This rulemaking is the first opportunity to codify the Negotiation Program in binding regulatory text rather than annual sub-regulatory guidance, and codification is the appropriate moment to close these gaps. Patients were promised that this program would deliver meaningful affordability and access improvements, and CMS should use this rulemaking to make good on that promise through enforceable, not merely discretionary, standards. Our comments address patient engagement in the negotiation process, transparency in how patient input is used, formulary access and utilization management protections for selected drugs, and additional concerns about the negotiation methodology itself.
Comments urging CMS administrator Oz to withdraw the Medicaid community engagement requirement for people living with HIV
Our comments focus on the rule’s narrowing of the medical frailty exclusion on people living with HIV. The rule requires states not just to determine if an enrollee has a serious or chronic medical condition, but also whether that condition “significantly impairs” their ability to work. This “significant impairment” standard is inconsistent with the statute, unworkable, and would harm people with HIV and stress the safety nets they rely on. We urge CMS to withdraw the rule and reissue it so as to make it compliant with the law.
Patient groups letter to CMS Administrator Oz Responding to the request for information on essential health benefits
While the Affordable Care Act (ACA) provides the opportunity for the Secretary of Health and Human Services (HHS) to periodically review the definition of Essential Health Benefits (EHBs), we caution HHS from making any changes or developing any new framework that would reduce the level of prescription drug coverage for beneficiaries. We believe that the current framework and requirements governing prescription drugs that are based on benchmark plans and allow states to add additional benefits are generally working well for patients. Our biggest concerns are the lack of adequate prescription drug coverage, the lack of enforcement of all EHB regulations, and allowing insurers and pharmacy benefit managers (PBMs) to skirt the EHB law and regulations. Below are our recommendations to strengthen prescription drug coverage and enforcement of existing EHB protections.