FTC Staff Comment Before the Alabama State Board of Medical Examiners Concerning the Proposed Regulation of Interventional Pain Management Services

Office of Policy Planning
Bureau of Economics
Bureau of Competition
UNITED STATES OF AMERICA
FEDERAL TRADE COMMISSION
WASHINGTON, D.C. 20580
November 3,2010
Patricia E. Shaner, Office of General Counsel
Alabama State Board of Medical Examiners
Post Office Box 946
848 Washington Avenue (36104)
Montgomery, Alabama 36101-0946
Dear Ms. Shaner:
The staffs of the Federal Trade Commission's Office of Policy Planning, Bureau of
Economics, and Bureau of CompetitionI appreciate this opportunity to comment on the proposed
regulation of interventional pain management services (Proposed Rule) issued by the Alabama
State Board of Medical Examiners.2 The Proposed Rule restricts the "interventional treatment of
pain" to "qualified, licensed medical doctors and doctors of osteopathy,,,3 who "may not delegate
to non-physician personnel the authority to utilize such procedures to diagnosis [sic], manage or
treat chronic pain patients.,,4 The rule appears to prohibit certified registered nurse anesthetists
(CRNAs) from performing, under the supervision of a physician, pain management procedures
that the Board of Nursing considers within the scope of CRNA practice. 5 Absent evidence that
the proposed restrictions are necessary to protect the public, there appears to be no reason to
sacrifice the benefits of CRNA pain management services as currently available under Alabama
law.
Unnecessary restrictions on the ability of physicians to provide pain management
services in collaboration with CRNAs are likely to reduce the availability, and raise the prices, of
pain management services in Alabama. In particular, the Proposed Rule may burden cancer
I This letter expresses the views of the Federal Trade Commission's Office of Policy Planning, Bureau of
Economics, and Bureau of Competition. The letter does not necessarily represent the views of the Federal Trade
Commission ("Commission") or of any individual Commissioner. The Commission has, however, voted to
authorize us to submit these comments.
2 See Alabama State Board of Medical Examiners, Proposed Rule 540-X-15, Interventional Pain Management,
available at http;//www.ala-cma.orgJdownloadiALANA-Call-to-action-BMEP-rule.pdf [hereinafter Proposed Rule].
3 I d. at 540-X-15-.01, 540-x-.05.
4 I d. at 540-x-.04.
5 See, e.g., In re Steve Sykes, MD, Petition for Declaratory Ruling Before the Alabama Board of Nursing, 4-6 (Mar.
19, 2010), available at http;//www.abn.state.al.uslUltimateEditorIncludelUserFilesidocslDeclaratorv-RulingJAP-
Steve-Sykes.pdf (enumerating various interventional pain management procedures currently within the scope of
CRNA practice).
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patients and others with chronic pain, rural Alabamans and others whose access to health care, or
ability to pay for it, is limited, and hospice patients.
We therefore urge the Board to consider carefully the impact of the Proposed Rule and to
avoid adopting provisions that would limit the role of CRNAs in pain management more strictly
than patient protection requires. The Proposed Rule provides no evidence that the current
practice has harmed patients. Further, studies that have examined CRNA provision of anesthesia
services have not found safety or quality defects in CRNA practice. 6
Interest and Experience of the Federal Trade Commission
The FTC is charged under the FTC Act with preventing unfair methods of competition
and unfair or deceptive acts or practices in or affecting commerce.7 Competition is at the core of
America's economy,8 and vigorous competition among sellers in an open marketplace gives
consumers the benefits of lower prices, higher quality products and services, more choices, and
greater innovation. Because of the importance of health care competition to the economy and
consumer welfare, anti competitive conduct in health care markets has long been a key target of
FTC law enforcement,9 research,lO and advocacy, such as this letter. 11 Recently, FTC staff have
urged several states to reject or narrow restrictions that limit health care access and raise prices to
consumers by limiting competition among health care providers and professionals. 12
6 See, e.g., A.F. Smith, et al., Comparative Effectiveness and Safety ofPhysician and Nurse Anaesthetists: A
Narrative Systematic Review, 93 BRIT. J. ANAESTHESIA 540, 544 (2004) (review article examining U.S. and foreign
studies finding "no recent, high-level evidence that there are significant differences in safety between different
anaesthesia providers"); Paul F. Hogan et aI., Cost Effectiveness Analysis ofAnesthesia Providers, 28 NURSING
ECON. 159, 161 (2010) ("there are no studies that show a significant difference between CRNAs and
anesthesiologists in patient outcomes.").
7 Federal Trade Commission Act, 15 U.S.C. § 45.
8 See National Society of Professional Engineers v. United States, 435 U.S. 679, 695 (1978) ("The heart of our
national economy long has been faith in the value of competition.").
9 See generally, e.g., FEDERAL TRADE COMMISSION (FTC), FTC ANTITRUST ACTIONS IN HEALTH CARE SERVICES
AND PRODUCTS (Mar. 2008), available at http://www.ftc.govibcl0608hcupdate.pdf ; see also Competition in the
Health Care Marketplace: Formal Commission Actions, available at http://www.ftc.govibcihealthcare/
antitrust!commissionactions.htm.
10 See, e.g., FTC & U.S. DEP'T OF JUSTICE, IMPROVING HEALTH CARE: A DOSE OF COMPETITION, Chapter 7 (2004),
available at http://www.ftc. gov/reportsihealthcare/040723 healthcaremt.pdf.
11 FTC and staff advocacy may comprise letters or comments addressing specific policy issues, Commission or staff
testimony before legislative or regulatory bodies, amicus briefs, or reports. See, e.g., Letter from FTC Staff to Hon.
Timothy Burns, Louisiana Legislature, (May 1,2009) (regarding proposed restrictions on mobile dentistry);
available at http://www.ftc.gov/os/2009/05N090009 louisianadentistrv.pdf; FTC and Department of Justice Written
Testimony before the Illinois Task Force on Health Planning Reform Concerning Illinois Certificate of Need Laws
(Sept. 2008), available at http://www.ftc.gov/osl2008/09N080018illconlaws.pdf; FTC Amicus Curiae Brief in In re
Ciprofloxacin Hydrochloride Antitrust Litigation Concerning Drug Patent Settlements Before the Court of Appeals
for the Federal Circuit (Case No. 2008-1097) (Jan. 2008), available at
http://www.ftc.gov/os/2008/0 1/080 129cipro.pdf; FEDERAL TRADE COMMISSION AND THE DEPARTMENT OF JUSTICE,
IMPROVING HEALTH CARE: A DoSE OF COMPETITION (July 2004), available at
http://www.usdoj.gov/atr/publicihealthcare/204694.htm.
12 See, e.g., Letter from FTC Staff to Hon. Timothy Burns, supra note 11; Letter from FTC Staff to Elain Nekritz,
Illinois Legislature (May 29,2008) (regarding proposed LSC regulations); available at
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I. 	Background
A. 	Brief Background on CRNAs
In Alabama, CRNAs are licensed under the Alabama Code l3 and Alabama Board of
Nursing regulations. 14 In general, "[p]ractice as a certified registered nurse anesthetist (CRNA)
means the performance of or the assistance in any act involving the determination, preparation,
administration, or monitoring of any drug used to render an individual insensible to pain for
surgical and other therapeutic or diagnostic procedures .... [by the CRNA] under the direction of
a physician licensed to practice medicine, or a dentist, who is immediately available.,,15
Under Board of Nursing regulations, CRNAs are required to have:
(a) An active Alabama registered nurse license....
(b) Met all requirements for completion of or graduation from an organized program of
study and clinical experience beyond the basic educational preparation as a registered
nurse that prepares nurse anesthetists and is accredited by the Council on
Accreditation of Nurse Anesthesia Educational Programs/Schools ... and recognized
by the Board of Nursing.
(c) Earned at least a master's degree, or post-master's certificate in advanced practice
nursing ... [and]
(d) Current certification as a registered nurse anesthetist .... 16
B. 	The Proposed Rule
As noted above, the Proposed Rule restricts the "interventional treatment of pain" to
"qualified, licensed medical doctors and doctors of osteopathy,,,l? who "may not delegate to non-
physician personnel the authority to utilize such procedures to diagnosis [sic], manage or treat
chronic pain patients.,,18 "Interventional pain management,,19 is defined broadly as "the
http://www.ftc.gov/osI200S/06NOS0013letter.pdf; Letter from FTC Staff to Massachusetts Dep't of Health
(September 27,2007) (regarding proposed LSC regulations); available at
http://www.ftc.gov/os/2007/1O/v070015massclinic.pd£ Many of these advocacy efforts have been successful in
preserving competition. For example, following the above referenced advocacy letters, the Louisiana and Illinois
legislatures rejected the proposed restrictions on competition, and Massachusetts followed FTC Staff
recommendations in adopting its final LSC regulations.
13 Code of Ala. §§ 34-21-S1, 34-21-90 (2010) (definitions and certification, respectively, for advance practice
nurses, including CRNAs).
14 Ala Admin. Code r. 61O-X-9-.01 (2010) (Qualifications For Approval To Practice As A Certified Registered
Nurse Anesthetist). Statutory authority to adopt standards of nursing practice is assigned to the Alabama Board of
Nursing by statute. Code of Ala. § 34-21-2(j) (2010).
15 Code of Ala. § 34-21-S1(4)(c) (2010).
16 Ala. Admin. Code r. 61O-X-9-.01 (2010)
17 Id. at 540-X-15-.01, 540-x-.04.
18Id. at 540-x-.04.
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diagnosis and treatment of pain-related disorders with the application of interventional
techniques in managing subacute, chronic, persistent, and intractable pain.,,20 The Proposed Rule
also includes examples of "interventional techniques," which
often involve injection of steroids, analgesics, and anesthetics and include:
lumbar, thoracic, and cervical spine injections, intra-articular injections,
intrathecal injections, epidural injections (both regular and transforaminal), facet
injections, discography, nerve destruction, occipital nerve blocks, lumbar
sympathetic blocks and vertebroplasty, and kyphoplasty.21
The Proposed Rule also provides a non-exhaustive list of several dozen specific interventions. 22
Because the proposed rule effectively prohibits non-physicians from providing
interventional pain treatment, and physicians from delegating authority to provide such treatment
to other licensed health care professionals, the Proposed Rule appears to prevent CRNAs from
performing many of the pain management procedures that the Board of Nursing considers to be
within the scope of CRNA practice in Alabama, subject to physician supervision?3 For example,
the scope of CRNA practice includes "intradermal, subcutaneous, or intramuscular
administration of a local anesthetic agent in a specified amount designated by order of a licensed
physician or dentist," and "the monitoring and adjustment oflocal anesthetic agent(s) and
analgesic agent(s) infusing via an epidural, brachial plexus, or femoral catheter placed by a
qualified [CRNA] or qualified licensed physician may be performed by a registered nurse ... as
ordered by a licensed prescriber.,,24
19 It is not clear from the plain language of the Proposed Rule whether "interventional treatment of pain" is meant to
be co-extensive with "interventional pain management" or a broader concept that includes it.
20 Proposed Rule at 540-X-15-.02.
21 !d.
22 Specific interventions include SI joint injections; spinal punctures; epidural blood patches; epidural
injections; epidural/spinal injections; lumbar injections; epidural/subarachnoid catheters; occipital nerve
blocks; axillary nerve blocks; intercostal nerve blocks; multiple intercostal nerve blocks; ilioinguinal nerve
blocks; peripheral nerve blocks; facet joint injections; cervical/thoracic facet joint injections; lumbar facet
injections; multiple lumbar facet injections; transforaminal epidural steroid injections; transforaminal
cervical steroid injections; sphenopalatine ganglion blocks; paravertebral sympathetic blocks; neurolysis of
the lumbar facet nerve; neurolysis of the cervical facet nerve; and destruction of the peripheral nerve.
Proposed Rule at 540-X-15-.02.
23 See, e.g., In re Steve Sykes, MD, supra note 5 (enumerating various interventional pain management procedures
within the scope ofCRNA practice).
24 Supra note 5, at 4. The Board of Nursing reports that, when it recently invited public comment regarding
revisions to the pertinent standards of practice, the Board of Medical Examiners did not question CRNA
qualification to perform such procedures. Id. at 5 (regarding November 2009 letter submitted by Board of Medical
Examiners Executive Director, Larry Dixon).
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II. 	Consumer Protection Concerns and the Scope of Practice
Patient safety or consumer protection concerns can justify licensure requirements and
scope of practice restrictions. 25 FTC staff recognize that particular pain management procedures
may require the specific training and experience of a board certified anesthesiologist and that
other particular interventions may require the special skills of a certified surgical sub-specialist.
Staff notes, however, that the Proposed Rule applies broadly and does not identify such
particular procedures. 26
Available evidence indicates that CRNAs operating within the scope oftheir licensure
provide pain management services safely.27 Published data tend to indicate that the baseline risk
of anesthesia is extremely low across all providers, and provider settings, with several studies
indicating that recent decades have seen "a remarkably abrupt decrease in anesthetic related
death rates, morbidity, and risk of perioperative deaths.,,28 In publishing its final rule regarding
the provision of hospital anesthesia services under the Medicare and Medicaid programs, the
U.S. Department of Health and Human Services (HHS) concluded that, ''the anesthesia-related
death rate is extremely low, and that the administration of anesthesia in the United States is safe
relative to surgical risk.,,29 Moreover, HHS found no "need for Federal intervention in State
professional practice laws governing CRNA practice .... [and] no reason to require a Federal
rule in these conditions of ~articipation mandating that physicians supervise the practice of
[state-licensed CRNAs].,,3
25 In competition terms, licensure requirements or scope of practice restrictions may sometimes offer an efficient
response to certain types of market failure that can occur in professional services markets. See CAROLYN COX &
SUSAN FOSTER. FEDERAL TRADE COMMISSION, BUREAU OF EcONOMICS, THE COSTS AND BENEFITS OF
OCCUPATIONAL REGULATION, 5-6 (1990), available at
http://www.ftc.govibe/consumerbehavior/docs/reports/CoxFoster90.pdf.
26 In addition, the Proposed Rule does not appear to restrict the scope of any pain management practices to any
particular physician specialists, instead referring generally to "qualified, licensed medical doctors and doctors of
osteopathy." Id. at 540-X-15-.01, 540-x-.04.
27 See supra note 6; cf Brian Dulisse & Jerry Cromwell, No Harm Found When Nurse Anesthetists Work Without
Supervision by Physicians, 29 HEALTH AFFAIRS 1469, 1469 (2010) ("adverse events related to anesthesia are rare
regardless of the provider. "). Much of the public data appears to regard the provision of anesthesia generally,
without distinguishing profession-related risks particularly related to chronic or acute pain management. FTC staff
notes a general question regarding the scope of Proposed Rule's intended limitation to chronic pain management
settings, in addition to the question whether there is evidence of consumer harms associated with CRNA practice in
particular chronic care contexts.
28 J.P. Abenstein & Mark A Warner, Anesthesia Providers, Patient Outcomes, and Costs, 82 ANESTHESIA &
ANALGESIA 1273, 1277 (1996) (citing, e.g., Mark A Warner, et aI., Major Morbidity and Mortality Within 1 Month
ofAmbulatory Surgery and Anesthesia, 270 JAMA 1437 (1993)); see also Dulisse & Cromwell, supra note 27, at
1469 ("adverse events related to anesthesia are rare regardless of the provider.").
29 Department of Health and Human Services (HHS), Health Care Financing Administration (HCFA), Medicare and
Medicaid Programs; Hospital Conditions of Participation: Anesthesia Services, 42 CFR Parts 416, 482, and 485,
Final Rule, 66 Fed. Reg. 4674, 4675 (Jan. 18,2001).
30Id. at 4674.
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The Proposed Rule appears to provide no countervailing evidence that CRNAs operating
within their established scope of practice impose substantial risks on Alabama health care
consumers in chronic care settings or otherwise. 31
III. 	Likely Effects on Alabama Health Care Consumers
The Proposed Rule's restrictions on the ability of physicians to direct and supervise
CRNA provision of interventional pain treatments to chronic pain patients practice may increase
prices for pain management services and decrease access to such services. By limiting the
number of health care professionals licensed to provide pain management services, the Proposed
Rule would reduce price competition. 32 Further, prices may rise to the extent that physician
services are substituted for lower-cost CRNA services. 33 Finally, the Proposed Rule may thwart
innovation in health care delivery by limiting the ability of health care providers to develop, test,
and implement the most efficient teams of pain management professionals. 34
Moreover, the burdens imposed by the Proposed Rule may be felt especially by some of
the most vulnerable citizens of Alabama. For example, CRNA practices disproportionately serve
31 A study by the Lewin Group notes directly that "there are no studies that show a significant difference between
CRNAs and anesthesiologists in patient outcomes." Paul F. Hogan et aI., supra note 6, at 161 (reviewing literature
on safety and efficiency of anesthesia). FTC staff recognize that the published evidence regarding aggregate or
comparative risks of anesthesia are complex, and staff do not wish to suggest that some particular anesthesia staffing
model is optimal. See, e.g., Abenstein & Warner, supra note 28, at 1276 (comorbidities and other difficulties in
attributing adverse events to anesthesia); cf Smith et aI., supra note 6, at 541 (studies too dissimilar to admit formal
meta-analysis). Still, published data generally indicate that CRNAs, working under physician supervision or
separately, provide pain management services safely -see supra notes 6, 27 - 30, and accompanying text - and there
does not appear to be countervailing evidence that CRNAs generally, or in particular chronic care contexts, are
unsafe. In addition, there are studies that compare various anesthesia workforce models. See, e.g., Laurent G.
Glance, The Cost Effectiveness ofAnesthesia Workforce Models: A Simulation Approach Using Decision Analysis
Modeling, 90 ANESTHESIA & ANALGESIA 584 (2000). FTC staff could fmd no evidence comparing the relative
safety, efficacy, or efficiency of CRNA pain management services with those provided by the larger population of
physicians and doctors of osteopathy. There is, however, some evidence that the risk of "failure to rescue" is
substantially higher in hospitals in which relatively few of the anesthesiologists are board-certified. /d. at 587 (2.5
times higher when 0-33% anesthesiologists board-certified than those where 66-99% of anesthesiologists are board
certified). Such studies could raise questions about when or whether it is safe to substitute physicians and
osteopaths who are not board-certified anesthesiologists for those who are.
32 Compare ALISON J. TERRY, ALABAMA BOARD OF NURSING, BIANNUAL ANALYSIS OF ALABAMA'S REGISTERED
NURSE WORKFORCE: 2008, p. 9, Table 4 (Apri12009), available at
http://www.abn.state.al.us!UltimateEditorincludelUserFilesidocsiresearchIVIII%20E%202%20Report%200f.102020
08%20RN%20Renewal%20Workforce%20Survey.pdf(indicating 1,378 CRNAs in Alabama) with Alabama
Department of Industrial Relations, Occupational Employment Projections in Alabama for Anesthesiologists for a
base year of 2006 and a projected year of 20 16, available at
http://216.226.191.114/vlmi/analyzer/gsoccproj.asp?guicksearch=True&setvar=True&cat=OCC&session=OCCPRO
J&subsession=99&areaname= (estimating 760 Alabama anesthesiologists in 2006 and projecting 950 for 2016), last
checked 10/18/10.
33 See, e.g., Editorial, Who Should Provide Anesthesia Care?, N.Y. TIMES, Sept. 6,2010 (relative costs of physician
and nurse provided care).
34 Glance, supra note 31, at 588-91 (regarding cost-effective models of anesthesia care for low, intermediate, and
high risk cases, and concluding that, "the physician-intensive model, in which physicians working alone anesthetize
all patients, is also not cost effective.")
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smaller, rural hospitals. 35 In addition, hospice providers and patients may face both increased
prices and reduced access to care if only physicians can provide palliative care for chronic pain.
It is possible that the Proposed Rule may, on balance, reduce patient safety. As noted,
economic or geographic access problems may place some Alabamans at risk of inadequate care.
Also, if CRNA pain management specialists are sometimes replaced not by board certified
anesthesiologists, but by physicians and osteopaths who do not specialize in pain management,
the average quality of interventional pain management in Alabama, or certain parts of Alabama,
could be reduced.
Conclusion
If particular interventional pain treatment services demonstrably require more specialized
training and experience than CRNAs working under physician supervision posses, then the
Board should tailor the rule to address those particular services. To the extent that there is no
evidence that CRNA practice harms patients, staff recommend that the Board reject the Proposed
Rule outright.
We appreciate your consideration of these issues.
Respectfully submitted,
Susan S. DeSanti, Director
Office of Policy Planning
Joseph Farrell, Director
Bureau of Economics
Richard A. Feinstein, Director
Bureau of Competition
35 See, e.g., Dulisse & Cromwell, supra note 27, at 1469 (CRNAs "provide thirty million anesthetics annually in the
United States and represent two-thirds of anesthetists in rural hospitals."); cf Abenstein & Warner, supra note 28, at
1279 (nurse anesthetist only practices found predominantly in smaller, rural hospitals).
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