission for the Accreditation of Hospitals and the hospital had retaliated by summarily and illegally suspending him from the staff. In 1980 he brought suit against the hospital for conspiring against him in making the suspension. There is no doubt that the hospital had reason to dislike him. But Coffield was not entitled in the administrative hearing in this case or in the district court to go into the hospital's motivation. As early as November 3, 1980, Coffield was advised by his own counsel that the motive of those requesting the investigation was irrelevant. Coffield contends that his efforts to improve medical care at the hospital subjected him to the investigation. But what is relevant here is not what caused the investigation but what it found. What it found was substantial evidence of Coffield's own violations of his obligation to provide professional care.

If any member of the NBPSRO itself was "motivated by malice," that member's statutory immunity under 42 U.S.C. § 1320c-16(b) (1) ceased by operation of section 1320c-16(b) (2). As Coffield argues, the statute implies that members of the NBPSRO are expected to act fairly. If they do not, they risk suit. But Coffield's theory of conspiracy between Vallejo General and NBPSRO is refuted by the record. The staff of the hospital was neither represented on the Board nor in the committee memberships of NBPSRO. [Government Exhibit 1, p. 44] At the same time that NBPSRO was contemplating action against Coffield, it was concerned with a variety of other problems at Vallejo General and was taking action to monitor the hospital. [Id. p. 140]. NBPSRO at this time wrote the hospital criticizing its peer review process and expressing NBPSRO's intent to monitor that activity. [Id. 147] Coffield's suggestion that NBPSRO was hand in glove with the hospital has no foundation. At points in the process, Coffield has put down the members of the NBPSRO as "company men" or as "going along to get along." No evidence has supported this disparagement. Cliches are not substitute for evidence.

Coffield also has not shown that bias infected the trier of fact in the process before the Secretary. Coffield contends that bureaucratic inertia made it less and less likely that he would get a favorable result once the NBPSRO had found against him. Another way of viewing the process is that it placed primary reliance on physicians--physicians generally thought to be reluctant to criticize their own and surely loth to say that a fellow physician had conducted himself grossly and flagrantly. The process then afforded Coffield a fresh opportunity to contest the adverse medical judgment before the Social Security Administration with new peer witnesses being examined and their testimony evaluated by a new decision-maker. The procedures involving Coffield have lasted ten years. If Coffield still believes himself oppressed, it is not for want of process. His complaint is against the judgment of physicians competent in their fields and conversant with his cases.

Coffield's allegations that Judge Pavlovsky was prejudiced depend largely on the administrative law judge's failure to consider evidence of the hospital's motive. Judge Pavlovsky correctly excluded as irrelevant the evidence Coffield wanted to introduce. There is no other probative evidence of prejudice on his part. A slip of a tongue when Judge Pavlovsky once referred to the government's witnesses as "our witnesses," immediately correcting himself, does not constitute substantial evidence of bias. Coffield's brief contends that Judge Pavlovsky did not mention the autopsy report. Judge Pavlovsky was not obliged to mention such ambiguous evidence.

Coffield was reviewed by peers whose lack of impartiality has not been shown. His case was reviewed by an administrative law judge and by the Appeals Council. Neither judge nor Council had any motive to be biased against him. The district court, again an unbiased authority, has upheld the Secretary. We have been given no reason to disturb the conclusions that have been reached at every level of adjudication.

AFFIRMED.