THE GENERAL ASSEMBLY OF PENNSYLVANIA

HOUSE BILL

INTRODUCED BY DeLUCA, KOTIK, MANDERINO, WALKO, FRANKEL, BELFANTI, BRENNAN, CALTAGIRONE, GIBBONS, GROVE, HARKINS, MANN, McILVAINE SMITH, MILLER, MUNDY, READSHAW, SIPTROTH, SOLOBAY, STABACK, VULAKOVICH, WHITE, WANSACZ, MURT, MYERS, EACHUS, MICOZZIE, HORNAMAN, SANTARSIERO, KORTZ AND MATZIE, JANUARY 28, 2009

AS AMENDED ON SECOND CONSIDERATION, HOUSE OF REPRESENTATIVES, MARCH 31, 2009   

AN ACT

Establishing a system for payment or reduction in payment for

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preventable serious adverse events within this Commonwealth;

and providing for the powers and duties of the Department of

Health and the Department of State.

Establishing a system for payment or reduction in payment for

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preventable serious adverse events within this Commonwealth;

developing bulletins; and providing for the powers and duties

of the Department of Public Welfare, the Department of Health

and the Department of State.

The General Assembly of the Commonwealth of Pennsylvania

hereby enacts as follows:

Section 1.  Short title.

This act shall be known and may be cited as the Preventable

Serious Adverse Events Act.

Section 2.  Definitions.

The following words and phrases when used in this act shall

have the meanings given to them in this section unless the

context clearly indicates otherwise:

"Health care facility."  A health care facility as defined

under section 802.1 of the act of July 19, 1979 (P.L.130, No.

48), known as the Health Care Facilities Act, or an entity

licensed as a hospital under the act of June 13, 1967 (P.L.31,

No.21), known as the Public Welfare Code.

"Health care provider."  A health care facility or a person,

including a corporation, university or other educational

institution, licensed or approved by the Commonwealth to provide

health care or professional medical services. The term shall

include, but not be limited to, a physician, a certified nurse

midwife, a podiatrist, a certified registered nurse

practitioner, a physician assistant, a chiropractor, a hospital,

an ambulatory surgery center, a nursing home or a birth center.

"Health payor."  An individual or entity paying for health

services for himself or itself or on behalf of another.

"Medical assistance."  The Commonwealth's medical assistance

program established under the act of June 13, 1967 (P.L.31, No.

21), known as the Public Welfare Code.

"National Quality Forum."  A not-for-profit membership

organization created to develop and implement a national

strategy for health care quality measurement and reporting.

"Preventable serious adverse event."  An event that occurs in

a health care facility that is within the health care provider's

control to avoid, but that occurs because of an error or other

system failure and results in a patient's death, loss of body

part, disfigurement, disability or loss of bodily function

lasting more than seven days or still present at the time of

discharge from a health care facility. Such Unless the events

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are listed in a preventable serious adverse events bulletin

issued by the Department of Public Welfare under section 4(a) or

with respect to medical assistance hospital payments under

section 7(a) and (b), such events shall be within the list of

reportable serious events adopted by the National Quality Forum.

"Principal."  A principal shall mean a nursing facility or

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trade association representing nursing facilities.

Section 3.  Payment policy for preventable serious adverse

events.

(a)  General rule.--Health care providers may not knowingly

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seek payment from health payors, or patients for a preventable

serious adverse event or services required to correct or treat

the problem created by such an event when such an event occurred

under their control.

(a)  General rule.--A health care provider may not knowingly

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seek payment from a health payor or patient:

(1)  for a preventable serious adverse event; or

(2)  for any services required to correct or treat the

problem created by a preventable serious adverse event when

that event occurred under their control.

(b)  Refunds.--A health care provider who discovers that

payment has unknowingly been sought for a preventable serious

adverse event or services required to correct or treat the

problem created by such an event shall immediately notify the

health payor, or patient and shall refund any payment received

within 30 days of discovery or receipt of payment, whichever is

later.

(c)  Notification.--A health care payor who discovers that

payment has been sought for a preventable serious adverse event

or services required to correct or treat a problem created by

such an event shall notify the health care provider that payment

may not be sought for such an event or services and that payment

shall not be made for such events or services.

(d)  Liability.--Any information provided to any health care

payor or health care provider, in compliance with subsections

(b) and (c), shall not be discoverable or admissible in any

civil or administrative action related to the act of March 20,

2002 (P.L.154, No.13), known as the Medical Care Availability

and Reduction of Error (Mcare) Act.

Section 4.  Nursing facility preventable serious adverse events

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bulletin.

(a)  Nursing facility bulletin.--The Department of Public

Welfare shall issue a preventable serious adverse events

bulletin for nursing facilities. For a nursing facility,

preventable serious adverse events shall be those listed in a

bulletin developed by the department under this section.

(b)  Consulting principals.--Prior to issuance of a bulletin,

the Department of Public Welfare shall consult with principals

concerning the development of a preventable serious adverse

events bulletin for nursing facilities.

(c)  Open meetings.--Meetings held under subsection (b) shall

be open to the public.

(d)  Publication.--The Department of Public Welfare shall

publish the proposed preventable serious adverse events bulletin

in the Pennsylvania Bulletin and solicit public comments for a

minimum of 30 days. After consideration of the comments it

receives, the Department of Public Welfare may proceed to adopt

the final preventable serious adverse events bulletin by

publication in the Pennsylvania Bulletin. The Department of

Public Welfare shall include its responses to the public

comments that it received concerning the proposed bulletin.

(e)  Department notice.--The Department of Public Welfare

shall notify the Department of Health of the final preventable

serious adverse events bulletin published under this section.

Section 45.  Duties of Department of Health.

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(a)  Publishing of updates.--The department shall publish in

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the Pennsylvania Bulletin any updates to the list of reportable

serious adverse events adopted by the National Quality Forum

within 30 days of the update issued by the National Quality

Forum.

(a)  Publishing of updates.--The Department of Health shall

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publish in the Pennsylvania Bulletin:

(1)  Any updates to the list of reportable serious

adverse events adopted by the National Quality Forum within

30 days of the update issued by the National Quality Forum.

(2)  A citation to the preventable serious adverse events

the bulletin published under section 4.

(b)  Health department responsibility.--In accordance with

the act of July 19, 1979 (P.L.130, No.48), known as the Health

Care Facilities Act, the Department of Health shall be

responsible for investigating patient or health payor complaints

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regarding a health care facility that is seeking payment

directly from the patient or health care payor for a preventable

serious adverse event.

Section 56.  Duties of Department of State.

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The Department of State shall be responsible for

investigating patient complaints regarding a health care

provider that is not a health care facility that is seeking or

causing to be sought payment directly from the patient or health

care payor for a preventable serious adverse event.

Section 67.  Applicability.

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(a)  Hospital medical assistance payment policy.--Nothing in

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this act shall require the Department of Public Welfare to

alter, amend or reissue any payment policy for inpatient

hospitals relating to preventable serious adverse events that

was promulgated prior to the enactment of this act. Any

modifications to the Department of Public Welfare payment policy

promulgated on or after the date of enactment of this act for a

health care provider for a preventable serious adverse event

shall require a 30-day public comment period.

(b)

(a)  Hospital preventable serious adverse events bulletin.--

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Nothing in this act shall require the Department of Public

Welfare to alter, amend, revise or reissue any preventable

serious adverse events bulletin relating to inpatient hospitals

issued prior to the effective date of this act.

(b)  Comment period.--Any modifications to the Department of

Public Welfare preventable serious adverse events bulletins

issued after the effective date of this act for a health care

provider for a preventable serious adverse event shall require a

30-day public comment period.

(c)  Contracts.--Nothing in this act shall prohibit a health

care provider and payor from establishing by contract any

policies and procedures associated with serious preventable

adverse events necessary to implement the provisions of this

act.

(c)(d)  Reporting.--

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(1)  Health care providers shall include all applicable

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medical codes in making reports in compliance with the act of

July 8, 1986 (P.L.408, No.89), known as the Health Care Cost

Containment Act.

(1)  Except for health care providers under section 4,

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health care providers shall include all applicable medical

codes in making reports to the Health Care Cost Containment

Council.

(2)  A preventable serious adverse event shall be

reported pursuant to the requirements of the act of March 20,

2002 (P.L.154, No.13), known as the Medical Care Availability

and Reduction of Error (Mcare) Act.

(d)(e)  Medicare payment.--Nothing in this act shall be

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construed to supersede Medicare payment policies where the

services provided to the patient are paid for by Medicare. If

Medicare denies payment based on a determination that a

preventable serious adverse event has occurred, nothing in this

act shall be construed to require medical assistance, any other

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department responsible for payment of a medical claim or a

health payor to pay a claim for the event or services.

(f)  Department initiation.--Nothing in this act may prevent

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the Department of Public Welfare from developing, revising or

amending a preventable serious adverse events bulletin in

consultation with health care providers.

(g)  Consultation by Department of Public Welfare.--Nothing

in this act may prevent the Department of Public Welfare from

consulting with any other agency or department that is

responsible for payment of medical claims submitted for payment

by a health care provider.

Section 78.  Effective date.

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This act shall take effect in 180 days.as follows:

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(1)  Section 4 shall take effect in one year.

(2)  The remainder of this act shall take effect in 60

days.