Regular Session 2023-2024 House Bill 1993 P.N. 3497

SENATE AMENDED

PRIOR PRINTER'S NOS. 2833, 3317, 3435,

2833

PRINTER'S NO. 3497

THE GENERAL ASSEMBLY OF PENNSYLVANIA

HOUSE BILL

No.

1993

Session of

2024

INTRODUCED BY BENHAM, GAYDOS, KENYATTA, BURGOS, HARKINS,

DONAHUE, MADDEN, MAJOR, SANCHEZ, CERRATO, HILL-EVANS,

D'ORSIE, CIRESI, DALEY, MATZIE, SOLOMON, MIHALEK, ECKER,

McNEILL, SCHLOSSBERG, PICKETT, PISCIOTTANO, WEBSTER,

HOHENSTEIN, KRUEGER, BOROWSKI, NEILSON, FEE, KIM, KHAN,

BERNSTINE, MENTZER, O'MARA, FLEMING, GROVE, MULLINS,

KOSIEROWSKI, ISAACSON, HEFFLEY, OBERLANDER, ARMANINI,

GREGORY, E. NELSON, STAATS, WAXMAN, STEELE, SALISBURY,

KINKEAD, McANDREW, KAUFFMAN, GIRAL, DELOZIER, FRITZ,

MUSTELLO, POWELL, D. WILLIAMS, HOGAN, CAUSER, FRIEL, SIEGEL,

WARNER, COOPER, SAMUELSON, KRAJEWSKI, SHUSTERMAN, FRANKEL,

KRUPA, MADSEN, ABNEY, BRIGGS, HANBIDGE, ROZZI, KAZEEM AND

GREEN, APRIL 3, 2024

AS AMENDED ON SECOND CONSIDERATION, IN SENATE, JULY 9, 2024

AN ACT

Amending the act of November 21, 2016 (P.L.1318, No.169),

entitled "An act providing for pharmacy audit procedures, for

registration of pharmacy benefits managers and auditing

entities, for maximum allowable cost transparency and for

prescription drugs reimbursed under the PACE and PACENET

program; and making related repeals," further providing for

title of act; in preliminary provisions, further providing

for short title and for definitions; in pharmacy audits,

further providing for limitations; and providing for pharmacy

benefits manager contract requirements and prohibited acts.

AMENDING THE ACT OF NOVEMBER 21, 2016 (P.L.1318, NO.169),

ENTITLED "AN ACT PROVIDING FOR PHARMACY AUDIT PROCEDURES, FOR

REGISTRATION OF PHARMACY BENEFITS MANAGERS AND AUDITING

ENTITIES, FOR MAXIMUM ALLOWABLE COST TRANSPARENCY AND FOR

PRESCRIPTION DRUGS REIMBURSED UNDER THE PACE AND PACENET

PROGRAM; AND MAKING RELATED REPEALS," FURTHER PROVIDING FOR

TITLE OF ACT; IN PRELIMINARY PROVISIONS, FURTHER PROVIDING

FOR SHORT TITLE, FOR SCOPE OF ACT AND FOR DEFINITIONS AND

PROVIDING FOR REGULATIONS; IN PHARMACY AUDITS, FURTHER

PROVIDING FOR LIMITATIONS; IN REGISTRATION, FURTHER PROVIDING

FOR PBM AND AUDITING ENTITY REGISTRATION; PROVIDING FOR

<--

PHARMACY BENEFITS MANAGER CONTRACTS; IN PBM COST TRANSPARENCY

REQUIREMENTS, PROVIDING FOR PBM TRANSPARENCY REPORT REQUIRED,

REPEALING PROVISIONS RELATING TO REGULATIONS AND PROVIDING

FOR PSAO REPORTING REQUIREMENTS; IN ENFORCEMENTS, FURTHER

PROVIDING FOR SCOPE OF ENFORCEMENT AUTHORITY; PROVIDING FOR

PHARMACY SERVICES; AND MAKING REPEALS.

The General Assembly of the Commonwealth of Pennsylvania

hereby enacts as follows:

Section 1. The title and section 101 of the act of November

21, 2016 (P.L.1318, No.169), known as the Pharmacy Audit

Integrity and Transparency Act, are amended to read:

AN ACT

Providing for pharmacy audit procedures, for registration of

pharmacy benefits managers and auditing entities, for maximum

allowable cost transparency and for prescription drugs

reimbursed under the PACE and PACENET program and for

pharmacy benefit managers contract requirements and

prohibited activities; and making related repeals.

Section 101. Short title.

This act shall be known and may be cited as the [Pharmacy

Audit Integrity and Transparency] Community Pharmacy Protection

Act.

Section 2. Section 103 of the act is amended by adding

definitions to read:

Section 103. 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:

* * *

" Brand effective rate." The reimbursement rate paid to the

pharmacy based on a percentage of the average wholesale cost for

brand-name drugs dispensed by the pharmacy under the contract

with the pharmacy benefit manager.

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* * *

"Effective rate contract." A contract that sets a specific

discount rate for all prescriptions filled by a member pharmacy

during the term of the contract.

* * *

"Generic effective rate." The reimbursement rate paid to the

pharmacy based on a percentage of the average wholesale cost for

generic drugs dispensed by the pharmacy under the contract with

the pharmacy benefit manager.

* * *

"Patient steering." One of the following:

(1) When a pharmacy benefit manager directs a patient to

use a preferred pharmacy through mandatory mail order

requirements or the creation by the PBM of a restricted

network that consists only of pharmacies approved by the PBM.

(2) The use of co-pay differentials between PBM-

affiliated pharmacies and nonaffiliated pharmacies.

* * *

"Spread pricing." An act of a pharmacy benefit manager

reimbursing a pharmacy for a prescription and then billing an

insurer or an employer that provides health insurance at a

higher price for the same prescription.

Section 3. Section 303 of the act is amended by adding a

subsection to read:

Section 303. Limitations.

* * *

not attributed to fraud, waste or abuse that is discovered

during an audit of the pharmacy by the PBM shall result in the

PBM recouping the dispensing fee for that particular

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transaction, not the entire amount of the medication received by

the patient.

Section 4. The act is amended by adding a chapter to read:

CHAPTER 6

PHARMACY BENEFITS MANAGER CONTRACT

REQUIREMENTS AND PROHIBITED ACTS

Section 601. Contract provisions.

A contract between a pharmacy benefit manager or a designee

of the pharmacy benefit manager and a pharmacy may not:

(1) Require participation in the PBM's network

contingent on the pharmacy signing either an effective rate

contract or a contract based on the National Average Drug

Acquisition Cost guidelines.

(2) Include provisions allowing for retroactive

recoupment of money paid to a pharmacy by the PBM, unless

both parties agree to that provision.

(3) Base reimbursement upon general effective rate or

the brand effective rate as a condition of entering a

network, unless both parties agree to that provision. Any

additional fees must be disclosed and applied at the time of

the adjudication of the claim. Fees may include:

(i) Transaction fees.

(ii) Chargebacks due to recalculation of the cost of

the ingredients used in a prescription drug.

(iii) Adjustments in the general effective rate,

brand effective rates or direct and indirect remuneration

fees made by the PBM.

Section 602. Spread pricing participation prohibited.

A pharmacy benefit manager may not conduct or participate in

spread pricing.

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Section 603. Patient steering prohibited.

A pharmacy benefit manager may not conduct or participate in

patient steering.

Section 604. Duties of the department.

The department shall:

(1) Develop a process for receiving, hearing and

resolving complaints a pharmacy filed against a PBM.

(2) Have the ability to set fixed amounts for PBM claim

processing fees and administrative fees.

(3) Develop a Statewide National Average Drug

Acquisition Cost guideline that uses wholesale pricing based

on manufacturer's invoices of those manufacturers who ship

drugs to this Commonwealth.

Section 605. Duties of pharmacy benefit managers.

Pharmacy benefit managers shall:

(1) Approve a request from a pharmacy to be a member of

the PBM's network within 30 days of the initial request to

join the network.

(2) Provide a dedicated telephone number and email

address for handling network admission requests.

Section 606. PBM for State Employee Health Plan.

A PBM hired for the State Employee Health Plan shall have a

transparent reimbursement methodology based on the National

Average Drug Acquisition Cost guidelines developed under

section 604(3) and a dispensing fee equal to or greater than the

maximum prevailing fee for service or PACE rate in this

Commonwealth.

Section 607. Reports by PBM.

A PBM shall report to the department the amount of rebates

and payments received from drug manufacturers and how the

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rebates and payments were distributed by the PBM.

Section 5. This act shall take effect in 60 days.

SECTION 1. THE TITLE AND SECTIONS 101 AND 102 OF THE ACT OF

NOVEMBER 21, 2016 (P.L.1318, NO.169), KNOWN AS THE PHARMACY

AUDIT INTEGRITY AND TRANSPARENCY ACT, ARE AMENDED TO READ:

AN ACT

PROVIDING FOR PHARMACY AUDIT PROCEDURES, FOR REGISTRATION OF

PHARMACY BENEFITS MANAGERS AND AUDITING ENTITIES, FOR MAXIMUM

ALLOWABLE COST TRANSPARENCY [AND], FOR PRESCRIPTION DRUGS

REIMBURSED UNDER THE PACE AND PACENET PROGRAM AND FOR

PHARMACY BENEFIT MANAGERS CONTRACT REQUIREMENTS AND

PROHIBITED ACTIVITIES; AND MAKING RELATED REPEALS

SECTION 101. SHORT TITLE.

THIS ACT SHALL BE KNOWN AND MAY BE CITED AS THE [PHARMACY

AUDIT INTEGRITY AND TRANSPARENCY] PHARMACY BENEFIT REFORM ACT.

SECTION 102. SCOPE OF ACT.

THE FOLLOWING APPLY:

(1) THIS ACT COVERS ANY AUDIT OF THE RECORDS OF A

PHARMACY CONDUCTED BY A MANAGED CARE COMPANY, THIRD-PARTY

PAYER, PHARMACY BENEFITS MANAGER OR AN ENTITY THAT REPRESENTS

A COVERED ENTITY.

(2) THIS ACT COVERS ANY CONTRACT BETWEEN A PHARMACY OR A

PBM AND A HEALTH INSURER OR A HEALTH BENEFIT PLAN, OR A

CONTRACT BETWEEN A PHARMACY AND A PBM ON BEHALF OF A HEALTH

INSURER OR HEALTH BENEFIT PLAN.

(3) EXCEPT FOR THE PROVISIONS OF CHAPTER 5, THIS ACT

SHALL NOT APPLY TO A SELF-INSURED HEALTH BENEFIT PLAN SUBJECT

TO ERISA OR EXEMPTED FROM ERISA UNDER SECTION 4(B) OF ERISA.

SECTION 2. THE DEFINITIONS OF "COVERED ENTITY" AND "HEALTH

INSURANCE POLICY" IN SECTION 103 OF THE ACT ARE AMENDED AND THE

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SECTION IS AMENDED BY ADDING DEFINITIONS TO READ:

SECTION 103. 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:

"AFFILIATE" OR "AFFILIATED." AN "AFFILIATE" AS DEFINED IN

SECTION 1401 OF THE ACT OF MAY 17, 1921 (P.L.682, NO.284), KNOWN

AS THE INSURANCE COMPANY LAW OF 1921.

* * *

"COMPLEX OR CHRONIC MEDICAL CONDITION." A PHYSICAL

BEHAVIORAL OR DEVELOPMENTAL CONDITION THAT HAS NO KNOWN CURE, IS

PROGRESSIVE OR CAN BE DEBILITATING OR FATAL IF UNMANAGED OR

UNTREATED.

"COVERED ENTITY." A CONTRACT HOLDER OR POLICY HOLDER

PROVIDING PHARMACY BENEFITS TO A COVERED INDIVIDUAL UNDER A

HEALTH [INSURANCE POLICY] BENEFIT PLAN PURSUANT TO A CONTRACT

ADMINISTERED BY A PHARMACY BENEFIT MANAGER.

* * *

"ERISA." THE EMPLOYEE RETIREMENT INCOME SECURITY ACT OF 1974

(PUBLIC LAW 93-406, 29 U.S.C. § 1001 ET SEQ.).

* * *

"HEALTH BENEFIT PLAN." A POLICY, CONTRACT OR CERTIFICATE

ENTERED INTO, OFFERED, ISSUED OR RENEWED BY A HEALTH INSURER TO

PROVIDE, DELIVER, ARRANGE FOR, PAY FOR OR REIMBURSE ANY OF THE

COSTS OF PHYSICAL, MENTAL OR BEHAVIORAL HEALTH CARE SERVICES.

THE TERM DOES NOT INCLUDE MEDICARE SUPPLEMENT OR ACCIDENT ONLY,

FIXED INDEMNITY, LIMITED BENEFIT, CREDIT, DENTAL, VISION,

SPECIFIED DISEASE, TRICARE SUPPLEMENTAL INSURANCE, LONG-TERM

CARE OR DISABILITY INCOME, WORKERS' COMPENSATION OR AUTOMOBILE

MEDICAL PAYMENT INSURANCE.

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* * *

["HEALTH INSURANCE POLICY." A POLICY, SUBSCRIBER CONTRACT,

CERTIFICATE OR PLAN THAT PROVIDES PRESCRIPTION DRUG COVERAGE.

THE TERM INCLUDES BOTH COMPREHENSIVE AND LIMITED BENEFIT HEALTH

POLICIES.]

* * *

"HEALTH INSURER CLIENT." THE TERM INCLUDES BOTH A HEALTH

INSURER AND A HEALTH BENEFIT PLAN OFFERED BY A HEALTH INSURER.

"LICENSEE OR REGISTRANT." AN ENTITY SUBJECT TO OVERSIGHT OF

THE DEPARTMENT UNDER THIS ACT. THE TERM INCLUDES:

(1) AN AUDITING ENTITY.

(2) A HEALTH INSURER.

(3) A PHARMACY BENEFIT MANAGER.

(4) A PHARMACY SERVICES ADMINISTRATION ORGANIZATION.

"MAIL ORDER PHARMACY." A PHARMACY WHERE PRESCRIPTIONS ARE

DISPENSED TO COVERED INDIVIDUALS VIA THE MAIL.

"MAINTENANCE MEDICATION." A MEDICATION PRESCRIBED FOR A

CHRONIC, LONG-TERM CONDITION AND TAKEN ON A REGULAR, RECURRING

BASIS.

* * *

"RARE MEDICAL CONDITION." A DISEASE OR CONDITION THAT

AFFECTS FEWER THAN 200,000 INDIVIDUALS IN THE UNITED STATES OR

APPROXIMATELY 1 IN 1,500 INDIVIDUALS WORLDWIDE.

"RETAIL PHARMACY." A PHARMACY WHERE PRESCRIPTIONS ARE ABLE

TO BE DISPENSED TO COVERED INDIVIDUALS ON THE PREMISES OF THE

PHARMACY.

* * *

"SPECIALTY DRUG." EITHER OF THE FOLLOWING:

(1) A PRESCRIPTION DRUG PRESCRIBED TO A COVERED

INDIVIDUAL WITH A COST THAT MEETS OR EXCEEDS THE COST OF A

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DRUG ON THE SPECIALTY TIER OF MEDICARE PART D UNDER 42 CFR

423.104(D)(2)(IV) (RELATING TO REQUIREMENTS RELATED TO

QUALIFIED PRESCRIPTION DRUG COVERAGE) AND MEETS THREE OR MORE

OF THE FOLLOWING CRITERIA:

(I) THE DRUG REQUIRES SPECIALIZED PRODUCT HANDLING

OR ADMINISTRATION BY THE DISPENSING PHARMACY.

(II) THE DRUG REQUIRES SPECIALIZED CLINICAL CARE,

INCLUDING, BUT NOT LIMITED TO, FREQUENT DOSING

ADJUSTMENTS TO THE PRESCRIPTION DRUG, CLINICAL MONITORING

OR EXPANDED PATIENT SERVICE, INTENSIVE PATIENT COUNSELING

AND ONGOING CLINICAL SUPPORT, SUCH AS INDIVIDUALIZED

DISEASE OR THERAPY MANAGEMENT TO SUPPORT PATIENT OUTCOMES

FOR A COVERED INDIVIDUAL.

(III) THE DRUG IS PRESCRIBED FOR A COVERED

INDIVIDUAL WITH A RARE MEDICAL CONDITION, COMPLEX OR

CHRONIC MEDICAL CONDITION OR LIFE-THREATENING MEDICAL

CONDITION.

(IV) THE PRESCRIPTION DRUG HAS A LIMITED OR

EXCLUSIVE DISTRIBUTION AND IS NOT TYPICALLY STOCKED OR

DISPENSED BY A RETAIL PHARMACY.

(2) A PRESCRIPTION DRUG THAT IS PRESCRIBED TO A COVERED

INDIVIDUAL AND THAT IS LISTED AS A SPECIALTY DRUG ON THE

MEDICAL ASSISTANCE FEE-FOR-SERVICE SPECIALTY PHARMACY DRUG

LIST.

"SPECIALTY PHARMACY." A PHARMACY THAT HAS BEEN NATIONALLY

ACCREDITED BY AN INDEPENDENT THIRD PARTY TO DISPENSE SPECIALTY

DRUGS.

"SPREAD PRICING." A MODEL OF PRESCRIPTION DRUG PRICING IN

WHICH THE PBM CHARGES A HEALTH BENEFIT PLAN OR HEALTH INSURER A

CONTRACTED PRICE FOR PRESCRIPTION DRUGS AND THE CONTRACTED PRICE

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FOR THE PRESCRIPTION DRUGS DIFFERS FROM THE AMOUNT THE PBM

DIRECTLY OR INDIRECTLY PAYS THE PHARMACIST OR PHARMACY FOR

PRESCRIPTION DRUGS AND RELATED PHARMACIST SERVICES.

SECTION 3. THE ACT IS AMENDED BY ADDING A SECTION TO READ:

SECTION 104. REGULATIONS.

EXCEPT AS PROVIDED FOR IN CHAPTER 10, THE DEPARTMENT MAY

PROMULGATE REGULATIONS NECESSARY FOR THE ADMINISTRATION OF THIS

ACT.

SECTION 4. SECTION 303 OF THE ACT IS AMENDED BY ADDING A

SUBSECTION TO READ:

SECTION 303. LIMITATIONS.

* * *

PHARMACY NOT ATTRIBUTED TO FRAUD, WASTE OR ABUSE THAT IS

DISCOVERED DURING A PHARMACY AUDIT BY THE PBM SHALL RESULT IN

THE PBM RECOUPING THE DISPENSING FEE FOR THAT PARTICULAR

TRANSACTION, NOT THE ENTIRE AMOUNT FOR THE MEDICATION RECEIVED

BY THE PATIENT.

SECTION 5. SECTION 501(B) OF THE ACT IS AMENDED AND THE

SECTION IS AMENDED BY ADDING A SUBSECTION TO READ:

SECTION 501. PBM AND AUDITING ENTITY REGISTRATION.

* * *

(A.1) PSAO REGISTRATION.--TO CONDUCT BUSINESS IN THIS

COMMONWEALTH, A PSAO SHALL REGISTER WITH THE DEPARTMENT ON AN

APPLICATION FORM PROVIDED BY THE DEPARTMENT. THE FORM SHALL

REFLECT THE REPORTING REQUIREMENTS UNDER SECTION 705. NOTHING

UNDER THIS SUBSECTION SHALL BE CONSTRUED AS REQUIRING A HEALTH

INSURER, HEALTH BENEFIT PLAN OR PBM TO ENTER INTO A CONTRACT

WITH A PSAO.

(B) TERM AND FEE.--

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(1) THE TERM OF REGISTRATION SHALL BE TWO YEARS FROM THE

DATE OF ISSUANCE.

(2) THE DEPARTMENT SHALL SET AN INITIAL APPLICATION FEE

AND A RENEWAL APPLICATION FEE, WHICH SHALL BE SUBMITTED WITH

AN APPLICATION FOR REGISTRATION. AN INITIAL APPLICATION FEE

SHALL BE NONREFUNDABLE. A RENEWAL APPLICATION FEE SHALL BE

RETURNED IF THE RENEWAL OF THE REGISTRATION IS NOT GRANTED.

(3) THE AMOUNT OF THE INITIAL APPLICATION FEE AND

RENEWAL APPLICATION FEE SHALL BE SUFFICIENT TO FUND THE

DEPARTMENT'S DUTIES IN RELATION TO ITS RESPONSIBILITIES UNDER

THIS CHAPTER BUT MAY NOT EXCEED [$1,000.]:

(I) $10,000 FOR A PBM OR AUDITING ENTITY.

(II) $500 FOR A PSAO.

* * *

SECTION 6. THE ACT IS AMENDED BY ADDING A CHAPTER TO READ:

CHAPTER 6

PHARMACY BENEFITS MANAGER CONTRACTS

SECTION 601. CONTRACT PROVISIONS.

(A) GENERAL RULE.--A PBM REGISTERED WITH THE DEPARTMENT AND

CONDUCTING BUSINESS ON BEHALF OF A HEALTH INSURER CLIENT IN THIS

COMMONWEALTH MAY NOT:

(1) REIMBURSE A RETAIL PHARMACY AN AMOUNT LESS THAN THE

AMOUNT THAT THE PBM REIMBURSES A PBM-AFFILIATED RETAIL

PHARMACY LOCATED IN THIS COMMONWEALTH FOR PROVIDING THE SAME

PHARMACIST SERVICES.

(2) REIMBURSE A FEDERALLY QUALIFIED HEALTH CENTER,

HEALTH CARE FACILITY OR OTHER ENTITY PARTICIPATING IN THE

PROGRAM UNDER SECTION 340(B) OF THE PUBLIC HEALTH SERVICE ACT

(58 STAT. 682, 42 U.S.C. § 256(B)), AN AMOUNT LESSER THAN

SIMILAR ENTITIES NOT PARTICIPATING IN THE PROGRAM.

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(3) AUTHORIZE THE PBM TO UNILATERALLY ALTER THE TERMS OF

A PARTICIPATION CONTRACT BEYOND THE TERMS AND CONDITIONS OF

THE ORIGINAL CONTRACT AGREED TO BY A PSAO OR PHARMACY WITH A

PBM BEYOND THE TERMS AND CONDITIONS OF THE ORIGINAL CONTRACT

AGREED TO BY THE PHARMACY OR PSAO WITH A PBM.

(4) DESIGNATE A PRESCRIPTION DRUG AS A SPECIALTY DRUG OR

REQUIRE A PRESCRIPTION DRUG TO BE DISPENSED EXCLUSIVELY AT A

SPECIALTY PHARMACY UNLESS IT MEETS THE CRITERIA OF A

SPECIALTY DRUG UNDER SECTION 103.

(B) REBATES.--BEGINNING ON THE EFFECTIVE DATE OF THIS

SECTION, A PBM SHALL PASS THROUGH TO THE HEALTH BENEFIT PLAN NO

LESS THAN 95% OF ANY PRESCRIPTION DRUG MANUFACTURER REBATE

OBTAINED BY THE PBM ON BEHALF OF A HEALTH INSURER CLIENT IF THE

HEALTH BENEFIT PLAN DELEGATES NEGOTIATION OF THE REBATE TO THE

PBM.

INFORMATION TO A PHARMACIST, PHARMACY OR PSAO PERTAINING TO THE

SCHEDULE AND TOTAL FOR ANY FEE CHARGED BY THE PBM FOR

PARTICIPATION IN THE PBM'S NETWORK.

SECTION 602. PATIENT STEERING.

(A) PROHIBITIONS.--A HEALTH BENEFIT PLAN, HEALTH INSURER OR

PBM CONTRACTING WITH A HEALTH BENEFIT PLAN OR HEALTH INSURER MAY

NOT:

(1) REQUIRE A COVERED INDIVIDUAL, AS A CONDITION OF

PAYMENT OR REIMBURSEMENT, TO PURCHASE PHARMACIST SERVICES,

INCLUDING, BUT NOT LIMITED TO, PRESCRIPTION DRUGS,

EXCLUSIVELY THROUGH A MAIL-ORDER PHARMACY OR PBM RETAIL

AFFILIATE.

(2) PROHIBIT OR LIMIT A COVERED INDIVIDUAL FROM

SELECTING AN IN-NETWORK PHARMACY OR IN-NETWORK PHARMACIST OF

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THE COVERED INDIVIDUAL'S CHOICE IF THAT PHARMACY OR

PHARMACIST MEETS AND AGREES TO THE TERMS AND CONDITIONS,

INCLUDING REIMBURSEMENTS, IN THE PBM'S CONTRACT.

(3) REQUIRE A COVERED INDIVIDUAL TO USE A PBM-AFFILIATED

RETAIL PHARMACY.

(4) TRANSFER A COVERED INDIVIDUAL'S PRESCRIPTIONS FROM

AN IN-NETWORK PHARMACY TO ANOTHER PHARMACY UNLESS REQUESTED

BY THE COVERED INDIVIDUAL.

(5) USE FINANCIAL INCENTIVES, INCLUDING, BUT NOT LIMITED

TO, ADJUSTMENTS IN COST SHARING OBLIGATIONS OF A COVERED

INDIVIDUAL, TO THE EXCLUSIVE BENEFIT OF A PBM-AFFILIATED

RETAIL PHARMACY.

(6) EXCEPT AS PROVIDED IN SUBSECTION (B), AUTO-ENROLL A

COVERED INDIVIDUAL IN MAIL-ORDER PHARMACY SERVICES.

(B) CONSTRUCTION.--NOTHING IN THIS SECTION SHALL BE

CONSTRUED:

(1) TO PREVENT A PBM, HEALTH BENEFIT PLAN OR HEALTH

INSURER FROM REQUIRING A COVERED INDIVIDUAL TO USE AN

APPROVED SPECIALTY PHARMACY OPERATING IN THE PBM'S NETWORK.

(2) TO PREVENT A HEALTH BENEFIT PLAN, HEALTH INSURER OR

PBM CONTRACTING WITH A HEALTH BENEFIT PLAN OR HEALTH INSURER,

FROM AUTO-ENROLLING A COVERED INDIVIDUAL IN MAIL-ORDER

SERVICES FOR A MAINTENANCE MEDICATION, PROVIDED THAT:

(I) A COVERED INDIVIDUAL MAY NOT BE AUTO-ENROLLED

FOR THE FIRST 90 DAYS OF A NEW MAINTENANCE MEDICATION;

AND

(II) A COVERED INDIVIDUAL SHALL HAVE THE ABILITY TO

OPT OUT OF MAIL-ORDER PHARMACY SERVICES AT ANY TIME.

SECTION 603. CLAWBACKS PROHIBITED.

(A) GENERAL RULE.--A PHARMACIST, PHARMACY INTERN OR

20240HB1993PN3497 - 13 -

TECHNICIAN MAY NOT CHARGE A PATIENT AN AMOUNT FOR A COVERED

PRESCRIPTION DRUG THAT EXCEEDS THE LESSER OF:

(1) THE NET REIMBURSEMENT PAID TO THE PHARMACY FOR THE

PRESCRIPTION DRUG BY THE HEALTH BENEFIT PLAN, HEALTH INSURER

OR PBM CONTRACTING WITH A HEALTH BENEFIT PLAN OR HEALTH

INSURER.

(2) THE AMOUNT AN INDIVIDUAL WOULD PAY FOR THE

PRESCRIPTION DRUG IF THE PRESCRIPTION DRUG WERE PURCHASED

WITHOUT COVERAGE UNDER A HEALTH BENEFIT PLAN.

(B) COLLECTION OF DIFFERENCE IN COST SHARING.--A HEALTH

BENEFIT PLAN, HEALTH INSURER OR PBM CONTRACTING WITH A HEALTH

BENEFIT PLAN OR HEALTH INSURER MAY NOT COLLECT FROM THE MEMBER

ANY DIFFERENCE IN COST SHARING THE MEMBER PAYS TO THE PHARMACY

AND THE MEMBER'S COST SHARING DEFINED IN THE MEMBER'S BENEFIT

PLAN.

SECTION 604. NETWORK ADEQUACY.

(A) GENERAL RULE.--A PBM SHALL ESTABLISH A REASONABLY

ADEQUATE AND ACCESSIBLE RETAIL PHARMACY NETWORK FOR THE

PROVISION OF PRESCRIPTION DRUGS UNDER A HEALTH BENEFIT PLAN THAT

SHALL PROVIDE FOR CONVENIENT PATIENT ACCESS TO PHARMACIES WITHIN

A REASONABLE DISTANCE FROM A PATIENT'S RESIDENCE IN ACCORDANCE

WITH THE FOLLOWING REQUIREMENTS:

(1) THE NETWORK MAY NOT BE LIMITED TO AFFILIATED

PHARMACIES ONLY.

(2) THE NETWORK SHALL MEET OR EXCEED THE REQUIREMENTS OF

42 CFR 423.120(A)(RELATING TO ACCESS TO COVERED PART D DRUGS)

OR A SUCCESSOR REGULATION. IF A PBM FAILS TO COMPLY WITH THE

REQUIREMENTS, IT SHALL NOT BE CONSIDERED A VIOLATION IF THE

PBM CONTRACTS WITH ALL RETAIL PHARMACIES WITHIN THE NETWORK

DISTANCE STANDARDS OF THE HEALTH BENEFIT PLAN PARTICIPANTS.

20240HB1993PN3497 - 14 -

(B) REPORT REQUIREMENT.--BEGINNING APRIL 1, 2026, AND

ANNUALLY THEREAFTER, A PBM SHALL FILE WITH THE DEPARTMENT A

NETWORK ADEQUACY REPORT, ON A FORM PRESCRIBED BY THE DEPARTMENT,

DESCRIBING THE PBM NETWORK AND THE PBM NETWORK'S ACCESSIBILITY

IN THIS COMMONWEALTH. THE REPORTS SHALL BE POSTED ON THE

DEPARTMENT'S PUBLICLY ACCESSIBLE INTERNET WEBSITE.

SECTION 7. THE ACT IS AMENDED BY ADDING A SECTION TO READ:

SECTION 703.1. PBM TRANSPARENCY REPORT REQUIRED.

(A) GENERAL RULE.--BEGINNING JULY 1, 2026, AND ANNUALLY

THEREAFTER, EACH REGISTERED PBM SHALL SUBMIT TO THE DEPARTMENT A

TRANSPARENCY REPORT CONTAINING DATA FOR EACH HEALTH INSURER

CLIENT IN THIS COMMONWEALTH FROM THE PRIOR CALENDAR YEAR. THE

TRANSPARENCY REPORT SHALL CONTAIN THE FOLLOWING INFORMATION:

(1) THE AGGREGATE AMOUNT OF ALL REBATES THAT THE PBM

RECEIVED FROM ALL PHARMACEUTICAL MANUFACTURERS FOR ALL HEALTH

INSURER CLIENTS AND FOR EACH HEALTH INSURER CLIENT.

(2) THE AGGREGATE ADMINISTRATIVE FEES THAT THE PBM

RECEIVED FROM ALL MANUFACTURERS FOR ALL HEALTH INSURER

CLIENTS AND FOR EACH HEALTH INSURER CLIENT.

(3) THE AGGREGATE-RETAINED REBATES THAT THE PBM RECEIVED

FROM ALL PHARMACEUTICAL MANUFACTURERS AND DID NOT PASS

THROUGH TO HEALTH INSURER CLIENTS.

(4) THE HIGHEST, LOWEST AND MEAN AGGREGATE RETAINED

REBATE PERCENTAGE FOR ALL HEALTH INSURER CLIENTS AND FOR EACH

HEALTH INSURER CLIENT.

(5) FOR A PBM THAT CONTROLS OR IS AFFILIATED WITH A

PHARMACY, A DESCRIPTION OF ANY DIFFERENCES BETWEEN WHAT THE

PBM REIMBURSES OR CHARGES AFFILIATED AND NONAFFILIATED

PHARMACIES.

(B) PUBLICATION.--WITHIN 60 DAYS OF RECEIPT, THE DEPARTMENT

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SHALL PUBLISH THE TRANSPARENCY REPORT UNDER THIS SECTION ON THE

DEPARTMENT'S PUBLICLY ACCESSIBLE INTERNET WEBSITE IN A FORM THAT

MEETS THE FOLLOWING REQUIREMENTS:

(1) DOES NOT DISCLOSE THE NAME OF A PBM.

(2) DOES NOT DIRECTLY OR INDIRECTLY DISCLOSE THE

IDENTITY OF A SPECIFIC HEALTH INSURER CLIENT OR PRESENT

INFORMATION IN A MANNER THAT CAN BE EXTRAPOLATED TO IDENTIFY

A SPECIFIC HEALTH INSURER CLIENT.

(3) DOES NOT LIST THE PRICE OR PRICES CHARGED FOR A

SPECIFIC DRUG OR CLASS OF DRUGS.

(4) DOES NOT SPECIFY THE AMOUNT OF ANY REBATES PROVIDED

FOR A SPECIFIC DRUG OR CLASS OF DRUG.

REGULATION, DIRECT PBMS TO INCLUDE ADDITIONAL CATEGORIES FOR

AGGREGATED DATA FROM HEALTH INSURER CLIENTS IN THE ANNUAL

TRANSPARENCY REPORT SUBMITTED UNDER THIS SECTION.

(D) CONFIDENTIALITY.--

(1) THE INFORMATION SUBMITTED TO THE DEPARTMENT IN

ACCORDANCE WITH THE TRANSPARENCY REPORT REQUIRED UNDER

SUBSECTION (A) SHALL BE PRIVILEGED AND GIVEN CONFIDENTIAL

TREATMENT AND SHALL NOT BE:

(I) SUBJECT TO DISCOVERY OR ADMISSIBLE AS EVIDENCE

IN A PRIVATE CIVIL ACTION;

(II) SUBJECT TO SUBPOENA;

(III) SUBJECT TO ACCESS UNDER THE ACT OF FEBRUARY

14, 2008 (P.L.6, NO.3), KNOWN AS THE RIGHT-TO-KNOW LAW;

(IV) MADE PUBLIC BY THE DEPARTMENT OR ANY OTHER

PERSON WITHOUT THE PRIOR WRITTEN CONSENT OF THE PBM,

INSURER OR INSURANCE GROUP TO WHICH IT PERTAINS, EXCEPT

20240HB1993PN3497 - 16 -

AS PROVIDED IN PARAGRAPH (3).

(2) THE COMMISSIONER, THE DEPARTMENT, A PERSON WHO

RECEIVES INFORMATION UNDER SUBSECTION (A) WHILE ACTING UNDER

THE AUTHORITY OF THE COMMISSIONER OR DEPARTMENT OR A PERSON

WITH WHOM THE INFORMATION IS SHARED UNDER THIS CHAPTER SHALL

NOT BE PERMITTED OR REQUIRED TO TESTIFY IN A PRIVATE CIVIL

ACTION CONCERNING CONFIDENTIAL INFORMATION IN THE

TRANSPARENCY REPORT.

(3) TO ASSIST IN THE PERFORMANCE OF ITS REGULATORY

DUTIES, THE DEPARTMENT MAY:

(I) USE INFORMATION SUBMITTED UNDER THIS SECTION IN

FURTHERANCE OF A REGULATORY OR LEGAL ACTION BROUGHT

PURSUANT TO THE DEPARTMENT'S OFFICIAL DUTIES.

(II) SHARE INFORMATION SUBMITTED UNDER THIS SECTION

WITH THE NAIC, REGULATORY OR LAW ENFORCEMENT OFFICIALS OF

THIS COMMONWEALTH OR OTHER JURISDICTIONS, AND THIRD-PARTY

CONSULTANTS, IF, PRIOR TO RECEIVING THE TRANSPARENCY

REPORT INFORMATION, THE RECIPIENT DEMONSTRATES BY WRITTEN

STATEMENT THE NECESSARY AUTHORITY AND INTENT TO GIVE

CONFIDENTIAL TREATMENT TO THE INFORMATION AS REQUIRED BY

THIS SECTION.

(III) PUBLISH ALL OR PART OF THE INFORMATION IF,

AFTER GIVING THE ENTITY WHO WOULD BE AFFECTED THEREBY

NOTICE AND OPPORTUNITY TO BE HEARD, THE DEPARTMENT

DETERMINES THAT THE INTEREST OF THE PUBLIC WILL BE SERVED

BY THE PUBLICATION THEREOF.

(4) THE SHARING OF INFORMATION BY THE DEPARTMENT UNDER

THIS SECTION DOES NOT CONSTITUTE A DELEGATION OF REGULATORY

AUTHORITY OR RULEMAKING. THE DEPARTMENT SHALL BE SOLELY

RESPONSIBLE FOR THE ADMINISTRATION, EXECUTION AND ENFORCEMENT

20240HB1993PN3497 - 17 -

OF THIS CHAPTER.

(5) THE SHARING OF TRANSPARENCY REPORT INFORMATION WITH,

TO OR BY THE DEPARTMENT AS AUTHORIZED BY THIS CHAPTER DOES

NOT CONSTITUTE A WAIVER OF ANY APPLICABLE PRIVILEGE OR CLAIM

OF CONFIDENTIALITY.

(6) INFORMATION SUBMITTED UNDER THIS SECTION THAT IS IN

THE POSSESSION OR CONTROL OF THE NAIC OR A THIRD-PARTY

CONSULTANT AS PROVIDED UNDER THIS SECTION SHALL:

(I) BE CONFIDENTIAL AND PRIVILEGED;

(II) BE EXEMPT FROM ACCESS UNDER THE RIGHT-TO-KNOW

LAW;

(III) NOT BE SUBJECT TO SUBPOENA; AND

(IV) NOT BE SUBJECT TO DISCOVERY OR ADMISSIBLE AS

EVIDENCE IN A PRIVATE CIVIL ACTION.

SECTION 8. SECTION 704 OF THE ACT IS REPEALED:

[SECTION 704. REGULATIONS.

THE DEPARTMENT MAY PROMULGATE REGULATIONS AS NECESSARY AND

APPROPRIATE TO IMPLEMENT THE PROVISIONS OF THIS CHAPTER.]

SECTION 9. THE ACT IS AMENDED BY ADDING A SECTION TO READ:

SECTION 704.1. PSAO REPORTING REQUIREMENTS.

A PSAO SHALL PROVIDE THE FOLLOWING INFORMATION TO THE

DEPARTMENT AND EACH PHARMACY THAT HAS CONTRACTED FOR SERVICES:

(1) CHANGES IN THE PSAO'S OWNERSHIP, INCLUDING A PARENT

COMPANY OR SUBSIDIARY OF THE PSAO, NO LATER THAN FIVE DAYS

PRIOR TO THE CHANGE IN OWNERSHIP OF THE PSAO, THE PARENT

COMPANY OF A PSAO OR A SUBSIDIARY OF THE PSAO.

(2) WHETHER THE CHANGE IN OWNERSHIP INCLUDES A COMPANY

OR ORGANIZATION THAT PROVIDES PHARMACEUTICAL, PRESCRIPTION

DRUG OR DEVICE SERVICES.

(3) WHETHER THE CHANGE IN OWNERSHIP INCLUDES A COMPANY

20240HB1993PN3497 - 18 -

THAT SELLS OR MANUFACTURERS PRESCRIPTION DRUGS, BIOLOGICS OR

MEDICAL DEVICES.

SECTION 10. SECTION 901 OF THE ACT IS AMENDED TO READ:

SECTION 901. SCOPE OF ENFORCEMENT AUTHORITY.

(A) SCOPE.--THE DEPARTMENT MAY INVESTIGATE AND ENFORCE THE

PROVISIONS OF THIS ACT ONLY INSOFAR AS THE ACTIONS OR INACTIONS

BEING INVESTIGATED RELATE TO PRESCRIPTION DRUG COVERAGE UNDER A

HEALTH [INSURANCE POLICY] BENEFIT PLAN.

[(B) REMEDY.--ACTIONS OR INACTIONS WITHIN THE SCOPE OF THE

DEPARTMENT'S INVESTIGATIVE AND ENFORCEMENT AUTHORITY UNDER

SUBSECTION (A) FOUND TO VIOLATE THIS ACT CONSTITUTE "UNFAIR

METHODS OF COMPETITION" AND "UNFAIR OR DECEPTIVE ACTS OR

PRACTICES" WITHIN THE MEANING OF SECTION 5 OF THE ACT OF JULY

22, 1974 (P.L.589, NO.205), KNOWN AS THE UNFAIR INSURANCE

PRACTICES ACT. A PROCEEDING UNDER THIS SECTION SHALL BE

CONDUCTED IN ACCORDANCE WITH 2 PA.C.S. CH. 5 SUBCH. A (RELATING

TO PRACTICE AND PROCEDURE OF COMMONWEALTH AGENCIES).]

(B.1) EXAMINATION AND ACCESS TO RECORDS.--THE FOLLOWING

APPLY:

(1) (I) THE DEPARTMENT MAY ORDER A PBM, A HEALTH

INSURER AND A PBM'S AFFILIATES TO PRODUCE RECORDS, BOOKS OR

OTHER INFORMATION AS REASONABLY NECESSARY TO ASCERTAIN

COMPLIANCE WITH THIS ACT.

(II) THE DEPARTMENT MAY RETAIN AN EXPERT OR EXPERTS

AS REASONABLY NECESSARY TO ASSIST THE DEPARTMENT TO

CONDUCT AN ANALYSIS OF PBM BUSINESS PRACTICES UNDER THIS

PARAGRAPH. THE REASONABLE AND NECESSARY COSTS FOR THE

EXPERT SERVICES SHALL BE PAID BY THE PBM, PAYABLE WITHIN

30 DAYS OF THE PBM'S RECEIPT OF A BILL FOR THE SERVICES.

ANALYSIS UNDER THIS SECTION SHALL INCLUDE:

20240HB1993PN3497 - 19 -

(A) THE IMPACT OF STEERING AND SPREAD PRICING ON

THE COST OF PRESCRIPTION DRUGS TO CONSUMERS IN THIS

COMMONWEALTH AND PHARMACY ACCESS.

(B) THE IMPACT TO CONSUMERS AND PHARMACIES IN

THIS COMMONWEALTH BY REQUIRING A HEALTH BENEFIT PLAN

OR PBM CONTRACTING WITH A HEALTH BENEFIT PLAN TO

REIMBURSE A PHARMACY UTILIZING THE NATIONAL AVERAGE

DRUG ACQUISITION COST AND A PROFESSIONAL DISPENSING

FEE OF $10.49.

(2) THE DEPARTMENT MAY EXAMINE OR AUDIT THE BOOKS AND

RECORDS OF A PBM, A HEALTH INSURER AND A PBM'S AFFILIATES TO

ASCERTAIN COMPLIANCE WITH THIS ACT. THE EXAMINATION SHALL BE

CONDUCTED IN ACCORDANCE WITH ARTICLE IX OF THE ACT OF MAY 17,

1921 (P.L.789, NO.285), KNOWN AS THE INSURANCE DEPARTMENT ACT

OF 1921.

ESTABLISH AN EFFICIENT PROCESS BY WHICH A PHARMACY MAY REFER

DESIGNATION OF A PRESCRIPTION DRUG UNDER A HEALTH BENEFIT PLAN,

BY A PBM CONTRACTING WITH A HEALTH BENEFIT PLAN, OR A HEALTH

INSURER AS A SPECIALTY DRUG WHICH FAILS TO MEET THE CRITERIA

UNDER SECTION 103. NO LATER THAN 60 DAYS FOLLOWING THE EFFECTIVE

DATE OF THIS SUBSECTION, THE DEPARTMENT SHALL PUBLISH GUIDANCE

TO EFFECTUATE THIS SUBSECTION, INCLUDING THE LIST OF

PRESCRIPTION DRUGS CLASSIFIED AS A SPECIALTY DRUG UNDER THE

MEDICAL ASSISTANCE FEE-FOR-SERVICE PROGRAM. THE LIST UNDER THIS

SUBSECTION SHALL NOT BE CONSIDERED EXCLUSIVE FOR THE PURPOSES OF

REVIEW BY THE DEPARTMENT UNDER THIS SECTION. THE DEPARTMENT

SHALL UPDATE GUIDANCE UNDER THIS SECTION TO REFLECT CHANGES IN

SPECIALTY DRUGS UNDER THE MEDICAL ASSISTANCE FEE-FOR-SERVICE

PROGRAM FOR EACH PLAN YEAR.

20240HB1993PN3497 - 20 -

(D) PENALTIES.--UPON THE DETERMINATION, AFTER NOTICE AND

HEARING, THAT THIS ACT HAS BEEN VIOLATED, THE COMMISSIONER MAY

IMPOSE THE FOLLOWING PENALTIES:

(1) SUSPENSION OR REVOCATION OF THE LICENSEE OR

REGISTRANT'S LICENSE, AUTHORIZATION TO OPERATE OR

REGISTRATION.

(2) REFUSAL TO ISSUE OR RENEW A LICENSE, AUTHORIZATION

TO OPERATE OR REGISTRATION.

(3) A CEASE AND DESIST ORDER.

(4) ORDER REIMBURSEMENT TO AN INSURED, PHARMACY OR

DISPENSER THAT HAS INCURRED A MONETARY LOSS AS A RESULT OF A

VIOLATION OF THIS ACT.

(5) FOR EACH VIOLATION OF THIS ACT THAT A LICENSEE OR

REGISTRANT KNEW OR REASONABLY SHOULD HAVE KNOWN WAS A

VIOLATION, A PENALTY OF NOT MORE THAN $100,000, NOT TO EXCEED

AN AGGREGATE PENALTY OF $1,000,000 IN A SINGLE CALENDAR YEAR.

(6) FOR EACH VIOLATION OF THIS ACT THAT A LICENSEE OR

REGISTRANT DID NOT KNOW NOR REASONABLY SHOULD HAVE KNOWN WAS

A VIOLATION, A PENALTY OF NOT MORE THAN $50,000, NOT TO

EXCEED AN AGGREGATE PENALTY OF $500,000 IN A SINGLE CALENDAR

YEAR.

(E) ADDITIONAL REMEDIES.--THE ENFORCEMENT REMEDIES IMPOSED

UNDER THIS SECTION ARE IN ADDITION TO ANY OTHER REMEDIES OR

PENALTIES THAT MAY BE IMPOSED UNDER ANY OTHER APPLICABLE LAW OF

THIS COMMONWEALTH, INCLUDING THE ACT OF JULY 22, 1974 (P.L.589,

NO.205), KNOWN AS THE UNFAIR INSURANCE PRACTICES ACT. A

VIOLATION OF THIS ACT SHALL BE DEEMED TO BE AN UNFAIR METHOD OF

COMPETITION AND AN UNFAIR OR DECEPTIVE ACT OR PRACTICE UNDER THE

UNFAIR INSURANCE PRACTICES ACT.

(F) ADMINISTRATIVE PROCEDURE.--THE ADMINISTRATIVE PROVISIONS

20240HB1993PN3497 - 21 -

OF THIS SECTION SHALL BE SUBJECT TO 2 PA.C.S. CH. 5 SUBCH. A

(RELATING TO PRACTICE AND PROCEDURE OF COMMONWEALTH AGENCIES).

A PARTY AGAINST WHOM PENALTIES ARE ASSESSED IN AN ADMINISTRATIVE

ACTION MAY APPEAL TO COMMONWEALTH COURT AS PROVIDED IN 2 PA.C.S.

CH. 7 SUBCH. A (RELATING TO JUDICIAL REVIEW OF COMMONWEALTH

AGENCY ACTION).

SECTION 11. THE ACT IS AMENDED BY ADDING A CHAPTER TO READ:

CHAPTER 10

PHARMACY SERVICES

SECTION 1001. DEFINITIONS.

THE FOLLOWING WORDS AND PHRASES WHEN USED IN THIS CHAPTER

SHALL HAVE THE MEANINGS GIVEN TO THEM IN THIS SECTION UNLESS THE

CONTEXT CLEARLY INDICATES OTHERWISE:

"BOARD." THE STATE BOARD OF PHARMACY.

"COVID-19" OR "CORONAVIRUS DISEASE 2019." A HIGHLY

CONTAGIOUS INFECTIOUS DISEASE CAUSED BY SEVERE ACUTE RESPIRATORY

SYNDROME CORONAVIRUS 2 (SARS-COV-2).

"DIRECT AND IMMEDIATE PERSONAL SUPERVISION." AS FOLLOWS:

(1) REVIEW BY THE PHARMACIST OF THE PRESCRIPTION OR DRUG

ORDER PRIOR TO DISPENSING.

(2) VERIFICATION BY THE PHARMACIST OF THE FINAL PRODUCT.

(3) IMMEDIATE AVAILABILITY OF THE PHARMACIST ON THE

PREMISES TO DIRECT THE WORK OF THE SUPERVISED INDIVIDUAL AND

TO RESPOND TO QUESTIONS OR PROBLEMS.

"LICENSEE." AN INDIVIDUAL LICENSED BY THE BOARD.

"PHARMACY ACT." THE ACT OF SEPTEMBER 27, 1961 (P.L.1700,

NO.699), KNOWN AS THE PHARMACY ACT.

"PHARMACY TECHNICIAN." AN INDIVIDUAL WHO:

(1) IS REQUIRED TO BE REGISTERED WITH THE BOARD AS A

PHARMACY TECHNICIAN FOLLOWING THE PROMULGATION OF FINAL-FORM

20240HB1993PN3497 - 22 -

REGULATIONS UNDER SECTION 3 OF THE ACT OF NOVEMBER 30, 2020

(P.L.1306, NO.140), ENTITLED "AN ACT AMENDING THE ACT OF

SEPTEMBER 27, 1961 (P.L.1700, NO.699), ENTITLED 'AN ACT

RELATING TO THE REGULATION OF THE PRACTICE OF PHARMACY,

INCLUDING THE SALES, USE AND DISTRIBUTION OF DRUGS AND

DEVICES AT RETAIL; AND AMENDING, REVISING, CONSOLIDATING AND

REPEALING CERTAIN LAWS RELATING THERETO,' FURTHER PROVIDING

FOR DEFINITIONS; AND PROVIDING FOR PHARMACY TECHNICIAN AND

PHARMACY TECHNICIAN TRAINEE REGISTRATION, QUALIFICATIONS AND

SUPERVISION, FOR PHARMACY TECHNICIAN DATA ENTRY AND FOR

LABORATORY WAIVER."

(2) MAY ASSIST IN THE PRACTICE OF PHARMACY UNDER THE

DIRECT AND IMMEDIATE PERSONAL SUPERVISION OF A LICENSED

PHARMACIST AFTER MEETING THE REQUIREMENTS OF THIS ACT, THE

PHARMACY ACT AND THE REGULATIONS PROMULGATED UNDER THIS ACT

OR THE PHARMACY ACT. THE TERM SHALL NOT INCLUDE AN INDIVIDUAL

PERFORMING CLERICAL SUPPORT WITH NO DIRECT INTERACTION WITH

PRESCRIPTION MEDICATION OR ABILITY TO ENTER A PRESCRIPTION

DRUG ORDER.

"PRACTICE OF PHARMACY." THE FOLLOWING:

(1) THE PROVISION OF HEALTH CARE SERVICES BY A

PHARMACIST, WHICH INCLUDES:

(I) THE INTERPRETATION, EVALUATION AND

IMPLEMENTATION OF MEDICAL ORDERS FOR THE PROVISION OF

PHARMACY SERVICES OR PRESCRIPTION DRUG ORDERS.

(II) THE DELIVERY, DISPENSING OR DISTRIBUTION OF

PRESCRIPTION DRUGS.

(III) PARTICIPATION IN DRUG AND DEVICE SELECTION.

(IV) DRUG ADMINISTRATION.

(V) DRUG REGIMEN REVIEW.

20240HB1993PN3497 - 23 -

(VI) DRUG THERAPY MANAGEMENT, INCLUDING SUCH

SERVICES PROVIDED UNDER THE MEDICARE PRESCRIPTION DRUG,

IMPROVEMENTS, AND MODERNIZATION ACT OF 2003 (PUBLIC LAW

108-173, 117 STAT. 2066).

(VII) DRUG OR DRUG-RELATED RESEARCH.

(VIII) COMPOUNDING.

(IX) PROPER AND SAFE STORAGE OF DRUGS AND DEVICES.

(X) MANAGEMENT OF DRUG THERAPY UNDER SECTION 9.3 OF

THE PHARMACY ACT, OR, IF IN AN INSTITUTIONAL SETTING,

CONSISTENT WITH THE INSTITUTION'S ASSIGNMENT OF CLINICAL

DUTIES PURSUANT TO A WRITTEN AGREEMENT OR PROTOCOL AS

SPECIFIED IN SECTION 9.1 OF THE PHARMACY ACT.

(XI) MAINTAINING PROPER RECORDS.

(XII) PATIENT COUNSELING.

(XIII) ACTS, SERVICES, OPERATIONS OR TRANSACTIONS

NECESSARY OR INCIDENT TO THE PROVISION OF THESE HEALTH

CARE SERVICES.

(2) THE TERM SHALL NOT INCLUDE THE OPERATIONS OF A

MANUFACTURER OR DISTRIBUTOR AS DEFINED IN THE CONTROLLED

SUBSTANCE, DRUG, DEVICE AND COSMETIC ACT.

"THE CONTROLLED SUBSTANCE, DRUG, DEVICE AND COSMETIC ACT."

THE ACT OF APRIL 14, 1972 (P.L.233, NO.64), KNOWN AS THE

CONTROLLED SUBSTANCE, DRUG, DEVICE AND COSMETIC ACT, OR THE

CONTROLLED SUBSTANCES ACT (PUBLIC LAW 91-513, 84 STAT. 1236).

SECTION 1002. ADMINISTRATION OF INJECTABLE MEDICATIONS,

BIOLOGICALS AND IMMUNIZATIONS.

(A) GENERAL RULE.--THE BOARD SHALL BY REGULATION ESTABLISH

EDUCATION AND TRAINING STANDARDS AND PRACTICE GUIDELINES

PURSUANT TO WHICH PHARMACISTS SHALL BE AUTHORIZED TO ADMINISTER

INJECTABLE MEDICATIONS, BIOLOGICALS AND IMMUNIZATIONS TO

20240HB1993PN3497 - 24 -

INDIVIDUALS EIGHT YEARS OF AGE OR OLDER AND INFLUENZA AND COVID-

19 IMMUNIZATIONS BY INJECTABLE OR NEEDLE-FREE DELIVERY METHODS

TO INDIVIDUALS FIVE YEARS OF AGE OR OLDER. THE STANDARDS AND

GUIDELINES SHALL INCLUDE, BUT NOT BE LIMITED TO, THE FOLLOWING:

(1) SATISFACTORY COMPLETION OF AN ACADEMIC AND PRACTICAL

CURRICULUM APPROVED BY THE BOARD THAT INCLUDES THE CURRENT

GUIDELINES AND RECOMMENDATIONS OF THE CENTERS FOR DISEASE

CONTROL AND PREVENTION IN THE PUBLIC HEALTH SERVICE OF THE

UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES, THE

AMERICAN COUNCIL ON PHARMACEUTICAL EDUCATION OR A SIMILAR

HEALTH AUTHORITY OR PROFESSIONAL BODY AND INCLUDES, BUT IS

NOT LIMITED TO, DISEASE EPIDEMIOLOGY, VACCINE

CHARACTERISTICS, INJECTION TECHNIQUE, EMERGENCY RESPONSE TO

ADVERSE EVENTS AND RELATED TOPICS.

(2) MAINTENANCE OF A CURRENT CARDIOPULMONARY

RESUSCITATION (CPR) CERTIFICATE ACCEPTABLE TO THE BOARD.

(3) THAT THE ADMINISTRATION OF INJECTABLE MEDICATIONS,

BIOLOGICALS AND IMMUNIZATIONS BE IN ACCORDANCE WITH A

DEFINITIVE SET OF TREATMENT GUIDELINES ESTABLISHED BY A

PHYSICIAN AND THE CENTERS FOR DISEASE CONTROL AND PREVENTION,

ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES GUIDELINES OR

ANOTHER COMPETENT AUTHORITY APPROVED BY THE BOARD.

(4) THAT A MINIMUM OF TWO HOURS OF THE 30-HOUR

REQUIREMENT FOR CONTINUING EDUCATION FOR LICENSE RENEWAL BE

DEDICATED TO ADMINISTERING INJECTABLE MEDICATIONS,

BIOLOGICALS AND IMMUNIZATIONS.

(5) FOR INDIVIDUALS UNDER 18 YEARS OF AGE, THAT PARENTAL

CONSENT BE OBTAINED PRIOR TO ADMINISTRATION.

(6) MAINTENANCE OF A LEVEL OF PROFESSIONAL LIABILITY

INSURANCE COVERAGE IN THE MINIMUM AMOUNT OF $1,000,000 PER

20240HB1993PN3497 - 25 -

OCCURRENCE OR CLAIMS MADE. FAILURE TO MAINTAIN INSURANCE

COVERAGE AS REQUIRED SHALL SUBJECT THE LICENSEES TO

DISCIPLINARY PROCEEDINGS. THE BOARD SHALL ACCEPT AS

SATISFACTORY EVIDENCE OF INSURANCE COVERAGE ANY OF THE

FOLLOWING:

(I) PERSONALLY PURCHASED LIABILITY INSURANCE;

(II) PROFESSIONAL LIABILITY INSURANCE COVERAGE

PROVIDED BY THE INDIVIDUAL LICENSEE'S EMPLOYER; OR

(III) SIMILAR INSURANCE COVERAGE ACCEPTABLE TO THE

BOARD.

(7) NOTIFICATION OF THE INDIVIDUAL'S PRIMARY CARE

PROVIDER, IF KNOWN, WITHIN 48 HOURS OF ADMINISTRATION.

(B) NO DELEGATION.--EXCEPT AS PROVIDED UNDER SUBSECTION (E),

A PHARMACIST'S AUTHORITY TO ADMINISTER INJECTABLE MEDICATIONS,

BIOLOGICALS AND IMMUNIZATIONS SHALL NOT BE DELEGATED TO ANY

OTHER INDIVIDUAL. A PHARMACY INTERN WHO HAS COMPLETED A COURSE

OF EDUCATION AND TRAINING WHICH MEETS THE REQUIREMENTS OF

SUBSECTION (A)(1) AND (2) AND MAINTAINS LIABILITY INSURANCE IN

THE AMOUNTS SPECIFIED UNDER SUBSECTION (A)(6), MAY ADMINISTER

INJECTABLE MEDICATIONS, BIOLOGICALS AND IMMUNIZATIONS, IN

KEEPING WITH THE REQUIREMENTS UNDER SUBSECTION (A)(3), TO

INDIVIDUALS WHO ARE EIGHT YEARS OF AGE OR OLDER AND INFLUENZA

AND COVID-19 IMMUNIZATIONS BY INJECTABLE OR NEEDLE-FREE DELIVERY

METHODS TO INDIVIDUALS FIVE YEARS OF AGE OR OLDER ONLY UNDER THE

DIRECT, IMMEDIATE AND PERSONAL SUPERVISION OF A PHARMACIST

HOLDING THE AUTHORITY TO ADMINISTER INJECTABLE MEDICATIONS,

BIOLOGICALS AND IMMUNIZATIONS OR A PHYSICIAN, PHYSICIAN

ASSISTANT OR CERTIFIED REGISTERED NURSE PRACTITIONER.

SHALL REPORT THE ADMINISTRATION OF IMMUNIZATIONS UNDER THIS

20240HB1993PN3497 - 26 -

SECTION TO THE IMMUNIZATION REGISTRY MAINTAINED BY THE

DEPARTMENT OF HEALTH WITHIN 72 HOURS OF IMMUNIZATION

ADMINISTRATION AND TO THE INDIVIDUAL'S PRIMARY CARE PROVIDER IN

ACCORDANCE WITH SUBSECTION (A)(7). NOTHING IN THIS SUBSECTION

SHALL BE CONSTRUED TO PROHIBIT A SUPERVISING PHARMACIST FROM

DELEGATING THE REPORTING OF IMMUNIZATION ADMINISTRATION TO A

PHARMACY INTERN OR TECHNICIAN.

(D) INFORMATION AND REFERRAL.--A PHARMACIST, PHARMACY INTERN

OR PHARMACIST TECHNICIAN WHO ADMINISTERS AN INFLUENZA OR COVID-

19 IMMUNIZATION TO AN INDIVIDUAL UNDER 18 YEARS OF AGE SHALL

INFORM THE PARENT OR ADULT CAREGIVER OF THE IMPORTANCE OF A

WELL-CHILD VISIT WITH A PEDIATRICIAN OR OTHER LICENSED PRIMARY

CARE PROVIDER AND REFER THE PATIENT AS APPROPRIATE.

(E) DELEGATION OF AUTHORITY.--A PHARMACIST WHO HOLDS THE

AUTHORITY TO ADMINISTER INJECTABLE MEDICATIONS, BIOLOGICALS AND

IMMUNIZATIONS MAY DELEGATE THE AUTHORITY TO ADMINISTER:

(1) INFLUENZA AND COVID-19 IMMUNIZATIONS TO A CERTIFIED

REGISTERED NURSE PRACTITIONER, PHYSICIAN ASSISTANT,

REGISTERED NURSE OR LICENSED PRACTICAL NURSE; OR

(2) COVID-19 IMMUNIZATIONS THAT ARE AUTHORIZED OR THAT

ARE LICENSED BY THE UNITED STATES FOOD AND DRUG

ADMINISTRATION TO INDIVIDUALS 13 YEARS OF AGE OR OLDER OR

INFLUENZA VACCINATIONS THAT ARE RECOMMENDED BY THE ADVISORY

COMMITTEE ON IMMUNIZATION PRACTICES TO INDIVIDUALS 13 YEARS

OF AGE OR OLDER TO A PHARMACY TECHNICIAN IF:

(I) THE PHARMACY TECHNICIAN:

(A) UNTIL THE BOARD PROMULGATES FINAL

REGULATIONS IMPLEMENTING REGISTRATION OF PHARMACY

TECHNICIANS, HOLDS A NATIONAL CERTIFICATION FROM THE

PHARMACY TECHNICIAN CERTIFICATION BOARD OR THE

20240HB1993PN3497 - 27 -

NATIONAL HEALTHCAREER ASSOCIATION; OR

(B) AFTER THE BOARD PROMULGATES FINAL

REGULATIONS IMPLEMENTING REGISTRATION OF PHARMACY

TECHNICIANS, IS REGISTERED WITH THE BOARD.

(II) THE FOLLOWING CONDITIONS ARE MET:

(A) THE SUPERVISING QUALIFIED PHARMACIST IS

PROVIDING DIRECT, IMMEDIATE AND PERSONAL SUPERVISION

TO THE QUALIFIED PHARMACY TECHNICIAN WHO IS

ADMINISTERING THE IMMUNIZATIONS OR VACCINATIONS.

(B) THE QUALIFIED PHARMACY TECHNICIAN HAS

COMPLETED A PRACTICAL TRAINING PROGRAM THAT IS

APPROVED BY THE ACCREDITATION COUNCIL FOR PHARMACY

EDUCATION AND THAT INCLUDES HANDS-ON INJECTION

TECHNIQUE AND THE RECOGNITION AND TREATMENT OF

EMERGENCY REACTIONS TO VACCINES.

CURRENT CERTIFICATE IN BASIC CARDIOPULMONARY

RESUSCITATION.

(D) THE QUALIFIED PHARMACY TECHNICIAN HAS

OBTAINED LIABILITY INSURANCE AS REQUIRED UNDER

SUBSECTION (A)(6) THROUGH THE QUALIFIED PHARMACY

TECHNICIAN'S EMPLOYER.

(E) ADMINISTRATION OF A COVID-19 IMMUNIZATION OR

INFLUENZA VACCINATIONS SHALL BE IN KEEPING WITH THE

REQUIREMENTS UNDER SUBSECTION (A)(3).

SECTION 1003. CLINICAL LABORATORY CERTIFICATE.

(A) CERTIFICATE.--IF A PHARMACY HOLDS A VALID CERTIFICATE OF

WAIVER ISSUED BY THE CENTERS FOR MEDICARE AND MEDICAID SERVICES,

A PHARMACY OR PHARMACIST MAY ORDER AND PERFORM LABORATORY

EXAMINATIONS AND PROCEDURES FOR COVID-19, INFLUENZA, RESPIRATORY

20240HB1993PN3497 - 28 -

SYNCYTIAL VIRUS AND STREPTOCOCCAL INFECTIONS AUTHORIZED OR

APPROVED BY THE UNITED STATES FOOD AND DRUG ADMINISTRATION UNDER

THE CLINICAL LABORATORY IMPROVEMENT AMENDMENTS OF 1988 (PUBLIC

LAW 100-578, 102 STAT. 2903) AND SHALL BE EXEMPT FROM THE

REQUIREMENTS UNDER SECTION 3 OF THE ACT OF SEPTEMBER 26, 1951

(P.L.1539, NO.389), KNOWN AS THE CLINICAL LABORATORY ACT.

(B) DESIGNATION.--A PHARMACIST MAY DESIGNATE THE

ADMINISTRATION OF A TEST UNDER SUBSECTION (A) TO A PHARMACY

INTERN OR PHARMACY TECHNICIAN IF THE DESIGNATION BY THE

PHARMACIST TO A PHARMACY INTERN OR PHARMACY TECHNICIAN AND THE

ADMINISTRATION OF THE TEST IS IN KEEPING WITH NATIONALLY

RECOGNIZED CLINICAL PRACTICE GUIDELINES THAT HAVE NOT BEEN

DISAPPROVED BY THE DEPARTMENT OF HEALTH THROUGH TRANSMISSION TO

THE LEGISLATIVE REFERENCE BUREAU FOR PUBLICATION IN THE NEXT

AVAILABLE ISSUE OF THE PENNSYLVANIA BULLETIN.

SECTION 1004. REPORT ON PHARMACY-ADMINISTERED VACCINES.

(A) REPORT.--THE DEPARTMENT OF HEALTH SHALL, IN CONSULTATION

WITH THE BOARD, REPORT TO THE PRESIDENT PRO TEMPORE OF THE

SENATE, THE MAJORITY LEADER AND THE MINORITY LEADER OF THE

SENATE, THE SPEAKER OF THE HOUSE OF REPRESENTATIVES AND THE

MAJORITY LEADER AND THE MINORITY LEADER OF THE HOUSE OF

REPRESENTATIVES INFORMATION CONCERNING PHARMACIST ACTIVITIES

AUTHORIZED UNDER THIS CHAPTER, INCLUDING:

(1) THE NUMBER OF INJECTABLE MEDICATIONS, BIOLOGICALS

AND IMMUNIZATIONS ADMINISTERED TO INDIVIDUALS UNDER 18 YEARS

OF AGE BROKEN DOWN BY AGE.

(2) THE NUMBER OF INJECTABLE MEDICATIONS, BIOLOGICALS

AND IMMUNIZATIONS ADMINISTERED TO INDIVIDUALS UNDER 18 YEARS

OF AGE BROKEN DOWN BY TYPE OF INJECTABLE MEDICATIONS,

BIOLOGICALS AND IMMUNIZATIONS.

20240HB1993PN3497 - 29 -

(3) SUBJECT TO INFORMATION BEING MADE AVAILABLE, AN

ASSESSMENT ON WHETHER THERE IS A CHANGE IN THE NUMBER OF WELL

VISITS FOR CHILDREN WITH THEIR PRIMARY PEDIATRIC CARE

PROVIDER ATTRIBUTABLE PHARMACIST SERVICES AUTHORIZED UNDER

THIS CHAPTER.

(4) BEGINNING FROM THE EFFECTIVE DATE OF THIS SECTION,

CHANGES IN THE PHARMACY IMMUNIZATION RATES FOR INDIVIDUALS

UNDER 18 YEARS OF AGE.

(B) SCOPE OF REPORT.--THE DEPARTMENT OF HEALTH SHALL REVIEW

DATA AVAILABLE FOR INJECTABLE MEDICATIONS, BIOLOGICALS AND

IMMUNIZATIONS ADMINISTERED BY A PHARMACIST, PHARMACY INTERN OR

TECHNICIAN IN THIS COMMONWEALTH. THE DEPARTMENT OF HEALTH SHALL

ALSO REVIEW DATA AVAILABLE FROM OTHER STATE GOVERNMENTS WHICH

HAVE AUTHORIZED PHARMACISTS TO PROVIDE SIMILAR PHARMACY SERVICES

AS AUTHORIZED UNDER THIS CHAPTER.

ITS FINDINGS NO LATER THAN FIVE YEARS FOLLOWING THE EFFECTIVE

DATE OF THIS SUBSECTION AND INCLUDE RECOMMENDATIONS FOR CHANGES

IN THE LAWS OF THIS COMMONWEALTH.

(D) PUBLICATION.--UPON COMPLETION OF THE REPORT AND

TRANSMISSION OF THE REPORT UNDER SUBSECTION (A), THE DEPARTMENT

OF HEALTH SHALL PUBLISH THE FINDINGS ON THE DEPARTMENT OF

HEALTH'S PUBLICLY ACCESSIBLE INTERNET WEBSITE.

SECTION 12. REPEALS ARE AS FOLLOWS:

(1) THE GENERAL ASSEMBLY DECLARES THAT THE REPEAL UNDER

PARAGRAPH (2) IS NECESSARY TO EFFECTUATE THE ADDITION OF

SECTION 1002 OF THE ACT.

(2) SECTIONS 9.2 AND 9.5 OF THE ACT OF SEPTEMBER 27,

1961 (P.L.1700, NO.699), KNOWN AS THE PHARMACY ACT, ARE

REPEALED.

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SECTION 13. THE ADDITION OF SECTION 1002 OF THE ACT IS A

CONTINUATION OF SECTIONS 9.2 AND 9.5 OF THE ACT OF SEPTEMBER 27,

1961 (P.L.1700, NO.699), KNOWN AS THE PHARMACY ACT. EXCEPT AS

OTHERWISE PROVIDED IN SECTION 1002 OF THE ACT, ALL ACTIVITIES

INITIATED UNDER SECTIONS 9.2 AND 9.5 OF THE PHARMACY ACT SHALL

CONTINUE AND REMAIN IN FULL FORCE AND EFFECT AND MAY BE

COMPLETED UNDER SECTION 1002 OF THE ACT. ORDERS, REGULATIONS,

RULES AND DECISIONS WHICH WERE MADE UNDER SECTIONS 9.2 AND 9.5

OF THE PHARMACY ACT AND WHICH ARE IN EFFECT ON THE EFFECTIVE

DATE OF SECTION 12(2) OF THIS ACT SHALL REMAIN IN FULL FORCE AND

EFFECT UNTIL REVOKED, VACATED OR MODIFIED UNDER SECTION 1002 OF

THE ACT. CONTRACTS, OBLIGATIONS AND COLLECTIVE BARGAINING

AGREEMENTS ENTERED INTO UNDER SECTIONS 9.2 AND 9.5 OF THE

PHARMACY ACT ARE NOT AFFECTED NOR IMPAIRED BY THE REPEAL OF

SECTIONS 9.2 AND 9.5 OF THE PHARMACY ACT.

SECTION 14. THE FOLLOWING SHALL APPLY:

(1) THE ADDITION OF CHAPTER 6 AND SECTION 703.1 OF THE

ACT SHALL APPLY TO A CONTRACT ISSUED, RENEWED OR AMENDED

AFTER THE EFFECTIVE DATE OF THIS SECTION.

(2) THE FOLLOWING SHALL APPLY:

(I) FOR A HEALTH INSURANCE POLICY FOR WHICH EITHER

RATES OR FORMS ARE REQUIRED TO BE FILED WITH THE FEDERAL

GOVERNMENT OR THE INSURANCE DEPARTMENT, THIS ACT SHALL

APPLY TO THE HEALTH INSURANCE POLICY FOR WHICH A FORM OR

RATE IS FIRST APPROVED ON OR AFTER THE EFFECTIVE DATE OF

THIS PARAGRAPH.

(II) FOR A HEALTH INSURANCE POLICY FOR WHICH NEITHER

RATES NOR FORMS ARE REQUIRED TO BE FILED WITH THE FEDERAL

GOVERNMENT OR THE INSURANCE DEPARTMENT, THIS ACT SHALL

APPLY TO THE HEALTH INSURANCE POLICY ISSUED OR RENEWED ON

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OR AFTER 180 DAYS AFTER THE EFFECTIVE DATE OF THIS

PARAGRAPH.

SECTION 15. THIS ACT SHALL TAKE EFFECT AS FOLLOWS:

(1) SECTION 14 OF THIS ACT SHALL TAKE EFFECT IN 90 DAYS.

(2) THIS SECTION SHALL TAKE EFFECT IMMEDIATELY.

(3) THE REMAINDER OF THIS ACT SHALL TAKE EFFECT IN 120

DAYS.

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