The Centers for Medicare & Medicaid Services (CMS, or Medicare) has developed a process called coverage with evidence development (CED), which allows Medicare to provide conditional coverage for some items or services while additional clinical or scientific information is collected. CED is used as a mechanism to provide coverage for promising new medical technologies that might not otherwise be covered until Medicare is assured that the clinical evidence supports the new technologies’ impact on the Medicare population. In theory, CED allows Medicare beneficiaries access to new and innovative items and services and promotes innovation; however, the CED process is in need of improvements that would make it more predictable and transparent. CMS is revising its existing CED policy guidance, and has asked the public for comments and feedback at several points in the process. At the same time, CMS has recently issued a number of National Coverage Determinations that require some form of CED.
Codes are numerical or alpha-numerical identifiers that are used on claims to identify medical services, procedures, and supplies. The process for developing, revising, and maintaining adequate reimbursement for codes is an ongoing challenge. The American Medical Association (AMA) owns the Current Procedural Terminology (CPT) book, which houses descriptors for the many codes that are used to bill for physician services. AdvaMed works with the AMA, on behalf of our members and through our participation in several AMA workgroups, to advocate for changes and adjustments to the CPT coding system that make the process more open, transparent, inclusive, and accommodating to industry stakeholders. We are also very engaged in other coding reform efforts with CMS including HCPCS, ICD-9, and the pending transition to ICD-10.
1n 2012, AdvaMed developed and submitted comments in response to a request by CMS for information on the use of CED and its impact on Medicare beneficiaries. Additionally, AdvaMed commented on a number of proposed NCDs that contained CED, requiring additional clinical studies, data gathering through the use of registries, or other forms of CED. In late 2012, CMS issued a revised CED guidance document and again asked for public input.
In early 2013, AdvaMed participated in a stakeholder summit convened by the AMA to discuss potential ways to improve or streamline the CPT-coding process. AdvaMed’s recommendations were positively received by the AMA, and we will continue to work together to ensure improvements in that process.
AdvaMed is committed to working with manufacturers and other stakeholders to improve Medicare’s coverage process and to ensure that Medicare beneficiaries have access to new and innovative medical technologies.
Coverage & Coding Best Practice Guides
The Coverage & Coding Overview and Best Practice Guides resource is a detailed overview describing the coding system and guidelines for device manufacturers seeking CMS coverage. These documents provide essential information for device manufacturers to consider concerning coverage and payment, such as:
- CMS coverage policy guidelines and criteria
- The interplay between CMS and FDA
- Key coverage considerations for developing an engagement strategy
- CPT, HCPCS, and ICD coding information
- Key coding considerations for device manufacturers
- Characteristics of a successful reimbursement strategy
- Medicare coverage landscape and processes
- National Coverage Determinations (NCDs)
- Local Coverage Determinations (LCDs)
- Successful engagement with Medicare Administrative Contractors (MACs)
- Parallel Review overview and criteria
- Case Studies: Cologuard and TAVR
To access the guides and webinar content, click here.