Defining Administration Complexity by the Drug, Not the Diagnosis

The ACR is working to keep biologic drugs accessible to rheumatology patients, defending the ability of rheumatology practices to use the complex chemotherapy codes for administration of biologics. Those codes take into account the complexity of these drugs and the additional time needed for their delivery.

Dr. Snow

“If there is not appropriate reimbursement for the administration of biologic drugs, practices may not be able to continue offering these critical therapies in office,” says Marcus Snow, MD, chair of the ACR Committee on Rheumatologic Care (CORC).

Currently, a number of Medicare contractors (MACs) do not recognize certain biologic drugs as reimbursable under complex administration codes. Instead, they require rheumatology practices to code administration of these drugs under simple/therapeutic codes.

Such policies fail to recognize that biologics, regardless of the disease they are used to treat, are inherently complex and therefore should be reimbursed at the higher rate under the complex administration codes.

An ACR position statement, presented by CORC and sent to key stakeholders in 2019, details the reasons biologics should be reimbursed under complex administration codes, regardless of the specialty using them.

Complexity Determined by the Drug, Not the Diagnosis

According to both Current Procedural Terminology (CPT) and Centers for Medicare & Medicaid Services (CMS) manuals, biologics meet the definitions for chemotherapy services and are reimbursed under complex chemotherapy codes (CPT 96401–96413). As detailed in the ACR’s position statement, the higher reimbursement based on these complex codes takes into account the comprehensive work required to approve, administer and monitor biologics, usually requiring direct physician supervision.

Administration of biologics in rheumatology and other specialties entails the same level of expertise as in oncology to ensure proper and safe use. “The determination of whether it is appropriate to use the complex chemotherapy administration codes is based on the complexity of the drug, not the patient’s diagnosis,” says Dr. Snow.

The ACR’s statement lists the following key positions on biologics:

• Use of biologics should be supervised and carried out by specially trained practitioners with knowledge, training, and experience to properly handle, administer, and monitor biological agents;
• All providers and payers should follow consistent policies for documentation of medical necessity, complex administration protocols, and proper coding and reimbursement for the infusion and injection of biologics;
• All biological agents should be considered highly complex for administration, monitoring, coding, and reimbursement purposes and be covered at an appropriate level by health plans;
• Unique CPT codes are warranted for biologics with separate formulations (such as those administered subcutaneous versus intravenous) given their distinct indications, risks and target populations; and
• Policies on where biologics are administered should promote the highest standards of safety and allow patients to receive treatments in facilities with specialty trained practitioners overseeing their infusion.

To date, however, certain MACs have set policy on coding and reimbursement of biologics in rheumatology by issuing Local Coverage Articles (LCAs) that require rheumatology practices to use the simple/therapeutic code (CPT 96365) for administering biologics, in effect barring the use of complex coding for these drugs. This move by the MACs appears to define complexity more by a patient’s diagnosis (e.g., cancer) than by the complexity of the drug itself.

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.”

If patients are forced to receive these therapies in alternative settings, such as a hospital, she underscores, the additional burden this would place on patients—including additional appointments, more time away from work and higher out-of-pocket costs—could ultimately lead them to miss or discontinue treatment.

Mary Beth Nierengarten is a freelance medical journalist based in Minneapolis.