Mar. 8, 2002
door on Medicare peer review
court ruling would give the results of peer review inquiries to patients. Some
think that's chilling news for physicians.
Wayne J. Guglielmo
The story of David
Shipp and his wife, Doris, began as a simple family matter.
On Dec. 15, 1998,
Mrs. Shipp was admitted to Baptist Hospital East in Louisville, KY, complaining
of abdominal pain. Over the next few days and months, internist Peter L. Thurman,
diagnostic radiologist David L. Jolgren, and general surgeon Thomas C. Dedman
III saw Mrs. Shipp, who was a Medicare beneficiary. Despite treatment, Mrs. Shipp
died of cancer of the cecum in June 1999.
David Shipp expressed concerns about the quality of care his wife had received
in a letter to Health Care Excel, the private peer review organization under contract
to monitor Medicare delivery in Kentucky. Health Care Excel promised Shipp it
would investigate his complaint.
The following August,
the PRO mailed three replies, one for each physician involved. In the case of
Dr. Thurman, Shipp was told, "no quality of care issues were identified." The
two other letters, however, contained little information beyond the reassurance
that a "thorough review" had been conducted. Without physician consent, the PRO
informed Shipp, "we are unable [because of federal laws and regulations] to provide
any specific information about the results of our review." If some problem was
identified, the letter concluded, "please be assured . . . we will take all necessary
The PRO's handling
of David Shipp's complaint is no longer a private matter. Since early last year,
it has been part of a suit brought by the Washington, DC-based consumer advocacy
group Public Citizen against the Department of Health and Human Services and its
Medicare oversight agency.
At issue is whether
HHS has the statutory authority to keep the nation's 53 PROs from revealing investigatory
information in cases like the Shipps'. If it doesn't, as Public Citizen argues,
then the results of an investigation, including details about any quality-of-care
issues, can be revealed to a complainant without consent from the physician under
If HHS does have
the statutory authority, as it argues, then physician confidentiality protections
will continue. Not surprisingly, provider groups, including the AMA, have sided
We sifted through
the arguments on both sides to see how all this could affect you.
A question of
interpretation turns on divining Congress' intent
In April 1985,
HCFA (now the Centers for Medicare & Medicaid Services) issued regulations
that spelled out, among other things, what data must be kept confidential following
a Medicare peer review investigation. In the case of physicians, no information
that explicitly or implicitly identified a doctor could be revealed, unless the
doctor consented to the release, and provided no other individual was identified.
A year after the
rules took effect, Congress amended peer review law to require PROs to investigate
all patient complaints (the original 1982 act gave PROs some discretion
in this regard) and to report the "final disposition of the complaint" to the
complainant. In 1989, HCFA proposed changing its policy to conform more precisely
to the amended statute, but to date no final rule has been issued.
In its suit, Public
Citizen argues that HCFA's (CMS') rules prohibiting disclosure without practitioner
consent are clearly out of step with the amended law. Not so, say defendants HHS
and CMS. The amended statute requires "only that PROs inform beneficiary complainants
that their complaint was received, that it was investigated, and that corrective
action was taken if appropriate." Even if the meaning of "final disposition" is
somewhat ambiguous, defendants say, deference should be given to the agency's
To break the deadlock,
US District Judge Ellen Segal Huvelle did what many judges do when faced with
conflicting interpretations of the law: "She went back into the legislative history
to try to divine the intent of Congress," says Robert T. Bernat, an internist
and Chicago-based health care attorney at Sonnenschein Nath & Rosenthal.
The history shows
that, in 1986, Congress struggled to reconcile competing versions of the statute.
The Senate version would have restricted disclosures to procedural matters—that
is, to telling patients only that the necessary and proper steps had been
taken. The House version authorized a more substantive disclosure.
Given that the
House version ultimately prevailed, Judge Huvelle concluded, one can reasonably
assume that it reflected the will of Congress. Thus, last July she granted Public
Citizen's motion for summary judgment and, in a separate order, gave HHS 20 days
to inform PROs that they "are required to disclose the results of . . . investigations
to beneficiary complainants." In September, HHS won a stay pending an appeal on
the merits. At press time, no appeal date had been set.
predict trouble ahead
Supporters of the
HHS position foresee dire consequences should the lower court's decision survive
appeal. (HHS declined to comment on the pending suit.)
For one, they worry
that disclosure of investigatory data will send a chill throughout the provider
community. The peer review "process can only work . . . if physicians are willing
to review each other and if the reviewing physicians can engage in completely
frank and candid exchanges with respect to the physician under review," writes
the AMA, the American Hospital Association, and the Federation of American Hospitals
in their friend-of-the-court brief. "[S]uch exchanges are only possible if confidentiality
is maintained throughout the peer review process."
"If the court decides
otherwise," says general and vascular surgeon and AMA Board of Trustees member
Donald J. Palmisano, "then we're going to see a retreat from serving on peer review
The AHA and FAH
share that concern, even though the district court decision about Medicare PROs
doesn't directly affect hospital peer review. "Cases can be cited as precedent
in other courts," says AHA senior counsel Maureen Mudron. "And so it's of interest
to hospitals that state or federal court decisions support the peer review process."
Critics of the
lower court decision also worry that disclosure would create a treasure trove
for plaintiffs' lawyers. Developing a plaintiff's case on contingency is often
risky, says Chicago's Robert Bernat. "If [plaintiffs' lawyers] can get somebody
else to build their case for them, they'd be much more willing to take on risky
On the other hand,
says Bernat, some "deserving cases" might also see the light of day if attorney
costs were kept down. "It's the classic tort dilemma: If you change the dynamics
for attorneys, are you doing something good or something bad—or perhaps
Finally, if confidentiality
protections are lifted, the PRO industry says, then even voluntary quality
improvement projects would suffer. Such projects, say industry officials, are
intended to help doctors fix systems—like those for monitoring diabetes—that
impede the delivery of good quality patient care despite doctors' best intentions.
think that by working with the QIOs ["quality improvement organizations," as CMS
now refers to PROs ] they're subject to punishment, then the main work of the
whole program will be set back, and that would be bad for health care," says David
Schulke, executive vice president of the Washington, DC-based American Health
Quality Association, the industry trade group.
A wake-up call
to HHS and the PRO industry?
and its supporters dismiss these warnings as overblown and self-serving. They're
especially critical of the notion that opening the investigatory process will
undermine the "main work" of the PROs.
Over the years,
the PRO program has moved "from a regulatory, policing mode into what they describe
as an educational mode," says internist Sidney Wolfe, director of Public Citizen's
Health Research Group. "Education is certainly part of what they do, but taking
some form of action should also be."
The lawsuit, he
says, should serve as a reminder that the balance has tilted too far in one direction—and
that HCFA (CMS) has allowed it to happen. As evidence, he points to the recent
HHS Office of Inspector General report, which referred to the beneficiary complaint
process as "a rusty safety valve." (See "The
PRO complaint process: Still flawed after all these years".)
Wolfe also views
the suit as a wake-up call to those who've forgotten that taxpayers are funding
Medicare and thus the PRO program: "At the very least, families would like to
know the results when an investigation is launched into a given doctor's performance."
on public disclosure and a more punitive role for PROs wouldn't enhance public
safety, and might even undermine it, his critics say. To illustrate, they point
to the history of the Aviation Safety Reporting System. "The moment they made
it completely confidential, [incident] reports went up dramatically," says the
AMA's Donald Palmisano. "Within a relatively short time, [after an incident is
reported], the [Federal Aviation Administration] is looking at the incident and
fixing the system." Health care attorney Robert Bernat agrees: "I don't see that
exposing PRO proceedings to the sunlight creates greater protections for the public."
Whichever way the
PRO program goes, the legal debate over public disclosure will likely be settled
once briefs are filed, oral arguments heard, and the appellate court reaches its
decision. (At this point, no one is talking about a hearing before the Supreme
Court, although that could happen.)
the suit—like the Institute of Medicine's 1999 report on medical errors
and patient safety—may appear to be one more step toward a system of "shame
and blame," as the AMA's Palmisano refers to it. Doctors would prefer to shift
the focus to how systems and individual performance can be improved.
Yet, at a time
when consumers are demanding more accountability, it's hard for many patient advocates
to accept that egregious errors and lapses in care can be shielded from public
view. Fortunately, less than 10 percent of the doctors investigated annually by
Medicare PROs are found to have delivered substandard care, according to industry
estimates. If accurate, that figure underscores a pertinent fact: The overwhelming
majority of doctors are doing a good job.
PRO complaint process: Still flawed after all these years
In 1995, HHS' Office
of Inspector General issued a report critical of the way PROs handled beneficiary
complaints. The process, the OIG said, was flawed in three significant ways: (1)
It was too secretive, which precluded the PROs from responding to complainants
in a meaningful way; (2) it was underutilized by beneficiaries, which made identifying
patterns of poor care difficult; and (3) it generally took too long.
Last August, the
OIG published a follow-up report and found that little had improved since then.
The OIG report
pegs the lack of progress to two underlying problems. First, contracts between
CMS and the PROs treat the complaint process "as a distinctly minor activity."
For the peer review organizations, the report says, quality improvement and payment-error
reduction take precedence.
The other reason
progress has been slow, according to the OIG: "PROs tend to be more oriented toward
the medical community than to the beneficiary community." That's great for conducting
quality improvement projects, the report notes, but not so good for developing
a better complaint process.
What to do? The
OIG lays out two options for CMS to consider. It can either fix the complaint
process within the existing PRO program, or establish an external, independent
program. Both options have pluses and minuses says the OIG.
The PRO industry
favors keeping the complaint process in-house, and has sent the OIG its own blueprint.
For example, if complaints are to be given higher priority, the American Health
Quality Association says, then funding for this labor-intensive activity must
be increased. But AHQA resists any attempts to turn the process into a traditional
enforcement program that fixes blame and names names. Similarly, the AMA has opposed
what it calls a "police-type role for PROs."
Such alarms may
be premature. Still, if plaintiffs in the Public Citizen-HHS suit win on appeal,
PROs could well become more police-like.
Wayne Guglielmo. Opening the door on Medicare peer review. Medical
Copyright © 2002 and published by Medical Economics Company at Montvale, NJ 07645-1742.
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