By Root Woldu, Health Policy Analyst
For Medicare patients on specialty therapies, access is often determined affordability – what they owe at the pharmacy counter, whether that cost is explained in advance, and whether they qualify for a support pathway. The Inflation Reduction Act (IRA) is reshaping each of those factors on a rolling schedule that adds a new group of selected drugs into scope every year, each on its own path toward a negotiated price.
Much of the IRA conversation has focused on pricing. For life sciences organizations and access partners, the more immediate question is how patient support programs (PSPs) should operate between drug selection and the date a negotiated price takes effect. That gap is where forecasting becomes harder, benefit verifications increase and patients feel the friction.
Key Definitions
A few definitions are helpful because IRA terminology is often used interchangeably, even though the distinctions matter for support program operations.
Maximum Fair Price (MFP): The negotiated price CMS sets for a selected drug. It applies several years after selection, not at the time of announcement.
Initial Price Applicability Year (IPAY): The year a selected drug’s MFP takes effect. Drugs are often described by cohort, such as IPAY 2026, IPAY 2027 or IPAY 2028, with each cohort running on its own timeline.
Manufacturer Discount Program: The Part D structure requiring life sciences organizations to provide discounts on applicable brand drugs under the redesigned benefit. These discounts are part of the benefit design and liability structure, but how they interact with beneficiary out-of-pocket accumulation can depend on the product, benefit phase and selected drug status.
Medicare Prescription Payment Plan (M3P): The Part D cost-smoothing option that lets beneficiaries spread out-of-pocket (OOP) costs across the calendar year in monthly installments rather than paying them at the pharmacy counter.
At a Glance: Current Policy Landscape
Three negotiation cycles are running at once
CMS announced 15 drugs for the third negotiation cycle on January 27, 2026, with negotiated prices effective January 1, 2028. Those drugs represent roughly $27 billion in combined Part B and Part D spending. CMS final guidance for IPAY 2028 sets the framework for the third negotiation cycle and related MFP effectuation policies.
At the same time, IPAY 2026 prices are live and the IPAY 2027 cohort is moving toward implementation. Organizations with Medicare-exposed portfolios must now manage brands at different stages of the same program, each with its own payer dynamics, formulary implications and patient messaging needs.
Part B drugs are in the program for the first time
IPAY 2028 is the first cycle to include drugs paid under Medicare Part B, alongside Part D products. That matters because Part B products operate through different access workflows, including buy-and-bill economics, HCP-administered settings, medical benefit verification and site-of-care considerations.
The core constitutional challenges have lost momentum
On May 18, 2026, the Supreme Court declined to hear constitutional challenges brought by several life sciences organizations, leaving lower court rulings in place. A denial of certiorari is not a ruling on the merits, and other legal challenges could still emerge. However, near-term implementation is unlikely to be delayed by the core constitutional cases.
How the IRA Affects Affordability for Medicare Patients
Several IRA provisions interact in ways that are easy to describe individually and difficult to model together.
The Part D redesign capped beneficiary OOP spending, set at $2,100 in 2026 and indexed annually, and eliminated catastrophic coinsurance. For patients on high-cost specialty therapies, that ceiling is meaningful. Discounts for life sciences organizations are also built into the redesigned Part D liability structure, with responsibilities varying by drug type and benefit phase.
However, the cap does not solve timing. A patient can still face a large cost early in the year. M3P helps spread those costs across the year, but patients still need to know the option exists and enroll, and this awareness gap often lands on the PSP to manage.
One constraint remains intact: copay assistance is not available to Medicare beneficiaries under the federal Anti-Kickback Statute. Medicare affordability still depends on independent charitable foundations, patient assistance programs and free goods, all of which have eligibility criteria, funding cycles and wait times.
How the IRA Impacts PSPs
Forecasting becomes less reliable
Once CMS selects a drug for negotiation, payers and life sciences organizations can start adjusting their plans right away — well before the negotiated price takes effect.
Plans may seek deeper concessions sooner, and life sciences organizations may adjust brand investment in response. Formulary position, utilization management and coverage rules can shift during the pre-MFP window, making program models less reliable.
Benefit verification volume and cadence increase
Every plan-year transition and formulary change can trigger the need for benefit reverification. With multiple cohorts moving through the program on staggered timelines, conducting reverification continuously becomes a more valuable strategy. For Part B products, that work spans both medical and pharmacy benefits.
Foundation and PAP demand shifts
As Medicare cost exposure shifts, demand for alternative funding pathways can shift too. PSPs need timely visibility into foundation fund availability, eligibility criteria and routing options when a fund closes.
Operational complexity compounds
GAO reporting and CMS guidance describe implementation rolling out across overlapping years. Access infrastructure must now support pre-MFP and post-MFP brands, Part B and Part D products, Medicare and commercial books of business, and evolving payer requirements.
How Life Sciences Organizations Are Preparing
Organizations with Medicare-exposed brands are preparing before MFP effective dates by:
- Segmenting the portfolio by IRA exposure to identify which brands are in each cohort and how much volume is Medicare.
- Strengthening Medicare affordability pathways through foundation navigation, patient assistance program qualification and free goods support.
- Making M3P part of the standard patient conversation, so patients understand cost smoothing before affordability becomes a barrier.
- Increasing reverification frequency using event-driven checks tied to plan-year transitions and coverage changes.
- Building Part B access capability across medical benefit investigation, site-of-care and buy-and-bill workflows.
- Setting patient expectations early by explaining what manufacturer assistance can and cannot do for Medicare beneficiaries.
How Life Sciences Organizations Navigate IRA Impact
There is no single fix for IRA-driven access complexity. Managing it requires the right balance of technology and human expertise — and working with an outcomes-driven partner.
AssistRx Advanced Benefit Verification establishes real-time coverage detail for each patient — including plan type, benefit design, cost exposure and coverage restrictions across pharmacy benefits. With insurance discovery, eMedBV can verify benefits without payer or member ID by identifying a patient’s active coverage using only demographic information and prescriber NPI, supporting reverification, unknown insurance, outdated coverage details and payer-list integration challenges. Those findings flow into our CRM, helping surface Medicare patients for intervention before cost disrupts therapy.
That coverage detail is paired with teams who bring deep expertise across pharmacy benefits, medical benefits, government and commercial insurance, and third-party foundations.
Additionally, Advanced Insurance Assistance is designed for Medicare patients, where copay assistance is not an option. Specialists assess available support, including foundation funds, patient assistance programs, low-income subsidy qualification and M3P enrollment, to identify a compliant path forward.
Our capabilities:
- Identify Medicare-exposed patients early using benefits investigation findings and plan-level detail.
- Monitor plan, formulary and benefit changes so patient routing stays current as brands move toward MFP effective dates.
- Navigate alternative funding including foundation assistance, patient assistance programs and low-income subsidy qualification.
- Educate patients, pharmacies and providers on M3P, cost expectations and Medicare assistance limits.
- Support pharmacy and medical benefit workflows as Part B products enter the negotiation program.
The goal is benefit optimization: helping patients start and stay on therapy as coverage requirements change.
Looking Ahead
The Medicare Drug Price Negotiation Program is already changing access planning. With three cohorts in motion, Part B drugs entering the program and core constitutional challenges losing momentum, the pre-MFP window is where access risk is likely to concentrate.
Life sciences organizations are making decisions now that will shape patient access in 2027 and beyond. PSPs that identify at-risk patients early, reverify coverage as conditions change, and navigate Medicare-specific funding can help reduce disruption before it affects treatment continuity.
AssistRx can help you evaluate how IRA-driven changes may affect your Medicare-exposed brands and identify strategies to protect patient continuity, reduce access disruption and optimize program performance ahead of MFP effective dates.
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About the Author
Root Woldu is a Health Policy Analyst at AssistRx with expertise in federal and state legislation, Medicare and Medicaid, and drug pricing and access. As AssistRx’s internal health policy expert, she monitors regulatory developments and translates complex changes into actionable intelligence for commercial stakeholders. Her work includes policy analysis, coverage impact assessments, and strategic communications that keep teams and partners informed and decision-ready.