Medical device companies will get faster Medicare payments for their life-saving products under an agency rule finalized Tuesday.
The regulation allows Medicare to start paying for certain devices right after they get a green light from the Food and Drug Administration. It will cut down the roughly nine to 12 months it usually takes for a new device to get Medicare reimbursement.
“Medicare beneficiaries have not had predictable, immediate access to innovative breakthrough devices,” Centers for Medicare & Medicaid Services Administrator Seema Verma said in a statement.
The goal is to encourage more companies to build equipment to treat or diagnose life-threatening or debilitating conditions and assure them the regulatory hoops they have to jump through will be worth the effort.
The new availability will apply to medical devices that the FDA deems “breakthrough” and could include technologies like implants or gene-based tests to diagnose or treat life-threatening or irreversibly debilitating diseases or conditions like cancer and heart disease.
The policy is also part of an effort to cut back on “redundant processes” between the FDA and the CMS, an FDA official said in August. The rule allows Medicare to provide national coverage of these devices simultaneously with FDA approval for up to four years.
The change will simplify what has been a frustrating process for device makers seeking clearance for Medicare coverage of their products. Those decisions are now made by 16 different Medicare Administrative Contractors (MACs) that make coverage decisions on the local level. That means seniors in some locations have access to devices that aren’t available to their counterparts elsewhere and device makers need to get individual clearance from each MAC. The rule makes those steps unnecessary for device makers.
Reprinted with Permission from Bloomberg Law by Jacquie Lee