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Resurrection of the New York Office-Based Surgery
Guidelines
S. Diane Turpin, J.D.
Associate Director of Governmental Affairs
Four years after the New York Public
Health Council unanimously adopted the “Clinical
Guidelines for Office-Based Surgery,” the
nurse anesthetists’ legal challenges have
ended. In a 6-1 decision, New York’s highest
court ruled that the New York State Association
of Nurse Anesthetists lacked standing to maintain
legal action.
The nurse anesthetists objected to the following
language in the guidelines:
Supervision of the anesthesia component of
the medical, dental or podiatric procedure should
be provided by a physician, dentist or podiatrist
who is physically present, who is qualified by
law, regulation or hospital appointment to perform
and supervise the administration of the anesthesia
and who has accepted responsibility for supervision.
The physician, dentist or podiatrist providing
supervision should:
- perform a preanesthetic examination and evaluation;
- prescribe the anesthesia;
- assure that qualified practitioners participate;
- remain physically present during the entire
perioperative period and immediately available
for diagnosis, treatment and management of anesthesia-related
complications or emergencies; and
- assure the provision of postanesthesia care.
Before the guidelines were issued, plaintiffs filed
suit asking the court to declare that the guidelines
were null and void because the Department of Health
did not have the statutory authority to regulate
the office setting. The lower court assumed that
the plaintiffs had standing and granted plaintiffs
summary judgment declaring the guidelines null and
void. The appellate court explicitly found that
plaintiffs had standing and agreed with the lower
court that the guidelines were in fact regulations
and as such were beyond the scope of authority granted
to the Department of Health. The Court of Appeals,
New York’s highest state court, reversed the
lower courts’ findings and held that plaintiffs
lacked standing because they could not show “injury
in fact,” the first prong of a two-part test
to determine a plaintiff’s right to sue.
Plaintiffs argued that the guidelines “effectively”
required nurse anesthetists to be supervised by
anesthesiologists; that it would be cost prohibitive
to have both an anesthesiologist and nurse anesthetist
involved in the case; and that the guidelines “effectively”
prohibited nurse anesthetists from performing in
an office-based setting and as such restricted the
scope of nurse anesthetists’ practice. The
court held that such assumptions lacked the concreteness
required for “injury in fact.” The majority
stated in the opinion:
“Plaintiff’s argument that CRNAs will
likely be injured is founded on two layers of speculation
— that the Guidelines will be rigorously enforced
as regulations and that, as such, they will effectively
harm CRNAs. At this juncture, it is not at all ‘obvious’
that, even if enforced as regulations, the Guidelines
would in fact injure any of the plaintiff’s
members as claimed.”
The good news is that after three years spent
developing the guidelines and four years spent litigating
whether the nurse anesthetists have standing to
file suit to block the guidelines, the guidelines
are expected to become effective once again.
The New York State Society of Anesthesiologists
and ASA filed amicus briefs on behalf of the Department
of Health.
New
Jersey Litigation Continues
As initially reported in last month’s “State
Beat,” the litigation continues in
New Jersey over office-based surgery
regulations, and the court’s initial decision
in that case is perhaps even more startling than
what occurred in New York at the trial court level.
Pending the outcome of the litigation, the court
has stayed the following provisions of the regulations:
N.J.A.C. 13:35-4A.6 (Standards for
performing surgery and special procedures in an
office; privileges necessary; preprocedure counseling;
patient records; recovery and discharge);
N.J.A.C. 13:35-4A.7 (Standards for
administering or supervising the administration
of anesthesia services in an office; preanesthesia
counseling; patient monitoring; recovery; patient
record; discharge of patient);
N.J.A.C. 13-34-4A.8 (Performance
of general anesthesia; authorized personnel);
N.J.A.C. 13:35-4A.9 (Administration
of regional anesthesia; authorized personnel);
N.J.A.C. 13:35-4A.10 (Administration
of conscious sedation; authorized personnel); and
N.J.A.C. 13:34-4A.12. (Alternative
privileging procedure).
The court’s ruling eviscerates the majority
of the 1998 regulation at least until the case
is heard later this fall.
As in the New York case, the New Jersey Association
of Nurse Anesthetists attempts to allege economic
harm to its members because nurse anesthetists
must practice under physician supervision.
The New Jersey State Society of Anesthesiologists
has been allowed to intervene in the lawsuit brought
by the New Jersey Association of Nurse Anesthetists,
Inc., against the New Jersey State Board of Medical
Examiners.
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