I
104TH CONGRESS
1ST SESSION
H. R. 1579
To require providers of home infusion therapy services to be licensed and
to limit physician referrals for home infusion therapy services in which
the physician has a financial interest.
IN THE HOUSE OF REPRESENTATIVES
MAY 9, 1995
Mr. BROWN of Ohio introduced the following bill; which was referred to the
Committee on Commerce, and in addition to the Committee on Ways and
Means, for a period to be subsequently determined by the Speaker, in
each case for consideration of such provisions as fall within the jurisdic-
tion of the committee concerned
A BILL
To require providers of home infusion therapy services to
be licensed and to limit physician referrals for home
infusion therapy services in which the physician has a
financial interest.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Sarah Weber Home
Infusion Consumer Protection Act of 1995’’.
SEC. 2. LICENSING OF PROVIDERS OF HOME INFUSION
THERAPY SERVICES.
(a) REQUIREMENT.—
(1) LICENSE REQUIREMENT.—No person shall
provide (or arrange for the provision of) home infu-
sion therapy services in a State unless the person is
licensed by the State in accordance with this section
to provide (or arrange for the provision of) such
services.
(2) LICENSING PROCEDURE.—No State shall li-
cense a person to provide (or arrange for the provi-
sion of) home infusion therapy services unless the
State finds that the person meets the standards for
licensing established under this section.
(3) EXCEPTION.—Paragraph (1) shall not
apply in the case of an individual providing home in-
fusion therapy services without compensation for
himself or herself or for a family or household mem-
ber.
(b) STANDARDS.—
(1) IN GENERAL.—The Secretary of Health and
Human Services (in this Act referred to as the ‘‘Sec-
retary’’) shall establish standards for the licensing of
persons providing (or arranging for the provision of)
home infusion therapy services consistent with this
subsection.
(2) SUPERVISION.—A person licensed under
this section shall only provide (or arrange for the
provision of) home infusion therapy services to an
individual who is under the care of a physician and
under a plan established and periodically reviewed
by a physician.
(3) PROVIDER
QUALIFICATIONS.—A person
shall not be licensed consistent with this section un-
less the person—
(A) has been determined to be capable of
providing, or arranging for the provision of,
home infusion therapy services;
(B) maintains clinical records on all indi-
viduals for whom the person provides (or ar-
ranges for the provision of) such services;
(C) adheres to written protocols and poli-
cies with respect to the provision (or arrange-
ment for the provision) of services;
(D) makes services available (as needed) 7
days a week on a 24-hour basis;
(E) coordinates all home infusion therapy
services with the patient’s physician;
(F) conducts a quality assessment and as-
surance program, including drug regimen re-
view and coordination of patient care;
(G) assures that only trained (or licensed
if necessary) personnel provide infusion prod-
ucts (and any other service for which training
is required to safely provide the service);
(H) assumes responsibility for the quality
of services provided by others under arrange-
ments with such person;
(I) establishes appropriate protocols and
explains such protocols clearly to patients be-
fore the initiation of a treatment plan;
(J) is certified to be a home health agency
for purposes of title XVIII of the Social Secu-
rity Act or meets the requirements to be so cer-
tified; and
(K) meets such other requirements as the
Secretary may determine are necessary (i) to
assure the safe and effective provision of home
infusion therapy services, and (ii) respecting the
quality of the provision of such services and the
charges for such services.
A protocol referred to in subparagraph (I) shall in-
clude a provision for appropriate notification of indi-
viduals receiving home infusion therapy services in
the event of the cancellation of the provision of those
services.
(c) ENFORCEMENT.—
(1) PROVIDERS.—Any person who provides (or
arranges for the provision of) home infusion therapy
services in violation of subsection (a)(1) is subject to
a civil money penalty (in an amount specified by the
Secretary, but not to exceed $10,000) for each such
violation. The Secretary may file an action to enjoin
persons from violating subsection (a)(1).
(2) STATES.—The Secretary shall establish a
process for determining whether or not a State is
complying with the requirement of subsection (a)(2).
Before determining that a State has not established
a licensing system that complies with such require-
ment, the Secretary shall provide the State with no-
tice and opportunity to respond and correct any defi-
ciencies identified by the Secretary.
(d) AUTHORIZATION
OF APPROPRIATIONS; STATE
GRANTS; LICENSING FEES.—
(1) AUTHORIZATION
OF
APPROPRIATIONS.—
There are authorized to be appropriated to the Sec-
retary such amounts as may be necessary for the
Secretary to carry out this section.
(2) STARTUP GRANTS.—The Secretary is au-
thorized to make grants to States in order to enable
those States initially to establish the licensing sys-
tem required under subsection (a)(2).
(3) LICENSING
FEES.—Nothing in this Act
shall be construed as preventing a State from requir-
ing payment of a fee from a provider as a condition
of licensing under subsection (a)(1) in order to reim-
burse the State for the costs of operating the licens-
ing system provided under subsection (a)(2).
SEC. 3. LIMITATION ON PHYSICIAN REFERRALS.
(a) GENERAL RULE.—Except as provided in this sec-
tion, if a physician (or an immediate family member of
such physician) has a financial relationship with an entity
described in section 1877(a)(2) of the Social Security Act,
then the physician may not make a referral to the entity
for the furnishing of home infusion therapy services.
(b) INCORPORATION OF MEDICARE PHYSICIAN OWN-
ERSHIP AND REFERRAL PROVISIONS.—The provisions of
subsections (b) through (h) of section 1877 of the Social
Security Act (other than subsections (f) and (g)(1)) shall
apply with respect to subsection (a) of this section in the
same manner as they apply to section 1877(a) of such Act.
In applying the previous sentence, any reference to a ‘‘des-
ignated health service’’ is deemed to be a reference to
home infusion therapy services.