Today, the US Supreme Court is scheduled to hear oral arguments in a legal challenge of an Arkansas law that regulates the reimbursement rates that pharmacy benefit managers (PBMs) pay to pharmacies.
The extent of a ruling against Arkansas would depend on key details of the decision. For example, even if the court decides that ERISA preempts Arkansas’ law as applied to PBMs serving self-funded employee plans, that would leave in place rate regulation for PBMs serving state-regulated health plans. This would create a patchwork regulatory scenario in which a state could ensure adequate reimbursement rates for pharmacies for some – but not all – transactions.
Since ERISA was enacted in 1974, Supreme Court rulings have gradually expanded its reach. It is possible that a ruling favoring the PCMA would continue the trend of expanding the reach of ERISA preemption and increase the roadblocks states face when attempting to regulate their insurance markets, with ramifications reaching beyond PBM regulation. A ruling in favor of Arkansas, however, would provide clarity on states’ ability to implement PBM regulations, putting to rest inconsistent lower court rulings on the subject of ERISA preemption. A decision in the case is expected by July 2021.
Arkansas Act 900
PBMs are third parties that organize pharmacy networks, negotiate rebates with drug manufacturers, and process claims for prescription drug coverage. In their contracts with PBMs, pharmacies agree to be reimbursed at a rate set by the PBM. For generic drugs, this rate is called the maximum allowable cost (MAC). Notably, in most PBM contracts, nothing prohibits PBMs from setting a MAC for a drug below a pharmacy’s actual acquisition cost, which can result in under-reimbursement to pharmacies. According to Arkansas’s brief, 12.6 percent of independent pharmacies in the state closed between 2006 and 2014, in part due to systematic below-cost reimbursement from PBMs.
In 2015, Arkansas enacted Act 900 to tie MAC reimbursements to pharmacies’ actual acquisition costs by allowing pharmacists to appeal when a PBM’s reimbursement is lower than a drug’s wholesale acquisition cost. The law also allows pharmacies to decline to dispense a drug if a PBM’s MAC is less than what the pharmacy paid to purchase the drug. The PBM trade group PCMA challenged the law in district court, where a judge ruled that the act was preempted by ERISA. Arkansas appealed the ruling in the Eighth Circuit Court of Appeals, which upheld the lower court’s decision on the grounds that Act 900 was preempted because it implicitly and impermissibly referenced ERISA plans because it regulated PBMs that acted on behalf of plans regulated by federal law under ERISA.
Lower Court Rulings
Lower courts have issued inconsistent rulings on whether ERISA preempts state PBM regulations. PCMA previously challenged two nearly identical PBM laws in circuit courts in Washington, DC and Maine with different outcomes. These laws required PBMs to owe a fiduciary duty to health plan clients, pass payments received from drug manufacturers to health plans, and disclose conflicts of interests. In the Maine case, the court ruled that ERISA did not preempt Maine’s PBM regulations because PBMs do not exercise authority in the management of health plans. However, in the Washington, DC case, the court ruled that laws regulating third-party administrators of an ERISA plan function as a regulation of an ERISA plan itself and were therefore invalid.
PCMA also challenged a MAC pricing regulation in Iowa, where the Eighth Circuit Court of Appeals held that the law’s explicit exclusion of self-funded employee benefit plans was a “reference to” ERISA. The court also ruled that the law implicitly referred to ERISA because it regulated PBMs that administer benefits for plans subject to ERISA. Similar to Rutledge, the court held that ERISA preempted the law. PCMA has also filed an appeal in the Eighth Circuit against two North Dakota laws that regulate PBM conduct after the US District Court of North Dakota rejected ERISA preemption claims. It remains unclear how the court will apply these rulings to Act 900.
In its court filings, Arkansas argues that Act 900 regulates drug reimbursement as a form of rate regulation to ensure PBMs reimburse pharmacies at reasonable rates. In her brief, Arkansas Attorney General Leslie Rutledge argues that the Supreme Court has previously held that ERISA does not shield plans or their third-party administrators from state laws that regulate rates charged for those services, and therefore Act 900 is saved from ERISA preemption.
PCMA argues that the Arkansas law “relates to” ERISA because it regulates central matters of plan administration and interferes with nationally uniform plan administration. PCMA also points to the Supreme Court’s decision in Gobeille v. Liberty Mutual Co., which held that ERISA preempted a Vermont law that required health plans or their benefit administrators to submit claims data to the state’s all-payer claims database. PCMA claims that this ruling invalidates the Maine circuit court finding that ERISA does not preempt PBM regulation.
For case filings and additional information about legal challenges to state prescription drug laws, explore NASHP’s legal resources webpage that includes the legal analysis, Navigating Legal Challenges to State Efforts to Control Drug Prices: PBM Regulation, Price Gouging, and Price Transparency.
Removing wasteful drugs from formularies and replacing them with drugs that offer the same benefits at a lower cost, helps state employee health plans and other public purchasers reduce spending without sacrificing value – a critical strategy for savings as states face tremendous budget pressures.
As prescription drug price increases greatly outpace inflation and new specialty drugs priced in the millions of dollars enter the market, several states have led the way as early adopters of drug price transparency legislation and are taking the first steps to curb costs with the help of transparent drug pricing information.
A new National Academy for State Health Policy (NASHP) report, What Are We Learning from State Reporting on Drug Pricing?, offers a cross-state analysis of drug price transparency findings through August 2019, based on reports from California, Maine, Nevada, Oregon, and Vermont. States are:
- Learning which drugs cost the most – and are the best targets for focused strategies;
- Tracking the percentage of health premiums attributed to drug spending – and identifying opportunities to leverage reporting on drug spending, such as implementing spending caps; and
- Beginning to capture information on net price – and profit – along the supply chain to inform fair and balanced policy approaches to ensure affordability.
Honing in on the Costliest Drugs to Take Action Where It Matters Most
States with transparency laws are identifying the drugs creating the greatest affordability challenges for both payers and consumers. State transparency laws require gathering data from a variety of sources, including through required reporting by public and private health plans (California, Oregon, Vermont), or through all-payer claims databases (Maine), or proprietary databases (Nevada), in order to report lists of:
- The costliest drugs in the state based on price and utilization;
- The drugs with the highest year-over-year cost growth; and
- The most commonly prescribed drugs.
A cross-state analysis of these reports identified 30 drugs that appear in common across drugs reported in three of five states. Many of the drugs reported are used for the treatment of diabetes, including Humalog, Lantus Solar, Novolog, Januvia, Metformin, and Victoza. Multiple drugs for the treatment of arthritis were also identified across states: Stelara, Cosentyx, Enbrel, and Humira.
Identifying the classes of drugs – and specific drugs within those categories – that are creating the greatest affordability challenges can help states hone in on strategies to address drug costs. For example, states working to leverage their purchasing power across agencies are seeking this type of information to guide potential approaches such as bulk purchasing or establishing single preferred drug list. State officials from Nevada have credited their transparency law, initially limited to diabetes medications and since expanded to include asthma medications, with bringing payers to the table to leverage their purchasing power through Nevada’s Silver State Scripts program.
Illuminating the Link between Rising Drug and Insurance Premium Costs
Several states (California, Vermont, and Oregon) require commercial health plans subject to state regulation to submit information on the impact of prescription drug spending on premiums rates. Results shared publicly to date include a range of prescription drug spending accounting for, on average, 13 percent in California, 15.67 percent in Vermont, and up to 18 percent of premiums in Oregon. Tracking prescription drug spending, as part of rate review or other initiatives, represents an important leverage point for states to take action on drug spending. Doing so can enable, for example, monitoring and enforcement of prescription drug spending caps. Several states, including New York, Massachusetts, and Maine, have established caps for drug spending – New York and Massachusetts have the authority to negotiate supplemental rebates to meet their caps while Maine tasks its Drug Affordability Review Board with identifying strategies to meet its voluntary cap on drug spending for public plans.
Uncovering the Factors Driving Up Prices along the Drug Supply Chain
One of the questions at the heart of drug price transparency laws is: What factors are driving high price increases and high launch prices? The only way for a state to determine the actual causes of high drug prices – and the relative profit accrued by players in the supply chain – is by requiring reporting across the entire supply chain, including manufacturers, pharmacy benefit managers (PBMs), wholesalers, and health plans. In order to be meaningful, this information must shed light on the net cost of drugs – an otherwise closely guarded secret behind a black box of secret rebate negotiations between manufacturers and PBMs.
Some of the early adopter states, while laying the foundation for future transparency efforts, enacted laws with limitations in terms of their ability to shine a light on net prices or to uncover the interplay between players in the drug supply chain. California, for example, limits manufacturer reporting to information that is already in the public domain. While Nevada did require reporting of some information considered to be trade secrets, and required reporting by both manufacturers and PBMs, the lack of alignment in reporting requirements (e.g., state versus national level) makes it difficult to “follow the money” across the supply chain.
A new wave of tougher state transparency measures, including a 2019 Maine law, An Act To Further Expand Drug Price Transparency, will have the ability to shine a light on net drug prices – and profits – in order to guide fair and effective state policy solutions. The Maine law, based on NASHP’s model legislation, requires reporting by entities across the entire drug supply chain, including manufacturers, PBMs, wholesalers, and health plans.
In addition to establishing reporting requirements with the ability to produce meaningful, actionable data, states must also have the ability to enforce reporting their new requirements. Early efforts at collecting data from manufacturers have yielded imperfect compliance at best. California received data justifying price increase from only one-third of manufacturers required to report, and Nevada recently levied $17.4 million in fines on manufacturers for failure to report in that state. While non-reporters in Nevada face fines up to $5,000 a day, Maine’s new law increases that penalty to up to $30,000 a day.
Taking Action on What Transparency Reveals
As actionable information on net drug prices and profits across the supply chain becomes available, states will use the data to make informed, impactful policy decisions. Though state policymakers are challenged by a number of limits on their authority to regulate drug prices, and meaningful action at the federal level currently remains pending, states are advancing a number of policy options to address drug prices building on what transparency laws are revealing. One model is a state Drug Affordability Review Board (DARB) with the authority to review data on drugs deemed unaffordable, and if warranted, set an upper payment limit for that drug within the state. Transparency data is essential to DARBs and related efforts. Such approaches do not seek to prohibit profit along the supply chain, but to ensure that those profits are reasonably balanced with the need to preserve access to essential drugs by ensuring their affordability.
In the face of rapidly rising prices, state Medicaid programs are asserting their prescription drug purchasing power through more active oversight of the administration of prescription drug benefits. As major drug purchasers, state Medicaid programs have leverage to lower costs without action from state legislatures. Ohio, Washington, and West Virginia have recently deployed a range of strategies to curb drug costs:
- Ohio requires Medicaid managed care plans to adopt transparent, pass-through payment models with their pharmacy benefit mangers (PBMs).
- To maximize rebate potential and reduce administrative burden, Washington State is implementing a single preferred drug list (PDL) across Medicaid fee-for-service and managed care plans.
- West Virginia carved out the prescription drug benefit from its managed care contracts and now acts as its own PBM to increase oversight of drug purchasing and reduce costs.
Below is a detailed explanation of how these three states have implemented innovative purchasing strategies for their Medicaid pharmacy purchases.
Ohio Requires a Transparent, Pass-Through PBM Payment Model
A 2018 report found that PBMs retained profits of $224 million by creating a “spread” between what Medicaid paid PBMs for pharmacy claims versus what PBMs paid pharmacies. In response, Ohio mandated that managed care plans switch to contracts with transparent, pass-through payment models with the PBMs. With a transparent, pass-through model, states can ensure PBMs do not profit off this spread-pricing practice and pass through drug discounts and rebates to managed care plans. PBMs are instead reimbursed more directly through fees. Wisconsin’s state employee health plan requires a similar, fully transparent, pass-through payment model. Through this change in contract terms, Wisconsin’s per member, per month drug costs were more than 10 percent below industry averages from 2016 to 2018.
Ohio state officials report making significant changes to managed care contracts to increase transparency, reporting, and accountability pertaining to their PBM contracts and drug payments. Through enhanced reporting from managed care plans, officials have been able to confirm the successful implementation of the pass-through model. Ohio’s 2020 budget goes a step farther, requiring all managed care plans to contract with a single PBM, which will be selected by Ohio’s Medicaid department, giving the state more authority over drug purchasing.
Washington State: Implementing a Single, Standard Medicaid PDL Across MCOs
In January 2018, the Washington Healthcare Authority implemented a single PDL – a list that indicates which drugs are “preferred” by the state and do not require prior authorization. Washington’s Medicaid program transitioned from six different PDLs across managed care organizations (MCO) to one. A single PDL provides a number of advantages, including:
- Administrative ease for providers, patients, and pharmacies;
- Rebate maximization by selecting drugs with the lowest cost or maximum rebate potential;
- Rebate transparency for more accurate cost management; and
- Fewer disruptions for patients who may switch between managed care plans.
To transition to a single PDL, Washington submitted two State Plan Amendments – one for the single PDL and one to include managed care plans in its supplemental rebate contracts through a multi-state purchasing pool for drugs on the PDL. Washington also added and amended contracts with a number of vendors to ensure the Medicaid agency and managed care plans had access to the same drug data sources to allow seamless collaboration – an important detail for ensuring care coordination. Officials met with managed care plans weekly to plan and roll out the three phases of implementation, ensuring that drugs added to the PDL were clinically appropriate and cost-effective for the state and the plans. Implementation began with 27 drug classes and is expected to be complete by April 2020 with almost 400 different drug classes included in the PDL.
West Virginia: Carving Prescription Drugs Out of Managed Care
In 2017, West Virginia Medicaid began acting as its own pharmacy benefit administrator under a fee-for-service model, after carving out prescription drug benefits from its managed care contracts. To accomplish the prescription drug carve-out, West Virginia:
- Added an additional pharmacist to its staff;
- Stress-tested its existing claims processing system;
- Increased its capacity for prior authorizations; and
- Educated the public and its help desk staff about the program change.
West Virginia’s Medicaid program now covers over 550,000 enrollees through a fee-for-service model. State officials report they are able to effectively manage the pharmacy benefit and maintain care coordination across MCOs, while obtaining savings for the state. The prescription drug carve-out led to a savings of $54.5 million in 2018. Additionally, changes to the state’s reimbursement methodology during the carve-out process led to an infusion of $122 million in dispensing fees to the state’s pharmacy community.
While West Virginia is acting as its own PBM, California is carving out the prescription drug benefit from its managed care contracts and contracting with a single PBM to leverage the state’s immense purchasing power. California will use strict contracting terms to ensure greater transparency and cost savings with the contracted PBM. Michigan is currently considering a drug carve-out and legislatures in Louisiana and Nevada prompted their Medicaid programs to explore a potential carve-out of prescription drugs from managed care.
As states strengthen their oversight of drug purchasing, the National Academy for State Health Policy (NASHP) has created and will soon release a model PBM contract for states. Informed by Ohio and Minnesota’s contracts, NASHP’s model contract is designed to help states ban spread pricing and better understand rebate arrangements with their PBMs. To learn more about other administrative actions to curb rising drug costs, read the Administrative Action section of NASHP’s Prescription Drug Pricing website.
Friday, Nov. 1, 2019
3:30-4:30 p.m. (ET)
Faced with rising prescription drug costs, state Medicaid programs are implementing innovative policies to manage their pharmacy benefit and find savings. This webinar, for state officials only, is an opportunity to hear officials from three leading states:
- West Virginia carved pharmacy benefits out of its Medicaid managed care program in 2017 and reports that its shift to a fee-for-service model saved the state over $54 million in state fiscal year 2018.
- In response to a report demonstrating the cost to the state when pharmacy benefit managers (PBMs) profit from “spread pricing,” Ohio began requiring managed care plans’ contracts with PBMs to include a transparent, pass-through payment model and to prohibit spread pricing as of January 2019. Ohio’s recently passed 2020 budget bill goes a step farther, requiring all managed care plans to contract with a single PBM, which is selected by the Ohio’s Medicaid department.
- To lower the cost of drugs and maximize rebate potential, Washington’s Medicaid program implemented a single formulary for all managed care and fee-for-service pharmacy benefits on Jan. 1, 2018.
This webinar is for state officials only and will not be recorded.
Moderator: Trish Riley, Executive Director, National Academy for State Health Policy
- Brian Thompson, MS, PharmD, Director of Pharmacy Services, Bureau for Medical Services, West Virginia Department of Health and Human Resources
- Vicki Cunningham, PharmD, former Director of Pharmacy Services, Bureau for Medical Services, West Virginia Department of Health and Human Resources
- Maureen Corcoran, MBA, MSN, Director, Ohio Department of Medicaid
- Donna Sullivan, MS, PharmD, Chief Pharmacy Officer, Washington Health Care Authority
In 2019, states built on the momentum that had been gaining in recent years and passed targeted legislation to address the role harmful pharmacy benefit manager (PBM) business practices play in escalating prescription drug prices. The laws supporting these approaches, described below, give states enforcement mechanisms to ensure that the discounts that PBMs recoup are ultimately used to lower drug and premium costs for consumers.
During the 2017 and 2018 legislative sessions, states increasingly passed laws focused on PBMs, often referred to as the “middleman” in the drug supply chain. Health plans contract with PBMs to manage their pharmacy benefit, which includes negotiating rebates with manufacturers and ensuring pharmacies have medications to dispense.
As states address prescription drug prices, there have been many questions raised about PBM practices. Where do the negotiated manufacturer rebates go? How much is the PBM keeping versus what is passed along to help consumers pay for prescriptions? Also, what about the differing amounts health plans pay for prescription drugs – compared to the often lower reimbursement amount paid to pharmacies? How much of that “spread in pricing” do PBMs keep as profit? Could opaque PBM payment practices be contributing to the overall high costs of prescription drugs?
Last year, Ohio’s state auditor released a report revealing that PBMs charged Medicaid managed care organizations (MCOs) a “spread” of more than 31 percent for generic drugs, which cost the state $208 million – all of which PBMs pocketed as profit. This issue is not unique to Ohio. Lack of defined regulations allow PBMs to pocket portions of manufacturer rebates or use spread pricing models instead of passing negotiated discounts back to health plans and their consumers.
To address those opaque practices, in 2019 several states enacted laws to:
- More clearly define PBM practices;
- Require transparency of specific prices, costs, and rebates; and
- Take steps to explicitly define fiduciary responsibilities of health plans for their contracted PBMs.
To date, 27 states require PBMs to obtain licensure from their states’ departments of insurance prior to operating in the state. This year, Minnesota, South Carolina, West Virginia, and Utah enacted laws to require PBM licensure. Licensure is a critical component of effective PBM regulation because it allows a state to know how many and what entities are operating as PBMs. This also gives the state power to suspend or revoke a license should the PBM break the law or engage in fraudulent activity.
States also passed stronger transparency reporting requirements for PBMs. New York passed and Minnesota enacted measures requiring transparency reporting to both health plans and relevant state agencies. Notably, under the New York bill, a health plan will have access to all financial and utilization information of a PBM in relation to pharmacy benefit management services provided to the plan. Access to a PBM’s financial information will allow health plans in New York to monitor their contracted PBMs for fraudulent activity and deceptive acts. It also empowers health plans to enforce provisions of its contract with a PBM. The measure passed the legislature with broad support and now awaits action by New York Gov. Andrew Cuomo.
The Minnesota law goes beyond other states’ transparency bills by requiring PBMs to submit de-identified claims level information to their plan sponsors. Under this law, PBMs must report any spread collected on a claim, along with the amount paid to the pharmacy for each prescription. The law also requires PBMs give information to plan sponsors that differentiates between payments made to pharmacies owned or controlled by the PBMs and those not affiliated with the PBM. Data reported to plans will highlight any PBM conflicts of interest and deceptive business practices. Health plans and the state can use this data to create a clearer picture of how PBMs make their profits and identify additional actions the state can take to rein in bad practices.
Health Plan Oversight
States are also increasingly focused on requiring health plans to take more responsibility for monitoring the PBMs they contract with. For example, under Maine’s new law, if a health insurance carrier uses a PBM to manage its prescription drug benefits, the carrier is responsible for monitoring all activities performed by the contracted PBM. By tasking carriers with PBM monitoring responsibilities, Maine is leveraging its Bureau of Insurance to enforce these provisions of the law. The law also stipulates that PBMs have a fiduciary duty to their insurance carriers when managing their prescription drug benefits and as such, carriers are empowered to hold PBMs accountable for their financial dealings. This law may be protected from an Employee Retirement Income Security Act of 1974 (ERISA) legal challenge because lawmakers purposefully used an existing definition of “carrier” in state law that imposes requirements on state-regulated insurance carriers only. Therefore, the law does not apply to plans governed by ERISA. (Read Maine Forges New Ground and Enacts Comprehensive Drug Package for more information about Maine’s comprehensive PBM law.)
The New York measure stipulates that in addition to health plans, PBMs have a duty and obligation to covered individuals to perform their services with care, diligence, and professionalism. Under this measure, all funds received by the PBM, including funds derived from spread pricing, must be used on behalf of the health plan and can only be used pursuant to the PBM’s contract with the plan. Medical loss ratio rules require health plans to spend 80 percent of a beneficiary’s premium on medical claims and the remaining 20 percent on overhead expenses, including profits. This means that any manufacturer discounts passed from PBMs to a health plan will be used to lower spending on pharmacy benefits, which will in turn decrease premium costs for beneficiaries.
Medicaid Managed Care Contracts
States are also increasing their Medicaid agencies’ oversight of PBMs. Informed by Ohio’s report last summer, lawmakers included provisions in their budget that require the state to contract with a single PBM for the entire Medicaid managed care program. The “state PBM” will have strict transparency reporting requirements and will be prohibited from requiring a Medicaid recipient to obtain a specialty drug from a specialty pharmacy owned by or associated with that state PBM. This will end the practice of “self direction,” which benefits PBMs but typically increases out-of-pocket costs for consumers. Conflicts of interest language along with transparency requirements limit anti-competitive practices and give state officials more control over how PBMs operate in the Ohio.
Similarly, a new law in Louisiana authorizes its Department of Health to carve out pharmacy services from Medicaid MCO contracts and assume direct responsibility for all pharmacy services. If the department chooses to use a PBM to administer the pharmacy benefit, the PBM can only be reimbursed with a transaction fee and cannot retain any portion of spread pricing or state supplemental rebates. This ensures the state will get all of the discounts the PBM negotiates with drug manufacturers. The transaction fee will be the only payment to the PBM, which prevents it from pocketing a spread or a portion of discounts intended for the state.
States cannot control which new drugs come to market or what their list prices will be, but they can impose Medicaid contracting requirements to ensure PBMs are working in the interest of the state. Through these laws, Ohio and Louisiana can take active roles in monitoring PBM practices and administering pharmacy benefits to ensure protections for the state.
The laws passed during the 2019 legislative session are the result of states’ iterative policymaking processes – lawmakers first work with state agencies to identify problems, build on prior legislation, and then develop legislative solutions. Targeted approaches like the ones highlighted here can help stem drug spending, but PBMs are only one part of the supply chain contributing to rising drug costs. To see all types of legislation to address drug costs, explore NASHP’s state Legislative Tracker and learn about other new laws states have enacted this year.