The Association for Clinical Oncology (ASCO) submitted comments to the Centers for Medicare & Medicaid Services (CMS) in response to two proposed rules: the 2025 Medicare Advantage and Part D proposed rule and the 2025 Notice of Benefit and Payment Parameters proposed rule. ASCO’s comments support provisions that address utilization management and health equity, which have the potential to improve access to care for the cancer community.
Key points from ASCO’s comments include:
Notice of Benefit and Payment Parameters Proposed Rule
ASCO strongly supports CMS’ proposal to codify essential health benefit (EHB) policy related to prescription drugs in excess of the benchmark plan. Under CMS’ proposal, if a health plan covers drugs beyond what is included in the benchmark plan, these drugs would still be considered EHBs and must count towards annual cost sharing and out of pocket limits.
ASCO’s physician members continue to express concerns over “specialty carve-out” schemes and “alternative funding programs,” which some refer to as the “EHB loophole” affecting patients in self-funded and large employer group plans. These tactics are an emerging trend among payers seeking to reduce their drug spending by excluding coverage for high-cost branded specialty drugs from an enrollee’s prescription drug benefit. These harmful policies add to confusion for patients, increase their out-of-pocket costs, and impede access to care.
Medicare Advantage and Part D Proposed Rule
Utilization Management and Health Equity
ASCO strongly supports CMS’ proposal to require Medicare Advantage health plans to analyze their prior authorization and other utilization management (UM) protocols from a health equity perspective. ASCO supports CMS’ proposal to require that a member of the UM committee have expertise in health equity, to require the UM committee to conduct an annual health equity analysis of prior authorization policies and procedures used by the Medicare Advantage plan organization, and to require Medicare Advantage plan organizations to make the results of the analysis publicly available on their website. In addition to supporting these proposals, ASCO strongly believes that CMS should include additional patient populations in the health equity analysis beyond what it proposed.
ASCO strongly urges CMS to monitor and remedy the predictable, adverse consequences that individuals with cancer may experience from barriers or delays in receiving preferred oncology therapies because of prior authorization requirements, including suboptimal clinical outcomes, increases in adverse events, increases in emergency department visits, and disparities in treatment or outcomes. For more information, please see our affiliate, the American Society of Clinical Oncology’s position statement on prior authorization.
Biosimilar Biological Products and Formulary Changes
In the 2024 Medicare Advantage/Part D proposed rule, ASCO opposed CMS’ proposal to allow Part D sponsors to make immediate formulary changes by substituting a new interchangeable biological product for its corresponding reference product without advanced beneficiary notification. ASCO was concerned that Part D plan sponsors could provide notice of these specific changes, including direct notice to affected beneficiaries, after formulary substitutions take place and would not need to provide a transition supply of the substituted drug. We reiterated our opposition to this proposal again this year.
In this proposed rule for 2025, CMS is proposing to permit Part D plan sponsors to treat formulary substitutions of biosimilar biological products other than interchangeable biological products for their reference products as “maintenance changes” that would not require prior approval by CMS.
ASCO supports the proposed flexibility and the efforts to enhance biosimilar use by Medicare beneficiaries in both the 2024 and 2025 proposals; however, we strongly believe that substitution of a patient’s drug therapy, regardless of an “interchangeable” designation, needs to be determined between the patient and the physician and that 30 days is insufficient to fully analyze and implement that change. Additionally, we do not support the distinction between “interchangeable” and “biosimilar biological products other than interchangeable.” We urge CMS to finalize policy that would allow payers to add “interchangeable” and “biosimilar biological products other than interchangeable” to formularies mid-year without removing the reference product during that plan year. Payers should ensure that changes to prescribed therapies for patients are made only in the context of prior consultation between the patient and physician. At a minimum, payers should continually update and ensure transparency by clearly describing their formulary design and preferred choice of biologic products.
Limit Out-of-Network Cost Sharing for D-SNP PPOs
Full-benefit dually eligible enrollees who are not Qualified Medicare Beneficiaries (QMBs), are liable for cost sharing if they go out of network to providers not enrolled in Medicaid. Cost sharing for out of network services is often much greater than cost sharing for in-network providers or for Traditional Medicare, preventing patients from accessing care.
The proposed rule would limit out-of-network cost sharing for Dual Eligible Special Need Plans (D-SNP) preferred provider organizations (PPOs) for specific services, including chemotherapy administration services, chemotherapy/radiation drugs, and radiation therapy integral to the treatment regimen, and other Part B drugs, beginning in 2026. ASCO agrees with the agency that if finalized, this updated cost-sharing policy could expand dually eligible enrollees’ access to providers, protect dually eligible enrollees from unaffordable costs, reduce cost shifting to Medicaid, and increase payments to safety net providers; therefore, ASCO strongly supports CMS’ proposal.
ASCO’s comments also commend CMS for its continued efforts to protect beneficiaries from predatory marketing tactics. Medicare beneficiaries need accurate information from reliable sources about Medicare coverage without the worry that they are being steered into a certain plan for the benefit of the agent—regardless of whether the plan will meet an enrollee’s needs.
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