Download RE: Proposed Rules Changes to OAR Chapter 847, Division 017

February 22, 2013
Ms. Kathleen Haley, J.D.
Executive Director
Oregon Medical Board
1500 SW 1st Avenue
Suite 620
Portland, Oregon 97201-5847
RE: Proposed Rules Changes to OAR Chapter 847, Division 017
Dear Ms. Haley:
On behalf of the American Academy of Dermatology Association (AADA) and the
Oregon Dermatology Society (ODS), we are writing to express our concerns and
respectfully request amending proposed rules changes to OAR Chapter 847, Division
017 regarding the performance of office-based surgery and cosmetic procedures. We
urge the Oregon Medical Board (“Board”) to reconsider certain requirements for Level 1
surgeries and its restrictions on liposuction under tumescent anesthesia. As detailed
below, basic life support (BLS) certification and written informed consent for Level 1
surgeries would impede patient access by imposing burdensome requirements on
physician practices.
Additionally, we urge the Board to reconsider its specific restrictions on the performance
of office-based liposuction procedures under tumescent local anesthesia extracting more
than 250 cubic centimeters of supernatant fat. As explained below, the AADA and ODS
respectfully propose 500 cubic centimeters of supernatant fat as a more appropriate
threshold for mandatory office accreditation.
First, we urge the Board to amend the mandatory requirement for Basic Life
Support for Level I surgeries. As proposed, OAR Chapter 847-017-003 (1)(b) states:
The licensee and clinical health care personnel must maintain active Basic Cardiac Life
Support (BCLS) certification.
While we certainly share the Board’s concern for patient safety and support the need for
appropriate emergency protocols in office-based settings, the proposed rules exceed
what is appropriate according to the level of anesthesia. The proposal is neither
consistent with widely recognized principles for office-based surgery nor does it
represent appropriate standards of care.
According to the American Medical Association (AMA), “guidelines or regulations for
office-based surgery should be developed by states according to levels of anesthesia
defined by the American Society of Anesthesiologists (ASA) excluding local anesthesia
or minimal sedation.”12 Most states with laws or guidelines governing office-based
surgery follow AMA policy and exclude local or minimal sedation.3
1
American Medical Association. H-475.984 Office-Based Surgery Regulation. Available at:
https://ssl3.ama-assn.org/apps/ecomm/PolicyFinderForm.pl?site=www.amaassn.org&uri=/resources/doc/PolicyFinder/policyfiles/HnE/H-475.984.HTM
2
Further, the AMA’s Core Principles on Office-Based Surgery, adopted by numerous medical specialties
in 2003, states:
For office-based surgery with moderate sedation/analgesia, deep
sedation/analgesia, or general anesthesia, at least one physician who is
credentialed or currently recognized as having successfully completed a course in advanced
resuscitative techniques (e.g., ATLS, ACLS, or PALS), must be present or immediately available
with age- and size-appropriate resuscitative equipment until the patient has met the criteria for
discharge from the facility. In addition, other medical personnel with direct patient contact should
at a minimum be trained in Basic Life Support (BLS).
Thus, the AADA and ODS respectfully propose limiting mandatory BLS certification to Level II and
Level III office-based surgeries. Specifically, we recommend modeling language after Florida, which is
widely considered to have one of the strictest office-based surgery requirements in the nation. Florida
law recommends but does not mandate BLS certification. 4 We respectfully propose language that
recommends the surgeon or other health care personnel in the surgical suite is BLS-certified
and an AED is available on site. This proposal is consistent with the principles above as adopted by
numerous medical specialties and reflects standards nationwide. As reflected in the attached chart,
only two states require BLS for Level I surgery and neither of those states require the physician and
clinical personnel to be BLS-certified as would be required by the proposed rules.5
Limiting BLS certification to Level II and III surgeries would not jeopardize patient safety. Such
requirement has not been shown to increase patient safety as cutaneous surgeries report to have
negligible cardiac risk.6
Second, we respectfully request amending the proposed changes in OAR 847-017-0015 that
would require written informed consent for Level 1 procedures.
AADA and ODS support transparency and providing patients with information that allows them to make
sound decisions concerning their health care. Both patients and the health care system benefit when
patients are informed consumers. Unfortunately, this section of the proposal does not benefit patients
or health care system.
Dermatologists discuss the procedure with the patient and seek pertinent information, such as any
medication allergies, during the patient evaluation. Requiring dermatologists and other physicians to
document such discussion for Level I procedures that carry minimal risk of complications only further
exacerbates access issues faced by Oregon patients. As currently written, the proposal would impose a
duplicative and unnecessary step on dermatologists who are trying to provide quality health care to as
many patients as possible.
The language we respectfully ask the board to consider balances the goal of providing patients with
information that allows them to be informed consumers while ensuring that physicians are able to
2
American Society of Anesthesiologists. Continuum of depth of sedation. Available at:
http://www.asahq.org/ForMembers/~/media/For%20Members/Standards%20and%20Guidelines/2012/CONTINUUM%20OF%2
0DEPTH%20OF%20SEDATION%20442012.ashx
3
See attached office-based surgery chart.
4
Florida Administrative Code Rules 64B8–9 (3)(b).
5
Tennessee and Texas
6
Gloster, Hugh M., ed. Complications in Cutaneous Surgery. New York: Springer, 2008.
3
practice medicine without overly burdensome regulations that could impede access. The language is as
follows:
Verbal informed consent should be obtained and documentation of a PARQ conference should be
recorded in the patient chart for diagnostic dermatologic procedures and other minor level 1
procedures limited to the skin and mucosa. Written informed consent is recommended for complex
level I procedures of the skin and mucosa.
Further, written informed consent is not consistent with the standards of care for minor surgical
procedures, such as skin biopsies, the excisions of moles, the cryosurgical destruction of warts, or the
repair of simple lacerations. A significant number of the states that mandate written informed consent
only do so for surgeries with moderate, deep, or general anesthesia.
Third, we would like to recommend amending the definition for minor conduction block as
found in OAR Chapter 847-017-0005 (12).
By including direct pressure and refrigeration, this proposed language would have the unintended
consequence of including the use of cooling sprays during laser treatments and the direct pressure a
physician applies or instructs a patient to apply as a minor conduction block.
Finally, we would like the Oregon Medical Board to reconsider the threshold requirement for
classifying lipoplasty procedures under tumescent local anesthesia extracting more than 100
cubic centimeters of material as Level II or III surgical procedures.
As dermatologists, our utmost concerns are quality patient care and patient safety. Tumescent local
anesthesia refers to a technique that very dilute local anesthetic (such as lidocaine, epinephrine, etc.
in extremely low concentrations) that is injected into subcutaneous fat compartments. This method,
introduced in 1987 by a dermatologic surgeon, revolutionized the liposuction procedure and eliminated
many problems associated with dry liposuction and with liposuction performed under general
anesthesia. This technique is the one most commonly used by dermatologists in the office setting.
A number of studies have clearly shown that serious complications increase when liposuction is
performed under general anesthesia or when it is combined with other surgical procedures. A survey
published in Dermatologic Surgery in 2002 of over 66,000 patients undergoing liposuction with
tumescent local anesthesia, no deaths were reported and the rate of serious adverse events was
0.68/1,000 cases.7 Furthermore, recent reviews of adverse event data in Florida and Alabama have
shown no correlation between office accreditation, physician board certification, or hospital privileges
and patient safety.8
Available scientific literature clearly demonstrates liposuction performed with tumescent local
anesthesia does not carry the safety or health risks associated with liposuction performed under
general anesthesia, or using both tumescent anesthesia and other sedation techniques. As written, the
proposed rules changes requiring accreditation for liposuction procedures under tumescent local
anesthesia removing more than 250 cubic centimeters of supernatant fat would represent the most
restrictive mandatory accreditation requirement in the country. For comparison, California’s threshold
for mandatory licensure, Medicare certification, or accreditation for outpatient settings where anesthesia
7
Houseman TS, Lawrence N, Mellen BG, et al: The safety of liposuction: results of a national survey. Dermatol Surg
2002; 28:971-978.
8
Starling J, Thosani MK, Coldiron BM: Determining the Safety of Office-Based Surgery: What 10 Years of Florida Data and 6
Years of Alabama Data Reveal. Dermatol Surg 2011; 1-7.
4
is used is 5,000 cubic centimeters of aspirate (referring to the quantity of both the liquid and
supernatant fat removed by aspiration during a liposuction procedure). As such, the AADA and ODS
strongly believe the proposed rules changes should be amended to only require office
accreditation for lipoplasty procedures using tumescent local anesthesia involving more than
500 cubic centimeters of supernatant fat.
The AADA and ODS commend the Board for recognizing the performance of cosmetic medical
procedures, involving the injection of a medication or substance and use of prescription devices for
cosmetic purposes, as the practice of medicine. Regulating the performance of these procedures is
crucial to protecting patient safety and reducing adverse complications.
The AADA and ODS would also like to recognize the Board’s commitment to truth in advertising and
transparency of health care provider credentials and qualifications. Requiring disclosure of a surgeon’s
board certification and specialty field in patient informed consent forms prior to a procedure being
performed provides patients with critical information about who is providing their care. In addition, the
proposed requirement for a physician to demonstrate qualifications and competency via appropriate
American Board of Medical Specialties’ board certification again allows patients to make informed
health care decisions. Dermatologists board-certified by the American Board of Dermatology are
uniquely trained and qualified physicians and surgeons practicing primarily in office-based settings.
In conclusion, the AADA and ODS urge you to reconsider requiring accreditation for the performance of
lipoplasty under tumescent local anesthesia involving 100 ccs and BLS certification and written
informed consent for Level 1 procedures. We commend you for your leadership in addressing the
performance of cosmetic medical procedures, truth in advertising and transparency of provider
qualifications. Should you have any questions, please do not hesitate to contact Lisa Albany, Assistant
Director of State Policy for the AADA at [email protected] or 202-712-2615 with any questions or
concerns. Thank you for your consideration.
Sincerely,
Daniel M. Siegel, MD, FAAD
President
American Academy of Dermatology Association
Jonathan Alexander, MD, FAAD
President
Oregon Dermatology Society