PRINTER'S NO. 805
No. 714 Session of 2005
INTRODUCED BY WALKO, DeLUCA, CALTAGIRONE, CURRY, FABRIZIO, FRANKEL, FREEMAN, GERGELY, GOODMAN, GRUCELA, JAMES, JOSEPHS, PALLONE, SHANER, STABACK, STURLA, TANGRETTI, WHEATLEY, YOUNGBLOOD, BELARDI, COSTA AND PISTELLA, MARCH 1, 2005
REFERRED TO COMMITTEE ON INSURANCE, MARCH 1, 2005
AN ACT 1 Regulating pharmacy benefit managers; and providing for powers 2 and duties of the Insurance Department and for enforcement. 3 TABLE OF CONTENTS 4 Chapter 1. Preliminary Provisions 5 Section 101. Short title. 6 Section 102. Purpose and intent. 7 Section 103. Definitions. 8 Section 104. Applicability and scope. 9 Chapter 3. Regulation of Pharmacy Benefit Managers 10 Section 301. Certificate of authority to act as PBM. 11 Section 302. Fidelity bond. 12 Section 303. Disclosure of ownership or affiliation. 13 Section 304. Records. 14 Section 305. Financial statement, filing fee and notice 15 requirements. 16 Section 306. Agreements between PBM and insurer. 17 Section 307. Agreements between PBM and pharmacist.
1 Section 308. Medication reimbursement costs; use of index 2 required. 3 Section 309. Timely payments to pharmacies and audits. 4 Section 310. Notice to covered person. 5 Section 311. Adjustment or settlement of claims, compensation 6 of PBM. 7 Chapter 5. Enforcement 8 Section 501. Grounds for suspension or revocation of 9 certificate of authority. 10 Section 502. Order of suspension or revocation of certificate 11 of authority and notice. 12 Section 503. Period of suspension, obligations during 13 suspension and reinstatement. 14 Section 504. Administrative fine in lieu of suspension or 15 revocation. 16 Chapter 21. Miscellaneous Provisions 17 Section 2101. Regulations. 18 Section 2102. Applicability of Unfair Trade Practices and 19 Consumer Protection Law. 20 Section 2103. Effective date. 21 The General Assembly of the Commonwealth of Pennsylvania 22 hereby enacts as follows: 23 CHAPTER 1 24 PRELIMINARY PROVISIONS 25 Section 101. Short title. 26 This act shall be known and may be cited as the Pharmacy 27 Benefit Manager Act. 28 Section 102. Purpose and intent. 29 The purpose of this act is to establish standards and 20050H0714B0805 - 2 -
1 criteria for regulation and licensing of pharmacy benefit 2 managers. This act is designed to promote, preserve and protect 3 the public health, safety and welfare by and through effective 4 regulation and licensing of pharmacy benefit managers. 5 Section 103. Definitions. 6 The following words and phrases when used in this act shall 7 have the meanings given to them in this section unless the 8 context clearly indicates otherwise: 9 "Board." The State Board of Pharmacy. 10 "Commissioner." The Insurance Commissioner of the 11 Commonwealth. 12 "Covered person." A policyholder, subscriber, enrollee or 13 other individual participating in a health benefit plan. 14 "Department." The Insurance Department of the Commonwealth. 15 "Health benefit plan." A policy, contract, certificate or 16 agreement offered or issued by a health carrier to provide, 17 deliver, arrange for, pay for or reimburse any of the cost of 18 health care services, including prescription drug benefits. 19 "Maintenance drug." A drug prescribed by a practitioner who 20 is licensed to prescribe drugs and used to treat a medical 21 condition for a period greater than 30 days. 22 "Multisource drug." A drug that is stocked and is available 23 from three or more suppliers. 24 "Pharmacist." Any individual properly licensed as a 25 pharmacist by the State Board of Pharmacy. 26 "Pharmacist services." Includes drug therapy and other 27 patient care services provided by a licensed pharmacist intended 28 to achieve outcomes related to the cure or prevention of a 29 disease, elimination or reduction of a patient's symptoms or 30 arresting or slowing of a disease process as defined in the 20050H0714B0805 - 3 -
1 rules of the State Board of Pharmacy. 2 "Pharmacy." Any appropriately licensed place within this 3 Commonwealth where drugs are dispensed and pharmacist services 4 are provided. 5 "Pharmacy benefit management plan." An arrangement for the 6 delivery of pharmacist services in which a pharmacy benefit 7 manager undertakes to pay for or reimburse any of the costs of 8 pharmacist services for a covered person on a prepaid or insured 9 basis which meets the following criteria: 10 (1) Contains one or more incentive arrangements intended 11 to influence the cost or level of pharmacist services between 12 the health benefit plan sponsor and one or more pharmacies 13 with respect to the delivery of pharmacist services. 14 (2) Requires or creates benefit payment differential 15 incentives for covered persons to use under contract with the 16 pharmacy benefit manager. 17 "Pharmacy benefit manager," or "PBM." A person, business or 18 other entity and any wholly or partially owned or controlled 19 subsidiary of a pharmacy benefit manager that administers the 20 prescription drug and device portion of health benefit plans on 21 behalf of a third party, including plan sponsors, insurance 22 companies, unions and health maintenance organizations in 23 accordance with a pharmacy benefit management plan. 24 "Usual and customary price." The price the pharmacist would 25 have charged a cash-paying patient, but not a patient where 26 reimbursement rates are set by a contract, for the same services 27 on the same date inclusive of any discounts applicable. 28 Section 104. Applicability and scope. 29 (a) Applicability.--This act shall apply to a PBM that 30 provides claims processing services, other prescription drug or 20050H0714B0805 - 4 -
1 device services, or both, to covered persons who are residents 2 of this Commonwealth. 3 (b) Construction.--Nothing in this act shall be construed to 4 apply to an employee welfare benefit plan as defined in section 5 3(1) of the Employee Retirement Income Security Act of 1974 6 (Public Law 93-406, 88 Stat. 829). 7 CHAPTER 3 8 REGULATION OF PHARMACY BENEFIT MANAGERS 9 Section 301. Certificate of authority to act as PBM. 10 (a) Certificate of authority required.--No person or 11 organization shall act or operate as a PBM in this Commonwealth 12 without a valid certificate of authority issued by the 13 department. The failure of any person to hold a certificate of 14 authority while acting as a PBM shall subject the person to a 15 fine of not less than $5,000 nor more than $10,000 for each 16 violation. 17 (b) Application.--Each person seeking a certificate of 18 authority to act as a PBM shall file with the department an 19 application for a certificate of authority upon a form to be 20 furnished by the department, which application shall include or 21 have attached the following information and documents: 22 (1) All basic organizational documents of the PBM, such 23 as the articles of incorporation, articles of association, 24 partnership agreement, trade name certificate, trust 25 agreement, shareholder agreement and other applicable 26 documents and all amendments to those documents. 27 (2) The bylaws, rules and regulations or similar 28 documents regulating the conduct or the internal affairs of 29 the PBM. 30 (3) The names, addresses, official positions and 20050H0714B0805 - 5 -
1 professional qualifications of the individuals who are 2 responsible for the conduct of the affairs of the PBM, 3 including all members of the board of directors, boards of 4 trustees, executive committee, other governing board or 5 committee, the principal officers in the case of a 6 corporation, the partners or members in the case of a 7 partnership or association and any other person who exercises 8 control or influence over the affairs of the PBM. 9 (4) A certificate issued by the board indicating that 10 the PBM's plan of operation is consistent with the act of 11 September 27, 1961 (P.L.1700, No.699), known as the Pharmacy 12 Act, and any regulations promulgated thereunder. 13 (5) Annual statements or reports for the three most 14 recent years, or any other information as the department may 15 require in order to review the current financial condition of 16 the applicant. 17 (6) If the applicant is not currently acting as a PBM, a 18 statement of the amounts and sources of funds available for 19 organization expenses and the proposed arrangements for 20 reimbursement and compensation of incorporators or other 21 principals. 22 (7) The name and address of the agent for service of 23 process in this Commonwealth. 24 (8) A detailed description of the claims processing 25 services, pharmacy services, insurance services, other 26 prescription drug or device services or other administrative 27 services to be provided. 28 (9) All incentive arrangements or programs such as 29 rebates, discounts, disbursements or any other similar 30 financial program or arrangement relating to income or 20050H0714B0805 - 6 -
1 consideration received or negotiated, directly or indirectly, 2 with any pharmaceutical company, that relates to prescription 3 drug or device services, including, at a minimum, information 4 on the formula or other method for calculation and amount of 5 the incentive arrangements, rebates or other disbursements, 6 the identity of the associated drug or device and the dates 7 and amounts of disbursements. 8 (10) A copy of the fidelity bond required under section 9 302 (relating to fidelity bond). 10 (11) Any other information as the commissioner may 11 require. 12 (12) A filing fee of $5,000. 13 (c) Availability of contracts.--The applicant shall make 14 available for inspection by the department copies of all 15 contracts with insurers or other persons utilizing the services 16 of the PBM. 17 (d) Nonissuance.--The department shall not issue a 18 certificate of authority if it determines that the PBM or any 19 principal thereof is not competent, trustworthy, financially 20 responsible or of good personal and business reputation or has 21 had an insurance license or pharmacy license denied for cause by 22 any state. 23 (e) Period of validity.--A certificate of authority issued 24 under this section shall remain valid, unless suspended or 25 revoked by the department, so long as the PBM continues to do 26 business in this Commonwealth. 27 Section 302. Fidelity bond. 28 A PBM shall have and keep in full force and effect a fidelity 29 bond equal to at least 10% of the amount of the funds handled or 30 managed annually by the PBM. However, the department, after due 20050H0714B0805 - 7 -
1 notice to all interested parties and an opportunity for hearing 2 and after consideration of the record, may require an amount in 3 excess of $500,000, but not more than 10% of the amount of the 4 funds handled or managed annually by the PBM. 5 Section 303. Disclosure of ownership or affiliation. 6 Each PBM shall identify to the department any ownership 7 interest or affiliation of any kind with: 8 (1) Any insurance company responsible for providing 9 benefits directly or through reinsurance to any plan for 10 which the PBM provides services. 11 (2) Any parent companies, subsidiaries and other 12 entities or businesses relative to the provision of pharmacy 13 services or other prescription drug or device services. 14 Section 304. Records. 15 (a) Maintenance of records.--Every PBM shall maintain for 16 the duration of the written agreement and for five years 17 thereafter books and records of all transactions between the 18 PBM, insurers, covered persons and pharmacies. 19 (b) Access.--The department shall have access to books and 20 records maintained by the PBM for the purposes of examination, 21 audit and inspection. The information contained in the books and 22 records is confidential. However, the department may use the 23 information in any proceeding instituted against the PBM or 24 insurer. 25 (c) Financial examination.--The commissioner shall conduct 26 periodic financial examinations of every PBM in this 27 Commonwealth to ensure an appropriate level of regulatory 28 oversight. The PBM shall pay the cost of the examination. 29 Section 305. Financial statement, filing fee and notice 30 requirements. 20050H0714B0805 - 8 -
1 (a) Financial statement.--Each authorized PBM shall file 2 with the department a full and true statement of its financial 3 condition, transactions and affairs. 4 (b) Verification.--The annual financial statement shall be 5 verified by at least two officers of the PBM. 6 (c) Filing fee.--At the time of filing its annual statement, 7 the PBM shall pay a filing fee of $1,000. 8 (d) Change of ownership.--The PBM must notify the department 9 in writing within five calendar days of any material change in 10 its ownership. 11 Section 306. Agreements between PBM and insurer. 12 (a) Written agreement required.--No person may act as a PBM 13 without a written agreement between the PBM and insurer. 14 (b) Prescription change.--No agreement shall mandate that a 15 pharmacist change a covered person's prescription unless the 16 prescribing physician and the covered person authorize the 17 pharmacist to make the change. 18 (c) Participation by pharmacist.-- 19 (1) An insurer and PBM may not discriminate with respect 20 to participation in the network or reimbursement as to any 21 pharmacist that is acting within the scope of the 22 pharmacist's license or certification. 23 (2) A PBM shall not exclude an otherwise qualified 24 pharmacist from participation in a particular network solely 25 because the pharmacist declined to participate in another 26 plan or network managed by the PBM. 27 (3) A PBM shall not require a pharmacist or pharmacy to 28 participate in one contract in order to participate in 29 another contract. 30 (d) Transfer of health benefit plan.--A PBM may not transfer 20050H0714B0805 - 9 -
1 a health benefit plan to another payment network unless it 2 receives written authorization from the insurer. 3 (e) Nonliability.--The written agreement between an insurer 4 and PBM shall not provide that the pharmacist is responsible for 5 the actions of the insurer or PBM. 6 (f) Payments.--All agreements shall provide that when a PBM 7 receives payment for the services of the pharmacist that the PBM 8 shall act as a fiduciary of the pharmacy who provided the 9 services. The PBM shall distribute the funds in accordance with 10 the time frames provided in section 309 (relating to timely 11 payments to pharmacies and audits). 12 (g) Maintenance of records.--Written agreements shall be 13 retained as part of the official records of both the PBM and the 14 insurer for the duration of the agreement and for five years 15 thereafter. 16 Section 307. Agreements between PBM and pharmacist. 17 (a) Prohibitions.--A pharmacist may not be terminated or 18 penalized by a PBM solely because of: 19 (1) Filing a complaint, grievance or appeal as permitted 20 under this act. 21 (2) Expressing disagreement with the PBM's decision to 22 deny or limit benefits to a covered person. 23 (3) Assisting a covered person who is seeking 24 reconsideration of the PBM's decision. 25 (4) Discussing alternative medications with a covered 26 person. 27 (b) Notice of termination.--Prior to the terminating of a 28 pharmacy from the network, a PBM must provide the pharmacy a 29 written explanation of the reason for the termination at least 30 30 days prior to the termination date unless the termination is 20050H0714B0805 - 10 -
1 based on the loss of the pharmacy's license to practice pharmacy 2 or cancellation of professional liability insurance or 3 conviction of fraud. 4 Section 308. Medication reimbursement costs; use of index 5 required. 6 PBMs shall use a current and nationally recognized benchmark 7 to base the reimbursement paid to network pharmacies for 8 medications and products. The reimbursement must be determined 9 as follows: 10 (1) For brand or single-source products, the average 11 wholesale price as listed in First DataBank or Facts & 12 Comparisons correct and current on the date of service 13 provided shall be used as an index. 14 (2) For generic drug or multisource products, maximum 15 allowable cost shall be established by referencing First 16 DataBank or Facts & Comparisons Baseline Price. Only products 17 that are compliant with pharmacy laws as equivalent and 18 generically interchangeable with a Food and Drug 19 Administration Orange Book rating of "A-B" may be reimbursed 20 from a maximum allowable cost price methodology. If a 21 multisource product has no baseline price, then it shall be 22 treated as a single-source branded drug for the purpose of 23 determining reimbursement. 24 Section 309. Timely payments to pharmacies and audits. 25 (a) Electronic payment.--If a PBM processes claims via 26 electronic review then it shall electronically transmit payment 27 within 14 calendar days of the claim's transmission to the 28 pharmacist. Specific time limits for the PBM to pay the 29 pharmacist for all other services rendered must be set forth in 30 the agreement. 20050H0714B0805 - 11 -
1 (b) Retroactive decisions.--Claims paid by the PBM shall not 2 be retroactively denied or adjusted after seven days from 3 adjudication of the claims except as provided in paragraph (c). 4 In no case shall acknowledgment of eligibility be retroactively 5 reversed. 6 (c) Exceptions.--The PBM may retroactively deny or adjust in 7 the event: 8 (1) the original claim was submitted fraudulently; 9 (2) the original claim payment was incorrect because the 10 provider was already paid for services rendered; or 11 (3) the services were not rendered by the pharmacist. 12 (d) Extrapolation audits.--The PBM may not require 13 extrapolation audits as a condition of participating in the 14 contract, network or program. 15 (e) Board review.--The PBM shall not recoup any moneys that 16 it believes are due as a result of the audit by setoff until the 17 pharmacist has the opportunity to review the PBM's findings and 18 concurs with the results. If the parties are unable to agree, 19 then the audit shall be subject to review by the board. 20 Section 310. Notice to covered person. 21 (a) General rule.--When the services of a PBM are utilized, 22 the PBM must provide a written notice approved by the insurer to 23 covered persons advising them of the identity of and 24 relationship among the PBM, the insured and the covered person. 25 (b) Rights of covered person.--The notice must contain a 26 statement advising the covered person of the person's right to 27 file a complaint, appeal or grievance with the department 28 concerning the PBM. 29 (c) Language.--The notice must be written in plain English, 30 using terms that will be generally understood by the prudent 20050H0714B0805 - 12 -
1 layperson. 2 (d) Copy of notice.--A copy of the notice shall be provided 3 to each pharmacy participating in the network. 4 Section 311. Adjustment or settlement of claims, compensation 5 of PBM. 6 Compensation to a PBM for any claim that the PBM adjusts or 7 settles on behalf of an insurer shall in no way be contingent on 8 claims experience. This section does not prohibit the 9 compensation of a PBM based on total number of claims paid or 10 processed. 11 CHAPTER 5 12 ENFORCEMENT 13 Section 501. Grounds for suspension or revocation of 14 certificate of authority. 15 (a) Mandatory suspension or revocation.--The certificate of 16 authority of a PBM shall be suspended or revoked if the 17 department determines that the PBM: 18 (1) Is in an unsound financial condition. 19 (2) Has used or is using methods or practices in the 20 conduct of its business so as to render its further 21 transaction of business in this Commonwealth hazardous or 22 injurious to insured persons or the public. 23 (3) Has failed to pay any judgment rendered against it 24 in this Commonwealth within 60 days after the judgment has 25 become final. 26 (b) Department discretion.--The department may, in its 27 discretion, suspend or revoke the certificate of authority of a 28 PBM if it finds that the PBM: 29 (1) Has violated any lawful rule or order of the 30 department or any provision of this chapter. 20050H0714B0805 - 13 -
1 (2) Has refused to be examined or to produce its 2 accounts, records and files for examination, or if any of its 3 officers has refused to give information with respect to its 4 affairs or has refused to perform any other legal obligation 5 as to examination, when required by the department. 6 (3) Has, without just cause, refused to pay proper 7 claims or perform services arising under its contracts or 8 has, without just cause, compelled covered persons to accept 9 less than the amount due them or to employ attorneys or bring 10 suit against the PBM to secure full payment or settlement of 11 claims. 12 (4) Has failed to reimburse pharmacists in a timely 13 manner as required by this act. 14 (5) Has failed to pay any fees or other financial 15 requirements levied by the department. 16 (6) Is or was affiliated with and under the same general 17 management or interlocking directorate or ownership as 18 another PBM which transacts business in this Commonwealth 19 without having a certificate of authority. 20 (7) At any time fails to meet any qualification for 21 which issuance of the certificate could have been refused had 22 the failure then existed and had been known to the 23 department. 24 (8) Has or any person on its behalf has advertised or 25 merchandised its services in an untrue, misrepresentative, 26 misleading, deceptive or unfair manner. 27 (9) Has been convicted of or has entered a plea of 28 guilty or nolo contendere to a felony relating to the 29 business of insurance or insurance administration in this 30 Commonwealth or in any other state without regard to whether 20050H0714B0805 - 14 -
1 adjudication was withheld. 2 (10) Is under suspension or revocation in another state. 3 (c) Grounds for immediate suspension.--The department may, 4 in its discretion, and without advance notice or hearing thereon 5 immediately suspend the certificate of any PBM if it finds that 6 one or more of the following circumstances exist: 7 (1) The PBM is insolvent or impaired. 8 (2) The fidelity bond required by section 302 (relating 9 to fidelity bond) is not maintained. 10 (3) A proceeding for receivership, conservationship, 11 rehabilitation or other delinquency proceeding regarding the 12 PBM has been commenced in any state. 13 (4) The financial condition or business practices of the 14 PBM otherwise poses an imminent threat to the public health, 15 safety or welfare of the residents of this Commonwealth. 16 Section 502. Order of suspension or revocation of certificate 17 of authority and notice. 18 (a) Order.--The suspension or revocation of a certificate of 19 authority of a PBM shall be affected by order of the department 20 mailed to the PBM by registered, certified or overnight mail. 21 (b) Notice.--In its discretion, the department may cause 22 notice of the revocation or suspension to be published in one or 23 more newspapers of general circulation published in this 24 Commonwealth. 25 Section 503. Period of suspension, obligations during 26 suspension and reinstatement. 27 (a) Period of suspension.--A certificate of authority of a 28 PBM shall be suspended for a period not to exceed one year as is 29 fixed in the order of suspension, unless the suspension or the 30 order upon which the suspension is based is modified, rescinded 20050H0714B0805 - 15 -
1 or reversed. 2 (b) Obligations during suspension.--During the period of 3 suspension, the PBM shall file its annual statement and pay fees 4 as required under this act as if the certificate had continued 5 in full force. 6 (c) Reinstatement.--Upon expiration of the suspension 7 period, if within the period the certificate has not otherwise 8 terminated, the certificate shall automatically be reinstated, 9 unless the causes of the suspension have not been removed or the 10 PBM is otherwise not in compliance with the requirements of this 11 act. 12 Section 504. Administrative fine in lieu of suspension or 13 revocation. 14 (a) Fine.--If the department finds that one or more grounds 15 exist for the suspension or revocation of a certificate of 16 authority issued under this act, the department may in lieu of 17 the suspension or revocation impose a fine upon the PBM. 18 (b) Unintentional violation.--With respect to any 19 unintentional violation, the fine may not exceed $1,000 per 20 violation. In no event may the fine exceed an aggregate amount 21 of $5,000 for all unintentional violations arising out of the 22 same action. When a PBM discovers an unintentional violation, 23 the PBM shall correct the violation and, if restitution is due, 24 the restitution shall include interest at the rate of 12% per 25 year from either the date of the violation or the date of 26 inception of the policy of the affected person, at the option of 27 the PBM. 28 (c) Willful violation.--With respect to any knowing and 29 willful violation of a lawful order or rule of the department or 30 this act, the department may impose a fine upon the PBM in an 20050H0714B0805 - 16 -
1 amount not to exceed $5,000 for each violation. In no event may 2 the fine exceed an aggregate amount of $25,000 for all knowing 3 and willful violations arising out of the same action. In 4 addition to the fine, the PBM shall make restitution when due in 5 accordance with subsection (b). 6 (d) Failure to make restitution.--The failure of a PBM to 7 make restitution when due as required under this section 8 constitutes a willful violation of this act. However, if a PBM 9 in good faith is uncertain as to whether any restitution is due 10 or as to the amount of restitution due, it shall promptly notify 11 the department of the circumstances and the failure to make 12 restitution pending a determination of whether restitution is 13 due or the amount of restitution due will not constitute a 14 violation of this act. 15 CHAPTER 21 16 MISCELLANEOUS PROVISIONS 17 Section 2101. Regulations. 18 The department may promulgate regulations to carry out this 19 act. The regulations shall be subject to review in accordance 20 with the act of June 25, 1982 (P.L.633, No.181), known as the 21 Regulatory Review Act. 22 Section 2102. Applicability of Unfair Trade Practices and 23 Consumer Protection Law. 24 A violation of this act shall be deemed to be a violation of 25 the act of December 17, 1968 (P.L.1224, No.387), known as the 26 Unfair Trade Practices and Consumer Protection Law. 27 Section 2103. Effective date. 28 This act shall take effect in 60 days. B1L35MSP/20050H0714B0805 - 17 -