FTC Staff Comment Before the Massachusetts House of Representatives Regarding House Bill 2009 (H.2009) Concerning Supervisory Requirements for Nurse Practitioners and Nurse Anesthetists

UNITED STATES OF AMERICA
FEDERAL TRADE COMMISSION
Offic e of Policy Planning
Bureau of Competition
Bureau of Economics
The Hon. Kay Khan
WASHINGTON , D.C. 20580
January 17, 2014
Massachusetts House of Representatives
Room 146, State House
Boston, MA 02133-1054
Dear Representative Khan:
The staffs of the Federal Trade Commission Office of Policy Planning, Bureau of
Economics, and Bureau of Competition 1 appreciate the opportunity to respond to your
invitation for comments on the likely competitive impact ofHouse Bill2009 ("H.2009"
or "the Bil1"). 2 The Bill would remove certain supervision requirements now imposed on
nurse practitioners ("NPs") and nurse anesthetists (''NAs") under Massachusetts law. In
particular, the Bill would permit NPs and NAs to order tests and therapeutics, and issue
written prescriptions, without establishing a formal supervisory agreement with a
particular Massachusetts physician. It would also permit properly licensed and registered
NAs and NPs to administer and dispense certain controlled substances without these
types of formal supervisory agreements. Absent good grounds to continue the current
supervision requirements, removing them may offer Massachusetts health care consumers
and third-party payors significant benefits.
A report by the Institute of Medicine ("10M") has identified a key role for
advanced practice registered nurses ("APRNs"), including NPs and NAs, in improving
the delivery of health care. 3 The IOM- established in 1970 as the health arm of the
National Academy of Sciences -provides expert advice to policy makers and the public .
Based on an intensive examination of APRN practice issues, the IOM found that
"[r]estrictions on scope of practice . .. have undermined [nurses') ability to provide and
improve both general and advanced care.'r4 Similarly, in 2012, the National Governors
Association (NGA) reported on APRNs' potential to address increased demand for
primary care services, particularly in historically underserved areas.s The report noted the
high quality of primary care services provided by APRNs, who ''may be able to mitigate
projected shortages of primary care services." 6
Additional research suggests that Massachusetts, specifically, is affected by the
national health care delivery problems discussed in the 10M and NGA Reports. While
Massachusetts as a whole is rich in medical resources, serious shortages exist in some
areas of practice and some geographic areas within the state. For example, a recent report

by the Massachusetts Medical Association observes that primary care doctors are in short
supply, describing statewide family medicine shortages as "critical" and internal
medicine shortages as "severe.'' 7 The same report highlights regional physician shortages,
especially in Western Massachusetts. 8 Existing supervision requirements in
Massachusetts limit the abilities of APRNs to alleviate these shortages.
APRN supervision requirements raise several related competitive concerns. By
restricting APRNs' access to the marketplace, supervision requirements may deprive
health care consumers 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 primary care
services.
We recognize that patient health and safety concerns are of critical importance
when states regulate the scope of practice of health care professionals, and FTC staff
defer to Massachusetts on the ultimate health and safety standards that the
Commonwealth may choose to establish. We recommend, however, that the legislature
seek to maintain only those NA and NP supervision requirements that advance patient
protection. In particular, we urge the legislature to examine carefully any purported
safety justifications for the Commonwealth's current NP and NA supervision
requirements, evaluate whether these justifications are well-founded, and consider
whether less restrictive alternatives would protect patients without unduly burdening
competition. To that end, it may be particularly useful to look at APRN practice in states
that do not require supervision, and to consider the available evidence regarding patient
benefits and harms in those states, including the findings of the IOM, the NGA, and other
experts in the field. If there are not good grounds to impose across-the-board supervision
restrictions on all services performed by NPs and NAs, removing these re strictions in
whole or part may offer significant benefits to Massachusetts health care consumers and
payors.
I. 	INTEREST AND EXPERIENCE OF THE FfC
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.9
Competition is at the core of America's economy, 10 and vigorous competition among
sellers in an open marketplace gives consumers the benefits of lower prices, higher
quality products and services, and greater innovation. 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, 11 research, 12
and advocacy. 13 Recently, 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.14
2

IT. 	HOUSE BILL 2009
H.2009 proposes numerous amendments to Massachusetts statutory provisions
governing advanced practice nursing. Collectively, these changes would permit what is
sometimes termed "independent practice" by NPs and NAs in Massachusetts. 15 For
purposes of FTC staff's response to your comment invitation, several provisions stand
out as relevant to our competition analysis.
First, amendments to Chapter 112, Section 80B of the General Laws of Massachusetts
would include NAs among the named categories of APRNs, or ..duly authorized nurses in
advanced roles," and would streamline APRN regulation by assigning rule-making
authority to the Board ofNursing. 16
Second, amendments to Chapter 112, Section 80E would remove the general
requirement that a NP order tests and therapeutics, or prescribe medications, only under a
formal supervis ory agreement with a physician. 17 Similarly, amendments to Section 80H
would remove the requirement that NAs delivering perioperative care - anesthesia and
pain medicine before and after surgery - order tests and therapeutics, or ftrescribe
medications, only under a formal supervisory agreement with physician. 8 Amendments
to Section 80H also would lift the requirement that prescriptions written by anNA,
otherwise consistent with Massachusetts and federal laws and regulations, include the
name of a supervising Massachusetts physician. 19
Third, amendments to Chapter 112, Section 211 would pennit NAs to administer
drugs or therapeutic agents via intravenous or extracorporeal circuit, and would pennit
NAs (as well as physicians) to administer (and order and supervise) anesthetic agents via
intravenous or extracorporeal circuit 20
Fourth, the Bill would amend Massachusetts controlled substances laws to remove
supervision requirements, for certain controlled substances, for NAs and NPs otherwise
registered and licensed to dispense, administer, or prescribe controlled substances.
Amendments to Chapter 94C, Section 1 would stipulate that NPs and NAs are
"practitioners" who are permitted to write medication orders -orders for a drug to be
dispensed for immediate administration in a hospital, ambulatory care clinic, or other
health care facility - for certain controlled substances.2 1 These amendments also would
include NPs and NAs among those providers allowed to administer controlled substances,
as appropriate, for the alleviation of pain and suffering, as well as treatment or alleviation
of disease.22 Amendments to Chapter 94C, Section 18 would provide that prescriptions
f or certain controlled substances (Schedules ill-VI) could be written by properly
authorized and registered NAs and NPs, as clinically appropriate. 23
ill. 	LIKELY COMPETITIVE BENEFITS OF H.2009
FTC staff recognize that certain professional licensure requirements and scope of
practice restrictions can be important to patient welfare.24 Consistent with patient safety,
however, we urge legislators to consider the potential benefits of enhanced competition
3

that H.2009 may facilitate. If APRNs are better able to practice to the extent of their
education, training, and abilities, and if institutional health care providers are better able
to deploy APRNs as needed, Massachusetts health care consumers are likely to benefit
from lower costs, additional innovation, and improved access to health care.
a. 	H.2009 WOULD LIKELY IMPROVE ACCESS TO PRIMARY
CARE SERVICES, AS IT HELPS EXPAND THE SUPPLY OF
SERVICES AND PROVIDERS
The United States faces substantial and growing shortages ofphysicians .2 s
While these shortages will exacerbate health care access problems for many American
consumers, the impact of reduced access is likely to be most acute among underserved
populations and areas, due not only to geographic misalignment between rural and low-
income communities and physician practice locations, but also to low physician
participation in state Medicaid programs.Z6 Expanding the supply of independent primary
care practitioners, and hence available primary care services, is one way to ameliorate
such shortages.
The Commonwealth also faces provider shortage issues and resulting access
challenges. According to a report by the Massachusetts Department of Public Health,
"[i]mplementation of Health Care Reform has identified and potentially exacerbated a
clear imbalance of primary care access across the state, with long wait times and closed
practices."27 A 2013 study by the Massachusetts Medical Association identifies
persistently high wait times for internal medicine and pediatric visits?8 The same report,
as noted above, observes that family medicine shortages are "critical," and internal
medicine shortages "severe," statewide. 29 Regional shortages are observed across practice
areas, including primary care, especially for Western Massachusetts.3
°Consistent with
those findings, the NGA report points out that there are 75 federally-designated primary
care Health Professional Shortage Areas ("HPSAs") in Massachusetts. 31
Many health care authorities see wider deployment of APRNs as crucial to
addressing both extant and projected access problems, including in Massachusetts.32
APRNs are the fastest-growing segment of the primary care professional workforce in the
United States, 33 and they make up a greater share of the primary care workforce in less
densely populated, less urban, and lower income areas, as well as in federally-designated
HPSAs. Relative to primary care physicians, APRNs are more likely to practice in
underserved areas and to care for large numbers of minority patients, Medicaid
beneficiaries, and uninsured patients. 34 In addition, some reports suggest that more
APRNs practice in states that allow independent practice (i.e., practice without immediate
supervision or collaborative agreement requirements). 35 A study of physician supply and
demand by the American Association of Medical Colleges recognizes that one way to
meet "future demand for physician services is expanding the role of .. . NPs where the
physician shortage is expected to be greatest, i.e., in primary care.'.J 6 The AAMC also
recognizes that expanding the primary care roles now filled by NPs (and physician
assistants~ can free up physicians to focus on more complex cases or more severely ill
patients. 3 With respect to Massachusetts, specifically, a study conducted for the
4

Massachusetts Division of Health Care Finance and Policy suggests some of the potential
for regulatory reform: "Given widespread agreement that there is a critical shortage of
primary care physicians in the Commonwealth, expanding scope-of-practice ... [for
APRNs] could be a viable mechanism for increasing primary care capacity and reducing
health care costs." 38 Thus, ifMassachusetts eliminates APRN supervision requirements,
the Commonwealth may benefit from growth, both in the number of APRNs providing
primary care services and in the overall availability of primary health care services. 39
Similar issues face rural hospitals and surgical facilities seeking to provide
adequate anesthesia services during surgery and adequate pain treatment before and after
surgery. According to one source, more than half of all anesthesiologists practicing in
Massachusetts are based in two counties, Suffolk and Middlesex. 40 Indeed, several
Massachusetts counties have very few board-certified anesthesiologists, and Nantucket
has none. 41 That may reflect a local undersupply of anesthesiologists; and because NAs
cannot practice without physician supervision, it may limit both providers' ability to
deploy NAs to help meet demand and training opportunities for NAs in underserved
areas. It is worth noting that, nationwide, NA practices disproportionately serve rural
patients,42 and NAs are better able to help fill unmet needs when they are able to practice
more flexibly in underserved areas. It appears that H.2009's proposed changes to NA
supervision requirements alone- with no increase or redistribution of the state's health
care workforce, and no further expansion of the scope ofNA practice- could have a
significant impact on access to NA providers and services. For example, H.2009 would
increase the population of independent, licensed anesthesia providers in Hampden
County by more than 60 percent.
In sum, the Bill's elimination of APRN supervision requirements may improve
access to primary care and other needed services, including surgical and perioperative
anesthesia services, especially for rural and other underserved populations.
b. 	B.2009 COULD HELP TO MODERATE HEALTH CARE COSTS
AND PRICES
Mandatory physician supervision requirements can impose unnecessary costs on
the supervising physician and the supervised APRN, as well as any institutional health
care providers potentially employing them. When this regulatory burden is reduced (e .g.,
by removing particular physician supervision requirements), the supply of professionals
willing to offer those services at any given price increases. Expansion of supply tends to
lower prices for everyone, which will be particularly beneficial in underserved areas and
for underserved populations. Even in well-served areas, supply expansion will tend to
lower prices and reduce health care costs.
Moreover, because APRNs tend to be relatively low cost providers, expanding
their ability to provide additional services may lower the average costs of those services,
potentially enhancing savings associated with a supply expansion. 43 Although FTC staff
have not independently projected any specific potential savings from H.2009, we note
that a study conducted for the Commonwealth of Massachusetts by RAND Health does
5

suggest a particular range of savings that expanded APRN (and physician assistant) scope
of practice could achieve, due to the lower costs and prices that tend to be associated with
APRN-delivered services: ''between 2010 and 2020, Massachusetts could save $4 .2 to
$8.4 billion thro~ greater reliance on NPs and PAs [physician assistants] in the delivery
of primary care.' 	The same report indicates additional potential savings of up to $6
billion, if regulatory and payment reform were to facilitate expanded use of retail
clinics. 45 NAs also are relatively low cost providers, and at least one study su~~ests that
independent NA practice is the most cost-effective model for anesthesia care.
c. 	H.2009 COULD HELP TO FOSTER INNOVATION IN HEALTH
CARE DELIVERY
As the health care marketplace evolves, new models of provider organization and
collaboration typically represent an important form of innovation in health care
delivery. 47 Restrictions on APRNs may limit not only physician-APRN collaborations,
but also the ability of health care providers to develop, test, and implement the most
efficient teams of primary care and anesthesia professionals.48 Proponents of team-based
care have recognized the importance of innovation in this area, and the diversity of
approaches to team-based care that may be successful in different practice settings, or in
treating different patient populations.49 In general, laws and regulations should promote
this kind of innovation, not limit it, directly or indirectly. Rigid physician supervision
requirements not only restrict competition by independent APRNs, but also may
constrain the ability of physician practices, hospitals, clinics, and other providers to
experiment with flexible oversight and collaboration arrangements for employed or
contractually-affiliated APRNs.
For example, APRNs have played an important role in the expansion of"retail" or
"limited service clinics" ("LSCs") in Massachusetts and many other states. LSCs
typically are staffed by APRNs50 and offer consumers an efficient and convenient way to
obtain basic medical care at competitive prices.51 APRN-staffed clinics generally offer
weekend and evening hours, which provide greater flexibility for patients, and may
provide competitive incentives for other types of clinics to offer extended hours as well. 52
By eliminating restrictions on APRNs' ability to work independently within their full
scope of practice, the Bill may increase both the number and types of clinics available to
Massachusetts consumers.53
Other reports highlight diverse private and public innovations in deploying
APRNs in team-based health care. 54 Regulatory flexibility may be key to this type of
innovation, to the extent that providers and other health experts have not settled on a
single best model of team based care. As one report observes, "[e Jach health care team is
unique-it has its own purpose, size, setting, set of core members, and methods of
communication." 55
6

IV. 	APRN SUPERVISION REQUIREMENTS SHOULD SERVE WELL-
FOUNDED PATIENT PROTECTION CONCERNS
FTC s taff fully recognize the critical importance of patient health and safety.
None of the forgoing discussion is meant to downplay the valid health and safety
concerns reflected in many regulations governing health care professionals. We defer to
state legislators to survey the available evidence, determine the optimal balance of policy
priorities, and define the appropriate scope of practice for APRNs and other health care
providers. As the Massachusetts legislature engages in this exercise, however, we urge it
to carefully consider the findings of the 10M and other expert bodies - findings based on
decades of research and experience - on issues of APRN safety, effectiveness, and
effici ency.56 The IOM, based on an extensive review of the safety literature, has
recommended that nurses be permitted by state licensing laws to practice to the full
extent of their training.57
The IOM Report notes that 16 states and the District of Columbia allow APRNs
to practice and prescribe independently, and that no differences in safety and ~uality have
been associated with state laws that permit APRNs to practice independently. 	The
ability to write prescriptions is one of the defining criteria f or independent APRN
practice and has been an ongoing source of contention.59 As the 10M ob serves, however,
studies have examined outcomes associated with APRNs that have independent
prescribing authority, and the results have suggested that APRN and physician primary
care outcomes are comparable.60 FTC staff are not aware of any contrary empirical
evidence to support the contention that there are patient harms or ris ks particularly
associated with APRN prescribing.
FTC staff also understand that the distribution, prescription, and use of controlled
substances may prompt heightened regulatory concern. There have b~ for example,
ongoing national concerns about diversion and misuse of pain medicines.61 Our sister
agency, the federal Food and Drug Administration, ''has become increasingly concerned
about the abuse and misuse of opioid products ," in particular, and may shortly propose
new regulations for hydrocodone combination products.62 Likewise, we understand that
various medical risks may be associated with certain pain management procedures, 63 and
we do not attempt to assess those risks for the medical contexts in which they apply.64
However, staff recommends that the legislature consider whether APRN
administration or prescription of controlled substances raises particular concerns and, if
so, whether physician supervision requirements are likely to be successful or cost-
effective ways minimize any added risk. It may be relevant to consider, in particular, that
H.2009 would not remove state or federal oversight of controlled substance prescribing,
distribution, or administration. In addition, the 2012 NGA Report identifies 15 states,
plus the District of Columbia, in which APRNs may independently prescribe controlled
substances and st aff encourages the legislature to look to the experience of those stat es
when weighing any health or safety risk that may be associated with H.2009.65
7

Current Massachusetts supervision requirements appear to impede NAs
particularly in their ability to provide anesthesia care and perioperative pain treatment to
the extent permitted in other states. The IOM Report observes that NAs administer more
than 65% of all anesthetics to U.S. patients, and that, generally, they "[a]dminister
anesthesia and provide related care before and after surgical, therapeutic, diagnostic, and
obstetrical procedures, as well as pain management."66 The U.S. Department of Health
and Human Services has reviewed several times the available literature on the quality of
anesthesia services in publishing rules regarding the provision of hospital anesthesia
services, under the Medicare and Medicaid programs, but has not found that risks suggest
further restrictions on NA practice. For example, in 2001, the Centers for Medicaid and
Medicare Services ("CMS") concluded that anesthesia services generally were safe and,
in particular, that there was "no need for Federal intervention in State professional
practice laws governing [NA] practice.. .. [and] no reason to require a Federal rule in
these conditions of participation mandating that physicians supervise the practice of
[state-licensed NAs]."67 The 10M too, has reviewed the safety literature, suggesting that
"evidence shows that [NAs] provide high-quality care ... [while] there is no evidence of
patient harm from their practice. 68
We encourage Massachusetts legislators to review available empirical literature,
as well as evidence from other states with less restrictive NP and NA supervision
requirements, particularly when assessing continued reliance on broad statutory
supervision requirements.
V. 	CONCLUSION
H.2009 would streamline APRN regulation and permit APRNs to more fully
employ their education and experience in serving Massachusetts health care consumers,
with regulatory oversight, but without certain formal physician supervision requirements
now imposed under Massachusetts law. Absent countervailing safety concerns regarding
APRN practice, removing these supervision requirements has the potential to benefit
consumers by improving access to care, containing costs, and expanding innovation in
health care delivery. Accordingly, we encourage legislators to consider whether these
requirements are necessary to assure patient safety in light of your own regulatory
experience, the findings of the IOM and other expert bodies, and the experience of other
states. Removing unnecessary and burdensome requirements may benefit Massachusetts
consumers by increasing competition among health care providers.
8

9
Respectfully submitted,
Andrew I. Gavil, Director
Office of Policy Planning
Martin S. Gaynor, Director
Bureau of Economics
Deborah Feinstein, Director
Bureau of Competition
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 Letter from the Hon. Kay Kahn, Massachusetts House of Representatives to Andrew I. Gavil, Director,
Fed. Trade Comm’n Office of Pol’y Planning, Aug. 20, 2013. FTC staff were asked to comment on
companion bills in the Massachusetts legislature, H 2009 and S 1079. For brevity, this comment refers
solely to H 2009, although its policy analysis applies equally to parallel provisions in the Senate bill.
3 See generally I NST. OF M ED., N AT’ L A CAD. OF S CIENCES, THE F UTURE OF N URSING : LEADING CHANGE,
A DVANCING H EALTH (2011) [hereinafter IOM F UTURE OF N URSING R EPORT] (especially Summary, 1-15).
4 Id. at 4.
5 National Governors Association, The Role of Nurse Practitioners in Meeting Increasing Demand for
Primary Care (Dec. 20, 2012), at: http://www.nga.org/cms/home/nga-center-for-best-practices/center-
divisions/page-health-division/col2-content/list---health-left/list-health-highlight/content-reference-2@/the-
role-of-nurse-practitioners html [hereinafter NGA, Role of Nurse Practitioners].
6 Id. at 11.
7 MASS . MED. S OC ’ Y, 2013 MMS P HYSICIAN W ORKFORCE S TUDY, 12 (Sept. 2013).
8 Id. at 3, 19-20.
9 Federal Trade Commission Act, 15 U.S.C. § 45.
10 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.”).
11 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/bc/healthcare/antitrust/commissionactions.htm.

12 See FTC & U.S. DEP'T OF JUSTICE {"DO.r'), IMPROVING HEALTH CARE: A DoSE OF COMPETITION (2004),
available at htto://www.ftc.gov/reports/bealthcare/ 040723healthcaremt.pdf [hereinafter FTC & DOJ,
IMPROVING HEALTH CARE].
13 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 Bums, Louisiana Legislature, (May l, 2009) (regarding proposed
restrictions on mobile dentistry), available at
http://www.ftc.gov/os/2009/05/V090009louisianadentistry.pdf; FTC and DOJ 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/os12008/0 9N0800 18illconlaws.pdf; FTC Amicus Curiae Brief in In
re Ciprojloxacin Hydrochloride Antitrust Litigation Concerning Drug Patent Settlements Before the Court
of Appeals for the Federal Circuit (Case No. 2008-1 097) (Jan. 2008), available at
http://www.ftc.gov/os/2008/Ql/080129cipro.pdf; FTC & DOJ,IMPROVING HEALTH CARE supra note 12.
14 See, e.g., FTC Staff Comment to the Hon. Heather A. SteaDS, Illinois State Senate, Concerning Illinois
Senate Bill1662 and the Regulation of Certified Registered Nurse Anesthetists (CRNAs) (Apr. 2013),
available at http://www.ftc.gov/os/20 13/04/l30424illioois-sb 1662. pdf; FTC Staff Letter to the Hon.
Theresa W. Conroy, Connecticut House of Representatives, Concerning the Likely Competitive Impact of
Connecticut House Bill6391 on Advance Practice Registered Nurses (Mar. 2013), available at
http://ftc.gov/os/20 13/03/1 303 19 apmconroy.pdf; FfC Staff Testimony Before Subcommittee A of the Joint
Committee on Health of the State of West Virginia Legislature on The Review of West Virginia Laws
Governing the Scope of Practice for Advanced Practice Registered Nurses and Consideration of Possible
Revisions to Remove Practice Restrictions (Sept. 2012), available at
http://www.ftc.gov/os/20 l2/09/120907wvatestimony.pdf: FTC Staff Comment Before the Louisiana House
of Representatives on the Likely Competitive Impact of Louisiana House Bill951 Concerning Advanced
Practice Registered Nurses ("APRNs") (Apr. 2012), available at
http://www.ftc.gov/os/20 12 /04/ 1204251ouisianastaffcomment.pdf; FTC Staff Letter to the Hon. Jeanne
Kirktoo, Missouri House of Representatives, Concerning Missouri House Bill1399 and the Regulation of
Certified Registered Nurse Anesthetists (March 20 12), available at
htto://www.ftc. gov/os/20 12/03 / 120327kirktonmissouriletter.pdf.
15 The phrase "independent practice" here, and commonly, refers to state regulatory schemes that do not
require direct supervision of an APRN by a particular physician for an APRN to deliver services otherwise
within his or her scope-of-practice. "Independent practice" does not, however, mean isolated or unregulated
practice. Collaboration and professional oversight are the norm in states that do not require direct physician
supervision. Patterns of collaboration are independently established by institutional providers, from large
hospital systems to small physician practices, to individual practitioners, with the particulars varying
according to resources and demands at the point of service, and standards of care, as well as other
regulations. It bas been reported that more than half of all nurse practitioners are employed in private
physician practices (27.9%) or hospitals (24.1%), among other institutional provider settings. John K.
Iglehart, Expanding the Role ofAdvanced Practice Nurse Practitioners - Risks and Rewards, 368 N. ENGL.
J. MED. 1935, 1937 (2013). Regarding diverse practice settings and APRN collaboration, see IOM FUTURE
OF N URSIN G REPORT, supra note 3, at 23, 58-59, 65-67, 72-76; regarding the evolution and diversity of
team-based care, see generally Pamela Mitchell et al ., Nat'1 Acad. of Sciences, lnst ofMed. Discussion
Paper, Core Principles & Values ofEffective Team-Based Health Care (2012),
http://www. iom.eduHmedia/Files/Perspectives-Files/20 12/Discussion-'PapersNSRT-Team-Based-Care-
Principles-Values. pdf (10M-sponsored inquiry into collaborative or team-based care).
16 H 2000, §§ 16-17. Existing law requires that nursing regulations be promulgated by the Board of Nursing
"in conjunction with the board of registration in medicine .... only after the two boards have met,
consulted and concurred on the content of such regulations." MAss. GEN . LAWS ch. 112 , § 80B. These
amendments further stipulate that the authority to promulgate rules that "govern the provision of advanced
practice nursing services and related care, including but not limited to the ordering and interpreting of tests
and the ordering of treatment and therapeutics," would rest with the Board ofNursing.
10

17 H 2000, § 17. Staff notes that this amendment would leave the requirement in place for psychiatric nurse
mental health specialists.
18 ld. at§ 18.
19'/d.
20 Id. at§§ 21-22.
21 Id. at§ 2.
22 ld. at§§ 21-22.
23 ld. at§§ lJ-15.
24 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. FEDERAL TRADE COMMISSION, BUREAU OF ECONOM1CS, THE COSTS AND BENEFITS OF
OCCUPATIONAL REGULATION 5-6 (1990), available at
htto://www.ftc.govibe/consumerb ehavior/docs/reports/Coxfoster90.pdf.
23 See K.aiser Commission on Medicaid and ·the Uninsured, Improving Access to Adult Primary Care in
Medicaid: Exploring the Potential Role ofNurse Practitioners and Physician Assistants, at 1 (Mar. 2011 ),
available at htto://www.kff.org/medicaidlupload/8167 .pdf [hereinafter "Kaiser Commission, Improving
Access"]; the Association of American Medical Colleges (AAMC) Physician Shortages Factsbeet,
available at https://www.arugc.orWdownload/150584/d atalphvsician shortages factsheet.pdf (in its
projections of physician supply and demand, the AAMC assumes that each additional two NPs (or
Physicians Assistants) reduce physician demand by one) [hereinafter "AAMC, Physician Shortages"]; U.S.
DEPARTMENT OF HEALTH AND HUMAN SERVICES, HEALTH RESOURCES AND SERVICES ADMINISTRATION
BUREAUOF HEALTH PROFESSIONS, THE PHYSICIAN WORKFORCE: PROJECfiONS AND RESEARCH INTO
CURRENT ISSUES AFFECTING SUPPLY AND DEMAND, 70-72, exhibits 51-52 (2008), available at
htto://bbpr.hrsa.govlhealthworkforce/reportslphyswfissues.pdf. [Hereinafter HRSAPHYSICIAN
WORKFORCE REPoRT] .
26 See Kaiser Commission, Improving Access, supra note 25, at 1.
27 Mass. Dep't Public Health. Health of Massachusetts, 38 (Apr. 2010).
28 2013 MMSPHYSICJANWORKFORCESTUDY,supra note 7, at6 (recent increases to a 25 day average for
new patient pediatric visits and 50 days for internal medicine).
29 2013 MMS PHYSICIAN WORKFORCE STUDY, supra note 7, at 12.
30 ld. at 3, 19 -20.
31 NGA, Role ofNurse Practitioners, supra note 5. See also Kaiser Family Foundation,
statebealthfacts.org, Primary Care Health Professional Shortage Areas (HPSAs), available at
http://www.statehealthfacts.org/comoaremapreport.jso7rep=l l2&cats8&utm source=shfonl&utm mediu
m=email&utm campaign=040512short (indicating 12.2% of Connecticut population living in HPSA) (last
checked Mar. 4, 2013). For a general description ofHPSAs, see U.S. Dep't Health and Human Servs.,
HRSA, Guidelines for Primary Medical Care/Dental HPSA Designation,
http://bhpr.hrsa.gov/shortagelhpsas/designationcriterialmedicaldentalbpsaguidelines.html (last checked
Mar. 4, 2013).
32 The ability of APRNs to provide safe and effective primary care services is a central observation of the
10M report and many other studies. IOM FUTURE OF NURSING REPORT, supra note 3, at 4, 8 ("key
message" and policy recommendation regarding scope of practice); OFFICE OF TEcH . ASSESSMENT, U.S.
CONG., HEALTH TECH. CASE STUDY 3 7, NURSE PRACfiTIONERS, PHYSICIAN AsSISTANTS, AND CERTIFIED
N URSE-M IDWIVES : APOUCY ANALYSIS, 39 (1986) ("Most observers conclude that most primary care
traditionally provided by physicians can be delivered by [nurse practitioners and physician assistants].");
see generally NGA PRIMARY CARE PAPER. sup ra note 5; KAISER FAMILY FOUND ., IMPROVING ACCESS TO
ADULT PRIMARY CARE IN MEDICAID: ExPLORING THE POTENTIAL ROLE OF NURSE PRACTITIONERS AND
11

PHYSICIAN AsSISTANTS (Mar. 20 11 ), http://kaisertamilyfoundation.files.wordpress.com/20 13/01/8167.pdf
(hereinafter KAISER FOUND. , IMPROVING ACCESS); MINN. HEALTH CARE REFORM TASK FORCE , ROADMAP
TO A HEALTHIER MINNESOTA : RECOMMENDATIONS OF THE MINNESOTA HEALTH CARE REFORM TASK
FORCE 25 -26 (2012), http://mn .gov/health-reform/images/TaskForce-20 12-12-14-Roadmap-Final.odf.
33 See Kaiser Commission, Improving Access, supra note 25, at 3; AAMC, Physician Shortages, supra note
20.
34 Kaiser Commission, Improving Access, supra note 25, at 3.
35 See, e.g ., TEXAS LEGIS LATlVE BUDGET BOARD STAFF, TEXAS STATE GOVERNMENT EFFECTIVENESS AND
EFFICIENCY: SELECTED ISSUES AND RECOMMENDATIONS 297,300 (Jan. 2011) (submitted to the 82nd Texas
Legislature) (indicating that the number of advanced practice nurses is lower in states with restrictive
regulatory environments, and these restrictions may "limit the expansion of retail clinics, which generally
employ APRNs to provide a limited range [o f] primary healthcare'') [hereinafter TEXAs B UDGET BOARD
STAFF REPORT]; Julie A. Fairman et al ., Perspective: Broadening the Scope ofNursing Practice, 364 N.
ENGL. J. MED. 193, 194 (2011} (noting "nurses tend to move from more restrictive to less restrictive states .
. . with a resulting loss of access to care for patients").
36 MJC HAELJ. DILL& EDWARDS . SALSBERO, CTR. FOR WORKFORCE STUDIES, AAMC, THE COMPLEXITIES
OF PHY SICIAN SUPPLY AND DEMAND: PROJECTIONS TIIROUGH 2025, 66 (Nov. 2008), available at
httns:l/members.aamc.org/eweb/upload/The%20Complexities%20of0/o20Physician%20Supply.pdf.
37 /d.
38 CHRISTINE E. EIBNER ET AL., RAND HEALTH REPORT SUBMITTED TO THE COMMONWEALTHOF
MASSACHU SETIS, CONTROLLING HEALTH CARE SPENDING IN MASSACHUS ETIS: AN ANALYSIS OF OPTIONS ,
100 (2009).
39 We do not suggest that reforming APRN scope of practice restrictions is a panacea for primary care
access problems in the U.S. Rather, reducing undue restrictions on APRN scope of practice can be one
significant way to help ameliorate existing and projected access problems. Cf. David I. Auerbach et al.,
Nurse-Managed Hea lth Cen ters and Patient-Centered Medical Homes Co uld Mi tigate E:.,.pected Primary
Care Phy sician Shortage, 32 HEALTH AFFAIRS 1933, 1938-40 (20 13) (projected shortages very unlikely to
be met by increase in number of primary care practitioners under current delivery models, but can be
substantially alleviated by increased use of, e.g., nurse managed health centers, which depend on changes
in scope of practice restrictions, among other things).
40 AANA Res. Div., Amer. Ass'n Nurse Anesthetists, Massachusetts Anesthesia Providers (Mar. 2013).
41 /d.
42 See, e.g., Brian Dulisse & Jerry Cromwell, No Harm Found When Nurse Anesthetists Work Without
Supervision by Physicians, 29 HEALTH AFFAIRS 1469, 1469 (2010) (CRNAs "provide thirty million
anesthetics annually in the United States and represent two-thirds of anesthetists in rural hospitals."); cf
J.P. Abenstein & Mark A Warner, Anesthesia Providers, Patient Outcomes, and Costs, 82 ANESTHESIA &
ANALGESIA 1273, 12 79 (1996) (nurse anesthetist-only practices found predominantly in smaller, rural
hospitals).
43 EIBNER ET AL.,supra note 38, at 103-4 (describing conditions for upper and lower bound estimates and
projections).
44 /d. at 99 ("Visits to NPs and PAs are considerably less expensive than visits to MDs. According to data
from the Medical Expenditure Panel Survey (MEPS), the average cost of an NP or PA visit is between 20
and 35 percent lower than the average cost of an office-based visit with a physician.").
4
s /d. at 87.
46 P.F. Hogan et al., Cost Effectiveness Analysis ofAnesthesia Providers, 28 NURSING ECONOMIC$ 159
(2010).
47 See IOM FuruRE OF NURSING REPORT, supra note 3, at 92-94.
12

48 Regarding diverse practice settings and APRN collaboration. see IOM FUTURE OF NURsiNO REPORT,
supra note 3, at 23, 58-59, 65-67, 72-76; regarding the evolution and diversity of team-based care, see
generally Pamela Mitchell ct al., Nat'l Acad. of Sciences, Inst ofMed. Discussion Paper, Core Principles
& Values ofEffective Team-Based Health Care (2012), http://www.iom.edu/-/media/Files/Persoectives-
Files/20 12/Discussion-Papers/VSRT-Team-Based-Care-Principles-V alues.pdf (10M-sponsored inquiry
into collaborative or team-based care).
49 Mitchell et al., supra note 48, at 3.
50 See generally William M. Sage, Might the Fact that 90% ofAmericans Live Within 15 Miles ofa Wa/-
Mart Help Achieve Universal Health Care?, 55 U. KAN. L. REv. 1233, 1238 (2007) (describing the size
and scope ofLSCs); Mary Kay Scott, Scott & Company, Health Care in the Express Lane: Retail Clinics
Go Mainstream, at 22 (Sept 2007) (report prepared for the California HealthCare Foundation), available at
htto://www.cbcf.org/publications.
51 See Massachusetts Dept. Pub. Health, Commonwealth to Propose Regulations for Limited Service
Clinics: Rules May Promote Convenience, Greater Access to Care (Jul. 17, 2007), available at
http://www.mass.gov/?pageiD=nressreleases&agld=Eeohhs2&prModName=dphpressrelease&,prFile=0707
17 clinics.xml. The types of care offered at LSCs arc similar to those offered in urgent care centers and
other limited care, outpatient settings. See, e.g., Ateev Mehrotra et al., Retail Clinics, Primary Care
Physicians, and Emergency Departments: A Comparison ofPatients Visits, 21 HEALTH AFFAIR.S 1272,
1279 (2008).
52 Cf Rena Rudavslcy, Craig Evan Pollack, & Ateev Mehrotra, The Geographic Distribution, Ownership,
Prices, and Scope ofPractice at Retail Clinics, 151 ANNALS lNTERNALMED . 315,317 (2009) ("In a
random sample of98 [limited service] clinics, all had weekday and weekend hours and 95 (97%) had
evening hours (after 6 p.m.) on weekdays.").
Sl See, e.g., TEXAS B UOOET BoARD STAFF REPoRT, supra note 35 at 300 (noting restrictions on APRNs'
scope of practice may limit both the number and types of LSCs available to Texas consumers); MARY
TAKACH &KATHY WITGERT, NATIONAL ACADEMY FOR STATE HEALTH P OLICY, ANALYSIS OF STATE
REGULATIONS AND POLICIES GOVERNING TilE OPERATION AND LICENSURE OF RETAIL CLINICS 6 (Feb.
2009) (noting "the mo st powerful state regulatory tools affecting [retail clinics '] operations are the scope of
practice regulations that govern nurse practitioners and other non-physician medical personnel").
"4 10M FUTURE OF NURSING REPORT, supra note 3, at 92-94 {regarding APRN primary care initiatives at
the Department of Veterans Affairs, Geisinger Health System, and Kaiser Permanente); cf Mitchell et al.,
supra note 48 (10M-sponsored inquiry into collaborative or team-based care generally).
ss Mitchell et al., supra note 48, at 6.
56 See IOMFUTUREOFNURSINGREPORT,supra note 3, at 98-99 (citing, e.g., S.A. Brown & D. E. Grimes,
A Meta-analysis ofNurse Practitioners and Nurse Midwives in Primary Care, 44(6) NURSING RESEARCH
332 (1995); S.W. Groth et al., Long-term Outcomes ofAdvanced Practice Nursing, in NURSE
PRACTITIONERS: EVOUJTION AND FUTURE OF ADVANCED PRACTICE (5 th ed., E. M. Sullivan-Marx et al.,
eds. 20 10); P.F. Hogan et al., Cost Effectiveness Analysis ofAnesthesia Providers, 28 NURSING
ECONOMICS 159 (2010); S.E. Horrocks et al., Systematic Review of Whether Nurse Practitioners Working
in Primary Care Can Provide Equivalent Care to Doctors, 324 BMJ 819 (2002); F. Hughes et al., Research
in Support ofNurse Practitioners, in NURSE PRACTITIONERS: EVOLUTION AND FuTURE OF ADVANCED
PRACfiCE(5th ed., E. M. Sullivan-Marx et al., eds. 2010); M. Laurant et al., Substitution ofDoctors by
Nurses in Primary Care, 2 Cochrane Database of Systematic Reviews, CD00 1271 (2004); M.O. Mundinger
et al., Primary Care Outcomes in Patients Treated by Nurse Practitioners or Physicians: A randomized
Trial, 283 JAMA 59 {2000); OFFICE OF TEC H. ASSESSMENT, U.S. CONG., HEALTH TECH. CASE STU DY 37,
NURSE PRACTITIONERS, PHYSICIAN ASSISTANTS, AND CERTIFIED NURSE-MIDWIVES: A POLICY ANALYSIS
(1986); see also Robin P. Newhouse et al. , Advanced Practice Nurse Outcomes 1990-2008: A Systematic
Review, 29 NURSING ECON. 1, 18 (2011) ("APRNs provide effective and high-quality patient care."); P.
Venning et al., Randomi.sed Controlled Trial Comparing Cost Effectiveness of General Practitioners and
Nurse Practitioners in Primary Care, 320 BMJ 1048 (2000) (no significant difference in patterns of
13

prescribing or health status outcome); see also Christine Everett et al., Physician Assistams and Nurse
Practitioners Peifomz Effective Roles 011 Teams Caring for Medicare Patiems with Diabetes, 32 HEALTH
AFFAIRS 1942 , 1945-6 (2013)(outcomes generally equivalent forNP, PA, and MD caregivers in 13
comparisons, superior for NP or PA care in 4, and superior for MD care in 3; ''PAs and NP s can fill a range
of roles on primary care teams, even for older patients with clinically challenging conditions such as
diabetes .j.
57 10M FliTURE OF NURSING REPORT, supra note 3, at 85-161; see especially id. at 98 (with respect to many
primary care services, "the contention that APRNs are less able than physicians to deliver care that is safe,
effective, and efficient is not supported by the decades of research that bas examined this question")
(internal citations omitted).
58 Jd. at 98-99 (noting "[n]o studies suggest that care is better in states that have more restrictive scope-of-
practice regulations for APRNs than in those that do not"). See also Julie A Fairman et aL , Perspective:
Broadening the Scope ofNursing Practice, 364 N. ENOL. J. MED. 193, 194 (2011) (stating "[t]here are no
data to suggest that nurse practitioners in states that impose greater restrictions on their practice provide
safer and better care than those in less restrictive states or that the role of the physician has changed or
deteriorated"); Cf Ateev Mehrotra et al., Comparing Costs and Quality ofCare at Retail Clinics with that
of Other Medical Settings for 3 Common Illnesses, 151 ANNAlS INTERNAL MED. 321, 326 (2009) (for retail
clinic settings largely staffed by APRNs, analyzing 14 quality metrics for commonly treated ailments,
including ear, strep, and urinary tract infections, and finding "[f]or most measures, quality scores of retail
clinics were equal to or higher than those of other care settings")..
59 See FTC Staff Louisiana APRN Comment, supra note 14, at 3, 5; West Virginia Testimony, supra note
14, at 3-6; cf IOM FliTURE OF NURSING REPORT, supra note 3, at 110-11 (regarding opposition by
physicians, including the American Medical Association).
60 See, e.g. Mundinger et al., supra note 56 (comparing outcomes for 1316 ambulatory care patients
randomly assigned to APRN and MD primary care providers., where APRNs had "same authority to
prescribe, consult, refer, and admit patients" found no significant difference in patients' health status or
physiologic test results); Lenz et al., Primary Care Outcomes in Patients Treated by Nurse Practitioners or
Physicians: Two-year Follow~up, 61 MED. CARE RES. REv. 332 (2004) (2-year follow-up data for
Mundinger et al. consistent with preliminary results); Ann B. Hamric et al., Outcomes Associated with
Advanced Nursing Practice Prescriptive Authority, 10 J. Amer. Acad. Nurse Practitioners 113 (1998)
(safety and effectiveness in study of 33 APRNs in 25 primary care si tes); Venning et al., supra note 56, at
1048 ((no significant difference in patteriJ.s ofprescnbing or health status outcome).
61 See, e.g. , Prescription Drug Diversion: Combating the Scourge: Hearing Before the H. Subcomm. On
Commerce, Manufacturing and Trade of the H. Comm. on Energy and Commerce, I 12 th Cong. (Mar. 1,
2012) (statement of Joseph T. Rannazzisi, Deputy Assistant Administrator, Drug Enforcement Admin.,
U.S. Dep't Justice); Nora D. Volkow et al., Research Letter: Characteristics ofOpioid Prescriptions in
2009, 305 JAMA 1299. 1300 (2011) (noting increases in opioid prescriptions and associated increases in
abuse and overdoses as cause of concern and need for further research). Looking at di stinct (or partly
distinct) populations, one might be simultaneously concerned about both abuse and under-treatment:
"Ironically, while many people with pain have difficulty obtaining opioid medications, nonmedical users
appear to obtain them far too easily ... so much so that the diversion of opioid analgesics has become a
national public health problem." IOM FliTURE OF NURSING REPORT, supra note 3, at 146.
62 Statement on Proposed Hydrocodone Reclassification from Janet Woodcock, M.D., Director, Center for
Drug Evaluation and Research, Nov. 24, 2013, available at
http://www.fda.gov/drugs/drugsafety/ucm372089.htm.
6·3 See, e.g., ROBIN HASHIMOTO ET AL., WASHINOTON STATE HEALTH CARE AUTHORITY, HEALTH
TECHNOLOGY AsSESSMENT, SPINAL INJECTIONS (Updated Final Evidence Report March 10, 201 1),
available at http://www.hta.hca.wa.gov/documents/updated final reoort spinal injections 0310-l.pdf
(reviewing evidence of efficacy, safety, and cost-effectiveness for diverse spinal injections); see also James
P. Rathmell et al., Injury and Liability Associated with Cervical Procedures for Chronic Pain, 114
ANESTHESIOLOGY 918 ( 20 ll) (based on data from Data from American Society of Anesthesiologists'
14

closed claims database between 2005 and 2008, injuries related to cervical interventional pain treatment
were often severe and related to direct needle trauma to the spinal cord); Dermot R. Fitzgibbon et al.,
Chronic Pain Management: American Society ofAnesthesiologists Closed Claims Project, 100
ANESTHESIOlOGY 98 (2004) (frequency and payments of claims associated with chronic pain management
by anesthesiologists increased in the 1990s; brain damage and death were associated with epidural steroid
injection only when opioids or local anesthetics were included).
64 See ROBIN HASHIMOTO ET AL, SPINAL INJECTIONS. Regarding effectiveness in different clinical contexts,
compare Stephen Choi & Richard Brull, Is Ultrasound Guidance Advantageous for Interventional Pain
Management? A Review ofAcute Pain Outcomes, 113 ANESTHESIA & ANALGESIA 596 (2011) (review of
randomized controlled clinical trials concluding "at present, there is insufficient evidence in the
contemporary literature to define the effect of US [ultrasound] guidance on acute pain and related outcomes
compared with traditional nerve localization techniques for interventional acute pain management) with
65 NGA, Role ofNurse Practitioners, supra note 5, at 12-13.
66 IOM FUTURE OF NURSING REPORT, supra note 3, at 26.
67 Dep't Health and Human Servs. (IDiS), Health Care Financing Administration (HCF A), 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); c.fHHS Health Care Financing Administration
(HCF A), Medicare and Medicaid Programs; Hospital Conditions of Participation: Anesthesia Services, 42
CFR Parts 416,482, and 485, Final Rule, 66 Fed. Reg. 56762, 56762-63 (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).
68 IOM FUTURE OF NURSING REPORT, supra note 3, 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.").
15