Pharmacy Benefit Manager Legislation
On October 10th, 2018, the Patient Right to Know Drug Prices Act became law. The Senate approved it by a 98-2 vote, and President Trump signed it into law. It prohibits gag clauses, which are provisions in PBM contracts that prohibit pharmacists from telling customers they could save money by paying cash out-of-pocket instead of using their insurance.
(Click here for specific Maximum Allowable Cost statutes)
S.B. 283 (2012); effective 8/1/2012: This bill requires providers of state-regulated insurance plans to provide coverage for the diagnosis and treatment of individuals with autism spectrum disorders through age 9 (Senate)/ through age 18 (House), and place no dollar cap on the annual benefit, except for ABA therapy at $50,000 per year.
AK 240, passed and signed into law, effective 09/04/2018. This law bans PBM gag clauses in contracts that prohibit pharmacies from telling patients about cheaper ways to buy drugs, and authorizes a role for the director of the division of insurance affecting drug benefits.
AK S 37, passed and signed into law on 7/24/2018. This law gives the Board the power to license and inspect the facilities of wholesale drug distributors, third-party logistics providers (PBMs), and outsourcing facilities located outside of Alaska.
AZ H 2107 (2018); signed into law by the Governor on 4/5/2018. This law prohibits PBMs from having gag clauses that forbid pharmacists or pharmacies from telling patients about cheaper ways to buy drugs, and prohibits PBMs from penalizing pharmacies for disclosing this information. It also prohibits PBMs from requiring pharmacies to collect copays that exceed their total submitted charges.
AR H 1010 (2018): Signed into law on 3/5/2018. This law prohibits gag clauses-PBMs can't proscribe pharmacies or pharmacists from discussing prescription drug costs or selling more affordable alternatives to patients.
AR S 542 (2015): This law modifies the responsibilities of a PBM and patient rights regarding payment for pharmacists' services. It provides that no one has to pay more for these services than the pharmacy may retain from all payment sources.
S.B. 1138 (2013): This is a transparency bill that should keep pharmacists better informed about how PBMs determine Maximum Allowable Costs (MACs). It passed the Senate unanimously with one vote against in the House, and was signed into law on April 12, 2013.
S.B. 688 (2015): Strengthens Arkansas’s existing MAC law enacted in 2013, attempting to create accountability in prescription drug pricing. Signed into law on April 1, 2015.
S.B. 487 (2015): This law addresses PBM registration as a third party administrator and will ideally develop a more structured pathway for PBM enforcement and oversight.
§17-92-1201: This law creates a Bill of Rights to be followed for any entity conducting an audit of a pharmacy.
§4-88-801 through 804: Requires PBMs to itemize by individual claim the amount actually paid to the pharmacy or pharmacist, and an identifier of the pharmacist services.
§Act 1007: This act preserves the professional independence of a pharmacist/pharmacy. Additionally this act limits the the retaliatory actions that a PBM can engage in vis a via a pharmacy.
Act 1194: Regulates how drugs can be put on the MAC list as well as requires the MAC lists be made available to pharmacies. The act also requires that necessary updates be performed on the MAC list every 7 days. It also creates an appeals process for pharmacies to dispute MAC price billing with PBMs. (Act signed into Law April 12, 2013)
CA S 1021 (2017): Signed into law on 9/26/2018. The bill prohibits drug formularies maintained by health insurers or health care service plans from containing more than four tiers. It also requires prescription drug benefits to provide that patients don't have to pay more than the retail price for a prescription drug if the retail price is less than the applicable copay.
A.B. 315 (2017): Signed into law on 9/29/2018. This bill requires PBMs to obtain licenses from the Board of Pharmacy, requires that PBMs have fiduciary duties to their health plan clients, and requires PBMs to disclose data regarding drug costs, rebates, and fees earned to their clients.
S.B. 1195 (2012): This bill would impose specified requirements on an audit of pharmacy services provided to beneficiaries of a health benefit plan. Among other things, the bill would prohibit the entity conducting the audit from receiving payment on any basis tied to the amount claimed or recovered from the pharmacy. Signed into law September 28, 2012.
A.B. 627 (2015): This bill would exempt certain contracts from the requirements governing the medicines and medical supplies that must be provided to injured employees in workers’ compensation cases. Signed into law July 13, 2015.
BPC §9.5-4430 through §4439: This law dictates the procedures governing how entities may conduct audits of pharmacies, specifically the regulations governing the timing of the audit as well as an appeals process for the pharmacies being audited.
CO H. 1284 (2018): Signed into law. This bill prohibits contracts that gag or penalize a pharmacy or pharmacist from providing patients with information about their cost shares, drug costs, or cheaper alternative drugs.
H.B. 14-1213 (2014): This bill concerns PBMs' MAC pricing requirements for prescription drugs, and, in connection therewith, making and reducing appropriations. Signed into law on June 6, 2014.
H.B. 1359 (2014): This bill concerns the creation of the Achieving a Better Life Experience (ABLE) Savings Program for individuals with disabilities. Signed into law on May 17, 2014.
§10-16-122: This law governs how PBM networks will be set up, and that any PBM or intermediary whose contract with a carrier includes an open network shall allow participation by each pharmacy provider in the contract service area. Additionally that no PBM or carrier offering a managed care plan shall transfer or request that a pharmacy provider transfer the prescriptions of a covered person to a different participating pharmacy provider unless certain conditions are met.
H.B. 13-1221: This law sets standards for a PBM or entity acting on behalf of a PBM to follow when auditing a pharmacy. The auditing entity shall give written notice prior to conducting an audit as well as conducting the audit with a licensed pharmacist when required. Further it forbids certain techniques in calculating the amount of recoupment or penalty and establishes a process for Pharmacies to appeal or dispute a claim. (Signed into law by Governor April 8, 2013)
CT H. 5384 (2018): Enacted on 5/31/2018. This bill requires drug companies to disclose net drug cost after rebates and to inform the state Office of Health Strategy when a company has submitted a drug approval application to the US Food and Drug Administration, and requires disclosing price increase justifications to the Office, which must be posted on the state website. Also, the Office of Health Strategy has to annually list the top 10 drugs whose wholesale acquisition cost has increased by 25 percent and that represent substantial state spending. Finally, the bill imposes additional disclosure and reporting requirements on PBMs concerning prescription drug rebates and the cost of prescription drugs
CT S 445 (2017): Signed into law on 7/10/2017. This bill prohibits future legislation preventing pharmacists from disclosing information to people purchasing drugs. It also prohibits health carriers or PBMs from requiring an individual to pay more for covered prescriptions than the lesser of the applicable copayment, the allowable claim account, or the amount an individual would pay for the drug if they had no insurance plan. It further authorizes the Insurance Commissioner to audit PBM contracts for compliance and to enforce violations by voiding contracts that are unfair.
S.B. 14 (2014): This act concerns copayments for breast ultrasound screenings and occupational therapy services. Signed into law on June 12, 2014.
S.B. 445 (2017): No contract between a PBM and a health carrier or pharmacist will have a section prohibiting the pharmacist from disclosing any relevant information to people buying drugs. This includes the cost of the medicine, reimbursement to the pharmacist, how effective the medicine is, or whether there are less expensive medications.
H.B. 5771 (2015): Authorizes pharmacists to dispense drugs in ninety-day quantities. Signed into law on June 23, 2015.
Act 07-200: This act governs the process that PBMs must engage in in order to receive a certificate of registration from the Connecticut Insurance Department. Also the act lays out what recourse the Insurance Commissioner has regarding PBMs who act contrary to the established rules.
DE H 425 (2018): Signed into law on 8/28/2018. This bill bans gag clauses-it establishes that a contract between a PBM and pharmacy can't stop the pharmacy from providing patients with information about drug prices or cost shares.
DE H 441 (2018): Enacted on 8/28/2018. This bill says a PBM may not require prior authorization for coverage of a 72 hour supply of medication that is for a non-controlled substance in an emergency situation.
FL H 351 (2018): Signed into law on 3/23/2018. This bill prohibits managed care plans from contracting with PBMs unless the PBMs meet certain requirements; among them that pharmacists shall inform customers of lower cost generic drugs for their prescriptions.
H.B. 1049 (2015): This bill requires the pharmacy benefits manager to periodically update the maximum allowable cost pricing information to remain consistent with changes in certain pricing data. Signed into law on June 10, 2015.
S.B. 702 (2014): An act relating to pharmacy audits, enumerating the rights of pharmacies relating to audits of pharmaceutical services. Signed into law on June 13, 2014.
Title XXXII §465.188: This law governs how entities may audit pharmacies participating in Florida Medicaid
programs. Specifically, this act particularly governs the timing of the audits, as well as the time period for which an auditor may look at.
GA H 276 and GA S 103 (2017): Signed into law on 5/8/2017. These bills ban gag clauses-forbids PBMs to have gag clauses or penalize pharmacies for disclosing information to patients, or selling them cheaper drugs if they are available. The Commissioner of Insurance can also investigate. Finally, PBMs can't require the use of mail order pharmacies, and pharmacies can't charge copays that exceed total charges.
§26-4-110.1: This law with a few exceptions requires PBMs to be licensed as pharmacies. As a function of being licensed as a pharmacy the PBM shall be obliged to permit inspections of their premises.
§26-4-118: This law governs the timing as well as the period of time under investigation for PBM audits of pharmacies. Additionally this law regulates the rights of pharmacies in responding to audits and establishes an appeals process to contest the PBMs conclusions.
H.B. 470 - Represents an agreement between interest groups and PBMs. Gives Georgia's Commissioner of Insurance enforcement authority over the Audit Bill of Rights and PBMs, including the ability to impose fines. Requires PBMs update MAC pricing every five days and that notification must include where drugs can be purchase. Provides standards for PBMs must correct a MAC, an appeals process, and standards for how drugs are MAC'd. Signed into law on April 1, 2015.
HI S 3104 (2017): This bill establishes requirements for PBMs and Maximum Allowable Cost, requiring PBMs to make MAC prices available to pharmacies and to have a clear process for appeals and complaints. It clarifies penalties for MAC violations, and allows contracting pharmacies to disclose the MAC list.
H.B. 62: This law aims to prohibit PBMs from using a patient's claim information to market or advertise to that patient the services of a preferred pharmacy network that is owned by the PBM. It goes on to say that a PBM company shall take no action that would restrict a patient's choice of pharmacy from which to receive prescription drug benefits. Signed into law July 2, 2013.
ID SCR 145, ID S 1289, ID S 1336 (2018): These bills would have established a committee to study PBM transparency (Bill 145), required PBMs to provide financial and utilization information to covered entities (Bill 1289), and provided for applicability, provided for required practices for pharmacy benefit managers, provided for enforcement, and provided maximum allowable cost transparency requirements for PBMs (Bill 1336).
IL S 1971 and IL H 3572 (2018): These bills provided regulation for the creation of a list of drugs used to set the maximum allowable cost (MAC) on which reimbursement to a pharmacy or pharmacist may be based, provided that before a PBM places or continues a particular drug on a maximum allowable cost list, the drug shall meet specified requirements, and provided for the duties of a PBM in his or her use of a MAC list, and provided for a reasonable administrative appeal. Both failed to pass.
IN H 1317 (2018): Passed on 3/25/2018. This law says state employee plans may not prohibit pharmacies from providing patients with information about drugs, especially more affordable alternative versions. And state employee plans may not require patients to pay more for drugs than their copays or deductibles, or the amount the pharmacy would charge if individuals were not covered.
§25-26-22: This law governs the procedures that a PBM must abide by when drafting an audit contract as well as the processes for conducting an audit. Additionally, the law dictates the time allowances and constraints that must be followed by both the PBM and the pharmacy regarding the auditing.
IA S 2298: This bill relates to the Board of Pharmacy composition and amends rules relating to the limited distributor license and the wholesale distribution of prescription drugs and devices, includes penalties
§510B.1 through §510B.7: This law requires that PBMs doing business in Iowa obtain a certificate as a third-party administrator and follow the rules outlined for third-party administrators that was previously set out. The law also regulates the process and procedures for the dispensing of substitute prescription drugs. Additionally the law provides a guide for the distribution of data while simultaneously forbidding the process of extrapolation.
HF 2297: This law regulates PBM management of Maximum Allowable Costs. Among the various provisions is a requirement for the PBM to include in its contract information regarding which of the national compendia is used to obtain pricing data used in the calculation of the maximum reimbursement amount pricing and a process to allow a pharmacy to comment on, contest, or appeal the maximum reimbursement amount rates or maximum reimbursement amount list. (Signed by the Governor March 14, 2014)
KS S 351 (2018): Signed into law on 3/29/2018. This law says that a pharmacy or pharmacist shall have the right to provide a covered person with information regarding the amount of the covered person's cost share for a prescription drug, and that co-payments applied by a health carrier for a prescription drug may not exceed the total submitted charges by the network pharmacy.
H.B. 2182: This law regulates the the timing and procedures for audits, including who must be present as well as how much prior written notice is required to conduct an on-site initial audit. The law also regulates the appeals process should the pharmacy contest the audit. Signed into law on June 9, 2011.
§40-3821 through §40-3828: This law requires PBMs to obtain certificates of registration from the insurance commissioner in order to do business in Kansas. It also states that there is a fee for obtaining this registration and that the insurance commissioner can adjust or adopt new rules concerning the certification.
KY S 5 (2018): Enacted on 4/13/2018. This law requires the Department for Medicaid Services to directly administer all outpatient pharmacy Medicaid benefits, and prohibits renewal or negotiation of new contracts to provide Medicaid managed care that allow administration of outpatient benefits by any entity but the Department for Medicaid Services, and reduces costs of future Medicaid managed care contracts by costs of all outpatient pharmacy benefits as they existed on a specified date. Department for Medicaid Services may change reimbursement rates, PBMs must give Department 30 days notice of proposed changes over 5 percent.
KY H 463 (2018):
§304.17A-740 through §304.17A-747: This law governs the timing and procedures for the audits of pharmacies by PBMs. It dictates what access pharmacists have to records and information to verify the pharmacy's records. Additionally the law discusses procedures as well as standards for how compensation for overpayments will be addressed.
HB 349: (2012) This law amended KRS 304.17A-741, to prohibit an auditing entity from requiring a pharmacy to keep records longer than two years, or longer than required by state or federal law. This law also prohibited an auditing entity from receiving payment based on the total amount recovered in an audit. Signed into law April 4, 2012.
SB 107: This law requires PBMs to include the methodology used to calculate drug product reimbursements as well as sets certain requirements surrounding the Maximum Allowable Cost. A PBM must include information identifying the national drug compendia or source used to obtain the drug price. Additionally a PBM must review the list of drugs subject to the MAC and to update it and make changes at least once every seven days. Signed into Law March 22, 2013.
KY H 463 (2018): Signed into law on 4/10/2018. This law defines cost sharing and prohibits PBMs from requiring payment for drugs in excess of available price choices. It also prohibits gag clauses and requires that any amount paid by insured people under this section is attributable toward any out-of-pocket maximums under their health benefit plans.
KY S 5 (2018): Enacted on 4/13/2018. The law requires the Department for Medicaid Services to directly administer all outpatient pharmacy Medicaid benefits, prohibits renewal or negotiation of new contracts to provide Medicaid managed care that allow administration of outpatient benefits by any entity but the Department for Medicaid Services, reduces costs of future Medicaid managed care contracts by costs of all outpatient pharmacy benefits as they existed on a specified date. Department for Medicaid Services may change reimbursement rates. PBMs must give Department 30 days notice of proposed changes over 5 percent.
S. 241 (2018): Signed by Governor into law on 5/18/2018. This law bans gag clauses, stating that no PBM or other entity shall prohibit pharmacies or pharmacists from informing patients of all relevant options when buying drugs. This includes lower cost alternative drugs.
S. 108 (2018): Enacted on 5/25/2018. This law requires the quarterly submission of certain data regarding PBMs, including total dollar amounts retained by the PBM and rebates.
S. 130 (2018): Enacted on 5/25/2018. This law establishes requirements for Medicaid contracts or subcontracts for PBM services, includes provisions on fees, supplemental rebates, pricing, and contract termination. Any contract fo PBM services shall be limited to a transaction fee. No PBM may retain any portion of spread pricing. No PBM shall retain any portion of state supplemental rebates or credits.
§22:1856.1: This law establishes rules concerning the timing and process that PBMs must abide by with regards to pharmacies. It spells out the regulations concerning recoupment of assets, as well as the appeals process that must be made available to pharmacists who wish to contest the audits findings.
S. 282 (2018): Enacted on 5/31/2018. This law defines excessive consumer cost burdens and rebates in the legal statutes.
S. 283 (2018): Enacted on 5/20/2018. This law requires PBMs to provide information about formularies, and to submit a transparency report every year with aggregate rebates and aggregate administrative fees.
H. 436 (2018): Enacted on 5/31/2018. This law provides amendments for the regulation of pharmacy benefit managers (PBM) and maximum allowable cost (MAC). PBMs are not allowed to prohibit pharmacies from disclosing costs and clinical alternatives to patients. It provides for reimbursements to non-affiliate pharmacies. It also changes time frame for administrative appeals relating to MACs.
ME S 10 (2018): Signed into law on 5/5/2018. This law prohibits PBMs from imposing copays that exceed prescription drug claim costs, and prohibits gag clauses. PBMs also can't penalize pharmacies for providing information about drug costs or alternatives to patients.
L.D. 44: This law limits the total amount that may be recouped in pharmacy audits to dispensing fees, unless a misfill occurs. The Law also limits access by pharmacy auditors to certain records as well as requires auditors to give advance notice of an audit. The law also specified that to preserve the neutrality of an audit, the auditor must use a random sample of pharmacy transactions so as to not unduly influence the audit. Signed into Law by Governor May 7, 2013.
MD S 576 and MD H 736 (2018): Signed into law on 4/24/2018. These bills prohibit PBM gag clauses in contracts-pharmacies and pharmacists can provide patients with information about retail drug prices, cost shares, or cheaper alternatives.
MD S 1079 (2018): This bill authorizes the State Insurance Commissioner to require certain additional information from a PBM, clarifies that certain actions of the Commissioner are subject to certain hearing provisions, and provides that a provision prohibiting reimbursements of a certain amount does not apply to reimbursements for certain drugs or to chain pharmacies. It requires a PBM to use updated pricing information in calculating payments immediately after a certain update. Vetoed by Republican Governor Larry Hogan on 5/25/2018.
MD S 1349 (2018): Enacted on 5/8/2018. This bill makes revisions to legislation regarding Pharmacy Benefits Managers (PBMs). It authorizes the Maryland Insurance Commissioner to require additional information from a PBM in a certain application, requires a PBM to use updated pricing information in calculating certain payments and alters certain requirements of a pharmacy benefits manager. It also adds additional clauses for the Commissioner concerning appeals, complaints, fees, and fines.
§15-10B-20: This law requires the Insurance Commissioner to conduct an examination of any PBM registered as a private review agent to ascertain if the PBM is acting in compliance with Maryland law. This review is to take place at least once every 3 years.
§15-1601 through §15-1610: This law regulates how PBMs may negotiate their contracts with pharmacies, including what must be disclosed as well as the timing for specific actions like audits. Additionally the law outlines the process that must be followed during during an after an audit as well as specifying the appeals process for pharmacies.
§15-16-1629: This law further specifies the requirements and processes regarding audits of pharmacies by Pharmacy Benefit Managers. For instance it outlines that an on-site audit of a pharmacy may not be conducted during the first five calender days of a month unless requested by a pharmacy or pharmacist. The law also outlines the processes for validating the pharmacy records as well as who may have access to what.
Title XXII-176D-3B: This law specifies how PBMs within Massachusetts may structure their restricted pharmacy networks as well as the requirements that may be imposed on pharmacies wishing to participate in the restricted network. To ensure that fair and competitive bidding ensue, the PBM must ensure that equal requirements are imposed on the prospective pharmacies and that equal information is dispersed.
MI H 5858 (2018): This bill requires contracts with third party administrators to allow pharmacies to disclose current drug prices. It also would have banned a PBM from including a gag clause. However it did not pass.
MN S 2669 (2018): The bill would have banned gag clauses, but it failed to pass the Senate Committee on Health and Human Services, and so died.
MN S 2597 (2018): The bill would have required the licensing of PBMs. It failed to pass on 2/22/2018.
MN H 3131 (2018): The bill would have prohibited drug manufacturers and PBMs from engaging in price increases. The State Attorney General could obtain drug pricing information and take action against drug companies and PBMs, and impose penalties.
§151.60 through §151.70: This law governs how PBMs may write their contracts with pharmacies. Specifically it addresses the notice period needed for changes in contracts or audit terms as well as the scope of information that can be required. Additionally the law describes the standards and processes for over-payment recoupment as well as the appeal process for a pharmacy wanting to contest the PBMs conclusions.
MS H 709 (2018): Signed into law on 3/8/2018. This law specifically says pharmacists can provide additional information to patients about drug prices and alternative drugs, and that all gag clauses are null and void.
MS H 456 (2016): Enacted into law. This bill states that pharmacies or pharmacists that contract with PBMs to provide covered drugs at negotiated reimbursement rates may decline to provide certain drugs or services if the network pays less than the acquisition cost for the product.
§73-21-151 through §73-21-159: This law regulates how PBMs must interact with the state Insurance Department as well as who will monitor the PBMs compliance with state laws. Additionally the law regulates the reference material that PBMs must use in making their pricing calculations. It should be noted that several sections of this law have been repealed as of July 1st, 2013.
§73-21-179 through §73-21-191: This law requires PBMs to clearly identify and describe the audit procedures that appear in their contracts with pharmacies. The law specified particular issues of timing and focus that the PBM must adhere to in conducting their audit. This includes the sample size under investigation, as well as policies involving overpayment and recoupment.
MO H 1542 (2018): This bill prohibits gag clauses. "No pharmacy benefits manager shall restrict or interfere with a pharmacists 's ability to provide pharmacy care to a covered person, including providing pharmacist-patient communications and discussing alternative drug options. No pharmacy benefits manager shall charge or hold a pharmacist or pharmacy responsible for any fee that is related to a claim unless the amount of the fee can be determined and has been dis closed to the pharmacist or pharmacy at the time of the claim's adjudication." However it did not pass the legislature.
Title XXII §338.600: This law outlines and establishes standards for audits of pharmacies by managed care companies, insurance companies, third party payors or any entity that represents such groups. It requires that when an entity audits a pharmacy, the entity will use the same standards and parameters consistently. Additionally, the law sets out standards for appeals processes for pharmacies that contest the auditors conclusions.
S.B. 211: Establishes procedures for maximum allowable cost lists for prescription drugs. Before PBMs put drugs on MAC lists, the drugs must be listed as A or B and be available for purchase by pharmacies in the state from wholesalers. When PBMs enter into contracts with pharmacies, they shall provide the pharmacies with the sources used to determine pricing for the MAC list. They will also provide a procedure for appeals. Signed into law on May 5, 2015.
NE L 324 (2018): The bill would have adopted the Pharmacy Benefit Fairness and Transparency Act, requiring PBMs to disclose to their customers the rebates and discounts obtained from manufacturers and their pricing structure. However it failed to pass.
S.B. 539: (2017) Passed the legislature and was enacted into law on 6/15/2017. The bill mandates transparency for both PBMs and pharmaceutical companies. Also requires that health care nonprofits disclose any contributions they receive from the pharmaceutical industry, PBMs, or insurance companies.
NH S 481 (2018): Enacted on 5/30/2018. It establishes a committee to study the impact of PBM operations on cost, administration, and distribution of prescription drugs. Committee is to report findings by November of 2018.
NH S 591 (2018): Enacted on 6/8/2018. It states that a PBM shall not require accreditation of providers other than requirements set forth by the New Hampshire pharmacy board or other state or federal entity.
NH S 1746 (2018): Enacted on 5/25/2018. It prohibits a pharmacy benefit manager (PBM) from requiring accreditation, credentialing, or licensing of providers other than by the New Hampshire Pharmacy Board or other state or federal entity.
NH H 1791 (2018): Signed into law by the Governor on 6/7/2018. This bill prohibits gag clauses and says that pharmacists may only substitute biological products if the FDA has licensed them as interchangeable.
H.B. 1664: Requires contracts between carriers and PBMs to include the sources PBMs use to calculate the drug price reimbursement paid for covered drugs, an appeals process to resolve disputes about MAC pricing, and conditions for drugs to be included on the MAC list. Signed into law on June 3, 2016.
NJ A 2214 (2018): This bill would have prohibited PBMs from collecting copays in excess of certain amounts of clawbacks, and banned gag clauses. However it did not emerge from committee.
S. 2301: This law requires PBMs to include sources used to determine generic drug pricing in contracts they have with pharmacies. They must also maintain a procedure to eliminate drugs from the list of drugs subject to multiple source generic drug pricing or to modify MAC rates in a timely fashion. Also, only drugs that meet certain conditions can be placed on the list. Signed into law on January 11, 2016.
H.B. 126: This legislation would provide a reasonable degree of transparency over how MAC pricing is determined and reported. The legislation also takes additional steps to reform PBM activities in New Mexico. This law will help preserve patient access to prescription drugs and better protect New Mexico’s small business community pharmacies from being reimbursed at a financial loss. It will establish guidelines and notice provisions for Maximum Allowable Cost for drugs and a system for challenging the MAC pricing. (Signed into law by the Governor March 5th, 2014).
§61-11-18.2: This law obligates managed care companies, insurance companies, third-party payors or their representatives to follow particular regulations and standards when conducting audits. The law gives pharmacies certain rights with respect to what must be provided to auditors as well as on what time frame. Among those rights include a guaranteed appeals process for the pharmacy to dispute the auditors conclusions. It should be noted that some sections of this law will be repealed as of July 1st, 2016.
NY S 2763 (2018): The bill would have enacted provisions governing the conduct of audits of pharmacies by PBMs, provided timeframes for reports, specified documentation to be used, and exempted certain investigations. However it failed to pass.
NY A 8781 (2018): The bill would have prohibited PBM gag clauses in contracts. However it passed the Senate but advanced no further.
A05502B: This law prohibits health insurers from requiring the insured purchase prescribed drugs from a mail order pharmacy or pay a co-payment fee when such purchases are not made from a mail order pharmacy if a similar fee is not charged for drugs from a mail order pharmacy.
S3346: This law establishes a pharmacy benefit manager contract appeals process for generic drugs and lays out the process's conditions. Signed into law on December 11, 2015.
NC H 466 (2018): Signed by the Governor into law on 7/18/2017. This law provides for consumer protections and bans gag clauses-pharmacies shall have the right to provide patients with cost share and drug price information, and cannot be penalized by a PBM for doing so.
§90-85.50 through 90-85.53: This law provides rights for pharmacies who would be audited by managed care companies, insurance companies, third-party payers or other entities. This includes a notice period prior to the start of the audit as well as an appeals process for the pharmacy. The law also describes the processes that must be followed for entities seeking recoupment of funds following an audit.
ND S 2258 (2017): Signed into law on 7/5/2017. This law bans gag clauses, and prohibits fee requirements from PBMs if metrics fall within the criteria for improvement.
§26.1-27.1-01 through §26.1-27.1-07: This law requires that for PBMs to conduct business in the North Dakota they must obtain a certificate of registration as an administrator. Additionally PBMs must comply with the laws concerning drug substitution for prescriptions that will be filled. Further PBMs may not require a pharmacy to participate in one contract in order to participate in another contract. It also states that a PBM may not exclude an otherwise qualified pharmacy from participation in a particular network if the pharmacy accepts the terms, conditions, and reimbursement rates of the PBM's contract.
H.B. 1418: This law regulates entities conducting audits of pharmacies by providing ground rules that must be followed. These regulations include the timing of notice given to the pharmacy by the auditing entity, as well what documents or records are to be made available to the auditor. The law also establishes the standards for seeking recoupment for overpayment as well as underpayment. Additionally, the law mandates the that any entity conducting an audit shall establish a written appeals process. Signed into law April 25, 2011.
H.B. 1363: Requires the PBMs to every year divulge the market-based source utilized to determine MAC and update the pricing information every seven calender days. Also ensures that the MAC prices are not set below market-based sources available for purchases without limitations by pharmacy providers. (Signed into Law April 12, 2013) - See our letter in support of H.B. 1363.
S.B. 2258: This law provides protection for pharmacies from charges that are not apparent at the point-of-sale or at the time the PBM processes the claim for the dispensed drug. It also prohibits PBMs from charging patients co-pays that exceed the cost of their medication and prohibits PBMs from automatically clawing back from the pharmacy the portions of co-pays that have been paid by the patient. (Signed into Law April 5th, 2017).
S.B. 2301: This law requires PBMs to provide more transparency for employers and to disclose if the PBM practices spread pricing. It also requires PBMs with ownership interests in mail order pharmacies to agree to fair competition and no self-dealing, and requires a firewall between the mail order pharmacy and the administrative functions. Signed into law on April 5, 2017.
OH H 479 (2018): This law requires pharmacies to share information about lower cost alternative drugs with their patients. It also forbids PBMs from requiring cost sharing in an amount greater than the amount someone would pay for the drug without coverage, or the net reimbursement for the drug.
OK S 1573 (2018): This bill prohibited PBMs from assessing fees under certain conditions, set forth prohibited acts, and directed the Oklahoma Insurance Commissioner to promulgate certain rules. However it failed to pass.
§59.356: This law necessitates that entities that would audit pharmacies clearly identify and describe the procedures of the audit within their contracts. The law goes on to define the process to be followed for entities seeking recoupment of disputed funds. Additionally, the law specifies that the entity conducting the audit must make available a written appeals process for pharmacies wishing to dispute the conclusions of the auditing entity.
OR H 4103 (2018): This bill would have limited PBMs' ability to require or encourage enrollees to fill or refill prescription drugs at mail order pharmacy, and prohibited PBMs from requiring special credentialing or similar requirements for pharmacists licensed by State Board of Pharmacy. However it failed to pass and died.
H.B. 2123:- Requires PBMs to disclose to pharmacies the sources used to determine the MAC pricing at the start of each contract and upon each subsequent renewal of the contract. PBMs also can no longer include the dispensing fee in the calculation of the MAC. (Signed into Law July 1, 2013)
RI S 2406 (2018): This bill would allow pharmacists to provide information to patients about less expensive drug alternatives, effectively banning gag clauses. It would also limit charges for drugs to the lesser of usual price or co-pay, provide restrictions on credit for insurance coverage gaps, and prohibit pharmacy benefit managers from placing a pharmacy logo to be placed on an insurance or savings cards. The act did not pass.
§27-29.1: This law identifies PBMs as third-party administrators who are obligated to to fill out and submit annual reports with the department of business. Should a third-party administrator be owned or affiliated with another entity it would be required to provide an organizational chart and description demarcating all of the relationships among the affiliates within a holding company or otherwise affiliated.
SC H 5038 (2018): Enacted on 5/3/2018. This bill bans gag clauses-it states that a PBM can't prohibit a pharmacist or pharmacy from providing people information on the amount of their cost share for a prescription drug, can't charge or hold a pharmacist or pharmacy responsible for certain fees, or it can't retaliate against them for exercising rights.
SC S 815 (2018): This bill would have prohibited gag clauses and required a PBM to reimburse a provider within seven business days of payment by a payor. It did not pass.
§38-71-1810 through §38-7140: This law identifies the rights of pharmacies who would be audited by a managed care organization, insurer, third-party payor, or any entity that represents a responsible party. The pharmacy must have at least fourteen days advance notice of the initial audit for each audit cycle, with no audit to be initiated or scheduled during the first five days of any month without prior expressed consent from the pharmacy, which shall cooperate with the auditor to find an alternate date for the audit if the audit would fall within an excluded day. The law also outlines how the process of recoupment for overpayments must take place, and specifies that the pharmacy must have an access to an appeals period should they wish to dispute the auditors conclusions.
SD S 141 (2018): Enacted on 2/27/2018. This bill bans gag clauses-PBMs can't prohibit pharmacists or pharmacies from sharing information about drug costs, or retaliating against them.
§59-29E: This law mandates that PBMs must obtain a valid license to operate as a third party administrator to conduct business in South Dakota. Additionally, the law requires disclosure of revenue received from pharmaceutical manufacturers or labelers under contract with the manager. The law allows for covered entities to request information on the nature, type and amount of all other revenue received from a pharmaceutical manufacturer or labeler for programs that the covered entity offers to its enrollees. With that information, the covered entity may audit the records of the PBM as it relates to rebates or other incentives.
TN S 2362 (2018): Signed into law on 5/21/2018. This law states that pharmacists and pharmacies have the right to provide patients with information about their cost shares for prescription drugs and shall not be penalized for doing so.
§56-7-3103: This law regulates the manner and process through which a covered entity or PBM may audit a Pharmacy. It states that the PBM shall give at least two weeks prior written notice before conducting the initial on-site audit for each audit cycle. Additionally, the PBM conducting an audit is required to establish an appeals process under which a pharmacist or pharmacy may appeal an unfavorable report. The law also outlines the processes for recoupment of any disputed funds, specifically that it shall only occur after final internal disposition of the audit, including the appeal process set out within.
§56-7-3104: This law regulates the calculation of reimbursement used by pharmacy benefit managers. It states that reimbursement by a PBM to a pharmacy for prescription drugs or other products using a nationally recognized reference for pricing shall use the most current nationally recognized reference for the price amount. To that end, PBMs shall be required to update the nationally recognized reference prices used for calculation no less than every three business days.
§56-7-3201 through 3204: This law states that a PBM or other covered entity may not in any way restrict a pharmacy from disclosing to the patient or authorized representative the actual reimbursement for a particular prescription or covered service. The law also specifies that when PBMs provide patients with information regarding out-of pocket costs, such as co-pay, for a prescription or service, they must provide the patient the actual reimbursement.
§1551.224: This law forbids a board of trustees or a health benefit plan for Texan Government workers to require participation in mail order programs for the purchase of prescription drugs.
§2158.401 & §2158.402: This law mandates that a state agency, upon request of another state agency will disclose information cataloging the charge for services rendered by a PBM no later than 30 days after the date the information is requested.
SB 332: Relating to the use of maximum allowable cost lists related to pharmacy benefits. It specifies that drugs may only be put on MAC lists if they are not obsolete, generally available for purchase by pharmacists and pharmacies from national or regional wholesalers, and if they have certain ratings. PBMs have to update MAC pricing every seven days to reflect market changes, sources of pricing data have to be disclosed, and the PBM has to establish an appeals process. Signed into law on June 30, 2015.
§843.339: This law regulates the deadlines for action on prescription claims. It states that for electronically submitted claims which have been affirmatively adjudicated, the PBMs must pay pharmacies through electronic fund transfer no later than the 18th day after the date on which the claim was affirmatively adjudicated. If the claim was not submitted electronically, the PBM shall pay the amount to the pharmacy no later than the 21st day after the date on which the claim was affirmatively adjudicated.
§843.3401: This law governs how PBMs may audit Pharmacies. It forbids the use of extrapolation to complete the audit of a pharmacy, as well as outlines how on-site audits will be conducted. PBMs must provide notice to a pharmacy, in writing, through certified mail no later than 15 days before the on-site audit is scheduled to occur.
S.B. 1106: This law regulates what drugs can be placed on the MAC cost list. Specifies information that must be given to pharmacies when entering or renewing contracts as well as creates an appeals process if the for pharmacies to contest MAC reimbursement rates. (Signed into Law June 14, 2013)
H.B 1358: This law regulates the procedures for conducting audits of Pharmacies by PBMs. The law lays out the specifications for notice that must be given to a pharmacy prior to it being audited. The law further goes on to describe the different kinds of audits that can take place as well as who must be present for one to take place. (Signed into Law June 14, 2013)
UT S 208 (2018): Enacted on 3/19/2018. This bill bans gag clauses and required a PBM that uses direct or indirect renumeration to report reimbursement information to pharmacies.
§49-20-501 through §49-20-503: This law establishes requirements for transparency for PBMs. When the Utah State Retirement Board solicits requests for proposals from PBMs to provide pharmacy benefits management services for the Public Employee's Benefit and Insurance Program, the PBMs must provide a billing option that requires the PBM to on a monthly basis submit to the board an invoice for all pharmacy services paid by the PBM on behalf of the program. That invoice will include the total amount due to the PBM for all pharmacy services and the total amount paid by the PBM for all the same pharmacy services.
§58-17b-622: This law governs how the the audits of pharmacies may be conducted. Some of the guidelines include, mandating that audits that involve clinical or professional judgement are to be conducted by, or in consultation with a pharmacist who is licensed through a State agency. Some of the other guidelines specify the timing of the audits and how much notice prior notice must be given. Signed into Law March 28, 2013.
H.B. 113: This law regulates certain reimbursement practices of Pharmacy Benefits Managers including the Maximum Allowable Cost as well as appeal rights for Pharmacies. The MAC may be determined be determined by using comparable and current data on drug prices obtained from multiple nationally recognized, comprehensive data sources, including wholesalers, drug file vendors, and pharmaceutical manufacturers for drugs that are available for purchase by pharmacies in the state. The PBM is however responsible for disclosing in their contract with a pharmacy the national drug pricing compendia and other sources used to obtain the drug prices, as well as review and make necessary changes to the MAC list once per week. (Signed into Law March 31, 2014)
VT S 92 (2018): Signed into law on 6/6/2018. This law prohibits PBMs from banning pharmacies from providing information to patients about cost sharing or lower cost drugs, and creates a working group to examine prescription drug pricing through the supply chain, so it can identify savings and ways to increase price transparency.
§18-221-9421: This law establishes the ground rules for conducting business for PBMs within the State of Vermont. First, a PBM is by law required to register with the commissioner to do business in the State. PBMs are obligated to alert health insurers that they are entitled to a quote for an administrative-services-only contract with full pass through of negotiated prices, rebates and other such financial benefits which would identify to the insurer external sources of revenue and profit generally available, and whether the PBM offers that type of arrangement.
§18-221-9471 through 9473: This section of laws state that unless contractually obligated otherwise a PBM that provides pharmacy benefit management for a health plan shall: Provide all financial and utilization information requested by a health insurer relating to the provision of benefits to beneficiaries through that health insurer's health plan and all financial and utilization information relating to services to that health insurer. The PBM must also notify a health insurer in writing if any proposed or ongoing activity, policy or practice of the PBM presents, directly or indirectly, any conflict of interest with the stated requirements.
§18-79-3801 through 3805: This section of laws establishes the processes for conducting audits of pharmacies within Vermont as well as the accompanying rights of pharmacies. One such right is a requirement that audits which involve clinical or professional judgement must be conducted in part, or in consultation with a pharmacist who is both licensed by a state agency and is familiar with Vermont pharmacy statutes and rules. It also provides that on-site audits must be conducted with at least 14 days' advance written notice as well as notice of the specific prescriptions to be included in the audit. The law also enshrines the appeals process that must be provided for pharmacies wishing to contest the auditing entities conclusions.
Act No. 150: This act updates and expands the rights of pharmacies that was established in 18-22-221 in several key ways, particularly as it applies to audit procedures and options available to pharmacists. PBM management of MAC, was signed into law by Gov. Terry Branstad (R) on March 14, 2014. Among the various provisions is a requirement for the PBM to include in its contract information regarding which of the national compendia is used to obtain pricing data used in the calculation of the maximum reimbursement amount pricing and a process to allow a pharmacy to comment on, contest, or appeal the maximum reimbursement amount rates or maximum reimbursement amount list.
VA H 1177 (2018): Signed into law on 3/9/2018. The law bans gag clauses-it prohibits PBMs from forbidding pharmacies from sharing information on drug prices, cheaper alternatives, and cost sharing with their patients.
HB 108: This law regulates PBM audit procedures, among the various provisions are prohibitions of recoupment by extrapolation and recoupment for clerical errors, if the act or omission was not specifically prohibited in the contract, if the claim was more than 24 months old or if the pharmacist was not allowed to submit an electronic record to validate a claim. (Signed into law by Gov. Terry McAuliffe (D) on March 27, 2014.)
HB 2031: This law updates maximum allowable cost pricing lists. It requires contracts between health insurance carriers and their intermediaries to contain provisions that allow the parties to update every seven days the maximum allowable cost list. Such contracts are also requires to contain certain provisions and process for the appeal, investigation, and resolution of such disputes. Signed into law on March 23, 2015.
WA HB 2296 (2018): This bill would have banned gag clauses, but it did not pass.
SB 6137: This law requires PBMs to register with the Department of Revenue, imposes limits on audits of pharmacies by PBMs and other entities, places restrictions on the use of MAC pricing and includes appeals processes for pharmacy audits and MAC pricing. Would regulate how Pharmacy Benefit Managers operate in the State broadly as well as outlines specifics including how audits are to be conducted and take place as well as details surrounding the application of a Maximum Allowable Cost list. A PBM would be required to make available to each network pharmacy at the beginning of the term of a contract, and upon renewal of a contract, the sources utilized to determine the MAC pricing of the PBM. Additionally a PBM is mandated to update each list every seven business days and make said updated lists available to network pharmacies. (Signed into law by Gov. Jay Inslee (D) on April 3, 2014)
WV S 46 (2018): Signed into law on 3/21/2018. This law allows pharmacists to inform customers of lower cost alternative drugs and bans gag clauses.
WI A 608 (2018): Enacted on 4/16/2018. This law further defines remote dispensing by allowing its use by any pharmacy-licensed entity, including a PBM.
HB 35: This law requires PBMs to be licensed by the Department of Insurance, provide notice to pharmacies before conducting audits, accept verifiable statements and records, and use consistent standards and parameters. PBMs must further establish a written appeals process and make this widely known to pharmacies. Audits shall comply with certain requirements, and only drugs subject to certain conditions shall be put on maximum allowable cost (MAC) lists. Signed into law on March 7, 2016.