Wednesday, May 5, 2021

CMS Proposes to Delete Coverage of Codes that Drive Care for Lung and Breast Cancer Patients






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?
SE1518 text is matched in the 2021 version of the CMS official ICD10 coding guideline (120pp) - Section I.B.18 - here.  It's also found in sources like the 2021 AHA ICD10 Coding Guide (700pp).

ICD-10 Coding: Lung Cancer
Let's look at coding for lung cancer.  It's anatomically complicated because of the multiple lobes and bronchi.  Similarly, breast cancer coding is complicated, because if the detail is known, you can code to a nodule in any of the 8 quadrants in the two breasts, even if the past is years post mastecomy.

Coding guides developed by certified coders follow conventions and list code levels as "billable" or "non-billable" (here).

As  you open the coding trees and reveal the decimal points, more and more billable codes appear:

The ICD10 principle is that the terms are categories (not billable "codes") if there is an additional digit available.  You need to know the table structure to read if a term is a "category/subcategory" or "code."  For example, Z10.1 is a code if there are no five-digit codes starting Z10.1.   As soon as ICD10 creates Z10.10 and Z10.11, then Z10.1 is itself no longer a code, rather, it is now a category that olds the billable codes Z010.10 + Z10.11.   But the key fact is that when higher levels of specifity are provided, they are not required.  Webbed fingers, left hand, and webbed fingers, right hand, are billable codes, but webbed fingers, hand not specified, is also a billable code if that is the status of the medical record available.  AHA Handbook for ICD10 notes that in some cases, information relevant to early encounters (e.g. needle biopsy of left upper outer breast contract) is no longer relevant (e.g. patient is status post metastectomy of left breast with mets to liver [breast quadrant not specified].)  AHA, 2021, p.38.

The Transmittal

In Transmittal 12124 (zip file therein, here), CMS proposed to delete normally payable cancer codes, codes payable for years under the NCD, if they contain the word "unspecified," even it's buried deep in the diagnosis tree, out in the decimal points that have no impact on care or drug choices.

This makes no sense.  

The codes are listed as payable under standard ICD10 coding conventions, as noted earlier.  The cancer patient's cancer isn't unspecified - it's lung cancer.  The lobe isn't specified - it's upper lobe, for example.   Only a decimal point nuance (position five or six in the code structure) is left flexible.  Details that were not available to the billing laboratory, and which have no impact whatever on coverage (under the rules of the NCD), nor FDA test approval, nor FDA drug approval, nor the oncologist's therapy choice.  

The deletions violate clear instructions in SE1518 - code to the level of detail available.  If the lab has lung cancer, lower lobe, right, they code to that.  If they have lung cancer lower lobe, side not stated [in the lab's document] - they code to that.

Hospital, Hospice, Private Payers, and More

AND - The widely-used codes being deleted on July 1 appear in carefully maintained hospital DRG coding rules at CMS - hereAND - They show up in coding instructions for hospice care - here.  AND - They show up in Blue Cross cancer policies - hereAND -  They show up in United Healthcare policies - here.  And they show up in CMS MAC coverage policies, and so on.

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.