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December 1998
Volume 62 |
Number 12
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| Physician Supervision:
Civics 101 for the Compleat Anesthesiologist |
Michael Scott, Director
Governmental and Legal Affairs
[The following article is an adaptation of remarks delivered
to the Texas Society of Anesthesiologists at its 1998 annual meeting.]
Last December, the federal government fired a shot "heard 'round
the anesthesia world" - it formally proposed to eliminate its
long-standing Medicare/Medicaid requirement that nurse anesthetists
be supervised by a physician. Since then, ASA has dedicated literally
thousands of staff hours and hundreds of thousands of resource
dollars to opposing this proposal and, as most ASA members know
by now, these efforts bore fruit when Congress adopted the omnibus
spending bill at the very end of the 105th Congress.
Specifically, the conference report on the FY'99 omnibus bill
recommended that the Health Care Financing Administration (HCFA)
base its decision whether to retain or eliminate its existing
physician supervision rule on scientifically valid outcomes data.
The exact language of the report appears on page 2 of this issue
of the NEWSLETTER. Although this language is not binding
on HCFA, the conference committee action is a very significant
step: preliminary results from a recent University of Pennsylvania
outcomes study disclose a 28-percent higher death rate when a
nurse anesthetist is supervised by a physician other than an anesthesiologist,
and there is no current reason to believe the results will be
much different in the definitive national study urged by the conference
report.
But this happy event really only provides the vehicle for my
real text. Rather my topic was chosen by an ASA member from Montana,
John M. Mott, M.D., who sent me an e-mail not too long ago expressing
confusion as to how the HCFA proposal got off the ground in the
first place, and what the relationship was between HCFA and Congress
in the possible implementation of the proposed rule. I thought
his questions were really legitimate; he characterized them as
calling for a "civics lesson," so I decided to put my response
down on paper. What follows, in the context of HCFA's proposed
rule on physician supervision, is "Civics 101 for the Compleat
Anesthesiologist."
A System of Checks and Balances
As you all know, the founding fathers created a system of government
based on a written constitution, under which the federal government
was given certain defined powers, with all other powers reserved
to the states. Federal powers were allocated to the three branches
of government: the legislative (the Senate and the House of Representatives),
the executive (the President and the various executive departments
such as Health and Human Services) and the judicial (the Supreme
Court and the various appellate and district courts). Each branch
enjoys the power to restrain the other two under a system that
John Adams originally styled as a system of "checks and balances."
Thus, except for very limited powers granted by the U.S. Constitution,
such as the power to command the armed forces, the President cannot
act except pursuant to legislation adopted by Congress. It is
the job of the President and the other 1.9 million members of
the executive branch to carry out the laws passed by Congress.
All major executive branch appointees, such as Health and Human
Services (HHS) Secretary Donna Shalala and HCFA Administrator
Nancy-Ann Min DeParle, must also be approved by the Senate. (It
was this requirement that proved the undoing of former Texas Senator
John Tower a few years ago and impeded the appointment of a new
Food and Drug Administration Administrator until the very last
day of the 105th Congress.) The President, on the other hand,
is given the power to veto legislation passed by the Congress,
subject always to Congress' reciprocal power to override a veto
by a two-thirds vote of both houses.
Federal judges constituting the judicial branch enjoy lifetime
appointments, assuring their insulation from the political process,
but they serve only on nomination by the President and confirmation
by the Senate. The sitting judiciary, on the other hand, enjoys
the power to determine whether acts of the executive and the legislature
are consistent with the terms of the constitution, and perhaps
more important for our purposes here, whether regulations and
other actions of the executive branch enjoy the necessary basis
in legislation passed by Congress, both procedurally and substantively.
Let me pause over this last check, or division of power, for
just a minute. Federal regulations are valid only if they 1) have
been properly adopted procedurally, and 2) are substantively based
in authority granted to the agency by Congress. On the former
point, there is a federal law called the Administrative Procedures
Act which, in general, requires that most federal agency rules
and regulations must initially be published in proposed form,
be available for public comment for a reasonable period and be
published in final form only after the agency has considered that
public comment. Publication of notice of proposed and final rules
is made in the Federal Register, which arrives in our office
every weekday. Final regulations, once published in the Federal
Register, are added to the multivolume Code of Federal Regulations,
in which all existing rules can be found, organized by subject
area.
HCFA Proposes to Eliminate Physician Supervision
When a proposed rule is inserted in the Federal Register,
the agency in question must always publish in the rule a description
of the legislative authority under which the agency purports to
be acting. Thus, in the case of the physician supervision proposal,
HCFA - an executive subagency of the Department of Health and
Human Services - last year officially published its proposed rule
in the December 19 issue of the Federal Register. In the
preamble to the proposed rule, HCFA noted that under Section 1861(e)
of that part of the Social Security Act dealing with the Medicare
program, a hospital participating in the program must meet those
requirements that the HHS Secretary "deems necessary in the interest
of the health and safety of the hospital's patients."
Now the courts have made clear that this kind of generalized,
statutory authority does not give carte blanche to the agency.
In general, although the agency is given wide discretion, there
must still be a reasonable connection between the action of the
agency and the extent of the legislative grant of authority. Bearing
this in mind, it would be surprising, for example, if the courts
would sustain a regulatory mandate that every Medicare-approved
hospital display a pink flamingo statuette at its emergency entrance.
Yet most people would agree that a proposed regulation dealing
with those qualified to deliver surgical anesthesia - and under
what supervision, if any - fairly comes under HCFA's "health and
safety" statutory mandate.
Where Did It All Begin?
But the December 19 proposed rule on physician supervision did
not spring full-blown from the brow of Zeus. The fact is, HCFA
first issued so-called hospital conditions of participation regulations
under the "health and safety" statutory mandate back in 1966,
within one year after adoption of the Medicare statute itself.
Curiously, the first set of anesthesia requirements contemplated
that anesthesia would be provided either by an anesthesiologist
or other physician, or by a nurse anesthetist under supervision
of the surgeon; the concept of anesthesiologist supervision of
the nurse anesthetist was not referred to in these earlier requirements.
Again, however, it is important to note that these original regulations
and the current anesthesia regulations adopted in 1986 were adopted
pursuant to authority granted HCFA by the 1965 Medicare amendments
to the Social Security Act - the same authority now being quoted
by HCFA as the basis for its proposed 1997 rule.
What moved HCFA, Dr. Mott asked me, to offer this new proposed
rule? Did the agency do it on its own, or did Congress give it
some impetus? The answer is that HCFA proposed the new rule on
its own motion, and Congress had nothing to do with it, except
for having given HCFA the original "health and safety" mandate
back in 1965. Rather, HCFA first noted about six years ago that
private hospital accrediting bodies had adopted a new approach
to the accrediting process, emphasizing focus on patient outcomes
rather than maintaining requirements about the way in which
the hospital was to perform its responsibilities. In early 1994,
an internal HCFA task force was appointed to consider whether
HCFA should emulate this approach. From the very outset, we have
known that the anesthesia conditions of participation were among
those under consideration for change.
It does not take a genius to figure out who or what moved HCFA
to consider the elimination of the physician supervision requirement.
Since the early 1980s, the American Association of Nurse Anesthetists
(AANA) had been lobbying HCFA, and subsequently Congress, to eliminate
the physician supervision requirement. AANA struck out badly in
1992 when HCFA publicly rejected the change on safety grounds,
but the issue remained alive within the task force. It is safe
to assume that AANA lobbied the task force heavily over the years
leading up to 1997. Perhaps due to its frustration with the slowness
of the task force project, however, AANA also began in mid-1995
to try to bypass the agency and seek legislation from Congress
mandating elimination of the physician supervision requirement.
Although the AANA's efforts with Congress were unavailing, principally
as a result of ASA opposition, there is still a valuable civics
sublesson to be learned here. Because all agencies of the executive
branch derive their power from legislation adopted by Congress,
there is always the option, if you do not like an agency's regulation,
to try to persuade Congress to change the agency's authority or
otherwise override agency action. This is, in general, very difficult
for at least three reasons: 1) getting Congress to adopt legislation
is always a huge and complex project, even for Presidents; 2)
it is always easier to block legislation than to gain its passage,
no matter who you are; and 3) Congress is always reluctant to
"micro-manage" the affairs of an executive agency (or perhaps
I should say almost always reluctant, because in Washington, one
person's micro-management is another person's vindication of principle).
Now let's be fair: What ASA has been trying to do in 1998 is
exactly what AANA was trying to do before 1998. Dissatisfied with
agency action (in this case, the December 19 proposed rule), we
have fought the physician supervision battle on two fronts: first,
with HCFA itself as part of the formal regulatory process, and
second, in the 105th Congress, as part of the legislative process.
Battle on the Regulatory Front
Let's talk about HCFA first. As noted previously, the Administrative
Procedures Act requires an agency to publish its proposed regulations
in the Federal Register for public comment. ASA not only
filed its own extensive comments with HCFA opposing the proposed
rule, it also successfully encouraged thousands of ASA members
to do so as well, not to mention letters of support from the American
Medical Association and a large number of state medical and national
specialty society organizations. One joint letter signed by 64
anesthesiologists who had originally trained as nurse anesthetists
was widely regarded as one of the most effective communications
sent to HCFA during the comment period.
ASA recognized early on, however, that the nurse anesthetists
would engage in a similar letter-writing campaign, so it was determined
to make sure that the views of the real interested parties, namely
the Medicare beneficiaries, were also made known to the agency.
This was accomplished, first, by asking a national polling organization
to survey Medicare beneficiaries and ask how they felt about the
proposal to eliminate physician supervision (81 percent were opposed),
and second, by retaining the services of a large grassroots solicitation
organization, to procure letters to HCFA from seniors and seniors'
organizations as well as a diversity of community and religious
organizations concerned with the welfare of seniors and Medicaid
beneficiaries.
Battle on the Congressional Front
ASA and AANA also undertook major efforts in Congress to persuade
individual members of the House and Senate to write HCFA in support
of their respective positions. For the most part, those supporting
AANA tended to come from the traditional liberal wing of the Democratic
party, together with a few conservative Republicans - resurrecting
the "states' rights" argument of John C. Calhoun - who believed
that the federal government should not be involved with scope
of practice issues.
Supporters of the Faircloth-Weldon bill, together with those
members writing HCFA to question the scientific basis for the
proposed rule, tended to come from, but not exclusively, the middle-of-the-road
Republican and conservative Democratic ranks, and included a number
of members of the GOP leadership in both houses. Technically,
these congressional letters have no special status in the rule-making
process, but conventional wisdom says that an outpouring of congressional
sentiment cannot help but influence the regulatory result.
ASA officers also met face-to-face with the HCFA Deputy Administrator
and several ranking HCFA officials to underscore the reasons for
ASA's opposition and to draw HCFA's attention to the preliminary
results of the University of Pennsylvania study that were just
beginning to emerge. Eventually, the principal authors of the
study themselves briefed those HCFA's officials directly responsible
for the proposed rule and HCFA's top scientific research personnel.
Here's another subcivics lesson: although many agencies adhere
to a policy of no contact with private interests during rule-making,
HCFA tends to encourage those contacts in many instances. AANA,
of course, was as aware of this as we were and made its own contacts.
Our HCFA efforts notwithstanding, the majority of our attention
since the first of the year has been on Congress. Before trying
to explain that exercise to you, let's open our civics textbook
to the chapter titled "Congress." As you already know, Congress
is a bicameral legislative body, consisting of the Senate and
the House of Representatives. There are 100 Senators, two from
each state, who serve six-year terms, staggered so that one-third
of the Senate seats are up for election every two years but also
so that both Senators from a particular state are not up for election
in the same year.
There are 435 Representatives, a number that has remained constant
since 1912. After each decennial census, the number of Representatives
from each state is reallocated so that each legislator represents
about the same number of people, currently about 550,000. Thus,
California has 52 Representatives, and the seven least populous
states, only one. Representatives must stand for election every
two years; it is often said they can never stop running.
Each Congress covers two years, divided into two one-year sessions,
appropriately called the first session and the second session,
both of which convene on January 3. We have just witnessed the
close of the second session of the 105th Congress.
Most of the work of the Congress is accomplished through the
passage of legislation. With minor exception, both bodies of Congress
have the same legislative powers, essentially meaning that both
must concur on a piece of legislation before it is sent to the
President. Thousands of bills are introduced in each Congress,
but only a few hundred ever make it through the legislative process
or, indeed, even receive a hearing before a congressional committee.
The committee structure really only became formalized in the 1920s
and now represents where most of the work of Congress is really
done. Every bill that is introduced is referred to the committee
that the parliamentarian deems has jurisdiction; some bills cut
across jurisdictional boundaries and are jointly referred to two
or more committees. Many bills enjoy sponsorship of a multiplicity
of members, potentially signaling the importance of the bill to
a large number of legislators; identical or almost identical companion
bills are often introduced in the Senate and the House at or about
the same time.
Supporters of ASA's Position Introduce Bills
As many ASA members know, Senator Lauch Faircloth of North Carolina
and Congressman Dave Weldon of Florida last spring introduced
companion bills that would have blocked implementation of the
proposed HCFA rule eliminating physician supervision of nurse
anesthetists. Needless to say, finding sponsors for a piece of
new legislation is not a simple task. In this case, it principally
resulted from the Senator's long and close political association
with a number of North Carolina anesthesiologists, and from Congressman
Weldon's deep commitment as a practicing physician to the importance
of physician control of the practice of medicine. The Senate bill
was referred to the Committee on Finance, and the House bill jointly
to the Committees on Commerce and Ways and Means, which are the
traditional committees of jurisdiction on Medicare matters.
Once a bill is introduced, the job of the proponents, both inside
and outside Congress, is to persuade other legislators to co-sponsor
the bill and, if possible, to persuade the leadership of the committees
of jurisdiction to hold hearings on the bill. The ultimate objective
is to get it voted out of committee and onto the floor of the
House or Senate, as the case may be. Once passed by each body,
often in differing detail, the bills are taken up by a "conference"
of committee leaders from each house, and if the conference is
successful, the compromise bill is then referred back to each
house for final passage.
It was never our intention, however, to follow this traditional
route with either the Faircloth bill in the Senate or the Weldon
bill in the House for two simple reasons: first, as a practical
matter, there simply was not enough time left in the session for
us to have any hope of getting this done; and second, there was
no potential legislative vehicle expected to go through those
committees to which this narrow, single-purpose proposal could
be attached. All, or virtually all, of the work of the 105th Congress
on Medicare was completed last year with passage of the Balanced
Budget Act of 1997.
A Matter of Appropriations Considered
There was actually a third reason, and you would do well to
note this in the margin of your civics textbook. Legislators hate
to choose sides between major contending forces, and pressing
the Faircloth/Weldon bill to an up-or-down vote would have forced
such a choice. Proponents of legislation should thus be prepared,
if possible, with an alternate legislative strategy that will
accomplish their purpose; that is, in this case, to block the
proposed HCFA action. To accomplish this, we decided to turn to
the appropriations process. Federal agencies are funded in their
activities, first, by action of the committees of jurisdiction,
the so-called "authorizing committees," which, in general, set
ceilings on the amounts that can be spent by the agencies within
their jurisdiction, and then subsequently by the appropriations
committees, which specify actual funding levels. There are
13 different appropriations bills that must be approved each year.
Taken together, they encompass the full range of federal activity.
Now there is a problem with using the appropriations process
to accomplish legislatively substantive objectives. Especially
in the Senate, that's a "no-no," and so you have to try to craft
legislation in appropriations terms such as "no funds shall be
expended by the Secretary for the purpose of implementing regulations
eliminating physician supervision of nurse anesthetists under
the Medicare program."
Even then, however, you can potentially face rough sledding
because opposition almost always will surface in the appropriations
process to such a baldly substantive provision. This happened
right at the end of the 105th Congress when Senator Don Nickles
(R-OK) tried to attach such a provision to the omnibus bill in
order to block physician-assisted suicide. Such a hue and cry
of opposition arose that he was forced to withdraw his proposal
even though he is a member of the GOP leadership team in the Senate.
It happens, however, that Senator Faircloth sits on the Senate
appropriations subcommittee, and eventually it was decided to
seek relief through this process. It became clear early on that
a simple rollback of the proposed HCFA regulations probably would
not float, both because of pro-nurse sentiment among some Democratic
members of the subcommittee and because of views by some GOP members
who, no matter how strongly they favored physician supervision
in principle, saw this was a scope of practice issue to be decided
at the state, not the federal level.
Hard-Won Language Calls for Study
So, in the end, the subcommittee on September 1, at Senator
Faircloth's initiative, reached agreement to urge HCFA to conduct
a study along the lines of the Pennsylvania study, prior to considering
whether to implement the proposed rule. Two days later, the full
Senate Appropriations Committee concurred. That result was viewed
as vindication for those supporting the Faircloth-Weldon bill
since, if the new study produces results similar to the Pennsylvania
preliminary results, HCFA would be hard pressed to put the proposed
rule in effect and fertile ground would exist for a renewed congressional
fight.
Thus, to answer one of Dr. Mott's original questions: Congress
always has the power to change the legislation under which an
agency acts in order to assure itself that the agency acts or
does not act in a particular way. Regulators are aware of this,
so that expressions of congressional sentiment such as contained
in the report on the FY'99 spending bill, although not binding
on the agency, are not without major significance. In general,
though, as noted early on, Congress is loath to micro-manage the
work of an agency, and if you are going to persuade it to intervene,
you must make a very strong case, preferably in a nonpartisan
way.
Speaking of partisanship, this civics lesson would not be complete
without referring to the activities of the American Society of
Anesthesiologists Political Action Committee (ASAPAC), which will
have given $1 million in contributions to federal legislative
candidates in this two-year election cycle ending on December
31. There is no question that this level of giving puts a political
committee on the radar screens of the congressional campaign committees
and individual candidates of both parties. That kind of attention
tends to assure the opportunity to be heard, but it by no means
is a guarantee to be heeded. In general, the process goes the
other way: ASAPAC tends to support those candidates who speak
and act in ways that suggest they are friendly to, or at least
open-minded about, physician interests. Without question, our
work with Congress has been aided by the role of ASAPAC as one
of medicine's primary contributors.
Running Out of Time, Efforts Redoubled
In bringing this civics lesson to a close, I need to say just
a word about what happened on our way to the fair. This chapter
could aptly be described "At the End of a Session, in an Election
Year, Anything Goes if You've Got the Votes."
In the ordinary course, we would have expected the Senate Labor-HHS
Appropriations bill to have been brought up on the Senate floor
for debate and passage, just as would be expected on the House
side. Then the leaders of the two committees would get together
in conference to work out the differences. The problem was, however,
that when Congress returned after the August recess, it had completed
work on only one of the 13 FY'99 appropriations bills, and it
rapidly became clear that there was not sufficient time left to
permit orderly consideration of the bill.
So what happened was that the GOP leadership decided to create
a massive spending bill to include eight of the 13 necessary bills,
and to cause staff members to work behind closed doors to work
out details. This is when the process becomes hairy for those
on the outside: the staff members, under tremendous pressure and
often working without adequate sleep, tend to become uncommunicative
- meaning that the outsiders often do not know what is going on.
As if by magic, however, the Senate provision on an anesthesia
outcomes study, in a slightly modified form, surfaced in the draft
of the conference committee report about one week before final
action on the bill. ASA representatives were given a window of
two hours to offer recommended changes, without assurance that
they would be accepted or that we would even learn what had been
done until the omnibus bill went to the floor of the House. This
is pretty normal at the end of the session, and it puts to the
test all the work you have done with various legislators and staff
members to keep your message before them - to be sure that someone
will be looking out for your interest at crucial times. They simply
don't teach you about such things in civics books: better training
could probably be found on the floor of the New York Stock Exchange
during a sell-off.
In any event, the provision relating to an anesthesia outcomes
study survived and became part of the report on the final draft
of the bill. Briefly, the nurse anesthetists attempted an end-run
around the provision by trying to organize a "colloquy" between
Senator Arlen Specter (R-PA), chair of the Senate Labor-HHS subcommittee,
and two Senators sympathetic to AANA interests. Colloquies are
attempts to include points in the statutory history in addition
to what is contained in a particular provision adopted by the
Senate or House, but because they have not withstood the scrutiny
of committee or floor debate, they are of limited value and importance.
This colloquy effort failed in the face of opposition by those
who had worked out the terms of the original Senate committee
language.
And so, there in a nutshell, combining both theory and practice,
is the civics lesson for today. What ASA achieved was report language
that will find its way into neither the Code of Federal Regulations
nor the United States Code, but which, nonetheless, can logically
be expected to have a substantial impact on how the federal government
ultimately deals with this issue. Without question, there is a
new civics lesson to be learned in the 106th Congress, so you
may want to sign up for Civics 102, which is given in the spring
semester.
Michael Scott has been Director of Governmental
and Legal Affairs in the ASA Washington Office since 1993, having
previously served many years as ASA legal counsel with Squire,
Sanders & Dempsey, Washington, D.C.
E-mail the author.
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