ORIGINAL MAY 5 BLOG BELOW
From time to time, a CMS regulatory change produces unintended consequences much larger than expected. Unless a recent announcement is adapted to make more sense, we’ll have one of those big events on July 1, 2022.
In addition to this blog, I've posted a four minute video explaining what is happening VIDEO HERE.
Coverage for Lung and Breast Cancer Patients Will be Slashed
In a nutshell, CMS controls a patient's eligibility for genomic testing in advanced cancer when FDA-approved tests are used. Some tests are covered for specific cancers (like lung cancer or colon cancer), and other tests are covered for any solid organ cancer (e.g. excluding leukemias and lymphomas). CMS has official instructions on how to code – see document SE1518.
In sharp contrast to the coding instructions provided in SE1518, which require providers to code ICD-10 decimal points only to the level of information available, CMS proposes to delete coverage nearly anywhere that any kind of unspecified term is found - for example, breast cancer, of left breast, and now status post mastectomy - but, quadrant not specified.
These instructions for code deletion contradict not only SE1518, but code lists used by Medicare's own MACs, by private payers, and CMS coding instructions for hospital and hospice care.
Patients Get Denial Notices, Too
Numerous stakeholders are becoming aware of the pending problem - and hope that CMS will delay the instructions to allow administrative review. The denials triggered by these edits won't just affect labs. Patients - or if the patient has died, families - will get the Medicare "explanation of benefit" denials that CMS under Biden has newly, and administratively, reclassified care for the patient's metastatic cancer as not medically necessary.
Deeper Dive - What's Happening
ICD-10 Rules - From CMS Itself
With that background, let's look at what CMS instructions for coding are. I'm going to quote them at length; skip downward once you get the idea. From SE1518:
• Sign/symptom and unspecified codes have acceptable, even necessary, uses. While you should report specific diagnosis codes when they are supported by the available medical record documentation and clinical knowledge of the patient’s health condition, in some instances signs/symptoms or unspecified codes are the best choice to accurately reflect the health care encounter.
• You should code each health care encounter to the level of certainty known for that encounter. If a definitive diagnosis has not been established by the end of the encounter, it is appropriate to report codes for sign(s) and/or symptom(s) in lieu of a definitive diagnosis.
• When sufficient clinical information is not known or available about a particular health condition to assign a more specific code, it is acceptable to report the appropriate unspecified code.
• You should report unspecified codes when such codes most accurately reflect what is known about the patient’s condition…[do not] select a specific code that is not supported by the available medical record documentation, or conduct unnecessary tests to determine a more specific code.
• The level of specificity of the [disease] code will not change the coverage and payment of most services.
- Got it?
What Should Happen
The transmittal should be delayed or deferred for further study, pending further review - a common mechanism for this type of problem at CMS. Alternatively, the instructions could be rescinded retroactively in August or so - withdrawal of a transmittal isn't rare, but in this case, the problem can still be avoided.