On Friday, August 14^th, CSRO received confirmation from senior staff in the Centers for Medicare and Medicaid Services (CMS) Administrator’s Office that the agency had reviewed the concerns raised by CSRO regarding Medicare coverage of IV Orencia (abatacept) and the information we provided about the impact of CGS’s policy on rheumatology practices and beneficiaries. CMS subsequently engaged with CGS, leading to a revision of CGS’s J0129 Orencia fact sheet.

The revised fact sheet removes the previous requirement for providers to demonstrate why a patient could not receive self-administered subcutaneous Orencia to support continued IV administration, including the prior three-month “trial” requirement. Importantly, CMS also informed CSRO that CGS will review recent audit findings on a claim-by-claim basis and consider any appeals accordingly. We are continuing to work with CMS and CGS regarding Targeted Probe and Educate (TPE) audits that may already be underway or otherwise affected by the prior policy. Practices should contact CGS with questions about individual claims or appeals, but CSRO also needs to hear from practices that are currently in a TPE audit involving IV Orencia, have received adverse findings, or continue to experience denials or other issues. This information will help inform our ongoing discussions with CMS and CGS.

Background:

CSRO first raised this issue after hearing from two rheumatology practices experiencing problems with CGS’s policy and being subject to TPE audits. Soon after, it became clear that the problem was more widespread, with at least eight affected practices and more than 100 Medicare beneficiaries facing difficulty accessing their medication. In some cases, beneficiaries who had been stable on IV Orencia were unable to continue their treatment, forcing physicians to identify the “least bad” alternative, or simply an available treatment option, to keep their patients stable.

CSRO initially worked directly with CGS to address the issue, including coordinating a call to discuss the policy and its impact. When those discussions did not result in a satisfactory resolution, CSRO elevated the issue to senior CMS leadership. CSRO provided CGS and CMS with data demonstrating that subcutaneous Orencia was not readily available to Medicare beneficiaries through Part D, calling into question the assumption that patients could simply transition from IV to the self-administered formulation. CSRO also pointed out that Medicare’s Self-Administered Drug (SAD) List directed practices administering Orencia intravenously to report J0129 with the JA modifier, but did not indicate that providers were also expected to locate a separate CGS fact sheet and satisfy additional medical necessity criteria for IV administration.

Outlook:

While this is an important win for CSRO advocacy, CSRO will continue working with the agency and its contractors to ensure that the issues that led to this situation do not recur, including concerns about how Medicare Administrative Contractors interpret Medicare manual guidance and communicate medical necessity requirements to providers. In the meantime, please let us know if your practice has an ongoing or recent TPE audit involving IV Orencia or continues to experience related claims or coverage issues.