FTC Comment to Texas Medical Board on Its Proposed Rule 193.13 to Add Supervision Requirements for Texas-Certified Nurse Anesthetists

Office of Policy Planning
Bureau of Competition
Bureau of Economics
Ms. Rita Chapin
Rules Development
Texas Medical Board
P.O. Box 2018
Austin, TX 78768-2018
UNITED STATES OF AMERICA
FEDERAL TRADE COMMISSION
WASHINGTON, D.C. 20580
December 6, 2019
Electronic submission: Rules.Development@tmb.state.tx.us
To whom it may concern:
The staff of the Federal Trade Commission [Office of Policy Planning, Bureau of
Economics, and Bureau of Competition1] appreciates the opportunity to respond to your
request for comments Proposed Rule§ 193.13 (Proposed Rule). 2 The Proposed Rule
appears to impose additional supervisory requirements on the administration of
anesthesia by a Texas certified registered nurse anesthetist (CRNA), and appears to
suggest additional exposure to potential liability for Texas physicians who delegate to a
CRNA "the ordering of drugs and devices necessary for the nurse anesthetist to
administer an anesthetic or an anesthesia-related service."3 Although the particular
supervisory requirements contemplated by the Proposed Rule are unclear, any such
requirements or increased liability may contract the supply, decrease the availability, or
increase the cost of anesthesia services in Texas, without offering countervailing benefits
to Texas health care consumers or third-party payors. Such risks might be greater in rural
and other medically underserved areas of Texas.
Supervision requirements for CRNAs and other advanced practice registered
nurses (APRNs) raise several related competitive concerns. By restricting CRNAs'
access to the marketplace, supervision requirements may deprive health care consumers
1 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 Proposed Chapter 193. Standing Delegation Orders, 22 TAC §§193.5, 193.13, 193.17, 193.21, 44 Tex.
Reg. 6669 et seq. (Nov. 8, 2019).
3 Id. at 6671 (proposing amendments to 22 TAC§ 193.13).
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of some of the benefits that provider competition can offer. Undue impediments to
competition can affect the cost and quality of available health care services and restrict
provider innovation in health care delivery. Excessive supervision requirements also can
exacerbate provider shortages and access problems, particularly for underserved
populations that already lack adequate and cost-effective health care services.
According to recent data, sixty-four of the eighty-five Critical Access Hospitals4
in Texas are located in counties where there are no anesthesiologists; and thirty-three of
those hospitals are in counties where CRNAs are the only licensed, specialized providers
of anesthesia and anesthesia-related services. 5 In light of that and related data, we urge
you to consider the supply and availability of specialist provider services across rural
Texas, as well as other underserved communities, which may face both provider and
facilities shortages. In particular, we urge you to examine carefully any purported safety
justifications for heightened supervision requirements, evaluate whether these
justifications are well founded, and consider whether less restrictive alternatives would
protect patients without unduly burdening competition and consumers. To that end, it
may be particularly useful to look at CRNA practice in states that do not require such
supervision, and to consider the available evidence regarding patient benefits and harms
in those states, including the findings of the Institute of Medicine and other experts in the
field. 6
I. 	INTEREST AND EXPERIENCE OF THE FTC
The FTC Act charges the FTC 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
4 Critical Access Hospitals (CAHs) are designated as such by both the states in which they are located and
the Department of Health and Human Services. They must, among other things, "[b ]e designated by the
State as a CAH; be located in a rural area or an area that is treated as rural; be located either more than 35-
miles from the nearest hospital or CAH or more than 15 miles in areas with mountainous terrain or only
secondary roads; .... [and] and furnish 24-hour emergency care services 7 days a week." Centers for
Medicare & Medicaid Servs., Critical Access Hospitals, https://www.cms.gov/Medicare/Provider
Enrollment-and-Certification/CertificationandComplianc/CAHs.html.
5 For locations ofCAHs, see Flex Monitoring Team, Univ. Minn., Univ. N.C. at Chapel Hill & Univ.
Southern Main, Critical Access Hospitals Locations, https://www.flexmonitoring.org/data/critical-access
hospital-locations/?search state=TX&filter search=yes#result-list (noting list current as of Oct. 11, 2019);
https://data.hrsa.gov/tools/data-explorer. For a map of Texas anesthesia providers based on the National
Provider Identifier Registry, see Texas Ass'n Nurse Anesthetists, County-Level Map,
https://www.txana.org/uploads/files/general/County TX map AANA.pdf.
6 See, e.g., INST. OF MED., NAT'L ACAD. OF SCIENCES, THE FUTURE OF NURSING: LEADING CHANGE,
Aov ANCING HEALTH 108-111 (2011) [hereinafter IOM FUTURE OF NURSING REPORT]) (citing diverse
evidence in concluding that CRNAs provide high-quality care, with no evidence of patient harm, with
respect to anesthesia and acute services).
7 Federal Trade Commission Act, 15 U.S.C. § 45.
8 Standard Oil Co. v. Fed. Tr. Comm'n, 340 U.S. 231,248 (1951) ("The heart of our national economic
policy long has been faith in the value of competition.").
2

gives consumers the benefits oflower prices, higher quality products and services, and
greater innovation. Competition among employers also helps employees secure fair returns
for their labor.9 Because of the importance of health care competition to the economy and
consumer welfare, anticompetitive conduct in health care markets has long been a key
focus of FTC law enforcement,10 research, 11 and advocacy. 12 FTC staffhave analyzed the
likely competitive effects of proposed advanced practice nursing regulations in other
states, observing that removing overly burdensome supervision requirements can achieve
significant benefits. 13 FTC staff have submitted analyses regarding CRNA or nurse
anesthetist restrictions in particular to both federal and state authorities. 14
9 See, e.g. , FED. TRADE COMM'N & U.S. DEPT'T OF JUSTICE, ANTITRUST GUIDANCE FOR HUMAN RESOURCE
PROFESSIONALS, 2 (2016), https://www.ftc.gov/system/files/documents/public statements/992623/ftc-
doj hr guidance final 10-20-16.pdf
10 See FTC, An Overview of FTC Antitrust Actions in Health Care Services and Products (Dec. 2011 ),
available at http://www.ftc.gov/bc/healthcare/antitrust/hcupdate.pdf; FTC, Competition in the Health Care
Marketplace: Formal Commission Actions (1996 - 2008), available at
http://www.ftc.gov/be/healthcare/antitrust/commissionactions.htm.
11 See FTC & U.S. DEP'T OF JUSTICE ("DOJ"), IMPROVING HEALTH CARE : A DOSE OF COMPETITION (2004),
available at http://www.ftc.gov/reports/hea1thcare/040723healthcarerpt.pdf [hereinafter FTC & DOJ ,
IMPROVING HEALTH CARE].
12 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.,
Joint Statement of the Fed. Trade Comm'n and the Antitrust Div. of the U.S. Dep't Justice Regarding
Certificate-of-Need (CON) Laws and Alaska Senate Bill 62, Which Would Repeal Alaska's CON Program
(2017), https://www .ftc.gov/system/files/documents/advocacy documents/joint-statement-federal-trade
commission-antitrust-division-us-department-justice-regarding/vl 70006 ftc-
doj comment on alaska senate bill re state con law.pdf; FTC Staff Comment Before the Dep 't of
Health & Human Servs. Regarding the 21 st Century Cures Act: Interoperability, Information Blocking, and
the ONC Health IT Certification Program (2019),
https://www.ftc.gov/system/files/documents/advocacy documents/ftc-staff-comment-department-health
human-services-regarding-21 st-century-cures-act-
interoperability/v 190002 hhs one info blocking staff comment 5-30-19.pdf; Brief for the United States
and the Fed. Trade Comm'n as Amici Curiae Supporting Plaintiffs-Appellees, Teladoc, Inc. v. Texas
Medical Board, (5 th Cir. Dec. 9, 2016) (Case: 16-50017); Fed. Trade Comm'n, The Strength of Competition
in the Sale of Rx Contact Lenses: An FTC Study (2005),
(https://www.ftc.gov/sites/default/files/documents/reports/strength-competition-sale-rx-contact-lenses-ftc
study/050214contactlensrpt.pdf) .
13 See generally FED. TRADE COMM'N, FTC STAFF, POLICY PERSPECTIVES: COMPETITION AND THE
REGULATION OF ADVANCED PRACTICE NURSES (2014),
https://www.ftc.gov/system/files/documents/reports/policy-perspectives-competition-regulation-advanced
practice-nurses/140307aprnpolicypaper.pdf.
14 See, e.g., FTC Staff Comment to the Senate of West Virginia Concerning the Competitive Impact of WV
Senate Bill 516 on the Regulation of Certain Advanced Practice Registered Nurses (2016),
https://www.ftc.gov/system/files/documents/advocacy documents/ftc-staff-comment-senate-west-virginia
concerning-competitive-impact-wv-senate-bill-516-regulation/160212westvirginiacomment.pdf; FTC Staff
Comment to the Dep't of Veterans Affairs: Proposed Rule Regarding Advanced Practice Registered Nurses
(2016), https://www.fie.gov/system/files/documents/advocacy documents/comment-staff-ftc-office-policy
planning-bureau-competition-bureau-economics-department-
veterans/v160013 staff comment department of veterans affairs.pdf; FTC Staff Comment Before the
Massachusetts House of Representatives Regarding House Bill 2009 Concerning Supervisory
Requirements for Nurse Practitioners and Nurse Anesthetists (Jan. 2014),
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II. 	Additional Background Supports the Competition Perspective
FTC staff policy work is cognizant of, and sometimes carried out in concert
with, 15 expert authorities in health and safety matters who may not have an express
competition mission. We note, for example, that Reports by the Institute of Medicine
(IOM) have identified a key role for advanced practice nurses-including CRNAs-in
improving the delivery of health care. 16 The IOM, established in 1970 as the health arm
of the National Academy of Sciences, provides expert advice to policy makers and the
public and has conducted an intensive examination of issues surrounding advanced
nursing practice. Among other things, the IOM found that "[r]estrictions on scope of
practice ... have undermined [nurses'] ability to provide and improve both general and
advanced care." 17 In a separate study examining pain as a public health problem, the IOM
found that regulatory barriers "limit the availability of pain care and contribute to
disparities found among some groups." 18
Additional research suggests that Texas, specifically, faces the health care
delivery problems identified in the IOM reports. Although some Texas cities enjoy
substantial specialized medical resources, rural Texas, as well as other underserved
communities, face both provider and facilities shortages. For example, a 2017 report by
the Texas A&M Rural Health Institute, discussing concerns about access to health care
for rural Texans, notes that "[i]n Texas, more than 170 of the 254 counties are rural." 19
That rural population of more than three million Texans tend to be "older, poorer,
https://www.ftc.gov/sites/default/files/documents/advocacy documents/ftc-staff-comment-massachusetts
house-representatives-regarding-house-bill-6-h.2009-conceming-supervisory-reguirements-nurse
practitioners-nurse-anesthetists/140123massachusettnursesletter.pdf; FTC Staff Comment to the Hon.
Heather A. Steans, Illinois State Senate, Concerning Illinois Senate Bill 1662 and the Regulation of
Certified Registered Nurse Anesthetists (CIUifAs) (April 2013),
http://www .ftc.gov/os/2013/04/l30424i11inois-sbl662.pdf.
15 For example, FTC staff provided informal technical assistance to the Department of Health and Human
Services as the Department was implementing certain provisions of the 21 st Century Cures Act. 21st
Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Criteria,
84 Fed. Reg. 7424, 7424 (proposed Mar. 4, 2019) (to be codified at 45 CFR Parts 170 and 171 ). In addition,
at ONC's invitation, the FTC have participated in the Federal Health IT Advisory Council that develops the
Federal Health IT Strategic Plan, and in the federal Interagency Information Blocking Working Group; and
FTC staff regularly collaborates with ONC staff to identify potential competition issues relating to health
IT platforms and standards, as well as on privacy and security issues.
16 IOM FUTURE OF NURSING REPORT INST. OF MED., supra note 6, at 98-99.
17 Id. at 4.
18 INSTITUTE OF MEDICINE, COMMITTEE ON ADVANCING PAIN RESEARCH, CARE, AND EDUCATION,
RELIEVING PAIN IN AMERICA: A BLUEPRINT FOR TRANSFORMING PREVENTION, CARE, EDUCATION, AND
RESEARCH 2, 80, 157 (2011) [hereinafter IOM PAIN REPORT].
19 TEXAS A&M UNIVERSITY RURAL & COMMUNITY HEALTH INSTITUTE (RCHI), WHAT'S NEXT?
PRACTICAL SUGGESTIONS FOR RURAL COMMUNITIES FACING A HOSP IT AL CLOSURE ( exec. summ. at iv.)
(2017). Retrieved from https://www.rchitexas.org/. "Of the 254 counties in Texas, 177 were deemed
"rural" by the Texas Department of Agriculture and 172 are deemed "rural" by the Texas Department of
State Health Services." Id. at 3.
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and--according to recent surveys--less healthy than their urban and suburban
counterparts." 20 As noted above, sixty-four of the eighty-five Critical Access Hospitals in
Texas are located in counties where there are no anesthesiologists; and thirty-three of
those hospitals are in counties where CRNAs are the only licensed, specialized providers
of anesthesia and anesthesia-related services.21
Heightened supervision requirements are likely to exacerbate such provider and
facilities shortages and access problems associated with them.
III. 	PROPOSED 22 TAC§ 193.13
The Proposed Rule would stipulate that physicians may delegate the authority to
administer anesthesia or anesthesia-related services only to a CRNA "acting under
adequate physician supervision."22 In addition, the Proposed Rule would stipulate that the
delegating physician is responsible for, inter alia, "determining and insuring that it is
reasonable, sound medical judgment to delegate to certified registered nurse anesthetist
[and] (2) that the delegated acts can be properly and safely delegated performed in its
customary manner.'m Although the particular requirements of"adequate physician
supervision" are not set forth in the Proposed Rule (or, apparently, in Texas statutes), the
Proposed Rule would hold that "[t]he delegating physician is ultimately responsible for
the certified registered nurse anesthetist performing delegated acts." 24 That is, the
Proposed Rule suggests that delegating physicians are subject to regulatory enforcement
for failure to adhere to unclear supervisory requirements; it may also suggest exposure to
civil liability.
IV. 	Discussion
A. Texas Law Requires Delegation of Authority to CRNAs, But Not the
Direct Supervision of CRNA Practice
The proposed amendments to Section 193.13 are supposed to add "clarifying
language and new subsections (d), (e) and (f) relating to the roles and responsibilities of
the delegating physician and CRNAs." 25 The Board notes that " [t]his clarifying language
is a direct result of a recent Attorney General Opinion directly on point." 26 However,
20 Id. at iv.
21 See supra note 5.
22 44 Tex. Reg. at 6671.
23 Id.
24 Id.
25 44 Tex. Reg. at 6669.
26 Id .
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some of the proposed regulations appear to be at odds with a recent opinion letter by
Texas Attorney General Ken Paxton, 27 as well as prior Attorney General Opinions. 28
The proposed assignments of responsibility seem to exceed, rather than
implement, Texas law. First, as Attorney General Paxton explained, Texas law expressly
limits the liability of a delegating physician for the act of delegation and the practice of a
CRNA to whom the physician delegates authority. In a 2019 opinion analyzing Texas law
on delegation to a CRNA, the Attorney General notes that Texas law expressly "limits a
physician's liability 'for an act of [an] ... advanced practice registered nurse solely
because the physician signed a standing medical order [and a] standing delegation order .
. . authorizing the ... advanced practice registered nurse to administer, provide,
prescribe, or order a drug or device. "' 29 The Attorney General notes that the limitation on
liability does not apply "if 'the physician has reason to believe the ... advanced practice
registered nurse lacked the competency to perform the act. '" 30 That is, the limitation on
liability appears to apply only when the delegating physician has actual or constructive
knowledge that the APRN--in this case, a CRNA--is not competent to perform the
delegated act.
The Attorney General's opinion also cites provisions of the Texas Occupations
Code declaring that the pertinent section "shall be liberally construed to permit the full
use of safe and effective medication orders to use the skills and services of certified
registered nurse anesthetists." 31 In particular, the physician's delegation to a CRNA "is
not required to specify a drug, dose, or administration technique," and "the nurse
anesthetist may select, obtain, and administer those drugs and apply the medical devices
appropriate to accomplish the order and maintain the patient within a sound physiological
status." 32 That is, under Texas law, the manner in which delegated anesthesia practice is
to be performed may be determined by the CRNA. The Attorney General does not cite,
and we are unaware of, any statutory basis for additional expectations of supervision by a
delegating physician.
Finally, the Attorney General notes that a prior opinion addressed the question
"whether section 157.058 requires a physician to directly supervise a certified registered
nurse anesthetist's provision of anesthesia and concluded that a physician is not required
to do so." 33
27 Letter from Ken Paxton, Attorney General of Texas, to Sherif Zaafran, M.D., President, Texas Medical
Board, Opinion No. KP-0266 (Sept. 5, 2019).
28 Tex. Att'yGen. Op. No. JC-0117 (1999).
29 Letter from Ken Paxton, Attorney General of Texas, supra note 27 at 3 (citing Tex. 0cc. Code§
157.060).
30 Id.
31 Id. (citing Tex. 0cc . Code§ 157.058).
32 Id.
33 Id. at 2 (citing Tex. Att'y Gen. Op. No. JC-01 17 (1999)).
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Although the Board of Medicine may have some regulatory authority over a
physician's act of delegation, the Attorney General's reading of the plain language of
Texa s statutes appears to suggest the following:
• 	first, the law does not require the direct supervision of CRNAs;
• 	second, the legal responsibility ( or liability) of delegating physicians is expressly
limited by Texas law;
• 	third, particular treatment decisions of CRNAs, acting under delegated authority,
are the independent responsibility of those CRNAs; and
• 	finally, Texas delegation requirements "shall be liberally construed to permit the
full use of safe and effective medication orders to use the skills and services of
certified registered nurse anesthetist s. " 34
Although the Proposed Rule does not stipulate particular supervisory acts
physicians must undertake, it does specify a requirement of "adequate supervision" that is
not required under Texas law, according to the Attorney General's recent opinion and the
plain language of Texas statutes. Moreover, the Proposed Rule would require a degree of
oversight regarding particular "delegated acts" and the "manner" in which they are
delivered not contemplated under Texas law. Delegating surgeons--who are not
specialized in anesthesia or related services--might be uncertain about their exposure to
Board discipline and other liability if the Proposed Rule were adopted; and rural hospitals
that depend on CRNAs for specialized care might also face additional liability if the
Proposed Rule were adopted. Moreover, uncertainty about the precise scope of adequate
supervision would itself impose a degree of risk, and hence cost, on delegating physicians
and institutional providers employing CRNAs.
B. Unnecessary Supervision Requirements Can Increase the Cost of, and
Decrease Access to, Needed Anesthesia-Related Services
FTC staff recognize that certain professional licensure requirements and scope-of
practice restrictions may protect patients. 35 Consistent with patient safety, however, we
have urged regulators and legislators to consider the benefits that more competition from
independent APRNs--including CRNAs-might provide-especially benefits to patients.
If APRNs are better able to practice to the full extent of their education, training, and
abilities, and if institutional health care providers are better able to deploy APRNs as
needed, health care consumers--patients--are likely to benefit from improved access to
health care, lower costs, and additional innovation.
34 Id. at 3 (quoting TEX. 0cc. Code§ 157.058
35 For example, licensure requirements or scope-of-practice restrictions may sometimes offer an efficient
response to certain types of market failure arising in professional services markets. See CAROLYN Cox &
SUSAN FOSTER, FED. TRADE COMM'N, BUREAU OF ECONOMICS, THE COSTS AND BENEFITS OF
OCCUPATIONAL REGULATION 5-6 (1990),
http://www. fie. go vibe/consumerbehavior/docs/reports/CoxF oster90 .pdf.
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Section III of the FTC s taffs 2014 Policy Paper discusses in detail the potential
competitive harms from overly restrictive APRN supervision requirements generally. 36
The Policy Paper analyzes these competitive harms as potential consequences of market
wide regulations, and the potential benefits of policy reform as those likely to follow the
repeal or retrenchment of such regulatory constraints. Imposing additional constraints can
interfere with the ability of Texas hospitals and Texas patients to recognize the benefits
that using CRNA s could provide.
The Policy Paper analyzes three basic issues of particular relevance to the
Proposed Rule. First, regulatory constraints on APRN practice limit the ability of APRNs
to expand access to care and to ameliorate both current and projected health care
workforce shortages. 37 Second, legal or regulatory hurdles to APRN practice may raise
the costs of APRN services, thereby reducing supply and further diminishing access to
basic primary care. APRNs tend to provide care at lower cost than physicians. 38
Mandatory supervision and "collaborative practice" requirements may, however, increase
the cost of those services. 39 In contrast, when these types of supervisory requirements are
relaxed, the supply of professionals willing to offer APRN services at any given price is
likely to increase. In underserved areas and for underserved populations, the benefits of
expanding supply are clear: consumers gain access to services that otherwise would be
unavailable.40 Even in well-served areas, expanding the supply of APRN services tends to
lower prices and drive down health care costs. Third, rigid supervision requirements may
impede, rather than foster, development of effective models of health care delivery
including team-based care.41
Supervision requirements for CRNAs raise competition concerns similar to those
raised by the imposition of supervision requirements on primary care APRNs or certified
nurse practitioners (CNPs).42 FTC staff recognize that certain licensure requirements and
36 See generally, FTC STAFF POLICY PAPER, supra note 13. According to the National Council of State
Boards of Nursing, 22 states and the District of Columbia permit "independent practice" by CRNAs,
requiring neither supervision nor delegation. Nat'l Council State Bds. Nursing, CRNA Independent
Practice Map, https://www.ncsbn.org/5404.htm.
37 FTC STAFF POLICY PAPER, supra note 13, at 20 (regarding APRNs generally).
38 Id. at 28.
39 FTC STAFF POLICY PAPER, supra note 13, at 27-31.
40 "Expanded APRN practice is widely regarded as a key strategy to alleviate provider shortages, especially
in primary care, in medically underserved areas, and for medically underserved populations." FTC STAFF
POLICY PAPER, supra note 13, at 20 (citing, e.g., IOM FUTURE OF NURSING REPORT , supra note 6, at 98-
103, 157-61, annex 3-1 (2011).
41 FTC STAFF POLICY PAPER, supra note 13, at 34.
42 As noted above, there are four types of APRNs: nurse practitioners ("CNPs"); nurse midwives
("CNMs"); certified registered nurse anesthetists ("CRNAs"); and clinical nurse specialists ("CNSs"). Id. at
33,155, 33,160 (to be codified at§ 17.415(a)); see also IOM FUTURE OF NURSING REPORT, supra note 6, at
23, 26 table 1-1 (types of APRN practice). All four types of APRN consist of nurse practitioners with
graduate nursing degrees, in addition to undergraduate nursing education and practice experience. Id. at 23,
26.
8

scope-of-practice restrictions can serve to protect patients. 43 This is true for all APRNs
and, indeed, for all health care professionals. In particular, special practice requirements
or other restrictions may be recommended for indications or treatments associated with
heightened patient risks. 44 We note, however, the IOM's concern that excessive
restrictions may impede access to specialized care that CRNAs are qualified to provide,
based on their training and experience. 45 We also note the IOM's observation that "most
states continue to restrict the practice of APRN s beyond what is warranted by either their
education or their training," which "support broader practice by all types of APRNs." 46
Because particular regulatory restrictions on CRNAs may dampen competition in ways
that harm patients, institutional health care providers, and payors-without offering
countervailing health and safety benefits-we have recommended that policy makers
apply the same competition-oriented framework and considerations to all APRN policies,
including those policies affecting specialist APRNs. 47
Importantly, access problems are not unique to primary care. As the IOM points
out, "[a]ccess to competent care is denied to patients, especially those located in rural,
frontier, or other underserved areas, in the absence of a willing and available
'supervising' physician." 48 Yet specialist physicians such as anesthesiologists-and not
just primary care doctors-may be in short supply, 49 particularly in rural areas. 50 A recent
report on rural health policy notes that physician supply generally decreases as areas
become more rural, and that this is particularly true for certain types of specialists. 51 For
43 FTC STAFF POLICY PAPER, supra note 13, at text accompanying notes 51-5 5.
44 See, e.g., FTC Staff Comment to the Dep't of Veterans Affairs, supra note 14 , at 6.
45 IOM FUTURE OF NURSING REPORT, supra note 13, at 96.
46 Id. at 98 (emphasis added).
47 See, e.g., FTC Staff Comment to the Dep't of Veterans Affairs, supra note 14; FTC Staff to the Hon.
Heather A. Steans, supra note 14; Letter from FTC Staff to Kay Khan,, supra note 14.
48 IOM FUTURE OF NURSING REPORT, supra note 6, at 450.
49 Ass'N OF AM. MED. COLLS., PHYSICIAN SHORTAGES TO WORSEN WITHOUT INCREASES IN RESIDENCY
TRAINING (n.d.), https://www.aamc.org/download/l 50584/data/physician shortages factsheet.pdf;
BUREAU OF HEALTH PROFESSIONS, HEALTH RESOURCES & SERVS. ADMIN., THE PHYSICIAN WORKFORCE:
PROJECTIONS AND RESEARCH INTO CURRENT ISSUES AFFECTING SUPPLY AND DEMAND 70-72, exs. 51-52
(2008), http://bhpr.hrsa.gov/healthworkforce/reports/physwfissues.pdf [hereinafter HRSA PHYSICIAN
WORKFORCE REPORT] (HRSA's most recent workforce report on physician supply and demand, projecting
increased shortages of both primary care physicians and specialists).
50 See Ass'N OF AM. MED. COLLS., supra note 49 (noting impact of physician shortfalls to be "most severe"
in rural and other underserved areas); see also HRSA PHYSICIAN WORKFORCE REPORT, supra note 49, at 8,
n. 4 (HRSA's supply model was designed primarily as a national model and thus did not track geographic
differences, but HRSA nonetheless noted that "[t]he physician workforce is ... unevenly distributed
throughout the Nation, with pockets of severe shortages (primarily in poor, rural and inner-city areas).");
IOM FUTURE OF NURSING REPORT, supra note 6, at 106-07; MICHAEL MEIT ET AL., RURAL HEALTH
REFORM POLICY RESEARCH CENTER, THE 2014 UPDATE OF THE RURAL-URBAN CHARTBOOK 56 (2014)
[hereinafter MEIT ET AL.].
51 MEIT ET AL., supra note 50, at 4. Overall, according to the National Rural Health Association, there are
more than three times as many specialists per 100,000 people practicing in urban areas as in rural areas.
What's Different About Rural Health Care, NAT'LRURALHEALTH Ass'N,
http://www.ruralhealthweb.org/go/left/about-rural-health (last visited Jan. 11, 2016).
9

example, many CRNAs provide basic anesthesia services in rural counties where there
are no anesthesiologists. 52 One hundred sixteen Texas counties lack practicing
anesthesiologists; 53 and, as noted above, sixty-four of the eighty-five Critical Access
Hospitals 54 in Texas are located in counties where there are no anesthesiologists; and
thirty-three of those hospitals are in counties where CRNAs are the only licensed,
specialized providers of anesthesia and anesthesia-related services. 55
FTC staff urge you to consider whether CRNAs can help alleviate the access
problems associated with specialist physician shortages, in a manner consistent with
patient health and safety. For example, the IOM Future of Nursing Report observes that
CRNAs administer more than 65 percent of all anesthetics to U.S. patients and that they
"[a]dminister anesthesia and provide related care before and after surgical, therapeutic,
diagnostic, and obstetrical procedures, as well as pain management." 56 Based on the
safety literature, the IOM states: "evidence shows that CRNAs provide high-quality care .
. . [while] there is no evidence of patient harm from their practice." 57 Similarly, the U.S.
52 See, e.g., FTC Staff Letter to the Hon. Jeanne Kirkton, Missouri House of Representatives, Concerning
Missouri House Bill 1399 and the Regulation of Certified Registered Nurse Anesthetists, at 3 (March
2012), http://www.ftc.gov/os/2012/03/120327kirktonmissouriletter.pdf ("Staff notes that CRNA practices
disproportionately serve rural patients, and the Missouri Association of Nurse Anesthetists has testified that
CRNAs are the only licensed providers of anesthesia services in 31 Missouri counties."); FTC Staff Letter
to the Hon. Gary Odom, Representative, Tennessee House of Representatives, Concerning Tennessee
House Bill 1896 and the Regulation of Providers oflnterventional Pain Management Services, at 4 (Sept.
2011 ), https://www.ftc.gov/sites/default/files/documents/advocacy documents/ftc-staff-letter-honorable
gary-odom-tennessee-house-representatives-concerning-tennessee-house-bill.b.1896-and-regulation
providers-interventional-pain-management-services/vl 1001 tennesseebill.pdf (CRNAs only licensed
providers of anesthesia services in 39 Tennessee counties); cf Letter from FTC Staff to the Hon. Kay
Khan, Representative, Mass. House of Representatives, supra note 13 , at 5 (geographic shortages of
anesthesiologists in rural Massachusetts counties).
53 Texas Ass'n Nurse Anesthetists, County-Level Map,
https://www.txana.org/uploads/files/generaVCounty TX map AANA.pdf.
54 Critical Access Hospitals (CAHs) are designated as such by both the states in which they are located and
the Department of Health and Human Services. They must, among other things, "[b]e designated by the
State as a CAH; be located in a rural area or an area that is treated as rural; be located either more than 35-
miles from the nearest hospital or CAH or more than 15 miles in areas with mountainous terrain or only
secondary roads; . ... [and] and furnish 24-hour emergency care services 7 days a week." Centers for
Medicare & Medicaid Servs., Critical Access Hospitals, https://www.cms.gov/Medicare/Provider
Enrollment-and-Certification/CertificationandComplianc/CAHs.html.
55 For locations ofCAHs , see Flex Monitoring Team, Univ. Minn., Univ. N.C. at Chapel Hill & Univ.
Southern Main, Critical Access Hospitals Locations, https://www.flexmonitoring.org/data/critical-access
hospital-locations/?search state=TX&filter search=yes#result-list (noting list current as of Oct. 11, 2019);
. For a map of Texas anesthesia providers based on the National Provider Identifier Registry, see Texas
Ass' n Nurse Anesthetists, County-Level Map,
https://www.txana.org/uploads/files/generaVCounty TX map AANA.pdf.
56 IOM FUTURE OF NURSING REPORT, supra note 6, at 26.
57 Id . at 111 ("A study .. . found no increase in inpatient mortality or complications in states that opted out
of the CMS requirement that an anesthesiologist or surgeon oversee the administration of anesthesia by a
CRNA.").
10

Department of Health and Human Services has, on multiple occasions relating to
Medicare and Medicaid rules for the provision of hospital anesthesia services, reviewed
the available literature on the quality of anesthesia services, and has not found risks that
would warrant further restrictions on CRNA practice. 58
V. 	Conclusion
Although the particular supervisory requirements contemplated by the Proposed
Rule are unclear, any such requirements or increased liability may contract the supply,
decrease the availability, or increase the cost of anesthesia services in Texas, without
providing offsetting benefits to Texas health care consumers or third-party payors. The
risk of competitive harm applies statewide, but it is likely to be greater in rural and other
medically underserved areas of Texas.
We recognize that patient health and safety concerns are critically important when
states regulate the scope of practice of health care professionals, and FTC staff defer to
the Texas legislature on the ultimate health and safety standards that the state may choose
to establish. We recommend, however, that Texas maintain only those CRNA supervision
requirements that advance patient protection, and that the Texas Medical Board avoid
adopting regulations that impede CRNA practice in ways that have not been
contemplated by the legislature, and that do not demonstrably advance consumer welfare.
Correspondingly, we recommend that the Board not impede physician delegation of
anesthesia or anesthesia-related services to CRNAs in ways that the legislature did not
contemplate and that do not demonstrably advance patient welfare. In particular, we urge
you to examine carefully any purported safety justifications for heightened supervision
requirements, evaluate whether these justifications are well founded, and consider
whether less restrictive alternatives would protect patients without unduly burdening
competition. In brief, pending further demonstration of the need for the Proposed Rule,
we recommend that you do not adopt it.
58 For example, in 2001, the Centers for Medicaid and Medicare Services concluded that anesthesia
services generally were safe and, in particular, that there was "no need for Federal intervention in State
professional practice laws governing [CRNA] practice .... [and] no reason to require a Federal rule ...
mandating that physicians supervise the practice of [state-licensed CRNAs]." Dep't Health & Human
Servs. (HHS), Health Care Financing Administration (HCFA), Medicare and Medicaid Programs; Hospital
Conditions of Participation: Anesthesia Services, 42 C.F.R. §§ 416,482 & 485, Final Rule, 66 Fed. Reg.
4674, 4675 (Jan. 18, 2001); cf HHS Health Care Financing Administration (HCFA), Medicare and
Medicaid Programs; Hospital Conditions of Participation: Anesthesia Services, 42 C.F.R. §§ 416,482 &
485, Final Rule, 66 Fed. Reg. 56,762, 56,762-63 (Nov. 13, 2001) (repeating observations on safety
literature, but noting potential utility of independent study of question whether safety or quality effects are
associated with state regulations permitting independent CRNA practice).
11

Ralyzr:-------(J J 	1J
Bilal Sayyed, Director
Offi: 	of Policyy7	·ing
[
/
Bruce Kobayashi, Director
Bureau of Economics
Ian Conner, Deputy Director
Bureau of Competition
12