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 protect 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 Committee 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 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.
2

•HR 3355 IH

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Patient Safety Act of

5 1996’’.

6 SEC. 2. FINDINGS.

7 Congress finds as follows:

8 (1) There has been increased and growing pub9 lic concern expressed regarding the quality and safe10 ty of services provided by health care facilities and

11 institutions, as such facilities have instituted aggres12 sive efforts to reduce levels of staff who provide di13 rect patient care services as a principal means of de14 creasing expenses.

15 (2) A growing body of data suggests a linkage

16 between the number and mix of nursing staff and

17 positive patient care outcomes, including the avoid18 ance of patient death and injury.

19 (3) Many employees of health care facilities

20 have expressed fear for their employment if they re21 port unsafe conditions, including violations of State

22 or Federal law.

23 (4) Unprecedented consolidation among health

24 care institutions has led to increasing concern re25 garding the effect of such activity on the health and
3

•HR 3355 IH

1 safety of communities served by these facilities, yet

2 the Federal Government has little authority to evalu3 ate such effect in deciding whether or not to approve

4 mergers and acquisitions among health care facili5 ties.

6 SEC. 3. DEFINITIONS.

7 For purposes of this Act:

8 (1) LICENSED PRACTICAL NURSE OR LICENSED

9 VOCATIONAL NURSE.—The term ‘‘licensed practical

10 nurse or licensed vocational nurse’’ means an indi11 vidual who is entitled under State law or regulation

12 to practice as a licensed practical nurse or a licensed

13 vocational nurse.

14 (2) MADE PUBLICLY AVAILABLE.—The term

15 ‘‘made publicly available’’ means, with respect to in16 formation of a provider, information that is—

17 (A) provided to the Secretary and to any

18 State agency responsible for licensing or accred19 iting the provider;

20 (B) provided to any State agency which

21 approves or oversees health care services deliv22 ered by the provider directly or through an in23 suring entity or corporation; and
4

•HR 3355 IH

1 (C) provided to any member of the public

2 which requests such information directly from

3 the provider.

4 (3) MEDICARE PROGRAM.—The term ‘‘medicare

5 program’’ means the programs under title XVIII of

6 the Social Security Act.

7 (4) PROVIDER.—The term ‘‘provider’’ means an

8 entity that is—

9 (A) a psychiatric hospital described in sec10 tion 1861(f) of the Social Security Act,

11 (B) a provider of services described in sec12 tion 1861(u) of such Act,

13 (C) a rural health clinic described in sec14 tion 1861(aa)(2) of such Act,

15 (D) an ambulatory surgical center de16 scribed in section 1832(a)(2)(F)(i) of such Act,

17 or

18 (E) a renal dialysis facility described in

19 section 1881(b)(1)(A) of such Act.

20 (5) REGISTERED NURSE.—The term ‘‘reg21 istered nurse’’ means an individual who is entitled

22 under State law or regulation to practice as a reg23 istered nurse.

24 (6) SECRETARY.—The term ‘‘Secretary’’ means

25 the Secretary of Health and Human Services.
5

•HR 3355 IH

1 SEC. 4. PUBLIC DISCLOSURE OF STAFFING AND OUTCOMES

2 DATA.

3 (a) DISCLOSURE OF STAFFING AND OUTCOMES.—

4 Any provider under the medicare program shall, as a con5 dition of continued participation in such program, make

6 publicly available information regarding nurse staffing

7 and patient outcomes as specified by the Secretary. Such

8 information shall include at least the following:

9 (1) The number of registered nurses providing

10 direct care. This information shall be expressed both

11 in raw numbers, in terms of total hours of nursing

12 care per patient (including adjustment for case mix

13 and acuity), and as a percentage of nursing staff,

14 and shall be broken down in terms of the total nurs15 ing staff, each unit, and each shift.

16 (2) The number of licensed practical nurses or

17 licensed vocational nurses providing direct care. This

18 information shall be expressed both in raw numbers,

19 in terms of total hours of nursing care per patient

20 (including adjustment for case mix and acuity), and

21 as a percentage of nursing staff, and shall be broken

22 down in terms of the total nursing staff, each unit,

23 and each shift.

24 (3) Numbers of unlicensed personnel utilized to

25 provide direct patient care. This information shall be

26 expressed both in raw numbers and as a percentage
6

•HR 3355 IH

1 of nursing staff and shall be broken down in terms

2 of the total nursing staff, each unit, and each shift.

3 (4) The average number of patients per reg4 istered nurse providing direct patient care. This in5 formation shall be broken down in terms of the total

6 nursing staff, each unit, and each shift.

7 (5) Patient mortality rate (in raw numbers and

8 by diagnosis or diagnostic-related group).

9 (6) Incidence of adverse patient care incidents,

10 including as such incidents at least medication er11 rors, patient injury, decubitus ulcers, nosocomial in12 fections, and nosocomial urinary tract infections.

13 (7) Methods used for determining and adjusting

14 staffing levels and patient care needs and the provid15 er’s compliance with these methods.

16 (b) DISCLOSURE OF COMPLAINTS.—Data regarding

17 complaints filed with the State agency, the Health Care

18 Financing Administration, or an accrediting agency, com19 pliance with the standards of which have been deemed to

20 demonstrate compliance with conditions of participation

21 under the medicare program, and data regarding inves22 tigations and findings as a result of those complaints and

23 the findings of scheduled inspection visits, shall be made

24 publicly available.
7

•HR 3355 IH

1 (c) INFORMATION ON DATA.—All data made publicly

2 available under this section shall indicate the source and

3 currency of the data provided.

4 (d) WAIVER FOR SMALL PROVIDERS.—The Secretary

5 may waive or reduce reporting requirements under this

6 section in the case of a small provider (as defined by the

7 Secretary) for whom the imposition of the requirements

8 would be unduly burdensome.

9 SEC. 5. PROTECTION OF CERTAIN ACTIVITIES BY EMPLOY10 EES OF MEDICARE PROVIDERS.

11 (a) IN GENERAL.—No provider under the medicare

12 program shall terminate or take other adverse action

13 against any employee or groups of employees for actions

14 taken for the purpose of—

15 (1) notifying the provider of conditions which

16 the employee or group of employees identifies, in

17 communications with the provider, as dangerous or

18 potentially dangerous or injurious to—

19 (A) patients who currently receive services

20 from the provider;

21 (B) individuals who are likely to receive

22 services from the provider; or

23 (C) employees of the provider;

24 (2) notifying a Federal or State agency or an

25 accreditation agency, compliance with the standards
8

•HR 3355 IH

1 of which have been deemed to demonstrate compli2 ance with conditions of participation under the medi3 care program, of such conditions as are identified in

4 paragraph (1);

5 (3) notifying other individuals of conditions

6 which the employee or group of employees reason7 ably believe to be such as are described in paragraph

8 (1);

9 (4) discussing such conditions as are identified

10 in paragraph (1) with other employees for the pur11 poses of initiating action described in paragraph (1),

12 (2), or (3); or

13 (5) other related activities as specified in regu14 lations promulgated by the Secretary.

15 (b) SANCTION.—A determination by the Secretary

16 that a provider has taken such action as described in sub17 section (a) shall result in termination from participation

18 in the medicare program for a period of time to be speci19 fied by the Secretary, such period to be not less than 1

20 month.

21 (c) EXCEPTION.—The protections of this section shall

22 not apply to any employee who knowingly or recklessly

23 provides substantially false information to the Secretary.
9

•HR 3355 IH

1 SEC. 6. EVALUATION OF HEALTH AND SAFETY OF CERTAIN

2 MERGERS AND ACQUISITIONS BY OR AMONG

3 MEDICARE PROVIDERS.

4 (a) IMPACT REPORT.—Any provider under the medi5 care program that files with the Department of Justice

6 and the Federal Trade Commission notification of a trans7 action which is required to be reported pursuant to section

8 7A of the Clayton Act (15 U.S.C. 18a) shall, on the same

9 date as such notification is submitted, provide the Sec10 retary with a written report that includes the overall im11 pact of such transaction on the health services available

12 and readily accessible to the community and that includes

13 the impact of such transaction on each of the following:

14 (1) On the availability and accessibility of pri15 mary, acute care, and emergency services.

16 (2) On the availability and accessibility of serv17 ices for mothers and children.

18 (3) On the availability and accessibility of serv19 ices to the elderly.

20 (4) On the availability and accessibility of serv21 ices to other specific populations, including the poor,

22 the uninsured, ethnic minorities, women, the dis23 abled, and the lesbian and gay communities.

24 (5) On the availability and accessibility of spe25 cialized services, including services for the preven26 tion, detection, and treatment of the human
10

•HR 3355 IH

1 immunodeficiency virus and related illnesses, mental

2 health services, and substance abuse services.

3 (6) On the safety and quality of health care

4 services to be provided, including anticipated

5 changes in numbers and mix of nursing and other

6 patient care staff and on other factors related to pa7 tient outcomes.

8 (7) On the availability and accessibility of social

9 services and other services within the community.

10 (8) On overall employment within the commu11 nity.

12 (9) On the provider’s workforce, including—

13 (A) the status of existing collective bar14 gaining contracts, if any; and

15 (B) plans for retraining and redeployment

16 of employees who are displaced as a result of

17 the contemplated transaction.

18 (10) On the financial stability of the merged

19 entity, taking into account at least projected acquisi20 tion costs, related expenses, and planned marketing

21 or advertising campaigns for the new entity.

22 (11) On other factors to be specified in regula23 tions to be promulgated by the Secretary.

24 Such report shall be in addition to any documentation re25 quired by any other Federal or State agency.
11

•HR 3355 IH

1 (b) AVAILABILITY.—A report under subsection (a)

2 shall be made publicly available by the provider and by

3 the Secretary upon request. In addition, the provider shall

4 make publicly available any documentation submitted to

5 the Department of Justice, the Federal Trade Commis6 sion, or other Federal or State agency regarding the con7 templated transaction.

8 (c) HEARINGS.—The Secretary shall conduct, or ar9 range for, public hearings on the elements of each report

10 submitted under subsection (a) and any other factors re11 lated to the health, safety, and welfare of patients served

12 by the provider and the community involved, including the

13 provider’s workforce. Such hearings shall be held at a time

14 or times and location or locations readily accessible to the

15 public and may be conducted jointly with relevant State

16 agencies.

17 (d) REVIEW.—The Secretary shall review each such

18 proposed transaction. Such review shall be based on the

19 written report submitted under subsection (a), a tran20 script of testimony at the public hearing under subsection

21 (c), and any other factors which the Secretary finds are

22 relevant to the health, safety, and welfare of the patients

23 served by the provider and the community, including the

24 provider’s workforce.
12

•HR 3355 IH

1 (e) FINDINGS.—(1) The Secretary shall, within 45

2 days of completion of a hearing under subsection (c), issue

3 written findings on the likely impact of the contemplated

4 transaction on the health and safety of the patients and

5 communities served by the provider, including the provid6 er’s workforce.

7 (2) If the Secretary determines that the overall im8 pact of the transaction on the health and safety of patients

9 and the community is a negative one, the Secretary shall

10 issue, as part of the findings, a finding of negative impact

11 on health and safety.

12 (3) In issuing findings under this subsection, the Sec13 retary may confer with such other agencies (such as the

14 Department of Justice, the Federal Trade Commission,

15 and the Department of Labor) as may have an interest

16 in the impact on the public of the proposed transaction.

17 (f) SANCTIONS.—A provider that executes a trans18 action which is the subject of a finding of negative impact

19 on health and safety under subsection (e)(2) (or a provider

20 which fails to file a report with the Secretary pursuant

21 to subsection (a)) shall be deemed not to be in compliance

22 with the conditions of participation under the medicare

23 program. Such a determination shall be subject to such

24 procedures and appeal as provided for in regulations pro25 mulgated by the Secretary. In the case of a determination
13

•HR 3355 IH

1 that conditions effected by the transaction in question

2 pose immediate jeopardy or irreparable harm to patient

3 health, safety, and welfare, the Secretary shall (if such

4 transaction is completed) immediately suspend the entity’s

5 participation in the medicare program and such suspen6 sion shall continue in force during any administrative or

7 judicial review for the transaction sought by the entity.

Æ