SENATE AMENDED
PRIOR PRINTER'S NOS. 2965, 3231, 3450, PRINTER'S NO. 4511
4346
No. 2098 Session of 2007
INTRODUCED BY DeLUCA, BELFANTI, FRANKEL, HALUSKA, KOTIK, MOYER,
SIPTROTH, WALKO, J. WHITE, WOJNAROSKI, PETRONE, YOUNGBLOOD,
GIBBONS AND CALTAGIRONE, DECEMBER 6, 2007
SENATOR ARMSTRONG, APPROPRIATIONS, IN SENATE, RE-REPORTED AS
AMENDED, OCTOBER 6, 2008
AN ACT
1 Establishing a system for payment or reduction in payment for <--
2 preventable serious adverse events within Commonwealth
3 programs; informing health insurers of payment policies used
4 by Medicaid and Medicare; and providing for the powers and
5 duties of the Department of Public Welfare, the Insurance
6 Department, the Department of Health and the Department of
7 State.
8 ESTABLISHING A SYSTEM FOR PAYMENT OR REDUCTION IN PAYMENT FOR <--
9 PREVENTABLE SERIOUS ADVERSE EVENTS WITHIN THIS COMMONWEALTH;
10 AND PROVIDING FOR THE POWERS AND DUTIES OF THE DEPARTMENT OF
11 HEALTH AND THE DEPARTMENT OF STATE.
12 The General Assembly of the Commonwealth of Pennsylvania
13 hereby enacts as follows:
14 Section 1. Short title. <--
15 This act shall be known and may be cited as the Preventable
16 Serious Adverse Events Act.
17 Section 2. Definitions.
18 The following words and phrases when used in this act shall
19 have the meanings given to them in this section unless the
20 context clearly indicates otherwise:
1 "Centers for Medicare and Medicaid Services" or "CMS." The
2 Centers for Medicare and Medicaid Services within the United
3 States Department of Health and Human Services.
4 "Department." The Insurance Department of the Commonwealth.
5 "Facility." A health care facility as defined in section
6 802.1 of the act of July 19, 1979 (P.L.130, No.48), known as the
7 Health Care Facilities Act, or an entity licensed as a hospital
8 under the act of June 13, 1967 (P.L.31, No.21), known as the
9 Public Welfare Code.
10 "Health care provider." A health care facility or a person,
11 including a corporation, university or other educational
12 institution licensed or approved by the Commonwealth to provide
13 health care or professional medical services as a physician, a
14 certified nurse midwife, a podiatrist, a certified registered
15 nurse practitioner, a physician assistant, a chiropractor, a
16 hospital, an ambulatory surgery center, a nursing home and a
17 birth center.
18 "Health payor." An individual or entity providing a group
19 health, sickness or accident policy, subscriber contract or
20 program issued or provided by an entity, including any one of
21 the following:
22 (1) The act of June 2, 1915 (P.L.736, No.338), known as
23 the Workers' Compensation Act.
24 (2) The act of May 17, 1921 (P.L.682, No.284), known as
25 The Insurance Company Law of 1921.
26 (3) The act of December 29, 1972 (P.L.1701, No.364),
27 known as the Health Maintenance Organization Act.
28 (4) The act of May 18, 1976 (P.L.123, No.54), known as
29 the Individual Accident and Sickness Insurance Minimum
30 Standards Act.
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1 (5) 40 Pa.C.S. Ch. 61 (relating to hospital plan
2 corporations).
3 (6) 40 Pa.C.S. Ch. 63 (relating to professional health
4 services plan corporations).
5 "Medical assistance." The Commonwealth's medical assistance
6 program established under the act of June 13, 1967 (P.L.31,
7 No.21), known as the Public Welfare Code.
8 "Preventable serious adverse event." A clearly defined
9 condition or negative consequence of care that results in
10 unintended injury or illness that could have been anticipated
11 and prepared for, but that occurs because of an error or other
12 system failure and results in a patient's death, loss of a body
13 part, disability or loss of bodily function lasting more than
14 seven days.
15 Section 3. Payment policy for preventable serious adverse
16 events.
17 (a) General rule.--The following criteria shall be used by
18 health payors in determining when payment or partial payment to
19 a health care provider will be withheld:
20 (1) A preventable serious adverse event must occur.
21 (2) The preventable serious adverse event must be within
22 the control of the health care provider.
23 (3) The preventable serious adverse event must occur in
24 a health care facility.
25 (b) Language addressing payment policy.--Payments can only
26 be withheld by health payors for services related to a
27 preventable serious adverse event or care made necessary by the
28 preventable serious adverse event if the agreement or contract
29 between the health payor and health care provider contains
30 language addressing payment policy for preventable serious
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1 adverse events.
2 (c) Restriction.--Health care providers shall not seek
3 payment directly from patients or the responsible party of the
4 patient for preventable serious adverse events.
5 Section 4. Duties of Department of Public Welfare.
6 (a) Department responsibilities.--The Department of Public
7 Welfare is responsible for the following:
8 (1) Determining payment policy under medical assistance
9 with respect to reduced reimbursements to health care
10 providers for preventable serious adverse events. This
11 payment policy includes the criteria and clearly stated
12 payment policies affecting health care providers.
13 (2) Publishing the payment policy in the Pennsylvania
14 Bulletin following a 30-day public comment period.
15 (b) Ongoing reviews.--Nothing in this section shall affect
16 ongoing reviews of medical assistance services conducted by the
17 Department of Public Welfare.
18 (c) Hospital payment policy.--Nothing in this section shall
19 require the department to alter, amend or reissue any payment
20 policy for inpatient hospitals relating to preventable serious
21 adverse events that was promulgated prior to the enactment of
22 this act.
23 Section 5. Duties of Insurance Department.
24 (a) Notice of preventable serious adverse events.--The
25 department shall annually notify health payors of the list of
26 preventable serious adverse events that CMS is using under the
27 Medicare program and for which health payors may withhold
28 reimbursement under section 3.
29 (b) Notice of CMS rule.--The department shall transmit
30 notice of the effective date of the CMS Hospital-Acquired
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1 Conditions, Including Infections, Final Rule, to the Legislative
2 Reference Bureau for publication in the Pennsylvania Bulletin.
3 Section 6. Duties of Department of Health.
4 In accordance with the act of July 19, 1979 (P.L.130, No.48),
5 known as the Health Care Facilities Act, the Department of
6 Health shall be responsible for investigating patient complaints
7 regarding a health care facility that is seeking payment
8 directly from the patient for a preventable serious adverse
9 event.
10 Section 7. Duties of Department of State.
11 The Department of State shall be responsible for
12 investigating complaints regarding a health care provider that
13 is not a health care facility that is seeking or causing to be
14 sought payment directly from the patient or responsible party of
15 the patient for a preventable serious adverse event.
16 Section 19. Applicability.
17 This act shall apply to preventable serious adverse events
18 that occur after the later of the following:
19 (1) Publication of the notice under section 5(b).
20 (2) October 1, 2008.
21 Section 20. Effective date.
22 This act shall take effect immediately.
23 SECTION 1. SHORT TITLE. <--
24 THIS ACT SHALL BE KNOWN AND MAY BE CITED AS THE PREVENTABLE
25 SERIOUS ADVERSE EVENTS ACT.
26 SECTION 2. DEFINITIONS.
27 THE FOLLOWING WORDS AND PHRASES WHEN USED IN THIS ACT SHALL
28 HAVE THE MEANINGS GIVEN TO THEM IN THIS SECTION UNLESS THE
29 CONTEXT CLEARLY INDICATES OTHERWISE:
30 "HEALTH CARE FACILITY." A HEALTH CARE FACILITY AS DEFINED
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1 UNDER SECTION 802.1 OF THE ACT OF JULY 19, 1979 (P.L.130,
2 NO.48), KNOWN AS THE HEALTH CARE FACILITIES ACT, OR AN ENTITY
3 LICENSED AS A HOSPITAL UNDER THE ACT OF JUNE 13, 1967 (P.L.31,
4 NO.21), KNOWN AS THE PUBLIC WELFARE CODE.
5 "HEALTH CARE PROVIDER." A HEALTH CARE FACILITY OR A PERSON,
6 INCLUDING A CORPORATION, UNIVERSITY OR OTHER EDUCATIONAL
7 INSTITUTION, LICENSED OR APPROVED BY THE COMMONWEALTH TO PROVIDE
8 HEALTH CARE OR PROFESSIONAL MEDICAL SERVICES. THE TERM SHALL
9 INCLUDE, BUT NOT BE LIMITED TO, A PHYSICIAN, A CERTIFIED NURSE
10 MIDWIFE, A PODIATRIST, A CERTIFIED REGISTERED NURSE
11 PRACTITIONER, A PHYSICIAN ASSISTANT, A CHIROPRACTOR, A HOSPITAL,
12 AN AMBULATORY SURGERY CENTER, A NURSING HOME OR A BIRTH CENTER.
13 "HEALTH PAYOR." AN INDIVIDUAL OR ENTITY PAYING FOR HEALTH
14 SERVICES FOR HIMSELF OR ITSELF OR ON BEHALF OF ANOTHER. <--
15 "MEDICAL ASSISTANCE." THE COMMONWEALTH'S MEDICAL ASSISTANCE
16 PROGRAM ESTABLISHED UNDER THE ACT OF JUNE 13, 1967 (P.L.31,
17 NO.21), KNOWN AS THE PUBLIC WELFARE CODE.
18 "NATIONAL QUALITY FORUM." A NOT-FOR-PROFIT MEMBERSHIP
19 ORGANIZATION CREATED TO DEVELOP AND IMPLEMENT A NATIONAL
20 STRATEGY FOR HEALTH CARE QUALITY MEASUREMENT AND REPORTING.
21 "PREVENTABLE SERIOUS ADVERSE EVENT." AN EVENT THAT OCCURS IN
22 A HEALTH CARE FACILITY THAT IS WITHIN THE HEALTH CARE PROVIDER'S
23 CONTROL TO AVOID, BUT THAT OCCURS BECAUSE OF AN ERROR OR OTHER
24 SYSTEM FAILURE AND RESULTS IN A PATIENT'S DEATH, LOSS OF BODY
25 PART, DISFIGUREMENT, DISABILITY OR LOSS OF BODILY FUNCTION
26 LASTING MORE THAN SEVEN DAYS OR STILL PRESENT AT THE TIME OF
27 DISCHARGE FROM A HEALTH CARE FACILITY. SUCH EVENTS SHALL BE
28 WITHIN THE LIST OF REPORTABLE SERIOUS EVENTS ADOPTED BY THE
29 NATIONAL QUALITY FORUM.
30 SECTION 3. PAYMENT POLICY FOR PREVENTABLE SERIOUS ADVERSE
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1 EVENTS.
2 (A) GENERAL RULE.--HEALTH CARE PROVIDERS MAY NOT KNOWINGLY
3 SEEK PAYMENT FROM HEALTH PAYORS, PATIENTS OR THE RESPONSIBLE <--
4 PARTY OF THE PATIENT OR PATIENTS FOR A PREVENTABLE SERIOUS <--
5 ADVERSE EVENT OR SERVICES REQUIRED TO CORRECT OR TREAT THE
6 PROBLEM CREATED BY SUCH AN EVENT WHEN SUCH AN EVENT OCCURRED
7 UNDER THEIR CONTROL.
8 (B) REFUNDS.--A HEALTH CARE PROVIDER WHO DISCOVERS THAT
9 PAYMENT HAS UNKNOWINGLY BEEN SOUGHT FOR A PREVENTABLE SERIOUS
10 ADVERSE EVENT OR SERVICES REQUIRED TO CORRECT OR TREAT THE
11 PROBLEM CREATED BY SUCH AN EVENT SHALL IMMEDIATELY NOTIFY THE
12 HEALTH PAYOR, PATIENT OR THE RESPONSIBLE PARTY OF THE PATIENT OR <--
13 PATIENT AND SHALL REFUND ANY PAYMENT RECEIVED WITHIN 30 DAYS OF
14 DISCOVERY OR RECEIPT OF PAYMENT, WHICHEVER IS LATER.
15 (C) NOTIFICATION.--A HEALTH CARE PAYOR WHO DISCOVERS THAT
16 PAYMENT HAS BEEN SOUGHT FOR A PREVENTABLE SERIOUS ADVERSE EVENT
17 OR SERVICES REQUIRED TO CORRECT OR TREAT A PROBLEM CREATED BY
18 SUCH AN EVENT SHALL NOTIFY THE HEALTH CARE PROVIDER THAT PAYMENT
19 MAY NOT BE SOUGHT FOR SUCH AN EVENT OR SERVICES AND THAT PAYMENT
20 SHALL NOT BE MADE FOR SUCH EVENTS OR SERVICES.
21 (D) LIABILITY.--ANY INFORMATION PROVIDED TO ANY HEALTH CARE
22 PAYOR OR HEALTH CARE PROVIDER, IN COMPLIANCE WITH SUBSECTIONS
23 (B) AND (C), SHALL NOT BE DISCOVERABLE OR ADMISSIBLE IN ANY
24 CIVIL OR ADMINISTRATIVE ACTION RELATED TO THE ACT OF MARCH 20,
25 2002 (P.L.154, NO.13), KNOWN AS THE MEDICAL CARE AVAILABILITY
26 AND REDUCTION OF ERROR (MCARE) ACT.
27 SECTION 4. DUTIES OF DEPARTMENT OF HEALTH.
28 (A) PUBLISHING OF UPDATES.--THE DEPARTMENT SHALL PUBLISH IN
29 THE PENNSYLVANIA BULLETIN ANY UPDATES TO THE LIST OF REPORTABLE
30 SERIOUS ADVERSE EVENTS ADOPTED BY THE NATIONAL QUALITY FORUM
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1 WITHIN 30 DAYS OF THE UPDATE ISSUED BY THE NATIONAL QUALITY
2 FORUM.
3 (B) HEALTH DEPARTMENT RESPONSIBILITY.--IN ACCORDANCE WITH
4 THE ACT OF JULY 19, 1979 (P.L.130, NO.48), KNOWN AS THE HEALTH
5 CARE FACILITIES ACT, THE DEPARTMENT OF HEALTH SHALL BE
6 RESPONSIBLE FOR INVESTIGATING PATIENT COMPLAINTS REGARDING A
7 HEALTH CARE FACILITY THAT IS SEEKING PAYMENT DIRECTLY FROM THE
8 PATIENT OR HEALTH CARE PAYOR FOR A PREVENTABLE SERIOUS ADVERSE
9 EVENT.
10 SECTION 5. DUTIES OF DEPARTMENT OF STATE.
11 THE DEPARTMENT OF STATE SHALL BE RESPONSIBLE FOR
12 INVESTIGATING PATIENT COMPLAINTS REGARDING A HEALTH CARE
13 PROVIDER THAT IS NOT A HEALTH CARE FACILITY THAT IS SEEKING OR
14 CAUSING TO BE SOUGHT PAYMENT DIRECTLY FROM THE PATIENT OR HEALTH
15 CARE PAYOR FOR A PREVENTABLE SERIOUS ADVERSE EVENT.
16 SECTION 6. APPLICABILITY.
17 (A) HOSPITAL MEDICAL ASSISTANCE PAYMENT POLICY.--NOTHING IN
18 THIS ACT SHALL REQUIRE THE DEPARTMENT OF PUBLIC WELFARE TO
19 ALTER, AMEND OR REISSUE ANY PAYMENT POLICY FOR INPATIENT
20 HOSPITALS RELATING TO PREVENTABLE SERIOUS ADVERSE EVENTS THAT
21 WAS PROMULGATED PRIOR TO THE ENACTMENT OF THIS ACT. ANY
22 MODIFICATIONS TO THE DEPARTMENT OF PUBLIC WELFARE PAYMENT POLICY
23 PROMULGATED ON OR AFTER THE DATE OF ENACTMENT OF THIS ACT FOR A
24 HEALTH CARE PROVIDER FOR A PREVENTABLE SERIOUS ADVERSE EVENT
25 SHALL REQUIRE A 30-DAY PUBLIC COMMENT PERIOD.
26 (B) CONTRACTS.--NOTHING IN THIS ACT SHALL PROHIBIT A HEALTH
27 CARE PROVIDER AND PAYOR FROM ESTABLISHING BY CONTRACT ANY
28 POLICIES AND PROCEDURES ASSOCIATED WITH SERIOUS PREVENTABLE
29 ADVERSE EVENTS NECESSARY TO IMPLEMENT THE PROVISIONS OF THIS
30 ACT.
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1 (C) REPORTING.--
2 (1) HEALTH CARE PROVIDERS SHALL INCLUDE ALL APPLICABLE
3 MEDICAL CODES IN MAKING REPORTS IN COMPLIANCE WITH THE ACT OF
4 JULY 8, 1986 (P.L.408, NO.89), KNOWN AS THE HEALTH CARE COST
5 CONTAINMENT ACT.
6 (2) A PREVENTABLE SERIOUS ADVERSE EVENT SHALL BE
7 REPORTED PURSUANT TO THE REQUIREMENTS OF THE ACT OF MARCH 20,
8 2002 (P.L.154, NO.13), KNOWN AS THE MEDICAL CARE AVAILABILITY
9 AND REDUCTION OF ERROR (MCARE) ACT.
10 (D) MEDICARE PAYMENT.--NOTHING IN THIS ACT SHALL BE <--
11 CONSTRUED TO SUPERSEDE MEDICARE PAYMENT POLICIES WHERE THE
12 SERVICES PROVIDED TO THE PATIENT ARE PAID FOR BY MEDICARE. IF
13 MEDICARE DENIES PAYMENT BASED ON A DETERMINATION THAT A
14 PREVENTABLE SERIOUS ADVERSE EVENT HAS OCCURRED, NOTHING IN THIS
15 ACT SHALL BE CONSTRUED TO REQUIRE MEDICAL ASSISTANCE OR A HEALTH
16 PAYOR TO PAY A CLAIM FOR THE EVENT OR SERVICES.
17 SECTION 7. EFFECTIVE DATE.
18 THIS ACT SHALL TAKE EFFECT IN 180 DAYS.
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