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Postponed CMS Proposal Would Remove Unspecified Cancer Dx Codes, Impacting Test Access

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NEW YORK – Just two months after proposing the deletion of unspecified cancer diagnosis codes, the Centers for Medicare and Medicaid Services postponed implementation of the policy for a year after stakeholders noted the potential disruptions to care and test access.

In a policy note released at the end of March, the agency proposed to delete cancer diagnosis codes from the list of payable codes if they contained the word "unspecified" in the description. The deletions were meant to go into effect on July 1.

These unspecified codes allow providers to submit claims to payors without knowing the full detail of a patient's condition, as long as it doesn't impact the actual diagnosis. Many unspecified codes aren't billable, because there are more specific codes related to that code – for example, a code for breast cancer isn't billable, because there are more specific codes for breast cancer of the right or left breast.

Without these codes, providers would receive denials from CMS if they submitted claims using the unspecified codes. Although they could amend the claim and add a more specific code, the resubmission process would take longer and prevent timely payment.

For healthcare advocates, CMS' proposal raised concerns about the repercussions for patients. Kristen Santiago, senior director of public policy initiatives at lung patient advocacy group LUNGevity Foundation, said that removing the unspecified codes could trigger a denial of coverage by an insurer, creating stress and possibly a financial burden for patients and their families.

"Having a patient receive the [denial of coverage] statement can cause a lot of confusion and concern and distress … they don't need," she said, adding that if doctors aren't sure what code to use for this testing, it could discourage them from providing the testing at all.

The proposal also goes against the CMS ICD-10-CM Official Guidelines for Coding and Reporting on how to code for these diagnoses, a healthcare consultant said.

The CMS official guidance says providers should code only to the level of information available. For cancer coding testing, this allows labs to code for what is provided in documentation. In a blog post about the proposal, healthcare consultant Bruce Quinn noted that many labs will have access to what kind of cancer and in what part of the body it is located, such as breast cancer of the left breast or lung cancer in the lower lobe but may not have further information about which quadrant the cancer is in or which side it is on.

According to the guidelines, "when sufficient clinical information isn't known or available about a particular health condition to assign a more specific code, it is acceptable to report the appropriate 'unspecified' code."

The instructions also note that "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," clarifying that "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."

Additional instructions note that the level of specificity of the disease code "will not change the coverage and payment of most services."

The new proposal violates those guidelines, Quinn said in an interview to discuss the change. He added that CMS "has always not liked unspecified codes" and was resistant to changing the proposal. However, for cancer testing coverage specifically, he said knowing the specific quadrant doesn't impact payment for the testing.

Quinn noted that sometimes the full medical record won't allow for a more specific code to be used, providing the example in his follow-up blog post about the postponed proposal that if a recorded location is "breast nodule, mastectomy specimen, left breast, 2 centimeters, 12 o'clock position," it would still require an unspecified code, because it hasn't recorded whether it is located in the upper lateral or upper medial quadrant, which is needed for a more specific code.

He added that the CMS proposal could be harmful to labs that provide cancer testing, and ultimately patients. As long as the test meets the criteria provided in CMS' national coverage decision for next-generation sequencing-based tests approved by the US Food and Drug Administration, it should be covered, Quinn said.

If the codes are deleted, coverage would be disrupted for this testing, and labs may receive denials that they will then have to address with CMS. Cancer patients may also be denied coverage for the tests by their insurers.

While the denials can eventually be reversed if the lab provides more information and recodes the procedure, the process will add a bump in the road for cancer patients receiving care. Quinn noted in his blog post that he had spoken to laboratories that said the changes would trigger denials "for about a third of breast and lung cancer patients," although he declined to identify the labs.

360Dx reached out to about 10 labs for comment. They either declined or were unable to provide comment on deadline.

These codes are also used in hospital and hospice care coding instructions and are found in cancer coverage policies from Blue Cross, United Healthcare, and Medicare Administrative Contractor coverage policies, Quinn said in his post.

Despite the agency's decision to postpone the proposal, "in a year it would create the same problems" if CMS doesn't significantly change the deletions, Quinn said. Luckily, the delay will give stakeholders, including laboratories and cancer patient representative organizations, time to educate CMS about the potential disruptions to testing access and care.

Santiago noted that right now, she has "more questions than answers" about the proposal and that there is a "need for more education" about the problems it could cause. The delay will hopefully allow time for that education, but she echoed Quinn's thoughts, saying the issue "sounds like this will come around again."

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