UNITED
STATES
OF
AMERICA
FEDERAL TRADE COMMISSION
WASHINGTON,
D.C. 20580
Di
vis
ion
of
Advertising Practices
C.
Thomas Crooks,
Ill,
O.D.
American Optometric Association
243 N. Lindbergh Boulevard, Floor 1
St. Louis,
MO
63141
Dear Dr. Crooks:
October 4,
2006
I am writing
in
response to your September 12, 2006 letter regarding 1-800 CONTACTS,
Inc.
's
("1-800") recent practice
of
requesting that contact lens prescribers provide copies
of
patients' contact lens prescriptions.
To
provide further guidance concerning how prescribers
should respond to these requests, the Federal Trade Commission
staff
offers the following views.
As you are aware, the Fairness to Contact Lens Consumers Act
("FCLCA") and the
Contact Lens Rule state that when a contact lens fitting has been completed, the prescriber
"shall,
as
directed
by
any person designated to act on
behalf
of
the patient, provide
or
verify the contact
lens prescription
by
electronic
or
other means."
15
U.S.C. § 7601(a)(2);16 C.F.R. § 315.3(a)(2).
Neither the FCLCA nor the Contact Lens Rule requires that sellers provide prescribers with
written
proof
that they have been designated as the agents
of
consumers. See Contact Lens Rule,
Statement
of
Basis and Purpose, 69 Fed. Reg. 40,482 at 40,493 (July 2, 2004). Thus, upon
receiving a request from
1-800 as the agent
of
a consumer without
any
written
proof
of
this
agency relationship, the prescriber must provide
1-800 with a copy
of
the prescription
or
verify
the prescription information.
At
the time that they want
to
order contact lenses, some consumers have neither their
prescription nor sufficient information about their prescription for
1-800 to prepare a proper
verification request. In these circumstances,
1-800 cannot communicate a proper verification
request to the prescriber, and therefore
may
ask that the prescriber provide a copy
of
the
prescription.
Upon receipt
of
a valid prescription from the prescriber, 1-800 can ship lenses to
the consumer.
Your letter raises the concern that a prescriber may question whether a particular
consumer
in
fact has designated 1-800 to act on his
or
her behalf.
If
such
a question arises, your
letter indicates that prescribers should demand that
1-800 provide the written documentation that
prescribers may typically require from others before releasing medical information under the
Health Insurance Portability and Accountability Act
("HIP AA")
of
1996 and its implementing
HIPAARule.
C. Thomas Crooks, III, O.D.
October
4, 2006
Page2
We
do
not believe that the prescriber has the legal right under the FCLCA or the Contact
Lens Rule to impose
the
burden
of
this written authorization requirement on 1-800.
If
1-800 is
the agent
of
the consumer, then the prescriber has an obligation under the FCLCA and the
Contact Lens Rule to provide the consumer's prescription to 1-800. The Commission has made
clear that this disclosure is permitted without written authorization under HIP
AA
and the HIP AA
Privacy Rule.
1
On
the other hand,
if
1-800 is not the agent
of
the consumer, then the prescriber
has no obligation under the FCLCA and the Contact Lens Rule to provide the prescription at all.
To clarify any misunderstanding, we have discussed with
1-800 adopting changes in its
practices that should reduce prescriber concerns related to the existence
of
an agency relationship
between
1-800 and consumers. As a result
of
these discussions, 1-800
has
made two changes in
its practices. First, 1-800 has taken steps to clarify for consumers that they are designating 1-800
to act as their agents.
In
taking telephone orders, 1-800 has commenced disclosing, immediately
after obtaining prescriber contact information, that it will act as the agent
of
consumers in
seeking verification
or
a prescription from their prescriber.
In
taking on-line orders, 1-800 has
begun disclosing, adjacent to the location on the order form for prescriber contact information,
that it will act as the agent
of
consumers in seeking verification
or
a prescription from their
prescriber.
Second, 1-800 now includes the express statement that it is the consumer's agent in
its letters to prescribers seeking copies
of
prescriptions.
These changes
in
1-800's practices likely will eliminate many concerns as to the
existence
of
an agency relationship.
In
the event that a prescriber who receives a letter from
1-800 requesting a consumer's prescription knows that 1-800 is not
in
fact the consumer's agent,
the prescriber should inform
1-800 that
he
or
she is refusing
to
provide it based on the absence
of
an agency relationship and submit
to
1-800 its affirmative evidence that
the
seller is not the
consumer's agent.
2
This information should serve as the basis for the prescriber and 1-800 to
resolve between themselves the issue
of
agency with regard
to
a particular request.
If
these
The Contact Lens
Rule's
Statement
of
Basis and Purpose ("SBP") noted that the
HIP AA Privacy Rule permits a covered entity to use or disclose protected health information
without patient authorization for treatment, and that providing, confirming,
or
correcting a
prescription for contact lenses constitutes
"treatment" under the HIP
AA
Privacy Rule. SBP at
40,501.
In
addition, the
SBP
notes that the HIP
AA
Privacy Rule allows covered entities to use or
disclose protected health information without patient authorization
if
the use
or
disclosure is
"required
by
law." Id. A disclosure
of
information required under the FCLCA and Contact Lens
Rule is a disclosure required
by
law under the HIP
AA
Privacy Rule.
2
The FCLCA and the Contact Lens Rule do not preclude prescribers from
contacting their patients to inquire whether they have designated a particular seller
as
their agent.
If
the patients indicate orally that 1-800 is their agent, prescribers should not impose the
unnecessary burden
on
their patients
of
completing an extensive written authorization form to
confirm the agency relationship.
C. Thomas Crooks, III, O.D.
October
4, 2006
Page3
communications do
not
resolve the issue, prescribers and sellers,
of
course, can submit
complaints and supporting information to the FTC.
We hope the foregoing is helpful
to
you. Please feel free to contact Thomas Pahl at (202)
326-2128
or
Kial Young at (206) 220-6351 with any further questions
or
concerns regarding this
matter.
Very truly yours,
Associate Director
