Defining Administration Complexity by the Drug, Not the Diagnosis

Pressure from the ACR

On a conference call in October 2021, ACR leaders asked the Medicare Contractor medical directors to clarify the scientific rationale and criteria used for determining which drugs are reimbursable under the complex administration codes and to permit the continued use of those complex codes for biologic drugs. The medical directors declined to provide criteria to justify their decision making and indicated no plans to change their LCAs.

Dr. Shepherd

Rebecca Shepherd, MD, chair of CORC’s Insurance Subcommittee, points out that LCAs are intended only to clarify existing policy and, unlike Local Coverage Determinations (LCDs), do not offer a formal opportunity for input from stakeholders. As such, the policy by MACs not to recognize complex coding of biologics in rheumatology practices was determined without input from the ACR or the rheumatology community.

“Policies that affect access to rheumatic treatments should be fair, be consistent among CMS regions and involve the input of stakeholders and contractor advisory committee members,” says Dr. Shepherd.

The ACR continues to press hard on MACs to recognize the need for complex coding of biologics administration. At the recent AMA House of Delegates interim meeting, the ACR sponsored a resolution opposing the use of LCAs by MACs to implement policies that directly impact coverage and access of biologics without input from relevant stakeholders. Several other organizations and specialties endorsed the resolution. AMA staff responded that they are actively working on addressing payer policies not informed by proper data and will work with stakeholders to address LCAs that potentially restrict coverage or access.

The ACR is also reaching out to the CMS regarding the lack of objective criteria for determining reimbursement of complex drugs, as well as the lack of transparency in the way policy has been implemented based on LCAs that do not include key stakeholders input.

Patients’ Health at Stake

Much is at stake to get the CMS to recognize the necessity for reimbursing biologic drugs appropriately. “Whether a drug is administered for dermatology, gastroenterology, oncology or rheumatology, reimbursement for intravenous biologics should be consistent across all specialties,” the 2019 position statement reads.

Without recognition that biologics used for rheumatologic indications carry the same complexity and risks as those used for other indications, the great benefits of these drugs may not be fully appreciated. “Downcoding these critical therapies will cause access problems,” says Dr. Shepherd. “Reimbursing these drugs at the lower therapeutic rate is not sufficient to cover the practices’ overhead, and practices may no longer be able to provide the therapies in office.”