Tallying the TrOOPs: Tracking cost implications under IRA Part D reforms

As part of its many provisions, the Inflation Reduction Act (IRA) includes a dramatic restructuring to the funding of the Medicare Part D benefit where costs are shifted away from patients and the government and onto plans and manufacturers. The specific distribution of these costs vary according to how much a patient has accumulated in ‘True’ out-of-pocket spend (TrOOP). Understanding how TrOOP is accumulated is key for understanding exactly who, when, and how much a given manufacturer, plan or patient will have to pay.

TrOOP in the Part D Benefit

Two TrOOP spending thresholds determine when specific coverage phases begin and end for a patient. The first TrOOP threshold of $590 in 2025, which is considered the first phase and also known as the deductible phase, is where patients assume all costs. Next is an initial coverage phase where patients pay 25% of costs up to a cap of $2,000. Once the $2,000 TrOOP cap is reached, patients enter the catastrophic phase and are no longer liable for Part D drug expenses and the costs are fully shifted onto plans, manufacturers and the government. These specific breakdown of costs – a deductible and 25% cost sharing in initial coverage – constitute the defined standard (DS) benefit and is the basis for broader Medicare Part D policies.

Tiered formularies and enhanced plans

While defined standard (DS) benefit is the benchmark for deductible and OOP ranges before patients are pushed into initial and catastrophic coverage respectively, plans generally do not offer coverage that reflect such breakdown of costs. Rather many plans offer what are known as enhanced alternative (EA) benefits allowing for greater coverage (lower cost sharing or lower/no deductible) in exchange for higher premiums. In 2024 a majority (62%)¹ of standalone prescription drug plans (PDP) were enhanced benefit and nearly all Medicare Advantage plans offered a Part D benefit (MA-PD) as well. Often these enhanced benefits are delivered by way of a tiered formulary. Tiered formularies provide a fixed fee schedule where patients have set cost sharing that vary according to whether a drug is branded or generic as well as its specific drug cost and available therapeutic alternatives.

Generic preferred	Other generic	Brand preferred	Other brand	Specialty
0$	5$	50$	100$	33% of drug cost

Table 1: Example of five-tiered formulary categories

In many cases the cost sharing under the formulary results in the patient paying less than what they otherwise would under the defined standard benefit. For example, under the DS benefit after the patient has reached their deductible, a generic drug that costs $100 would have a patient OOP of $25. With a EA plan with a tiered formulary, this OOP may be partially covered by the plan, reducing patient cost to just $5.

TrOOP under enhanced alternative plans – IRA change

TrOOP spending includes both patient cost sharing as well as amounts that are deemed to have been spent on behalf of the patient. New with the IRA is that supplemental spending by enhanced alternative plans has now been deemed to contribute to TrOOP. This means that if a patient is responsible for $25 under the DS benefit but only pays $5 due to their specific EA benefit, the full $25 counts towards TrOOP. This change will result in patients covered by EA plans reaching initial and catastrophic coverage much more quickly than might be expected.

In the table below, we demonstrate how a patient can reach max out-of-pocket (mOOP) without being responsible for the full $2,000 cost threshold under an EA plan. For this particular example, we select an EA plan with no deductible and fixed copay of $50 for the drug in question. We also demonstrate how much of the costs are covered by the plan, manufacturer and government until the TrOOP cap is reached on a drug that costs $1,000 filled once a month where the patient has no other product fills.

Plan costs (Indirect and Direct)

Plan paid on behalf of patient (Indirect) – TrOOP eligible:

In January because the patient has an enhanced alternative plan with no deductible the plan in effect pays the patient’s deductible costs under the defined standard benefit ($590). In addition, the patient is responsible under the DS benefit for 25% of costs above the deductible costs ($410 * 25% = $102.50). The plan charges the patient $50 copay so while $692.50 is owed by the patient, the patient, as noted in column 3, pays $50 according to their plan copay and the remaining $642.50 is paid by the plan on behalf of the patient.

Plan paid (Direct) – Not TrOOP eligible:

In addition to this cost the plan is directly responsible for 65% of costs or in this instance (410 * 65% = $266.5). After the deductible, the plan is responsible for 65% of costs and after a patient has accumulated $2,000 in OOP, the plan pays 60%.

Reaching the OOP threshold: Before the July claim in the above example the patient has $57.50 in OOP spend remaining before $2,000 is reached, which translates to $230 ($57.50 / 25% = $230) in drug spend before the patient reaches the OOP max. This means for a $1,000 claim, $230 occurs before the OOP max in initial coverage. The plan owes $149.50 (65% of $230). $770 occurs above $2,000 OOP and the plan pays 60% of drug costs or $462 (60% of $770). The total plan pay is $149.50 (pre-oop max reached) + $ 462 (post-oop reached), or $611.50

Manufacturer cost: After the deductible and in the initial coverage phase, manufacturers are obligated for a 10% discount up to the $2,000 max, after which the catastrophic phase begins and manufacturers are obligated up to 20% in discounts. In January this discount obligation is $410 * 10% = $41. For July, after a patient has amassed $2,000 in OOP, the discount obligation increases to 20%. Before the July claim, the patient has $57.50 in OOP spend remaining before $2,000 which translates to $230 ($57.50 / 25% = $230) in drug spend before the patient reaches the OOP max. This means for a $1,000 claim, $230 occurs before the OOP max in initial coverage and the manufacturer owes $23 ($230 * 10%). $770 dollars occurs above $2,000 OOP and is subject to a 20% discount obligation or $154 ($770 * 20%). The total discount obligation is $154 + $23 or $177. As patients fill prescriptions and their oop max has already been reached, discount obligations on each subsequent will be 20%.

Government cost: There is no reinsurance prior to the oop max and after a patient has accumulated $2,000 in OOP, the government assumes 20% in reinsurance costs. For a $1,000 claim in the EA plan referenced above, $770 dollars occurs above $2,000 OOP and is subject to 20% reinsurance or $154.

Tracking TrOOPs and market dynamics

ICON’s regulatory intelligence anticipates that the Part D benefit reforms will lower consumer costs, which will likely spur drug consumption. However, the cost-reduction will vary across Medicare beneficiaries depending on their plan structures and formularies. Manufacturers will need to be aware just how quickly patients will progress through the benefit as reaching the TrOOP sooner will trigger higher costs to manufacturers by way of increased obligatory discounts. The rate-determining variable is the unique mix of drugs a patient takes along with their specific cost sharing amounts as determined by the plan the patient is enrolled in.

Symphony Health’s real-world and real-time claims data coupled with a proprietary algorithm allows stakeholders to understand how this specific dynamic plays out across products and markets. While manufacturers stand to benefit from the increased demand prompted by the Part D changes, this must be weighed against their updated discount obligations to ensure optimal commercial positioning, forecasting and developing strategies to keep patients adherent while the burden of the costs shift further to the manufacturer.

The myriads of assumptions and regulations spanning beneficiary attributes necessitates adopting an approach that is both tailored to specific products of interest while considering the broader changes of the program. Along with an enhanced Medicare Part D algorithm, Symphony Health’s payer strategy consulting team is available to help design and scope custom solutions for manufacturers for the following activities:

Forecasting discount obligations
- Forecasting future discounts will require understanding consumption patterns according to TrOOP progression and LIS status.
Impact of IRA Negotiated Drug Forecasting
- Drugs selected for IRA price negotiations are exempted from the mandatory discount. Competing in a class where a competitor product has undergone a price cut while simultaneously facing lower CMS invoicing requires understanding where and how the competition is consumed in the benefit.
Patient Responsibility Modelling
- Understanding when patients are reaching their $2000 oop max will help inform strategies for Medicare Prescription Payment Plan (M3P) enrolment and patient adherence strategies
- Previously, adherence may have been an issue with the doughnut hole / coverage gap. Now Medicare recipients are likely to increase consumption as their cost sharing is eliminated.
Tracking rejections due to access restrictions
- Payers are expected to respond to the IRA’s shifting of cost to plans by implementing greater access restrictions. Tracking and profiling patients facing barriers to brands is critical in understanding the potential impact.

Connect with us to learn how ICON’s healthcare intelligence and Symphony’s robust data can help shape new strategies to find success under the IRA changes.