In June of last year, the Centers for Medicare and Medicaid Services (CMS) issued Transmittal 108321, which specified removal from coverage of 126 “Not Otherwise Specified (NOS)” diagnosis (ICD-10) codes from use under their own National Coverage Determination (NCD) 90.2 for Next Generation Sequencing (NGS). This change was due to go into effect on July 1, 2022.
No planned transitionary phase existed to support this change, and this could have resulted in numerous NGS reimbursement coding errors whereby HCPs continued using these NOS codes. Ultimately, this could have caused an increase in denials following incorrect coding practice and thus leading to patients experiencing delays in treatment.
CMS’s NCD 90.2 has been covering NGS as a diagnostic laboratory test for somatic cancer since March 2018 and for germline cancer since January 2020. To obtain coverage for a somatic cancer, a patient must fall into a well-defined set of criteria for advanced cancer. To obtain coverage for a germline cancer, a patient must have breast or ovarian cancer and have a clinical indication as well as a risk factor for breast or ovarian cancer. In either the somatic or germline case, the patient must not have been previously tested with the same test using NGS for the same cancer genetic content. In either case, the diagnostic test must have a US Food and Drug Administration (FDA) approval or clearance as an in vitro companion diagnostic, as well an FDA-approved or -cleared indication for use in that patient’s cancer. Results must be provided to the treating physician for management of the patient using a report template to specify treatment options.
Seeming as if the above criteria weren’t specific enough, CMS reset the coverage criteria last year through Transmittal 10832 to eliminate NOS diagnosis codes. Vocal industry pushback delayed implementation by a year, and most recently came in the form of a letter to CMS organized by Guardant Health2, with 33 organizations signing the letter, cautioning the agency about the difficulties patients may face in getting properly tested and treated as a result of this decision. Other organizations also aired their concerns.
Several facts were communicated in this collective industry feedback: ICD-10 NOS codes are used for patients with metastatic cancer when the precise location in the organ of the primary cancer remains unknown. These codes are also appropriate post-surgery with recurrence when the primary tumor has been resected and location-specific coding is no longer applicable. Patients with advanced disease are often treated with systemic therapy that doesn’t target a specific location of the body.
Contradictions between CMS’s rulings were highlighted: CMS’s FY2022 IPPS Final Rule3 states that advanced cancer “is an acceptable and necessary use-case for NOS codes because laterality affected might be difficult to determine”. CMS has affirmed that these ICD-10 NOS codes remain valid for other [non-NGS testing] services for the same cancer patients. By issuing NCD 90.2 in 2018, CMS acknowledged that NGS is an important technology for patients with advanced cancer who may benefit from a specific treatment path. Moreover, the CMS ICD-10 Guide (Document SE1518) instructs: “Code to the specificity available to you, and then use unspecified codes. Do not do extra tests to be able to code to more specificity4.”
These ICD-10 NOS codes would remain covered for other services aside from NGS, under Medicare Part A (Including Hospice), Part B and Part D – but no longer covered for NGS. Patients could be put in danger of not receiving targeted therapy.
Diaceutics investigated the potential impact of Transmittal 10832 on cancer patients and on labs:
- A retrospective study of CMS claims from 2021 revealed that more than 3500 cancer patients receiving a NGS test in 2021 would be affected by the retiring of ICD-10 NOS codes. This is approximately 10% of all cancer patients who received an NGS test in 2021.
- Around 1/3 of NGS testing on patients with lung cancer would be affected (Diaceutics recently communicated these findings in a letter to CMS’s Coverage Analysis Group).
- However, there is a much larger potential pool of cancer patients who could receive an NGS test. Diaceutics estimates that because use of NGS is increasing, when looking at the 2021 data we saw that there are approximately 99,000 lung cancer patients who could be eligible for NGS. From the estimate of approximately 1/3 lung cancer patients being affected by retiring these ICD-10 codes, Diaceutics calculated that up to 33,000 patients with advanced or recurrent lung cancer could be affected.
- Retirement of ICD-10 codes does not just affect patients. Diaceutics estimates that as much as $76.5 million in laboratory revenue could potentially be lost because of the retirement of NOS diagnosis codes.
- Due to the analysis methodology, these are conservative estimates and the numbers stated here should be regarded as minimum.
Just last week, the agency made an eleventh-hour decision to rescind Transmittal 10832 and replace it with Transmittal 114535, which specifies continued coverage of these codes. Thanks to the collective and collaborative efforts from Precision Medicine stakeholders, the industry has dodged a bullet. However, Transmittal 11453 also made clear: “CMS continues to strongly encourage providers and laboratories to ensure the best possible and most specific code is provided on the claim in accordance with the implementation of ICD-10 in 2015.” The transmittal also stated:
“CMS will be monitoring these laboratory claims and may take future action to reinstate removal of these ICD-10 NOC codes.”
We are fortunate today in knowing that coverage of Not-Otherwise-Classified diagnosis codes will continue to be covered under the NCD, and patients will not be blocked from receiving the testing and targeted therapy because of what could have been a poorly informed policy decision. However, continued vigilance is warranted.
We encourage discussions to align coding and coverage with disease-associated biomarker status and not just with body site. To lead in this effort, Diaceutics is establishing a policy working group to monitor and report on this and other important policy developments. Interested stakeholders can register for alert updates by joining us on DXRX, the Diagnostic Network®, the world’s first Precision Medicine platform that puts labs and diagnostic testing at the center of the Precision Medicine ecosystem.
Join DXRX and be part of the discussion: DXRX - The Diagnostic Network
For more information, contact [email protected]
2 "Coding Red Tape has Consequences for Patients with Cancer”, Guardant Health NCD 90.2 ICD-10 Coding One Pager
3 Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2022 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Changes to Medicaid Provider Enrollment; and Changes to the Medicare Shared Savings Program. 86 FR 44774. August 13, 2021.