ABA 10th Annual Conference on
Emerging Issues in Healthcare Law
February 18-20, 2009
_________________________________________________
DEVELOPMENT AND OPERATION OF
CONVENIENT CARE CLINICS:
LEGAL AND POLICY CONSIDERATIONS
_________________________________________________
Ruth E. Granfors
K&L Gates LLP
Harrisburg, PA
ruth.granfors@klgates.com
717.231.5835
I.
DEVELOPMENT OF CONVENIENT CARE CLINICS
A.
Introduction
1.
Background
In 2000, the first convenient care clinics, also called retail clinics, opened in
Minnesota. The concept arose when a father was unable to obtain prompt medical care for his
child’s sore throat. That father, Rick Krieger, conceived the idea that medical clinics located in
heavily utilized retail areas operating with longer hours would be utilized by persons seeking
prompt care at a reasonable price. As a result, Krieger and his business partners formed
QuickMedX clinics in the Minneapolis St. Paul area. 1 Nationally, these clinics became known
as MinuteClinic, now a subsidiary of CVS Caremark, with more than 500 clinics in 25 states. 2
From its beginnings in 2000, the idea of convenient and affordable health care
grew as other large retailers, chain pharmacies and grocery stores recognized the potential value
of offering customers not only a drug store, but a place where a minor ailment could be
diagnosed and treated and a prescription drug could be not only dispensed but also prescribed.
Clinic growth expanded gradually until December 2005; at that time there were 60 clinics in 18
states. 2006 was an explosive year for the industry, resulting in 800 clinics in 23 states by
December of that year. Another 100 clinics were added by the ended of 2007. 3
2.
Definition
What is a convenient care clinic? The Convenient Care Association describes
these clinics as:
healthcare facilities located in high-traffic retail outlets with
pharmacies adjacent that provide affordable and accessible,
episodic care to consumers who otherwise would have to wait for
1
M.K.Scott, “Health Care in the Express Lane: The Emergence of Retail Clinics” Prepared
for the California Health Care Foundation, July 2006. Available for download at the CHCF
website, http://www.chcf.org/topics/view.cfm?itemID=123218 (last visited January 14, 2009).
2
http://www.cvscaremark.com/our-company/cvs-caremark-facts (last visited January 14,
2009).
3
H.T.Tu, G.R. Cohen “Checking Up on Retail-Based Health Clinics: Is the Boom
Ending?” Issue Brief of the Center for Studying Health System Change, The Commonwealth
Fund, December 2008, available for download at The Commonwealth Fund website:
http://www.commonwealthfund.org/publications/publications_show.htm?doc_id=730365 (last
visited January 14, 2009).
appointments with a traditional Primary Care Physician or Provider
(PCP). 4
Three key terms in this definition are: affordable, accessible, and episodic care.
In addition, the location is critical; the terms high traffic retail outlets and with pharmacies
adjacent describe a setting where people congregate for other purposes than health care and can
easily obtain prescribed treatment through an available pharmacy.
As with other health care trends, and unlike other traditional health care facilities
such as hospitals or nursing facilities, convenient care clinics are not uniformly defined or
covered under state or federal laws. Some states have given these clinics specific names, such as
limited service clinics in Massachusetts. Other states have laws that regulate ambulatory care or
primary care facilities, and convenient care clinics may fall within those definitions, often
depending on ownership, operations and services provided.
Formation of these clinics requires evaluation of state law to determine whether a
pre-development approval, license or other government certification is required. Since
regulation of these clinics is gaining attention in a number of states, clinic developers should also
research statutory and regulatory proposals to determine whether the regulatory environment is
on the brink of change for this industry sector. The application of these laws will depend in part
on the services to be provided, who owns and operates the service, who renders the service, and
who pays the bills.
B.
Defining the Scope of Services
State laws regulate health care through licensure of health care facilities and individuals.
These laws define not only the health care services the facility or individual may provide, but
also prohibit unlicensed individuals and entities from providing these services. Since licensure
focuses on the services provided rather than on what the entity calls itself, it is important to
define the scope of services first.
Convenient care clinics provide primary care, usually in response to an episode of illness,
but sometimes as part of a well visit. The following questions can be used to begin to evaluate
the extent of regulation of a particular state:
•
Does the state regulate primary care, ambulatory care or outpatient care offered
through a clinic or facility?
•
Will the clinic provide any specialized preventive or diagnostic service, such as
diet and weight loss counseling, immunizations or mammography? Do those
services give rise to a separate category of regulation? Does the regulation
4
This description is found at the Convenient Care Association website,
www.ccaclinics.org, in the “About Our Clinics” content on the “About Us” page,
http://www.ccaclinics.org/index.php?option=com_content&view=article&id=7&Itemid=14 (last
visited January 14, 2009).
-2-
exempt particular operators or owners that may be otherwise regulated through a
separate law, such as physician offices, hospitals or health systems?
•
Does the state regulate how a clinic may be owned, organized or operated, e.g.,
through laws prohibiting the corporate practice of medicine or fee-splitting?
•
What is the nature of the regulation that exists? Is pre-development approval,
such as a certificate of need, required?
•
Is an institutional license required? If so, what is the extent of the licensure
standards associated with the license?
•
Are there limitations on staffing of clinics because of scope of practice laws?
What is the extent of physician supervision or involvement that would be
required?
Answers to these questions provide some direction in whether to enter a state, how to structure
the business entity and how to organize operations.
C.
Business Organization and Structure
1.
Organization
To date, convenient care clinics have developed primarily in two ways: (1)
through large retailers, such as pharmacy chains or “big box” stores, often with individual
entrepreneurial initiative, including physicians; and (2) through hospitals and health systems.
Under the retail-based clinics, the primary retail business may own or control the
retail clinic. An example is Take Care Clinics, which are part of Take Care Health Systems, a
wholly owned subsidiary of Walgreens. 5 In other instances, although the clinic takes on the
brand of the retail outlet, it is actually wholly separate organizationally from the retail chain. For
example, Target partners with local health care providers to operate Target Clinics. 6
Health system based convenient care clinics are operated and controlled by
traditional health systems or affiliated entities. The clinics may be owned or operated by an
affiliated medical group as in the case of AtlanticCare in New Jersey, 7 or as part of the overall
health system, as with Geisinger Health System’s CareWorks in Pennsylvania. 8 Some health
systems partner with local retailers to place their clinics on the premises. In other instances the
health system establishes the clinic in a separate building of a highly trafficked retail area.
5
http://www.walgreens.com/dmi/takecare/default.jsp.
6
http://www.gbmc.org/mediarelations/releases/2007/gbmctarget.cfm.
7
http://www.atlanticarephysiciangroup.com/services/healthrite_services.php.
8
http://www.careworkshealth.com/.
-3-
In 2007, retail-based models dominated the market holding about 85% of the then
existing retail clinics. 9 In the past year, more health systems and physician practices have
considered or initiated development of these clinics as part of their service offerings.
Ownership and operation of the clinics is important to an evaluation of applicable
law for both start-up companies and existing companies entering a state for the first time. Key
questions include:
•
Who will own the clinic? Is the owner a licensed health care provider? Does the
owner operate other licensed health care facilities or businesses that provide
health care?
•
Will a licensed health care provider be in charge of the clinical and business
operations, or will the business be managed by a non-medical professional? What
type of medical license is held by the individual in charge of the clinical services?
•
Will health care services be provided by employed or contracted individuals?
Who will provide those services and how are the individuals licensed?
•
Where will the facility be located? Inside a retail establishment? In connection
with a pharmacy? As a standalone clinic in a retail district?
•
What state or states are being considered as targets for development? Will
different models be necessary for different states?
2.
Structure
In addition to questions about ownership or organization of the convenient care
company, the legal entity structure for the company may be affected by certain factors and laws.
The following questions should be among those considered in deciding the form of entity and
other structural issues for the convenient care business:
•
What is the risk tolerance of the individual(s) and entit(ies) involved, particularly
with respect to potential medical liability?
•
How will the convenient care business brand and advertise its services? Will it be
strongly aligned with a particular retail business or local health care provider?
9
M.K.Scott, “Health Care in the Express Lane: Retail Clinics Go Mainstream” Prepared
for the California Health Care Foundation, Sepatember 2007. Available for download at the
CHCF website, http://www.chcf.org/topics/view.cfm?itemID=133464. (last visited January 14,
2009).
-4-
•
Are there other related health care companies that the proponents of the
convenient care business operate or plan to operate? Will there be referrals
between the businesses?
With respect to both ownership and business structure, statutes and regulations
that need to be considered in the legal evaluation include: (1) certificate of need or other predevelopment review and approval process, (2) licensing, (3) corporate practice of medicine and
fee splitting, and (4) physician, nurse practitioner and physician assistant licensing and scope of
practice.
D.
Government Approvals
1.
Certificate of Need
Approximately 36 states operate certificate of need laws. 10 These laws often do
not require approval for establishment of outpatient non-surgical facilities such as primary care
clinics. However, some states require review of such services. For example, New York State
requires “diagnostic and treatment centers” to undergo certificate of need review. 11 However,
certain factors are to be considered to determine whether an entity is a diagnostic and treatment
center. 12 Business corporations or not-for profit corporations that operate such facilities are
within the definition, while professional corporations are not. Furthermore, the law provides that
it “shall be prima facie evidence that a diagnostic or treatment center is being operated when any
10
http://www.ncsl.org/programs/health/cert-need.htm. (Last visited January 14, 2009).
11
A diagnostic and treatment center is within the definition of “hospital” in the New York
Public Health Code. N.Y. Public Health Code, art 28, § 2801. The law provides that
No hospital, as defined in this article, shall be established except with the written
approval of the public health council. No certificate of incorporation of a
business membership or not-for-profit corporation shall hereafter be filed which
includes among its corporate purposes or powers the establishment or operation of
any hospital, as defined in this article, or the solicitation of contributions for any
such purpose, or two or more of such purposes, except with the written approval
of the public health council, and when otherwise required by law of a justice of
the supreme court, endorsed on or annexed to the certificate of incorporation. No
articles of organization of a limited liability company established pursuant to the
New York limited liability company law which includes among its powers or
purposes the establishment or operation of any hospital as defined in this article,
shall be filed with the department of state except upon the approval of the public
health council.
N.Y. Public Health Code, art 28, § 2801-a.
12
See 10 NYCRR § 600.8.
-5-
provider of medical or health services describes itself to the public as a ‘center,’ ‘clinic’ or by
any name other than the name of one or more of the practitioners providing these services.” 13
In any state with a CON law that appears to cover an outpatient service to be
provided by the clinic, the applicable definitions need to be reviewed.
2.
Licensure
Almost all states license inpatient facilities and outpatient surgical facilities, and
some states also license outpatient facilities that provide preventive care and non-invasive
treatment. The requirement to obtain a license often depends on the services the facility
provides, who operates and owns the facility, and where it is located. The state licensure statute
or regulations should define the term and provide the requirements for licensure. In addition,
even if a state requires a license for the convenient care clinic, the clinic may be exempt from
certain obligations depending on how it is owned or organized.
New Jersey regulates ambulatory care facilities, which are defined as “a health
care facility or a distinct part of a health care facility in which preventive, diagnostic, and
treatment services are provided to persons who come to the facility to receive services and depart
from the facility on the same day.” A “health care facility” is defined in New Jersey statute as
the facility or institution whether public or private, engaged
principally in providing services for health maintenance
organizations, diagnosis or treatment of human disease, pain,
injury, deformity or physical condition, including, but not limited
to, a general hospital, special hospital, mental hospital, public
health center, diagnostic center, treatment center, rehabilitation
center, extended care facility, skilled nursing home, nursing home,
intermediate care facility, tuberculosis hospital, chronic disease
hospital, maternity hospital, outpatient clinic, dispensary, home
health care agency, residential health care facility and bioanalytical
laboratory (except as specifically excluded hereunder) or central
services facility serving one or more such institutions but
excluding institutions that provide healing solely by prayer and
excluding such bioanalytical laboratories as are independently
owned and operated, and are not owned, operated, managed or
controlled, in whole or in part, directly or indirectly by any one or
more health care facilities, and the predominant source of business
of which is not by contract with health care facilities within the
State of New Jersey and which solicit or accept specimens and
operate predominantly in interstate commerce.
N.J.S.A. 26:2H-2. In response to comments on proposed changes to the regulations for licensure
of health care facilities, in which one commenter alleged “the Department [of Health and Senior
13
10 NYCRR § 600.8(b).
-6-
Services] has not even begun to look at the problems imposed by the proliferation of clinics in
retail stores,” the Department explained:
Entities that have approached the Department with respect to retail
clinic operations have generally provided documentation showing
that one or more private physicians own the retail clinic. This
establishes that the clinic’s operation consists of the private
practice of medicine, over which the State Board of Medical
Examiners … has jurisdiction.
40 N.J.R. 702(a) (January 22, 2008). Thus, physician ownership and control of the retail clinic
in New Jersey moves it out of the definition of an ambulatory care facility.
Massachusetts is one of the first states to develop regulations specific to
convenient care clinics, under the title “limited service clinic.” These regulations took effect in
February 2008. 14 The regulations cover requirements for policies and procedures including, but
not limited to: identification of the scope of services to be provided, clinical practice guidelines,
procedures for referrals, medical records, staffing patterns, relationship to the host retail site.
Licensure laws involving retail health are evolving and are likely to continue to
increase as long as development of retail clinics is on the rise. In addition, various trade
associations or other interest groups may attempt to influence the rise of these clinics to ensure
quality of care, affect competition, limit their scope of services, or respond to other concerns
regarding ownership or operation.
3.
Corporate practice of medicine
Corporate practice of medicine laws arise in the context of medical professional
licensing statutes and statues regulating business, non-profit and professional corporations. In
addition, even without an express prohibition on the corporate practice of medicine, courts have
interpreted existing statutes to limit the ability of business corporations or other unlicensed
entities to practice medicine through the employment of doctors and medical professionals who
practice the healing arts and direct the course of treatment.
A review of the state’s applicable statutes and case law is appropriate to
determine the current status of the prohibition. In states that actively enforce the corporate
practice of medicine doctrine, alternative organizational structures to consider may include:
•
14
Physician ownership and control of the business through a professional
corporation or other legitimate business structure permitted under state law for the
practice of medicine.
See 105 CMR §§140.1000-14.1002.
-7-
•
A joint venture with a professional corporation in which the medical service is
controlled and provided by the medical partner and administration of the business
is provided by the business partner.
•
A contract between the convenient care entity and a medical practice.
Under each of these scenarios, the arrangement must ensure that the professional clinical service
remains under the control of the medical team and that the corporation is not perceived as
directing the treatment. Evidence that medical professionals are directing medical care requires a
division of responsibility that places control over development of medical policies and practices
in the hands of the medical professionals and not the business entity or non-medical professional
management.
4.
Fee-splitting
Some states also expressly prohibit the sharing of professional medical fees
between the medical professional and the non-medical professionals. These prohibitions may
present obstacles to the convenient care clinic business entity model, even when clinical services
are controlled by medical professionals. Fee splitting statutes may prohibit a non-medical
professional individual or entity from taking a share of professional fees in connection with
billing for, referring or generating business to the medical professional. 15 These laws are often
cited in conjunction with the corporate practice of medicine prohibition because sharing
professional fees with laypersons is regarded as another means for exploiting the medical
profession and potentially the practice of medicine without a license.16
5.
Scope of practice
Many convenient care clinics save costs by using nurse practitioners and
physician assistants to varying degrees, depending on a state’s scope of practice rules for those
professionals. If a convenient care company chooses to provide most services through nurse
practitioners and physician assistants, it will need to locate in a state where the scope of practice
rules are broader for these professionals, including prescriptive authority to cover treatment for
common ailments.
Clinics that operate under close supervision by physicians, particularly with a
physician always on the premises, may still use nurse practitioners and physician assistants in
states with more narrow scope of practice rules. The costs may be higher, however, and the
utilization of nurse practitioners and physician assistants more limited, potentially reducing the
efficiency and affordability of the convenient care model.
15
See, e.g., Center for Athletic Medicine, Ltd. V. Independent Medical Billers of Illinois,
Inc., 889 N.E.2d 750 (Ill. 2008)
16
See N. Huberfeld, “Be Not Afraid of Change: Time to Eliminate the Corporate Practice
of Medicine Doctrine” Health Matrix: Journal of Law-Medicine of Case Western Reserve
University 14, p. 243 (Summer 2004)
-8-
A practice model that has emerged more recently is the use of remote physicians
through a telemedicine link. Wal-Mart is one of the first sites to use telemedicine clinics in some
of its Texas stores. 17 The decision to switch to a telemedicine model reportedly was based not
on Texas regulations, but on inability to hire nurse practitioners at an affordable cost.
Telemedicine brings its own set of potential operational and legal issues,
including licensure (if the remote physicians are not based in the state in which the medical care
is being provided to the patient), payment (if a third party payor does not reimburse for services
provided via a telemedicine link), scope of practice of practitioners at the site, scope of services
that may be offered, and technical difficulties that could affect the ability to use the link, which
could affect the convenience that is promoted by these clinics.
6.
Related regulation
a.
Ban on Tobacco Sales
Several states and municipalities have proposed legislation to prohibit the
sale of tobacco in a setting that also provides health care. For example, the City of San Francisco
passed a law banning the sale of tobacco in pharmacies, with exceptions for big box stores and
grocery stores. 18 Walgreens sued the City to obtain injunctive relief before the law’s effective
date of October 1, 2008. The City prevailed and the ban is in effect.
In an ordinance of broader applicability, the City of Boston’s Public
Health Commission passed regulations in December 2008, banning the sale of tobacco products
in any “health care institution” and in any “retail establishment that operates or has a health care
institution within it, such as a pharmacy or drug store. “Health care institution” is defined
broadly to include clinics and health centers. 19
Similar laws have been proposed in Illinois, New Hampshire, New York,
Rhode Island and Tennessee, but were defeated. While some large retailers, pharmacies and
grocery chains have voluntarily chosen not to sell tobacco products, others continue to maintain
the right to do so. In response to Illinois proposed House Bill 5372, the Federal Trade
Commission (“FTC”) provided the following in its response to an Illinois Representative:
The Bill’s prohibition against locating a clinic ‘in any store or
place that provides alcohol or tobacco products for sale to the
17
See Retail Health Clinics Reopen with New Model, Houston Business Journal, August 1,
2008, http://houston.bizjournals.com/houston/stories/2008/08/04/story4.html. (Last visited
January 14, 2009).
18
See Pressure Mounts for Pharmacies to Put Out Smokes, USA Today, May 9, 2008,
http://www.sfgov.org/site/mayor_index.asp?id=80466. (Last visited January 14, 2009).
19
See http://www.bphc.or/board/regs_main.asp. (Last visited January 14, 2009).
-9-
public’ may also limit competition. FTC staff recognizes the
state’s interest in safeguarding the health and welfare of its citizens
and the fact that such interests may prompt regulatory restrictions
that guard against, for example, the sale of otherwise lawful
alcohol and tobacco products to minors. However, the rationale
for not allowing a clinic in a retail store that also sells tobacco or
alcohol is unclear. At the same time, this restriction could limit the
supply of retail clinics and the basic medical services they would
provide if retail stores were to decide sales of tobacco and alcohol
were more profitable than having a retail health clinic. Or, the
requirement could raise the retail clinic’s costs and increase prices
for those services.
Further, there is no such general restriction that applies to other
health care services, such as a prohibition on tobacco sales in
doctors’ buildings or free-standing pharmacies, or on the
placement of pharmacies and pharmacy services in establishments
such as grocery stores or big-box retailers that also sell tobacco
products. The rationale for restricting tobacco sales in proximity
to one particular type of health care service provider is also
unclear. 20
The Illinois bill did not become law.
b.
Advertising
Another form of regulation that has been proposed is limitation on
advertising by retail clinics. In 2007, Massachusetts proposed rules for limited service clinics,
which, among other things, required such clinics to obtain pre-approval of all advertising,
including Internet sites, by the Massachusetts Department of Public Health. The FTC provided
comments, recommending that the pre-screening provision be struck as potentially unduly
burdensome and restrictive on truthful and non-misleading information that could be helpful to
consumers and promote competition. 21 The pre-screening provision did not survive final
regulations. A prohibition on false or misleading advertising is in the regulations.
The FTC provided similar comments to Illinois House Bill 5372, which
did not pass.
22
20
See May 29, 2008 letter from the FTC to Illinois State Representative Elaine Nekritz,
http://www.ftc.gov/opa/2008/06/hb5372.shtm
21
See September 27, 2007 letter from the FTC to the Massachusetts Department of Public
Health, http://www.ftc.gov/opa/2007/10/massdph.shtm.
22
See May 29, 2008 letter from the FTC to Illinois State Representative Elaine Nekritz,
http://www.ftc.gov/opa/2008/06/hb5372.shtm.
- 10 -
II.
LEGAL ISSUES IN CONVENIENT CARE OPERATIONS
A.
Payment
1.
Third Party Insurance
In the early years, most convenient care clinics charged patients directly for
services and did not bill third party insurers. Initially, commercial insurers were unfamiliar with
the clinics and would not reimburse for services otherwise covered if provided in a physician’s
office. Clinics also were hesitant to undertake the additional administrative burdens of contract
administration and billing. In addition, some clinics do not see the need for third party insurance
because the uninsured and underinsured population is a large user of some convenient care
clinics. 23
Blue Cross Blue Shield of Minnesota was one of the first large insurers to pay
retail clinics as participating providers. In April 2008, this insurer announced that many of its
small group plan designs would eliminate the office visit copay for members who received their
services and retail clinics. 24 Most large health plans now reimburse for clinic services, and
approximately 85% of convenient care clinics accept private insurance. 25
Entering into the third party insurance world is nothing new for health care
provider (physician, health system) sponsored clinics. Companies that are unfamiliar with these
contractual relationships should be advised of the following:
•
Clinics should familiarize themselves with the detail of the contract and
appendices, in particular any provider manuals. Guidance documents may be
issued providing additional billing, coverage and policy clarifications, and clinics
should be sure that appropriate staff are properly trained on these updates, as well
as any contract amendments.
•
Payors may not monitor contracts closely; a deviation from a contract requirement
may not be caught initially and may become standardized over time. Once the
payor realizes an error, the provider will be held to compliance with the contract
and the payor may seek recoupment, potentially creating a substantial liability.
For example, if a condition of payment for administration of a particular
23
See H.T.Tu, G.R. Cohen “Checking Up on Retail-Based Health Clinics: Is the Boom
Ending?”, supra, n.3
24
See Insurer’s website for the announcement and related Retail Clinic Brochure:
http://www.bluecrossmn.com/bc/wcs/groups/bcbsmn/@mbc_bluecrossmn/documents/public/mb
c1_agnt_news_retail_co.hcsp.
25
M. Laws, M. K. Scott, “The Emergence of Retail-Based Clinics in the United States:
Early Observations” Health Affairs, Vol. 27, No. 5 (Sept./Oct. 2008), p. 1294.
- 11 -
immunization requires documented consultation with a physician, any deviation
from that requirement could result in repayment for all noncompliant services,
even if the payor should have been aware of the deviation, and even if state law
does not require such a condition.
•
Claims that are not submitted in accordance with contract requirements or are
arguably in violation of law are subject to pre-payment denial, post-payment audit
and, in a worst case scenario, investigation for fraud. Responding to these denials
or investigations can be an extremely time-consuming and expensive process.
Some states provide a basis for private payors to seek prosecution for or sue for
recovery of allegedly fraudulent claims.
•
An insurer’s requirements for payment and coverage may exceed state laws
relating to scope of practice unless state law otherwise expressly requires payors
to recognize and reimburse for services provided within a practitioner’s scope of
practice as permitted under his or her license.
•
Clinics should develop a working relationship with the assigned provider
representative(s) to facilitate the smooth flow of information and communications
between the parties. Answers to specific or general billing and coverage details
should be documented to respond to any later payment denials, recoupment
activities or disputes over practices.
2.
Government payors
With clinics beginning to participate in Medicare and Medicaid programs, some
unique considerations arise with respect to referrals and patient incentives. Indeed one of the
criticisms aimed at retail medicine is that retail clinics and in-house pharmacies will have referral
arrangements that encourage patients to take their clinic prescriptions directly to the pharmacy to
be dispensed. Such arrangements should be unnecessary if the touted convenience of the model
is allowed to operate. But, such arrangements could be considered illegal under federal Stark or
Anti-Kickback laws. 26 Any clinic that receives Medicare or Medicaid reimbursement should
evaluate its policies regarding the prescribing and dispensing of items and drugs payable by a
government health care program, its written or unwritten arrangements with the co-located
pharmacy and any store or clinic incentives that might be used to direct patients to that
pharmacy.
B.
Practitioner - Patient Relationship
Unique liability issues may arise in the convenient care clinic setting because these
providers typically do not form a relationship with patients over time and often do not have a
complete patient history upon which to make diagnoses and prescribe treatments. In fact one of
the primary criticisms from the established medical community is that retail clinics are disruptive
26
Although these federal laws apply for Medicare and Medicaid reimbursement, some
states have similar laws that cover private third party payment.
- 12 -
to continuity of care and fail to provide a medical home. The response by clinics is that many of
the patients they treat do not have a primary care physician and would otherwise obtain care at
an emergency room.
Convenient care clinics should develop policies that clearly define the scope of services
available and the circumstances that require a referral to a tertiary, emergency or specialized
provider. Most convenient care clinics form referral relationships with hospitals and physician
practices in order to facilitate such referrals. In addition, these clinics often encourage patients to
follow-up with their primary care practitioner or a specialist.
Illustrating the potential for liability, Wiedenbeck v. Searle, 895 N.E. 2d 1067, 324 Ill.
Dec. 352 (2008), was an action brought against a hospital-based convenient care clinic, its
physician, and other defendants for malpractice because a delay in referral for a CT scan by a
convenient care clinic physician was found to be in breach of the standard of medical care. The
action eventually was dismissed for lack of proof of a causal connection between the negligent
behavior and the patient’s later injuries and death. 27
While the circumstances in Wiedenbeck could arise in any physician office or other
primary care or outpatient hospital setting, observers may use this case to support greater
regulation of these clinics. The Convenient Care Association has established Quality and Safety
Standards for its members that reflect, among other things, the need to build relationships with
other health care providers in the community and to make referrals for necessary follow-up
evaluation and care where warranted. 28
27
In Wiedenbeck, a 38 year-old woman experiencing severe headache, fever, sinus and
nasal congestion, and nausea was seen in the clinic by a physician who performed a routine
neurological exam. The patient was discharged with a prescription for antibiotics to treat
sinusitis. The next day, the patient contacted the clinic complaining that her headache was
worse. The nurse at the clinic advised her to give the antibiotics time to take effect. When the
patient’s husband called later that evening and described more severe symptoms, the clinic
advised him to take his wife to the emergency room, where a CT scan was performed, and
reviewed by a neurologist. The cause of her symptoms was determined and the patient was
transferred to a university hospital. About two hours after arrival at the University hospital, the
patient’s condition led to irreversible brain damage and she died four years later in a
rehabilitation hospital. After settling with the University Hospital and dropping the action
against the University physician, the local hospital and its ER physician, as well as the clinic, the
plaintiff administrator of the patient’s estate appealed a summary judgment in favor of the clinic
physician. The case against the clinic physician for failure to refer the patient for a CT scan was
dismissed because the court determined there was insufficient evidence to establish a causal
connection between the physician’s behavior and the plaintiff’s injuries. Nonetheless, the court
found no dispute that the physician had breached the applicable standard of care by neglecting to
order a CT scan.
28
The complete Quality and Safety Standards are found at the CCA’s website:
http://www.ccaclinics.org/index.php?option=com_content&view=article&id=6&Itemid=13.
- 13 -
C.
Electronic Health Records and Privacy
Many convenient care clinics utilize electronic health records. Indeed, according to the
Quality and Safety Standards of the Convenient Care Association, all members “use Electronic
Health Records (EHR) to ensure high-quality efficient care” and “are committed to providing
all patients with the opportunity to share health information with other providers electronically
or in paper format.”
With respect to the use of EHR, several issues arise that are somewhat unique to
convenient care clinics:
1. Because these clinics may not be integrated with a health system, the records of
treatment would not be integrated with the other providers of care. For example,
if a patient receives an immunization at a convenient care clinic, that information
should be provided to the patient’s primary physician, in a manner consistent with
HIPAA privacy and security rules.
2. Conversely, when a convenient care clinic is part of an organized health system,
the clinic should be able to access the records of the patient that are otherwise
available in the records of the health system, allowing for greater continuity of
care. Proper sharing of information across the system in relation to treatment
must be designed to comply with HIPAA and other privacy rules.
3. Clinics may be asked to share patient information with the host store or pharmacy
that may raise issues under HIPAA. At a minimum, any proposal for disclosure
or use of clinic patient information by the clinic, pharmacy or host store should be
evaluated under the marketing provisions of HIPAA. 29
29
See 45 C.F.R. § 164.508(a)(3).
- 14 -