Frequently Asked Questions

Beginning in 2026, ACA marketplace silver plans are moving GLP‑1 agonists like semaglutide and tirzepatide into higher‑cost, nonpreferred brand tiers with coinsurance around 40–50% after deductibles. The CMS rule stops manufacturer copay coupons from counting toward out‑of‑pocket limits, raising member costs and prompting insurers to revise silver plan premiums.

ACA marketplace plans group drugs into tiers—preferred generics, non‑preferred brands, and specialty drugs—based on negotiated pricing and cost controls. Each tier carries different cost‑sharing rules, with lower tiers encouraging cheaper generics and higher tiers requiring greater patient payments or prior authorization.

The ACA Marketplace benchmark plan—the second‑lowest‑cost Silver option—sets the reference premium that determines subsidy amounts, indirectly shaping drug coverage and network access. Because each insurer designs its own formulary, small benchmark price shifts can redirect enrollment toward plans with varying medication lists, prior‑authorization rules, and pharmacy networks.

ACA marketplace plans usually start with the formulary, then require a non-formulary exception or medical necessity review if the prescribed drug is not listed. The plan typically checks whether covered alternatives are appropriate first, and approval often depends on documentation showing intolerance, contraindications, lack of effectiveness, or the need to maintain treatment stability.

ACA marketplace plans may still cover an off-formulary drug, but usually only through a formulary exception request backed by medical justification from the prescriber. Even then, the plan can still require prior authorization or step therapy, and a denial can usually be appealed through the plan’s formal review process.

By mid‑2026, PBMs are overhauling rebate and formulary structures for aflibercept biosimilars after CMS finalized interchangeability guidance and faster ASP reporting. These updates compress rebate margins and push plans toward net‑effective‑price models that reward biosimilar uptake, altering rebate guarantees and tier placements across Medicare and commercial formularies.

UnitedHealthcare’s 2026 formulary strategy places at least one interchangeable Humira biosimilar, such as Amjevita or Hadlima, on Tier 2 as preferred drugs, while Humira itself moves to Tier 3 or non‑formulary status. This shift follows CMS guidance promoting interchangeable biosimilars and is expected to lower member costs by about 20% compared to Humira’s net price.

CMS’s 2026 billing guidance standardized coding for interchangeable adalimumab biosimilars, prompting Medicare Advantage plans to favor Amjevita and Cyltezo in step‑therapy sequences. Amjevita’s early market entry and Cyltezo’s interchangeability status led PBMs to place them on preferred specialty tiers ahead of Humira and other non‑interchangeable biosimilars.

For 2026 ACA Marketplace plans, insurers are shifting interchangeable Stelara biosimilars into preferred specialty tiers with lower coinsurance, typically 25–35%, compared to Stelara’s 35–50% in non-preferred tiers. The FDA’s interchangeability approval allows substitution at the pharmacy, driving payers to promote biosimilar use while controlling premium growth.

In 2026, employer prescription plans are being reshaped by the arrival of ustekinumab biosimilars for Stelara, now granted FDA interchangeability under new CMS rules. These biosimilars are driving formulary changes, with many employer plans shifting them to lower specialty tiers and using IRA-aligned Medicare pricing to reduce overall specialty drug costs.

Step therapy requires patients to try a plan’s preferred biosimilar before accessing the reference biologic, while interchangeability rules govern if a pharmacist can automatically substitute a biosimilar. Most biosimilars lack FDA interchangeability status, so substitution typically needs prescriber approval under state and plan policies.

State Medicaid programs base mandatory biosimilar substitution decisions on FDA definitions of interchangeability and state-specific pharmacy laws. Agencies assess whether pharmacists can substitute without prescriber approval, then weigh clinical data, interchangeability status, and net cost to assign preferred drug list placement.

Commercial health plans individually decide how to structure step therapy sequences for interchangeable biosimilars versus reference biologics, since no binding regulation mandates a uniform approach. Some plans start with the biosimilar as the first step, while others keep the reference biologic first, often influenced by rebates or utilization patterns.

Interchangeability and formulary placement are related but separate. Interchangeability affects whether a pharmacist may substitute a biosimilar under applicable rules, while formulary placement determines which product a plan prefers, covers, or places on a lower tier. A biosimilar can be covered or preferred even if it is not interchangeable.

Yes. A health plan can require prior authorization for a reference biologic, a biosimilar, or both to confirm formulary rules, step therapy, site-of-care, or other benefit terms. That payment decision is separate from whether a pharmacist may legally substitute the biosimilar without a new prescription.

Mid-year formulary tier changes in employer health plans are typically triggered by factors such as manufacturer price adjustments, new generic launches, safety advisories, or rebate and cost shifts. Pharmacy benefit managers use these updates to keep formularies financially balanced and ensure coverage reflects current market and regulatory conditions.

Self‑funded employers analyze claims data to identify high‑cost specialty drugs, often biologics or infused therapies, and assess alternatives like direct purchasing through specialty pharmacies or manufacturer programs. They weigh cost transparency, clinical interchangeability, and network rules to manage these drugs outside PBM formularies and reduce administrative and rebate‑related costs.

Employer-sponsored health plans sometimes adjust their prescription drug formularies mid-year in response to pricing shifts, new generics, or safety updates. When they do, they must follow notice rules requiring prior communication to employees, explaining timing and impact to prevent sudden cost or treatment disruptions.

Self-funded employer plans review formulary exception requests through their pharmacy benefit manager (PBM), which evaluates medical necessity, prior treatment history, and documentation. Employers can set their own criteria and involvement level, balancing cost management with clinical evidence before approving or denying coverage for non-formulary specialty drugs.

Employer-sponsored health plans use a structured process to review formulary exception requests for non-covered or higher-tier drugs. Physicians submit clinical justification showing why formulary alternatives failed or caused adverse reactions. The insurer or PBM conducts a clinical review under employer oversight, ensuring consistent, evidence-based determinations aligned with ERISA duties.

Starting January 2026, CMS’s first negotiated price cuts under the Inflation Reduction Act lowered Eliquis and Xarelto list prices by about 25–30%, prompting Part D plans to move them to lower formulary tiers. Many major sponsors like SilverScript and Humana now list both drugs as Tier 2 preferred brands, reducing coinsurance and overall patient out-of-pocket costs.

A Medicare Part D formulary exception lets a plan cover a drug not on its official list when medical need is shown. The prescriber submits documentation explaining why listed alternatives don’t work, and the plan must decide within required timeframes. Once approved, the drug is treated as covered—often at a certain tier—for the rest of the plan year.

Medicare Part D plans compare the reference biologic’s rebate with the biosimilar’s net cost after discounts to assign formulary tiers. CMS rules let sponsors substitute FDA‑designated interchangeable biosimilars without prior approval if member costs don’t rise, aligning placement decisions with cost and rebate incentives.

Medicare Part D step therapy rules require patients to try lower‑tier, often lower‑cost drugs before a plan covers more expensive or brand‑name options. Pharmacy and Therapeutics committees determine tier placement based on safety, outcomes, and cost‑effectiveness, while CMS oversees compliance and ensures exception processes protect patients when first‑step drugs aren’t suitable.

Medicare Part D plans may require prior authorization or step therapy for insulin to ensure clinical appropriateness and cost control. Prior authorization means the prescriber must show medical necessity before coverage, while step therapy requires trying a preferred insulin first. CMS reviews and monitors these rules to keep them consistent and non‑discriminatory.

A Medicare Part D tier exception asks a plan to move a covered drug to a lower cost-sharing tier, which is different from asking whether the drug is covered at all. When a member, prescriber, or authorized representative submits the request through the plan’s exception process, the plan must review it and make a determination; if denied, the member can appeal.

Medicare Part D protected-class rules mainly protect access: plans generally cannot exclude drugs in certain protected classes from their formularies. But plans may still use higher cost-sharing tiers, prior authorization, and step therapy, as long as those controls do not undermine required access within CMS rules.

A formulary is a list of prescription drugs covered by a health insurance plan. Plans organize drugs into tiers, with lower tiers generally having lower out-of-pocket costs. Not all drugs are on every formulary, and tier placement varies by plan.

Most plans use a tier system: Tier 1 (preferred generics, lowest cost), Tier 2 (non-preferred generics or preferred brands), Tier 3 (non-preferred brands, higher cost), Tier 4 or 5 (specialty drugs, highest cost). Your copay or coinsurance depends on which tier your drug is placed on.

Prior authorization (PA) is a requirement from your insurance plan that your doctor must get approval before the plan will cover a specific drug. The plan reviews whether the drug is medically necessary based on your diagnosis, treatment history, and their clinical criteria.

Step therapy requires you to try one or more less expensive drugs before your plan will cover a more expensive drug. For example, a plan might require you to try metformin before covering a GLP-1 drug like Ozempic. Your doctor can request an exception if there is a clinical reason to skip a step.

Check your plan's formulary, which lists all covered drugs and their tier placement. You can usually find it on your insurance company's website. InsureWith.ai aggregates formulary data from Medicare Part D, ACA Marketplace plans, and major commercial insurers so you can search across plans in one place.

First, ask your doctor for the specific denial reason. Common paths forward: request a formulary exception from your plan (your doctor submits a letter of medical necessity), appeal the denial through your plan's formal appeals process, ask your doctor about therapeutic alternatives that are on formulary, or check if the drug manufacturer offers a patient assistance program.

A copay is a fixed dollar amount you pay for a prescription (e.g., $10 for a generic). Coinsurance is a percentage of the drug's cost (e.g., 20% of a $500 specialty drug = $100). Plans may use copays for lower tiers and coinsurance for higher tiers and specialty drugs.

Plans can update their formularies throughout the year. Major changes typically happen at the start of the plan year (January for Medicare, plan renewal date for employer plans). Mid-year changes are less common but can occur. CMS requires Part D plans to provide 60 days notice before removing a drug or moving it to a less favorable tier.

Medicaid applies prior authorization to verify that GLP‑1 prescriptions meet approved indications before coverage is granted. For diabetes, these drugs are generally covered once the prescriber confirms diagnosis and necessity, but for weight management, states decide individually, often adding stricter criteria like proof of comorbidities or prior lifestyle interventions.

Employer plans often review GLP-1 requests differently based on the diagnosis. For diabetes, they usually check formulary status and utilization rules like prior authorization or step therapy, while for obesity they may first determine whether anti-obesity drugs are covered at all under the employer’s benefit design before clinical review.

Yes—under Medicare Part D, GLP-1 coverage depends on the use being processed, not just the drug name. A GLP-1 may be covered when prescribed for a medically accepted diabetes indication, but rejected when submitted for weight-loss use, which can fall into an excluded category; plan formulary rules and prior authorization also affect the claim.

Medicare Part D covers Ozempic (semaglutide) when prescribed for Type 2 diabetes. Medicare does not currently cover GLP-1 drugs prescribed solely for weight loss. The Treat and Reduce Obesity Act has been introduced in Congress to change this, but as of 2026 it has not been enacted.

Ozempic (semaglutide injection, for Type 2 diabetes), Wegovy (semaglutide injection, for weight management), Mounjaro (tirzepatide injection, for Type 2 diabetes), Zepbound (tirzepatide injection, for weight management), and Rybelsus (oral semaglutide, for Type 2 diabetes). Coverage varies significantly by plan type and indication.

Following the 2025 CMS update to Medicaid Drug Rebate calculations, states are revising how GLP‑1 drugs like semaglutide and tirzepatide are placed on formularies. Many are moving these drugs to 'preferred with criteria met' tiers, adding prior authorization and step‑therapy rules to balance access with budget control for weight‑management indications.

State Medicaid programs require prescribers to submit clinical documentation proving medical necessity before covering GLP‑1 drugs for weight management. These reviews confirm qualifying diagnoses, prior lifestyle therapy attempts, and ongoing benefit, reflecting CMS’s broader utilization management framework to ensure appropriate, cost‑effective use of high‑priced medications.

State Medicaid programs apply separate prior authorization and clinical criteria depending on whether GLP‑1 drugs are prescribed for diabetes or obesity. Diabetes use is generally covered under the Medicaid rebate system but still requires documentation of diagnosis and prior treatment, while obesity use may be excluded entirely or subject to BMI thresholds and periodic re‑evaluation.

In Medicaid, specialty drug coverage often depends on how preferred drug lists, carve-outs, and fee-for-service rules interact. A carve-out can shift control from the managed care plan to fee-for-service Medicaid, changing who sets prior authorization, whether the drug is billed under the pharmacy or medical benefit, and which pharmacy or site-of-care rules apply.

Medicaid rebates can make a high-list-price drug cheaper to the state after statutory and supplemental discounts, so preferred drug list placement often follows net cost rather than sticker price. Preferred drugs usually face less prior authorization, while nonpreferred drugs are more likely to require it to support the state’s rebate and utilization strategy.

For 2026, CMS’s negotiated prices for Eliquis, Imbruvica, and Entresto are driving major tier and coinsurance shifts. Part D plans are trimming specialty coinsurance from about 33% to roughly 25% on selected drugs, introducing preferred specialty tiers, and rebalancing oncology costs to offset reduced manufacturer rebates.

When a prescribed drug isn’t on a Part D plan’s formulary, the member can request a formulary exception asking the plan to cover it or lower its cost tier. If denied, there’s a structured appeal process involving multiple review levels, where medical necessity evidence and persistence can help overturn the decision.

Medicare Part D catastrophic coverage begins once a beneficiary’s true out‑of‑pocket costs reach a set threshold. Qualifying payments include the deductible, copayments, coinsurance, and certain manufacturer discounts for covered or approved drugs. Premiums, plan payments, or contributions from other insurers or assistance programs do not count toward this limit.

The coverage gap (or "donut hole") was a phase in Part D where you paid more for drugs after initial coverage was exhausted but before catastrophic coverage kicked in. The Inflation Reduction Act eliminated the coverage gap starting in 2025, and in 2026 caps total out-of-pocket costs at $2,000 per year.

Starting in 2026, Medicare Part D beneficiaries will pay no more than $2,000 out of pocket for prescription drugs in a calendar year. Once you reach that threshold, you pay nothing for covered drugs for the rest of the year. This replaces the old catastrophic coverage phase where you still paid 5% coinsurance.

Medicare Advantage and Part D plans are interpreting CMS coverage rules differently for these Alzheimer’s drugs, even after full FDA approval. While CMS requires evidence of amyloid buildup for mild cognitive impairment or dementia, plans add extra steps like neurologist sign‑offs, MRIs, or cognitive stability reports, creating inconsistent and delayed access.

In 2026, ACA marketplace insurers are tightening prior authorization rules for obesity‑related GLP‑1 drugs like Wegovy and Zepbound following new CMS guidance. Plans now require higher BMI thresholds, proof of structured lifestyle programs, and more frequent renewal checks, while shifting these costly drugs to higher specialty tiers with increased coinsurance.

Urgent 72-hour prior authorization reviews start immediately when delay could endanger a patient’s health or recovery. Plans must receive complete documentation including medical justification, recent clinical notes, and proof that alternatives failed. Missing data restarts the clock, so complete submissions are key to timely approval.

Plans usually want proof of both medical necessity and urgency. That often includes the diagnosis, symptoms, prior treatments, treatment response or adverse effects, and why the requested drug or service is appropriate, plus a clinician statement explaining why waiting for the standard timeline would jeopardize the patient’s health or function.

Specialty-drug prior authorization uses separate coverage tests: medical necessity, step-therapy failure, contraindications, and ongoing monitoring for renewals. Plans often require specific documentation showing whether a preferred drug failed, caused intolerance, was contraindicated, and whether follow-up labs, notes, or symptom measures support continued coverage.

A Summary of Benefits and Coverage (SBC) is a standardized document that every health plan must provide. It outlines your plan's deductible, copays, coinsurance, and out-of-pocket maximum in a consistent format. You can find yours through your employer's HR portal, your insurance company's website, or on Healthcare.gov if you have a Marketplace plan.