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CMS Retains Unspecified Cancer Dx Codes After Industry Stakeholder Feedback


NEW YORK – One year after postponing a decision that would impact reimbursement for certain cancer diagnostic tests, the Centers for Medicare and Medicaid Services has rescinded the original proposal — a move industry stakeholders have pushed for.

A policy note released in March 2021 said the agency would delete certain cancer diagnosis codes from the list of payable codes if the code location was "unspecified," with the decision intended to go into effect on July 1. Two months after the original note, the agency postponed implementation for one year after industry stakeholders said the decision would adversely affect cancer patients' access to testing and treatment. 

The codes under consideration were those covered by the national coverage determination 90.2, which ensures coverage for next-generation sequencing-based tests approved by the US Food and Drug Administration for patients with advanced cancer.

As the deadline for final implementation of the decision drew near earlier this year, those same stakeholders, including diagnostic companies and professional organizations, reiterated their fears that the deletion of the codes would make it more difficult for laboratories to get reimbursed for the codes. But earlier this month, CMS released a transmittal saying it would retain the unspecified codes after feedback from stakeholders.

Unspecified codes under NCD 90.2 are intended for use when a provider has a diagnosis but doesn't know the full details of a patient's condition. If a laboratory knows that the patient has breast cancer of the left breast, for example, but doesn't know which quadrant the cancer is in, an unspecified code may be the best option to submit the claim to a payor. And according to the 2021 CMS ICD-10-CM Official Guidelines for Coding and Reporting, providers should code only to the level of information available — in the case of a laboratory, that would cover what is in the documentation.

"Unspecified codes should be reported when they are the codes that most accurately reflect what is known about the patient's condition at the time of that particular encounter," the guidelines say. "It would be inappropriate to select a specific code that is not supported by the medical record documentation or conduct medically unnecessary diagnostic testing in order to determine a more specific code."

CMS's proposed decision would have been "blocking … perfectly payable codes," reimbursement expert Bruce Quinn said. The codes are flagged as billable, despite not being the most specific possible codes, he said.

If a claim using an unspecified code was denied, it could be resubmitted by providing more information and using a more specific code, but the process would add additional administrative work to a lab's plate.

An agency spokesperson said via email that the original decision was part of CMS's "overarching aim" to cut down on the use of unspecified codes when more specific codes are appropriate. The agency has done this with other NCDs since ICD-10, the official list of medical service and diagnosis codes developed by the World Health Organization, was implemented, since ICD-10 increased the level of "specificity and granularity" in coding, the spokesperson added.

Although the agency is still in support of this mission, it "determined after stakeholder feedback, specifically from the laboratory community, that it would retain the unspecified codes proposed for removal for the present time and further assess the use and frequency of such codes to determine if future actions would be warranted."

In an interview conducted before CMS withdrew its original decision, Mark McCoy, senior VP of reimbursement and client services at Guardant Health, noted that a review by CMS of the agency's Hospital Inpatient Prospective Payment System codes — which cover inpatient services — last summer found that coverage with the same types of use cases would be appropriate. The inpatient setting is where the diagnosis originates, so clinicians would be allowed to order the tests and would be fully paid for treatment of these patients, but outpatient labs wouldn't be covered for conducting a companion diagnostic test covered under NCD 90.2.

This decision would "harm the patient's ability to get optimized treatment," he said, and put the burden of payment on the patient directly.

McCoy added that the laboratory industry supports CMS's quest for further specificity in coding and was merely asking for "parity with all other services."

The CMS decision would not occur in a bubble, he noted. Although the deletion would only apply to Medicare insurance plans, many private payors take their cues from CMS coverage and could have followed suit in deleting coverage of unspecified codes, affecting an even broader swath of patients. 

Providers may also have changed their strategies for treating patients, he said. If an ordering physician recognized that a companion diagnostic test wouldn't be covered, that physician may not have ordered the test at all and missed out on the chance to choose the best treatment for a patient. 

Laboratory professional organizations were also concerned about the potential impact of the decision. In April 2021, the Association for Molecular Pathology wrote a letter to CMS urging the agency to retain the codes because it was concerned the removals would restrict patient access and increase the administrative burden to ensure coverage. 

It said that eliminating general "unspecified" location codes would assume breast cancer only exists in "the usual anatomic locations," ignoring the presence of breast cancer in the chest wall or other locations. 

It also noted that unspecified location codes are appropriate for metastatic patients with cancer of an unknown primary or for patients where the primary disease was resected, so location-specific coding is no longer applicable. 

In an email after the withdrawal was announced, AMP Director of Public Policy and Advocacy Sarah Thibault-Sennett said that over the past year, AMP continued to engage with the agency and provide feedback on the decision. She added that the organization was concerned deletion of these codes would have led to "tens of thousands" of inappropriately denied claims and was "relieved" about the withdrawal.

Susan Van Meter, the American Clinical Laboratory Association's president, also said via email that the organization was "pleased" about CMS's decision. Multiple other labs declined to comment on the record but said via email that they supported the withdrawal. 

CMS is still committed to ensuring specific codes are used, with the agency's spokesperson saying that "this is a continuous process." The spokesperson added that the agency issues quarterly ICD-10 coding updates for its national coverage decisions that could include unspecified codes "that we may or may not retain or include based on careful and thorough review."