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District Court vs. PTAB: Strategic Forum Selection in Life Sciences Patent Disputes
December 10, 2026 | 12:00 PM – 1:00 PM ET
On January 22, the U.S. House of Representatives passed on a bipartisan basis HR 7148, the Consolidated Appropriations Act, 2026 (HR 7148). If it also wins passage in the Senate, the bill would, among other Trump administration priorities, impose new rules and requirements for pharmacy benefit managers (PBMs) and pharmacy benefit administration more generally. As with prior federal legislative proposals, HR 7148 attempts to bring more transparency to the administration of pharmacy benefits for both fully insured and self-funded groups and would impose enhanced transparency requirements for PBMs contracting with Medicare Part D prescription drug plans PDP sponsors. Specifically, among other requirements, HR 7148 proposes the following new rules and regulations impacting PBM arrangements:
1. PBM Rebate Pass-Through and Compensation Disclosures for ERISA Fully Insured and Self-Funded Plan: Mandates 100% pass-through of rebates and expands the definition of “covered service provider” beyond brokers and consultants, resulting in a PBM (and other entities supporting group health plans) being subject to the ERISA compensation disclosure rules.
Effective Date: This provision would be effective for contracts entered into, extended, or renewed for plan years beginning on or after 30 months after the date of the enactment of the change.
Section 6702 of HR 7148 provides for an amendment to Section 408(b)(2)(B) of the Employee Retirement Income Security Act of 1974, as amended (ERISA), as follows:
2. PBM Reporting Obligations for Fully Insured and Self-Funded Group Health Plans: Requires entities providing “pharmacy benefit management services”[3] to provide reports to certain self-funded plan sponsors and health insurers, as well as summary reports that can be disclosed to their participants or beneficiaries.
Effective Date: This provision would be effective for contracts entered into, extended, or renewed for plan years beginning on or after 30 months after the date of the enactment of the change to applicable coordinating statutes in the Public Health Service Act (PHSA), ERISA and the Internal Revenue Code, as amended (IRC).
Section 6701 of HR 7148 would amend Section 2799A-11 of the PHSA, Section 726 of ERISA, and Section 9826 of the IRC to include a substantial additional report to be provided by a PBM to its group health plan clients over and above those required by the Consolidated Appropriations Act of 2021 (CAA 2021).[4] The PBM must provide the group health plan with a semi-annual report (quarterly upon request, or annually for self-funded large plan opt-in) that includes:
3. Compensation Disclosures and Reporting Obligations for Medicare Part D Prescription Drug Program: Requires PBMs contracting with PDP sponsors to only accept “bona fide service fees” from drug companies and to pass through all rebates received from drug manufacturers to the PDP sponsors, report information to PDP sponsors, and allow PDP sponsors to audit the PBMs at least annually.
Effective Date: Plan years beginning on or after January 1, 2028.
Section 6224 of HR 7148 would amend Section 1860D-12 of the Social Security Act and introduce additional reporting requirements and obligations that go beyond the current requirements that were introduced by the Affordable Care Act. Some key additions include:
The Senate is expected to take action on HR 7148 this week and, if this bill passes the Senate without changes, it could become law by the end of the week. With bipartisan Senate support, which has been apparent, HR 7148 still could be passed easily despite growing congressional concerns over the other government funding bill, HR 7147 (Department of Homeland Security Appropriations Act, 2026) that contains funding for ICE, border security, and other DHS initiatives.
[1] The term “pharmacy benefit management services” is undefined in HR 7148.
[2] The Consolidated Appropriations Act of 2021 (CAA 2021) amended ERISA Section 408(b)(2)(B) to require compensation disclosures only by “brokers” and “consultants” and defines the activities of such parties in a way that would not apply to most PBMs and many other service providers to group health plans, such as third party or claims administrators.
[3] The term “pharmacy benefit management services” is undefined in the amendment.
[4] CAA 2021 required group health plan sponsors to annually report certain health plan information to the Tri-Agencies[4], including data relating to the top 50 costliest and most frequently used drugs and certain rebate information related to drugs covered by the plan.
[5] This provision applies to group health plans sponsored by a “specified large employer” (100 or more employees on business days during prior year and at least 1 employee on first day of plan year) or a “specified large plan” (union or multiple employer welfare arrangement covering 100 or more participants on business days during prior year).
[6] Large self-funded group health plans are permitted to allow the PBM to provide all required disclosures on an annual basis instead of semi-annually (or quarterly).
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District Court vs. PTAB: Strategic Forum Selection in Life Sciences Patent Disputes
December 10, 2026 | 12:00 PM – 1:00 PM ET
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