The 2024 election results will create significant tailwinds for Republican legislative and regulatory priorities in US Congress, federal agencies, and state houses across the country. This client alert considers the outlook for pharmacy regulation under the second incoming Trump administration and a unified Republican Congress, as well as state-level pharmacy policies that may advance as Republican public policy momentum builds.
The McDermott+ Check-Up features updates on healthcare legislative and regulatory activities that could impact health insurers, group health plan sponsors, healthcare providers and others in the health benefits industry. This post covers a recent Federal Trade Commission report on anticompetitive behaviors by pharmacy benefit managers as well as recent Senate hearings on medical debt and healthcare transparency.
The price of prescription drugs has brought scrutiny to the entire drug supply chain. Congress and other policymakers continue to seek opportunities to lower costs for patients and the federal government. Pharmacy benefit managers (PBMs) are a key stakeholder in the drug supply chain, functioning as intermediaries between insurance providers and pharmaceutical manufacturers.
Congress and other stakeholders are raising questions about PBMs’ operations and their impact on drug prices and out-of-pocket costs for patients. In the 118th Congress, six key committees have advanced legislation that would increase PBM transparency and reporting obligations and modify other business practices. In the House, three committees combined to introduce H.R. 5378, the Lower Costs, More Transparency Act, which passed the House December 11, 2023. Read on as we review and compare policies in the Lower Costs, More Transparency Act and the PBM bills considered individually by the relevant House and Senate committees.
The US Court of Appeals for the Tenth Circuit recently held in Pharmaceutical Care Management Association v. Mulready (PCMA) that the Employee Retirement Income Security Act (ERISA) and Medicare Part D preempted several provisions of Oklahoma law regulating pharmacy benefit managers and pharmacy networks. Left unchallenged, these provisions threaten the ability of employers and Medicare Advantage organizations to design uniform nationwide health plans. The Tenth Circuit’s decision in favor of PCMA overturned a lower court decision that caused great concern about the ability of states to indirectly dictate the design of plans governed by ERISA and Medicare Part D.
The US House and Senate returned from recess, beginning a three-week sprint toward the August break. The bipartisan healthcare legislation on pharmacy benefit managers (PBMs) and healthcare transparency is moving through both the House and Senate.
The House Education and the Workforce Committee held a markup of a bipartisan healthcare package of four bills. The July 12 markup included four bills under the committee’s jurisdiction related to the Employee Retirement Income Security Act of 1974, to increase cost transparency for employers and patients, increase oversight of pharmacy benefit managers (PBMs), lower premiums, reduce healthcare spending and increase competition by removing incentives for provider consolidation.
Almost every House and Senate committee with healthcare jurisdiction has now considered bipartisan PBM reform and healthcare transparency and consolidation reforms. This week, the Senate Finance Committee released a draft bill that would require increased disclosures by PBMs about their business practices. The Senate Finance Committee also announced a markup on July 26 to consider a package of PBM legislation.
After almost a year of negotiations among congressional Democrats and the White House, the Inflation Reduction Act of 2022 (IRA) was signed into law by President Biden on August 16, 2022. It passed in the US Senate by a vote of 50–50, with the vice president breaking the tie, on August 7, 2022. The bill passed the US House of Representatives August 12, 2022, by a party-line vote of 220-207. This McDermott+Consulting article summarizes the key healthcare provisions of the IRA, including prescription drug reform, inflationary rebates, a cap on insulin costs, a Medicare Part D benefit redesign and a new pharmacy benefit manager rebate rule.
ERISA broadly preempts state laws that “relate to” ERISA-governed employee benefit plans to ensure a uniform federal regulatory scheme and to relieve ERISA plans from the burdens of satisfying a patchwork of state laws. Recently, however, several states have enacted legislation designed to regulate the prices that pharmacy benefit managers, as third-party administrators for ERISA-governed plans, agree to reimburse pharmacies for dispensing prescription drugs to ERISA plan members. These regulations run afoul of ERISA, as the US Court of Appeals for the Eighth Circuit has twice held.
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