II

106TH CONGRESS

1ST SESSION S. 966

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 SENATE OF THE UNITED STATES

MAY 5, 1999

Mr. REID introduced the following bill; which was read twice and referred to

the Committee on Finance

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.

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

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

3 1999’’.

4 SEC. 2. FINDINGS.

5 Congress finds the following:

6 (1) There has been increased and growing pub7 lic concern expressed regarding the quality and safe8 ty of services provided by health care facilities, as

9 such facilities have instituted aggressive efforts to

10 reduce levels of staff who provide direct patient care

11 services as a principal means of decreasing expenses.

12 (2) A growing body of data suggests—

13 (A) a linkage between the number and mix

14 of nursing staff and positive patient care out15 comes, including the avoidance of patient death

16 and injury; and

17 (B) that certain adverse patient care indi18 cators, including medication errors, patient in19 jury, decubitus ulcers, nosocomial infections,

20 and nosocomial urinary tract infections, signal

21 a deterioration of the quality of care that may

22 lead to patient death and injury.

23 (3) Many employees of health care facilities

24 have expressed fear for their employment if they re25 port unsafe conditions, including violations of State

26 or Federal law.
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1 (4) Unprecedented consolidation among health

2 care facilities has led to increasing concern regard3 ing the effect of such activity on the health and safe4 ty of communities served by these facilities, yet the

5 Federal Government has little authority to evaluate

6 such effect in deciding whether or not to approve

7 mergers and acquisitions among health care facili8 ties.

9 SEC. 3. DEFINITIONS.

10 For purposes of this Act:

11 (1) LICENSED PRACTICAL NURSE OR LICENSED

12 VOCATIONAL NURSE.—The term ‘‘licensed practical

13 nurse or licensed vocational nurse’’ means an indi14 vidual who is entitled under State law or regulation

15 to practice as a licensed practical nurse or a licensed

16 vocational nurse.

17 (2) MADE PUBLICLY AVAILABLE.—The term

18 ‘‘made publicly available’’ means, with respect to in19 formation of a provider, information that is

20 provided—

21 (A) to the Secretary and to any State

22 agency responsible for licensing or accrediting

23 the provider;

24 (B) to any State agency which approves or

25 oversees health care services delivered by the
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1 provider directly or through an insuring entity

2 or corporation; and

3 (C) to any member of the public which re4 quests such information directly from the pro5 vider.

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

7 program’’ means the programs under title XVIII of

8 the Social Security Act.

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

10 entity that is—

11 (A) a psychiatric hospital described in sec12 tion 1861(f) of the Social Security Act;

13 (B) a provider of services described in sec14 tion 1861(u) of such Act;

15 (C) a rural health clinic described in sec16 tion 1861(aa)(2) of such Act;

17 (D) an ambulatory surgical center de18 scribed in section 1832(a)(2)(F)(i) of such Act;

19 or

20 (E) a renal dialysis facility described in

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

22 (5) REGISTERED NURSE.—The term ‘‘reg23 istered nurse’’ means an individual who is entitled

24 under State law or regulation to practice as a reg25 istered nurse.
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1 (6) SECRETARY.—The term ‘‘Secretary’’ means

2 the Secretary of Health and Human Services.

3 SEC. 4. PUBLIC DISCLOSURE OF STAFFING AND OUTCOMES

4 DATA.

5 (a) DISCLOSURE OF STAFFING AND OUTCOMES.—

6 Any provider under the medicare program shall, as a con7 dition of continued participation in such program, make

8 publicly available information regarding nurse staffing

9 and patient outcomes as specified by the Secretary. Such

10 information shall include at least the following:

11 (1) The number of registered nurses providing

12 direct care. This information shall be expressed both

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

14 care per patient (including adjustment for case mix

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

16 and shall be broken down in terms of the total nurs17 ing staff, each unit, and each shift.

18 (2) The number of licensed practical nurses or

19 licensed vocational nurses providing direct care. This

20 information shall be expressed both in raw numbers,

21 in terms of total hours of nursing care per patient

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

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

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

25 and each shift.
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1 (3) Numbers of unlicensed personnel utilized to

2 provide direct patient care. This information shall be

3 expressed both in raw numbers and as a percentage

4 of nursing staff and shall be broken down in terms

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

6 (4) The average number of patients per reg7 istered nurse providing direct patient care. This in8 formation shall be broken down in terms of the total

9 nursing staff, each unit, and each shift.

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

11 by diagnosis or diagnostic-related group).

12 (6) Incidence of adverse patient care incidents,

13 including as such incidents at least medication er14 rors, patient injury, decubitus ulcers, nosocomial in15 fections, and nosocomial urinary tract infections.

16 (7) Methods used for determining and adjusting

17 staffing levels and patient care needs and the pro18 vider’s compliance with these methods.

19 (b) DISCLOSURE OF COMPLAINTS.—Data regarding

20 complaints filed with the State agency, the Health Care

21 Financing Administration, or an accrediting agency, com22 pliance with the standards of which have been deemed to

23 demonstrate compliance with conditions of participation

24 under the medicare program, and data regarding inves25 tigations and findings as a result of those complaints and
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1 the findings of scheduled inspection visits, shall be made

2 publicly available.

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

4 available under this section shall indicate the source and

5 currency of the data provided.

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

7 may waive or reduce reporting requirements under this

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

9 Secretary) for whom the imposition of the requirements

10 would be unduly burdensome.

11 SEC. 5. PROTECTION OF CERTAIN ACTIVITIES BY EMPLOY12 EES OF MEDICARE PROVIDERS.

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

14 program shall terminate or take other adverse action

15 against any employee or groups of employees for actions

16 taken for the purpose of—

17 (1) notifying the provider of conditions which

18 the employee or group of employees identifies, in

19 communications with the provider, as dangerous or

20 potentially dangerous or injurious to—

21 (A) patients who currently receive services

22 from the provider;

23 (B) individuals who are likely to receive

24 services from the provider; or

25 (C) employees of the provider;
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1 (2) notifying a Federal or State agency or an

2 accreditation agency, compliance with the standards

3 of which have been deemed to demonstrate compli4 ance with conditions of participation under the medi5 care program, of such conditions as are identified in

6 paragraph (1);

7 (3) notifying other individuals of conditions

8 which the employee or group of employees reason9 ably believe to be such as are described in paragraph

10 (1);

11 (4) discussing such conditions as are identified

12 in paragraph (1) with other employees for the pur13 poses of initiating action described in paragraph (1),

14 (2), or (3); or

15 (5) other related activities as specified in regu16 lations promulgated by the Secretary.

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

18 that a provider has taken such action as described in sub19 section (a) shall result in suspension from participation

20 in the medicare program for a period of time to be speci21 fied by the Secretary, such period to be not less than 1

22 month.

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

24 not apply to any employee who knowingly or recklessly

25 provides substantially false information to the Secretary.
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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 im-
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1 munodeficiency 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.
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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.

25 (e) FINDINGS.—
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1 (1) The Secretary shall, within 45 days of com2 pletion of a hearing under subsection (c), issue writ3 ten findings on the likely impact of the contemplated

4 transaction on the health and safety of the patients

5 and communities served by the provider, including

6 the provider’s workforce.

7 (2) If the Secretary determines that the overall

8 impact of the transaction on the health and safety

9 of patients and the community is a negative one, the

10 Secretary shall issue, as part of the findings, a find11 ing of negative impact on health and safety.

12 (3) In issuing findings under this subsection,

13 the Secretary may confer with such other agencies

14 (such as the Department of Justice, the Federal

15 Trade Commission, and the Department of Labor)

16 as may have an interest in the impact on the public

17 of the proposed transaction.

18 (f) SANCTIONS.—A provider that executes a trans19 action which is the subject of a finding of negative impact

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

21 which fails to file a report with the Secretary pursuant

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

23 with the conditions of participation under the medicare

24 program. Such a determination shall be subject to such

25 procedures and appeal as provided for in regulations pro-
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1 mulgated by the Secretary. In the case of a determination

2 that conditions effected by the transaction in question

3 pose immediate jeopardy or irreparable harm to patient

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

5 transaction is completed) immediately suspend the entity’s

6 participation in the medicare program and such suspen7 sion shall continue in force during any administrative or

8 judicial review for the transaction sought by the entity.

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