FTC and USDOJ Joint Comment to the Massachusetts House of Representatives Regarding House Bill 1973 to Allow Non-Surgical Treatment of Glaucoma by Optometrists

February 18, 2016
The Honorable Bradley H. Jones, Jr.
Massachusetts House of Representatives
Room 124, State House
Boston, MA 02133-1054
Dear Representative Jones:
The Antitrust Division of the U.S. Department of Justice (the “Division”)
and the staff of the Federal Trade Commission1 (the “FTC”) welcome the
opportunity to share our views on Massachusetts House Bill 1973 (the “Bill”),
which would allow optometrists to treat glaucoma patients, with certain
restrictions.2 Glaucoma is a group of chronic, progressive diseases of the optic
nerve that can lead to irreversible vision loss and blindness.3 Currently, the
treatment of glaucoma in Massachusetts is limited to ophthalmologists.
We recognize the critical importance of patient health and safety and the
role of state legislators and regulators in determining the optimal balance of
policy priorities and defining the appropriate scope of practice for medical
professionals, including ophthalmologists and optometrists. At the same time,
however, we note that unnecessarily broad scope of practice restrictions can
1 This letter expresses the views of the FTC’s Office of Policy Planning, Bureau of Competition,
and Bureau of Economics. The letter does not necessarily represent the views of the FTC or of any
individual Commissioner. The Commission, however, has voted to authorize staff to submit
these comments.
2 Letter from Massachusetts State Representative Bradley H. Jones, Jr. to Marina Lao, Director,
Office of Policy Planning, Fed. Trade Comm’n (Dec. 3, 2015).
3 See Facts About Glaucoma, N AT’L E YE I NST., N AT’L INST. OF HEALTH,
https://nei.nih.gov/health/glaucoma/glaucoma_facts (last visited Jan. 21, 2016).

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impose significant competitive costs on health care consumers and other payors.4
For this reason, we generally have encouraged legislatures to avoid restrictions
that are not necessary to address well-founded patient safety concerns.5
Similarly, we write now to highlight the potential competitive costs of a
continued prohibition on Massachusetts optometrists’ ability to treat glaucoma
and to encourage the legislature to consider the competitive implications of such
a restriction in its evaluation of the Bill.6
4 For example, the FTC staff’s 2014 policy paper on the regulation of advanced practice nurses
details the competition concerns with unnecessarily broad scope of practice regulations. See FED .
T RADE C OMM’N S TAFF, POLICY PERSPECTIVES: COMPETITION AND THE REGULATION OF A DVANCED
PRACTICE N URSES (2014), http://www.ftc.gov/system/files/documents/reports/policy-
perspectives-competition-regulation-advanced-practice-nurses/140307aprnpolicypaper.pdf
[hereinafter FTC S TAFF POLICY PERSPECTIVES].
5 See, e.g., Letter from FTC Staff to Hon. Kay Khan, Massachusetts House of Representatives (Jan.
14, 2014) (regarding removal of supervision requirements for nurse practitioners and nurse
anesthetists), https://www.ftc.gov/sites/default/files/documents/advocacy_documents/ftc-
staff-comment-massachusetts-house-representatives-regarding-house-bill-6-h.2009-concerning-
supervisory-requirements-nurse-practitioners-nurse-
anesthetists/140123massachusettnursesletter.pdf; Letter from FTC Staff to Hon. Heather A.
Steans, Illinois State Senate (Apr. 19, 2013),
https://www.ftc.gov/sites/default/files/documents/advocacy_documents/ftc-staff-comment-
honorable-heather.steans-illinois-state-senate-concerning-illinois-senate-bill-1662-and-regulation-
certified/130424illinois-sb1662.pdf; FTC Staff Letter to Hon. Jeanne Kirkton, Missouri House of
Representatives (Mar. 27, 2012),
https://www.ftc.gov/sites/default/files/documents/advocacy_documents/ftc-staff-letter-
honorable-representative-jeanne-kirkton-missouri-house-representatives-
concerning/120327kirktonmissouriletter.pdf; FED . T RADE COMM’N & U.S. DEP’T OF J USTICE ,
I MPROVING HEALTH C ARE : A DOSE OF COMPETITION , Ch. 2, 25-33 (July 2004),
http://www.usdoj.gov/atr/public/health_care/204694.htm (considering the competitive impact
of licensing restrictions). See also Letter from Scott D. Hammond, Acting Assistant Att’y Gen.,
U.S. Dep’t of Just., & Jon Leibowitz, Chairman, Fed. Trade Comm’n, to the Hawai'i State Bar
Association (Apr. 20, 2009), http://www.justice.gov/atr/comments-revised-proposed-rule-
concerning-unauthorized-practice-law (addressing the competitive effects of a rule that unduly
restricts unauthorized practice of law); Letter from J. Robert Kramer, II, Director of Operations,
U.S. Dep’t of Just., to Hon. Mark Boitano, New Mexico Senate (Feb. 13, 2009) (addressing the
competitive impact of “minimum service laws” in real estate).
6 We recognize that the Bill’s scope extends beyond the treatment of glaucoma. Our comments,
however, are limited to the Bill’s effect on glaucoma care.

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I. 	The Agencies’ Interest and Experience in Health Care Competition
Competition is the core organizing principle of America’s economy,7 and
vigorous competition among sellers in an open marketplace gives consumers the
benefits of lower prices, higher quality goods and services, increased access to
goods and services, and greater innovation.8 The FTC and the Division (the
“Agencies”) work to promote competition through enforcement of the antitrust
laws, which prohibit certain transactions and business practices that harm
competition and consumers, and through competition advocacy, whereby the
Agencies advance outcomes that benefit competition and consumers via
comments on legislation, discussions with regulators, and court filings, among
other means.
Because of the importance of health care competition to the economy and
consumer welfare, this sector has long been a priority for the Agencies.9 The
Agencies have extensive experience investigating the competitive effects of
mergers and business practices by hospitals, insurers, pharmaceutical
companies, physicians, and other providers of health care goods and services.
The Agencies also have provided guidance to the health care community on the
antitrust laws, and have devoted significant resources to examining the health
care industry by sponsoring various workshops and studies. Finally, through
their competition advocacy program, the Agencies have encouraged states to
consider the competitive impact of various health care-related legislative and
regulatory proposals, including scope of practice restrictions.10
7 See, e.g., N.C. State Bd. of Dental Exam’rs v. FTC, 135 S. Ct. 1101, 1109 (2015) (“Federal antitrust
law is a central safeguard for the Nation’s free market structures.”); Standard Oil Co. v. FTC, 340
U.S. 231, 248 (1951) (“The heart of our national economic policy long has been faith in the value of
competition.”).
8 See, e.g., Nat’l Soc’y of Prof’l Eng’rs v. United States, 435 U.S. 679, 695 (1978) (noting that the
antitrust laws reflect “a legislative judgment that ultimately competition will produce not only
lower prices, but also better goods and services. . . . The assumption that competition is the best
method of allocating resources in a free market recognizes that all elements of a bargain—quality,
service, safety, and durability—and not just the immediate cost, are favorably affected by the free
opportunity to select among alternative offers.”).
9 A description of, and links to, the FTC’s various health care-related activities can be found at
https://www.ftc.gov/tips-advice/competition-guidance/industry-guidance/health-care. An
overview of the Division’s health care-related activities is available at
http://www.justice.gov/atr/health-care.
10 See supra note 5.

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II. 	Glaucoma Care in the United States
Glaucoma is the second leading cause of blindness worldwide, and
glaucoma is increasingly prevalent among Americans.11 Past estimates have
suggested that 50 percent of Americans with glaucoma are undiagnosed,
including many who present with severe disease when seeking care.12 	Early
diagnosis, when the disease is generally asymptomatic, and managed treatment
can protect against serious vision loss and blindness from glaucoma. Early
diagnosis and treatment may also be cost-effective, as costs escalate with disease
severity.13
Because there is no single test for glaucoma, a diagnosis involves a
probabilistic assessment based on symptoms and clinical results.14 Managing a
patient’s glaucoma may include monitoring his or her progress with regular
visits and treatment with eye drops, laser procedures, or intraocular surgery.15
All aspects of glaucoma care, including surgery, can be provided by an
ophthalmologist, a medical doctor, or doctor of osteopathy specializing in eye
and vision care.
Massachusetts law currently does not permit optometrists to treat
glaucoma patients.16 Our understanding is that in all other states, some aspects
of glaucoma care, such as pharmaceutical treatment, can also be provided by an
11 Harry A. Quigley et al., The Cost of Glaucoma Care Provided to Medicare Beneficiaries from 2002 to
2009, 120 OPHTHALMOLOGY 2249, 2249 (2013); Glaucoma, Open-angle, N AT’L E YE I NST., N AT’L INST.
OF HEALTH , https://nei.nih.gov/eyedata/glaucoma (last visited Jan. 21, 2016) (approximately 2.7
million Americans have been estimated to have primary open angle glaucoma).
12 Hussein Hollands et al., Do Findings on Routine Examination Identify Patients at Risk for Primary
Open-Angle Glaucoma? The Rational Clinical Examination Systematic Review, 309 JAMA 2035, 2035
(2013) (citing research from 1978 to 2001).
13 Harry A. Quigley et al., supra note 11 at 2256 (citing studies that cost escalates with disease
severity); J. Scheetz et al., Validity and Reliability of Eye Healthcare Professionals in the Assessment of
Glaucoma – A Systematic Review, 69 I NT’L J. OF C LINICAL PRAC . 689, 690 (2015) (reporting an
estimate that costs for U.S. patients average $623 per patient in early stages of the disease and
$2511 in late stages of the disease).
14 J. Scheetz et al., supra note 13 at 690; Anna C. Momont & Richard P. Mills, Glaucoma Screening:
Current Perspectives and Future Directions, 28 S EMINARS IN OPHTHALMOLOGY 185, 185-88 (2013).
15 Hussein Hollands et al., supra note 12 at 2035.
16 M ASS. GEN . L AWS ch. 112, §§ 66-66B (2015).

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optometrist, sometimes with certain additional requirements and restrictions.
For instance, states neighboring Massachusetts impose requirements that
optometrists who wish to treat glaucoma patients complete a certain number of
training hours and pass an examination. 17 Specifically, Rhode Island,18
Connecticut, 19 and New York20 require optometrists to complete a certain
number of clinical hours. Other common requirements are that optometrists
consult with ophthalmologists for a period of time after completing their
glaucoma training21 or refer glaucoma patients to ophthalmologists under certain
circumstances.
III. 	House Bill 1973
With respect to glaucoma, the Bill under consideration would allow
“registered optometrists” in Massachusetts to “utilize and prescribe topical and
oral therapeutic pharmaceutical agents” to diagnose, prevent, correct, manage or
treat the disease.22 Optometrists would continue to be prohibited from treating
patients in need of invasive surgical treatment or with newly diagnosed
congenital glaucoma, and the Bill includes a requirement that optometrists refer
those patients to qualified physicians.23 Patients who, during the course of
optometric examination, are found to be exhibiting “signs of previously
unevaluated disease” requiring treatment outside of the scope of optometric
practice also would be referred to physicians or other qualified health care
practitioners.24
17 Conn. Gen. Stat. Ann. § 20-127 (West 2015); N.H. Rev. Stat. Ann. § 327:6-c (2015); N.Y. Educ.
Law § 7101-a (McKinney 2015); R.I. Gen. Laws Ann. § 5-35.1-12 (West 2015); Vt. Stat. Ann. Tit. 26
§ 1728d, 1729a (West 2015).
18 R.I. Gen. Laws Ann. § 5-35.1-12 (West 2015).
19 Conn. Gen. Stat. Ann. § 20-127(d) (West 2015).
20 N.Y. Educ. Law § 7101-a(4)(b) (McKinney 2015).
21 N.H. Rev. Stat. Ann. § 327:6-c(IV) (2015) (two years); N.Y. Educ. Law § 7101-a (McKinney 2015)
(three years or seventy-five patients); Vt. Stat. Ann. Tit. 26 § 1729a (West 2015) (six months and at
least five patients).
22 H.1973, §§ 66C(a).
23 H.1973, § 66C(d).
24 H.1973, § 66C(c).

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Additionally, the Bill imposes certain educational and reporting
requirements on optometrists. First, it would require that optometrists take an
examination designed to test the qualifications necessary to safely utilize and
prescribe pharmaceutical agents, including those used in the treatment of
glaucoma. To utilize and prescribe certain pharmaceuticals, optometrists would
be required to provide “evidence of the satisfactory completion of 40 hours of
didactic education and 20 hours of supervised clinical education.”25 Second,
“[a]s a condition of license renewal,” the Bill would require optometrists to
complete three hours of continuing education specific to glaucoma.26 Third, it
would require both optometrists and insurers or risk management organizations
providing coverage to optometrists to participate in federal and state reporting
and data collection efforts on patient safety and error reduction. The reported
data will be used to develop “evidence-based best practices to reduce errors and
enhance patient safety.”27
IV. 	Competitive Considerations Regarding House Bill 1973
We recognize that certain professional scope of practice regulations can be
important to ensure quality and patient safety, and regulation of glaucoma care
is no exception. Competition consistent with patient safety, however, can bring
important benefits to health care consumers. Generally, competition in health
care markets benefits consumers by containing costs, expanding access and
choice, and promoting innovation. Unnecessarily strict scope of practice
restrictions can suppress these important benefits by limiting the supply of
qualified care providers. Additionally, they can inhibit the development of new,
collaborative models of care. For this reason, we recommend that the legislature
consider the potential benefits of enhanced competition among glaucoma care
providers that could be facilitated by the Bill and maintain only those scope of
practice limitations necessary to ensure patient health and safety.
In this case, additional competition among providers of glaucoma care
could help to alleviate, in particular, two important barriers to glaucoma care:
access and cost. First, optometrists tend to be more convenient to see than
ophthalmologists. Across the United States, optometrists outnumber
ophthalmologists, and U.S. counties in rural areas and other underserved
25 H.1973, § 68C(b).
26 H.1973, § 68C(e).
27 H.1973, §66C(e).

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communities tend to have fewer ophthalmologists.28 Optometrists see patients
for routine eye exams and optical care, positioning them to serve as a first line of
defense, which may facilitate earlier diagnosis and less costly treatment of
glaucoma. Second, certain patients may forego or delay needed care if it is too
costly. Excluding optometrists from providing non-surgical glaucoma care may
limit price competition to serve these patients.29 By contrast, allowing
optometrists to deliver glaucoma care at a level commensurate with their
training could help to ensure that more patients have access to affordable
providers.
Thus, insofar as optometrists can adequately serve as substitute providers
for aspects of glaucoma care, they may enable more patients to obtain and
maintain treatment. Further, to the extent that optometrists can serve as
complementary providers, ophthalmologists and patients may benefit from
collaboration between the two types of providers. These consumer benefits may
produce overall public health benefits for Massachusetts’ glaucoma patients,
many of whom may be undiagnosed or face an extended course of treatment to
preserve their vision.
Under current law, however, Massachusetts prohibits optometrists from
treating glaucoma. Unwarranted restrictions may be reducing patient access,
raising costs, and foreclosing opportunities for early treatment. For these
reasons, we encourage the legislature to consider whether patient welfare can be
appropriately served by loosening this restriction. Though the existing
published health services research is limited,30 we note that the experience of
other states may be informative as the legislature considers the Bill. Aside from
28 Diane M. Gibson, The Geographic Distribution of Eye Care Providers in the United States:
Implications for a National Strategy to Improve Vision Health, 73 PREVENTIVE M ED . 30, 32 (2015)
(finding 17,793 ophthalmologists and 44,402 optometrists in the U.S. in 2011 and finding that U.S.
counties with fewer ophthalmologists per capita had significantly lower population densities,
larger proportions of rural residents, and higher proportions of residents aged 65 years and
older).
29 See, e.g., N EW HAMPSHIRE INS. DEP’T, PAYMENT DIFFERENCES IN REIMBURSEMENT TO
OPHTHALMOLOGISTS AND OPTOMETRISTS (2013),
https://www.nh.gov/insurance/reports/documents/diff_reimb_optha_optom.pdf (comparing
the charges and payments for procedures performed by optometrists and ophthalmologists);
Mordachai Soroka, Comparison of Examination Fees and Availability of Routine Vision Care by
Optometrists and Ophthalmologists, 106 PUB . HEALTH REP. 455, 457-459 (1991) (comparing
examination fees and appointment availability between optometrists and ophthalmologists).
30 See J. Scheetz et al., supra note 13 at 701 (systematically characterizing existing studies
comparing the performance of providers, such as optometrists, in assessing glaucoma, and
finding that the quality of existing evidence makes robust inferences “difficult”).

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Massachusetts, we understand that the other 49 states and the District of
Columbia currently allow optometrists to have a role in treating glaucoma
patients. Some states do require additional glaucoma-specific training or
certifications and impose requirements for when a case must be referred to an
ophthalmologist. Similarly, relaxing Massachusetts’ prohibition on optometrists’
ability to treat glaucoma patients, with conditions the legislature finds
appropriate to ensure patient safety, would be broadly consistent with the
approaches taken in other states.31
V. 	Conclusion
As we detail above, competition among health care professionals has the
potential to benefit consumers by improving access to care, containing costs, and
encouraging more ways to deliver needed care. By allowing optometrists to
participate in glaucoma care at a level commensurate with their training, patients
in Massachusetts may experience increased access to care, more choice in how
their care is delivered, and more cost-effective treatment. Because these benefits
of competition could be significant to Massachusetts glaucoma patients, we
encourage the legislature to carefully consider whether a continued prohibition
on optometric treatment of glaucoma is warranted. Relaxing the prohibition
consistent with patient safety has the potential to bring the benefits of additional
competition to Massachusetts health care consumers.
We appreciate this opportunity to present our views.
Marina Lao, Director 	Robert Potter, Chief
Office of Policy Planning 	Legal Policy Section
Federal Trade Commission 	Antitrust Division
U.S. Department of Justice
31 See Section II, supra.