“If a reimbursement methodology is based on a proprietary number that the pharmacy cannot independently see or test, it is difficult to have a meaningful discussion about whether reimbursement reflects acquisition cost. NADAC provides a publicly available reference point that pharmacies, plans, regulators, and policymakers can all see.”
The Legacy of Rutledge: How States and Congress Can Still Regulate Pharmacy Benefit Managers
Six years after Rutledge, new court rulings, federal PBM reforms, and state ownership bans are redrawing the limits of pharmacy benefit regulation.
For years, states confronted pharmacy benefit managers (PBMs) with a patchwork of laws addressing maximum allowable cost lists, reimbursement, pharmacy networks, appeals, patient choice, and other practices affecting pharmacies. Just as routinely, those laws faced a familiar challenge: Employee Retirement Income Security Act (ERISA) preemption.
That created a practical problem for policymakers and pharmacies. States regulate pharmacies and the delivery of healthcare within their borders, yet some of the most consequential decisions affecting whether a pharmacy could afford to dispense a prescription were being made through PBM arrangements connected to employer-sponsored health plans governed by federal law.
By 2020, that tension had become one of the central legal questions surrounding PBM regulation. Then came Rutledge v. Pharmaceutical Care Management Association.
The Supreme Court's decision did not give states unlimited authority to regulate PBMs. It did something more important. It rejected the idea that ERISA automatically prevents a state from regulating the price a PBM pays a pharmacy simply because that regulation could affect the cost of an employee health plan.1
That decision helped define a path states could follow. Regulation directed toward pharmacy reimbursement and other healthcare costs could be treated differently from regulation dictating the structure or administration of an ERISA plan.
Six years later, however, the PBM debate looks different.
The problem for pharmacies today is not primarily the retrospective direct and indirect remuneration (DIR)-fee system that dominated the discussion several years ago. The Centers for Medicare & Medicaid Services (CMS) substantially changed the Part D pharmacy price-concession framework beginning in 2024.2
Yet the underlying economic dispute never disappeared.
Community and specialty pharmacies continue to confront a more basic question: whether reimbursement adequately covers the cost of acquiring and dispensing a prescription. Audits, recoupments, contractual requirements, network restrictions, and other payment practices can further erode already thin pharmacy margins.
At the same time, PBMs occupy a much larger role in a vertically integrated healthcare marketplace than they did when many of the earliest state PBM laws were written. The legal landscape has changed as well.
Rutledge established an important opening for state regulation. Pharmaceutical Care Management Association v. Mulready demonstrated that the opening has limits when state law begins dictating how ERISA plans structure or administer pharmacy benefits.
The Supreme Court declined to review Mulready on June 30, 2025, leaving the Tenth Circuit's decision in place.3 Then, in August 2026, the Seventh Circuit added another important piece.
In Central States, Southeast and Southwest Areas Health and Welfare Fund v. McClain, the court upheld an Arkansas rule requiring fair and reasonable pharmacy dispensing reimbursement and related reporting requirements against an ERISA preemption challenge.4 Congress has also entered the debate more directly.
The Consolidated Appropriations Act, 2026 added substantial requirements involving PBM reporting, compensation, rebates, and audits. Those provisions do not all take effect immediately, but they establish a much stronger federal framework around the commercial pharmacy benefit.5
That changes the discussion. The question in 2026 is not whether states can regulate PBMs.
The better questions are where state authority ends, where federal oversight begins, and whether the regulatory structure now taking shape will address the reimbursement and contracting practices that continue to put pressure on pharmacies. Those questions begin with Rutledge.
How the Pharmacy Reimbursement Problem Evolved
In our 2017 white paper published by Pharmcacy Times, “
Pharmacies often struggled to determine how those amounts were calculated, which standards applied, or whether those standards accurately reflected the services they provided. Specialty pharmacies faced an additional concern.
A percentage-based assessment on an expensive specialty drug could have a very different financial effect than the same methodology applied to a traditional retail prescription. Measures developed around conventional retail pharmacy operations also did not necessarily reflect the services involved in oncology, HIV, transplant, or other complex therapies.
Effective January 1, 2024, CMS required Part D sponsors to apply all pharmacy price concessions to the negotiated price at the point of sale. Under the revised definition, the negotiated price must reflect the lowest possible reimbursement a network pharmacy can receive for a drug.That system has since changed substantially.2
The change addressed one mechanism. It did not resolve the larger problem: whether reimbursement reflects what pharmacies actually pay to acquire and dispense medications. Audits, recoupments, network requirements, and other contract terms can add further pressure.
Seen from that perspective, DIR was one chapter in a much longer regulatory story. The larger issue is the extent to which PBMs can determine the economic terms under which pharmacies participate in prescription drug networks, and which level of government has the authority to regulate those terms.
What Rutledge Changed
In Rutledge v. Pharmaceutical Care Management Association, 592 U.S. 80 (2020), the Supreme Court considered Arkansas Act 900, which regulated PBM maximum allowable cost reimbursement and provided pharmacies with appeal and decline-to-dispense protections when reimbursement fell below acquisition cost.1 The PBM industry argued that ERISA preempted the law.
The Supreme Court unanimously rejected that argument. The Court treated Act 900 as cost regulation.
The law could affect what an ERISA plan ultimately paid for pharmacy benefits, but it did not require a plan to provide a particular benefit or force it to adopt a particular scheme of substantive coverage.1 That distinction remains critical.
Rutledge did not establish unlimited state authority over PBMs. It established that ERISA does not automatically preempt a state law because the law regulates what a PBM pays a pharmacy and may increase costs for an ERISA plan.
For states trying to address pharmacy reimbursement, that was significant. The decision provided a clearer path for laws directed at reimbursement methodology, maximum allowable cost practices, pharmacy appeals, dispensing costs, and other economic terms without directly controlling the design of an ERISA benefit plan.
What Mulready Clarified
The limits became clearer three years later in Pharmaceutical Care Management Association v. Mulready, 78 F.4th 1183 (10th Cir. 2023), cert. denied, No. 23-1213 (U.S. June 30, 2025).3 The case involved Oklahoma's Patient's Right to Pharmacy Choice Act.
Unlike the Arkansas reimbursement law at issue in Rutledge, the challenged Oklahoma provisions reached into pharmacy-network structure. They included geographic-access standards, restrictions involving preferred pharmacies and cost-sharing incentives, and an any-willing-provider requirement.
The Tenth Circuit concluded that the challenged provisions went beyond regulating the cost of benefits and impermissibly affected how ERISA plans structured their pharmacy networks. It also concluded that Medicare Part D preempted the state's any-willing-provider provision as applied to Part D plans.3
Mulready did not overrule Rutledge, it drew a boundary around it. A state law aimed at what a PBM pays a pharmacy may stand on firmer ground when it regulates cost without dictating benefit design.
The preemption risk becomes greater when a law tells an ERISA plan how its pharmacy network must be structured or how the benefit must be administered. Oklahoma asked the Supreme Court to review that distinction and the Court declined.
What McClain Adds in 2026
The Seventh Circuit's August 2026 decision in Central States v. McClain is important because it shows that the cost-regulation path identified in Rutledge remains open. Arkansas Insurance Department Rule 128 authorizes the Insurance Commissioner to require additional dispensing fees when pharmacy reimbursement is not “fair and reasonable.”
It also requires health plans to provide information related to pharmacy compensation. A self-funded ERISA plan challenged both requirements.
The Seventh Circuit rejected the challenge. It concluded that the dispensing-fee requirement was cost regulation under Rutledge, not an attempt to dictate a particular benefit structure.
The court also upheld the reporting requirement because, on the record before it, the reporting was incidental to enforcing the underlying reimbursement rule.4 That matters for the next generation of state PBM laws.
Mulready demonstrates the risk of regulating plan design. McClain shows that states still have meaningful room to regulate pharmacy economics.
The court also identified an issue that may return. Congress has now enacted new federal PBM reporting requirements under ERISA § 726.
Those requirements are not yet operative, and the Seventh Circuit expressly left open whether they could change the preemption analysis for Arkansas's reporting requirement once they take effect.4
That makes McClain particularly important in 2026. It connects Rutledge directly to the new federal framework Congress has just created.
The Consolidated Appropriations Act, 2026 Changes the Federal Landscape
The Consolidated Appropriations Act, 2026 (CAA 2026), Pub. L. No. 119-75, was signed into law on February 3, 2026. Two provisions are especially important for PBM oversight under ERISA.5
Section 6701 added ERISA § 726, now codified at 29 U.S.C. § 1185o. The provision creates a federal PBM reporting framework for group health plans.
The timing matters. The new requirements generally apply to plan years beginning on or after the date that is 30 months after February 3, 2026, and to covered contracts entered into, renewed, or extended on or after that effective date. For a calendar-year plan, that generally points to January 1, 2029.5
Once operative, PBMs covered by the provision generally must report to group health plans at least every six months. A plan may request quarterly reporting under the same conditions, terms, and cost as the semiannual report.5
The statute also distinguishes among plans. Detailed drug-level reporting applies to certain self-funded plans offered by specified large employers or qualifying large plans, generally using a 100-employee or 100-participant threshold.
Large insured plans may elect to receive the expanded reporting. Other covered plans receive specified plan-level and participant-facing summary information.5
The information reaches far beyond a simple rebate total. Depending on the plan, it can include amounts paid to the PBM, amounts paid to pharmacies, differences between those amounts, net drug spending, rebates and other remuneration, dispensing channels, affiliated-pharmacy arrangements, broker and consultant compensation, and benefit-design features that encourage or require use of affiliated mail, retail, or specialty pharmacies.5
Section 6702 amended ERISA § 408(b)(2). For contracts subject to the new requirements after the same 30-month phase-in, a PBM arrangement will not qualify as reasonable under that provision unless the PBM remits 100% of covered rebates, fees, alternative discounts, and other drug-related remuneration to the plan or issuer, subject to the statute's terms.
Those amounts generally must be remitted quarterly, no later than 90 days after the end of the quarter.6 The statute also gives plans meaningful audit rights.
Records relating to the rebates and other remuneration must be available for audit at least once per plan year. Rebate contracts with manufacturers and rebate aggregators must also be made available for audit subject to confidentiality protections.
The responsible plan fiduciary selects the auditor, and the PBM cannot directly or indirectly pay for that auditor.6 This is much more than another transparency provision.
Congress has put PBM compensation, rebate flows, affiliated arrangements, pharmacy payments, and auditability much closer to the center of the relationship between PBMs and the employers purchasing their services.
The Department of Labor and Fiduciary Oversight
The Department of Labor (DOL) had already started moving in this direction before CAA 2026 became law. In January 2026, DOL proposed regulations under ERISA § 408(b)(2) that would require PBMs and certain affiliated brokers and consultants serving self-insured ERISA group health plans to provide more detailed compensation disclosures.
The proposal covers manufacturer payments, spread compensation, pharmacy recoupments, price-protection arrangements, and other compensation, and would give plan fiduciaries audit rights to test the accuracy of those disclosures.7 Congress enacted CAA 2026 only days after DOL published the proposal.
DOL then extended the comment period so stakeholders could address how the proposed rule should work with the new statute. As of September 20, 2026, DOL continues to identify the PBM fee-disclosure rule as a rulemaking rather than a completed final rule.7
That proposal now has to be read alongside what Congress enacted in CAA 2026. For employers, the practical question is becoming harder to avoid.
Getting more information about a PBM arrangement also means deciding what to do with it. Disclosure alone does not answer whether the arrangement is reasonable.
The FTC and Market Structure
The Federal Trade Commission has approached PBMs from another direction. Its Section 6(b) study and interim reports have examined market concentration, vertical integration, specialty-drug reimbursement, affiliated pharmacies, spread pricing, and differences between payments to affiliated and unaffiliated pharmacies.8
The FTC staff reports have raised concerns about the market power and incentives created by vertically integrated PBM structures. The PBM industry disputes important parts of that analysis and argues that PBMs and integration can reduce drug costs and create efficiencies.8
Either way, the debate has clearly moved beyond whether one pharmacy contract contains a bad reimbursement term. Ownership itself is becoming part of the discussion.
Vertical Integration Is Becoming a Structural Issue
Tennessee provides one of the clearest examples. In May 2026, Tennessee enacted the Freedom, Access, and Integrity in Registered Pharmacy, or FAIR Rx, Act, Public Chapter 1111.9
The enacted law is important, but its scope needs to be stated precisely. Beginning July 1, 2028, Tennessee law prohibits a person or entity from directly or indirectly owning, operating, controlling, or directing any part of a pharmacy while also owning, operating, controlling, or directing any part of both a health insurance issuer and a PBM.
The prohibition applies when the ownership interest held by the person, entity, or affiliate exceeds 5%.9 The law contains several exceptions and qualifications.
A hospital or health-system pharmacy is not treated as a PBM for purposes of the provision. Independently owned or unaffiliated pharmacies remain free to provide mail-order, specialty, or delivery services.
The law contains exceptions involving certain orphan drugs and drugs subject to Risk Evaluation and Mitigation Strategy limited-distribution requirements, permits an employer to operate a pharmacy or administer pharmacy benefits solely for its own employees, retirees, and dependents, and excludes specified federal healthcare-program contracts.9
A pharmacy that falls within the prohibited ownership arrangement may continue operating through December 31, 2028 if it is actively pursuing a bona fide sale to an unaffiliated entity, with a possible single 6-month extension upon proof of substantial progress.9 The law is already being litigated.
CVS, Express Scripts and other parties filed federal challenges, and four cases were consolidated in July 2026 into the lead CVS Pharmacy, Inc. v. Tennessee Board of Pharmacy action.10 The ultimate validity of the law therefore remains to be decided.
Even with that litigation unresolved, Tennessee marks an important development. The policy debate is no longer limited to asking how a vertically integrated PBM should behave.
Legislatures are beginning to ask whether particular ownership combinations should exist at all. Congress is considering that question too.
The bipartisan Patients Before Monopolies Act, H.R. 8779 and S. 4509, would address common ownership between PBMs and pharmacies and establish a federal divestiture framework. As of September 20, 2026, both bills remain at the committee stage after being introduced on May 13, 2026.11
The Break Up Big Medicine Act, S. 3822, is broader. It addresses certain common-ownership arrangements involving PBMs or insurers and medical-service providers, management services organizations, and certain drug or medical-device wholesalers.
It is therefore less directly focused on the PBM-pharmacy relationship, but it belongs in the same emerging discussion over whether some healthcare integration issues should be addressed structurally rather than solely through disclosure or conduct rules.12
For community and specialty pharmacies, the ownership question is connected to reimbursement. When the entity influencing what a pharmacy is paid also has an economic interest in an affiliated pharmacy, reimbursement and market structure are difficult to examine separately.
Other Federal PBM Proposals
Several additional federal PBM bills remain active in the 119th Congress. Their status should be understood separately because they address different programs and have moved at different speeds.
H.R. 6610, the Pharmacists Fight Back in Federal Employee Health Benefit Plans Act, addresses PBM practices in the Federal Employees Health Benefits Program. On July 22, 2026, the House Oversight and Government Reform Committee ordered the bill reported, as amended, by a 40–2 vote, but it has not been enacted.13
H.R. 6609, the Pharmacists Fight Back in Medicare and Medicaid Act, would establish PBM and pharmacy-payment requirements within Medicare and Medicaid. As of September 20, 2026, it remains referred to the House Energy and Commerce and Ways and Means Committees following its December 2025 introduction.14
H.R. 7895, the PBM Kickback Prohibition Act, addresses certain compensation connected with PBM contracting under ERISA § 408(b)(2). The House Education and Workforce Committee reported the bill with an amendment on July 2, 2026, and recommended that the amended bill pass. It has not yet been enacted.15
S. 4106, the Rx Access, Choice, Cost Equity, and Supply Stability Act, addresses prescription-drug access and reimbursement under TRICARE. It was introduced March 17, 2026 and referred to the Senate Armed Services Committee.16
S. 3549, the PBM Fiduciary Accountability, Integrity, and Reform Act, would amend ERISA to treat PBMs as fiduciaries under specified circumstances. It was introduced December 17, 2025 and remains referred to the Senate Health, Education, Labor, and Pensions Committee.17
These bills should not be lumped together as though they would do the same thing. A TRICARE reimbursement proposal does not govern an ERISA plan.
A Medicare or Medicaid provision does not automatically apply to commercial coverage. A structural ownership bill raises different legal questions from a reimbursement bill. Scope matters as much as the title.
The Noninterference Clause and the IRA
The Medicare Part D noninterference clause, 42 U.S.C. § 1395w-111(i), remains an important part of the PBM debate. The provision limits the Department of Health and Human Services Secretary's ability to interfere in negotiations among manufacturers, pharmacies, and Part D plan sponsors, limits federal formulary intervention subject to statutory exceptions, and restricts the Secretary from instituting a Part D reimbursement price structure.
The Inflation Reduction Act did not repeal that provision. It did, however, amend it.
Congress expressly added exceptions connected to the Medicare Drug Price Negotiation Program, including language providing that the Secretary may not institute a Part D reimbursement price structure “except as provided under part E of title XI.”18
That is more than a theoretical exception. Maximum fair prices negotiated under the program took effect for the first group of selected Part D drugs on January 1, 2026.18
That history matters when noninterference is discussed as though it creates an absolute prohibition on federal action involving the pharmacy benefit. It does not. Congress has demonstrated that it can make specific exceptions and grant specific federal authority when it chooses to do so.
For the pharmacy community, that creates a policy argument worth developing: the noninterference clause can be read in light of the exceptions and federal authorities Congress has actually enacted, rather than as a blanket bar to federal PBM oversight.
The legal question is not simply whether the noninterference clause exists. It is what Congress has authorized despite it.
What Pharmacy Executives Should Do Now
For pharmacy executives, reimbursement remains the place to start. Pharmacies should know what they are actually earning on the prescriptions they dispense after acquisition cost, dispensing cost, contract adjustments, audit exposure, recoupments, and other economic terms are taken into account.
A claim-level review can identify which drugs, plans, networks, PBMs, and reimbursement methodologies create the greatest exposure. Pharmacy executives should also understand how their reimbursement compares with the National Average Drug Acquisition Cost, or NADAC.
CMS develops NADAC as an acquisition-cost benchmark based on pharmacy survey data and invoice information and publishes updated NADAC files regularly, including weekly updates.19 That transparency is important.
If a reimbursement methodology is based on a proprietary number that the pharmacy cannot independently see or test, it is difficult to have a meaningful discussion about whether reimbursement reflects acquisition cost. NADAC provides a publicly available reference point that pharmacies, plans, regulators, and policymakers can all see.
States may use NADAC as a reference price when establishing Medicaid reimbursement methodologies, subject to CMS state-plan requirements.19 NADAC is not a complete measure of pharmacy economics.
It is primarily an acquisition-cost benchmark. It does not by itself account for the professional cost of dispensing a prescription, and it may not capture every purchasing circumstance faced by a particular pharmacy or every specialty-drug arrangement.
That is why a NADAC-based discussion also has to include an appropriate professional dispensing fee and a way to address situations in which the published benchmark does not reflect the pharmacy's actual acquisition cost. Still, NADAC gives the pharmacy community something that many reimbursement methodologies do not: a visible starting point.
For state policymakers considering reimbursement standards, it provides a way to ask a straightforward question with public data: how does the amount being paid compare with what pharmacies are actually paying to acquire the drug? Contracts should also be reviewed for reimbursement formulas, maximum allowable cost list procedures, appeal rights, audit provisions, recoupment standards, network terms, affiliated-pharmacy provisions, and provisions that permit the economics of the transaction to change after the claim is processed.
Audit exposure deserves particular attention. When margins are already narrow, an audit recoupment is not simply a compliance problem.
It can change whether an entire category of prescriptions remains economically viable for a pharmacy. Specialty pharmacies should also evaluate whether reimbursement and performance methodologies reflect the clinical and operational services associated with complex therapies.
Pharmacies should preserve evidence showing how reimbursement and audit practices affect inventory decisions, staffing, patient access, and their ability to continue providing particular services. That information can matter in contract disputes, regulatory proceedings, litigation, and legislative debates over pharmacy access.
What Employers and Plan Sponsors Should Do Now
Employers and other plan fiduciaries should prepare for a different relationship with their PBMs. Compensation disclosures, rebate arrangements, affiliated entities, audit rights, pricing guarantees, formulary incentives, pharmacy-network arrangements, and amounts paid to pharmacies should be considered as part of the overall cost of purchasing the pharmacy benefit.
CAA 2026 makes that exercise more important, even though major portions of the new statutory framework are still in the implementation period. Employers should use that period to understand their contracts and determine whether they will be able to obtain, review, and audit the information the new law contemplates.
The larger point is simple. More disclosure creates more information, it does not make the purchasing decision for the fiduciary.
What Policymakers Should Take From Rutledge, Mulready, and McClain
For state policymakers, the lesson is to write with precision. If reimbursement is the problem, legislation can address reimbursement methodology, acquisition costs, dispensing costs, appeal rights, audit standards, and payment practices directly.
Rutledge provides the foundation for that approach, and McClain gives states a new appellate decision applying that reasoning to fair-and-reasonable dispensing reimbursement.
Mulready identifies the other side of the line. The farther a state moves into prescribing the design of an ERISA pharmacy network or the administration of plan benefits, the more serious the preemption question becomes.
That difference can determine whether a state PBM law survives long enough to reach the pharmacies it was intended to address.
The Continuing Legacy of Rutledge
The legacy of Rutledge is that states retained meaningful authority to regulate pharmacy costs. Six years later, that principle is being tested from several directions at once.
Mulready has defined limits around plan design. McClain has reinforced the ability of states to regulate reimbursement.
Congress has created a new federal reporting, rebate, and audit framework. Tennessee has moved the vertical-integration debate into ownership itself.
NADAC gives states and pharmacies a transparent benchmark for discussing acquisition cost. For pharmacies, however, the question underneath all of this remains remarkably practical: Can the pharmacy afford to fill the prescription?
That is the question reimbursement rules, audits, contracting practices, ownership structures, and federal transparency requirements ultimately come back to.
Rutledge opened a legal path for states to regulate pharmacy costs. McClain shows that path is still open. The next cases, statutes, and enforcement actions will determine how far it extends and whether the rules being written around PBMs materially change the economics of filling a prescription.
That is where the next chapter of PBM regulation will be written.
About Lanton, Lanton & Sosa Law PLLC
Lanton, Lanton & Sosa Law PLLC is a healthcare and life-sciences law firm advising pharmacies, healthcare organizations, employers, and regulated businesses on reimbursement, PBM contracts, pharmacy regulation, government affairs, compliance, licensing, audits, and healthcare transactions. The firm helps clients understand how legislation, agency action, litigation, and business arrangements affect the way healthcare is delivered and paid for. Its pharmacy practice includes PBM reimbursement, network participation, specialty pharmacy, pharmacy operations, regulatory inquiries, contracting, audits, and legislative strategy.
This article is provided for general informational purposes and does not constitute legal advice. The discussion of proposed legislation, litigation, and regulatory proposals reflects developments available as of September 20, 2026 and may change.
Notes and Authorities
- Rutledge v. Pharmaceutical Care Management Ass'n, 592 U.S. 80, 83–92 (2020), U.S. Supreme Court opinion.
https://www.supremecourt.gov/opinions/20pdf/18-540_m64o.pdf - Centers for Medicare & Medicaid Services, Application of Pharmacy Price Concessions to the Negotiated Price at the Point of Sale Beginning January 1, 2024 (Nov. 6, 2023); Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs, 87 Fed. Reg. 27,704 (May 9, 2022).
https://www.cms.gov/files/document/pharmacypriceconcessionshpmsmemonovember2023final508g.pdf - Pharmaceutical Care Management Ass'n v. Mulready, 78 F.4th 1183 (10th Cir. 2023), cert. denied, No. 23-1213 (U.S. June 30, 2025).
https://www.ca10.uscourts.gov/sites/ca10/files/opinions/010110903570.pdf - Central States, Southeast & Southwest Areas Health & Welfare Fund v. McClain, No. 25-2727, slip op. at 7–15 (7th Cir. Aug. 26, 2026).
https://media.ca7.uscourts.gov/cgi-bin/OpinionsWeb/processWebInputExternal.pl?Path=Y2026%2FD08-26%2FC%3A25-2727%3AJ%3AKolar%3Aaut%3AT%3AfnOp%3AN%3A3598241%3AS%3A0&Submit=Display - Consolidated Appropriations Act, 2026, Pub. L. No. 119-75, div. J, tit. VII, § 6701, 140 Stat. 173, 713–22; ERISA § 726, 29 U.S.C. § 1185o. The statute establishes the 30-month phase-in, semiannual reporting with quarterly reporting available at plan request, the detailed-reporting rules for specified large employers and plans, and participant-facing summary requirements.
https://www.law.cornell.edu/uscode/text/29/1185o - Consolidated Appropriations Act, 2026, § 6702; ERISA § 408(b)(2), 29 U.S.C. § 1108(b)(2). The statute provides for 100% pass-through of covered remuneration, quarterly remittance generally within 90 days, annual audit access, access to specified rebate contracts, and selection of the auditor by the responsible plan fiduciary.
https://uscode.house.gov/view.xhtml?req=%28title%3A29+section%3A1108+edition%3Aprelim%29 - U.S. Department of Labor, Employee Benefits Security Administration, Improving Transparency Into Pharmacy Benefit Manager Fee Disclosure, proposed rule, RIN 1210-AB37; DOL extension of comment period following enactment of CAA 2026.
https://www.dol.gov/agencies/ebsa/about-ebsa/our-activities/resource-center/fact-sheets/proposed-pharmacy-benefit-manager-fee-disclosure-rule - Federal Trade Commission, Pharmacy benefit managers: The powerful middlemen inflating drug costs and squeezing Main Street pharmacies (interim staff report, July 2024); FTC, Specialty generic drugs: A growing profit center for vertically integrated pharmacy benefit managers (second interim staff report, Jan. 2025); Pharmaceutical Care Management Association response to the FTC's 2024 interim report.
- Tennessee Freedom, Access, and Integrity in Registered Pharmacy (FAIR Rx) Act, 2026 Tenn. Pub. Acts ch. 1111; Tenn. Code Ann. § 63-10-316. Signed May 22, 2026; Public Chapter 1111 issued May 27, 2026. The operative ownership restriction begins July 1, 2028.
https://wapp.capitol.tn.gov/apps/BillInfo/Default?BillNumber=SB2040 - CVS Pharmacy, Inc. v. Tennessee Board of Pharmacy, No. 3:26-cv-00685 (M.D. Tenn. filed May 22, 2026); related actions consolidated into lead case in July 2026.
- Patients Before Monopolies Act, H.R. 8779, 119th Cong. (2026); S. 4509, 119th Cong. (2026). Both introduced May 13, 2026 and referred to the respective Judiciary Committees.
- Break Up Big Medicine Act, S. 3822, 119th Cong. (2026), introduced Feb. 10, 2026 and referred to the Senate Committee on the Judiciary.
- Pharmacists Fight Back in Federal Employee Health Benefit Plans Act, H.R. 6610, 119th Cong. (2025). House Committee on Oversight and Government Reform ordered the bill reported, as amended, July 22, 2026, 40–2.
- Pharmacists Fight Back in Medicare and Medicaid Act, H.R. 6609, 119th Cong. (2025), introduced Dec. 11, 2025 and referred to the House Committees on Energy and Commerce and Ways and Means.
- PBM Kickback Prohibition Act, H.R. 7895, 119th Cong. (2026), H.R. Rep. No. 119-729 (2026). Reported with amendment July 2, 2026.
- Rx Access, Choice, Cost Equity, and Supply Stability Act, S. 4106, 119th Cong. (2026), introduced Mar. 17, 2026 and referred to the Senate Committee on Armed Services.
- PBM Fiduciary Accountability, Integrity, and Reform (FAIR) Act, S. 3549, 119th Cong. (2025), introduced Dec. 17, 2025 and referred to the Senate Committee on Health, Education, Labor, and Pensions.
- 42 U.S.C. § 1395w-111(i); Inflation Reduction Act of 2022, Pub. L. No. 117-169, § 11001, 136 Stat. 1818, 1833–34. CMS's first negotiated maximum fair prices took effect January 1, 2026.
- Centers for Medicare & Medicaid Services, Retail Price Survey—National Average Drug Acquisition Cost (NADAC)and CMS Pharmacy Pricing resources.
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