I
104TH CONGRESS
2D SESSION
H. R. 3355
To require Medicare providers to disclose publicly staffing and performance
in order to promote improved consumer information and choice, to pro-
tect employees of Medicare providers who report concerns about the
safety and quality of services provided by Medicare providers or who
report violations of Federal or State law by those providers, and to
require review of the impact on public health and safety of proposed
mergers and acquisitions of Medicare providers.
IN THE HOUSE OF REPRESENTATIVES
APRIL 30, 1996
Mr. HINCHEY introduced the following bill; which was referred to the Commit-
tee on Ways and Means, and in addition to the Committee on Commerce,
for a period to be subsequently determined by the Speaker, in each case
for consideration of such provisions as fall within the jurisdiction of the
committee concerned
A BILL
To require Medicare providers to disclose publicly staffing
and performance in order to promote improved consumer
information and choice, to protect employees of Medicare
providers who report concerns about the safety and qual-
ity of services provided by Medicare providers or who
report violations of Federal or State law by those provid-
ers, and to require review of the impact on public health
and safety of proposed mergers and acquisitions of Medi-
care providers.
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 ‘‘Patient Safety Act of
1996’’.
SEC. 2. FINDINGS.
Congress finds as follows:
(1) There has been increased and growing pub-
lic concern expressed regarding the quality and safe-
ty of services provided by health care facilities and
institutions, as such facilities have instituted aggres-
sive efforts to reduce levels of staff who provide di-
rect patient care services as a principal means of de-
creasing expenses.
(2) A growing body of data suggests a linkage
between the number and mix of nursing staff and
positive patient care outcomes, including the avoid-
ance of patient death and injury.
(3) Many employees of health care facilities
have expressed fear for their employment if they re-
port unsafe conditions, including violations of State
or Federal law.
(4) Unprecedented consolidation among health
care institutions has led to increasing concern re-
garding the effect of such activity on the health and
safety of communities served by these facilities, yet
the Federal Government has little authority to evalu-
ate such effect in deciding whether or not to approve
mergers and acquisitions among health care facili-
ties.
SEC. 3. DEFINITIONS.
For purposes of this Act:
(1) LICENSED PRACTICAL NURSE OR LICENSED
VOCATIONAL NURSE.—The term ‘‘licensed practical
nurse or licensed vocational nurse’’ means an indi-
vidual who is entitled under State law or regulation
to practice as a licensed practical nurse or a licensed
vocational nurse.
(2) MADE
PUBLICLY
AVAILABLE.—The term
‘‘made publicly available’’ means, with respect to in-
formation of a provider, information that is—
(A) provided to the Secretary and to any
State agency responsible for licensing or accred-
iting the provider;
(B) provided to any State agency which
approves or oversees health care services deliv-
ered by the provider directly or through an in-
suring entity or corporation; and
(C) provided to any member of the public
which requests such information directly from
the provider.
(3) MEDICARE PROGRAM.—The term ‘‘medicare
program’’ means the programs under title XVIII of
the Social Security Act.
(4) PROVIDER.—The term ‘‘provider’’ means an
entity that is—
(A) a psychiatric hospital described in sec-
tion 1861(f) of the Social Security Act,
(B) a provider of services described in sec-
tion 1861(u) of such Act,
(C) a rural health clinic described in sec-
tion 1861(aa)(2) of such Act,
(D) an ambulatory surgical center de-
scribed in section 1832(a)(2)(F)(i) of such Act,
or
(E) a renal dialysis facility described in
section 1881(b)(1)(A) of such Act.
(5) REGISTERED
NURSE.—The term ‘‘reg-
istered nurse’’ means an individual who is entitled
under State law or regulation to practice as a reg-
istered nurse.
(6) SECRETARY.—The term ‘‘Secretary’’ means
the Secretary of Health and Human Services.
SEC. 4. PUBLIC DISCLOSURE OF STAFFING AND OUTCOMES
DATA.
(a) DISCLOSURE OF STAFFING AND OUTCOMES.—
Any provider under the medicare program shall, as a con-
dition of continued participation in such program, make
publicly available information regarding nurse staffing
and patient outcomes as specified by the Secretary. Such
information shall include at least the following:
(1) The number of registered nurses providing
direct care. This information shall be expressed both
in raw numbers, in terms of total hours of nursing
care per patient (including adjustment for case mix
and acuity), and as a percentage of nursing staff,
and shall be broken down in terms of the total nurs-
ing staff, each unit, and each shift.
(2) The number of licensed practical nurses or
licensed vocational nurses providing direct care. This
information shall be expressed both in raw numbers,
in terms of total hours of nursing care per patient
(including adjustment for case mix and acuity), and
as a percentage of nursing staff, and shall be broken
down in terms of the total nursing staff, each unit,
and each shift.
(3) Numbers of unlicensed personnel utilized to
provide direct patient care. This information shall be
expressed both in raw numbers and as a percentage
of nursing staff and shall be broken down in terms
of the total nursing staff, each unit, and each shift.
(4) The average number of patients per reg-
istered nurse providing direct patient care. This in-
formation shall be broken down in terms of the total
nursing staff, each unit, and each shift.
(5) Patient mortality rate (in raw numbers and
by diagnosis or diagnostic-related group).
(6) Incidence of adverse patient care incidents,
including as such incidents at least medication er-
rors, patient injury, decubitus ulcers, nosocomial in-
fections, and nosocomial urinary tract infections.
(7) Methods used for determining and adjusting
staffing levels and patient care needs and the provid-
er’s compliance with these methods.
(b) DISCLOSURE OF COMPLAINTS.—Data regarding
complaints filed with the State agency, the Health Care
Financing Administration, or an accrediting agency, com-
pliance with the standards of which have been deemed to
demonstrate compliance with conditions of participation
under the medicare program, and data regarding inves-
tigations and findings as a result of those complaints and
the findings of scheduled inspection visits, shall be made
publicly available.
(c) INFORMATION ON DATA.—All data made publicly
available under this section shall indicate the source and
currency of the data provided.
(d) WAIVER FOR SMALL PROVIDERS.—The Secretary
may waive or reduce reporting requirements under this
section in the case of a small provider (as defined by the
Secretary) for whom the imposition of the requirements
would be unduly burdensome.
SEC. 5. PROTECTION OF CERTAIN ACTIVITIES BY EMPLOY-
EES OF MEDICARE PROVIDERS.
(a) IN GENERAL.—No provider under the medicare
program shall terminate or take other adverse action
against any employee or groups of employees for actions
taken for the purpose of—
(1) notifying the provider of conditions which
the employee or group of employees identifies, in
communications with the provider, as dangerous or
potentially dangerous or injurious to—
(A) patients who currently receive services
from the provider;
(B) individuals who are likely to receive
services from the provider; or
(C) employees of the provider;
(2) notifying a Federal or State agency or an
accreditation agency, compliance with the standards
of which have been deemed to demonstrate compli-
ance with conditions of participation under the medi-
care program, of such conditions as are identified in
paragraph (1);
(3) notifying other individuals of conditions
which the employee or group of employees reason-
ably believe to be such as are described in paragraph
(1);
(4) discussing such conditions as are identified
in paragraph (1) with other employees for the pur-
poses of initiating action described in paragraph (1),
(2), or (3); or
(5) other related activities as specified in regu-
lations promulgated by the Secretary.
(b) SANCTION.—A determination by the Secretary
that a provider has taken such action as described in sub-
section (a) shall result in termination from participation
in the medicare program for a period of time to be speci-
fied by the Secretary, such period to be not less than 1
month.
(c) EXCEPTION.—The protections of this section shall
not apply to any employee who knowingly or recklessly
provides substantially false information to the Secretary.
SEC. 6. EVALUATION OF HEALTH AND SAFETY OF CERTAIN
MERGERS AND ACQUISITIONS BY OR AMONG
MEDICARE PROVIDERS.
(a) IMPACT REPORT.—Any provider under the medi-
care program that files with the Department of Justice
and the Federal Trade Commission notification of a trans-
action which is required to be reported pursuant to section
7A of the Clayton Act (15 U.S.C. 18a) shall, on the same
date as such notification is submitted, provide the Sec-
retary with a written report that includes the overall im-
pact of such transaction on the health services available
and readily accessible to the community and that includes
the impact of such transaction on each of the following:
(1) On the availability and accessibility of pri-
mary, acute care, and emergency services.
(2) On the availability and accessibility of serv-
ices for mothers and children.
(3) On the availability and accessibility of serv-
ices to the elderly.
(4) On the availability and accessibility of serv-
ices to other specific populations, including the poor,
the uninsured, ethnic minorities, women, the dis-
abled, and the lesbian and gay communities.
(5) On the availability and accessibility of spe-
cialized services, including services for the preven-
tion, detection, and treatment of the human
immunodeficiency virus and related illnesses, mental
health services, and substance abuse services.
(6) On the safety and quality of health care
services to be provided, including anticipated
changes in numbers and mix of nursing and other
patient care staff and on other factors related to pa-
tient outcomes.
(7) On the availability and accessibility of social
services and other services within the community.
(8) On overall employment within the commu-
nity.
(9) On the provider’s workforce, including—
(A) the status of existing collective bar-
gaining contracts, if any; and
(B) plans for retraining and redeployment
of employees who are displaced as a result of
the contemplated transaction.
(10) On the financial stability of the merged
entity, taking into account at least projected acquisi-
tion costs, related expenses, and planned marketing
or advertising campaigns for the new entity.
(11) On other factors to be specified in regula-
tions to be promulgated by the Secretary.
Such report shall be in addition to any documentation re-
quired by any other Federal or State agency.
(b) AVAILABILITY.—A report under subsection (a)
shall be made publicly available by the provider and by
the Secretary upon request. In addition, the provider shall
make publicly available any documentation submitted to
the Department of Justice, the Federal Trade Commis-
sion, or other Federal or State agency regarding the con-
templated transaction.
(c) HEARINGS.—The Secretary shall conduct, or ar-
range for, public hearings on the elements of each report
submitted under subsection (a) and any other factors re-
lated to the health, safety, and welfare of patients served
by the provider and the community involved, including the
provider’s workforce. Such hearings shall be held at a time
or times and location or locations readily accessible to the
public and may be conducted jointly with relevant State
agencies.
(d) REVIEW.—The Secretary shall review each such
proposed transaction. Such review shall be based on the
written report submitted under subsection (a), a tran-
script of testimony at the public hearing under subsection
(c), and any other factors which the Secretary finds are
relevant to the health, safety, and welfare of the patients
served by the provider and the community, including the
provider’s workforce.
(e) FINDINGS.—(1) The Secretary shall, within 45
days of completion of a hearing under subsection (c), issue
written findings on the likely impact of the contemplated
transaction on the health and safety of the patients and
communities served by the provider, including the provid-
er’s workforce.
(2) If the Secretary determines that the overall im-
pact of the transaction on the health and safety of patients
and the community is a negative one, the Secretary shall
issue, as part of the findings, a finding of negative impact
on health and safety.
(3) In issuing findings under this subsection, the Sec-
retary may confer with such other agencies (such as the
Department of Justice, the Federal Trade Commission,
and the Department of Labor) as may have an interest
in the impact on the public of the proposed transaction.
(f) SANCTIONS.—A provider that executes a trans-
action which is the subject of a finding of negative impact
on health and safety under subsection (e)(2) (or a provider
which fails to file a report with the Secretary pursuant
to subsection (a)) shall be deemed not to be in compliance
with the conditions of participation under the medicare
program. Such a determination shall be subject to such
procedures and appeal as provided for in regulations pro-
mulgated by the Secretary. In the case of a determination
that conditions effected by the transaction in question
pose immediate jeopardy or irreparable harm to patient
health, safety, and welfare, the Secretary shall (if such
transaction is completed) immediately suspend the entity’s
participation in the medicare program and such suspen-
sion shall continue in force during any administrative or
judicial review for the transaction sought by the entity.
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