ICD 11 - Where Is It or Is It Coming?

So here we are post-pandemic such that COVID has become a part of our lives going forward, and the healthcare industry is trying to recover from its effects. But then, along comes the issues with the ransomware attack on Change Healthcare that has roiled many providers for its financial effects. We also see growing regulatory demands on healthcare organizations on a variety of fronts including implementation of the No Surprises Act, facing growing requirements for meeting federal health equity policy requirements, addressing staffing shortages, and facing many other demands. Sounds like a perfect time to ask the question - where is ICD-11?

If you were around from, say 2008 to 2015, you will recall the painful episode that was ICD-10 adoption. After several delays in the compliance date, ICD-10 was finally adopted on October 1, 2015. It also took months (perhaps years) after that of for the smoothing out of ICD-10's disruptive effects on things like medical necessity policies, AHA/industry guidance for proper coding practices. Providers, Health IT developers, and payers alike had to account for the myriad effects that had to be remediated by health information technology for the use of ICD-9 in all sorts of hard coded and embedded ways in programmatic logic and processing routines. I lived this for Cerner as I was intimately involved in our remediation efforts for a number of years for ICD-10 leading up to October 1, 2015. As an aside, I owe a lot to Rose Dunn for providing the most practical guidance in a presentation she did to a Missouri wide HFMA conference I helped organize back in about Fall 2007 on how to get ready for ICD-10. She may not recall that or me, but she gave me insights into how to review ICD-10's impact on all different kinds and layers of use of the code set within a broad range of types of health IT. Her sage guidance shortcut things for me to really understand how broad ICD-10's impact was.

So here we are with ICD-11. ICD-11 was approved by the World Health Organization (WHO) in 2019 for use in illness and death reporting, and there have been extensive discussions in the U.S. about its need for updating of ICD-10 for the way the U.S. uses ICD-10 for diagnosis coding for a wide variety of purposes including as a code set for the Health Insurance Portability and Accountability Act (HIPAA) for Electronic Data Interchange (EDI). In my last several years at Cerner, we tried to predict when we might see rulemaking for ICD-11 as it will require federal regulatory development for it to be adopted as a HIPAA code set; and used in HIPAA electronic administrative transactions. One can rest assured the Office of the National Coordinator for Health IT (ONC) will follow suit with ICD-11 becoming a certification requirement for diagnosis coding which broadens ICD-11's impact. I have been following the proceedings of the National Committee on Vital Health Statistics (NCVHS) as the designated Federal Advisory Committee (FACA) for all things HIPAA to the U.S. Department of Health and Human Services (HHS). Most notably to me, the NCVHS outlined a series of recommendations to the Secretary of HHS in September 2021 for ICD-11. These included recommendations for the Secretary to use his authority to "conduct research to evaluate the impact of different approaches to the transition to and implementation of ICD-11" and to "conduct outreach and communicate regularly to the U.S. healthcare industry about the ICD transition".

No one wants to repeat the painful experience of ICD-10 with its multiple false starts, and repeated compliance delays. My high school AP history teacher, Wayne Wingo (2nd greatest man I ever knew right behind my dad) used to share that throughout history "mobilization means war". If you stand up the troops, you had better be prepared to use them. With ICD-10, we saw HHS stand up the troops multiple times and fail to use them. Congress even intervened once to delay ICD-10 by statute. These multiple delays exhausted and frustrated the industry. They might have seemed helpful at the time, but they also led to many "ready", "set", "wait a minute not yet" moments. My take is that HHS grossly underestimated the breadth, impact, costs, and effort needed to remediate current state practices, Health IT capabilities, and business processes impacted by ICD-10. It never was "just" a billing code set. It was a profoundly impactful code set that affected many things. That was Rose Dunn's point I took back in 2007.

ICD-11 promises to have the same kind of impact. I understand that it should not involve impact for procedure coding (the "other" ICD-10 code set aside from diagnosis coding). I also understand that the jury is out on it impacting "Clinical Modification" (the "CM" in ICD-10-CM) as was necessary for the U.S. realm for ICD-10 diagnosis coding. But I have to assume that ICD-11 will have the same scope of impact as did ICD-10-CM for the use of diagnosis codes broadly. Why would it not? If I were in the same shoes I was in back in 2007, I would conduct gap assessment for ICD-11's impact on the use of all different kinds of Health IT where diagnosis coding is used. I would also assume that given that we are now 9 years on with ICD-10 that one would be wise to investigate for the same gaps caused by how ICD-9 was used over more than 20 years of use. These gaps included the hardwiring of ICD-9 codes into all manners of programmatic logic and setting ICD-9 as a code set default (or again, hardwiring it) for search functions. The gaps also included hardcoding ICD-9 codes as user preferences or favorites for many use cases, in indexes to reference data for everything from surgical procedure kits to order sets, and all kinds of other impacts. I hate to say it but HIT developers and users alike get into all sorts of such habits overtime. Can anyone say Y2K?

So, let's make the sort of prediction I did back in my Cerner days. As we sit here today, we have no proposed rule for ICD-11, and nothing seems imminent as in something coming out this year. There is no ICD-11 item on the regulatory docket at the federal Office of Management and Budget. So, let's say nothing will happen in 2024 to change that state. Let's say for argument we see a proposed rule in the first half of 2025. Then it may follow that we would see a final rule by the end of 2025. As a major HIPAA rule, it would require 26 months from a final rule's formal publication date in the federal register to have a compliance date. That would put the minimum date for ICD-11 out into early 2028. Seems a long way off. However, experience tells me that if I were still where I was, I better at least start laying in plans to do gap analysis now and figure out how to convince my organization to fund gap assessment and impact analysis so I could develop a plan for remediation that could be acted on once proposed rulemaking occurs.

Therein lies the rub that I think the Secretary of HHS has already fouled up by not following the NCVHS recommendations in a more public way. The industry needs clear signal of when, and then it needs sufficient lead time to address ICD-11's requirements. It is no small impact. It cannot be overestimated. Until someone can convincingly tell me different and resolve for such things as will there be a clinical modification to ICD-11 for U.S. implementation as a HIPAA code set, I see no reason to think why this time will be any less impactful for ICD-11 than last time for ICD-10-CM. Just avoid the multiple compliance date resets that exhausted the industry, HHS. Get it right this time.

If you have any desire to reach out to me, debate me, or offer your own opinions on ICD-11 or on other Health IT related regulatory topics, let me know! I am always here for a good robust discussion! Message me on Linked In or e-mail me at [email protected].

Meantime, keep your powder dry! ICD-11 will come.... sometime!

#ICD-11 #HIPAA #HHS #CMS #ONC #ICD-10 #HealthIT