BILL ANALYSIS Ó SENATE COMMITTEE ON BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT Senator Jerry Hill, Chair 2015 - 2016 Regular Bill No: AB 627 Hearing Date: June 15, 2015 ----------------------------------------------------------------- |Author: |Gomez | |----------+------------------------------------------------------| |Version: |May 27, 2015 | ----------------------------------------------------------------- ---------------------------------------------------------------- |Urgency: |No |Fiscal: |No | ---------------------------------------------------------------- ----------------------------------------------------------------- |Consultant|Sarah Mason | |: | | ----------------------------------------------------------------- Subject: Pharmacy benefit managers: contracting pharmacies. SUMMARY: Updates Pharmacy Law related to reimbursement to pharmacies by pharmacy benefit managers for prescription medication dispensed to patients. Existing law: 1)Under the Pharmacy Law, provides for the licensure and regulation of pharmacies, pharmacists and wholesalers of dangerous drugs or devices by the Board within the Department of Consumer Affairs (DCA). (Business and Professions Code (BPC) § 4000 et seq.) 2)Establishes requirements for audits of pharmacy benefits. (BPC §§ 4430 - 4439) 3)Defines "Pharmacy audit" as an audit, either onsite or remotely, of any records of a pharmacy conducted by or on behalf of a carrier or a pharmacy benefit manager (PBM), or a representative thereof, for prescription drugs that were dispensed by that pharmacy to beneficiaries of a health benefit plan pursuant to a contract with the health benefit plan or the issuer or administrator thereof. "Pharmacy audit" does not include a concurrent review or desk audit that occurs within three business days of transmission of a claim, or a concurrent review or desk audit where no chargeback or recoupment is demanded. (BPC § 4430(f)) AB 627 (Gomez) Page 2 of ? 4)Defines "pharmacy benefit manager" (PBM) as a person, business, or other entity that, pursuant to a contract or under an employment relationship with a carrier, health benefit plan sponsor, or other third-party payer, either directly or through an intermediary, manages the prescription drug coverage provided by the carrier, plan sponsor, or other third-party payer, including the processing and payment of claims for prescription drugs, the performance of drug utilization review, the processing of drug prior authorization requests, the adjudication of appeals or grievances related to prescription drug coverage, contracting with network pharmacies, and controlling the cost of covered prescription drugs. (BPC § 4430(g)) 5)Defines "carrier" as a health care service plan, as defined in Section 1345 of the Health and Safety Code, or a health insurer that issues policies of health insurance, as defined in Section 106 of the Insurance Code. (BPC § 4430(a)) 6)Defines "health benefit plan" as any plan or program that provides, arranges, pays for, or reimburses the cost of health benefits. "Health benefit plan" includes, but is not limited to, a health care service plan contract issued by a health care service plan, as defined in Section 1345 of the Health and Safety Code, and a policy of health insurance, as defined in Section 106 of the Insurance Code, issued by a health insurer. (BPC § 4430(d)) 7)Provides that notwithstanding any other law, a contract that is issued, amended or renewed on or after January 1, 2013 between a pharmacy and a carrier or a PBM to provide pharmacy services to beneficiaries of a health benefit plan shall comply with the provisions of this chapter. (BPC § 4432) This bill: 1) Adds the following definitions to Pharmacy Law related to audits of pharmacy benefits: a) "Maximum allowable cost" (MAC) means the maximum amount that a PBM will reimburse a pharmacy for the cost of a drug. AB 627 (Gomez) Page 3 of ? b) "Maximum allowable cost list" (MAC List) means a list of drugs for which a maximum allowable cost has been established by a PBM. c) "Obsolete" means a drug that may be listed in national drug pricing compendia but is no longer available to be dispensed based on the expiration date of the last lot manufactured. 2)Requires a PBM that reimburses a contracting pharmacy for a drug on a MAC basis to comply with this section. 3)Requires a PBM to include information identifying any national drug pricing compendia or other data sources used to determine the MAC for the drugs on a MAC List in a contract entered into or renewed on or after January 1, 2016 with a contracting pharmacy. 4)Requires a PBM to make available to a contracting pharmacy, upon request, the most up-to-date MAC List or lists used by the PBM for patients served by that pharmacy in a readily accessible, secure, and usable Web-based format or other comparable format. 5)Prohibits a drug from being included on a MAC list or reimbursed on a MAC basis unless all of the following apply: a) The drug is listed as "A" or "B" rated in the most recent version of the federal Food and Drug Administration's (FDA) approved drug products with therapeutic equivalent evaluations, also known as the Orange Book or has an "NA" or "NR" rating or a similar rating by a nationally recognized pricing reference, such as Medi-Span or First DataBank. b) The drug is generally available for purchase in the state from a national or regional wholesaler. c) The drug is not obsolete. 6)Requires a PBM, for contracts entered into or renewed on or after January 1, 2016, to review and make necessary adjustments to the MAC of each drug on a MAC List using the most recent data sources available at least once every seven AB 627 (Gomez) Page 4 of ? days and requires a PBM to have a clearly defined process for a contracting pharmacy to appeal the MAC for a drug on a MAC List. Requires the appeal to be based on either the fact that the MAC for a drug is below the cost at which the drug is available for purchase by similarly situated pharmacies in the state from a national or regional wholesaler or the drug did not meet the requirements to be included on a MAC list. Provides a contracting pharmacy no less than 14 business days following receipt of payment for the claim upon which the appeal is based to file an appeal with a PBM. Requires a PBM to make a final determination regarding a contracting pharmacy's appeal within seven business days of the PBM receiving the appeal. 7)Provides that if a PBM denies an appeal, the PBM must provide the reason for the denial and the national drug code (NDC) of an equivalent drug that may be purchased by a similarly situated pharmacy at the price that is equal to or less than the MAC of the appealed drug to the contracting pharmacy. 8)Provides that if an appeal is upheld by a PBM, the PBM must adjust the MAC of the appealed drug for the appealing contracting pharmacy and all similarly situated contracting pharmacies in the state within one calendar day of the date of determination. Requires the PBM to allow the appealing pharmacy to reverse and resubmit the claim upon which the appeal was based in order to receive the corrected reimbursement. 9)Prohibits a contracting pharmacy from disclosing the MAC list and any information it receives from a PBM or through a pharmacy services administrative organization to a third party. FISCAL EFFECT: None. This bill has been keyed "nonfiscal" by Legislative Counsel. COMMENTS: 1. Purpose. The California Pharmacists Association is the Sponsor of this measure. According to the Author, pharmacies generally purchase prescription drugs and pay for them up AB 627 (Gomez) Page 5 of ? front. When a patient with health coverage is prescribed a covered drug that is dispensed by a contracted pharmacy, the health plan or insurer (or a contracted pharmacy benefit manager (PBM)) reimburses the pharmacy for the cost of the drug dispensed as well as a pre-set professional dispensing fee. According to the Author, most health plans and PBMs reimburse pharmacies for name brand drugs based on national pricing lists and for generic drugs based on proprietary maximum allowable cost (MAC) lists which PBMs establish based on national and regional drug pricing data in an attempt to reimburse pharmacies as close as possible to the current market rate for drugs. According to the Author, drug prices fluctuate frequently and if the price of a drug increases, the pharmacy pays that higher price. The Author adds that if a PBM does not update its MAC list regularly, the pharmacy may be reimbursed far less for a drug than they paid to acquire it, incurring a financial loss. The Author states that the percentage of generic drugs dispensed at a loss to pharmacies has increased significantly in recent years due to frequent price increases in generic drug prices. While pharmacies can appeal these rates to a health plan, insurer, or PBM, the Author notes that they frequently receive no response for several months, all the while receiving negative reimbursement for subsequent dispensing of the drug in question. Through this bill, the Author wishes to prevent pharmacies from potentially stopping purchasing a drug altogether in instances where the acquisition cost of the drug and the MAC list rate is significantly different, thus ensuring that patients can obtain prescription drugs and pharmacies do not suffer unnecessary financial losses. 2. Pharmacy Benefit Managers (PBMs). According to a 2005 Federal Trade Commission report on Pharmacy Benefit Managers (PBMs) and mail-order pharmacies, many health plan sponsors offer their members prescription drug insurance and hire PBMs to manage these pharmacy benefits on their behalf. As part of the management of these benefits, PBMs assemble networks of retail and mail-order pharmacies so that the plan sponsor's members can fill prescriptions easily and in multiple locations. When a consumer fills a prescription at a local pharmacy, the pharmacist usually asks whether the consumer has insurance to cover the prescription's cost. If there is AB 627 (Gomez) Page 6 of ? coverage, the consumer provides the insurance card to the pharmacist. While the pharmacist fills the prescription, sophisticated computer interactions between the pharmacy and the PBM ensure that the prescription is filled according to the insurance coverage provided by the plan sponsor. According to the report, the consumer usually is unaware of these processing interactions, and the consumer's only additional responsibility is to pick up the filled prescription and pay the retail pharmacy the copayment that is due. According to the Sponsor, legislation similar to this bill has passed in seventeen states since 2013 and fifteen states currently have pending legislation to address appeals and transparency in MAC-based pharmacy reimbursement. 3. Arguments in Support. The California Pharmacists Association (CPhA) notes that it will establish fair standards for reimbursement to pharmacies and enacts important transparency and accuracy requirements that will help independent community pharmacies continue to provide care to California patients. CPhA writes that "Like all healthcare providers, pharmacies cannot care for patients when they are forced to continually do so at a loss. This bill sets fair standards that ensure pharmacies can continue serving patients while also allowing health plans and PBMs to control costs through the use of fair MAC-based reimbursement. 4. Suggested Author's Amendment. The provisions of this bill and chapter in Pharmacy Law for audits of pharmacy benefits apply to PBMs offering services as part of a Department of Managed Health Care licensed health plan or Department of Insurance licensed health insurer. However, CompPharma (PBMs who operate in the workers' compensation market) is concerned that this bill lacks clarity about whether the provisions would in fact apply to contract standards for pharmacy networks set by the Division of Workers' Compensation (DWC), and thus subject PBMs like CompPharma members to the requirements set forth in the bill. Under the Labor Code, DWC has the authority to set contract standards for pharmacy networks. The Labor Code also establishes maximum reimbursement fees for pharmacy services provided to injured workers, and DWC has established an independent bill review process for claim disputes. AB 627 (Gomez) Page 7 of ? In order to remove any possible confusion about whether workers' compensation PBMs would be subject to the requirements of this bill, given the fact that DWC has authority over their contracts, the Committee suggests that the Author amend BPC Section 4432 to ensure contracts are not those for workers' compensation PBMs. On page 3, between lines 27 and 28, insert: SEC. 2. Section 4432 of the Business and Professions Code is amended to read: 4432. Notwithstanding any other law, a contract that is issued, amended, or renewed on or after January 1, 2013, between a pharmacy and a carrier or a pharmacy benefit manager to provide pharmacy services to beneficiaries of a health benefit plan shall comply with the provisions of this chapter. This chapter shall not apply to contracts authorized by Section 4600.2 of the Labor Code. On page 3, in line 28, strike "SEC. 2." and replace with "SEC.3." SUPPORT AND OPPOSITION: Support: California Pharmacists Association (Sponsor) Opposition: None on file as of June 9, 2015. -- END --